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老年抑郁症临床试验报告结局的异质性:系统调查。

Heterogeneity across outcomes reported in clinical trials for older adults with depression: a systematic survey.

机构信息

Health Research Methodology Graduate Program, Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

Life Sciences Undergraduate Program, School of Interdisciplinary Science, McMaster University, Hamilton, Ontario, Canada.

出版信息

J Clin Epidemiol. 2023 May;157:59-73. doi: 10.1016/j.jclinepi.2023.03.002. Epub 2023 Mar 6.

Abstract

OBJECTIVES

The objective of our study was to identify outcomes reported in trials for older adults with depression and describe outcome heterogeneity.

STUDY DESIGN AND SETTING

We searched four databases to identify trials assessing any intervention for major depressive disorder among older adults published between 2011 and 2021. We grouped reported outcomes thematically and mapped them onto core outcome areas (physiological/clinical, life impact, resource use, adverse events, and death) and used descriptive analysis to summarize outcome heterogeneity.

RESULTS

There were 434 total outcomes reported by 49 included trials, which were measured using 135 different outcome measurement instruments and grouped into 100 unique outcome terms. Most outcome terms mapped to the physiological/clinical core area (47%), followed by life impact (42%). More than half of all terms (53%) were reported by only a single study. Most trials (n = 31/49) reported a single, discernible primary outcome. The most commonly reported outcome "depressive symptom severity" was assessed by 36 studies using 19 different outcome measurement instruments.

CONCLUSION

There is substantial heterogeneity in the outcomes and outcome measurement instruments used in geriatric depression trials. A standard set of outcomes and accompanying measurement tools is necessary to facilitate comparison and synthesis of trial findings.

摘要

目的

我们的研究目的是确定针对老年抑郁症患者的试验报告的结局,并描述结局的异质性。

研究设计与设置

我们在四个数据库中进行检索,以确定 2011 年至 2021 年间发表的评估老年成年人重度抑郁症的任何干预措施的试验。我们根据主题对报告的结局进行分组,并将其映射到核心结局领域(生理/临床、生活影响、资源利用、不良事件和死亡),并使用描述性分析来总结结局的异质性。

结果

49 项纳入试验共报告了 434 项总结局,这些结局使用 135 种不同的结局测量工具进行测量,并分为 100 个独特的结局术语。大多数结局术语映射到生理/临床核心领域(47%),其次是生活影响(42%)。超过一半的所有术语(53%)仅由一项研究报告。大多数试验(n=49/31)报告了单一的、可识别的主要结局。最常报告的结局“抑郁症状严重程度”,有 36 项研究使用 19 种不同的结局测量工具进行评估。

结论

老年抑郁症试验中结局和结局测量工具存在很大的异质性。需要一套标准的结局和配套的测量工具,以促进试验结果的比较和综合。

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