elizabeth orr, bsn, msn, fnp-bc priscilla massey … · np care in ckd np care in cardioversion...
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E L I Z A B E T H O R R B S N M S N F N P - B C
P R I S C I L L A M A S S E Y A G A C N P - B C C C R N
Literature Review
Changes in Collaborative Practice
NP care in CKD
NP care in cardioversion
Diabetes Outcomes MD NP or PA
Autonomy and Leadership
Nurse Practitioner Care Improves Renal Outcomes in Patients with CKD
Peeters MJ1 van Zuilen AD van den Brand JA Bots ML van Buren M Ten Dam MA Kaasjager KA
Ligtenberg G Sijpkens YW Sluiter HE van de VenPJ Vervoort G Vleming LJ Blankestijn PJ Wetzels
JF
Study Design End Point Analysis
Randomized controlled trial conducted in nine centers of nephrology in the Netherlands
After initial assessment patients split between NP support added to specialist MD vs specialist MD alone
Each implemented mandatory medications and current guidelines
NPs help facilitate motivational interviewing and coaching to improve self management
Clients in NP group received extra follow up if NP felt necessary
Death
ESRD (dialysis or transplant)
50 increase in creatinine
Methods
Results and Conclusions
Small but significant different between two groups in favor of NP
support
Improvement in
bull Blood pressure management
bull Proteinuriabull LDL controlbull Use of supporting
Medications
Additional support by Nurse practitioners
attenuated the decline of kidney function
and improved renal outcomes for patients
with CKD
N O R T O N L 1 T S I P E R F A L A 2 C O O K K 3 B A G D A S A R I A N A 4 V A R A D Y J 1 S H A H M 5 W A N G
P 6
A M J C A R D I O L 2 0 1 6 D E C 1 5 1 1 8 ( 1 2 ) 1 8 4 2 - 1 8 4 6 D O I 1 0 1 0 1 6 J A M J C A R D 2 0 1 6 0 8 0 7 4 E P U B
2 0 1 6 S E P 1 5
Effectiveness and Safety of an Independently run Nurse Practitioner
Outpatient Cardioversion Program
Methods
Due to a sustained growth of the electrophysiology and arrhythmia service a direct current cardioversion program was developed baised on reach guidelines
Utilized templates to ensure standardized care
NPs required to establish competencies with supervised DCCVs
Total of 557 subjects under went 869 DCCVs from 2009-2014
Results and Conclusions
MD
bull 939 success 61 failurebull Served more complicated
patients
NP MDbull 941 success 59 failure
NP
bull 927 success 73 failure bull Shorter Length of stay May
be due to less CHADVASC
Novel program supports the expanded
role of the advanced practice provider in
high specialized areas of practice
J A C K S O N G L 1 S M I T H V A 1 E D E L M A N D 1 W O O L S O N S L 2 H E N D R I X C C 1 E V E R E T T C M 3 B E R K O W I T Z T S 2 W H I T E B S 2 M O R G A N P A 3
A N N I N T E R N M E D 2 0 1 8 D E C 1 8 1 6 9 ( 1 2 ) 8 2 5 -8 3 5 D O I 1 0 7 3 2 6 M 1 7 - 1 9 8 7 E P U B 2 0 1 8 N O V
2 0
Intermediate Diabetes Outcomes in Patients managed by Physicians Nurse
Practitioners or Physician Assistants
Background and Method
Primary care provided by Nurse Practitioners and Physicians Assistance has been proposed as a solution to expected workforce shortages
Examined 368481 adult patients treated pharmaceutically through the US Department of Veterans Affairs electronic health record
Measures
HbA1c
Systolic BP
LDL
Results
No significant difference in
intermediate diabetes or control of patients in the NP PA or MD
PCP group
No meaningful difference in
percentage of NP PA or MD patients who
were using endocrine or specialty diabetes
services
Difficult to track some due to ldquoincident tordquo
billing where services are provided by NP or
PA but changed unclear the
collaborating physicians billing for
reimbursement
L U S I N E P A G H O S Y A N P H D M P H R N F A A N
J I A N G A N G L I U P H D M A S
J G E N I N T E R N M E D 2 0 1 6 J U L 3 1 ( 7 ) 7 7 1 - 7 D O I 1 0 1 0 0 7 S 1 1 6 0 6 - 0 1 6 - 3 6 5 2 - Z E P U B 2 0 1 6
M A R 7
Nurse Practitioner Autonomy and Relationships with leadership affect
teamwork in primary care practices a Cross-Sectional Survey
Objective and Design
Investigate whether NP autonomy within primary care practices and the relationships they ha ve with leadership affect teamwork between NPs and Physicians
314 primary care NPs returned surveys
Study utilized scales to measure independence and teamwork
Conclusions
1bull NP autonomy and leadership improves
teamwork
2
bull Suggested policies and organization changes should focus on promoting NP autonomy and improving relationships between NPs and leadership to improve tem work and consequently improve patient care outcomes
Changes in Headache
Erenumab
Fermanezumab
Galcanezumab
Coming Soonhellip
E D V I N S S O N L 1
H A N D B E X P P H A R M A C O L 2 0 1 9 F E B 7 D O I 1 0 1 0 0 7 1 6 4 _ 2 0 1 8 _ 2 0 1
Role of CGRP in Migraine
Migraines are common affecting up to 15 of the adult population
New medications targeting calcitonin gene related peptide (CGTR) or its receptor
Little to no adverse affects
Why Monoclonal Antibodies
S I M O N A L A T T A N Z IF R A N C E S C O B R I G O
E U G E N T R I N K AF A B R I Z I O V E R N I E R I
T O M M A S O C O R R A D E T T IM A U R O D O B R A N
M A U R O S I L V E S T R I N I
D R U G S 2 0 1 9 F E B 2 2 D O I 1 0 1 0 0 7 S 4 0 2 6 5 - 0 1 9 - 0 1 0 6 9 - 1
Erenumab for Preventive Treatment of Migraine A Systematic Review and Meta-Analysis of Efficacy and Safety
Background and Objective
Novel therapeutic options for daily uses for migraine prophylaxis
Inhibition of calcitonin gene related peptide
First fully human monoclonal antibody directed against CGRP
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Changes in Collaborative Practice
NP care in CKD
NP care in cardioversion
Diabetes Outcomes MD NP or PA
Autonomy and Leadership
Nurse Practitioner Care Improves Renal Outcomes in Patients with CKD
Peeters MJ1 van Zuilen AD van den Brand JA Bots ML van Buren M Ten Dam MA Kaasjager KA
Ligtenberg G Sijpkens YW Sluiter HE van de VenPJ Vervoort G Vleming LJ Blankestijn PJ Wetzels
JF
Study Design End Point Analysis
Randomized controlled trial conducted in nine centers of nephrology in the Netherlands
After initial assessment patients split between NP support added to specialist MD vs specialist MD alone
Each implemented mandatory medications and current guidelines
NPs help facilitate motivational interviewing and coaching to improve self management
Clients in NP group received extra follow up if NP felt necessary
Death
ESRD (dialysis or transplant)
50 increase in creatinine
Methods
Results and Conclusions
Small but significant different between two groups in favor of NP
support
Improvement in
bull Blood pressure management
bull Proteinuriabull LDL controlbull Use of supporting
Medications
Additional support by Nurse practitioners
attenuated the decline of kidney function
and improved renal outcomes for patients
with CKD
N O R T O N L 1 T S I P E R F A L A 2 C O O K K 3 B A G D A S A R I A N A 4 V A R A D Y J 1 S H A H M 5 W A N G
P 6
A M J C A R D I O L 2 0 1 6 D E C 1 5 1 1 8 ( 1 2 ) 1 8 4 2 - 1 8 4 6 D O I 1 0 1 0 1 6 J A M J C A R D 2 0 1 6 0 8 0 7 4 E P U B
2 0 1 6 S E P 1 5
Effectiveness and Safety of an Independently run Nurse Practitioner
Outpatient Cardioversion Program
Methods
Due to a sustained growth of the electrophysiology and arrhythmia service a direct current cardioversion program was developed baised on reach guidelines
Utilized templates to ensure standardized care
NPs required to establish competencies with supervised DCCVs
Total of 557 subjects under went 869 DCCVs from 2009-2014
Results and Conclusions
MD
bull 939 success 61 failurebull Served more complicated
patients
NP MDbull 941 success 59 failure
NP
bull 927 success 73 failure bull Shorter Length of stay May
be due to less CHADVASC
Novel program supports the expanded
role of the advanced practice provider in
high specialized areas of practice
J A C K S O N G L 1 S M I T H V A 1 E D E L M A N D 1 W O O L S O N S L 2 H E N D R I X C C 1 E V E R E T T C M 3 B E R K O W I T Z T S 2 W H I T E B S 2 M O R G A N P A 3
