Trondheim University Hospital, Trondheim, Norway.
BMC Musculoskelet Disord. 2013 Apr 26;14:148. doi: 10.1186/1471-2474-14-148.
The need for cost effectiveness analyses in randomized controlled trials that compare treatment options is increasing. The selection of the optimal utility measure is important, and a central question is whether the two most commonly used indexes - the EuroQuol 5D (EQ5D) and the Short Form 6D (SF6D) - can be used interchangeably. The aim of the present study was to compare change scores of the EQ5D and SF6D utility indexes in terms of some important measurement properties. The psychometric properties of the two utility indexes were compared to a disease-specific instrument, the Oswestry Disability Index (ODI), in the setting of a randomized controlled trial for degenerative disc disease.
In a randomized controlled multicentre trial, 172 patients who had experienced low back pain for an average of 6 years were randomized to either treatment with an intensive back rehabilitation program or surgery to insert disc prostheses. Patients filled out the ODI, EQ5D, and SF-36 at baseline and two-year follow up. The utility indexes was compared with respect to measurement error, structural validity, criterion validity, responsiveness, and interpretability according to the COSMIN taxonomy.
At follow up, 113 patients had change score values for all three instruments. The SF6D had better similarity with the disease-specific instrument (ODI) regarding sensitivity, specificity, and responsiveness. Measurement error was lower for the SF6D (0.056) compared to the EQ5D (0.155). The minimal important change score value was 0.031 for SF6D and 0.173 for EQ5D. The minimal detectable change score value at a 95% confidence level were 0.157 for SF6D and 0.429 for EQ5D, and the difference in mean change score values (SD) between them was 0.23 (0.29) and so exceeded the clinical significant change score value for both instruments. Analysis of psychometric properties indicated that the indexes are unidimensional when considered separately, but that they do not exactly measure the same underlying construct.
This study indicates that the difference in important measurement properties between EQ5D and SF6D is too large to consider them interchangeable. Since the similarity with the "gold standard" (the disease-specific instrument) was quite different, this could indicate that the choice of index should be determined by the diagnosis.
在比较治疗方案的随机对照试验中,需要进行成本效益分析。选择最佳效用测量方法非常重要,一个核心问题是最常用的两个指标——欧洲五维健康量表(EQ5D)和六维健康量表简表(SF6D)——是否可以互换使用。本研究的目的是比较 EQ5D 和 SF6D 效用指数在一些重要测量特性方面的变化分数。在退行性椎间盘疾病的随机对照试验中,将这两种效用指数的心理测量特性与疾病特异性工具——Oswestry 残疾指数(ODI)进行比较。
在一项随机对照多中心试验中,172 名平均腰痛 6 年的患者被随机分为接受强化背部康复计划治疗或接受椎间盘假体手术治疗。患者在基线和两年随访时填写 ODI、EQ5D 和 SF-36。根据 COSMIN 分类法,对效用指数的测量误差、结构有效性、标准有效性、反应性和可解释性进行比较。
随访时,113 名患者的所有三种仪器均有变化分数。SF6D 在敏感性、特异性和反应性方面与疾病特异性仪器(ODI)更为相似。SF6D 的测量误差(0.056)低于 EQ5D(0.155)。SF6D 的最小重要变化分数值为 0.031,EQ5D 的最小重要变化分数值为 0.173。在 95%置信水平下,SF6D 的最小可检测变化分数值为 0.157,EQ5D 的最小可检测变化分数值为 0.429,两者之间的平均变化分数值(标准差)差值为 0.23(0.29),超过了两种仪器的临床显著变化分数值。心理测量特性分析表明,当分别考虑时,这些指标是单维的,但它们并没有完全测量相同的潜在结构。
本研究表明,EQ5D 和 SF6D 在重要测量特性方面的差异太大,不能认为它们可以互换。由于与“金标准”(疾病特异性仪器)的相似性非常不同,这可能表明指数的选择应根据诊断确定。