Brennan C. Kahan
Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions
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; Montgomery, Alan
Authors
Professor ED JUSZCZAK ED.JUSZCZAK@NOTTINGHAM.AC.UK
PROFESSOR OF CLINICAL TRIALS AND STATISTICS IN MEDICINE
Elaine Beller
Megan Birchenall
An-Wen Chan
Dr SOPHIE HALL Sophie.Hall@nottingham.ac.uk
SENIOR RESEARCH FELLOW
Paul Little
John Fletcher
Robert M. Golub
Beatriz Goulao
Sally Hopewell
Nazrul Islam
Merrick Zwarenstein
Diana Elbourne
Professor ALAN MONTGOMERY ALAN.MONTGOMERY@NOTTINGHAM.AC.UK
DIRECTOR NOTTINGHAM CLINICAL TRIALS UNIT
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.
Citation
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, Article e080785. https://doi.org/10.1136/bmj-2024-080785
| Journal Article Type | Article |
|---|---|
| Acceptance Date | Sep 24, 2024 |
| Online Publication Date | Feb 4, 2025 |
| Publication Date | Feb 4, 2025 |
| Deposit Date | Feb 4, 2025 |
| Publicly Available Date | Feb 4, 2025 |
| Journal | BMJ |
| Print ISSN | 0959-8138 |
| Electronic ISSN | 1756-1833 |
| Publisher | BMJ Publishing Group |
| Peer Reviewed | Peer Reviewed |
| Volume | 388 |
| Article Number | e080785 |
| DOI | https://doi.org/10.1136/bmj-2024-080785 |
| Public URL | https://nottingham-repository.worktribe.com/output/45036377 |
| Publisher URL | https://www.bmj.com/content/388/bmj-2024-080785 |
Files
Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions
(577 Kb)
PDF
Licence
https://creativecommons.org/licenses/by/4.0/
Publisher Licence URL
https://creativecommons.org/licenses/by/4.0/