A N N I N T E R N M E D 2 0 1 8 D E C 1 8 1 6 9 ( 1 2 ) 8 2 5 -8 3 5 D O I 1 0 7 3 2 6 M 1 7 - 1 9 8 7 E P U B 2 0 1 8 N O V
2 0
Intermediate Diabetes Outcomes in Patients managed by Physicians Nurse
Practitioners or Physician Assistants
Background and Method
Primary care provided by Nurse Practitioners and Physicians Assistance has been proposed as a solution to expected workforce shortages
Examined 368481 adult patients treated pharmaceutically through the US Department of Veterans Affairs electronic health record
Measures
HbA1c
Systolic BP
LDL
Results
No significant difference in
intermediate diabetes or control of patients in the NP PA or MD
PCP group
No meaningful difference in
percentage of NP PA or MD patients who
were using endocrine or specialty diabetes
services
Difficult to track some due to ldquoincident tordquo
billing where services are provided by NP or
PA but changed unclear the
collaborating physicians billing for
reimbursement
L U S I N E P A G H O S Y A N P H D M P H R N F A A N
J I A N G A N G L I U P H D M A S
J G E N I N T E R N M E D 2 0 1 6 J U L 3 1 ( 7 ) 7 7 1 - 7 D O I 1 0 1 0 0 7 S 1 1 6 0 6 - 0 1 6 - 3 6 5 2 - Z E P U B 2 0 1 6
M A R 7
Nurse Practitioner Autonomy and Relationships with leadership affect
teamwork in primary care practices a Cross-Sectional Survey
Objective and Design
Investigate whether NP autonomy within primary care practices and the relationships they ha ve with leadership affect teamwork between NPs and Physicians
314 primary care NPs returned surveys
Study utilized scales to measure independence and teamwork
Conclusions
1bull NP autonomy and leadership improves
teamwork
2
bull Suggested policies and organization changes should focus on promoting NP autonomy and improving relationships between NPs and leadership to improve tem work and consequently improve patient care outcomes
Changes in Headache
Erenumab
Fermanezumab
Galcanezumab
Coming Soonhellip
E D V I N S S O N L 1
H A N D B E X P P H A R M A C O L 2 0 1 9 F E B 7 D O I 1 0 1 0 0 7 1 6 4 _ 2 0 1 8 _ 2 0 1
Role of CGRP in Migraine
Migraines are common affecting up to 15 of the adult population
New medications targeting calcitonin gene related peptide (CGTR) or its receptor
Little to no adverse affects
Why Monoclonal Antibodies
S I M O N A L A T T A N Z IF R A N C E S C O B R I G O
E U G E N T R I N K AF A B R I Z I O V E R N I E R I
T O M M A S O C O R R A D E T T IM A U R O D O B R A N
M A U R O S I L V E S T R I N I
D R U G S 2 0 1 9 F E B 2 2 D O I 1 0 1 0 0 7 S 4 0 2 6 5 - 0 1 9 - 0 1 0 6 9 - 1
Erenumab for Preventive Treatment of Migraine A Systematic Review and Meta-Analysis of Efficacy and Safety
Background and Objective
Novel therapeutic options for daily uses for migraine prophylaxis
Inhibition of calcitonin gene related peptide
First fully human monoclonal antibody directed against CGRP
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Nurse Practitioner Care Improves Renal Outcomes in Patients with CKD
Peeters MJ1 van Zuilen AD van den Brand JA Bots ML van Buren M Ten Dam MA Kaasjager KA
Ligtenberg G Sijpkens YW Sluiter HE van de VenPJ Vervoort G Vleming LJ Blankestijn PJ Wetzels
JF
Study Design End Point Analysis
Randomized controlled trial conducted in nine centers of nephrology in the Netherlands
After initial assessment patients split between NP support added to specialist MD vs specialist MD alone
Each implemented mandatory medications and current guidelines
NPs help facilitate motivational interviewing and coaching to improve self management
Clients in NP group received extra follow up if NP felt necessary
Death
ESRD (dialysis or transplant)
50 increase in creatinine
Methods
Results and Conclusions
Small but significant different between two groups in favor of NP
support
Improvement in
bull Blood pressure management
bull Proteinuriabull LDL controlbull Use of supporting
Medications
Additional support by Nurse practitioners
attenuated the decline of kidney function
and improved renal outcomes for patients
with CKD
N O R T O N L 1 T S I P E R F A L A 2 C O O K K 3 B A G D A S A R I A N A 4 V A R A D Y J 1 S H A H M 5 W A N G
P 6
A M J C A R D I O L 2 0 1 6 D E C 1 5 1 1 8 ( 1 2 ) 1 8 4 2 - 1 8 4 6 D O I 1 0 1 0 1 6 J A M J C A R D 2 0 1 6 0 8 0 7 4 E P U B
2 0 1 6 S E P 1 5
Effectiveness and Safety of an Independently run Nurse Practitioner
Outpatient Cardioversion Program
Methods
Due to a sustained growth of the electrophysiology and arrhythmia service a direct current cardioversion program was developed baised on reach guidelines
Utilized templates to ensure standardized care
NPs required to establish competencies with supervised DCCVs
Total of 557 subjects under went 869 DCCVs from 2009-2014
Results and Conclusions
MD
bull 939 success 61 failurebull Served more complicated
patients
NP MDbull 941 success 59 failure
NP
bull 927 success 73 failure bull Shorter Length of stay May
be due to less CHADVASC
Novel program supports the expanded
role of the advanced practice provider in
high specialized areas of practice
J A C K S O N G L 1 S M I T H V A 1 E D E L M A N D 1 W O O L S O N S L 2 H E N D R I X C C 1 E V E R E T T C M 3 B E R K O W I T Z T S 2 W H I T E B S 2 M O R G A N P A 3
A N N I N T E R N M E D 2 0 1 8 D E C 1 8 1 6 9 ( 1 2 ) 8 2 5 -8 3 5 D O I 1 0 7 3 2 6 M 1 7 - 1 9 8 7 E P U B 2 0 1 8 N O V
2 0
Intermediate Diabetes Outcomes in Patients managed by Physicians Nurse
Practitioners or Physician Assistants
Background and Method
Primary care provided by Nurse Practitioners and Physicians Assistance has been proposed as a solution to expected workforce shortages
Examined 368481 adult patients treated pharmaceutically through the US Department of Veterans Affairs electronic health record
Measures
HbA1c
Systolic BP
LDL
Results
No significant difference in
intermediate diabetes or control of patients in the NP PA or MD
PCP group
No meaningful difference in
percentage of NP PA or MD patients who
were using endocrine or specialty diabetes
services
Difficult to track some due to ldquoincident tordquo
billing where services are provided by NP or
PA but changed unclear the
collaborating physicians billing for
reimbursement
L U S I N E P A G H O S Y A N P H D M P H R N F A A N
J I A N G A N G L I U P H D M A S
J G E N I N T E R N M E D 2 0 1 6 J U L 3 1 ( 7 ) 7 7 1 - 7 D O I 1 0 1 0 0 7 S 1 1 6 0 6 - 0 1 6 - 3 6 5 2 - Z E P U B 2 0 1 6
M A R 7
Nurse Practitioner Autonomy and Relationships with leadership affect
teamwork in primary care practices a Cross-Sectional Survey
Objective and Design
Investigate whether NP autonomy within primary care practices and the relationships they ha ve with leadership affect teamwork between NPs and Physicians
314 primary care NPs returned surveys
Study utilized scales to measure independence and teamwork
Conclusions
1bull NP autonomy and leadership improves
teamwork
2
bull Suggested policies and organization changes should focus on promoting NP autonomy and improving relationships between NPs and leadership to improve tem work and consequently improve patient care outcomes
Changes in Headache
Erenumab
Fermanezumab
Galcanezumab
Coming Soonhellip
E D V I N S S O N L 1
H A N D B E X P P H A R M A C O L 2 0 1 9 F E B 7 D O I 1 0 1 0 0 7 1 6 4 _ 2 0 1 8 _ 2 0 1
Role of CGRP in Migraine
Migraines are common affecting up to 15 of the adult population
New medications targeting calcitonin gene related peptide (CGTR) or its receptor
Little to no adverse affects
Why Monoclonal Antibodies
S I M O N A L A T T A N Z IF R A N C E S C O B R I G O
E U G E N T R I N K AF A B R I Z I O V E R N I E R I
T O M M A S O C O R R A D E T T IM A U R O D O B R A N
M A U R O S I L V E S T R I N I
D R U G S 2 0 1 9 F E B 2 2 D O I 1 0 1 0 0 7 S 4 0 2 6 5 - 0 1 9 - 0 1 0 6 9 - 1
Erenumab for Preventive Treatment of Migraine A Systematic Review and Meta-Analysis of Efficacy and Safety
Background and Objective
