Safety Reporting in Randomized Trials of Mental Health Interventions
Abstract
OBJECTIVE: The authors aimed to evaluate the adequacy of the reporting of safety information in publications of randomized trials of mental-health-related interventions. METHOD: The authors randomly selected 200 entries from the PsiTri registry of mental-health-related controlled trials. This yielded 142 randomized trials that were analyzed for adequacy and relative emphasis of their content on safety issues. They examined drug trials as well as trials of other types of interventions. RESULTS: Across the 142 eligible trials, 103 involved drugs. Twenty-five of the 142 trials had at least 100 randomly chosen subjects and at least 50 subjects in a study arm. Among drug trials, only 21.4% had adequate reporting of clinical adverse events, and only 16.5% had adequate reporting of laboratory-determined toxicity, while 32.0% reported both the numbers and the reasons for withdrawals due to toxicity in each arm. On average, drug trials devoted 1/10 of a page in their results sections to safety, and 58.3% devoted more space to the names and affiliations of authors than to safety. None of the trials of nondrug interventions had adequate or even partially adequate reporting of either clinical adverse events or laboratory-determined toxicity. In multivariate modeling, long-term trials and trials conducted in the United States devoted even less space to safety, while schizophrenia trials devoted more space to safety than did trials in other areas. CONCLUSIONS: Safety reporting is largely neglected across trials of mental-health-related interventions, thus hindering the assessment of risk-benefit ratios for rational decision making in mental health care.
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In mental health trials, reporting of harm in drug trials was adequate in only 21.4% of the trials reviewed, but none of the non-drug trials had adequate reporting of clinical adverse events.
“In mental health, the reporting of harm in drug trials was adequate in only 21.4% of the trials reviewed but none of the non-drug trials had adequate reporting of clinical adverse events [20].”
From The recording of adverse events from psychological treatments in clinical trials: evidence from a review of NIHR-funded trials (2014) · cites this paper as [20]
There remain inadequacies of adverse event reporting in non-pharmacological interventions in general and particularly in mental health trials.
“Despite these injunctions, there remain inadequacies of adverse event reporting in non-pharmacological interventions in general and particularly in mental health trials.”
From The recording of adverse events from psychological treatments in clinical trials: evidence from a review of NIHR-funded trials (2014) · cites this paper as [20]
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- Authors
- Papanikolaou, P. N., Churchill, R., Wahlbeck, K., Ioannidis, J. P. A., & The EU-PSI Project
- Affiliations
- University of Ioannina (GR)
- Venue
- American Journal of Psychiatry
- Published
- 2004-09-01
- Volume
- 161
- Issue
- 9
- Pages
- 1692-1697
- ISSN
- 0002-953X (ISSN-L)
- 1535-7228
- OpenAlex
- W2089799205
- Cited by
- 84
- References
- 21
- Citations by year
- 2026: 4 · 2024: 3 · 2023: 4 · 2022: 6 · 2021: 3 · 2020: 1 · 2019: 3 · 2018: 1 · 2016: 7 · 2015: 4 · 2014: 7 · 2013: 6 · 2012: 3
- FWCI
- 5.08
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- American Journal of Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Research Portal (King's College London) (submittedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Keywords
- safety reporting, adverse events, mental health interventions, drug trials, reporting quality, risk-benefit assessment, publication bias
- MeSH terms
- Mental Disorders, Decision Making, Humans, Patient Dropouts, Psychotropic Drugs, Publishing, Quality of Health Care, Registries, Regression Analysis, Research Design, Schizophrenia, United States, Models, Statistical, Multivariate Analysis, Randomized Controlled Trials as Topic, Safety Management, Risk Assessment
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