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PMID: 19001484 Published · epublish English Journal Article Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

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

BMJ (Clinical research ed.) ·Vol. 337 ·2008-11-11 ·Pages a2390

Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D, CONSORT group, Pragmatic Trials in Healthcare Practihc group

Abstract

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.

MeSH Terms
Consensus Development Conferences as Topic Decision Making Health Planning Guidelines Health Services Research/methods,standards Humans Patient Selection Publishing/standards Quality Control Randomized Controlled Trials as Topic/methods,standards Reproducibility of Results Research Design/standards
Authors & Affiliations
10 authors, click to expand affiliations / ORCID
Zwarenstein Merrick
Health Services Sciences, Sunnybrook Hospital, Toronto, Ontario, Canada. [email protected]
Treweek Shaun
Gagnier Joel J
Altman Douglas G
Tunis Sean
Haynes Brian
Oxman Andrew D
Moher David
CONSORT group
Pragmatic Trials in Healthcare (Practihc) group
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Article Info
Journal
BMJ (Clinical research ed.)
Abbr.
BMJ
ISSN
1756-1833
DOI
10.1136/bmj.a2390
Email
[email protected]
Published
2008-11-11
Epub
2008-00-11
Pages
a2390
Language
English
Region
England
NLM ID
8900488
PMCID
PMC3266844
Subset
IM
Grants
Cancer Research UK · United Kingdom
Medical Research Council · United Kingdom
External Links
PubMed source DOI: 10.1136/bmj.a2390 PMC Full Text View journal details
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