Department of Health Services Research, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.
Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre, and CAPHRI Research Institute, Maastricht University, Maastricht, The Netherlands.
J Med Econ. 2022 Jan-Dec;25(1):829-839. doi: 10.1080/13696998.2022.2087409.
This study compared the psychometric properties of EQ-5D-5L and SF-6D to assess the interchangeability of both instruments in patients with a recent fracture presenting at a Fracture Liaison Service (FLS).
Data from a prospective observational study in a Dutch FLS clinic were used. Over 3 years, subjects were interviewed at several time points using EQ-5D-5L and SF-36. Floor and ceiling effects were evaluated. Agreement was evaluated by intra-class correlation coefficients and visualized in Bland-Altman plots. Spearman's rank correlation coefficients were applied to assess convergent validity. Mann-Whitney test or Kruskal-Wallis test as well as effect size (ES) were used to explore known-groups validity. Responsiveness was explored using standardized response mean (SRM) and ES. For each measurement property, hypotheses on direction and magnitude of effects were formulated.
A total of 499 patients were included. EQ-5D-5L had a considerable ceiling effect in comparison to SF-6D (21 vs. 1.2%). Moderate agreement between the (UK and Dutch) EQ-5D-5L and SF-6D was identified with intra-class correlation coefficients of 0.625 and 0.654, respectively. Bland-Altman plots revealed proportional bias as the differences in utilities between two instruments were highly dependent on the health states. High correlation between instruments was found (UK: rho = 0.758; Dutch: rho = 0.763). EQ-5D-5L and SF-6D utilities showed high correlation with physical component score but low correlation with mental component score of SF-36. Both instruments showed moderate discrimination (ES > 0.5) for subgroup by baseline fracture type, and moderate responsiveness (SRM > 0.5) in patients that sustained a subsequent fracture.
Both EQ-5D-5L and SF-6D appeared to be valid utility instruments in patients with fractures attending the FLS. However, they cannot be used interchangeably given only moderate agreement was identified, and differences in utilities and ceiling effect were revealed. Comparable construct validity and responsiveness were indicated, and neither instrument was found to be clearly superior.
本研究比较了 EQ-5D-5L 和 SF-6D 的心理测量特性,以评估这两种工具在骨折联络服务(FLS)就诊的近期骨折患者中的可互换性。
使用荷兰 FLS 诊所的前瞻性观察研究的数据。在 3 年的时间里,使用 EQ-5D-5L 和 SF-36 对受试者进行了多次访谈。评估了地板和天花板效应。通过组内相关系数评估一致性,并在 Bland-Altman 图中可视化。应用 Spearman 秩相关系数评估收敛效度。采用 Mann-Whitney 检验或 Kruskal-Wallis 检验以及效应量(ES)来探索已知组别的有效性。使用标准化反应均值(SRM)和 ES 来探索反应性。对于每种测量特性,都提出了关于效果方向和幅度的假设。
共纳入 499 例患者。与 SF-6D 相比,EQ-5D-5L 具有相当大的天花板效应(21%比 1.2%)。EQ-5D-5L(英国和荷兰)与 SF-6D 之间的一致性中等,组内相关系数分别为 0.625 和 0.654。Bland-Altman 图显示,由于两种仪器之间的效用差异高度依赖于健康状况,因此存在比例偏差。仪器之间相关性较高(英国:rho=0.758;荷兰:rho=0.763)。EQ-5D-5L 和 SF-6D 效用与 SF-36 的身体成分得分高度相关,但与心理成分得分低度相关。两种仪器在基线骨折类型的亚组中均表现出较高的区分度(ES>0.5),在发生后续骨折的患者中具有较高的反应性(SRM>0.5)。
在接受 FLS 治疗的骨折患者中,EQ-5D-5L 和 SF-6D 似乎都是有效的效用工具。然而,由于仅发现中等程度的一致性,并且效用和天花板效应存在差异,因此不能互换使用。表明具有可比的结构有效性和反应性,并且两种仪器都没有明显优势。