Novel therapeutic options for daily uses for migraine prophylaxis
Inhibition of calcitonin gene related peptide
First fully human monoclonal antibody directed against CGRP
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Study Design End Point Analysis
Randomized controlled trial conducted in nine centers of nephrology in the Netherlands
After initial assessment patients split between NP support added to specialist MD vs specialist MD alone
Each implemented mandatory medications and current guidelines
NPs help facilitate motivational interviewing and coaching to improve self management
Clients in NP group received extra follow up if NP felt necessary
Death
ESRD (dialysis or transplant)
50 increase in creatinine
Methods
Results and Conclusions
Small but significant different between two groups in favor of NP
support
Improvement in
bull Blood pressure management
bull Proteinuriabull LDL controlbull Use of supporting
Medications
Additional support by Nurse practitioners
attenuated the decline of kidney function
and improved renal outcomes for patients
with CKD
N O R T O N L 1 T S I P E R F A L A 2 C O O K K 3 B A G D A S A R I A N A 4 V A R A D Y J 1 S H A H M 5 W A N G
P 6
A M J C A R D I O L 2 0 1 6 D E C 1 5 1 1 8 ( 1 2 ) 1 8 4 2 - 1 8 4 6 D O I 1 0 1 0 1 6 J A M J C A R D 2 0 1 6 0 8 0 7 4 E P U B
2 0 1 6 S E P 1 5
Effectiveness and Safety of an Independently run Nurse Practitioner
Outpatient Cardioversion Program
Methods
Due to a sustained growth of the electrophysiology and arrhythmia service a direct current cardioversion program was developed baised on reach guidelines
Utilized templates to ensure standardized care
NPs required to establish competencies with supervised DCCVs
Total of 557 subjects under went 869 DCCVs from 2009-2014
Results and Conclusions
MD
bull 939 success 61 failurebull Served more complicated
patients
NP MDbull 941 success 59 failure
NP
bull 927 success 73 failure bull Shorter Length of stay May
be due to less CHADVASC
Novel program supports the expanded
role of the advanced practice provider in
high specialized areas of practice
J A C K S O N G L 1 S M I T H V A 1 E D E L M A N D 1 W O O L S O N S L 2 H E N D R I X C C 1 E V E R E T T C M 3 B E R K O W I T Z T S 2 W H I T E B S 2 M O R G A N P A 3
A N N I N T E R N M E D 2 0 1 8 D E C 1 8 1 6 9 ( 1 2 ) 8 2 5 -8 3 5 D O I 1 0 7 3 2 6 M 1 7 - 1 9 8 7 E P U B 2 0 1 8 N O V
2 0
Intermediate Diabetes Outcomes in Patients managed by Physicians Nurse
Practitioners or Physician Assistants
Background and Method
Primary care provided by Nurse Practitioners and Physicians Assistance has been proposed as a solution to expected workforce shortages
Examined 368481 adult patients treated pharmaceutically through the US Department of Veterans Affairs electronic health record
Measures
HbA1c
Systolic BP
LDL
Results
No significant difference in
intermediate diabetes or control of patients in the NP PA or MD
PCP group
No meaningful difference in
percentage of NP PA or MD patients who
were using endocrine or specialty diabetes
services
Difficult to track some due to ldquoincident tordquo
billing where services are provided by NP or
PA but changed unclear the
collaborating physicians billing for
reimbursement
L U S I N E P A G H O S Y A N P H D M P H R N F A A N
J I A N G A N G L I U P H D M A S
J G E N I N T E R N M E D 2 0 1 6 J U L 3 1 ( 7 ) 7 7 1 - 7 D O I 1 0 1 0 0 7 S 1 1 6 0 6 - 0 1 6 - 3 6 5 2 - Z E P U B 2 0 1 6
M A R 7
Nurse Practitioner Autonomy and Relationships with leadership affect
teamwork in primary care practices a Cross-Sectional Survey
Objective and Design
Investigate whether NP autonomy within primary care practices and the relationships they ha ve with leadership affect teamwork between NPs and Physicians
314 primary care NPs returned surveys
Study utilized scales to measure independence and teamwork
Conclusions
1bull NP autonomy and leadership improves
teamwork
2
bull Suggested policies and organization changes should focus on promoting NP autonomy and improving relationships between NPs and leadership to improve tem work and consequently improve patient care outcomes
Changes in Headache
Erenumab
Fermanezumab
Galcanezumab
Coming Soonhellip
E D V I N S S O N L 1
H A N D B E X P P H A R M A C O L 2 0 1 9 F E B 7 D O I 1 0 1 0 0 7 1 6 4 _ 2 0 1 8 _ 2 0 1
Role of CGRP in Migraine
Migraines are common affecting up to 15 of the adult population
New medications targeting calcitonin gene related peptide (CGTR) or its receptor
Little to no adverse affects
Why Monoclonal Antibodies
S I M O N A L A T T A N Z IF R A N C E S C O B R I G O
E U G E N T R I N K AF A B R I Z I O V E R N I E R I
T O M M A S O C O R R A D E T T IM A U R O D O B R A N
M A U R O S I L V E S T R I N I
D R U G S 2 0 1 9 F E B 2 2 D O I 1 0 1 0 0 7 S 4 0 2 6 5 - 0 1 9 - 0 1 0 6 9 - 1
Erenumab for Preventive Treatment of Migraine A Systematic Review and Meta-Analysis of Efficacy and Safety
Background and Objective
Novel therapeutic options for daily uses for migraine prophylaxis
Inhibition of calcitonin gene related peptide
First fully human monoclonal antibody directed against CGRP
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Results and Conclusions
Small but significant different between two groups in favor of NP
support
Improvement in
bull Blood pressure management
bull Proteinuriabull LDL controlbull Use of supporting
Medications
Additional support by Nurse practitioners
attenuated the decline of kidney function
and improved renal outcomes for patients
with CKD
N O R T O N L 1 T S I P E R F A L A 2 C O O K K 3 B A G D A S A R I A N A 4 V A R A D Y J 1 S H A H M 5 W A N G
P 6
A M J C A R D I O L 2 0 1 6 D E C 1 5 1 1 8 ( 1 2 ) 1 8 4 2 - 1 8 4 6 D O I 1 0 1 0 1 6 J A M J C A R D 2 0 1 6 0 8 0 7 4 E P U B
2 0 1 6 S E P 1 5
Effectiveness and Safety of an Independently run Nurse Practitioner
Outpatient Cardioversion Program
Methods
Due to a sustained growth of the electrophysiology and arrhythmia service a direct current cardioversion program was developed baised on reach guidelines
Utilized templates to ensure standardized care
NPs required to establish competencies with supervised DCCVs
Total of 557 subjects under went 869 DCCVs from 2009-2014
Results and Conclusions
MD
bull 939 success 61 failurebull Served more complicated
patients
NP MDbull 941 success 59 failure
NP
bull 927 success 73 failure bull Shorter Length of stay May
be due to less CHADVASC
Novel program supports the expanded
role of the advanced practice provider in
high specialized areas of practice
J A C K S O N G L 1 S M I T H V A 1 E D E L M A N D 1 W O O L S O N S L 2 H E N D R I X C C 1 E V E R E T T C M 3 B E R K O W I T Z T S 2 W H I T E B S 2 M O R G A N P A 3
A N N I N T E R N M E D 2 0 1 8 D E C 1 8 1 6 9 ( 1 2 ) 8 2 5 -8 3 5 D O I 1 0 7 3 2 6 M 1 7 - 1 9 8 7 E P U B 2 0 1 8 N O V
2 0
Intermediate Diabetes Outcomes in Patients managed by Physicians Nurse
Practitioners or Physician Assistants
Background and Method
Primary care provided by Nurse Practitioners and Physicians Assistance has been proposed as a solution to expected workforce shortages
Examined 368481 adult patients treated pharmaceutically through the US Department of Veterans Affairs electronic health record
Measures
HbA1c
Systolic BP
LDL
Results
No significant difference in
intermediate diabetes or control of patients in the NP PA or MD
PCP group
No meaningful difference in
percentage of NP PA or MD patients who
were using endocrine or specialty diabetes
services
Difficult to track some due to ldquoincident tordquo
billing where services are provided by NP or
PA but changed unclear the
collaborating physicians billing for
reimbursement
L U S I N E P A G H O S Y A N P H D M P H R N F A A N
J I A N G A N G L I U P H D M A S
J G E N I N T E R N M E D 2 0 1 6 J U L 3 1 ( 7 ) 7 7 1 - 7 D O I 1 0 1 0 0 7 S 1 1 6 0 6 - 0 1 6 - 3 6 5 2 - Z E P U B 2 0 1 6
M A R 7
Nurse Practitioner Autonomy and Relationships with leadership affect
teamwork in primary care practices a Cross-Sectional Survey
