Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): Extension checklist with explanation and elaboration

Anthony Muchai Manyara, Philippa Davies, Derek Stewart, Christopher J. Weir, Amber E. Young, Jane Blazeby, Nancy J. Butcher, Sylwia Bujkiewicz, An Wen Chan, Dalia Dawoud, Martin Offringa, Mario Ouwens, Asbjørn Hróbjartssson, Alain Amstutz, Luca Bertolaccini, Vito Domenico Bruno, Declan Devane, Christina D.C.M. Faria, Peter B. Gilbert, Ray HarrisMarissa Lassere, Lucio Marinelli, Sarah Markham, John H. Powers, Yousef Rezaei, Laura Richert, Falk Schwendicke, Larisa G. Tereshchenko, Achilles Thoma, Alparslan Turan, Andrew Worrall, Robin Christensen, Gary S. Collins, Joseph S. Ross, Rod S. Taylor, Oriana Ciani

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

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: CONSORTSurrogate. 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.

Original languageEnglish
Article numbere078524
JournalThe BMJ
DOIs
StatePublished - Jul 9 2024

Funding

Funding: The research was funded as part of the development of SPIRIT and CONSORT extensions by the UK Medical Research Council (grant MR/V038400/1). GSC was supported by Cancer Research UK (programme grant C49297/A27294). JB was supported by the NIHR Bristol Biomedical Research centre. SB was supported by the UK Medical Research Council (MR/T025166/1) and Leicester NIHR Biomedical Research Centre. AA receives his salary from the Research Fund Junior Researchers of the University of Basel. RC acknowledges that the Section for Biostatistics and Evidence-Based Research (Parker Institute, Bispebjerg and Frederiksberg Hospital) is supported by core grants. CDCMF receives research productivity fellowships from the Oak Foundation (OCAY-18-774-OFIL) and National Council for Scientific and Technological Development (CNPq/Brazil grant 08516/2021-4). The views expressed in this article are those of the authors and not their employers or funders. The funders had no role in the design and conduct of the study; the data collection, management, analysis, and interpretation; the drafting, review, or approval of the manuscript; or the decision to submit the manuscript for publication. This article reflects personal the views of the authors, the Delphi participants, and the consensus meeting delegates, and may not represent the views of the broader stakeholder groups, authors\u2019 institutions, or other affiliations.

FundersFunder number
core grants
NIHR Bristol Biomedical Research Centre
Section for Biostatistics and Evidence-Based Research
Universität Basel
NIHR Leicester Biomedical Research Centre
National Council for Scientific and Technological Development
CNPq
Brazil08516/2021-4
Cancer Research UKC49297/A27294
Cancer Research UK
Medical Research CouncilMR/T025166/1, MR/V038400/1
Medical Research Council
Oak FoundationOCAY-18-774-OFIL
Oak Foundation

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