Reporting of factorial randomized trials: extension of the CONSORT 2010 statement
Reporting of factorial randomized trials: extension of the CONSORT 2010 statement
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.
2106-2114
Kahan, Brennan C.
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Hall, Sophie S.
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Beller, Elaine M.
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Birchenall, Megan
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Chan, An-Wen
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Elbourne, Diana
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Little, Paul
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Fletcher, John
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Golub, Robert M.
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Goulao, Beatriz
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Hopewell, Sally
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Islam, Nazrul
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Zwarenstein, Merrick
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Juszczak, Edmund
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Montgomery, Alan A.
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5 December 2023
Kahan, Brennan C.
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Hall, Sophie S.
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Beller, Elaine M.
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Birchenall, Megan
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Chan, An-Wen
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Elbourne, Diana
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Little, Paul
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Fletcher, John
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Golub, Robert M.
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Goulao, Beatriz
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Hopewell, Sally
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Islam, Nazrul
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Zwarenstein, Merrick
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Juszczak, Edmund
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Montgomery, Alan A.
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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 and Montgomery, Alan A.
(2023)
Reporting of factorial randomized trials: extension of the CONSORT 2010 statement.
JAMA, 330 (21), .
(doi:10.1001/jama.2023.19793).
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.
Text
CONSORT extension paper_JAMA_AuthorAcceptedVersion
- Accepted Manuscript
More information
Accepted/In Press date: 13 September 2023
Published date: 5 December 2023
Additional Information:
Funding/Support: this work was supported by the Medical Research Council (grant No. MR/V020803/1).
Identifiers
Local EPrints ID: 486969
URI: http://eprints.soton.ac.uk/id/eprint/486969
ISSN: 0098-7484
PURE UUID: 29cea319-ad47-4eae-8e8c-e10110ea64ea
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Date deposited: 09 Feb 2024 17:31
Last modified: 18 Mar 2024 04:08
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Contributors
Author:
Brennan C. Kahan
Author:
Sophie S. Hall
Author:
Elaine M. Beller
Author:
Megan Birchenall
Author:
An-Wen Chan
Author:
Diana Elbourne
Author:
John Fletcher
Author:
Robert M. Golub
Author:
Beatriz Goulao
Author:
Sally Hopewell
Author:
Nazrul Islam
Author:
Merrick Zwarenstein
Author:
Edmund Juszczak
Author:
Alan A. Montgomery
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