Objective and Design
Investigate whether NP autonomy within primary care practices and the relationships they ha ve with leadership affect teamwork between NPs and Physicians
314 primary care NPs returned surveys
Study utilized scales to measure independence and teamwork
Conclusions
1bull NP autonomy and leadership improves
teamwork
2
bull Suggested policies and organization changes should focus on promoting NP autonomy and improving relationships between NPs and leadership to improve tem work and consequently improve patient care outcomes
Changes in Headache
Erenumab
Fermanezumab
Galcanezumab
Coming Soonhellip
E D V I N S S O N L 1
H A N D B E X P P H A R M A C O L 2 0 1 9 F E B 7 D O I 1 0 1 0 0 7 1 6 4 _ 2 0 1 8 _ 2 0 1
Role of CGRP in Migraine
Migraines are common affecting up to 15 of the adult population
New medications targeting calcitonin gene related peptide (CGTR) or its receptor
Little to no adverse affects
Why Monoclonal Antibodies
S I M O N A L A T T A N Z IF R A N C E S C O B R I G O
E U G E N T R I N K AF A B R I Z I O V E R N I E R I
T O M M A S O C O R R A D E T T IM A U R O D O B R A N
M A U R O S I L V E S T R I N I
D R U G S 2 0 1 9 F E B 2 2 D O I 1 0 1 0 0 7 S 4 0 2 6 5 - 0 1 9 - 0 1 0 6 9 - 1
Erenumab for Preventive Treatment of Migraine A Systematic Review and Meta-Analysis of Efficacy and Safety
Background and Objective
Novel therapeutic options for daily uses for migraine prophylaxis
Inhibition of calcitonin gene related peptide
First fully human monoclonal antibody directed against CGRP
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
N O R T O N L 1 T S I P E R F A L A 2 C O O K K 3 B A G D A S A R I A N A 4 V A R A D Y J 1 S H A H M 5 W A N G
P 6
A M J C A R D I O L 2 0 1 6 D E C 1 5 1 1 8 ( 1 2 ) 1 8 4 2 - 1 8 4 6 D O I 1 0 1 0 1 6 J A M J C A R D 2 0 1 6 0 8 0 7 4 E P U B
2 0 1 6 S E P 1 5
Effectiveness and Safety of an Independently run Nurse Practitioner
Outpatient Cardioversion Program
Methods
Due to a sustained growth of the electrophysiology and arrhythmia service a direct current cardioversion program was developed baised on reach guidelines
Utilized templates to ensure standardized care
NPs required to establish competencies with supervised DCCVs
Total of 557 subjects under went 869 DCCVs from 2009-2014
Results and Conclusions
MD
bull 939 success 61 failurebull Served more complicated
patients
NP MDbull 941 success 59 failure
NP
bull 927 success 73 failure bull Shorter Length of stay May
be due to less CHADVASC
Novel program supports the expanded
role of the advanced practice provider in
high specialized areas of practice
J A C K S O N G L 1 S M I T H V A 1 E D E L M A N D 1 W O O L S O N S L 2 H E N D R I X C C 1 E V E R E T T C M 3 B E R K O W I T Z T S 2 W H I T E B S 2 M O R G A N P A 3
A N N I N T E R N M E D 2 0 1 8 D E C 1 8 1 6 9 ( 1 2 ) 8 2 5 -8 3 5 D O I 1 0 7 3 2 6 M 1 7 - 1 9 8 7 E P U B 2 0 1 8 N O V
2 0
Intermediate Diabetes Outcomes in Patients managed by Physicians Nurse
Practitioners or Physician Assistants
Background and Method
Primary care provided by Nurse Practitioners and Physicians Assistance has been proposed as a solution to expected workforce shortages
Examined 368481 adult patients treated pharmaceutically through the US Department of Veterans Affairs electronic health record
Measures
HbA1c
Systolic BP
LDL
Results
No significant difference in
intermediate diabetes or control of patients in the NP PA or MD
PCP group
No meaningful difference in
percentage of NP PA or MD patients who
were using endocrine or specialty diabetes
services
Difficult to track some due to ldquoincident tordquo
billing where services are provided by NP or
PA but changed unclear the
collaborating physicians billing for
reimbursement
L U S I N E P A G H O S Y A N P H D M P H R N F A A N
J I A N G A N G L I U P H D M A S
J G E N I N T E R N M E D 2 0 1 6 J U L 3 1 ( 7 ) 7 7 1 - 7 D O I 1 0 1 0 0 7 S 1 1 6 0 6 - 0 1 6 - 3 6 5 2 - Z E P U B 2 0 1 6
M A R 7
Nurse Practitioner Autonomy and Relationships with leadership affect
teamwork in primary care practices a Cross-Sectional Survey
Objective and Design
Investigate whether NP autonomy within primary care practices and the relationships they ha ve with leadership affect teamwork between NPs and Physicians
314 primary care NPs returned surveys
Study utilized scales to measure independence and teamwork
Conclusions
1bull NP autonomy and leadership improves
teamwork
2
bull Suggested policies and organization changes should focus on promoting NP autonomy and improving relationships between NPs and leadership to improve tem work and consequently improve patient care outcomes
Changes in Headache
Erenumab
Fermanezumab
Galcanezumab
Coming Soonhellip
E D V I N S S O N L 1
H A N D B E X P P H A R M A C O L 2 0 1 9 F E B 7 D O I 1 0 1 0 0 7 1 6 4 _ 2 0 1 8 _ 2 0 1
Role of CGRP in Migraine
Migraines are common affecting up to 15 of the adult population
New medications targeting calcitonin gene related peptide (CGTR) or its receptor
Little to no adverse affects
Why Monoclonal Antibodies
S I M O N A L A T T A N Z IF R A N C E S C O B R I G O
E U G E N T R I N K AF A B R I Z I O V E R N I E R I
T O M M A S O C O R R A D E T T IM A U R O D O B R A N
M A U R O S I L V E S T R I N I
D R U G S 2 0 1 9 F E B 2 2 D O I 1 0 1 0 0 7 S 4 0 2 6 5 - 0 1 9 - 0 1 0 6 9 - 1
Erenumab for Preventive Treatment of Migraine A Systematic Review and Meta-Analysis of Efficacy and Safety
Background and Objective
Novel therapeutic options for daily uses for migraine prophylaxis
Inhibition of calcitonin gene related peptide
First fully human monoclonal antibody directed against CGRP
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Methods
Due to a sustained growth of the electrophysiology and arrhythmia service a direct current cardioversion program was developed baised on reach guidelines
Utilized templates to ensure standardized care
NPs required to establish competencies with supervised DCCVs
Total of 557 subjects under went 869 DCCVs from 2009-2014
Results and Conclusions
MD
bull 939 success 61 failurebull Served more complicated
patients
NP MDbull 941 success 59 failure
NP
bull 927 success 73 failure bull Shorter Length of stay May
be due to less CHADVASC
Novel program supports the expanded
role of the advanced practice provider in
high specialized areas of practice
J A C K S O N G L 1 S M I T H V A 1 E D E L M A N D 1 W O O L S O N S L 2 H E N D R I X C C 1 E V E R E T T C M 3 B E R K O W I T Z T S 2 W H I T E B S 2 M O R G A N P A 3
A N N I N T E R N M E D 2 0 1 8 D E C 1 8 1 6 9 ( 1 2 ) 8 2 5 -8 3 5 D O I 1 0 7 3 2 6 M 1 7 - 1 9 8 7 E P U B 2 0 1 8 N O V
2 0
Intermediate Diabetes Outcomes in Patients managed by Physicians Nurse
Practitioners or Physician Assistants
Background and Method
Primary care provided by Nurse Practitioners and Physicians Assistance has been proposed as a solution to expected workforce shortages
Examined 368481 adult patients treated pharmaceutically through the US Department of Veterans Affairs electronic health record
Measures
HbA1c
Systolic BP
LDL
Results
No significant difference in
intermediate diabetes or control of patients in the NP PA or MD
PCP group
No meaningful difference in
percentage of NP PA or MD patients who
were using endocrine or specialty diabetes
services
Difficult to track some due to ldquoincident tordquo
billing where services are provided by NP or
PA but changed unclear the
collaborating physicians billing for
reimbursement
L U S I N E P A G H O S Y A N P H D M P H R N F A A N
J I A N G A N G L I U P H D M A S
J G E N I N T E R N M E D 2 0 1 6 J U L 3 1 ( 7 ) 7 7 1 - 7 D O I 1 0 1 0 0 7 S 1 1 6 0 6 - 0 1 6 - 3 6 5 2 - Z E P U B 2 0 1 6
M A R 7
Nurse Practitioner Autonomy and Relationships with leadership affect
teamwork in primary care practices a Cross-Sectional Survey
Objective and Design
Investigate whether NP autonomy within primary care practices and the relationships they ha ve with leadership affect teamwork between NPs and Physicians
