Department of Ophthalmology, Oslo University Hospital, Postboks 4950 Nydalen, 0424, Oslo, Norway.
Institute of Clinical Medicine, University of Oslo, Postboks 1171 Blindern, 0318, Oslo, Norway.
Health Qual Life Outcomes. 2019 Aug 14;17(1):140. doi: 10.1186/s12955-019-1203-0.
Although visual acuity and optical coherence tomography (OCT) are most widely used as outcomes in treatment of neovascular age-related Macular Degeneration (nAMD), patient reported outcome measures are increasingly recognized. National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) was developed to capture the perceived visual function. Yet, evidence of psychometric performance in the target population is required. The aim of this study was to examine the psychometric properties of NEI-VFQ 25 in a Norwegian cohort of newly diagnosed nAMD patients followed with a Treat and Extend (T/E) protocol.
Patients receiving intravitreal anti-vascular endothelial growth factor (anti-VEGF) injection treatment according to a T/E protocol completed a Norwegian translation of NEI-VFQ 25, EuroQoL Health Questionnaire (EQ-5D), and Patient acceptable symptom state (PASS 5) at baseline, 3, 6 and 12 months. In addition, a control population completed the same questionnaires. Visual acuity was assessed with LogMar for best/treated eye. Validity testing comprised face validity by a 0-10 numeric rating scale about relevance of NEI-VFQ 25 as well as regression analyses and correlations between NEI-VFQ 25 and other relevant variables. Reliability was examined with Intraclass Correlation Coefficient (ICC) and Cronbach's alpha for internal consistency were performed. Responsiveness, discriminatory power and predictive value were also explored.
Number of respondents at baseline, after 3, 6 and 12 months was 197, 186, 176 and 168, respectively. The control population comprised 26 individuals. Face validity of NEI-VFQ 25 had a mean (SD) of 7.8 (1.7) (n = 84). NEI-VFQ was significantly correlated to visual acuity and PASS 5 as well as EQ-5D at baseline. Reliability (ICC) of the overall and sub scores for the patients/controls ranged from 0.49-0.97/0.59-0.97. Cronbach's alpha was 0.61-0.85. Discriminatory power was confirmed by significant differences of the overall score between controls and patients (P < 0.001). NEI-VFQ 25 indicates responsiveness showing overall score improved significantly (P ≤ 0.001) from baseline to 3 months. NEI-VFQ 25, general health and visual acuity at baseline were the strongest predictors for how patients reported vision after 6 months follow-up.
NEI-VFQ 25 showed acceptable psychometric performance, which supports that the Norwegian version can be used to monitor patients treated for nAMD.
尽管视力和光学相干断层扫描(OCT)是治疗新生血管性年龄相关性黄斑变性(nAMD)最常用的结果,但患者报告的结果测量指标越来越受到重视。国家眼科研究所视觉功能问卷(NEI-VFQ 25)旨在捕捉感知视觉功能。然而,需要在目标人群中证明心理测量性能。本研究的目的是在接受根据治疗和扩展(T/E)方案进行的玻璃体内抗血管内皮生长因子(抗 VEGF)注射治疗的新诊断 nAMD 患者的挪威队列中检查 NEI-VFQ 25 的心理测量特性。
接受玻璃体内抗血管内皮生长因子(抗 VEGF)注射治疗的患者根据 T/E 方案完成了挪威语翻译的 NEI-VFQ 25、EuroQoL 健康问卷(EQ-5D)和患者可接受症状状态(PASS 5)的基线、3、6 和 12 个月。此外,对照组完成了相同的问卷。使用 LogMar 评估最佳/治疗眼的视力。有效性测试包括通过 0-10 数字评分量表评估 NEI-VFQ 25 的相关性,以及回归分析和 NEI-VFQ 25 与其他相关变量之间的相关性。使用组内相关系数(ICC)和 Cronbach's alpha 检验内部一致性来检验可靠性。还探讨了反应性、判别能力和预测值。
基线、3、6 和 12 个月时的应答者人数分别为 197、186、176 和 168,对照组由 26 人组成。NEI-VFQ 25 的表面效度平均(SD)为 7.8(1.7)(n=84)。NEI-VFQ 与基线时的视力和 PASS 5 以及 EQ-5D 显著相关。患者/对照组的总体和子评分的可靠性(ICC)范围为 0.49-0.97/0.59-0.97。Cronbach's alpha 为 0.61-0.85。通过对照组和患者之间的总体评分差异确认了判别能力(P<0.001)。NEI-VFQ 25 表明有反应性,表明总体评分从基线到 3 个月显著提高(P≤0.001)。基线时的 NEI-VFQ 25、一般健康状况和视力是预测患者 6 个月随访后视力的最强因素。
NEI-VFQ 25 表现出可接受的心理测量性能,支持使用挪威语版本监测接受 nAMD 治疗的患者。