g. biondi zoccai – ricerca in cardiologia what to expect? core modules introductionintroduction...

G. Biondi Zoccai – Ricerca in cardiologia

What to expect?

Core modules

• IntroductionIntroduction• Finding out relevant literatureFinding out relevant literature• General guidelines for literature appraisalGeneral guidelines for literature appraisal• Abstract and Introduction appraisalAbstract and Introduction appraisal• Methods and Results appraisal 1Methods and Results appraisal 1 - - Patients and proceduresPatients and procedures

• Methods and Results appraisal 2Methods and Results appraisal 2 - - Data collection/management and Data collection/management and

descriptive analysisdescriptive analysis

• Methods and Results appraisal 3Methods and Results appraisal 3 - - Inferential analysisInferential analysis

• Discussion and Conclusions appraisalDiscussion and Conclusions appraisal

CONSORT statementCONSORT statement

Moher JAMA 2001

STARD guidelinesSTARD guidelines

QUADAS guidelinesQUADAS guidelines

Whiting BMCMRM 2003

QUOROM statementQUOROM statement

MOOSEMOOSE

Stroup JAMA 2000

MOOSEMOOSE

The EBM 3-step approachThe EBM 3-step approach

Appraising and using an article from Appraising and using an article from the medical literature in three steps: the medical literature in three steps:

Step 1Step 1 – Are the results of the study (internally) valid? – Are the results of the study (internally) valid?

Step 2Step 2 – What are the results? – What are the results?

Step 3Step 3 – How can I apply these results to patient care? – How can I apply these results to patient care?

Articles about therapyArticles about therapy

• Are the results valid?Are the results valid?Did experimental and control groups begin the study with a Did experimental and control groups begin the study with a

similar prognosis?similar prognosis?• Were pts randomized?Were pts randomized?• Was randomization concealed?Was randomization concealed?• Were pts analyzed in the groups to which they were Were pts analyzed in the groups to which they were

randomized?randomized?• Were pts in the treatment and control groups similar with Were pts in the treatment and control groups similar with

respect to known prognostic factors?respect to known prognostic factors?Did experimental and control groups retain a similar prognosis Did experimental and control groups retain a similar prognosis

after the study started?after the study started?• Were pts aware of group allocation?Were pts aware of group allocation?• Were clinicians aware of group allocation?Were clinicians aware of group allocation?• Were outcome assessors aware of group allocation?Were outcome assessors aware of group allocation?• Was follow-up complete?Was follow-up complete?

• What are the results?What are the results?

• How large was the treatment effect?How large was the treatment effect?• How precise was the estimate of the treatment effect?How precise was the estimate of the treatment effect?

• How can I apply the results to patient care?How can I apply the results to patient care?

• Were the study patients similar to my patient?Were the study patients similar to my patient?• Were all clinically important outcomes considered?Were all clinically important outcomes considered?• Are the likely treatment benefits worth the potential harm and Are the likely treatment benefits worth the potential harm and

costs?costs?

Ardissino JAMA 2004

costs?costs?

Internal validity appraisalInternal validity appraisalaccording to The Cochrane Collaborationaccording to The Cochrane Collaboration

http://www.cochrane.org

4 MAIN TYPE OF BIAS POTENTIALLY UNDERMINING RCTs4 MAIN TYPE OF BIAS POTENTIALLY UNDERMINING RCTs

• Ascertainment biasAscertainment biasNon-uniform adjudication of eventsNon-uniform adjudication of events

• Attrition biasAttrition biasNon-uniform follow-up or compliance to treatmentNon-uniform follow-up or compliance to treatment

• Performance biasPerformance biasNon-uniform performance of corollary treatmentsNon-uniform performance of corollary treatments

• Selection biasSelection biasThe non-random allocation of pts one of the treatment groupsThe non-random allocation of pts one of the treatment groups

Articles about harmArticles about harm

• Are the results valid?Are the results valid?

Did experimental and control groups begin the study with a Did experimental and control groups begin the study with a similar prognosis?similar prognosis?

• Did the investigators demonstrate similarity in all known Did the investigators demonstrate similarity in all known determinants of outcome; did they adjust for differences in the determinants of outcome; did they adjust for differences in the analysis?analysis?

• Were exposed patients equally likely to be identified in the Were exposed patients equally likely to be identified in the two groups?two groups?

Did experimental and control groups retain a similar prognosis Did experimental and control groups retain a similar prognosis after the study started?after the study started?

• Were the outcomes measured in the same way in the groups Were the outcomes measured in the same way in the groups being compared?being compared?

• Was follow-up sufficiently complete?Was follow-up sufficiently complete?

• How strong is the association between exposure and How strong is the association between exposure and outcome?outcome?

• How precise is the estimate of the risk?How precise is the estimate of the risk?

• Were the study patients similar to the patient under Were the study patients similar to the patient under consideration in my practice?consideration in my practice?

