Journal article
Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions
- 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.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, pdf, 564.0KB, Terms of use)
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- Publisher copy:
- 10.1136/bmj-2024-080785
Authors
+ Medical Research Council
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- Funder identifier:
- https://ror.org/03x94j517
- Grant:
- MC_UU_00004/09
- MC_UU_00004/07
- MR/V020803/1
- Publisher:
- BMJ Publishing Group
- Journal:
- British Medical Journal More from this journal
- Volume:
- 388
- Article number:
- e080785
- Place of publication:
- England
- Publication date:
- 2025-02-04
- Acceptance date:
- 2024-09-24
- DOI:
- EISSN:
-
0959-8138
- ISSN:
-
1759-2151
- Pmid:
-
39904527
- Language:
-
English
- Keywords:
- Pubs id:
-
2084718
- Local pid:
-
pubs:2084718
- Deposit date:
-
2025-03-31
- ARK identifier:
Terms of use
- Copyright holder:
- Kahan et al
- Copyright date:
- 2025
- Rights statement:
- © 2025 The Authors. This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.
- Licence:
- CC Attribution (CC BY)
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