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

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

BMJ· 2024-07-09· article· 53 citationshybrid

Meta-analysis and systematic reviews Statistical Methods in Clinical Trials Delphi Technique in Research

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.

Cite this

Anthony Muchai Manyara, Philippa A. Davies, Derek Stewart, Christopher John Weir, Amber E. Young, Jane M. Blazeby, … Oriana Ciani (2024). Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration. BMJ. https://doi.org/10.1136/bmj-2023-078524

@article{muchai2024reporting,
  title  = {Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration},
  author = {Manyara, Anthony Muchai and Davies, Philippa A. and Stewart, Derek and Weir, Christopher John and Young, Amber E. and Blazeby, Jane M. and Butcher, Nancy J. and Bujkiewicz, Sylwia and Chan, An‐Wen and Dawoud, Dalia and Offringa, Martin and Ouwens, Mario and Hróbjartsson, Asbjørn and Amstutz, Alain and Bertolaccini, Luca and Bruno, Vito Domenico and Devane, Declan and Faria, Christina Danielli Coelho de Morais and Gilbert, Peter B. and Harris, Ray and Lassere, Marissa Nichole and Marinelli, Lucio and Markham, Sarah and Powers, John H. and Rezaei, Yousef and Richert, Laura E. and Schwendicke, Falk and Tereshchenko, Larisa G. and Turan, Alparslan and Worrall, Andrew and Christensen, Robin and Collins, Professor Gary S. and Ross, Joseph S. and Taylor, Rod Stephen and Ciani, Oriana},
  year   = {2024},
  journal = {BMJ},
  doi    = {10.1136/bmj-2023-078524}
}