evidence-based journal club: an overview
DESCRIPTION
Evidence-Based Journal Club: An Overview. Akbar S oltani MD. Tehran University of Medical Sciences (TUMS) Endocrine and Metabolism Research Center (EMRC) Evidence-Based Medicine Research Center (EBMRC) Shariati Hospita l www.soltaniebm.com www.ebm.ir. Agenda. Introduction and problems - PowerPoint PPT PresentationTRANSCRIPT
EBMRC Dr SOLTANI RDC
Evidence-Based Journal Club An
Overview
Akbar Soltani MDTehran University of Medical Sciences (TUMS)
Endocrine and Metabolism Research Center (EMRC)Evidence-Based Medicine Research Center (EBMRC)
Shariati Hospitalwwwsoltaniebmcom
wwwebmir
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
The ProblemsThe Problems
bull We need information to make decisions We need information to make decisions
bull How oftenHow often
From From 55 times for every times for every in-patientin-patient
To 2 times for every 3 out-patientsTo 2 times for every 3 out-patients
bull We get less than a third of itWe get less than a third of it
bull To keep up to date it is estimatedTo keep up to date it is estimated
I need to read 17 articles a day 365 days a I need to read 17 articles a day 365 days a yearyear
Covell DG Uman GC Manning PR Information needs in office practice Are they being met Ann Intern Med 1985103596-9
EBMRC Dr SOLTANI RDC
Sample scenario
bull In ICU patients do you suggest tight blood glucose control
bull Wrong format
EBMRC Dr SOLTANI RDC
Traditional approach
bull Pathophysiologic approach
bull Recency bias (in a paper that i read last night or a case that i had hellip
bull Rarity bias (complicationshellip)
bull Personal habit bias
bull Territory bias
bull In my experience (selection bias information biashellip)
EBMRC Dr SOLTANI RDC
bull Journal clubs are dying or dead in many clinical centers especially when they rely on a rotating schedule by which members are asked to summarize the latest issues of pre-assigned journals
Traditional journal clubTraditional journal club
bull UsefulnessUsefulnessbull Postman
EBMRC Dr SOLTANI RDC
Information Sources for Use at the Point of Care
Usefulness = Usefulness = Relevance x ValidityRelevance x Validity
WorkWork
POEM
EBM
EBMRC Dr SOLTANI RDC
1Translate these needs into answerable 1Translate these needs into answerable questionsquestions2 2 TrackTrack downdown the best evidence to answer them the best evidence to answer them3 3 AppraiseAppraise that evidence for its validity that evidence for its validity (closeness to the truth) and applicability (closeness to the truth) and applicability (usefulness in our clinical practices)(usefulness in our clinical practices)4Integrate that evidence with our clinical 4Integrate that evidence with our clinical expertise and expertise and applyapply it in practice (MDM) it in practice (MDM)5 5 EvaluateEvaluate our performance our performance
Evidence Based Medicine Evidence Based Medicine
EBMRC Dr SOLTANI RDC
bull Journal club members describe patients who exemplify clinical situations which they are uncertain how best to diagnose or manage
bull This discussion continues until there is consensus that a particular clinical problem is worth the time and effort necessary to find its solution
part 1Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Pt Name Mr XY
Patient Elderly Stroke HTNhellip
Exposure Intervention Carotid Stenosis
(+- comparison)
Outcome Risk of (dying from) recurrent Stroke
Date and Place to be filled
Learner Resident
Discuss Search strategy
Search results
Validity
Importance of the valid results
Can you apply this to your pt
EBMRC Dr SOLTANI RDC
P P Among patients who are Among patients who are in ICU
I I does the use of intensive insulin therapy to maintain tight blood glucose control
C C standard therapy
OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying
Right formatRight format
PICOPICO
EBMRC Dr SOLTANI RDC
The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence
part 2Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession
part 3Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
Evidence Based Journal Club Evidence Based Journal Club part 3
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Definition
bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo
EBMRC Dr SOLTANI RDC
Six Necessary Elements of CATs
bull 1 Date of completion (of the CAT)
bull 2 Question
ndash The person or problem being addressed
ndash The intervention or exposure being considered
ndash The comparison of the intervention or exposure when relevant
ndash The outcomes of interest
bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)
bull 4 Evidence (CAT summary should include a summary of evidence)
bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments
bull 6 Notes (important issues your reflections)
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
The ProblemsThe Problems
bull We need information to make decisions We need information to make decisions
bull How oftenHow often
From From 55 times for every times for every in-patientin-patient
To 2 times for every 3 out-patientsTo 2 times for every 3 out-patients
bull We get less than a third of itWe get less than a third of it
bull To keep up to date it is estimatedTo keep up to date it is estimated
I need to read 17 articles a day 365 days a I need to read 17 articles a day 365 days a yearyear
Covell DG Uman GC Manning PR Information needs in office practice Are they being met Ann Intern Med 1985103596-9
EBMRC Dr SOLTANI RDC
Sample scenario
bull In ICU patients do you suggest tight blood glucose control
bull Wrong format
EBMRC Dr SOLTANI RDC
Traditional approach
bull Pathophysiologic approach
bull Recency bias (in a paper that i read last night or a case that i had hellip
bull Rarity bias (complicationshellip)
bull Personal habit bias
bull Territory bias
bull In my experience (selection bias information biashellip)
EBMRC Dr SOLTANI RDC
bull Journal clubs are dying or dead in many clinical centers especially when they rely on a rotating schedule by which members are asked to summarize the latest issues of pre-assigned journals
Traditional journal clubTraditional journal club
bull UsefulnessUsefulnessbull Postman
EBMRC Dr SOLTANI RDC
Information Sources for Use at the Point of Care
Usefulness = Usefulness = Relevance x ValidityRelevance x Validity
WorkWork
POEM
EBM
EBMRC Dr SOLTANI RDC
1Translate these needs into answerable 1Translate these needs into answerable questionsquestions2 2 TrackTrack downdown the best evidence to answer them the best evidence to answer them3 3 AppraiseAppraise that evidence for its validity that evidence for its validity (closeness to the truth) and applicability (closeness to the truth) and applicability (usefulness in our clinical practices)(usefulness in our clinical practices)4Integrate that evidence with our clinical 4Integrate that evidence with our clinical expertise and expertise and applyapply it in practice (MDM) it in practice (MDM)5 5 EvaluateEvaluate our performance our performance
Evidence Based Medicine Evidence Based Medicine
EBMRC Dr SOLTANI RDC
bull Journal club members describe patients who exemplify clinical situations which they are uncertain how best to diagnose or manage
bull This discussion continues until there is consensus that a particular clinical problem is worth the time and effort necessary to find its solution
part 1Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Pt Name Mr XY
Patient Elderly Stroke HTNhellip
Exposure Intervention Carotid Stenosis
(+- comparison)
Outcome Risk of (dying from) recurrent Stroke
Date and Place to be filled
Learner Resident
Discuss Search strategy
Search results
Validity
Importance of the valid results
Can you apply this to your pt
EBMRC Dr SOLTANI RDC
P P Among patients who are Among patients who are in ICU
I I does the use of intensive insulin therapy to maintain tight blood glucose control
C C standard therapy
OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying
Right formatRight format
PICOPICO
EBMRC Dr SOLTANI RDC
The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence
part 2Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession
part 3Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
Evidence Based Journal Club Evidence Based Journal Club part 3
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Definition
bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo
EBMRC Dr SOLTANI RDC
Six Necessary Elements of CATs
bull 1 Date of completion (of the CAT)
bull 2 Question
ndash The person or problem being addressed
ndash The intervention or exposure being considered
ndash The comparison of the intervention or exposure when relevant
ndash The outcomes of interest
bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)
bull 4 Evidence (CAT summary should include a summary of evidence)
bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments
bull 6 Notes (important issues your reflections)
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
The ProblemsThe Problems
bull We need information to make decisions We need information to make decisions
bull How oftenHow often
From From 55 times for every times for every in-patientin-patient
To 2 times for every 3 out-patientsTo 2 times for every 3 out-patients
bull We get less than a third of itWe get less than a third of it
bull To keep up to date it is estimatedTo keep up to date it is estimated
I need to read 17 articles a day 365 days a I need to read 17 articles a day 365 days a yearyear
Covell DG Uman GC Manning PR Information needs in office practice Are they being met Ann Intern Med 1985103596-9
EBMRC Dr SOLTANI RDC
Sample scenario
bull In ICU patients do you suggest tight blood glucose control
bull Wrong format
EBMRC Dr SOLTANI RDC
Traditional approach
bull Pathophysiologic approach
bull Recency bias (in a paper that i read last night or a case that i had hellip
bull Rarity bias (complicationshellip)
bull Personal habit bias
bull Territory bias
bull In my experience (selection bias information biashellip)
EBMRC Dr SOLTANI RDC
bull Journal clubs are dying or dead in many clinical centers especially when they rely on a rotating schedule by which members are asked to summarize the latest issues of pre-assigned journals
Traditional journal clubTraditional journal club
bull UsefulnessUsefulnessbull Postman
EBMRC Dr SOLTANI RDC
Information Sources for Use at the Point of Care
Usefulness = Usefulness = Relevance x ValidityRelevance x Validity
WorkWork
POEM
EBM
EBMRC Dr SOLTANI RDC
1Translate these needs into answerable 1Translate these needs into answerable questionsquestions2 2 TrackTrack downdown the best evidence to answer them the best evidence to answer them3 3 AppraiseAppraise that evidence for its validity that evidence for its validity (closeness to the truth) and applicability (closeness to the truth) and applicability (usefulness in our clinical practices)(usefulness in our clinical practices)4Integrate that evidence with our clinical 4Integrate that evidence with our clinical expertise and expertise and applyapply it in practice (MDM) it in practice (MDM)5 5 EvaluateEvaluate our performance our performance
Evidence Based Medicine Evidence Based Medicine
EBMRC Dr SOLTANI RDC
bull Journal club members describe patients who exemplify clinical situations which they are uncertain how best to diagnose or manage
bull This discussion continues until there is consensus that a particular clinical problem is worth the time and effort necessary to find its solution
part 1Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Pt Name Mr XY
Patient Elderly Stroke HTNhellip
Exposure Intervention Carotid Stenosis
(+- comparison)
Outcome Risk of (dying from) recurrent Stroke
Date and Place to be filled
Learner Resident
Discuss Search strategy
Search results
Validity
Importance of the valid results
Can you apply this to your pt
EBMRC Dr SOLTANI RDC
P P Among patients who are Among patients who are in ICU
I I does the use of intensive insulin therapy to maintain tight blood glucose control
C C standard therapy
OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying
Right formatRight format
PICOPICO
EBMRC Dr SOLTANI RDC
The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence
part 2Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession
part 3Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
Evidence Based Journal Club Evidence Based Journal Club part 3
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Definition
bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo
EBMRC Dr SOLTANI RDC
Six Necessary Elements of CATs
bull 1 Date of completion (of the CAT)
bull 2 Question
ndash The person or problem being addressed
ndash The intervention or exposure being considered
ndash The comparison of the intervention or exposure when relevant
ndash The outcomes of interest
bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)
bull 4 Evidence (CAT summary should include a summary of evidence)
bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments
bull 6 Notes (important issues your reflections)
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Sample scenario
bull In ICU patients do you suggest tight blood glucose control
bull Wrong format
EBMRC Dr SOLTANI RDC
Traditional approach
bull Pathophysiologic approach
bull Recency bias (in a paper that i read last night or a case that i had hellip
bull Rarity bias (complicationshellip)
bull Personal habit bias
bull Territory bias
bull In my experience (selection bias information biashellip)
EBMRC Dr SOLTANI RDC
bull Journal clubs are dying or dead in many clinical centers especially when they rely on a rotating schedule by which members are asked to summarize the latest issues of pre-assigned journals
Traditional journal clubTraditional journal club
bull UsefulnessUsefulnessbull Postman
EBMRC Dr SOLTANI RDC
Information Sources for Use at the Point of Care
Usefulness = Usefulness = Relevance x ValidityRelevance x Validity
WorkWork
POEM
EBM
EBMRC Dr SOLTANI RDC
1Translate these needs into answerable 1Translate these needs into answerable questionsquestions2 2 TrackTrack downdown the best evidence to answer them the best evidence to answer them3 3 AppraiseAppraise that evidence for its validity that evidence for its validity (closeness to the truth) and applicability (closeness to the truth) and applicability (usefulness in our clinical practices)(usefulness in our clinical practices)4Integrate that evidence with our clinical 4Integrate that evidence with our clinical expertise and expertise and applyapply it in practice (MDM) it in practice (MDM)5 5 EvaluateEvaluate our performance our performance
Evidence Based Medicine Evidence Based Medicine
EBMRC Dr SOLTANI RDC
bull Journal club members describe patients who exemplify clinical situations which they are uncertain how best to diagnose or manage
bull This discussion continues until there is consensus that a particular clinical problem is worth the time and effort necessary to find its solution
part 1Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Pt Name Mr XY
Patient Elderly Stroke HTNhellip
Exposure Intervention Carotid Stenosis
(+- comparison)
Outcome Risk of (dying from) recurrent Stroke
Date and Place to be filled
Learner Resident
Discuss Search strategy
Search results
Validity
Importance of the valid results
Can you apply this to your pt
EBMRC Dr SOLTANI RDC
P P Among patients who are Among patients who are in ICU
I I does the use of intensive insulin therapy to maintain tight blood glucose control
C C standard therapy
OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying
Right formatRight format
PICOPICO
EBMRC Dr SOLTANI RDC
The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence
part 2Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession
part 3Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
Evidence Based Journal Club Evidence Based Journal Club part 3
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Definition
bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo
EBMRC Dr SOLTANI RDC
Six Necessary Elements of CATs
bull 1 Date of completion (of the CAT)
bull 2 Question
ndash The person or problem being addressed
ndash The intervention or exposure being considered
ndash The comparison of the intervention or exposure when relevant
ndash The outcomes of interest
bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)
bull 4 Evidence (CAT summary should include a summary of evidence)
bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments
bull 6 Notes (important issues your reflections)
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Traditional approach
bull Pathophysiologic approach
bull Recency bias (in a paper that i read last night or a case that i had hellip
bull Rarity bias (complicationshellip)
bull Personal habit bias
bull Territory bias
bull In my experience (selection bias information biashellip)
EBMRC Dr SOLTANI RDC
bull Journal clubs are dying or dead in many clinical centers especially when they rely on a rotating schedule by which members are asked to summarize the latest issues of pre-assigned journals
Traditional journal clubTraditional journal club
bull UsefulnessUsefulnessbull Postman
EBMRC Dr SOLTANI RDC
Information Sources for Use at the Point of Care
Usefulness = Usefulness = Relevance x ValidityRelevance x Validity
WorkWork
POEM
EBM
EBMRC Dr SOLTANI RDC
1Translate these needs into answerable 1Translate these needs into answerable questionsquestions2 2 TrackTrack downdown the best evidence to answer them the best evidence to answer them3 3 AppraiseAppraise that evidence for its validity that evidence for its validity (closeness to the truth) and applicability (closeness to the truth) and applicability (usefulness in our clinical practices)(usefulness in our clinical practices)4Integrate that evidence with our clinical 4Integrate that evidence with our clinical expertise and expertise and applyapply it in practice (MDM) it in practice (MDM)5 5 EvaluateEvaluate our performance our performance
Evidence Based Medicine Evidence Based Medicine
EBMRC Dr SOLTANI RDC
