Pragmatic vs explanatory trials: the Pragmascope tool to help measure differences in protocols of mental health randomized controlled trials
Open accessAbstract
In the pragmatic-explanatory continuum, a randomized controlled trial (RCT) can at one extreme investigate whether a treatment could work in ideal circumstances (explanatory), or at the other extreme, whether it would work in everyday practice (pragmatic). How explanatory or pragmatic a study is can have implications for clinicians, policy makers, patients, researchers, funding bodies, and the public. There is an increasing need for studies to be open and pragmatic; however, explanatory trials are also needed. The previously developed Pragmatic-explanatory continuum indicator summary (PRECIS) was adapted into the Pragmascope tool to assist mental health researchers in designing RCTs, taking the pragmatic-explanatory continuum into account. Ten mental health trial protocols were randomly chosen and scored using the tool by three independent raters. Their results were compared for consistency and the tool was found to be reliable and practical. This preliminary work suggests that evaluating different domains of an RCT at the protocol level is useful, and suggests that using the Pragmascope tool presented here might be a practical way of doing this.
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We interpret the effects reported in Grieve et al. (2022) as those of a randomized field or pragmatic trials.
“As such, we interpret the effects reported in Grieve et al . (2022) as those of a randomized field or pragmatic trials (Thorpe et al ., 2009; Torgerson and Torgerson, 2008; Tosh et al ., 2011).”
From The impact of internet-based cognitive behavior therapy for perfectionism: a reinterpretation through the lens of the Model of Excellencism and Perfectionism (2024) · cites this paper as Tosh et al., 2011
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Weiss, S. L., Balamuth, F., Long, E., Thompson, G. C., Hayes, K. L., Katcoff, H., Cook, M., Tsemberis, E., Hickey, C. P., Williams, A., et al. (2021) · Figshare · doi:10.6084/m9.figshare.16944425
Galindo, M. S., Lambert, Y., Mutricy, L., Garancher, L., Miller, J. B., Gomes, J. H., Sanna, A., Peterka, C., Cairo, H., Hiwat, H., et al. (2022) · Figshare · doi:10.6084/m9.figshare.19607418
Galindo, M. S., Lambert, Y., Mutricy, L., Garancher, L., Miller, J. B., Gomes, J. H., Sanna, A., Peterka, C., Cairo, H., Hiwat, H., et al. (2022) · Figshare · doi:10.6084/m9.figshare.19607424
Weiss, S. L., Balamuth, F., Long, E., Thompson, G. C., Hayes, K. L., Katcoff, H., Cook, M., Tsemberis, E., Hickey, C. P., Williams, A., et al. (2021) · Figshare · doi:10.6084/m9.figshare.16944419
Synthesizing Computational Stylistics, Pragmatic Theory, and Generative AI for Translation Pedagogy
Alsheikhidris, M. A. F. A. (2026) · IGI Global eBooks · doi:10.4018/979-8-3373-8317-0.ch002
- Authors
- Tosh, G., Soares-Weiser, K., & Adams, C. E.
- Affiliations
- Psychiatrist, East Midlands Workforce Deanery, Nottingham, UK
- Director, Enhance Reviews Ltd, Oxford, UK
- University of Nottingham (GB)
- Corresponding author
- Adams, Clive E.
- ORCID
- Adams, Clive E.
- Venue
- Dialogues in Clinical Neuroscience
- Publisher
- Informa UK Limited
- Published
- 2011-06-30
- Volume
- 13
- Issue
- 2
- Pages
- 209-215
- ISSN
- 1294-8322 (ISSN-L)
- 1958-5969
- PMC
- PMC3182001
- OpenAlex
- W4322697870
- Cited by
- 84
- References
- 23
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 2 · 2023: 2 · 2022: 7 · 2021: 14 · 2020: 7 · 2019: 8 · 2018: 4 · 2017: 8 · 2016: 4 · 2015: 6 · 2014: 4 · 2013: 6 · 2012: 5
- FWCI
- 4.48
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Licence
- Locations
- Dialogues in Clinical Neuroscience (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- PubMed
- 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
- pragmatic trials, explanatory trials, Precis, trial protocol design, inter-rater reliability
- MeSH terms
- Mental Disorders, Decision Making, Humans, Research Design, Antipsychotic Agents, Reproducibility of Results, Randomized Controlled Trials as Topic
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