314 primary care NPs returned surveys
Study utilized scales to measure independence and teamwork
Conclusions
1bull NP autonomy and leadership improves
teamwork
2
bull Suggested policies and organization changes should focus on promoting NP autonomy and improving relationships between NPs and leadership to improve tem work and consequently improve patient care outcomes
Changes in Headache
Erenumab
Fermanezumab
Galcanezumab
Coming Soonhellip
E D V I N S S O N L 1
H A N D B E X P P H A R M A C O L 2 0 1 9 F E B 7 D O I 1 0 1 0 0 7 1 6 4 _ 2 0 1 8 _ 2 0 1
Role of CGRP in Migraine
Migraines are common affecting up to 15 of the adult population
New medications targeting calcitonin gene related peptide (CGTR) or its receptor
Little to no adverse affects
Why Monoclonal Antibodies
S I M O N A L A T T A N Z IF R A N C E S C O B R I G O
E U G E N T R I N K AF A B R I Z I O V E R N I E R I
T O M M A S O C O R R A D E T T IM A U R O D O B R A N
M A U R O S I L V E S T R I N I
D R U G S 2 0 1 9 F E B 2 2 D O I 1 0 1 0 0 7 S 4 0 2 6 5 - 0 1 9 - 0 1 0 6 9 - 1
Erenumab for Preventive Treatment of Migraine A Systematic Review and Meta-Analysis of Efficacy and Safety
Background and Objective
Novel therapeutic options for daily uses for migraine prophylaxis
Inhibition of calcitonin gene related peptide
First fully human monoclonal antibody directed against CGRP
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Results and Conclusions
MD
bull 939 success 61 failurebull Served more complicated
patients
NP MDbull 941 success 59 failure
NP
bull 927 success 73 failure bull Shorter Length of stay May
be due to less CHADVASC
Novel program supports the expanded
role of the advanced practice provider in
high specialized areas of practice
J A C K S O N G L 1 S M I T H V A 1 E D E L M A N D 1 W O O L S O N S L 2 H E N D R I X C C 1 E V E R E T T C M 3 B E R K O W I T Z T S 2 W H I T E B S 2 M O R G A N P A 3
A N N I N T E R N M E D 2 0 1 8 D E C 1 8 1 6 9 ( 1 2 ) 8 2 5 -8 3 5 D O I 1 0 7 3 2 6 M 1 7 - 1 9 8 7 E P U B 2 0 1 8 N O V
2 0
Intermediate Diabetes Outcomes in Patients managed by Physicians Nurse
Practitioners or Physician Assistants
Background and Method
Primary care provided by Nurse Practitioners and Physicians Assistance has been proposed as a solution to expected workforce shortages
Examined 368481 adult patients treated pharmaceutically through the US Department of Veterans Affairs electronic health record
Measures
HbA1c
Systolic BP
LDL
Results
No significant difference in
intermediate diabetes or control of patients in the NP PA or MD
PCP group
No meaningful difference in
percentage of NP PA or MD patients who
were using endocrine or specialty diabetes
services
Difficult to track some due to ldquoincident tordquo
billing where services are provided by NP or
PA but changed unclear the
collaborating physicians billing for
reimbursement
L U S I N E P A G H O S Y A N P H D M P H R N F A A N
J I A N G A N G L I U P H D M A S
J G E N I N T E R N M E D 2 0 1 6 J U L 3 1 ( 7 ) 7 7 1 - 7 D O I 1 0 1 0 0 7 S 1 1 6 0 6 - 0 1 6 - 3 6 5 2 - Z E P U B 2 0 1 6
M A R 7
Nurse Practitioner Autonomy and Relationships with leadership affect
teamwork in primary care practices a Cross-Sectional Survey
Objective and Design
Investigate whether NP autonomy within primary care practices and the relationships they ha ve with leadership affect teamwork between NPs and Physicians
314 primary care NPs returned surveys
Study utilized scales to measure independence and teamwork
Conclusions
1bull NP autonomy and leadership improves
teamwork
2
bull Suggested policies and organization changes should focus on promoting NP autonomy and improving relationships between NPs and leadership to improve tem work and consequently improve patient care outcomes
Changes in Headache
Erenumab
Fermanezumab
Galcanezumab
Coming Soonhellip
E D V I N S S O N L 1
H A N D B E X P P H A R M A C O L 2 0 1 9 F E B 7 D O I 1 0 1 0 0 7 1 6 4 _ 2 0 1 8 _ 2 0 1
Role of CGRP in Migraine
Migraines are common affecting up to 15 of the adult population
New medications targeting calcitonin gene related peptide (CGTR) or its receptor
Little to no adverse affects
Why Monoclonal Antibodies
S I M O N A L A T T A N Z IF R A N C E S C O B R I G O
E U G E N T R I N K AF A B R I Z I O V E R N I E R I
T O M M A S O C O R R A D E T T IM A U R O D O B R A N
M A U R O S I L V E S T R I N I
D R U G S 2 0 1 9 F E B 2 2 D O I 1 0 1 0 0 7 S 4 0 2 6 5 - 0 1 9 - 0 1 0 6 9 - 1
Erenumab for Preventive Treatment of Migraine A Systematic Review and Meta-Analysis of Efficacy and Safety
Background and Objective
Novel therapeutic options for daily uses for migraine prophylaxis
Inhibition of calcitonin gene related peptide
First fully human monoclonal antibody directed against CGRP
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
J A C K S O N G L 1 S M I T H V A 1 E D E L M A N D 1 W O O L S O N S L 2 H E N D R I X C C 1 E V E R E T T C M 3 B E R K O W I T Z T S 2 W H I T E B S 2 M O R G A N P A 3
A N N I N T E R N M E D 2 0 1 8 D E C 1 8 1 6 9 ( 1 2 ) 8 2 5 -8 3 5 D O I 1 0 7 3 2 6 M 1 7 - 1 9 8 7 E P U B 2 0 1 8 N O V
2 0
Intermediate Diabetes Outcomes in Patients managed by Physicians Nurse
Practitioners or Physician Assistants
Background and Method
Primary care provided by Nurse Practitioners and Physicians Assistance has been proposed as a solution to expected workforce shortages
Examined 368481 adult patients treated pharmaceutically through the US Department of Veterans Affairs electronic health record
Measures
HbA1c
Systolic BP
LDL
Results
No significant difference in
intermediate diabetes or control of patients in the NP PA or MD
PCP group
No meaningful difference in
percentage of NP PA or MD patients who
were using endocrine or specialty diabetes
services
Difficult to track some due to ldquoincident tordquo
billing where services are provided by NP or
PA but changed unclear the
collaborating physicians billing for
reimbursement
L U S I N E P A G H O S Y A N P H D M P H R N F A A N
J I A N G A N G L I U P H D M A S
J G E N I N T E R N M E D 2 0 1 6 J U L 3 1 ( 7 ) 7 7 1 - 7 D O I 1 0 1 0 0 7 S 1 1 6 0 6 - 0 1 6 - 3 6 5 2 - Z E P U B 2 0 1 6
M A R 7
Nurse Practitioner Autonomy and Relationships with leadership affect
teamwork in primary care practices a Cross-Sectional Survey
Objective and Design
Investigate whether NP autonomy within primary care practices and the relationships they ha ve with leadership affect teamwork between NPs and Physicians
314 primary care NPs returned surveys
Study utilized scales to measure independence and teamwork
Conclusions
1bull NP autonomy and leadership improves
teamwork
2
bull Suggested policies and organization changes should focus on promoting NP autonomy and improving relationships between NPs and leadership to improve tem work and consequently improve patient care outcomes
Changes in Headache
Erenumab
Fermanezumab
Galcanezumab
Coming Soonhellip
E D V I N S S O N L 1
H A N D B E X P P H A R M A C O L 2 0 1 9 F E B 7 D O I 1 0 1 0 0 7 1 6 4 _ 2 0 1 8 _ 2 0 1
Role of CGRP in Migraine
Migraines are common affecting up to 15 of the adult population
New medications targeting calcitonin gene related peptide (CGTR) or its receptor
Little to no adverse affects
Why Monoclonal Antibodies
S I M O N A L A T T A N Z IF R A N C E S C O B R I G O
E U G E N T R I N K AF A B R I Z I O V E R N I E R I
T O M M A S O C O R R A D E T T IM A U R O D O B R A N
M A U R O S I L V E S T R I N I
D R U G S 2 0 1 9 F E B 2 2 D O I 1 0 1 0 0 7 S 4 0 2 6 5 - 0 1 9 - 0 1 0 6 9 - 1
Erenumab for Preventive Treatment of Migraine A Systematic Review and Meta-Analysis of Efficacy and Safety
Background and Objective
Novel therapeutic options for daily uses for migraine prophylaxis
Inhibition of calcitonin gene related peptide
First fully human monoclonal antibody directed against CGRP
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Background and Method