bull Journal club members describe patients who exemplify clinical situations which they are uncertain how best to diagnose or manage
bull This discussion continues until there is consensus that a particular clinical problem is worth the time and effort necessary to find its solution
part 1Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Pt Name Mr XY
Patient Elderly Stroke HTNhellip
Exposure Intervention Carotid Stenosis
(+- comparison)
Outcome Risk of (dying from) recurrent Stroke
Date and Place to be filled
Learner Resident
Discuss Search strategy
Search results
Validity
Importance of the valid results
Can you apply this to your pt
EBMRC Dr SOLTANI RDC
P P Among patients who are Among patients who are in ICU
I I does the use of intensive insulin therapy to maintain tight blood glucose control
C C standard therapy
OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying
Right formatRight format
PICOPICO
EBMRC Dr SOLTANI RDC
The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence
part 2Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession
part 3Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
Evidence Based Journal Club Evidence Based Journal Club part 3
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Definition
bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo
EBMRC Dr SOLTANI RDC
Six Necessary Elements of CATs
bull 1 Date of completion (of the CAT)
bull 2 Question
ndash The person or problem being addressed
ndash The intervention or exposure being considered
ndash The comparison of the intervention or exposure when relevant
ndash The outcomes of interest
bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)
bull 4 Evidence (CAT summary should include a summary of evidence)
bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments
bull 6 Notes (important issues your reflections)
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
bull Journal clubs are dying or dead in many clinical centers especially when they rely on a rotating schedule by which members are asked to summarize the latest issues of pre-assigned journals
Traditional journal clubTraditional journal club
bull UsefulnessUsefulnessbull Postman
EBMRC Dr SOLTANI RDC
Information Sources for Use at the Point of Care
Usefulness = Usefulness = Relevance x ValidityRelevance x Validity
WorkWork
POEM
EBM
EBMRC Dr SOLTANI RDC
1Translate these needs into answerable 1Translate these needs into answerable questionsquestions2 2 TrackTrack downdown the best evidence to answer them the best evidence to answer them3 3 AppraiseAppraise that evidence for its validity that evidence for its validity (closeness to the truth) and applicability (closeness to the truth) and applicability (usefulness in our clinical practices)(usefulness in our clinical practices)4Integrate that evidence with our clinical 4Integrate that evidence with our clinical expertise and expertise and applyapply it in practice (MDM) it in practice (MDM)5 5 EvaluateEvaluate our performance our performance
Evidence Based Medicine Evidence Based Medicine
EBMRC Dr SOLTANI RDC
bull Journal club members describe patients who exemplify clinical situations which they are uncertain how best to diagnose or manage
bull This discussion continues until there is consensus that a particular clinical problem is worth the time and effort necessary to find its solution
part 1Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Pt Name Mr XY
Patient Elderly Stroke HTNhellip
Exposure Intervention Carotid Stenosis
(+- comparison)
Outcome Risk of (dying from) recurrent Stroke
Date and Place to be filled
Learner Resident
Discuss Search strategy
Search results
Validity
Importance of the valid results
Can you apply this to your pt
EBMRC Dr SOLTANI RDC
P P Among patients who are Among patients who are in ICU
I I does the use of intensive insulin therapy to maintain tight blood glucose control
C C standard therapy
OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying
Right formatRight format
PICOPICO
EBMRC Dr SOLTANI RDC
The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence
part 2Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession
part 3Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
Evidence Based Journal Club Evidence Based Journal Club part 3
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Definition
bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo
EBMRC Dr SOLTANI RDC
Six Necessary Elements of CATs
bull 1 Date of completion (of the CAT)
bull 2 Question
ndash The person or problem being addressed
ndash The intervention or exposure being considered
ndash The comparison of the intervention or exposure when relevant
ndash The outcomes of interest
bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)
bull 4 Evidence (CAT summary should include a summary of evidence)
bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments
bull 6 Notes (important issues your reflections)
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Information Sources for Use at the Point of Care
Usefulness = Usefulness = Relevance x ValidityRelevance x Validity
WorkWork
POEM
EBM
EBMRC Dr SOLTANI RDC
1Translate these needs into answerable 1Translate these needs into answerable questionsquestions2 2 TrackTrack downdown the best evidence to answer them the best evidence to answer them3 3 AppraiseAppraise that evidence for its validity that evidence for its validity (closeness to the truth) and applicability (closeness to the truth) and applicability (usefulness in our clinical practices)(usefulness in our clinical practices)4Integrate that evidence with our clinical 4Integrate that evidence with our clinical expertise and expertise and applyapply it in practice (MDM) it in practice (MDM)5 5 EvaluateEvaluate our performance our performance
Evidence Based Medicine Evidence Based Medicine
EBMRC Dr SOLTANI RDC
bull Journal club members describe patients who exemplify clinical situations which they are uncertain how best to diagnose or manage
bull This discussion continues until there is consensus that a particular clinical problem is worth the time and effort necessary to find its solution
part 1Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Pt Name Mr XY
Patient Elderly Stroke HTNhellip
Exposure Intervention Carotid Stenosis
(+- comparison)
Outcome Risk of (dying from) recurrent Stroke
Date and Place to be filled
Learner Resident
Discuss Search strategy
Search results
Validity
Importance of the valid results
Can you apply this to your pt
EBMRC Dr SOLTANI RDC
P P Among patients who are Among patients who are in ICU
I I does the use of intensive insulin therapy to maintain tight blood glucose control
C C standard therapy
OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying
Right formatRight format
PICOPICO
EBMRC Dr SOLTANI RDC
The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence
part 2Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession
part 3Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
Evidence Based Journal Club Evidence Based Journal Club part 3
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Definition
bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo
EBMRC Dr SOLTANI RDC
Six Necessary Elements of CATs
bull 1 Date of completion (of the CAT)
bull 2 Question
ndash The person or problem being addressed
ndash The intervention or exposure being considered
ndash The comparison of the intervention or exposure when relevant
ndash The outcomes of interest
bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)
bull 4 Evidence (CAT summary should include a summary of evidence)
bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments
bull 6 Notes (important issues your reflections)
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
1Translate these needs into answerable 1Translate these needs into answerable questionsquestions2 2 TrackTrack downdown the best evidence to answer them the best evidence to answer them3 3 AppraiseAppraise that evidence for its validity that evidence for its validity (closeness to the truth) and applicability (closeness to the truth) and applicability (usefulness in our clinical practices)(usefulness in our clinical practices)4Integrate that evidence with our clinical 4Integrate that evidence with our clinical expertise and expertise and applyapply it in practice (MDM) it in practice (MDM)5 5 EvaluateEvaluate our performance our performance
Evidence Based Medicine Evidence Based Medicine
EBMRC Dr SOLTANI RDC
bull Journal club members describe patients who exemplify clinical situations which they are uncertain how best to diagnose or manage
bull This discussion continues until there is consensus that a particular clinical problem is worth the time and effort necessary to find its solution
part 1Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Pt Name Mr XY
Patient Elderly Stroke HTNhellip
Exposure Intervention Carotid Stenosis
(+- comparison)
Outcome Risk of (dying from) recurrent Stroke
Date and Place to be filled
Learner Resident
Discuss Search strategy
Search results
Validity
Importance of the valid results
Can you apply this to your pt
EBMRC Dr SOLTANI RDC
P P Among patients who are Among patients who are in ICU
I I does the use of intensive insulin therapy to maintain tight blood glucose control
C C standard therapy
OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying
Right formatRight format
PICOPICO
EBMRC Dr SOLTANI RDC
The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence
part 2Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession
part 3Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
Evidence Based Journal Club Evidence Based Journal Club part 3
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Definition
bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo
EBMRC Dr SOLTANI RDC
Six Necessary Elements of CATs
bull 1 Date of completion (of the CAT)
bull 2 Question
ndash The person or problem being addressed
ndash The intervention or exposure being considered
ndash The comparison of the intervention or exposure when relevant
ndash The outcomes of interest
bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)
bull 4 Evidence (CAT summary should include a summary of evidence)
bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments
bull 6 Notes (important issues your reflections)
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
bull Journal club members describe patients who exemplify clinical situations which they are uncertain how best to diagnose or manage
bull This discussion continues until there is consensus that a particular clinical problem is worth the time and effort necessary to find its solution
part 1Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Pt Name Mr XY
Patient Elderly Stroke HTNhellip
Exposure Intervention Carotid Stenosis
(+- comparison)
Outcome Risk of (dying from) recurrent Stroke
Date and Place to be filled
Learner Resident
Discuss Search strategy
Search results
Validity
Importance of the valid results
Can you apply this to your pt
EBMRC Dr SOLTANI RDC
P P Among patients who are Among patients who are in ICU
I I does the use of intensive insulin therapy to maintain tight blood glucose control
C C standard therapy
OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying
Right formatRight format
PICOPICO
EBMRC Dr SOLTANI RDC
The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence
part 2Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession
part 3Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
Evidence Based Journal Club Evidence Based Journal Club part 3
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Definition
bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo
EBMRC Dr SOLTANI RDC
Six Necessary Elements of CATs
bull 1 Date of completion (of the CAT)
bull 2 Question
ndash The person or problem being addressed
ndash The intervention or exposure being considered
ndash The comparison of the intervention or exposure when relevant
ndash The outcomes of interest
bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)
