Department of Pharmacy Administration and Practice, Western University of Health Sciences, Pomona, CA 91766-1854, USA.
Health Qual Life Outcomes. 2013 Apr 12;11:59. doi: 10.1186/1477-7525-11-59.
To determine the minimal clinically important difference (MCID) for the health-utility measures EuroQol-5 dimensions (EQ-5D) and Quality of Well Being Self-Administered (QWB-SA) Scale in PTSD patients.
Two hundred patients aged 18 to 65 years with PTSD enrolled in a doubly randomized preference trial (DRPT) examining the treatment and treatment-preference effects between cognitive behavioral therapy and pharmacotherapy with sertraline and completed the EQ-5D and QWB-SA at baseline and 10-week post-treatment. The anchor-based methods utilized a Clinical Global Impression-Improvement (CGI-I) and Clinical Global Impression-Severity. We regressed the changes in EQ-5D and QWB-SA scores on changes in the anchors using ordinary least squares regression. The slopes (beta coefficients) were the rates of change in the anchors as functions of change in EQ-5D and QWB, which represent our estimates of MCID. In addition, we performed receiver operating characteristic (ROC) curve analysis to examine the relationship between the changes in EQ-5D and QWB-SA scores and treatment-response status. The MCIDs were estimated from the ROC curve where they best discriminate between treatment responders and non-responders. The distribution-based methods used small to moderate effect size in terms of 0.2 and 0.5 of standard deviation of the pre-treatment EQ-5D and QWB-SA scores.
The anchor-based methods estimated the MCID ranges of 0.05 to 0.08 for the EQ-5D and 0.03 to 0.05 for the QWB. The MCID ranges were higher with the distribution-based methods, ranging from 0.04 to 0.10 for the EQ-5D and 0.02 to 0.05 for the QWB-SA.
The established MCID ranges of EQ-5D and QWB-SA can be a useful tool in assessing meaningful changes in patient's quality of life for researchers and clinicians, and assisting health-policy makers to make informing decision in mental health treatment.
Clinicaltrials.gov; Identifier: NCT00127673.
确定创伤后应激障碍（PTSD）患者健康效用测量量表 EuroQol-5 维度（EQ-5D）和自我评估健康状况问卷（QWB-SA）的最小临床重要差异（MCID）。
200 名年龄在 18 至 65 岁之间的 PTSD 患者参加了一项双随机偏好试验（DRPT），该试验检查了认知行为疗法与舍曲林药物治疗之间的治疗效果和治疗偏好，并在基线和 10 周治疗后完成了 EQ-5D 和 QWB-SA。基于锚定的方法利用了临床总体印象改善（CGI-I）和临床总体印象严重程度。我们使用普通最小二乘法回归将 EQ-5D 和 QWB-SA 评分的变化与锚定的变化进行回归。斜率（β系数）是锚定随 EQ-5D 和 QWB 变化的变化率，代表我们对 MCID 的估计。此外，我们进行了接收器操作特征（ROC）曲线分析，以检查 EQ-5D 和 QWB-SA 评分变化与治疗反应状态之间的关系。MCID 是从 ROC 曲线中估计出来的，在该曲线中，它们可以最好地区分治疗反应者和非反应者。基于分布的方法使用了 0.2 和 0.5 个标准差的小到中等效应大小，用于治疗前 EQ-5D 和 QWB-SA 评分。
基于锚定的方法估计 EQ-5D 的 MCID 范围为 0.05 至 0.08，QWB 的 MCID 范围为 0.03 至 0.05。基于分布的方法的 MCID 范围更高，EQ-5D 的范围为 0.04 至 0.10，QWB-SA 的范围为 0.02 至 0.05。
为研究人员和临床医生确定的 EQ-5D 和 QWB-SA 的 MCID 范围可以作为评估患者生活质量有意义变化的有用工具，并帮助卫生政策制定者在精神卫生治疗方面做出知情决策。
Clinicaltrials.gov；标识符：NCT00127673。
