Yoshimatsu Hiroki, Imaeda Takayuki, Yoshiyama Tamotsu, Higa Shingo, Nomoto Keisuke
Biometrics and Data Management, Pfizer R&D Japan G.K., Shibuya-ku, Tokyo, Japan.
Regulatory Affairs, Pfizer R&D Japan G.K., Shibuya-ku, Tokyo, Japan.
J Child Adolesc Psychopharmacol. 2022 May;32(4):224-232. doi: 10.1089/cap.2021.0141. Epub 2022 May 11.
We aimed to identify which of the 17 items comprising the Children's Depression Rating Scale-Revised (CDRS-R) can sensitively capture changes in depression severity. We used data from four studies involving two antidepressants. For each of the 17 CDRS-R items, we conducted item response analyses to identify and evaluate those that reflect changes in depression severity. We created plots of the item characteristic curves (ICCs) estimated by the graded response model, and option characteristic curves and ICCs using nonparametric item response theory. The change from baseline in the CDRS-R subscale score with specified reflective items by item response analyses and the effect size between the treatment group and placebo group were calculated and compared with those of the CDRS-R total score. CDRS-R items #2 (difficulty having fun), #3 (social withdrawal), #10 (low self-esteem), #11 (depressed feelings), and #15 (depressed facial expression) have favorable profiles that reflect disease severity. Changes from baseline in the CDRS-R total score (least square mean ± standard error) at week 8 were -22.3 ± 0.7 and -23.9 ± 0.7 in the placebo group and treatment group, respectively (difference, -1.5; estimated effect size, -0.113), changes from baseline in the CDRS-R5 (CDRS-R subscale consisting of the specified reflective items [#2, #3, #10, #11, and #15]) score at week 8 were -8.4 ± 0.3 and -9.6 ± 0.3 in each group, respectively (difference, -1.2; effect size, -0.202). The item response analyses clarified the properties of 17 items of the CDRS-R for major depressive disorder in children and adolescents. The CDRS-R5 might optimize the assessment of changes in overall depression severity and differentiation of treatment responses.
我们旨在确定构成儿童抑郁评定量表修订版(CDRS-R)的17个项目中,哪些能够敏感地捕捉抑郁严重程度的变化。我们使用了来自四项涉及两种抗抑郁药的研究数据。对于CDRS-R的17个项目中的每一个,我们进行了项目反应分析,以识别和评估那些反映抑郁严重程度变化的项目。我们绘制了由等级反应模型估计的项目特征曲线(ICC),以及使用非参数项目反应理论的选项特征曲线和ICC。通过项目反应分析计算了指定反映性项目的CDRS-R子量表得分相对于基线的变化,以及治疗组和安慰剂组之间的效应大小,并与CDRS-R总分的变化和效应大小进行了比较。CDRS-R项目#2(难以获得乐趣)、#3(社交退缩)、#10(自卑)、#11(抑郁情绪)和#15(抑郁的面部表情)具有良好的特征,能够反映疾病严重程度。安慰剂组和治疗组在第8周时CDRS-R总分相对于基线的变化(最小二乘均值±标准误差)分别为-22.3±0.7和-23.9±0.7(差异为-1.5;估计效应大小为-0.113),每组在第8周时CDRS-R5(由指定反映性项目[#2、#3、#10、#11和#15]组成的CDRS-R子量表)得分相对于基线的变化分别为-8.4±0.3和-9.6±0.3(差异为-1.2;效应大小为-0.202)。项目反应分析阐明了CDRS-R中17个项目对于儿童和青少年重度抑郁症患者所具有的特性。CDRS-R5可能会优化对总体抑郁严重程度变化以及治疗反应差异的评估。