bull 4 Evidence (CAT summary should include a summary of evidence)
bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments
bull 6 Notes (important issues your reflections)
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Pt Name Mr XY
Patient Elderly Stroke HTNhellip
Exposure Intervention Carotid Stenosis
(+- comparison)
Outcome Risk of (dying from) recurrent Stroke
Date and Place to be filled
Learner Resident
Discuss Search strategy
Search results
Validity
Importance of the valid results
Can you apply this to your pt
EBMRC Dr SOLTANI RDC
P P Among patients who are Among patients who are in ICU
I I does the use of intensive insulin therapy to maintain tight blood glucose control
C C standard therapy
OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying
Right formatRight format
PICOPICO
EBMRC Dr SOLTANI RDC
The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence
part 2Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession
part 3Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
Evidence Based Journal Club Evidence Based Journal Club part 3
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Definition
bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo
EBMRC Dr SOLTANI RDC
Six Necessary Elements of CATs
bull 1 Date of completion (of the CAT)
bull 2 Question
ndash The person or problem being addressed
ndash The intervention or exposure being considered
ndash The comparison of the intervention or exposure when relevant
ndash The outcomes of interest
bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)
bull 4 Evidence (CAT summary should include a summary of evidence)
bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments
bull 6 Notes (important issues your reflections)
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Pt Name Mr XY
Patient Elderly Stroke HTNhellip
Exposure Intervention Carotid Stenosis
(+- comparison)
Outcome Risk of (dying from) recurrent Stroke
Date and Place to be filled
Learner Resident
Discuss Search strategy
Search results
Validity
Importance of the valid results
Can you apply this to your pt
EBMRC Dr SOLTANI RDC
P P Among patients who are Among patients who are in ICU
I I does the use of intensive insulin therapy to maintain tight blood glucose control
C C standard therapy
OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying
Right formatRight format
PICOPICO
EBMRC Dr SOLTANI RDC
The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence
part 2Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession
part 3Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
Evidence Based Journal Club Evidence Based Journal Club part 3
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Definition
bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo
EBMRC Dr SOLTANI RDC
Six Necessary Elements of CATs
bull 1 Date of completion (of the CAT)
bull 2 Question
ndash The person or problem being addressed
ndash The intervention or exposure being considered
ndash The comparison of the intervention or exposure when relevant
ndash The outcomes of interest
bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)
bull 4 Evidence (CAT summary should include a summary of evidence)
bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments
bull 6 Notes (important issues your reflections)
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
P P Among patients who are Among patients who are in ICU
I I does the use of intensive insulin therapy to maintain tight blood glucose control
C C standard therapy
OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying
Right formatRight format
PICOPICO
EBMRC Dr SOLTANI RDC
The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence
part 2Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession
part 3Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
Evidence Based Journal Club Evidence Based Journal Club part 3
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Definition
bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo
EBMRC Dr SOLTANI RDC
Six Necessary Elements of CATs
bull 1 Date of completion (of the CAT)
bull 2 Question
ndash The person or problem being addressed
ndash The intervention or exposure being considered
ndash The comparison of the intervention or exposure when relevant
ndash The outcomes of interest
bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)
bull 4 Evidence (CAT summary should include a summary of evidence)
bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments
bull 6 Notes (important issues your reflections)
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence
part 2Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession
part 3Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
Evidence Based Journal Club Evidence Based Journal Club part 3
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Definition
bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo
EBMRC Dr SOLTANI RDC
Six Necessary Elements of CATs
bull 1 Date of completion (of the CAT)
bull 2 Question
ndash The person or problem being addressed
ndash The intervention or exposure being considered
ndash The comparison of the intervention or exposure when relevant
ndash The outcomes of interest
bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)
bull 4 Evidence (CAT summary should include a summary of evidence)
bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments
bull 6 Notes (important issues your reflections)
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession
part 3Evidence based journal clubEvidence based journal club
EBMRC Dr SOLTANI RDC
Evidence Based Journal Club Evidence Based Journal Club part 3
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Definition
bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo
EBMRC Dr SOLTANI RDC
Six Necessary Elements of CATs
bull 1 Date of completion (of the CAT)
bull 2 Question
ndash The person or problem being addressed
ndash The intervention or exposure being considered
ndash The comparison of the intervention or exposure when relevant
