Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.
Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.
Sleep Med Rev. 2021 Apr;56:101412. doi: 10.1016/j.smrv.2020.101412. Epub 2020 Nov 29.
Adverse events are undesirable events that can occur during medical or psychological treatment. There has been limited attention to adverse events in psychological treatment trials relative to pharmacotherapy trials. Cognitive behavioural therapy (CBTI) is the first line treatment for insomnia but studies have reported potential negative effects during acute implementation. This review aimed to understand the extent to which adverse events are monitored for and reported in the CBTI trial literature. Ninety-nine randomised controlled trials were identified for inclusion, with findings showing that 32.3% (n = 32) of studies addressed adverse events in some way, while only 7.1% (n = 7) of studies met all criteria for adequate reporting of adverse events. For studies that reported on adverse events by group, there did not appear to be consistent differences between trial arms, however the limited evidence-base coupled with marked heterogeneity in monitoring and reporting makes it difficult to draw clear conclusions at this time. We outline recommendations for the field aimed at improving prospective monitoring and reporting of adverse events in psychological/behavioural treatment trials.
不良事件是在医疗或心理治疗过程中可能发生的不良事件。与药物治疗试验相比，心理治疗试验对不良事件的关注有限。认知行为疗法（CBTI）是失眠的一线治疗方法，但研究报告称在急性实施过程中可能存在潜在的负面影响。本综述旨在了解不良事件在 CBTI 试验文献中监测和报告的程度。确定了 99 项随机对照试验进行纳入，研究结果表明，32.3%（n=32）的研究以某种方式解决了不良事件问题，而只有 7.1%（n=7）的研究完全符合不良事件报告的标准。对于按组报告不良事件的研究，试验组之间似乎没有一致的差异，但是监测和报告方面的证据基础有限，且存在明显的异质性，使得目前难以得出明确的结论。我们概述了该领域的建议，旨在改善心理/行为治疗试验中不良事件的前瞻性监测和报告。
