Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.
Centre for Addiction and Mental Health, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.
J Clin Epidemiol. 2020 Oct;126:71-79. doi: 10.1016/j.jclinepi.2020.06.013. Epub 2020 Jun 17.
The objective of this review was to identify outcomes reported in adolescent major depressive disorder trials and quantify outcome heterogeneity.
Three databases were searched to identify trials evaluating therapies for major depressive disorder in adolescents published from 2008 to 2017. Identified outcomes were thematically grouped and mapped into predefined outcome core areas (physiological/clinical, life impact, resource use, adverse events, and death). Outcome heterogeneity was quantified using descriptive analyses.
Of 2,686 articles yielded from the search, 42 articles describing 32 trials were included. A total of 434 outcomes measured using 118 different outcome measurement instruments were grouped into 86 unique outcome terms. Most outcome terms mapped to the physiological/clinical core area (62%), followed by the life impact (27%). Nearly half (45%) were reported in only a single trial each. Of 18 primary outcomes reported, 13 (72%) were each only reported in a single trial. "Depressive symptom severity", reported in 30 trials (94%), was measured using 19 different outcome measurement instruments.
Heterogeneity exists in the outcomes and outcome measurement instruments used in adolescent depression trials. To enable reproducibility, comparison, and synthesis of trial results, a standard set of agreed-on outcomes and methods of measurement is needed.
本综述旨在确定青少年重度抑郁症临床试验中报告的结局,并对结局异质性进行量化分析。
检索了三个数据库,以确定 2008 年至 2017 年间评估青少年重度抑郁症治疗方法的临床试验。确定的结局按照主题进行分组,并映射到预先设定的结局核心领域(生理/临床、生活影响、资源利用、不良事件和死亡)。采用描述性分析来量化结局异质性。
从搜索中得到 2686 篇文章,其中 42 篇文章描述了 32 项试验,共纳入 32 项试验。使用 118 种不同的结局测量工具测量了 434 个结局,分为 86 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(62%),其次是生活影响(27%)。近一半(45%)的结局仅在单个试验中报告。在报告的 18 个主要结局中,13 个(72%)仅在单个试验中报告。在 30 项试验(94%)中报告了“抑郁症状严重程度”,使用了 19 种不同的结局测量工具。
青少年抑郁症临床试验中存在结局和结局测量工具的异质性。为了实现试验结果的可重复性、可比性和综合分析,需要一套商定的标准结局和测量方法。