Journal article
Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration
- Abstract:
- Randomised controlled trials commonly use surrogate endpoints to substitute for a target outcome (outcome of direct interest and relevance to trial participants, clinicians, and other stakeholders—eg, all cause mortality) to improve their efficiency (through shorter trial duration, reduced sample size, and thus lower research costs), or for ethical or practical reasons. But reliance on surrogate endpoints can increase the uncertainty of an intervention’s treatment effect and potential failure to provide adequate information on intervention harms, which has led to calls for improved reporting of trials using surrogate endpoints. This report presents a consensus driven reporting guideline for trials using surrogate endpoints as the primary outcomes—the CONSORT (Consolidated Standards of Reporting Trials) extension checklist: CONSORT-Surrogate. The extension includes nine items modified from the CONSORT 2010 checklist and two new items. Examples and explanations for each item are provided. We recommend that all stakeholders (including trial investigators and sponsors, journal editors and peer reviewers, research ethics reviewers, and funders) use this extension in reporting trial reports using surrogate endpoints. Use of this checklist will improve transparency, interpretation, and usefulness of trial findings, and ultimately reduce research waste.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
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(Preview, Version of record, pdf, 278.9KB, Terms of use)
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- Publisher copy:
- 10.1136/bmj-2023-078524
Authors
+ Cancer Research UK
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- Funder identifier:
- https://ror.org/054225q67
- Grant:
- 27294
- Publisher:
- BMJ Publishing Group
- Journal:
- British Medical Journal More from this journal
- Volume:
- 386
- Article number:
- e078524
- Place of publication:
- England
- Publication date:
- 2024-07-09
- Acceptance date:
- 2024-04-30
- DOI:
- EISSN:
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0959-8138
- ISSN:
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1759-2151
- Pmid:
-
38981645
- Language:
-
English
- Keywords:
- Pubs id:
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2015544
- Local pid:
-
pubs:2015544
- Deposit date:
-
2025-03-17
- ARK identifier:
Terms of use
- Copyright holder:
- Manyara et al
- Copyright date:
- 2024
- Rights statement:
- © the Author(s) 2024. 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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