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1. 2016-10-17 | UC Berkeley Alasdair Cohen | Lecture for Publich Health 250B 81
Addi(onal Slides

2. Publica(on Bias
Trends…
2016-10-17 | UC Berkeley
Alasdair Cohen | Lecture for Publich Health 250B
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3. P-hacking
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4. Negligent/sub-
standard Science
2016-10-17 | UC Berkeley
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5. Cochrane Reviews
2016-10-17 | UC Berkeley
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hkp://community.cochrane.org/cochrane-reviews
“We gather and
summarize the best
evidence from research
to help you make
informed choices about
treatment...
Cochrane contributors -
37,000 from more than
130 countries - work
together to produce
credible, accessible
health informa)on that
is free from commercial
sponsorship and other
conflicts of interest.”

6. Transparent Repor(ng
& Systema(c Reviews
• “Systema)c reviews seek to collate all evidence that fits pre-specified
eligibility criteria in order to address a specific research ques)on
• Systema)c reviews aim to minimize bias by using explicit, systema)c
methods
• The Cochrane Collabora)on prepares, maintains and promotes systema)c
reviews to inform healthcare decisions: Cochrane Reviews”
2016-10-17 | UC Berkeley
Alasdair Cohen | Lecture for Publich Health 250B
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hkp://
community.cochrane.or
g/about-us/evidence-
based-health-care

7. 2016-10-17 | UC Berkeley Alasdair Cohen | Lecture for Publich Health 250B 87
Details on CONSORT Checklist

8. CONSORT Checklist
Introduc(on
TITLE & ABSTRACT
• 1a. Iden)fica)on as a randomised trial in the )tle
• 1b. Structured summary of trial design, methods, results, and conclusions (for
specific guidance see CONSORT for abstracts)
BACKGROUND & OBJECTIVES
• 2a. Scien)fic background and explana)on of ra)onale
• 2b. Specific objec)ves or hypotheses
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9. CONSORT Checklist:
Methods
TRIAL DESIGN
• 3a. Descrip)on of trial design (such as parallel, factorial) including alloca)on
ra)o
• 3b. Important changes to methods ajer trial commencement (such as
eligibility criteria), with reasons
PARTICIPANTS
• 4a. Eligibility criteria for par)cipants
• 5a. Se{ngs and loca)ons where the data were collected
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10. CONSORT Checklist:
Methods
INTERVENTIONS
• 5. The interven)ons for each group with sufficient details to allow replica)on,
including how and when they were actually administered
OUTCOMES
• 6a. Completely defined pre-specified primary and secondary outcome
measures, including how and when they were assessed
• 6b. Any changes to trial outcomes ajer the trial commenced, with reasons
SAMPLE SIZE
• 7a. How sample size was determined
• 7b. When applicable, explana)on of any interim analyses and stopping
guidelines
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11. CONSORT Checklist:
Methods
RANDOMIZATION: SEQUENCE GENERATION
• 8a. Method used to generate the random alloca)on sequence
• 8b. Type of randomisa)on; details of any restric)on (such as blocking and
block size)
RANDOMIZATION: ALLOCATION CONCEALMENT
• 9. Mechanism used to implement the random alloca)on sequence (such as
sequen)ally numbered containers), describing any steps taken to conceal the
sequence un)l interven)ons were assigned
RANDOMIZATION: IMPLEMENTATION
• 10. Who generated the random alloca)on sequence, who enrolled
par)cipants, and who assigned par)cipants to interven)ons
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12. CONSORT Checklist:
Methods
BLINDING
• 11a. If done, who was blinded ajer assignment to interven)ons (for example,
par)cipants, care providers, those assessing outcomes) and how
• 11b. If relevant, descrip)on of the similarity of interven)ons
STATISTICAL METHODS
• 12a. Sta)s)cal methods used to compare groups for primary and secondary
outcomes
• 12b. Methods for addi)onal analyses, such as subgroup analyses and adjusted
analyses
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13. CONSORT Checklist:
Results
PARTICIPANT FLOW
(DIAGRAM
RECOMMENDED)
• 13a. For each group, the
numbers of par)cipants
who were randomly
assigned, received
intended treatment, and
were analysed for the
primary outcome
• 13b. For each group,
losses and exclusions
ajer randomisa)on,
together with reasons
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CONSORT 2010 Flow Diagram
Assessed for eligibility (n= )
Excluded (n= )
¨ Not meeting inclusion criteria (n= )
¨ Declined to participate (n= )
¨ Other reasons (n= )
Analysed (n= )
¨ Excluded from analysis (give reasons) (n= )
Lost to follow-up (give reasons) (n= )
Discontinued intervention (give reasons) (n= )
Allocated to intervention (n= )
¨ Received allocated intervention (n= )
¨ Did not receive allocated intervention (give
reasons) (n= )
Lost to follow-up (give reasons) (n= )
Discontinued intervention (give reasons) (n= )
Allocated to intervention (n= )
¨ Received allocated intervention (n= )
¨ Did not receive allocated intervention (give
reasons) (n= )
Analysed (n= )
¨ Excluded from analysis (give reasons) (n= )
Allocation
Analysis
Follow-Up
Randomized (n= )
Enrollment

14. CONSORT Checklist:
Results
RECRUITMENT
• 14a. Dates defining the periods of recruitment and follow-up
• 14b. Why the trial ended or was stopped
BASELINE DATA
• 15. A table showing baseline demographic and clinical characteris)cs for each
group
NUMBER ANALYZED
• 16. For each group, number of par)cipants (denominator) included in each
analysis and whether the analysis was by original assigned groups
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15. CONSORT Checklist:
Results
OUTCOMES AND ESTIMATION
• 17a. For each primary and secondary outcome, results for each group, and the
es)mated effect size and its precision (such as 95% confidence interval)
• 17b. For binary outcomes, presenta)on of both absolute and rela)ve effect
sizes is recommended
ANCILLARY ANALYSES
• 18. Results of any other analyses performed, including subgroup analyses and
adjusted analyses, dis)nguishing pre-specified from exploratory
HARMS
• All important harms or unintended effects in each group
(for specific guidance see CONSORT for harms)
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16. CONSORT Checklist:
Discussion
LIMITATIONS
• 20. Trial limita)ons, addressing sources of poten)al bias, imprecision, and, if
relevant, mul)plicity of analyses
GENERALIZABILITY
• 21. Generalizability (external validity, applicability) of the trial findings
INTERPRETATION
• 22. Interpreta)on consistent with results, balancing benefits and harms, and
considering other relevant evidence
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17. CONSORT Checklist:
Other Informa(on
REGISTRATION
• 23. Registra)on number and name of trial registry
PROTOCOL
• 24. Where the full trial protocol can be accessed, if available
FUNDING
• 25. Sources of funding and other support (such as supply of drugs), role of
funders
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