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

By Merrick Zwarenstein, Shaun P. Treweek, J. Gagnier, Douglas G. Altman, S. Tunis, B. Haynes, Andrew D. Oxman, David Moher. British medical journal, 2008

1,746 citations recorded by the source corpus.

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

Subfields: Economics and Econometrics, General Health Professions, Statistics and Probability

View Paper: https://www.semanticscholar.org/paper/cc645b12fe43acc13c35fb39178afa55de3df9ed

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Citations in the corpus

A Primer on Effectiveness and Efficacy Trials (2014, positive): “Guidelines for reporting results of efficacy and effectiveness studies should be followed to standardize reporting of results.(28,29)”
An introduction to implementation science for the non-specialist (2015, background): “Several overlapping names, and conceptual structures, have developed for these latter types of trials including “effectiveness trials” [7, 8] “pragmatic clinical trials” [9]“practical clinical trials” [10] and “large simple trials” [11].”
Improving Emotional Intelligence: A Systematic Review of Existing Work and Future Challenges (2018, methodology): “, 2009) such as the CONSORT checklist (Merrick et al., 2008), to ensure common standards in designing and reporting studies.”
A pragmatic–explanatory continuum indicator summary (PRECIS): a tool to help trial designers (2009, neutral): “Hence, reporting of pragmatic trials is addressed elsewhere [4].”
CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. (2012, methodology): “If relevant, we also recommend reading CONSORT extensions for cluster randomised trials,(40) non-inferiority and equivalence trials,(39) non-pharmacological treatments,(43) herbal interventions,(44) and pragmatic trials.(41) Additional extensions are forthcoming: for those and for up to date referen”