关键词: Antidepressants Clinical trial Depression Factor analysis Invariance Psychometrics RCT

Mesh : Humans Male Female Psychometrics / standards Antidepressive Agents / therapeutic use Middle Aged Psychiatric Status Rating Scales / standards Randomized Controlled Trials as Topic Adult Depression / drug therapy Aged Factor Analysis, Statistical

来  源:   DOI:10.1016/j.psychres.2024.116057

Abstract:
BACKGROUND: The 17-item Hamilton Rating Scale for Depression (HRSD-17) is the most popular depression measure in antidepressant clinical trials. Prior evidence indicates poor replicability and inconsistent factorial structure. This has not been studied in pooled randomised trial data, nor has a psychometrically optimal model been developed.
OBJECTIVE: To examine the psychometric properties of the HRSD-17 for pre-treatment and post-treatment clinical trial data in a large pooled database of antidepressant randomised controlled trial participants, and to determine an optimal abbreviated version.
METHODS: Data for 6843 participants were obtained from the data repository Vivli.org and randomly split into groups for exploratory (n = 3421) and confirmatory (n = 3422) factor analysis. Invariance methods were used to assess potential sex differences.
RESULTS: The HRSD-17 was psychometrically sub-optimal and non-invariant for all models. High item variances and low variance explained suggested redundancy in each model. EFA failed at baseline and produced four item models for outcome groups (five for placebo-outcome), which were metric but not scalar invariant.
CONCLUSIONS: In antidepressant trial data, the HRSD-17 was psychometrically inadequate and scores were not sex invariant. Neither full nor abbreviated HRSD models are suitable for use in clinical trial settings and the HRSD\'s status as the gold standard should be reconsidered.
摘要:
背景:抑郁症的17项汉密尔顿评定量表(HRSD-17)是抗抑郁药临床试验中最受欢迎的抑郁症衡量标准。先前的证据表明,可复制性差,阶乘结构不一致。这还没有在汇总随机试验数据中进行研究,也没有开发出心理上的最佳模型。
目的:在抗抑郁药随机对照试验参与者的大型汇总数据库中,研究HRSD-17对治疗前和治疗后临床试验数据的心理测量特性,并确定最佳的缩写版本。
方法:从数据库Vivli.org获得6843名参与者的数据,并随机分成几组进行探索性(n=3421)和验证性(n=3422)因素分析。不变性方法用于评估潜在的性别差异。
结果:对于所有模型,HRSD-17在心理上都是次优且非不变的。高项目方差和低方差解释了每个模型中的建议冗余。EFA在基线时失败,并为结果组产生了四个项目模型(安慰剂结果为五个),它们是公制的,但不是标量不变的。
结论:在抗抑郁药试验数据中,HRSD-17在心理测量方面不足,并且评分不具有性别不变性.完整或缩写的HRSD模型均不适合在临床试验环境中使用,并且应重新考虑HRSD作为黄金标准的地位。
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