Journal Article

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

Tunis, Sean, Moher, David, Gagnier, Joel J, Zwarenstein, Merrick, Altman, Douglas G, Haynes, Brian, Oxman, Andrew D, Treweek, Shaun

2008

Overview

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.

• Publisher: British Medical Journal Publishing Group,British Medical Association,BMJ Publishing Group LTD,BMJ Publishing Group Ltd
• Subject: Acupuncture / Attitudes / Back pain / Check lists / Clinical trials / Consensus Development Conferences as Topic / Decision Making / Epidemiology / Health care / Health care industry / Health outcomes / Health Planning Guidelines / Health Services Research - methods / Health Services Research - standards / Humans / Intervention / Medical practice / Medical research / Mortality / Patient satisfaction / Patient Selection / Pragmatism / Psychoeducational intervention / Publishing - standards / Quality Control / Randomized Controlled Trials as Topic - methods / Randomized Controlled Trials as Topic - standards / Recommendations / Reproducibility of Results / Research Design - standards / Research Methods & Reporting / Stroke / Strokes