Article type
Year
Abstract
Background: There is accumulating evidence that reporting of harms in randomized trials is suboptimal in various medical fields. No prior empirical evaluation has examined the reporting of safety issues in trials of mental health-related interventions.
Objective: We aimed to evaluate the adequacy of reporting of safety information in publications of randomized trials of mental health-related interventions.
Methods: We randomly selected 200 entries from the PsiTri registry of mental health-related controlled trials. These yielded 142 randomized trials that were analyzed for adequacy and relative emphasis of their content on safety issues. We 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 randomized 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 reasons for withdrawals due to toxicity in each arm. On average, drug trials devoted one-tenth of a page in their Results to safety and harms and 58.3% devoted more space to the names and affiliations of authors than to safety and harms. None of the trials of non-drug 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 issues, while schizophrenia trials devoted more space to safety issues than trials in other areas. Reporting of harms did not improve in more recent trials. The odds of adequate reporting of clinical adverse events, laboratory-determined toxicity, and reasons for withdrawals due to toxicity non-significantly changed by 0.78-fold (p=0.29), 0.86-fold (p=0.54), and 0.94-fold (p=0.76) per 10 years, respectively, while the pages devoted to safety and harms non-significantly decreased by 0.05 per 10 years (p=0.29).
Conclusions: Reporting of safety and harms 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.
Objective: We aimed to evaluate the adequacy of reporting of safety information in publications of randomized trials of mental health-related interventions.
Methods: We randomly selected 200 entries from the PsiTri registry of mental health-related controlled trials. These yielded 142 randomized trials that were analyzed for adequacy and relative emphasis of their content on safety issues. We 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 randomized 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 reasons for withdrawals due to toxicity in each arm. On average, drug trials devoted one-tenth of a page in their Results to safety and harms and 58.3% devoted more space to the names and affiliations of authors than to safety and harms. None of the trials of non-drug 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 issues, while schizophrenia trials devoted more space to safety issues than trials in other areas. Reporting of harms did not improve in more recent trials. The odds of adequate reporting of clinical adverse events, laboratory-determined toxicity, and reasons for withdrawals due to toxicity non-significantly changed by 0.78-fold (p=0.29), 0.86-fold (p=0.54), and 0.94-fold (p=0.76) per 10 years, respectively, while the pages devoted to safety and harms non-significantly decreased by 0.05 per 10 years (p=0.29).
Conclusions: Reporting of safety and harms 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.