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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers
Journal of Clinical Epidemiology, Volume 62, No. 5, Year 2009
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Description
Objective: To propose a tool to assist trialists in making design decisions that are consistent with their trial's stated purpose. Study Design and Setting: Randomized trials have been broadly categorized as either having a pragmatic or explanatory attitude. Pragmatic trials seek to answer the question, "Does this intervention work under usual conditions?," whereas explanatory trials are focused on the question, "Can this intervention work under ideal conditions?" Design decisions make a trial more (or less) pragmatic or explanatory, but no tool currently exists to help researchers make the best decisions possible in accordance with their trial's primary goal. During the course of two international meetings, participants with experience in clinical care, research commissioning, health care financing, trial methodology, and reporting defined and refined aspects of trial design that distinguish pragmatic attitudes from explanatory. Results: We have developed a tool (called PRECIS) with 10 key domains and which identifies criteria to help researchers determine how pragmatic or explanatory their trial is. The assessment is summarized graphically. Conclusion: We believe that PRECIS is a useful first step toward a tool that can help trialists to ensure that their design decisions are consistent with the stated purpose of the trial. © 2009 Elsevier Inc. All rights reserved.
Authors & Co-Authors
Thorpe, Kevin E.
Canada, Toronto
University of Toronto
Zwarenstein, Merrick F.
Canada, Toronto
Sunnybrook Health Sciences Centre
Oxman, Andrew David
Norway, Oslo
Nasjonalt Kunnskapssenter for Helsetjenesten
Treweek, Shaun P.
Norway, Oslo
Nasjonalt Kunnskapssenter for Helsetjenesten
Furberg, Curt D.
United States, Winston Salem
Wake Forest University School of Medicine
Altman, Douglas G.
United Kingdom, Oxford
University of Oxford Medical Sciences Division
Bergel, Eduardo F.
Switzerland, Geneva
Organisation Mondiale de la Santé
Harvey, Ian M.
United Kingdom, Norwich
University of East Anglia
Chalkidou, Kalipso
United Kingdom, London
National Institute for Health and Care Excellence Nice
Statistics
Citations: 849
Authors: 9
Affiliations: 9
Identifiers
Doi:
10.1016/j.jclinepi.2008.12.011
ISSN:
08954356
Research Areas
Health System And Policy
Study Design
Randomised Control Trial