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Pragmatic randomised controlled trials in psychiatry
Abstract
BACKGROUND: Randomised controlled trials (RCTs) are the most important method of evaluating new treatments and treatment policies. Despite this, there are relatively few large pragmatic RCTs in psychiatry. AIMS: To explore the main advantages of large pragmatic RCTs and the obstacles to performing them in psychiatry. METHOD: A narrative review of literature on pragmatic RCTs with examples drawn from psychiatry and other medical specialities. RESULTS: Obstacles to performing pragmatic RCTs in psychiatry include the complexity of psychiatric interventions, the complexity of outcomes used in psychiatry and the difficulties of blinding subjects and investigators to some psychiatric interventions. CONCLUSIONS: Researchers need to frame questions in a form that is relevant to clinicians and to convince clinicians to cooperate in simple large pragmatic trials.
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“Conducting clinical trials in real-world health system practice can be challenging, especially in psychiatry (18).”
From Total Sleep Deprivation Followed by Bright Light Therapy as Rapid Relief for Depression: A Pragmatic Randomized Controlled Trial (2021) · cites this paper as [18]
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Metadata
- Authors
- Hotopf, M., Churchill, R., & Lewis, G.
- Affiliations
- Guy's Hospital (GB)
- Cardiff University (GB)
- Corresponding author
- Hotopf, Matthew
- Venue
- British Journal of Psychiatry
- Publisher
- Royal College of Psychiatrists
- Published
- 1999-09
- Volume
- 175
- Issue
- 3
- Pages
- 217-223
- ISSN
- 0007-1250 (ISSN-L)
- 1472-1465
- OpenAlex
- W2058332740
- Cited by
- 165
- References
- 42
- Citations by year
- 2025: 2 · 2024: 2 · 2022: 2 · 2021: 3 · 2020: 3 · 2019: 2 · 2018: 2 · 2017: 1 · 2016: 2 · 2015: 7 · 2014: 2 · 2013: 5 · 2012: 9
- FWCI
- 2.23
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The British Journal of Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- UCL Discovery (University College London) (submittedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- pragmatic randomized controlled trial, psychiatry, mental health outcomes, clinician involvement in research, research question formulation
- MeSH terms
- Mental Disorders, Costs and Cost Analysis, Ethics, Medical, Humans, Prognosis, Random Allocation, Observer Variation, Cluster Analysis, Randomized Controlled Trials as Topic, Patient Satisfaction, Patient Selection
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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