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Jama

Cardiology

Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement.

Last Revised:
PMID: 38051324
DOI: 10.1001/jama.2023.19793
PII: 2812475

Summary

This abstract discusses the development of a consensus-based extension to the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement for factorial trials. The process involved a review of methodological articles, a 3-round Delphi survey, and a hybrid consensus meeting. The extension modifies 16 items in the CONSORT 2010 checklist and adds one new item, providing guidance on reporting for factorial randomized trials to improve understanding and transparency.

Key Takeaways

  • The extension to the CONSORT 2010 Statement for factorial trials has been developed using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework.
  • The process involved a review of methodological articles, a three-round Delphi survey, and a final consensus meeting, resulting in the modification of 16 checklist items and the addition of one new item.
  • The extension provides guidance on how to report factorial randomized trials, such as clearly identifying main comparisons and reporting the estimated interaction effect, thus facilitating greater transparency and understanding.

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Authors

Brennan C Kahan, Sophie S Hall, Elaine M Beller, Megan Birchenall, An-Wen Chan, Diana Elbourne, Paul Little, John Fletcher, Robert M Golub, Beatriz Goulao, Sally Hopewell, Nazrul Islam, Merrick Zwarenstein, Edmund Juszczak, Alan A Montgomery

Full Abstract

  • IMPORTANCE: Transparent reporting of randomized trials is essential to facilitate critical appraisal and interpretation of results. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique methodological considerations. However, reporting of factorial trials is suboptimal.
  • OBJECTIVE: To develop a consensus-based extension to the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement for factorial trials.
  • DESIGN: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT extension for factorial trials was developed by (1) generating a list of reporting recommendations for factorial trials using a scoping review of methodological articles identified using a MEDLINE search (from inception to May 2019) and supplemented with relevant articles from the personal collections of the authors; (2) a 3-round Delphi survey between January and June 2022 to identify additional items and assess the importance of each item, completed by 104 panelists from 14 countries; and (3) a hybrid consensus meeting attended by 15 panelists to finalize the selection and wording of items for the checklist.
  • FINDINGS: This CONSORT extension for factorial trials modifies 16 of the 37 items in the CONSORT 2010 checklist and adds 1 new item. The rationale for the importance of each item is provided. Key recommendations are (1) the reason for using a factorial design should be reported, including whether an interaction is hypothesized, (2) the treatment groups that form the main comparisons should be clearly identified, and (3) for each main comparison, the estimated interaction effect and its precision should be reported.
  • CONCLUSIONS AND RELEVANCE: This extension of the CONSORT 2010 Statement provides guidance on the reporting of factorial randomized trials and should facilitate greater understanding of and transparency in their reporting.

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