心理健康应用程序临床试验中不良事件的系统评价与荟萃分析
Systematic review and meta-analysis of adverse events in clinical trials of mental health apps.
作者信息
Linardon Jake, Fuller-Tyszkiewicz Matthew, Firth Joseph, Goldberg Simon B, Anderson Cleo, McClure Zoe, Torous John
机构信息
School of Psychology, Deakin University, Geelong, VIC, Australia.
Center for Social and Early Emotional Development, Deakin University, Burwood, VIC, Australia.
出版信息
NPJ Digit Med. 2024 Dec 18;7(1):363. doi: 10.1038/s41746-024-01388-y.
Mental health apps are efficacious, yet they may pose risks in some. This review (CRD42024506486) examined adverse events (AEs) from mental health apps. We searched (May 2024) the Medline, PsycINFO, Web of Science, and ProQuest databases to identify clinical trials of mental health apps. The risk of bias was assessed using the Cochrane Risk of Bias tool. Only 55 of 171 identified clinical trials reported AEs. AEs were more likely to be reported in trials sampling schizophrenia and delivering apps with symptom monitoring technology. The meta-analytic deterioration rate from 13 app conditions was 6.7% (95% CI = 4.3, 10.1, I = 75%). Deterioration rates did not differ between app and control groups (OR = 0.79, 95% CI = 0.62-1.01, I = 0%). Reporting of AEs was heterogeneous, in terms of assessments used, events recorded, and detail provided. Overall, few clinical trials of mental health apps report AEs. Those that do often provide insufficient information to properly judge risks related to app use.
心理健康应用程序是有效的，但在某些情况下可能会带来风险。本综述（CRD42024506486）研究了心理健康应用程序的不良事件（AE）。我们检索了（2024年5月）Medline、PsycINFO、Web of Science和ProQuest数据库，以确定心理健康应用程序的临床试验。使用Cochrane偏倚风险工具评估偏倚风险。在确定的171项临床试验中，只有55项报告了不良事件。在对精神分裂症进行抽样的试验以及提供具有症状监测技术的应用程序的试验中，更有可能报告不良事件。来自13种应用程序情况的荟萃分析恶化率为6.7%（95%CI = 4.3, 10.1，I = 75%）。应用程序组和对照组之间的恶化率没有差异（OR = 0.79, 95%CI = 0.62 - 1.01，I = 0%）。在使用的评估、记录的事件和提供的细节方面，不良事件的报告存在异质性。总体而言，很少有心理健康应用程序的临床试验报告不良事件。那些报告的试验往往提供的信息不足，无法正确判断与应用程序使用相关的风险。
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