Research Unit, Basurto University Hospital (Osakidetza), Avda. Montevideo, 18, 48013, Bilbao, Bizkaia, Spain.
Health Service Research Network on Chronic Diseases (REDISSEC), Bilbao, Spain.
Qual Life Res. 2018 Nov;27(11):2897-2908. doi: 10.1007/s11136-018-1929-x. Epub 2018 Jul 5.
To study the psychometric properties, including reliability, validity and responsiveness, of the Spanish EQ-5D-5L questionnaire for patients with hip or knee osteoarthritis (OA).
We included 758 patients with hip or knee OA who completed the EQ-5D-5L and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline, of whom 644 also did 6 months later. The EQ-5D-5L contains five questions from which a utility index is derived. The WOMAC covers three dimensions: pain, stiffness and physical function. Floor and ceiling effects were calculated. Reliability was assessed using Cronbach's alpha. Convergent validity was tested using the Spearman correlation coefficient between EQ-5D-5L and WOMAC. We examined known-groups validity by comparing the EQ-5D-5L between subgroups defined by WOMAC scores using ANOVA or the Kruskal-Wallis test. Effect sizes were calculated to assess responsiveness, and minimal clinically important difference (MCID) was estimated.
The EQ-5D-5L showed minimal floor and ceiling effects (< 3%). Cronbach's alpha was 0.86. The EQ-5D-5L index was strongly correlated with WOMAC pain and function scores (- 0.688 and - 0.782). Patients with higher WOMAC scores had significantly (p < 0.0001) lower EQ-5D-5L index. The 20.19% had hip or knee replacement during the follow-up. Effect sizes were small among non-surgical patients, but > 0.80 among "improved" surgical patients, being the MCID for improvement 0.32 points.
The results support the reliability, validity and responsiveness of the EQ-5D-5L, overcoming the limitations of the EQ-5D-3L in these patients. Therefore, the EQ-5D-5L could be very useful as an outcome measure, at least in patients with hip or knee OA.
研究西班牙版 EQ-5D-5L 问卷在髋或膝关节骨关节炎（OA）患者中的心理测量特性，包括可靠性、有效性和反应度。
我们纳入了 758 名髋或膝关节 OA 患者，他们在基线时完成了 EQ-5D-5L 和西部安大略省和麦克马斯特大学骨关节炎指数（WOMAC）的评估，其中 644 名患者在 6 个月后再次进行了评估。EQ-5D-5L 包含五个问题，从中得出效用指数。WOMAC 涵盖三个维度：疼痛、僵硬和身体功能。我们计算了地板效应和天花板效应。使用 Cronbach's alpha 评估可靠性。使用 EQ-5D-5L 和 WOMAC 之间的 Spearman 相关系数来检验收敛有效性。我们通过 ANOVA 或 Kruskal-Wallis 检验比较 WOMAC 评分定义的亚组之间的 EQ-5D-5L 值，以评估已知组间有效性。我们计算效应大小以评估反应度，并估计最小临床重要差异（MCID）。
EQ-5D-5L 的地板效应和天花板效应均较小（<3%）。Cronbach's alpha 为 0.86。EQ-5D-5L 指数与 WOMAC 疼痛和功能评分呈强相关性（-0.688 和 -0.782）。WOMAC 评分较高的患者的 EQ-5D-5L 指数显著降低（p<0.0001）。在随访期间，20.19%的患者接受了髋或膝关节置换。非手术患者的效应大小较小，但“改善”手术患者的效应大小>0.80，改善的 MCID 为 0.32 分。
结果支持 EQ-5D-5L 的可靠性、有效性和反应度，克服了该问卷在这些患者中的局限性。因此，EQ-5D-5L 可能非常有用作为一种结局测量指标，至少在髋或膝关节 OA 患者中如此。
