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 CONSORT and Practihc groups describe modifications to the CONSORT guidelines to help readers assess the applicability of the results

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

Abstract

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.

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