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

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

BMJ 2024; 386 doi: https://doi.org/10.1136/bmj-2023-078524 (Published 09 July 2024) Cite this as: BMJ 2024;386:e078524

Linked Research Methods and Reporting

Reporting of surrogate endpoints in randomised controlled trial protocols (SPIRIT-Surrogate): extension checklist with explanation and elaboration
  1. Anthony Muchai Manyara, honorary research fellow and senior research associate1 2,
  2. Philippa Davies, senior research associate3,
  3. Derek Stewart, patient and public involvement partner4,
  4. Christopher J Weir, professor5,
  5. Amber E Young, honorary professor3,
  6. Jane Blazeby, professor3 6 7,
  7. Nancy J Butcher, assistant professor8 9,
  8. Sylwia Bujkiewicz, professor10,
  9. An-Wen Chan, professor11 12,
  10. Dalia Dawoud, associate director13 14,
  11. Martin Offringa, professor8 15,
  12. Mario Ouwens, group director of biostatistics16,
  13. Asbjørn Hróbjartsson, professor and head of centre17 18,
  14. Alain Amstutz, postdoctoral researcher19 20 21,
  15. Luca Bertolaccini, deputy director22,
  16. Vito Domenico Bruno, cardiac surgeon23,
  17. Declan Devane, professor and director24 25,
  18. Christina D C M Faria, associate professor26,
  19. Peter B Gilbert, professor27,
  20. Ray Harris4,
  21. Marissa Lassere, staff specialist rheumatologist28,
  22. Lucio Marinelli, associate professor29 30,
  23. Sarah Markham, visiting researcher4 31,
  24. John H Powers III, professor32,
  25. Yousef Rezaei, general practitioner and research fellow33 34 35,
  26. Laura Richert, professor36,
  27. Falk Schwendicke, director37,
  28. Larisa G Tereshchenko, associate professor38,
  29. Achilles Thoma, clinical professor39,
  30. Alparslan Turan, professor40,
  31. Andrew Worrall4,
  32. Robin Christensen, professor41,
  33. Gary S Collins, professor42,
  34. Joseph S Ross, professor43 44,
  35. Rod S Taylor, professor1 45,
  36. Oriana Ciani, associate professor46
  1. 1MRC/CSO Social and Public Health Sciences Unit, School of Health and Wellbeing, University of Glasgow, Glasgow, UK
  2. 2Global Health and Ageing Research Unit, Bristol Medical School, University of Bristol, Bristol, UK
  3. 3Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
  4. 4Patient author, UK
  5. 5Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK
  6. 6Bristol NIHR Biomedical Research Centre, Bristol, UK
  7. 7University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK
  8. 8Child Health Evaluative Sciences, Hospital for Sick Children Research Institute, Toronto, ON, Canada
  9. 9Department of Psychiatry, University of Toronto, Toronto, ON, Canada
  10. 10Biostatistics Research Group, Department of Population Health Sciences, University of Leicester, Leicester, UK
  11. 11Women’s College Research Institute, Toronto, ON, Canada
  12. 12Department of Medicine, University of Toronto, Toronto, ON, Canada
  13. 13Science, Evidence, and Analytics Directorate, Science Policy and Research Programme, National Institute for Health and Care Excellence, London, UK
  14. 14Faculty of Pharmacy, Cairo University, Cairo, Egypt
  15. 15Department of Paediatrics, University of Toronto, Toronto, ON, Canada
  16. 16AstraZeneca, Mölndal, Sweden
  17. 17Centre for Evidence-Based Medicine Odense and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark
  18. 18Open Patient data Explorative Network, Odense University hospital, Odense, Denmark
  19. 19CLEAR Methods Centre, Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland
  20. 20Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway
  21. 21Bristol Medical School, University of Bristol, Bristol, UK
  22. 22Department of Thoracic Surgery, IEO, European Institute of Oncology IRCCS, Milan, Italy
  23. 23IRCCS Galeazzi-Sant’Ambrogio Hospital, Department of Minimally Invasive Cardiac Surgery, Milan, Italy
  24. 24University of Galway, Galway, Ireland
  25. 25Health Research Board-Trials Methodology Research Network, University of Galway, Galway, Ireland
  26. 26Department of Physical Therapy, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil
  27. 27Fred Hutchinson Cancer Centre, Seattle, WA, USA
  28. 28St George Hospital and School of Population Health, University of New South Wales, Sydney, NSW, Australia
  29. 29Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genova, Genoa, Italy
  30. 30IRCCS Ospedale Policlinico San Martino, Genoa, Italy
  31. 31Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK
  32. 32George Washington University School of Medicine, Washington, DC, USA
  33. 33Heart Valve Disease Research Centre, Rajaie Cardiovascular Medical and Research Centre, Iran University of Medical Sciences, Tehran, Iran
  34. 34Ardabil University of Medical Sciences, Ardabil, Iran
  35. 35Behyan Clinic, Pardis New Town, Tehran, Iran
  36. 36University of Bordeaux, Centre d’Investigation Clinique-Epidémiologie Clinique 1401, Research in Clinical Epidemiology and in Public Health and European Clinical Trials Platform & Development/French Clinical Research Infrastructure Network, Institut National de la Santé et de la Recherche Médicale/Institut Bergonié/Centre Hospitalier Universitaire Bordeaux, Bordeaux, France
  37. 37Charité Universitätsmedizin Berlin, Berlin, Germany
  38. 38Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA
  39. 39McMaster University, Hamilton, ON, Canada
  40. 40Department of Outcomes Research, Anaesthesiology Institute, Cleveland Clinic, OH, USA
  41. 41Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen and Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark
  42. 42UK EQUATOR Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, UK
  43. 43Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA
  44. 44Section of General Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA
  45. 45Robertson Centre for Biostatistics, School of Health and Well Being, University of Glasgow, Glasgow, UK
  46. 46Centre for Research on Health and Social Care Management, Bocconi University, Milan 20136, Italy
  1. Correspondence to: O Ciani oriana.ciani{at}unibocconi.it (or @OrianaCiani on Twitter)
  • Accepted 30 April 2024

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.

Evidence from well designed, conducted, and reported randomised controlled trials (referred to as trials in this article) assessing the effect of an intervention on the target outcome of interest (eg, all cause mortality) are required to determine the efficacy or effectiveness of interventions.1 Inadequate reporting of trials reduces their usefulness for decision making and, thus, contributes to the rising problem of research waste.23 Using reporting guidelines has been shown to be successful in improving the usefulness of trial evidence and reduce research waste.3 The CONSORT (Consolidated Standards of Reporting Trials) statement is a 25 item checklist widely used for the reporting of parallel group trial reports.4 While the CONSORT checklist …

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