Cited by 1,846Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsHealth Policy Implementation Science

The PRECIS-2 tool: designing trials that are fit for purpose

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Loudon, K., Treweek, S., Sullivan, F., Donnan, P., Thorpe, K. E., Zwarenstein, M.·2015·BMJ

Abstract

PRECIS is a tool to help trialists make design decisions consistent with the intended purpose of their trial. This paper gives guidance on how to use an improved, validated version, PRECIS-2, which has been developed with the help of over 80 international trialists, clinicians, and policymakers. Keeping the original simple wheel format, PRECIS-2 has nine domains—eligibility criteria, recruitment, setting, organisation, flexibility (delivery), flexibility (adherence), follow-up, primary outcome, and primary analysis—scored from 1 (very explanatory) to 5 (very pragmatic) to facilitate domain discussion and consensus. It is hoped PRECIS-2 will be valuable in supporting the explicit matching of design decisions to how the trial results are intended to be used

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Authors
Loudon, K., Treweek, S., Sullivan, F., Donnan, P., Thorpe, K. E., & Zwarenstein, M.
Affiliations
  • University of Aberdeen (GB)
  • North York General Hospital (CA)
  • University of Dundee (GB)
  • St. Michael's Hospital (CA)
  • Western University (CA)
Corresponding author
Loudon, K.
Venue
BMJ
Publisher
BMJ
Published
2015-05-08
Volume
350
Issue
may08 1
Pages
h2147-h2147
ISSN
1756-1833 (ISSN-L)
OpenAlex
W1931781407
Cited by
1,846
References
26
Citations by year
2026: 165 · 2025: 196 · 2024: 222 · 2023: 202 · 2022: 225 · 2021: 201 · 2020: 234 · 2019: 142 · 2018: 113 · 2017: 89 · 2016: 43 · 2015: 14
FWCI
76.85
Type
journal article
Language
en
Open access
Locations
  • BMJ (publishedVersion)
  • PubMed (publishedVersion)
  • Discovery Research Portal (University of Dundee) (publishedVersion)
  • Aberdeen University Research Archive (Aberdeen University) (submittedVersion)
  • Stirling Online Research Repository (University of Stirling) (submittedVersion, cc-by-nc)
Funders
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-2, Precis, clinical trial design, inclusion and exclusion criteria, trial recruitment, follow-up, primary outcomes, primary analysis
MeSH terms
Decision Support Techniques, Humans, Research Design, Randomized Controlled Trials as Topic, Patient Selection

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