Safety reporting in randomized trials of mental health interventions.
OBJECTIVE
The authors aimed to evaluate the adequacy of the reporting of safety information in publications of randomized trials of mental-health-related interventions.


METHODS
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.
Papanikolaou
Panagiotis N
PN
Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina 45110, Greece.
Churchill
Rachel
R
Wahlbeck
Kristian
K
Ioannidis
John P A
JP
D003657:Decision Making; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy / Q000628:therapy*; D015233:Models, Statistical; D015999:Multivariate Analysis; D010352:Patient Dropouts / Q000706:statistics & numerical data; D011619:Psychotropic Drugs / Q000009:adverse effects / Q000627:therapeutic use; D011643:Publishing / Q000592:standards*; D011787:Quality of Health Care / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000009:adverse effects / Q000592:standards* / Q000706:statistics & numerical data; D012042:Registries; D012044:Regression Analysis; D012107:Research Design / Q000592:standards*; D018570:Risk Assessment / Q000592:standards; D017751:Safety Management / Q000592:standards*; D012559:Schizophrenia / Q000188:drug therapy / Q000628:therapy; D014481:United States
D011619:Psychotropic Drugs