Improving the reporting of pragmatic trials: an extension of the CONSORT statement (original) (raw)

  1. Research
  2. Improving the...
  3. Improving the reporting of pragmatic trials: an extension of the CONSORT statement

Research Methods & Reporting BMJ 2008;337 doi: https://doi.org/10.1136/bmj.a2390 (Published 11 November 2008) Cite this as: BMJ 2008;337:a2390

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  1. Merrick Zwarenstein, director123,
  2. Shaun Treweek, senior research fellow45,
  3. Joel J Gagnier, post-graduate fellow56,
  4. Douglas G Altman, director7,
  5. Sean Tunis, director8910,
  6. Brian Haynes, Michael Gent professor and chair11,
  7. Andrew D Oxman, senior researcher5,
  8. David Moher, senior scientist1213
  9. for the CONSORT and Pragmatic Trials in Healthcare (Practihc) groups
  10. 1Health Services Sciences, Sunnybrook Hospital, Toronto, Ontario, Canada
  11. 2Institute for Clinical Evaluative Sciences, Toronto Department of Health Policy, Management and Evaluation, University of Toronto, Toronto
  12. 3Division of International Health (IHCAR), Karolinska Institute, Stockholm, Sweden
  13. 4Clinical and Population Sciences and Education, University of Dundee, Dundee
  14. 5Norwegian Knowledge Centre for the Health Services, Oslo, Norway
  15. 6Faculty of Medicine, University of Toronto
  16. 7Centre for Statistics in Medicine, University of Oxford, Oxford
  17. 8Center for Medical Technology Policy, Baltimore, MD, USA
  18. 9Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD
  19. 10Center for Healthcare Policy, Stanford University School of Medicine, Palo Alto, CA, USA
  20. 11Department of Clinical Epidemiology and Biostatistics and Department of Medicine, McMaster University Faculty of Health Sciences, Hamilton, ON, Canada
  21. 12Clinical Epidemiology Program, Ottawa Health Research Institute, Ottawa, Canada
  22. 13Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, Ottawa
  23. Correspondence to: M Zwarenstein merrick.zwarenstein{at}ices.on.ca

Background The CONSORT statement is intended to improve reporting of randomised controlled trials and focuses on minimising the risk of bias (internal validity). The applicability of a trial’s results (generalisability or external validity) is also important, particularly for pragmatic trials. A pragmatic trial (a term first used in 1967 by Schwartz and Lellouch) can be broadly defined as a randomised controlled trial whose purpose is to inform decisions about practice. This extension of the CONSORT statement is intended to improve the reporting of such trials and focuses on applicability.

Methods At two, two-day meetings held in Toronto in 2005 and 2008, we reviewed the CONSORT statement and its extensions, the literature on pragmatic trials and applicability, and our experiences in conducting pragmatic trials.

Recommendations We recommend extending eight CONSORT checklist items for reporting of pragmatic trials: the background, participants, interventions, outcomes, sample size, blinding, participant flow, and generalisability of the findings. These extensions are presented, along with illustrative examples of reporting, and an explanation of each extension. Adherence to these reporting criteria will make it easier for decision makers to judge how applicable the results of randomised controlled trials are to their own conditions. Empirical studies are needed to ascertain the usefulness and comprehensiveness of these CONSORT checklist item extensions. In the meantime we recommend that those who support, conduct, and report pragmatic trials should use this extension of the CONSORT statement to facilitate the use of trial results in decisions about health care.

Pragmatic trials are designed to inform decisions about practice, but poor reporting can reduce their usefulness. The CONSORT and Practihc groups describe modifications to the CONSORT guidelines to help readers assess the applicability of the results

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