ndash The outcomes of interest
bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)
bull 4 Evidence (CAT summary should include a summary of evidence)
bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments
bull 6 Notes (important issues your reflections)
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Evidence Based Journal Club Evidence Based Journal Club part 3
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Definition
bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo
EBMRC Dr SOLTANI RDC
Six Necessary Elements of CATs
bull 1 Date of completion (of the CAT)
bull 2 Question
ndash The person or problem being addressed
ndash The intervention or exposure being considered
ndash The comparison of the intervention or exposure when relevant
ndash The outcomes of interest
bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)
bull 4 Evidence (CAT summary should include a summary of evidence)
bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments
bull 6 Notes (important issues your reflections)
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Definition
bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo
EBMRC Dr SOLTANI RDC
Six Necessary Elements of CATs
bull 1 Date of completion (of the CAT)
bull 2 Question
ndash The person or problem being addressed
ndash The intervention or exposure being considered
ndash The comparison of the intervention or exposure when relevant
ndash The outcomes of interest
bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)
bull 4 Evidence (CAT summary should include a summary of evidence)
bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments
bull 6 Notes (important issues your reflections)
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Definition
bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo
EBMRC Dr SOLTANI RDC
Six Necessary Elements of CATs
bull 1 Date of completion (of the CAT)
bull 2 Question
ndash The person or problem being addressed
ndash The intervention or exposure being considered
ndash The comparison of the intervention or exposure when relevant
ndash The outcomes of interest
bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)
bull 4 Evidence (CAT summary should include a summary of evidence)
bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments
bull 6 Notes (important issues your reflections)
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Six Necessary Elements of CATs
bull 1 Date of completion (of the CAT)
bull 2 Question
ndash The person or problem being addressed
ndash The intervention or exposure being considered
ndash The comparison of the intervention or exposure when relevant
ndash The outcomes of interest
bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)
bull 4 Evidence (CAT summary should include a summary of evidence)
bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments
bull 6 Notes (important issues your reflections)
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Bottom line read in seconds
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Declarative title
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Get bottom line quickly (seconds)
Tight blood glucose control improves ICU survival
For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)
Increased risk of biochemical but not symptomatic hypoglycaemia
Level 1+ evidence
Summary of treatment effect and level of evidence
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Citation details and search strategy read in hours
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Read the study (for hours)
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Hyperlink to journal web site
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)
Search terms used for reference and to repeat in future
Read the study (for hours)
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Trial details read in minutes
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Key design validity features
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
The Study Single-blinded randomised controlled trial with intention-to-treat
The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care
Intervention (s)
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Outcome (s) of interest
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Control group event rate Experimental group event rate
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Relative risk reduction Absolute risk reduction
Negative risk reduction = an increase
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Read trial details (minutes)
Outcome Time to outcome
CER EER RRR ARR NNT
Mortality ICU 63783
008
35765
0046
43 0034 29
95 Confidence Intervals 001 to 0058
17 to 101
Hypoglycaemia
(biochemical)
ICU 6783
0008
39765
0059
-61 -0043 -23
95 Confidence Intervals -006 to
-0026-38 to
-17
Number needed to treat to benefit
Number needed to treat to harm
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Particularised for your own practice integrate with your expertise
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could
this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ
failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for
normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG
recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated
protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical
complications7 We have a higher MR death (and death due to sepsis) is more
common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Antioxidant vitamins did not reduce death vascular events or cancer in
high risk patients
presenter endocrine fellowsEMRC
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Q
bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Design
bull RCT
bull Blinded
bull FU 5 y
bull Setting 69 UK hospitals
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Patients
bull 20536 patients who were 40-80y(28were gt70y 75men)
bull Total cholestrol gt35mmoll
bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Exclusion Criteria
