Rutten-van Mölken Maureen P M H, Oostenbrink Jan B, Tashkin Donald P, Burkhart Deborah, Monz Brigitta U
Erasmus MC, Institute for Medical Technology Assessment (IMTA), PO Box 1738, 3000 DR Rotterdam, the Netherlands.
Chest. 2006 Oct;130(4):1117-28. doi: 10.1378/chest.130.4.1117.
To assess the discriminative properties of the EuroQol five-dimension questionnaire (EQ-5D) with respect to COPD severity according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria in a large multinational study.
Baseline EQ-5D visual analog scale (VAS) scores, EQ-5D utility scores, and St. George Respiratory Questionnaire scores were obtained from a subset of patients in the Understanding the Potential Long-term Impact on Function with Tiotropium trial, which was a 4-year placebo-controlled trial designed to assess the effect of tiotropium on the rate of decline in FEV(1) in COPD patients aged > or = 40 years, an FEV(1) of < 70% predicted, an FEV(1)/FVC ratio of < or = 70%, and a smoking history of >/= 10 pack-years.
A total of 1,235 patients (mean post bronchodilator FEV(1), 48.8% predicted) from 13 countries completed the EQ-5D. The EQ-5D VAS and utility scores differed significantly among patients in GOLD stages 2, 3, and 4, also after correction for age, sex, smoking, body mass index (BMI), and comorbidity (p < 0.001). The mean EQ-5D VAS scores for patients in GOLD stages 2, 3, and 4 were 68 (SD, 16), 62 (SD, 17), and 58 (SD, 16), respectively. The mean utility scores were 0.79 (SD, 0.20) for patients in GOLD stage 2, 0.75 (SD, 0.21) for patients in GOLD stage 3, and 0.65 (SD, 0.23) for patients in GOLD stage 4. Effect sizes for the difference in utility scores between patients in GOLD stages 3 and 4 were more than twice as high as those for the difference between patients in GOLD stages 2 and 3. Gender, postbronchodilator FEV(1) percent predicted, the number of hospital admissions and emergency department visits in the year prior to baseline measurements, measures of comorbidity, and BMI were independently associated with EQ-5D utility. EQ-5D utility scores also differed between patients from different countries. French patients especially had lower utility scores than US patients. Utility scores calculated with the US value set were on average 5% higher than those calculated with the UK value set.
Increasing severity of COPD was associated with a significant decline in EQ-5D VAS scores and utility scores. These results demonstrate that a generic instrument can assess COPD impact on quality of life and that the scores discriminate between patient groups of known severity. These utility scores will be useful in cost-effectiveness assessments.
在一项大型跨国研究中，根据慢性阻塞性肺疾病全球倡议组织（GOLD）标准，评估欧洲五维健康量表（EQ-5D）对慢性阻塞性肺疾病（COPD）严重程度的区分特性。
从噻托溴铵对功能潜在长期影响的理解试验中的一部分患者获取基线EQ-5D视觉模拟量表（VAS）评分、EQ-5D效用评分和圣乔治呼吸问卷评分。该试验是一项为期4年的安慰剂对照试验，旨在评估噻托溴铵对年龄≥40岁、预测第一秒用力呼气容积（FEV₁）<70%、FEV₁/用力肺活量（FVC）比值≤70%且吸烟史≥10包年的COPD患者FEV₁下降速率的影响。
来自13个国家的1235例患者（支气管扩张剂后平均FEV₁为预测值的48.8%）完成了EQ-5D评估。在对年龄、性别、吸烟、体重指数（BMI）和合并症进行校正后，GOLD 2、3、4期患者的EQ-5D VAS评分和效用评分仍存在显著差异（p<0.001）。GOLD 2、3、4期患者的平均EQ-5D VAS评分分别为68（标准差，16）、62（标准差，17）和58（标准差，16）。GOLD 2期患者的平均效用评分为0.79（标准差，0.20），GOLD 3期患者为0.75（标准差，0.21），GOLD 4期患者为0.65（标准差，0.23）。GOLD 3期和4期患者效用评分差异的效应量是GOLD 2期和3期患者差异效应量的两倍多。性别、支气管扩张剂后FEV₁预测百分比、基线测量前一年的住院次数和急诊科就诊次数、合并症指标以及BMI与EQ-5D效用独立相关。不同国家患者的EQ-5D效用评分也存在差异。法国患者的效用评分尤其低于美国患者。用美国值集计算的效用评分平均比用英国值集计算的高5%。
COPD严重程度增加与EQ-5D VAS评分和效用评分显著下降相关。这些结果表明，一种通用工具可以评估COPD对生活质量的影响，且评分能够区分已知严重程度的患者组。这些效用评分将有助于成本效益评估。
