All Outputs (4)

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.

Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement (2023)
Journal Article
Kahan, B. C., Hall, S. S., Beller, E. M., Birchenall, M., Chan, A.-W., Elbourne, D., Little, P., Fletcher, J., Golub, R. M., Goulao, B., Hopewell, S., Islam, N., Zwarenstein, M., Juszczak, E., & Montgomery, A. A. (2023). Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA Network Open, 330(21), 2106-2114. https://doi.org/10.1001/jama.2023.19793

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 method... Read More about Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement.

Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement (2023)
Journal Article
Kahan, B. C., Hall, S. S., Beller, E. M., Birchenall, M., Elbourne, D., Juszczak, E., Little, P., Fletcher, J., Golub, R. M., Goulao, B., Hopewell, S., Islam, N., Zwarenstein, M., Chan, A.-W., & Montgomery, A. A. (2023). Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement. JAMA Network Open, 6(12), Article e2346121. https://doi.org/10.1001/jamanetworkopen.2023.46121

Importance

Trial protocols outline a trial’s objectives as well as the methods (design, conduct, and analysis) that will be used to meet those objectives, and transparent reporting of trial protocols ensures objectives are clear and facilitates... Read More about Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement.