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

doi:10.1136/bmj-2024-080785

All Outputs (2)

Mixed-methods study to develop extensions to the SPIRIT and CONSORT statements for factorial randomised trials: the Reporting Factorial Trials (RAFT) study (2025)
Journal Article
Hall, S. S., Juszczak, E., Birchenall, M., Elbourne, D., Beller, E., Chan, A.-W., Little, P., Montgomery, A. A., & Kahan, B. C. (2025). Mixed-methods study to develop extensions to the SPIRIT and CONSORT statements for factorial randomised trials: the Reporting Factorial Trials (RAFT) study. BMJ Open, 15(2), Article e082917. https://doi.org/10.1136/bmjopen-2023-082917

Background Extensions to Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) reporting recommendations specifically for factorial trials have been developed by the Repor... Read More about Mixed-methods study to develop extensions to the SPIRIT and CONSORT statements for factorial randomised trials: the Reporting Factorial Trials (RAFT) study.

Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions (2025)
Journal Article
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

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. Factori... Read More about Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions.