The clinical relevance of changes in the Montgomery-Asberg Depression Rating Scale using the minimum clinically important difference approach
The clinical relevance of changes in the Montgomery-Asberg Depression Rating Scale using the minimum clinically important difference approach
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DOI：
10.1185/030079908x291958
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发表时间：
2008-05-01
影响因子：
2.3
通讯作者：
Fantino, Bruno
中科院分区：
文献类型：
--
作者：
Duru, Gerard;Fantino, Bruno
目的：确定蒙哥马利-艾斯伯格抑郁评定量表（MADRS）在抑郁症随机研究中的最小临床重要差异（MCID），并交叉验证估计的MCID。设计和方法：来自三个设计相似、为期8周、双盲、基线至第1周健康状况稳定的随机抑郁症试验（临床总体印象改善量表的“无变化”评级）合格。为了使用基于分布的方法计算MCID，使用基线MADRS数据估计标准差，而可靠性参数测量为基线和第1周之间的组内相关系数。为了交叉验证，将来自观察性研究的患者进行匹配，以确定“MCID变化”（从基线到终点评分的MADRS变化加上估计的MCID）和“对照”组。临床和健康相关的生活质量的措施进行了比较。结果：总共有177名安慰剂治疗的患者被确定。MADRS的MCID估计值范围为1.6至1.9。共确定了105对匹配的交叉验证分析。MADRS评分（10.6 +/- 8.5 vs. 12.5 +/- 7.9，p = 0.038）和缓解率（71.6% vs. 57.1%，p < 0.05）较基线的平均变化在“MCID变化”组和“对照”组之间存在显著差异。数值上更高的响应率和更大的改善HRQoL分数在“MCID的变化”group.Conclusion：这些初步研究结果支持的价值估计MCID的MADRS，并可能有助于决策者在评估抗抑郁治疗效果和改善长期患者的结局。
Objective: To identify the minimal clinically important difference (MCID) for the Montgomery-Asberg Depression Rating Scale (MADRS) in randomised studies of depression, and to cross-validate the estimated MCID.Design and methods: Placebo-treated patients from three similarly-designed, 8-week, double-blind, randomised depression trials with a stable health status between baseline and Week 1 ('no change' rating on the Clinical Global Impression-Improvement scale) were eligible. To calculate the MCID using the distribution-based approach, the standard deviation was estimated using baseline MADRS data while the reliability parameter was measured as the intraclass correlation coefficient between baseline and Week 1. For cross-validation, patients from an observational study were matched to identify the 'MCID change' (MADRS change from baseline to endpoint score plus the estimated MCID) and 'control' groups. Comparisons of clinical and health-related quality of life measures were performed.Results: In total, 177 placebo-treated patients were identified. MCID estimates for MADRS ranged from 1.6 to 1.9. A total of 105 matched pairs were identified for the cross-validation analyses. Mean change from baseline in MADRS scores (10.6 +/- 8.5 vs. 12.5 +/- 7.9, p = 0.038) and remission rates (71.6% vs. 57.1%, p < 0.05) significantly differed between the 'MCID change' and 'control' groups at endpoint. Numerically higher response rates and greater improvements in HRQoL scores in the 'MCID change' group were also found.Conclusion: These preliminary findings support the value of the estimated MCID for the MADRS and may aid decision makers in evaluating antidepressant treatment effects and improving long-term patient outcomes.