Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Department of Ophthalmology, Bristol Eye Hospital, Bristol, UK.
Qual Life Res. 2020 Jul;29(7):1935-1946. doi: 10.1007/s11136-020-02443-3. Epub 2020 Feb 20.
PURPOSE: The validity and responsiveness of the EQ-5D-3L in visual conditions has been questioned, inspiring development of a vision 'bolt-on' domain (EQ-5D-3L + VIS). Developments in preference-based measures (PBM) also includes the EQ-5D-5L and the ICECAP-O capability wellbeing measure. This study aimed to examine the construct validity and responsiveness of the EQ-5D-3L, EQ-5D-5L, EQ-5D-3L + VIS and ICECAP-O in cataract surgery patients for the first time, to inform choice of PBM for economic evaluation in this population. METHODS: The analyses used data from the UK Predict-CAT cataract surgery cohort study. PBMs and the Cat-PROM5 [a validated measure of cataract quality of life (QOL)] were completed before surgery and 4-8 weeks after. Construct validity was assessed using correlations and known-group differences evaluated using regression. Responsiveness was evaluated using effect sizes and analysis of variance to compare change scores between groups, defined by patient-reported and clinical outcomes. RESULTS: The sample comprised 1315 patients at baseline. No PBMs were associated with visual acuity and only the ICECAP-O (Spearman's rs = - 0.35), EQ-5D-3L + VIS (rs = - 0.42) and EQ-5D-5L (Value Set for England rs = - 0.31) correlated at least moderately with the Cat-PROM5. Effect sizes of change were consistently largest for the EQ-5D-3L + VIS (range 0.34-0.41), followed by the ICECAP-O (range 0.20-0.34). Results indicated no improvement in responsiveness using the EQ-5D-5L (range 0.13-0.16) compared to the EQ-5D-3L (range 0.17-0.20). CONCLUSIONS: Whilst no PBMs comprehensively demonstrated evidence of construct validity and responsiveness in cataract surgery patients, the ICECAP-O was the most responsive generic PBM to improvements in QOL. Surprisingly the EQ-5D-5L was not more responsive than the EQ-5D-3L in this setting.
目的:EQ-5D-3L 在视觉条件下的有效性和反应度受到了质疑,这激发了视觉“附加”域(EQ-5D-3L+VIS)的开发。偏好测量的发展(PBM)还包括 EQ-5D-5L 和 ICECAP-O 能力福利衡量标准。本研究首次旨在检验 EQ-5D-3L、EQ-5D-5L、EQ-5D-3L+VIS 和 ICECAP-O 在白内障手术患者中的构念有效性和反应度,为该人群中的经济评估选择 PBM 提供信息。 方法:该分析使用了来自英国预测-CAT 白内障手术队列研究的数据。在手术前和 4-8 周后完成了 PBM 和 Cat-PROM5(一种经过验证的白内障生活质量(QOL)衡量标准)。构念有效性通过相关性评估,使用回归评估已知组间差异。使用效应大小和方差分析来评估反应度,以比较两组之间的变化得分,根据患者报告的和临床结果定义。 结果:基线时样本包括 1315 名患者。没有 PBM 与视力相关,只有 ICECAP-O(斯皮尔曼 rs= -0.35)、EQ-5D-3L+VIS(rs= -0.42)和 EQ-5D-5L(英格兰值集 rs= -0.31)与 Cat-PROM5 至少中度相关。变化的效应大小始终最大的是 EQ-5D-3L+VIS(范围 0.34-0.41),其次是 ICECAP-O(范围 0.20-0.34)。结果表明,与 EQ-5D-3L(范围 0.17-0.20)相比,EQ-5D-5L(范围 0.13-0.16)的反应度没有改善。 结论:虽然没有 PBM 全面证明了在白内障手术患者中的构念有效性和反应度,但 ICECAP-O 是对 QOL 改善最敏感的通用 PBM。令人惊讶的是,在这种情况下,EQ-5D-5L 并不比 EQ-5D-3L 更敏感。
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