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在测量等待全髋关节置换术或全膝关节置换术的患者的健康相关生活质量方面,EQ-5D-5L 优于 -3L 版本。

The EQ-5D-5L Is Superior to the -3L Version in Measuring Health-related Quality of Life in Patients Awaiting THA or TKA.

机构信息

X. Jin, F. Al Sayah, A. Ohinmaa, J. A. Johnson, School of Public Health, University of Alberta, Edmonton, Alberta, Canada D. A. Marshall, Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada C. Smith, Alberta Bone & Joint Health Institute, Calgary, Alberta, Canada.

出版信息

Clin Orthop Relat Res. 2019 Jul;477(7):1632-1644. doi: 10.1097/CORR.0000000000000662.

DOI:10.1097/CORR.0000000000000662
PMID:30801280
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6999959/
Abstract

BACKGROUND

As a generic measure of health-related quality of life among patients awaiting THA or TKA, the three-level version of the EQ-5D (EQ-5D-3L), which has three response levels of severity (no problems, some problems, and extreme problems/unable) to five questions, is widely used. Previous studies indicated that the ceiling effect of the EQ-5D-3L limits its application. The five-level version of the EQ-5D (EQ-5D-5L) was developed to enhance the measurement properties of the tool by adding two levels: slight problems and severe problems. However, only a few small studies have compared the EQ-5D-3L and EQ-5D-5L in patients awaiting THA and TKA.

QUESTIONS/PURPOSES: The purpose of this study was to examine the performance of the EQ-5D-3L and EQ-5D-5L among patients awaiting THA or TKA in terms of (1) response patterns, (2) convergent construct validity, (3) known-group validity, and (4) informativity and discriminatory power.

METHODS

This is a retrospective analysis of the Alberta Bone and Joint Health Data Repository, which recorded information on all patients receiving hip or knee arthroplasties between April 2010 and March 2017 in Alberta, Canada (n = 37,377). Patients receiving THA or TKA and who completed the EQ-5D and WOMAC at baseline (presurgery) were included in this study (n = 24,766). The EQ-5D-3L was administered to all patients in 2010, and was gradually replaced by the EQ-5D-5L between 2013 and 2016; the EQ-5D-5L reached full application in all clinics by 2017.A propensity score was used to match patients 1:1 who completed either the EQ-5D-3L or EQ-5D-5L before surgery. Response patterns have been explored using ceiling and floor effects and distribution across severity levels of each dimension. Convergent construct validity was examined using Spearman's correlation (rho) against the WOMAC. Known-group validity was examined by gender, preoperative risk factors, mental health, obesity, and WOMAC physical function score. Informativity and discriminatory power were examined using the Shannon (H') and Shannon evenness (J') indices. A total of 3446 pairs of patients awaiting THA (55% women; mean age, 66 years) and 5428 pairs of patients awaiting TKA (59% women; mean age 67 years) were included in this analysis; the study group included all patients who were kept in the propensity score matching.

RESULTS

Ceiling and floor effects were comparable and small (less than 0.5%) for both versions; the responses across severity levels for each dimension were more evenly distributed for the EQ-5D-5L. Convergent construct validity was stronger for the EQ-5D-5L as it consistently had stronger correlations with the WOMAC overall and domain scores than the EQ-5D-3L (rho(3L-THA), -0.77 to -0.31; rho(3L-TKA), -0.71 to -0.24; rho(5L-THA), -0.71 to -0.17; rho(5L-TKA), -0.64 to -0.17; all p values < 0.001). The hypotheses of known-group analyses were confirmed for both versions. The EQ-5D-5L demonstrated stronger informativity and discriminatory power than the EQ-5D-3L, particularly for the mobility dimension (THA, H'(5L/3L)=1.66/0.37, J'(5L/3L)=0.72/0.23; TKA, H'(5L/3L)=1.66/0.41, J'(5L/3L)=0.71/0.26).

CONCLUSIONS

This study demonstrates the superior construct validity, and informativity and discriminatory power of the EQ-5D-5L compared with the EQ-5D-3L among patients awaiting THA or TKA.

