数字心理健康干预的安全性:系统审查和建议
Rayan Taher1, Che-Wei Hsu1, Chloe Hampshire2
1Psychosis Studies Department, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London, London, United Kingdom.
JMIR mental health
|October 9, 2023
概括
数字心理健康干预 (DMHI) 显示安全数据收集不一致,许多研究缺乏不良事件 (AE) 评估. 对于DMHIs,需要标准化的安全实践,以确保好处超过风险.
科学领域:
- 心理健康 心理健康
- 数字健康数字健康
- 临床安全 临床安全
背景情况:
- 数字心理健康干预 (DMHI) 对常见的心理健康状况有希望.
- 然而,像传统疗法一样,DMHIs具有潜在的风险.
- 确保患者安全需要利益超过减轻风险.
研究的目的:
- 审查DMHIs如何评估安全.
- 在研究和市场后阶段识别报告的风险和缓解策略.
- 为DMHIs提供标准化的安全评估和报告.
主要方法:
- 在PsycINFO,Embase和MEDLINE搜索了关于DMHI安全性的研究.
- 包括评估成年人群安全性的研究,无论主要结果如何.
- 采用定性分析来对结果进行对比;尽可能使用表格,百分比和赔率比率合成定量数据.
主要成果:
- 包括23项研究;35%未能收集任何安全数据.
- 安全数据收集的方法各不相同,统计分析有限.
- 症状恶化是主要报告的不良事件;排除高风险群体是常见的缓解策略.
结论:
- 在DMHIs中存在对标准化的AE分类和评估方法的需求.
- 在研究和市场后阶段都需要基于证据的风险减轻策略.
- 制定了建议,以提高DMHI安全数据的质量和对利益风险评估的信心.
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