• Was the duration of follow-up adequate?Was the duration of follow-up adequate?• What was the magnitude of risk?What was the magnitude of risk?• Should I attempt to stop the exposure?Should I attempt to stop the exposure?

GrahamLancet 2005

Graham Lancet 2005

GrahamLancet 2005

Articles about diagnostic testingArticles about diagnostic testing

• Are the results valid?Are the results valid?• Did clinicians face diagnostic uncertainty?Did clinicians face diagnostic uncertainty?• Was there a blind comparison between the test and an Was there a blind comparison between the test and an

independent gold standard?independent gold standard?• Did the results being evaluated influence the decision to Did the results being evaluated influence the decision to

perform the gold standard?perform the gold standard?

• What are the results?What are the results?• What likelihood ratios were associated with the range of What likelihood ratios were associated with the range of

possible test results?possible test results?

• How can I apply the results to patient care?How can I apply the results to patient care?• Will the reproducibility of the test result and its interpretation Will the reproducibility of the test result and its interpretation

be satisfactory in my clinical setting?be satisfactory in my clinical setting?• Are the results applicable to the pts in my practice?Are the results applicable to the pts in my practice?• Will the results change my management strategy?Will the results change my management strategy?• Will pts be better off as a result of the test?Will pts be better off as a result of the test?

Articles about prognosisArticles about prognosis

• Are the results valid?Are the results valid?• Was the sample of patients representative?Was the sample of patients representative?• Were the pts sufficiently homogeneous with respect to Were the pts sufficiently homogeneous with respect to

prognostic risk?prognostic risk?• Was follow-up sufficiently complete?Was follow-up sufficiently complete?• Were objective and unbiased outcome criteria used?Were objective and unbiased outcome criteria used?

• What are the results?What are the results?• How likely are the outcomes over time?How likely are the outcomes over time?• How precise are the estimates of likelihood?How precise are the estimates of likelihood?

• How can I apply the results to patient care?How can I apply the results to patient care?• Were the study pts and their management similar to those in Were the study pts and their management similar to those in

my clinical practice?my clinical practice?• Was the follow-up sufficiently long?Was the follow-up sufficiently long?• Can I use the results in managing pts of my practice?Can I use the results in managing pts of my practice?

Review articlesReview articles

• Are the results valid?Are the results valid?• Did the review explicitly address a sensible clinical question?Did the review explicitly address a sensible clinical question?• Was the search for relevant studies detailed and exhaustive?Was the search for relevant studies detailed and exhaustive?• Were the primary studies of high methodological quality?Were the primary studies of high methodological quality?• Were assessments of studies reproducible?Were assessments of studies reproducible?

• What are the results?What are the results?• Were the results similar from study to study?Were the results similar from study to study?• What are the overall results of the review?What are the overall results of the review?• How precise were the results?How precise were the results?

• How can I apply the results to patient care?How can I apply the results to patient care?• How can I best interpret the results to apply them to the care How can I best interpret the results to apply them to the care

of patients in my practice?of patients in my practice?• Were all clinically relevant outcomes considered?Were all clinically relevant outcomes considered?• Are the benefits worth the costs and potential risks?Are the benefits worth the costs and potential risks?

Treatment guidelines and decision analysesTreatment guidelines and decision analyses

• Did the recommendations consider all relevant patient Did the recommendations consider all relevant patient groups, management options, and possible outcomes?groups, management options, and possible outcomes?

• Is there a systematic review of evidence linking options Is there a systematic review of evidence linking options for each relevant question?for each relevant question?

• Is there an appropriate specification of values or Is there an appropriate specification of values or preferences associated with outcomes?preferences associated with outcomes?

• Do the authors indicate the strength of their Do the authors indicate the strength of their recommendations?recommendations?

Articles about economic analysesArticles about economic analyses

Did the recommendations consider all relevant patient groups, Did the recommendations consider all relevant patient groups, management options, and possible outcomes?management options, and possible outcomes?

• Did investigators adopt a sufficiently broad viewpoint?Did investigators adopt a sufficiently broad viewpoint?• Are results reported separately for pts whose baseline risk Are results reported separately for pts whose baseline risk

differs?differs?

Is there a systematic review and summary of evidence linking Is there a systematic review and summary of evidence linking options to outcomes for each relevant question?options to outcomes for each relevant question?

• Were costs measured accurately?Were costs measured accurately?• Did investigators consider the timing of costs and Did investigators consider the timing of costs and

consequences?consequences?

Articles about economic analysesArticles about economic analyses

• What were the incremental costs and effects of each What were the incremental costs and effects of each strategy?strategy?

• Do incremental costs and effects differ between subgroups?Do incremental costs and effects differ between subgroups?• How much does allowance for uncertainty change the How much does allowance for uncertainty change the

results?results?

• Are the treatment benefits worth the risks and costs?Are the treatment benefits worth the risks and costs?• Can I expect similar costs in my setting?Can I expect similar costs in my setting?

g. biondi zoccai – ricerca in cardiologia what to expect? core modules introductionintroduction...

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