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

Hdl Handle:
Improving the reporting of pragmatic trials: an extension of the CONSORT statement.
Zwarenstein, Merrick; Treweek, Shaun; Gagnier, Joel J; Altman, Douglas G; Tunis, Sean; Haynes, Brian; Oxman, Andrew David; Moher, David
BMJ 2008, 337:a2390
Additional Links:

Full metadata record

DC FieldValue Language
dc.contributor.authorZwarenstein, Merrick-
dc.contributor.authorTreweek, Shaun-
dc.contributor.authorGagnier, Joel J-
dc.contributor.authorAltman, Douglas G-
dc.contributor.authorTunis, Sean-
dc.contributor.authorHaynes, Brian-
dc.contributor.authorOxman, Andrew David-
dc.contributor.authorMoher, David-
dc.identifier.citationBMJ 2008, 337:a2390en
dc.identifier.doidoi: 10.1136/bmj.a2390-
dc.description.abstractBACKGROUND: 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.en
dc.subjectVDP::Medisinske Fag: 700::Helsefag: 800::Helsetjeneste- og helseadministrasjonsforskning: 806en
dc.subject.meshQuality Controlen
dc.subject.meshResearch Designen
dc.titleImproving the reporting of pragmatic trials: an extension of the CONSORT statement.en
dc.typeJournal articleen
dc.typepeer revieweden
dc.contributor.departmentHealth Services Sciences, Sunnybrook Hospital, Toronto, Ontario, Canada. merrick.zwarenstein@ices.on.caen
dc.identifier.journalBMJ (Clinical research ed.)en
All Items in HeRA are protected by copyright, with all rights reserved, unless otherwise indicated.