Primary care provided by Nurse Practitioners and Physicians Assistance has been proposed as a solution to expected workforce shortages
Examined 368481 adult patients treated pharmaceutically through the US Department of Veterans Affairs electronic health record
Measures
HbA1c
Systolic BP
LDL
Results
No significant difference in
intermediate diabetes or control of patients in the NP PA or MD
PCP group
No meaningful difference in
percentage of NP PA or MD patients who
were using endocrine or specialty diabetes
services
Difficult to track some due to ldquoincident tordquo
billing where services are provided by NP or
PA but changed unclear the
collaborating physicians billing for
reimbursement
L U S I N E P A G H O S Y A N P H D M P H R N F A A N
J I A N G A N G L I U P H D M A S
J G E N I N T E R N M E D 2 0 1 6 J U L 3 1 ( 7 ) 7 7 1 - 7 D O I 1 0 1 0 0 7 S 1 1 6 0 6 - 0 1 6 - 3 6 5 2 - Z E P U B 2 0 1 6
M A R 7
Nurse Practitioner Autonomy and Relationships with leadership affect
teamwork in primary care practices a Cross-Sectional Survey
Objective and Design
Investigate whether NP autonomy within primary care practices and the relationships they ha ve with leadership affect teamwork between NPs and Physicians
314 primary care NPs returned surveys
Study utilized scales to measure independence and teamwork
Conclusions
1bull NP autonomy and leadership improves
teamwork
2
bull Suggested policies and organization changes should focus on promoting NP autonomy and improving relationships between NPs and leadership to improve tem work and consequently improve patient care outcomes
Changes in Headache
Erenumab
Fermanezumab
Galcanezumab
Coming Soonhellip
E D V I N S S O N L 1
H A N D B E X P P H A R M A C O L 2 0 1 9 F E B 7 D O I 1 0 1 0 0 7 1 6 4 _ 2 0 1 8 _ 2 0 1
Role of CGRP in Migraine
Migraines are common affecting up to 15 of the adult population
New medications targeting calcitonin gene related peptide (CGTR) or its receptor
Little to no adverse affects
Why Monoclonal Antibodies
S I M O N A L A T T A N Z IF R A N C E S C O B R I G O
E U G E N T R I N K AF A B R I Z I O V E R N I E R I
T O M M A S O C O R R A D E T T IM A U R O D O B R A N
M A U R O S I L V E S T R I N I
D R U G S 2 0 1 9 F E B 2 2 D O I 1 0 1 0 0 7 S 4 0 2 6 5 - 0 1 9 - 0 1 0 6 9 - 1
Erenumab for Preventive Treatment of Migraine A Systematic Review and Meta-Analysis of Efficacy and Safety
Background and Objective
Novel therapeutic options for daily uses for migraine prophylaxis
Inhibition of calcitonin gene related peptide
First fully human monoclonal antibody directed against CGRP
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Results
No significant difference in
intermediate diabetes or control of patients in the NP PA or MD
PCP group
No meaningful difference in
percentage of NP PA or MD patients who
were using endocrine or specialty diabetes
services
Difficult to track some due to ldquoincident tordquo
billing where services are provided by NP or
PA but changed unclear the
collaborating physicians billing for
reimbursement
L U S I N E P A G H O S Y A N P H D M P H R N F A A N
J I A N G A N G L I U P H D M A S
J G E N I N T E R N M E D 2 0 1 6 J U L 3 1 ( 7 ) 7 7 1 - 7 D O I 1 0 1 0 0 7 S 1 1 6 0 6 - 0 1 6 - 3 6 5 2 - Z E P U B 2 0 1 6
M A R 7
Nurse Practitioner Autonomy and Relationships with leadership affect
teamwork in primary care practices a Cross-Sectional Survey
Objective and Design
Investigate whether NP autonomy within primary care practices and the relationships they ha ve with leadership affect teamwork between NPs and Physicians
314 primary care NPs returned surveys
Study utilized scales to measure independence and teamwork
Conclusions
1bull NP autonomy and leadership improves
teamwork
2
bull Suggested policies and organization changes should focus on promoting NP autonomy and improving relationships between NPs and leadership to improve tem work and consequently improve patient care outcomes
Changes in Headache
Erenumab
Fermanezumab
Galcanezumab
Coming Soonhellip
E D V I N S S O N L 1
H A N D B E X P P H A R M A C O L 2 0 1 9 F E B 7 D O I 1 0 1 0 0 7 1 6 4 _ 2 0 1 8 _ 2 0 1
Role of CGRP in Migraine
Migraines are common affecting up to 15 of the adult population
New medications targeting calcitonin gene related peptide (CGTR) or its receptor
Little to no adverse affects
Why Monoclonal Antibodies
S I M O N A L A T T A N Z IF R A N C E S C O B R I G O
E U G E N T R I N K AF A B R I Z I O V E R N I E R I
T O M M A S O C O R R A D E T T IM A U R O D O B R A N
M A U R O S I L V E S T R I N I
D R U G S 2 0 1 9 F E B 2 2 D O I 1 0 1 0 0 7 S 4 0 2 6 5 - 0 1 9 - 0 1 0 6 9 - 1
Erenumab for Preventive Treatment of Migraine A Systematic Review and Meta-Analysis of Efficacy and Safety
Background and Objective
Novel therapeutic options for daily uses for migraine prophylaxis
Inhibition of calcitonin gene related peptide
First fully human monoclonal antibody directed against CGRP
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
L U S I N E P A G H O S Y A N P H D M P H R N F A A N
J I A N G A N G L I U P H D M A S
J G E N I N T E R N M E D 2 0 1 6 J U L 3 1 ( 7 ) 7 7 1 - 7 D O I 1 0 1 0 0 7 S 1 1 6 0 6 - 0 1 6 - 3 6 5 2 - Z E P U B 2 0 1 6
M A R 7
Nurse Practitioner Autonomy and Relationships with leadership affect
teamwork in primary care practices a Cross-Sectional Survey
Objective and Design
Investigate whether NP autonomy within primary care practices and the relationships they ha ve with leadership affect teamwork between NPs and Physicians
314 primary care NPs returned surveys
Study utilized scales to measure independence and teamwork
Conclusions
1bull NP autonomy and leadership improves
teamwork
2
bull Suggested policies and organization changes should focus on promoting NP autonomy and improving relationships between NPs and leadership to improve tem work and consequently improve patient care outcomes
Changes in Headache
Erenumab
Fermanezumab
Galcanezumab
Coming Soonhellip
E D V I N S S O N L 1
H A N D B E X P P H A R M A C O L 2 0 1 9 F E B 7 D O I 1 0 1 0 0 7 1 6 4 _ 2 0 1 8 _ 2 0 1
Role of CGRP in Migraine
Migraines are common affecting up to 15 of the adult population
New medications targeting calcitonin gene related peptide (CGTR) or its receptor
Little to no adverse affects
Why Monoclonal Antibodies
S I M O N A L A T T A N Z IF R A N C E S C O B R I G O
E U G E N T R I N K AF A B R I Z I O V E R N I E R I
T O M M A S O C O R R A D E T T IM A U R O D O B R A N
M A U R O S I L V E S T R I N I
D R U G S 2 0 1 9 F E B 2 2 D O I 1 0 1 0 0 7 S 4 0 2 6 5 - 0 1 9 - 0 1 0 6 9 - 1
Erenumab for Preventive Treatment of Migraine A Systematic Review and Meta-Analysis of Efficacy and Safety
Background and Objective
Novel therapeutic options for daily uses for migraine prophylaxis
Inhibition of calcitonin gene related peptide
First fully human monoclonal antibody directed against CGRP
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Objective and Design
Investigate whether NP autonomy within primary care practices and the relationships they ha ve with leadership affect teamwork between NPs and Physicians
314 primary care NPs returned surveys
Study utilized scales to measure independence and teamwork
Conclusions
1bull NP autonomy and leadership improves
teamwork
2
bull Suggested policies and organization changes should focus on promoting NP autonomy and improving relationships between NPs and leadership to improve tem work and consequently improve patient care outcomes
Changes in Headache
Erenumab
Fermanezumab
Galcanezumab
Coming Soonhellip
E D V I N S S O N L 1
H A N D B E X P P H A R M A C O L 2 0 1 9 F E B 7 D O I 1 0 1 0 0 7 1 6 4 _ 2 0 1 8 _ 2 0 1
Role of CGRP in Migraine
Migraines are common affecting up to 15 of the adult population
New medications targeting calcitonin gene related peptide (CGTR) or its receptor
Little to no adverse affects
Why Monoclonal Antibodies
S I M O N A L A T T A N Z IF R A N C E S C O B R I G O
