Prisciandaro James J, Tolliver Bryan K
Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, United States.
Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, United States.
J Affect Disord. 2016 Nov 15;205:73-80. doi: 10.1016/j.jad.2016.06.062. Epub 2016 Jul 13.
The Young Mania Rating Scale (YMRS) and Montgomery-Asberg Depression Rating Scale (MADRS) are among the most widely used outcome measures for clinical trials of medications for Bipolar Disorder (BD). Nonetheless, very few studies have examined the measurement characteristics of the YMRS and MADRS in individuals with BD using modern psychometric methods. The present study evaluated the YMRS and MADRS in the Systematic Treatment Enhancement Program for BD (STEP-BD) study using Item Response Theory (IRT).
Baseline data from 3716 STEP-BD participants were available for the present analysis. The Graded Response Model (GRM) was fit separately to YMRS and MADRS item responses. Differential item functioning (DIF) was examined by regressing a variety of clinically relevant covariates (e.g., sex, substance dependence) on all test items and on the latent symptom severity dimension, within each scale.
Both scales: 1) contained several items that provided little or no psychometric information, 2) were inefficient, in that the majority of item response categories did not provide incremental psychometric information, 3) poorly measured participants outside of a narrow band of severity, 4) evidenced DIF for nearly all items, suggesting that item responses were, in part, determined by factors other than symptom severity.
Limited to outpatients; DIF analysis only sensitive to certain forms of DIF.
The present study provides evidence for significant measurement problems involving the YMRS and MADRS. More work is needed to refine these measures and/or develop suitable alternative measures of BD symptomatology for clinical trials research.
青年躁狂评定量表(YMRS)和蒙哥马利-阿斯伯格抑郁评定量表(MADRS)是双相情感障碍(BD)药物临床试验中使用最广泛的疗效指标。尽管如此,很少有研究使用现代心理测量方法来检验BD患者中YMRS和MADRS的测量特性。本研究在双相情感障碍系统治疗强化项目(STEP-BD)研究中使用项目反应理论(IRT)对YMRS和MADRS进行了评估。
本分析可获得3716名STEP-BD参与者的基线数据。分别对YMRS和MADRS的项目反应拟合等级反应模型(GRM)。通过在每个量表内,将各种临床相关协变量(如性别、物质依赖)对所有测试项目和潜在症状严重程度维度进行回归,来检验项目功能差异(DIF)。
两个量表均:1)包含几个提供很少或没有心理测量信息的项目;2)效率低下,因为大多数项目反应类别没有提供增量心理测量信息;3)对严重程度狭窄范围之外的参与者测量效果不佳;4)几乎所有项目都存在DIF,这表明项目反应部分由症状严重程度以外的因素决定。
限于门诊患者;DIF分析仅对某些形式的DIF敏感。
本研究为涉及YMRS和MADRS的重大测量问题提供了证据。需要开展更多工作来完善这些测量方法和/或开发适用于临床试验研究的BD症状学替代测量方法。