A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers

Kevin E. Thorpe; Merrick Zwarenstein; Andrew D. Oxman; Shaun Treweek; Curt D. Furberg; Douglas G. Altman; Sean Tunis; Eduardo Bergel; Ian Harvey; David J. Magid; Kalipso Chalkidou

doi:10.1016/j.jclinepi.2008.12.011

A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers

Kevin E. Thorpe^*, Merrick Zwarenstein, Andrew D. Oxman, Shaun Treweek, Curt D. Furberg, Douglas G. Altman, Sean Tunis, Eduardo Bergel, Ian Harvey, David J. Magid, Kalipso Chalkidou

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

860 Citations (Scopus)

Abstract

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. (C) 2009 The Authors. Published by Elsevier Inc. All rights reserved.

Original language	English
Pages (from-to)	464-475
Number of pages	12
Journal	Journal of Clinical Epidemiology
Volume	62
Issue number	5
DOIs	https://doi.org/10.1016/j.jclinepi.2008.12.011
Publication status	Published - May 2009

Keywords

decision-making
pragmatic trial
randomized controlled trials
women
preeclampsia
clinical-research
trial design
low-dose aspirin
explanatory trial
clinical trial
clinical trial methodology

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10.1016/j.jclinepi.2008.12.011

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title = "A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers",

abstract = "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. (C) 2009 The Authors. Published by Elsevier Inc. All rights reserved.",

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author = "Thorpe, {Kevin E.} and Merrick Zwarenstein and Oxman, {Andrew D.} and Shaun Treweek and Furberg, {Curt D.} and Altman, {Douglas G.} and Sean Tunis and Eduardo Bergel and Ian Harvey and Magid, {David J.} and Kalipso Chalkidou",

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AU - Treweek, Shaun

AU - Furberg, Curt D.

AU - Altman, Douglas G.

AU - Tunis, Sean

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AU - Harvey, Ian

AU - Magid, David J.

AU - Chalkidou, Kalipso

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A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers

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Keywords

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