Department of Molecular Pharmacology and Experimental Therapeutics, Mayo Clinic, Rochester, Minnesota, USA.
Department of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota, USA.
J Child Adolesc Psychopharmacol. 2022 Jun;32(5):278-287. doi: 10.1089/cap.2021.0111.
The Clinical Global Impressions-Improvement (CGI-I) scale is widely used in clinical research to assess symptoms and functioning in the context of treatment. The correlates of the CGI-I with efficacy scales for adolescent major depressive disorder are poorly understood. This study focused on benchmarking CGI-I scores with changes in the Children's Depression Rating Scale-Revised (CDRS-R) and the Quick Inventory of Depressive Symptomatology-Adolescent (17-item) Self-Report (QIDS-A17-SR). We examined three datasets with the clinician-rated CDRS-R to ascertain equivalent percent changes in total scores and CGI-I ratings. Exploratory analyses examined corresponding percentage changes in the QIDS-A17-SR and the CGI-I ratings. The CGI-I was the reference scale for nonparametric equipercentile linking with the Equate package in R. CGI-I scores of 1 mapped to ≥78%-95% change in CDRS-R scores at 4-6 weeks across three datasets. CGI-I scores of 2 mapped to 56%-94% change in CDRS-R scores at 4-6 weeks across three studies. CGI-I scores of 3 mapped to 30%-68% changes in CDRS-R scores at 4-6 weeks across three studies. CGI-I scores of 4 mapped to a range of 29%-44% at 4-6 weeks across three studies. There was no significant difference ( ≥ 0.6) between treatment groups in both the Treatment of Adolescents with Depression and Treatment of Resistant Depression in Adolescents studies, for each CGI-I score ( = 1, or = 2 or = 3, or ≥4), associated mapping of total depression severity score, or associated percent change from baseline for corresponding follow-up visits. There was no significant sex difference ( > 0.2) in CGI-I linkages to CDRS-R total or percentage changes. These findings establish clear relationships among CGI-I scores and the CDRS-R and the QIDS-A17-SR. These benchmarks have utility for clinical trial study design, inter-rater reliability training, and clinical implementation.
临床总体印象改善(CGI-I)量表在临床研究中被广泛用于评估治疗背景下的症状和功能。CGI-I 与青少年重度抑郁症疗效量表的相关性尚不清楚。本研究侧重于用儿童抑郁评定量表修订版(CDRS-R)和青少年抑郁症状快速清单 17 项自我报告版(QIDS-A17-SR)的变化来对 CGI-I 评分进行基准测试。我们用临床评定的 CDRS-R 检查了三个数据集,以确定总分和 CGI-I 评分的等效百分比变化。探索性分析检查了 QIDS-A17-SR 和 CGI-I 评分的相应百分比变化。CGI-I 为参考量表,使用 R 中的 Equate 包进行非参数等百分位链接。在三个数据集的 4-6 周时,CGI-I 评分 1 映射到 CDRS-R 评分变化的≥78%-95%。在三个研究中,CGI-I 评分 2 映射到 CDRS-R 评分变化的 56%-94%,在 4-6 周。在三个研究中,CGI-I 评分 3 映射到 CDRS-R 评分变化的 30%-68%,在 4-6 周。在三个研究中,CGI-I 评分 4 在 4-6 周时映射到 29%-44%的范围。在每个 CGI-I 评分(=1 或=2 或=3 或≥4),与总抑郁严重程度评分相关的映射,或与对应随访的基线相比的相关百分比变化,青少年抑郁症治疗和青少年难治性抑郁症治疗研究中的治疗组之间均无显著差异(≥0.6)。CGI-I 与 CDRS-R 总分或百分比变化的关联没有显著的性别差异(>0.2)。这些发现确立了 CGI-I 评分与 CDRS-R 和 QIDS-A17-SR 之间的明确关系。这些基准对临床试验研究设计、评分者间可靠性培训和临床实施具有实用价值。