Clinical trial: reporting results

Notes related to clinical trial reporting

Resources

• Coursera course Design and interpretation of clinical trials by Johns Hopkins University

CONSORT

Consolidated Standards of Reporting Trials

25 item checklist. Not a guideline of how to do the trial; but a guideline for writers on how to report clearly.

Title

• key design items
• treatment(s) evaluated
• disease or population studied

Abstract

• design, method, results, conclusions

Introduction

• backgrounds, rationale, establish equipoise (balance), systematic review, objectives / hypothesis

Method

• IRB review and approvals
• trial design, allocation ratio
• eligibility criteria
• setting and location of the trial
• intervention - detailed enough to allow replication
• outcomes - primary, secondary, how assessed and defined
• sample size - how determined, interim analyses
• important changes during trial
• randomization, allocation concealment, implementation
• masking - who, how
• statistical methods - primary and secondary; subgroup analyses

Convenient to use a flow-chart

Baseline characteristics by treatment group

p-values (common to not report in rct?)

Evaluate literature

• Legitimacy, is it a fair comparison
• Trustworthy investigators? conflict of interest
• Adequate protections against bias
  • randomization
  • masking
  • follow-up design and execution
• ITT analysis
  • have all events (outcomes) observed been counted in the treatment group assigned?
  • variations in denominators explained and consistent with good practice?
• appropriate subgroup analysis interpretation
  • ad hoc or post hoc status