心理治疗随机对照试验中的不良事件:系统性审查
Rahel Klatte1, Bernhard Strauss1, Christoph Flückiger2
1University Hospital Jena, Institute of Psychosocial Medicine, Psychotherapy and Psychooncology, Jena, Germany.
概括
心理治疗不良事件 (AE) 在85个随机对照试验 (RCT) 中进行了研究. 副作用影响了超过10%的参与者,严重的副作用影响了超过4%的参与者,突出显示了对持续危害监测的需要.
科学领域:
- 心理学 心理学 心理学
- 精神病学是一个精神病学.
- 临床试验 临床试验
背景情况:
- 心理治疗对益处的证据广泛,但对潜在危害的数据仍然有限.
- 心理治疗中的不良事件 (AE) 需要进行系统的调查,以确保患者的安全.
研究的目的:
- 系统地总结心理治疗的随机对照试验 (RCT).
- 收集基于证据的关于心理治疗中不良事件 (AE) 的频率和特征的数据.
主要方法:
- 基于对心理治疗研究协议中危害考虑的审查,对结果发表的系统审查.
- 包括85个RCT,126个心理治疗和61个对照条件,涉及14420名患有常见精神障碍的参与者.
主要成果:
- 有害事件的明确报告,如副作用和症状恶化,发生在60%的研究中.
- 对AE的概念化,记录和报告方法在研究中异质,限制了可比性.
- 据报道,AE影响了超过10%的参与者,严重的AE影响了心理治疗RCT中的4%以上.
结论:
- 在AE记录方法的实质性差异限制了研究结果的可比性.
- 在心理治疗RCT中进行一致的危害监测和报告对于平衡的风险/益处评估至关重要.
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