Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions
Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions
This report presents the explanation and elaboration paper for the CONSORT (Consolidated Standards of Reporting Trials) 2010 and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 extensions for factorial trials. Factorial trials involve randomising participants to more than one intervention, often with the aim of evaluating multiple interventions in one study or assessing whether treatments interact. The CONSORT and SPIRIT statements have been extended to allow for the unique features of the factorial design. Reporting items along with detailed explanations and examples of good practice are provided, as well as a glossary of key terms and an overview of the methodological features of factorial trials.
Kahan, Brennan C.
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Juszczak, Edmund
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Beller, Elaine
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Birchenall, Megan
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Chan, An-Wen
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Hall, Sophie
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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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Elbourne, Diana
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Montgomery, Alan
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4 February 2025
Kahan, Brennan C.
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Juszczak, Edmund
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Beller, Elaine
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Birchenall, Megan
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Chan, An-Wen
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Hall, Sophie
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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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Elbourne, Diana
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Montgomery, Alan
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Kahan, Brennan C., Juszczak, Edmund, Beller, Elaine, Birchenall, Megan, Chan, An-Wen, Hall, Sophie, Little, Paul, Fletcher, John, Golub, Robert M, Goulao, Beatriz, Hopewell, Sally, Islam, Nazrul, Zwarenstein, Merrick, Elbourne, Diana and Montgomery, Alan
(2025)
Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions.
BMJ, 388, [e080785].
(doi:10.1136/bmj-2024-080785).
Abstract
This report presents the explanation and elaboration paper for the CONSORT (Consolidated Standards of Reporting Trials) 2010 and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 extensions for factorial trials. Factorial trials involve randomising participants to more than one intervention, often with the aim of evaluating multiple interventions in one study or assessing whether treatments interact. The CONSORT and SPIRIT statements have been extended to allow for the unique features of the factorial design. Reporting items along with detailed explanations and examples of good practice are provided, as well as a glossary of key terms and an overview of the methodological features of factorial trials.
Text
bmj-2024-080785.full
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Accepted/In Press date: 24 September 2024
Published date: 4 February 2025
Identifiers
Local EPrints ID: 498956
URI: http://eprints.soton.ac.uk/id/eprint/498956
ISSN: 0959-8138
PURE UUID: 2b2de1f7-b4bd-4e77-aa43-ea0ae2414ef9
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Date deposited: 05 Mar 2025 17:38
Last modified: 06 Mar 2025 03:06
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Contributors
Author:
Brennan C. Kahan
Author:
Edmund Juszczak
Author:
Elaine Beller
Author:
Megan Birchenall
Author:
An-Wen Chan
Author:
Sophie Hall
Author:
John Fletcher
Author:
Robert M Golub
Author:
Beatriz Goulao
Author:
Sally Hopewell
Author:
Nazrul Islam
Author:
Merrick Zwarenstein
Author:
Diana Elbourne
Author:
Alan Montgomery
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