Improving the reporting of pragmatic trials: an extension of the CONSORT statement

doi:10.1136/bmj.a2390

Published 11 November 2008, doi:10.1136/bmj.a2390
Cite this as: BMJ 2008;337:a2390

Research Methods & Reporting

Improving the reporting of pragmatic trials: an extension of the CONSORT statement

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

Merrick Zwarenstein, director¹^,2^,3, Shaun Treweek, senior research fellow⁴^,5, Joel J Gagnier, post-graduate fellow⁵^,6, Douglas G Altman, director⁷, Sean Tunis, director⁸^,9^,10, Brian Haynes, Michael Gent professor and chair¹¹, Andrew D Oxman, senior researcher⁵, David Moher, senior scientist¹²^,13, for the CONSORT and Pragmatic Trials in Healthcare (Practihc) groups

¹ Health Services Sciences, Sunnybrook Hospital, Toronto, Ontario, Canada, ² Institute for Clinical Evaluative Sciences, Toronto Department of Health Policy, Management and Evaluation, University of Toronto, Toronto , ³ Division of International Health (IHCAR), Karolinska Institute, Stockholm, Sweden, ⁴ Clinical and Population Sciences and Education, University of Dundee, Dundee , ⁵ Norwegian Knowledge Centre for the Health Services, Oslo, Norway, ⁶ Faculty of Medicine, University of Toronto, ⁷ Centre for Statistics in Medicine, University of Oxford, Oxford, ⁸ Center for Medical Technology Policy, Baltimore, MD, USA, ⁹ Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD, ¹⁰ Center for Healthcare Policy, Stanford University School of Medicine, Palo Alto, CA, USA, ¹¹ Department of Clinical Epidemiology and Biostatistics and Department of Medicine, McMaster University Faculty of Health Sciences, Hamilton, ON, Canada, ¹² Clinical Epidemiology Program, Ottawa Health Research Institute, Ottawa, Canada, ¹³ Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, Ottawa

Correspondence to: M Zwarenstein merrick.zwarenstein{at}ices.on.ca

Abstract

Background The CONSORT statement is intended to improve reportingof randomised controlled trials and focuses on minimising therisk of bias (internal validity). The applicability of a trial’sresults (generalisability or external validity) is also important,particularly for pragmatic trials. A pragmatic trial (a termfirst used in 1967 by Schwartz and Lellouch) can be broadlydefined as a randomised controlled trial whose purpose is toinform decisions about practice. This extension of the CONSORTstatement is intended to improve the reporting of such trialsand focuses on applicability.

Methods At two, two-day meetings held in Toronto in 2005 and2008, we reviewed the CONSORT statement and its extensions,the literature on pragmatic trials and applicability, and ourexperiences in conducting pragmatic trials.

Recommendations We recommend extending eight CONSORT checklistitems for reporting of pragmatic trials: the background, participants,interventions, outcomes, sample size, blinding, participantflow, and generalisability of the findings. These extensionsare presented, along with illustrative examples of reporting,and an explanation of each extension. Adherence to these reportingcriteria will make it easier for decision makers to judge howapplicable the results of randomised controlled trials are totheir own conditions. Empirical studies are needed to ascertainthe usefulness and comprehensiveness of these CONSORT checklistitem extensions. In the meantime we recommend that those whosupport, conduct, and report pragmatic trials should use thisextension of the CONSORT statement to facilitate the use oftrial results in decisions about health care.

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