Improving the reporting of pragmatic trials

An extension of the Consort statement

Dados Bibliográficos

ID23387771
AutoresMerrick Zwarenstein (0000-0003-0162-7027, University of Toronto, autor correspondente), Shaun Treweek (0000-0002-7239-7241, University of Dundee), Joel Gagnier (0000-0002-3162-3935, University of Toronto), J J Gagnier, D G Altman, Doug Altman (University of Oxford), Sean Tunis (0000-0003-4037-2733, Johns Hopkins University), Brian Haynes (McMaster University), Andrew D Oxman (0000-0002-5608-5061, Nasjonalt Kunnskapssenter for Helsetjenesten), David Moher (0000-0003-2434-4206, University of Ottawa), for the CONSORT and Pragmatic Trials in Healthcare groups
Ano2008
Volume337
Fascículonov11 2
Páginasa2390-a2390
Data de publicação2008-12-30
Peer ReviewedSim
Open AccessSim
TipoARTICLE
PeriódicoBMJ (JOURNAL)
Identificadores do periódicoISSN: 0007-1447 • E-ISSN: 0267-0623
EditoraBMJ (PUBLISHER • GB)
DOI10.1136/bmj.a2390
PMID19001484
OpenAlexW2167165853
IdiomaEN
Citações recebidas94
Referências citadas14

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.

Blinding · Checklist · Clinical trial · Consolidated Standards of Reporting Trials · External validity · Family medicine · MEDLINE · Psychological intervention · Systematic review · Health Systems, Economic Evaluations, Quality of Life · Healthcare cost, quality, practices · Medicine · Meta-analysis and systematic reviews · Nursing · Psychology · Social Psychology