E U G E N T R I N K AF A B R I Z I O V E R N I E R I
T O M M A S O C O R R A D E T T IM A U R O D O B R A N
M A U R O S I L V E S T R I N I
D R U G S 2 0 1 9 F E B 2 2 D O I 1 0 1 0 0 7 S 4 0 2 6 5 - 0 1 9 - 0 1 0 6 9 - 1
Erenumab for Preventive Treatment of Migraine A Systematic Review and Meta-Analysis of Efficacy and Safety
Background and Objective
Novel therapeutic options for daily uses for migraine prophylaxis
Inhibition of calcitonin gene related peptide
First fully human monoclonal antibody directed against CGRP
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Conclusions
1bull NP autonomy and leadership improves
teamwork
2
bull Suggested policies and organization changes should focus on promoting NP autonomy and improving relationships between NPs and leadership to improve tem work and consequently improve patient care outcomes
Changes in Headache
Erenumab
Fermanezumab
Galcanezumab
Coming Soonhellip
E D V I N S S O N L 1
H A N D B E X P P H A R M A C O L 2 0 1 9 F E B 7 D O I 1 0 1 0 0 7 1 6 4 _ 2 0 1 8 _ 2 0 1
Role of CGRP in Migraine
Migraines are common affecting up to 15 of the adult population
New medications targeting calcitonin gene related peptide (CGTR) or its receptor
Little to no adverse affects
Why Monoclonal Antibodies
S I M O N A L A T T A N Z IF R A N C E S C O B R I G O
E U G E N T R I N K AF A B R I Z I O V E R N I E R I
T O M M A S O C O R R A D E T T IM A U R O D O B R A N
M A U R O S I L V E S T R I N I
D R U G S 2 0 1 9 F E B 2 2 D O I 1 0 1 0 0 7 S 4 0 2 6 5 - 0 1 9 - 0 1 0 6 9 - 1
Erenumab for Preventive Treatment of Migraine A Systematic Review and Meta-Analysis of Efficacy and Safety
Background and Objective
Novel therapeutic options for daily uses for migraine prophylaxis
Inhibition of calcitonin gene related peptide
First fully human monoclonal antibody directed against CGRP
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Changes in Headache
Erenumab
Fermanezumab
Galcanezumab
Coming Soonhellip
E D V I N S S O N L 1
H A N D B E X P P H A R M A C O L 2 0 1 9 F E B 7 D O I 1 0 1 0 0 7 1 6 4 _ 2 0 1 8 _ 2 0 1
Role of CGRP in Migraine
Migraines are common affecting up to 15 of the adult population
New medications targeting calcitonin gene related peptide (CGTR) or its receptor
Little to no adverse affects
Why Monoclonal Antibodies
S I M O N A L A T T A N Z IF R A N C E S C O B R I G O
E U G E N T R I N K AF A B R I Z I O V E R N I E R I
T O M M A S O C O R R A D E T T IM A U R O D O B R A N
M A U R O S I L V E S T R I N I
D R U G S 2 0 1 9 F E B 2 2 D O I 1 0 1 0 0 7 S 4 0 2 6 5 - 0 1 9 - 0 1 0 6 9 - 1
Erenumab for Preventive Treatment of Migraine A Systematic Review and Meta-Analysis of Efficacy and Safety
Background and Objective
Novel therapeutic options for daily uses for migraine prophylaxis
Inhibition of calcitonin gene related peptide
First fully human monoclonal antibody directed against CGRP
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
E D V I N S S O N L 1
H A N D B E X P P H A R M A C O L 2 0 1 9 F E B 7 D O I 1 0 1 0 0 7 1 6 4 _ 2 0 1 8 _ 2 0 1
Role of CGRP in Migraine
Migraines are common affecting up to 15 of the adult population
New medications targeting calcitonin gene related peptide (CGTR) or its receptor
Little to no adverse affects
Why Monoclonal Antibodies
S I M O N A L A T T A N Z IF R A N C E S C O B R I G O
E U G E N T R I N K AF A B R I Z I O V E R N I E R I
T O M M A S O C O R R A D E T T IM A U R O D O B R A N
M A U R O S I L V E S T R I N I
D R U G S 2 0 1 9 F E B 2 2 D O I 1 0 1 0 0 7 S 4 0 2 6 5 - 0 1 9 - 0 1 0 6 9 - 1
Erenumab for Preventive Treatment of Migraine A Systematic Review and Meta-Analysis of Efficacy and Safety
Background and Objective
Novel therapeutic options for daily uses for migraine prophylaxis
Inhibition of calcitonin gene related peptide
First fully human monoclonal antibody directed against CGRP
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Migraines are common affecting up to 15 of the adult population
New medications targeting calcitonin gene related peptide (CGTR) or its receptor
Little to no adverse affects
Why Monoclonal Antibodies
S I M O N A L A T T A N Z IF R A N C E S C O B R I G O
E U G E N T R I N K AF A B R I Z I O V E R N I E R I
T O M M A S O C O R R A D E T T IM A U R O D O B R A N
M A U R O S I L V E S T R I N I
D R U G S 2 0 1 9 F E B 2 2 D O I 1 0 1 0 0 7 S 4 0 2 6 5 - 0 1 9 - 0 1 0 6 9 - 1
Erenumab for Preventive Treatment of Migraine A Systematic Review and Meta-Analysis of Efficacy and Safety
Background and Objective
Novel therapeutic options for daily uses for migraine prophylaxis
Inhibition of calcitonin gene related peptide
First fully human monoclonal antibody directed against CGRP
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
S I M O N A L A T T A N Z IF R A N C E S C O B R I G O
E U G E N T R I N K AF A B R I Z I O V E R N I E R I
T O M M A S O C O R R A D E T T IM A U R O D O B R A N
M A U R O S I L V E S T R I N I
D R U G S 2 0 1 9 F E B 2 2 D O I 1 0 1 0 0 7 S 4 0 2 6 5 - 0 1 9 - 0 1 0 6 9 - 1
Erenumab for Preventive Treatment of Migraine A Systematic Review and Meta-Analysis of Efficacy and Safety
Background and Objective
Novel therapeutic options for daily uses for migraine prophylaxis
Inhibition of calcitonin gene related peptide
First fully human monoclonal antibody directed against CGRP
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Background and Objective
Novel therapeutic options for daily uses for migraine prophylaxis
Inhibition of calcitonin gene related peptide
First fully human monoclonal antibody directed against CGRP
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Results
Randomized placebo-controlled single or
double blinded trials
Primary Outcomes changes from baseline of monthly migraine days monthly
acute migraine medication days adverse events severe
adverse events and treatment withdrawal
Significant decrease in
monthly migraine days
with 70 mg and 140 mg dosing
Efficacious and well tolerated No change in AE SAEs or drug withdrawal
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
F Ouml R D E R R E U T H E R S 1 Z H A N G Q 2 S T A U F F E R V L 3 A U R O R A S K 4 L Aacute I N E Z M J A 5
J H E A D A C H E P A I N 2 0 1 8 D E C 2 9 1 9 ( 1 ) 1 2 1 D O I 1 0 1 1 8 6 S 1 0 1 9 4 - 0 1 8 - 0 9 5 1 - 2
Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent data from the phase 3 randomized
double-blind placebo-controlled EVOLVE-1 EVOLVE-2 and REGAIN studies
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Background Method
Compared maintenance of effect following treatment with glacanezumabcompared to placebo with episodic or chronic migraines
Two separate studies ( 3 months and 6 months)
Randomized to receive subcutaneous injection vs placebo
Galcanezumab
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Results and Conclusions
Effects Results
gt50 response decrease in 41 of patients
190 and 205
compared to 214
and 8 of placebo
1773 patients episodic
migraines
1113 patients with Chronic
migraines
120 mg and 240 mg
glacanezumab
Treatment demonstrated
statistically significant and
meaningful persistence of
effect
Participants
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Changes in supplements
Carbohydrate quality and
human health
Importance of Breakfast
Sleepmore in Seattle
Vitamin D supplements
and prevention of Cancer and
CV diease
Marine n-3 fatty acids and prevention of CV disease and Cancer
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Effect of breakfast on weight and energy intake systematic review and
meta-analysis of randomized controlled trials
B M J 2 0 1 9 3 6 4 1 4 2 D O I 1 0 1 1 3 6 B M J 1 4 2
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Which studies were reviewed
Randomized trials using adults comparing breakfast consumption as compared with no breakfast consumption
Primary end point was measurement of body weight and energy intake
13 trials reviewed
Follow up was 7 weeks or less
