The PRECIS-2 tool: designing trials that are fit for purpose
Open accessAbstract
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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A pragmatic perspective was used during study design, scoring 42/45 on the PRECIS-2 tool.
“A pragmatic perspective was used during study designing, scoring 42/45 using the PRECIS-2 tool (19) (Table 1).”
From Total Sleep Deprivation Followed by Bright Light Therapy as Rapid Relief for Depression: A Pragmatic Randomized Controlled Trial (2021) · cites this paper as [19]
This trial is closer to the definition of an explanatory trial within the PRECIS-2 framework.
“This trial is closer to the definition of an explanatory trial within the PRECIS-2 framework (Loudon et al., 2015).”
From A randomised controlled trial of acceptance and commitment therapy for improving quality of life in people with muscle diseases. (2023) · cites this paper as Loudon et al., 2015
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“Using the PRECIS-2 pragmatic continuum tool, we choose a typical patient population with minimal inclusion criteria, bedside recruitment during already occurring ED visits, and the research occurring in an ED where the results will be applied [23].”
- 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
- bronze
- doi.org
- 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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