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评估接受玻璃体内阿柏西普治疗的糖尿病性黄斑水肿患者的视力与效用之间的关系。

Evaluating the Relationship Between Visual Acuity and Utilities in Patients With Diabetic Macular Edema Enrolled in Intravitreal Aflibercept Studies.

作者信息

Brazier John, Muston Dominic, Konwea Henrietta, Power G Sarah, Barzey Victor, Lloyd Adam, Sowade Olaf, Vitti Bob, Gerlinger Christoph, Roberts Jennifer

机构信息

School of Health and Related Research (ScHARR), Health Economics and Decision Science, University of Sheffield, Sheffield, United Kingdom.

Bayer US LLC, Whippany, New Jersey, United States.

出版信息

Invest Ophthalmol Vis Sci. 2017 Sep 1;58(11):4818-4825. doi: 10.1167/iovs.17-21945.

Abstract

PURPOSE

The purpose of this study was to explore the relationship between visual acuity and utility (health-related quality of life) in diabetic macular edema (DME) using intravitreal aflibercept data.

METHODS

The relationship between visual acuity in the best-seeing eye (BSE) and worse-seeing eye (WSE) and utility was explored using ordinary least squares (OLS) and random-effects models adjusted for different covariates (age, age2, sex, body mass index, smoking status, glycated hemoglobin, diabetes severity, comorbidities, and geographic region). Utility was measured using the EuroQoL-five dimensions questionnaire (EQ-5D) and Visual Functioning Questionnaire-Utility Index (VFQ-UI). For each model, coefficients (R2) were reported, and WSE/BSE was expressed as the ratio of coefficients (OLS models). Models were independent of treatment effects, and outcomes from all time points (up to week 100) were included where available.

RESULTS

Data from 1320 patients with DME were analyzed. In all models, the association between visual acuity (BSE > WSE) was stronger with VFQ-UI- than EQ-5D-derived utilities. The estimated relationship between VFQ-UI and visual acuity in the BSE and WSE was robust, even with an increasing number of covariates. WSE/BSE coefficient ratios were similar across VFQ-UI OLS models (32%) compared with EQ-5D models (41%-48%). Actual (unadjusted) versus predicted data plots also showed a better fit with VFQ-UI- than EQ-5D-derived utilities.

CONCLUSIONS

These analyses show that VFQ-UI was more sensitive than EQ-5D-derived utilities for measuring the impact of visual acuity in the BSE and WSE. Visual acuity in the BSE was a major contributor to utility, but WSE is also important though to a lesser degree as shown by the coefficient ratios. These new data will be useful for health technology assessments in DME, where utilities data are lacking.

摘要

目的

本研究旨在利用玻璃体内注射阿柏西普的数据,探讨糖尿病性黄斑水肿(DME)患者的视力与效用(健康相关生活质量)之间的关系。

方法

采用普通最小二乘法(OLS)和随机效应模型,对不同协变量(年龄、年龄平方、性别、体重指数、吸烟状况、糖化血红蛋白、糖尿病严重程度、合并症和地理区域)进行调整,探讨最佳视力眼(BSE)和较差视力眼(WSE)的视力与效用之间的关系。效用采用欧洲五维健康量表问卷(EQ-5D)和视觉功能问卷效用指数(VFQ-UI)进行测量。对于每个模型,报告系数(R2),并将WSE/BSE表示为系数之比(OLS模型)。模型独立于治疗效果,所有可用时间点(直至第100周)的结果均纳入分析。

结果

分析了1320例DME患者的数据。在所有模型中,视力(BSE > WSE)与VFQ-UI得出的效用之间的关联比EQ-5D得出的效用更强。即使协变量数量增加,VFQ-UI与BSE和WSE视力之间的估计关系仍然稳健。与EQ-5D模型(41%-48%)相比,VFQ-UI OLS模型的WSE/BSE系数比相似(32%)。实际(未调整)数据与预测数据图也显示,VFQ-UI得出的效用比EQ-5D得出的效用拟合度更好。

结论

这些分析表明,在测量BSE和WSE视力的影响方面,VFQ-UI比EQ-5D得出的效用更敏感。BSE的视力是效用的主要贡献因素,但WSE也很重要,尽管系数比显示其重要程度较低。这些新数据将有助于在缺乏效用数据的DME健康技术评估中发挥作用。

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