Cited by 84Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsHealth Policy Implementation Science

Pragmatic vs explanatory trials: the Pragmascope tool to help measure differences in protocols of mental health randomized controlled trials

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Tosh, Graeme, Soares-Weiser, Karla, Adams, Clive E.·2011·Dialogues in Clinical Neuroscience

Abstract

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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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.
Venue
Dialogues in Clinical Neuroscience
Published
2011-06-30
Volume
13
Issue
2
Pages
209-215
ISSN
  • 1294-8322 (ISSN-L)
  • 1958-5969
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
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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