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Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement
Brennan C Kahan1, Sophie S Hall2, Elaine M Beller3
1MRC Clinical Trials Unit at UCL, London, United Kingdom.
JAMA Network Open
|December 5, 2023
Summary
This study developed a new reporting guideline for factorial trials to improve transparency. The guideline, an extension of the SPIRIT 2013 Statement, includes 9 new items for trial protocols.
Area of Science:
- Clinical Trials Methodology
- Health Research Reporting Standards
Background:
- Transparent reporting of trial protocols is crucial for clarity and assessing study methods.
- Factorial trials, assessing multiple interventions simultaneously, present unique reporting challenges.
- Existing guidelines like the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement lack specific extensions for factorial designs.
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