Cited by 1,389Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsHealth Policy Implementation Science

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

Open access
Thorpe, Kevin E., Zwarenstein, Merrick, Oxman, Andrew D., Treweek, Shaun, Furberg, Curt D., Altman, Douglas G., Tunis, Sean, Bergel, Eduardo +3 more·2009·Journal of Clinical Epidemiology

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.

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Authors
Thorpe, K. E., Zwarenstein, M., Oxman, A. D., Treweek, S., Furberg, C. D., Altman, D. G., Tunis, S., Bergel, E., Harvey, I., Magid, D. J., & Chalkidou, K.
Affiliations
  • University of Toronto (CA)
  • Nasjonalt Kunnskapssenter for Helsetjenesten (NO)
  • University of Dundee (GB)
  • Wake Forest University Health Sciences (US)
  • University of Oxford (GB)
  • Center for Medical Technology Policy (US)
  • World Health Organization (CH)
  • University of East Anglia (GB)
  • Kaiser Permanente (US)
  • National Institute for Health and Care Excellence (GB)
Corresponding author
Thorpe, Kevin E.
Venue
Journal of Clinical Epidemiology
Publisher
Elsevier BV
Published
2009-05
Volume
62
Issue
5
Pages
464-475
ISSN
0895-4356 (ISSN-L)
OpenAlex
W2128659393
Cited by
1,389
References
2
Citations by year
2026: 44 · 2025: 46 · 2024: 56 · 2023: 67 · 2022: 69 · 2021: 92 · 2020: 93 · 2019: 120 · 2018: 87 · 2017: 108 · 2016: 82 · 2015: 120 · 2014: 108 · 2013: 93 · 2012: 83
FWCI
55.34
Type
journal article
Language
en
Open access
Locations
  • Journal of Clinical Epidemiology (publishedVersion)
  • PubMed (publishedVersion)
  • Discovery Research Portal (University of Dundee) (publishedVersion)
  • UEA Digital Repository (University of East Anglia) (submittedVersion)
Funders
  • European Commission
  • Medical Research Council
Topics
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
Keywords
Precis, pragmatic trials, explanatory trials, trial design, research questions, design decision-making, clinical trials
MeSH terms
Clinical Trials as Topic, Decision Making, Humans, Research Design, Randomized Controlled Trials as Topic, Practice Guidelines as Topic, Consensus

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