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Conclusions
Studies found that eating
breakfast might not be a good
strategy if weight loss is the
desired outcome
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Limitations
Low quality studies with
inconsistencies
Those eating breakfast had overall higher calorie intake
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Buthellip
Keep your eyes peeled for ongoing studies that may reveal mom was wrong and it was really ok that I didnrsquot want to eat breakfast all those years
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
N E N G L J M E D 2 0 1 9 3 8 0 3 3 - 4 4 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A L 1 8 0 9 9 4 4
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Methods
Randomized placebo-
controlled trial
Two-by-two factorial design
Vitamin D3 fat 2000 IU
daily and Omega 3 fatty acids at 1g per
day
Utilized men over age 50 women over 55 in the US
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Primary End Points
Invasive cancer of any type
Major cardiovascular
events (MI Stroke or CV related death)
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Results
25 871 participants
Median follow-up of 53 years
1617 participants diagnosed with cancer in vitamin D group and 824 in the placebo group
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Conclusions
Supplementation of vitamin D did not lower rates of invasive cancer or cardiovascular events when compared with placebo in initially healthy adults
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Limitations
1bull Other positive and negative trials have used bolus dosing vitamin D
2
bull Some trials had also looked at the inhibition of the carcinogenesis process in cancer related to vitamin D and showed some delays in cancer growths development and spread
2
bull Trial looked at moderately low vitamin D levels It could be that a different result was obtained in severe vitamin D deficiency (20 ng per ml or below) but would be unethical to keep a person that low long enough to complete a study comparing
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Marine n-3 Fatty Acids and Prevention of Cardiovascular
Disease and Cancer
N E N G L J M E D 2 0 1 9 3 8 0 2 3 - 3 2 ( J A N 2 0 1 9 )
D O I 1 0 1 0 5 6 N E J M O A 1 8 1 1 4 0 3
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Methods and Results
Same study design and methods as described above for the vitamin D study observing simultaneously the effects of Omega 3 fatty acids on cancer and CV disease
Omega 3 fatty acids supplementation did not lower the incidence of major cardiovascular disease or cancer in those 25 871 participants studied over 5 years when compared to placebo
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Further Study Recommendations
Studies at different dosages of omega 3 fatty acids (however the studied dose was the AHA recommended dose for those with history of CAD)
Perhaps consider follow up longer than 5 years
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Changes in Critical Care
Low vs Intermediate tidal Volume
Strategy
Early Sustained Prophylactic Hypothermia
Delirium in Critical Care
Illness
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
T D G I R A R D M C E X L I N E S S C A R S O N C L H O U G H P R O C K M N G O N G
I S D O U G L A S A M A L H O T R A R L O W E N S D J F E I N S T E I N B K H A N M A P I S A N I R C H Y Z Y G A S C H M I D T W D S C H W E I C K E R T R D H I T E D L B O W T O N A L M A S I C A J L
T H O M P S O N R C H A N D R A S E K H A R B T P U N C S T R E N G T H L M B O E H M J C J A C K S O N P P
P A N D H A R I P A N D E N E B R U M M E L C G H U G H E S M B P A T E L J L S T O L L I N G S G R B E R N A R D R S D I T T U S A N D E W E L Y F O R
T H E M I N D - U S A I N V E S T I G A T O R S
N E N G L J M E D 3 7 9 2 6 N E J M O R G D E C E M B E R 2 7 2 0 1 8
Haloperidol and Ziprasidone for Treatment of Delirium in
Critical Illness
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Method
Randomized double-blind placebo-controlled trial
Looked at 566 acute respiratory failure and shock patients who
developed hypoactive or hyperactive delirium
They were randomly assigned to haloperidol placebo or
ziprasidone
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Conclusions
No significant benefits from haloperidol or ziprasidone over placebo in treating delirium in acute respiratory failure or shock critically ill patients
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
W R I T I N G G R O U P F O R T H E P R E V E N T I N V E S T I G A T O R S S I M O N I S F D 1 S E R P A N E T O
A 1 2 B I N N E K A D E J M 1 B R A B E R A 3 B R U I N K C M 4 D E T E R M A N N R M 5 G O E K O O P G J 4 H E I D T
J 6 H O R N J 1 I N N E M E E G 6 D E J O N G E E 7 J U F F E R M A N S N P 1 S P R O N K P E 3 S T E U T E N
L M 8 T U I N M A N P R 9 D E W I L D E R B P 7 V R I E N D S M 9 G A M A D E A B R E U M 1 0 P E L O S I P 1 1 S C H U L T Z
M J 1 1 2
J A M A 2 0 1 8 3 2 0 ( 1 8 ) 1 8 7 2 - 1 8 8 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 4 2 8 0 P U B L I S H E D
O N L I N E O C T O B E R 2 4 2 0 1 8
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without
ARDS A Randomized Clinical Trial
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Design and Interventions
Randomized control trial from 9114-
82017
Intubated patients not expecting to be extubated within 24
hours without ARDS
477 patients randomized to low tidal volumes and
484 to intermediate tidal volumes
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Primary outcomes and secondary outcomes
Number of ventilator free days and 28 day mortality
Secondary- Length of ICU stay hospital stay 28 and 90 day mortality development of ARDS PNA severe atelectasis or pneumothorax
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Results Conclusions
No clinical significance in any of the outcomes between the low
tidal volumes and intermediate tidal volume group in patients
without ARDS
More Research Needed
bull So there were no improved outcomes but is harm done if low tidal volumes were used in ARDS patients
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
C O O P E R D J 1 2 N I C H O L A D 1 2 3 4 5 B A I L E Y M 1 B E R N A R D S 2 6 C A M E R O N P A 7 8 9 1 0 P I L I -
F L O U R Y S 1 1 F O R B E S A 7 G A N T N E R D 1 2 8 H I G G I N S A M 1 H U E T O 1 1 2 1 3 K A S Z A J 7 M U R R A Y L 1 N E W B Y L 1 1 4 P R E S N E I L L
J J 1 1 5 1 6 R A S H F O R D S 1 7 R O S E N F E L D J V 1 8 1 9 2 0 S T E P H E N S O N M 1 6 V A L L A N C E
S 1 2 V A R M A D 1 9 2 1 W E B B S A R 1 2 2 T R A P A N I T 1 2 M C A R T H U R C 1 1 4 P O L A R T R I A L
I N V E S T I G A T O R S A N D T H E A N Z I C S C L I N I C A L T R I A L S G R O U P
J A M A 2 0 1 8 D E C 4 3 2 0 ( 2 1 ) 2 2 1 1 - 2 2 2 0 D O I 1 0 1 0 0 1 J A M A 2 0 1 8 1 7 0 7 5
Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury
The POLAR Randomized Clinical Trial
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Question
Question
Does prophylactic hypothermia improve long-term neurologic
outcomes in TBI
Design
bull Recruited from 2010- 2017 with follow-up ending in 2018 Multicenter randomized trial in 6 countries
bull 511 patients
Interventions
bull 266 Patients randomized to the hypothermia group (33-35 degrees Celsius) Cooled at least 72 hours but up to 7 days if continued elevated intracranial pressures
bull 245 to normothermia (37 degrees celsius)
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
Outcomes and Conclusion
Measurable Outcomes
Favorable neurological outcomes measured by GlascowOutcome Scale- Extended score 5-8 at 6 months
Conclusion
Patients with TBI with early prophylactic hypothermia did not have improved neurological outcomes at 6 months over normothermia group
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour
J OIN US DOWNTOWN A T 6 PMPA SSERELLE BISTRO
Networking Hour