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

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

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.

Citation

Kahan, B. C., Hall, S. S., Beller, E. M., Birchenall, M., Chan, A.-W., Elbourne, D., …Montgomery, A. A. (2023). Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA Network Open, 330(21), 2106-2114. https://doi.org/10.1001/jama.2023.19793

• Journal Article Type: Article
• Acceptance Date: Sep 13, 2023
• Online Publication Date: Dec 5, 2023
• Publication Date: Dec 5, 2023
• Deposit Date: Oct 30, 2023
• Publicly Available Date: Oct 30, 2023
• Journal: JAMA Network Open
• Electronic ISSN: 2574-3805
• Publisher: American Medical Association
• Peer Reviewed: Peer Reviewed
• Volume: 330
• Issue: 21
• Pages: 2106-2114
• DOI: https://doi.org/10.1001/jama.2023.19793
• Keywords: General Medicine
• Public URL: https://nottingham-repository.worktribe.com/output/26795042
• Publisher URL: https://jamanetwork.com/journals/jama/fullarticle/2812475