Evans Kenneth R, Sills Terrence, DeBrota David J, Gelwicks Steve, Engelhardt Nina, Santor Darcy
Axon Clinical Research, Toronto, ON, Canada M5V 3B5.
J Psychiatr Res. 2004 May-Jun;38(3):275-84. doi: 10.1016/j.jpsychires.2003.11.003.
Although the Hamilton Depression Rating Scale (HAMD) remains the most widely used outcome measure in clinical trials of Major Depressive Disorder, the psychometric properties of the individual HAMD items have not been extensively studied. In the present paper, data from four separate clinical trials conducted independently by two pharmaceutical companies were analyzed to determine the relationship between scores on the individual HAMD items and overall depressive severity in an outpatient population. Option characteristic curves (the probability of scoring a particular option in relation to overall HAMD scores) were generated in order to illustrate the relationship between scoring patterns for each item and the range of total HAMD scores. Results showed that Items 1 (Depressed Mood) and 7 (Work and Activities), and to a lesser degree, Items 2 (Guilt), 10 (Anxiety/Psychic), 11 (Anxiety/Somatic), and 13 (Somatic/General) demonstrated a good relationship between item responses and overall depressive severity. However, other items (e.g. Insight, Hypochondriasis) appeared to be more problematic with regard to their ability to discriminate over the full range of depression severity. The present results illustrate that co-operative data sharing between pharmaceutical companies can be a useful tool for improving clinical methods.
尽管汉密尔顿抑郁量表（HAMD）在重度抑郁症的临床试验中仍是使用最广泛的疗效指标，但HAMD各个项目的心理测量特性尚未得到广泛研究。在本文中，对两家制药公司独立开展的四项不同临床试验的数据进行了分析，以确定在门诊患者群体中HAMD各个项目的得分与总体抑郁严重程度之间的关系。生成了选项特征曲线（根据HAMD总分获得特定选项得分的概率），以说明每个项目的得分模式与HAMD总分范围之间的关系。结果显示，第1项（抑郁情绪）和第7项（工作和活动），以及程度稍低的第2项（有罪感）、第10项（焦虑/精神性）、第11项（焦虑/躯体性）和第13项（躯体性/一般性）在项目反应与总体抑郁严重程度之间呈现出良好的关系。然而，其他项目（如自知力、疑病）在区分整个抑郁严重程度范围方面的能力似乎存在更多问题。目前的结果表明，制药公司之间的合作数据共享可以成为改进临床方法的有用工具。
