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非感染性中后葡萄膜炎患者的国家眼科研究所视觉功能问卷和视觉功能问卷效用指数的心理测量评估。

Psychometric evaluation of the National Eye Institute Visual Function Questionnaire and Visual Function Questionnaire Utility Index in patients with non-infectious intermediate and posterior uveitis.

机构信息

Global Health Outcomes Strategy and Research, Allergan Inc., 2525 Dupont Drive, Irvine, CA, 92612, USA.

出版信息

Qual Life Res. 2013 Dec;22(10):2801-8. doi: 10.1007/s11136-013-0412-y. Epub 2013 May 5.

Abstract

OBJECTIVE

To evaluate the psychometric properties of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and Visual Function Questionnaire Utility Index (VFQ-UI) in patients with non-infectious intermediate and posterior uveitis.

METHODS

Secondary analysis of pooled data from a 26-week, multicenter, masked, randomized, sham-controlled Phase 3 clinical trial. Health-related quality of life was assessed using the NEI VFQ-25, the EQ-5D, and SF-36. Internal consistency reliability, reproducibility, convergent validity, and known groups of BCVA and vitreous haze severity were assessed. Clinically significant difference was assessed using anchor-based and distribution-based methods.

RESULTS

The study included 224 subjects with non-infectious intermediate (80.4 %) or posterior uveitis (19.6 %). The NEI VFQ-25 and the VFQ-UI demonstrated good internal consistency (Cronbach's alpha 0.87-0.94) and test-retest reliability (ICCs 0.58-0.88). Spearman's product-moment rank correlations between the NEI VFQ-25 and VFQ-UI scores and the SF-6D, EQ-5D, and BCVA ranged from small to moderate. There was a significant association between visual functioning and known groups of visual acuity (p < 0.05). Clinical significance, using the anchor-based method (difference between visual acuity groups ≥10-<15 letter better and no change), was 10.2 for change from baseline to week 26 for the NEI VFQ-25 composite score and 0.05 for the VFQ-UI. Using the distribution-based method, the clinical significance was 3.86 for the composite score and 0.04 for the VFQ-UI.

CONCLUSION

The NEI VFQ-25 and the VFQ-UI are reliable and valid measures of vision-related functioning and preference-based status in patients with non-infectious intermediate and posterior uveitis.

摘要

目的

评估国家眼科研究所视觉功能问卷-25(NEI VFQ-25)和视觉功能问卷效用指数(VFQ-UI)在非传染性中后部葡萄膜炎患者中的心理测量特性。

方法

对 26 周、多中心、盲法、随机、假对照 3 期临床试验的汇总数据进行二次分析。使用 NEI VFQ-25、EQ-5D 和 SF-36 评估健康相关生活质量。评估了内部一致性、再现性、收敛有效性以及与 BCVA 和玻璃体混浊严重程度相关的已知组。使用基于锚点和基于分布的方法评估了临床显著差异。

结果

研究纳入了 224 名非传染性中间(80.4%)或后部葡萄膜炎(19.6%)患者。NEI VFQ-25 和 VFQ-UI 表现出良好的内部一致性(Cronbach's alpha 0.87-0.94)和测试-重测可靠性(ICC 0.58-0.88)。NEI VFQ-25 和 VFQ-UI 评分与 SF-6D、EQ-5D 和 BCVA 之间的 Spearman 产品矩秩相关系数从小到大不等。视力功能与已知的视力(p<0.05)组之间存在显著关联。使用基于锚点的方法(视力组之间的差异为 10-<15 字母更好且无变化),NEI VFQ-25 综合评分从基线到 26 周的变化为 10.2,VFQ-UI 为 0.05。使用基于分布的方法,综合评分的临床意义为 3.86,VFQ-UI 为 0.04。

结论

NEI VFQ-25 和 VFQ-UI 是可靠和有效的衡量非传染性中后部葡萄膜炎患者视觉相关功能和基于偏好的状态的工具。

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