Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions

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

doi:10.1136/bmj-2024-080785

Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions

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

^*Corresponding author for this work

Institute for Evidence-Based Healthcare

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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.

Original language	English
Article number	e080785
Pages (from-to)	1-21
Number of pages	21
Journal	BMJ
Volume	388
DOIs	https://doi.org/10.1136/bmj-2024-080785
Publication status	Published - 4 Feb 2025

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10.1136/bmj-2024-080785Licence: CC BY

Guidance for protocol content and reporting of factorial randomised trials explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensionsFinal published version, 564 KBLicence: CC BY

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Kahan, B. C., Juszczak, E., Beller, E., Birchenall, M., Chan, A. W., Hall, S., Little, P., Fletcher, J., Golub, R. M., Goulao, B., Hopewell, S., Islam, N., Zwarenstein, M., Elbourne, D., & Montgomery, A. (2025). Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions. BMJ, 388, 1-21. Article e080785. https://doi.org/10.1136/bmj-2024-080785

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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.",

author = "Kahan, {Brennan C.} and Edmund Juszczak and Elaine Beller and Megan Birchenall and Chan, {An Wen} and Sophie Hall and Paul Little and John Fletcher and Golub, {Robert M.} and Beatriz Goulao and Sally Hopewell and Nazrul Islam and Merrick Zwarenstein and Diana Elbourne and Alan Montgomery",

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doi = "10.1136/bmj-2024-080785",

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Kahan, BC, Juszczak, E, Beller, E, Birchenall, M, Chan, AW, Hall, S, Little, P, Fletcher, J, Golub, RM, Goulao, B, Hopewell, S, Islam, N, Zwarenstein, M, Elbourne, D & Montgomery, A 2025, 'Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions', BMJ, vol. 388, e080785, pp. 1-21. https://doi.org/10.1136/bmj-2024-080785

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AU - Kahan, Brennan C.

AU - Juszczak, Edmund

AU - Beller, Elaine

AU - Birchenall, Megan

AU - Chan, An Wen

AU - Hall, Sophie

AU - Little, Paul

AU - Fletcher, John

AU - Golub, Robert M.

AU - Goulao, Beatriz

AU - Hopewell, Sally

AU - Islam, Nazrul

AU - Zwarenstein, Merrick

AU - Elbourne, Diana

AU - Montgomery, Alan

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Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions

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