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Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement
Brennan C Kahan1, Sophie S Hall2, Elaine M Beller3
1MRC Clinical Trials Unit at UCL, London, United Kingdom.
JAMA
|December 5, 2023
Summary
Reporting of factorial randomized trials is improved with a new CONSORT extension. This guidance enhances transparency and understanding of complex trial designs, ensuring better critical appraisal of results.
Area of Science:
- Clinical Trials Methodology
- Health Research Reporting Standards
Background:
- Transparent reporting of randomized trials is crucial for critical appraisal.
- Factorial trials, assessing multiple interventions simultaneously, have unique reporting needs.
- Current reporting practices for factorial trials are suboptimal.
Purpose of the Study:
- To develop a consensus-based extension to the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement specifically for factorial trials.
Main Methods:
- A scoping review of methodological articles was conducted.
- A 3-round Delphi survey involving 104 panelists from 14 countries was performed.
- A hybrid consensus meeting with 15 panelists finalized the reporting checklist.
Main Results:
- The CONSORT extension modifies 16 existing items and adds 1 new item to the CONSORT 2010 checklist.
- Key recommendations include reporting the rationale for factorial design, identifying main comparison groups, and reporting interaction effects.
Conclusions:
- This CONSORT extension provides essential guidance for reporting factorial randomized trials.
- The extension aims to improve transparency and facilitate a greater understanding of these complex trial designs.
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