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髋或膝关节骨关节炎患者的 EQ-5D-5L 量表的心理测量特性:信度、效度和反应度。

Psychometric properties of the EQ-5D-5L in patients with hip or knee osteoarthritis: reliability, validity and responsiveness.

机构信息

Research Unit, Basurto University Hospital (Osakidetza), Avda. Montevideo, 18, 48013, Bilbao, Bizkaia, Spain.

Health Service Research Network on Chronic Diseases (REDISSEC), Bilbao, Spain.

出版信息

Qual Life Res. 2018 Nov;27(11):2897-2908. doi: 10.1007/s11136-018-1929-x. Epub 2018 Jul 5.

Abstract

PURPOSE

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).

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

摘要

目的

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。

方法

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)。

结果

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。

结论

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。

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