CLINICAL RELEVANCE

Compared with the three-level version, the five-level version of the EQ-5D differentiates between patients awaiting THA and TKA much better based on their mobility, which is a key health aspect or outcome in these patients. Our findings suggest that the EQ-5D-5L is more appropriate for this population.

摘要

背景

作为一种通用的衡量患者接受全髋关节置换术或全膝关节置换术前健康相关生活质量的指标,EQ-5D 的三水平版本(EQ-5D-3L)被广泛应用,该版本有五个问题的三个严重程度级别(无问题、有些问题和严重问题/无法)。先前的研究表明,EQ-5D-3L 的天花板效应限制了其应用。EQ-5D 的五水平版本(EQ-5D-5L)的开发是为了通过增加两个级别:轻微问题和严重问题来提高工具的测量性能。然而,只有少数小型研究比较了接受全髋关节置换术和全膝关节置换术的患者的 EQ-5D-3L 和 EQ-5D-5L。

问题/目的:本研究旨在探讨 EQ-5D-3L 和 EQ-5D-5L 在接受全髋关节置换术或全膝关节置换术的患者中的表现,包括(1)反应模式,(2)收敛性结构有效性,(3)已知组有效性和(4)信息量和区分能力。

方法

这是对加拿大阿尔伯塔省骨与关节健康数据仓库的回顾性分析,该数据库记录了 2010 年 4 月至 2017 年 3 月期间在加拿大阿尔伯塔省接受髋关节或膝关节置换术的所有患者的信息(n=37377)。本研究纳入了接受全髋关节置换术或全膝关节置换术且在术前(手术前)完成 EQ-5D 和 WOMAC 的患者(n=24766)。2010 年所有患者都接受了 EQ-5D-3L 测试,2013 年至 2016 年之间逐渐被 EQ-5D-5L 取代;到 2017 年,所有诊所都全面应用了 EQ-5D-5L。使用倾向评分将手术前完成 EQ-5D-3L 或 EQ-5D-5L 的患者进行 1:1 匹配。使用天花板和地板效应以及每个维度严重程度水平的分布来探索反应模式。使用 Spearman 相关系数(rho)对 WOMAC 进行收敛性结构有效性检验。通过性别、术前危险因素、心理健康、肥胖和 WOMAC 躯体功能评分检验已知组有效性。使用 Shannon(H')和 Shannon 均匀性(J')指数检验信息量和区分能力。共纳入 3446 对接受全髋关节置换术的患者(55%为女性;平均年龄 66 岁)和 5428 对接受全膝关节置换术的患者(59%为女性;平均年龄 67 岁);研究组包括所有保留在倾向评分匹配中的患者。

结果

两个版本的天花板和地板效应都比较小(小于 0.5%);每个维度的严重程度水平的反应分布更为均匀,EQ-5D-5L 更优。EQ-5D-5L 与 WOMAC 总体和各领域评分的相关性更强,因此其收敛性结构有效性更强,而 EQ-5D-3L 的相关性较弱(rho(3L-THA),-0.77 至-0.31;rho(3L-TKA),-0.71 至-0.24;rho(5L-THA),-0.71 至-0.17;rho(5L-TKA),-0.64 至-0.17;所有 p 值均<0.001)。两个版本的已知组分析假设均得到验证。EQ-5D-5L 与 EQ-5D-3L 相比,信息量和区分能力更强,尤其是对移动性维度(THA,H'(5L/3L)=1.66/0.37,J'(5L/3L)=0.72/0.23;TKA,H'(5L/3L)=1.66/0.41,J'(5L/3L)=0.71/0.26)。

结论

本研究表明,与 EQ-5D-3L 相比,接受全髋关节置换术或全膝关节置换术的患者的 EQ-5D-5L 具有更强的结构有效性,信息量和区分能力。

临床相关性

与三水平版本相比,EQ-5D 的五水平版本在移动性方面更好地区分了接受全髋关节置换术和全膝关节置换术的患者,这是这些患者的关键健康方面或结果。我们的研究结果表明,EQ-5D-5L 更适合这一人群。