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抑郁症试验中结局测量指标的异质性,以及结局测量指标的内容与患者的相关性:系统评价。

Heterogeneity of outcome measures in depression trials and the relevance of the content of outcome measures to patients: a systematic review.

机构信息

Université Paris Cité and Université Sorbonne Paris Nord, INSERM INRAE, Centre for Research in Epidemiology and Statistics, Paris, France; Centre d'Epidémiologie Clinique, AP-HP, Hôpital Hôtel Dieu, Paris, France.

Department of Psychiatry, University of Oxford, Oxford, UK.

出版信息

Lancet Psychiatry. 2024 Apr;11(4):285-294. doi: 10.1016/S2215-0366(23)00438-8.

Abstract

Research waste occurs when randomised controlled trial (RCT) outcomes are heterogeneous or overlook domains that matter to patients (eg, relating to symptoms or functions). In this systematic review, we reviewed the outcome measures used in 450 RCTs of adult unipolar and bipolar depression registered between 2018 and 2022 and identified 388 different measures. 40% of the RCTs used the same measure (Hamilton Depression Rating Scale [HAMD]). Patients and clinicians matched each item within the 25 most frequently used measures with 80 previously identified domains of depression that matter to patients. Seven (9%) domains were not covered by the 25 most frequently used outcome measures (eg, mental pain and irritability). The HAMD covered a maximum of 47 (59%) of the 80 domains that matter to patients. An interim solution to facilitate evidence synthesis before a core outcome set is developed would be to use the most common measures and choose complementary scales to optimise domain coverage. TRANSLATIONS: For the French and Dutch translations of the abstract see Supplementary Materials section.

摘要

当随机对照试验(RCT)的结果存在异质性或忽略了对患者重要的领域(例如,与症状或功能相关)时,就会出现研究浪费。在这项系统评价中,我们回顾了 2018 年至 2022 年间登记的 450 项成人单相和双相抑郁症 RCT 中使用的结局测量指标,共确定了 388 种不同的测量指标。40%的 RCT 使用了相同的测量指标(汉密尔顿抑郁评定量表[HAMD])。患者和临床医生将 25 种最常用的测量指标中的每个项目与之前确定的 80 个对患者重要的抑郁症领域进行了匹配。有 7 个(9%)领域未被 25 种最常用的结局测量指标涵盖(例如,精神痛苦和易怒)。HAMD 最多涵盖了对患者重要的 80 个领域中的 47 个(59%)。在开发核心结局集之前,促进证据综合的临时解决方案是使用最常见的测量指标,并选择补充量表以优化领域覆盖。

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