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- 6. Transparent Repor(ng & Systema(cReviews • “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 86 hkp:// community.cochrane.or g/about-us/evidence- based-health-care
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- 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 2016-10-17 | UC Berkeley Alasdair Cohen | Lecture for Publich Health 250B 88
- 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 2016-10-17 | UC Berkeley Alasdair Cohen | Lecture for Publich Health 250B 89
- 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 2016-10-17 | UC Berkeley Alasdair Cohen | Lecture for Publich Health 250B 90
- 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 2016-10-17 | UC Berkeley Alasdair Cohen | Lecture for Publich Health 250B 91
- 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 2016-10-17 | UC Berkeley Alasdair Cohen | Lecture for Publich Health 250B 92
- 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 2016-10-17 | UC Berkeley Alasdair Cohen | Lecture for Publich Health 250B 93 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 2016-10-17 | UC Berkeley Alasdair Cohen | Lecture for Publich Health 250B 94
- 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) 2016-10-17 | UC Berkeley Alasdair Cohen | Lecture for Publich Health 250B 95
- 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 2016-10-17 | UC Berkeley Alasdair Cohen | Lecture for Publich Health 250B 96
- 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 2016-10-17 | UC Berkeley Alasdair Cohen | Lecture for Publich Health 250B 97