bull Indication of statin therapy
bull Abnormal LFT or RFT
bull Severe heart failure
bull COPD
bull Cancer
bull Indication Of high dose vitamin E
fu 997
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Intervention
bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd
(n=10269)
bull Placebo(10267)
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Outcome
bull All causevascular or non vascular mortality
bull Secondary outcomecoronary(non fatal MI or death from CHD)
stroke
revascularisation
cancer
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Main results
bull Antioxidants did not differ from placebo for any outcome
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRI
(95CI)NNH
All cause mortality
141 1354
(-3_12)Not significant
Vascular
Mortality 86 82
5
(-5_15)Not significant
Non vas
Mortality 55 53
4
(-8_17)Not significant
Major coronary event
104 1022
(-6_11)Not significant
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Outcome Vitamins PlaceboRRR
(95CI)NNT
Stroke 5 51
(-12_13)
Not significant
Revascularisation
103 1062
(-6_10)
Not significant
Cancer 78 8
2
(-8_11)
Not significant
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Conclusion
Antioxidants did not reduce mortality
coronary events
stroke
revascularization or
cancer
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
In the name of godJournal club
Dr hasani ranjbarsh21 Jan 2006
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
The New England Journalof Medicine
3505wwwnejmorg january
29 2004
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Q In postmenopausal women with osteoporosis is strontium ranelate
more effective than placebo for reducing the risk of vertebral fractures
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Designrandomized controlled trial Follow up3 Y
Blinded (patients and healthcare providers)
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2
Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years
(casen=828)and(controln=821)
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Outcomebull New vertebral fracture the semiquantitative
grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more
bull Non vertebral fracture andbull BMD (spine and proximal femur)
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than
in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of
144 percent 83 percent and 98 percent
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Outcome Strontium PlaceboRRR
(95CI)
NNT
(CI)
New V Fx 21 3336
(24-47)
9
(7-14)
Vertebral Height Lossgt1cm
30 37520
(7-31)
14
(9-40)
Non Vertebral
Fx16 17
8
(-17-27)
Not
significant
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
ConclusionStrontium ranelate ingested daily reduced the
risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Commentarybull 2 trials (PREVOS and SOTI)showed that strontium
increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric
vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y
bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)
5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21
months of treatment
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
CAT Ferritin can diagnose iron deficiency in the elderly
Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly
Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of
80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her
probability of iron deficiency is 1 out of 2 or 50
Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted
Example Diagnosis
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a
great single study and an overview
Appraised by Sackett in the CEBM Oxford Friday July 09 1999
The study
Independent hellip Yes
Blind hellip Yes
Standard applied regardless of test result hellip Yes
Appropriate spectrum hellip Canrsquot tell
Target disorder and gold standard Bone marrow stained for iron
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded
Diagnostic test Serum ferritin by radioimmunoassay
The evidence
Present Absent
Test result No Prop No Prop LR
lt 15 474 059 20 001 5185
15ndash34 175 022 79 004 485
35ndash64 82 010 171 011 105
65ndash94 30 004 168 009 039
95 48 006 1332 075 008
Comments
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)
A one page summaryA one page summary
bull Declarative titleDeclarative title
bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting
bull PatientsPatients
bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and
ConclusionConclusion
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)
Making Your PresentationMaking Your Presentation
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario
bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature
bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al
bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process
bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance
bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files
Goals for Journal Club Goals for Journal Club
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Agenda
bull Introduction and problems
bull Conventional Vs Evidence-Based Journal club
bull What is CAT
bull Examples
bull Goals for journal club
bull Limitations of CATs
bull Summary
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Limitations bull 1048698First is the limited applicability of individual CAT
ndashCreated in busy practice
ndashIt is a single piece of evidence summarized
ndashIncomplete non-representative of the entire body of evidence
bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review
ndashMay contain inferior evidence or errors of fact calculation or interpretation
bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Bottom LineBottom Line
1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)
2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation
Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work
3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
EBMRC Dr SOLTANI RDC
Thank you
EBMRC Dr SOLTANI RDC
Thank you