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

TLDR

The CONSORT statement was designed to improve reporting of randomized controlled trials by minimizing bias, but its focus on external validity is crucial for pragmatic trials that aim to inform real‑world practice. This extension of CONSORT seeks to enhance the reporting of pragmatic trials by emphasizing applicability, and the authors recommend its use while calling for empirical studies to evaluate its effectiveness. After two meetings in Toronto reviewing CONSORT, pragmatic trial literature, and practical experience, the authors proposed extending eight checklist items—background, participants, interventions, outcomes, sample size, blinding, participant flow, and generalizability—with illustrative examples and explanations. Adhering to these enhanced reporting criteria will enable decision makers to more readily assess the applicability of randomized trial results to their own contexts.

Abstract

<b>Background</b> 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. <b>Methods </b>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. <b>Recommendations</b> 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.