Pragmatic design in randomized controlled trials
Open accessAbstract
At more than 10 years after the paper by Hotopf and colleagues regarding pragmatic trials in psychiatry, the field has evolved and is evolving further. There have been many developments in our understanding of what pragmatism really means, and excellent examples of truly pragmatic trials in psychiatry are currently available. Funders have helped encourage more emphasis on the need for such studies, but ‘local’ and trans-national regulations could help more. Consumers of the evidence should have a greater voice in generating the research agenda and, as this happens, the questions generated are more likely to be answered by a pragmatic approach to trials.
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Pragmatic trials give more information regarding the feasibility of integrating a treatment within existing care because they are provided closer to real-world circumstances.
“pragmatic trials, because they are provided closer to ‘real-world’ circumstances, give us more information regarding the feasibility of integrating said treatment within existing care.”
From Psilocybin-assisted therapy for severe alcohol use disorder: protocol for a double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial (2024) · cites this paper as [21]
The Introduction (page not available) describes pragmatic trials as testing treatments in real-world circumstances and discusses their applicability to everyday clinical practice. It does not specifically say that they assess the feasibility of integrating a treatment into existing care; that is a more specific claim than the passages support. (LLM, conf=0.82)
Experimental — accuracy not yet measuredTrials integrated within real-world clinical pathways provide access to a participant sample more realistically representing the target population, thereby enhancing external validity.
“Trials integrated within real-world clinical pathways also provide access to a participant sample more realistically representing the target population, thereby enhancing the external validity of obtained results [20, 21].”
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Expectancy in placebo-controlled trials of psychedelics: if so, so what?
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“The latter are trials which are broader in scope than a typical RCT and investigated whether treatments given in real-world circumstances have clinically meaningful effects (Purgato et al. 2015) and have been suggested by some as a good fit for psychedelic trials (Carhart-Harris et al.”
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“Trials integrated within real-world clinical pathways also provide access to a participant sample more realistically representing the target population, thereby enhancing the external validity of obtained results [20, 21].”
Background
- Authors
- Purgato, M., Barbui, C., Stroup, S., & Adams, C.
- Affiliations
- University of Verona (IT)
- University of Nottingham (GB)
- Corresponding author
- Purgato, M.
- Venue
- Psychological Medicine
- Publisher
- Cambridge University Press (CUP)
- Published
- 2014-06-02
- Volume
- 45
- Issue
- 2
- Pages
- 225-230
- ISSN
- 0033-2917 (ISSN-L)
- 1469-8978
- OpenAlex
- W2102083881
- Cited by
- 19
- References
- 33
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 4 · 2022: 1 · 2021: 1 · 2020: 2 · 2019: 1 · 2017: 1 · 2016: 1 · 2015: 5
- FWCI
- 2.46
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Psychological Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Health Sciences › Health Professions › General Health Professions › Mental Health and Patient Involvement
- Keywords
- pragmatic trials, randomized controlled trials, psychiatric research, research design, research funding, research regulation, patient involvement in research, research agenda setting
- MeSH terms
- Humans, Psychiatry, Research Design, Pragmatic Clinical Trials as Topic
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