Fantino Bruno, Moore Nicholas
ADIM-AGORAS, Lyon, France.
BMC Psychiatry. 2009 May 27;9:26. doi: 10.1186/1471-244X-9-26.
The use of Patient-reported Outcomes (PROs) as secondary endpoints in the development of new antidepressants has grown in recent years. The objective of this study was to assess the psychometric properties of the 9-item, patient-administered version of the Montgomery-Asberg Depression Rating Scale (MADRS-S).
Data from a multicentre, double-blind, 8-week, randomised controlled trial of 278 outpatients diagnosed with Major Depressive Disorder were used to evaluate the validity, reliability and sensitivity to change of the MADRS-S using psychometric methods. A Receiver Operating Characteristic (ROC) curve was plotted to identify the most appropriate threshold to define perceived remission.
No missing values were found at the item level, indicating good acceptability of the scale. The construct validity was satisfactory: all items contributed to a common underlying concept, as expected. The correlation between MADRS-S and physicians' MADRS was moderate (r = 0.54, p < 0.001) indicating that MADRS-S is complementary rather than redundant to the MADRS. Cronbach's alpha was 0.84, and the stability over time of the scale, estimated on a sub-sample of patients whose health status did not change during the first week of the study, was good (intraclass correlation coefficient of 0.78). MADRS-S sensitivity to change was shown. Using a threshold value of 5, the definition of "perceived remission" reached a sensitivity of 82% and a specificity of 75%.
Taking account of patient's perceptions of the severity of their own symptoms along with the psychometric properties of the MADRS-S enable its use for evaluative purposes in the development of new antidepressant drugs.
近年来,患者报告结局(PROs)作为新型抗抑郁药研发中的次要终点的应用有所增加。本研究的目的是评估蒙哥马利-阿斯伯格抑郁评定量表9项患者自评版(MADRS-S)的心理测量特性。
来自一项多中心、双盲、为期8周的随机对照试验的数据,该试验纳入了278名被诊断为重度抑郁症的门诊患者,使用心理测量方法评估MADRS-S的有效性、可靠性和对变化的敏感性。绘制受试者工作特征(ROC)曲线以确定定义感知缓解的最合适阈值。
在项目层面未发现缺失值,表明该量表具有良好的可接受性。结构效度令人满意:所有项目都如预期那样促成了一个共同的潜在概念。MADRS-S与医生评定的MADRS之间的相关性为中等(r = 0.54,p < 0.001),表明MADRS-S是MADRS的补充而非冗余。克朗巴哈系数为0.84,在研究第一周健康状况未改变的患者子样本中估计的量表随时间的稳定性良好(组内相关系数为0.78)。显示了MADRS-S对变化的敏感性。使用阈值5,“感知缓解”的定义达到了82%的敏感性和75%的特异性。
考虑患者对自身症状严重程度的感知以及MADRS-S的心理测量特性,使其能够在新型抗抑郁药研发中用于评估目的。