Article Text

Original research
Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE)
  1. Mahrukh Imran1,
  2. Linda Kwakkenbos2,
  3. Stephen J McCall3,4,5,
  4. Kimberly A McCord6,
  5. Ole Fröbert7,
  6. Lars G Hemkens6,
  7. Merrick Zwarenstein8,9,
  8. Clare Relton10,
  9. Danielle B Rice1,11,
  10. Sinéad M Langan12,
  11. Eric I Benchimol13,14,15,
  12. Lehana Thabane16,
  13. Marion K Campbell17,
  14. Margaret Sampson18,
  15. David Erlinge19,
  16. Helena M Verkooijen20,21,
  17. David Moher22,
  18. Isabelle Boutron23,24,25,
  19. Philippe Ravaud23,24,25,
  20. Jon Nicholl26,
  21. Rudolf Uher27,
  22. Maureen Sauvé28,29,
  23. John Fletcher30,
  24. David Torgerson31,
  25. Chris Gale32,
  26. Edmund Juszczak3,33,
  27. Brett D Thombs1,34
  1. 1Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada
  2. 2Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, Netherlands
  3. 3National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK
  4. 4Center for Research on Population and Health, Faculty of Health Sciences, American University of Beirut, Ras Beirut, Lebanon
  5. 5Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK
  6. 6Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland
  7. 7Faculty of Health, Department of Cardiology, Örebro University, Örebro, Sweden
  8. 8Department of Family Medicine, Western University, London, Ontario, Canada
  9. 9IC/ES Western, London, Ontario, Canada
  10. 10Centre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, UK
  11. 11Department of Psychology, McGill University, Montreal, Quebec, Canada
  12. 12Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK
  13. 13Department of Pediatrics and School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada
  14. 14ICES uOttawa, Ottawa, Ontario, Canada
  15. 15Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada
  16. 16Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
  17. 17Health Services Research Unit, University of Aberdeen, Aberdeen, UK
  18. 18Library Services, Children’s Hospital of Eastern Ontario, Ontario, Ottawa, Canada
  19. 19Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden
  20. 20University Medical Center Utrecht, Utrecht, Netherlands
  21. 21University of Utrecht, Utrecht, Netherlands
  22. 22Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  23. 23INSERM, Paris, France
  24. 24Centre d’Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique–Hôpitaux de Paris, Paris, France
  25. 25Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France
  26. 26School of Health and Related Research, University of Sheffield, Sheffield, UK
  27. 27Department of Psychiatry, Dalhousie University, Halifax, Nova Scotia, Canada
  28. 28Scleroderma Society of Ontario, Hamilton, Ontario, Canada
  29. 29Scleroderma Canada, Hamilton, Ontario, Canada
  30. 30British Medical Journal, London, UK
  31. 31York Trials Unit, Department of Health Sciences, University of York, York, UK
  32. 32Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK
  33. 33Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK
  34. 34Departments of Psychiatry; Epidemiology, Biostatistics and Occupational Health; Medicine; and Educational and Counselling Psychology; and Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada
  1. Correspondence to Dr Brett D Thombs; brett.thombs{at}mcgill.ca

Abstract

Objectives Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) has been developed with the goal of improving reporting quality. This article describes the processes and methods used to develop the extension and decisions made to arrive at the final checklist.

Methods The development process involved five stages: (1) identification of the need for a reporting guideline and project launch; (2) conduct of a scoping review to identify possible modifications to CONSORT 2010 checklist items and possible new extension items; (3) a three-round modified Delphi study involving key stakeholders to gather feedback on the checklist; (4) a consensus meeting to finalise items to be included in the extension, followed by stakeholder piloting of the checklist; and (5) publication, dissemination and implementation of the final checklist.

Results 27 items were initially developed and rated in Delphi round 1, 13 items were rated in round 2 and 11 items were rated in round 3. Response rates for the Delphi study were 92 of 125 (74%) invited participants in round 1, 77 of 92 (84%) round 1 completers in round 2 and 62 of 77 (81%) round 2 completers in round 3. Twenty-seven members of the project team representing a variety of stakeholder groups attended the in-person consensus meeting. The final checklist includes five new items and eight modified items. The extension Explanation & Elaboration document further clarifies aspects that are important to report.

Conclusion Uptake of CONSORT-ROUTINE and accompanying Explanation & Elaboration document will improve conduct of trials, as well as the transparency and completeness of reporting of trials conducted using cohorts and routinely collected data.

  • statistics & research methods
  • general medicine (see internal medicine)
  • clinical trials

Data availability statement

All data relevant to the study are included in the article or uploaded as supplemental information.

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Data availability statement

All data relevant to the study are included in the article or uploaded as supplemental information.

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Footnotes

  • Twitter @LGHemkens, @ericbenchimol, @msampso, @dmoher, @DrCGale

  • Correction notice This article has been corrected since it was published. Deatils regarding final CONSORT-ROUTINE checklist under section Project phase 5: publication, dissemination and implementation has been corrected.

  • Contributors MI, LK, OF, LGH, MZ, CR, SML, DM, MSam, CG, EJ and BDT were involved in initial phases of study conception, design of the search strategy and development of conceptual frameworks. SJM, KAM, DBR, EIB, LT, MKC, DE, HMV, IB, PR, JN, RU, MSau, JF and DT provided regular feedback on each of these steps. MI wrote the first draft with LK and BDT. All authors made provided critical revisions to the development of this manuscript and approved the final version.

  • Funding The development of CONSORT-ROUTINE was supported by the Canadian Institutes of Health Research (CIHR; PJT156172; PCS-161863), and the UK National Institute of Health Research (NIHR) Clinical Trials Unit Support Funding – Supporting efficient/innovative delivery of NIHR research (Principal Investigator (PI): EJ, co-PI: CG). DBR was supported by a Vanier CIHR Graduate Scholarship; SML was supported by a Wellcome Senior Clinical Fellowship in Science (205039/Z/16/Z); EIB was supported by a New Investigator Award from CIHR, the Canadian Association of Gastroenterology and Crohn’s and Colitis Canada, and the Career Enhancement Program of the Canadian Child Health Clinician Scientist Program; RU was supported by the Canada Research Chairs Program (Award #231397); CG was supported by the UK Medical Research Council through a Clinician Scientist Fellowship; and BDT was supported by a Tier 1 Canada Research Chair, all outside of the present work.

  • Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.