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.

中文翻译：

---

与对照组相比，国家眼科研究所视觉功能问卷（NEI-VFQ 25）在挪威新血管性年龄相关性黄斑变性患者中的心理计量学特征

尽管视力敏锐度和光学相干断层扫描（OCT）在治疗新生血管性年龄相关性黄斑变性（nAMD）中作为治疗结局最广泛，但患者报告的治疗结局越来越得到认可。美国国家眼科学院视觉功能问卷（NEI-VFQ 25）被开发来捕获感知的视觉功能。但是，仍需要在目标人群中进行心理计量学表现的证据。这项研究的目的是在挪威新诊断的nAMD患者队列中，按照“治疗与扩展”（T / E）方案，检查NEI-VFQ 25的心理测量特性。根据T / E方案接受玻璃体内抗血管内皮生长因子（anti-VEGF）注射治疗的患者完成了NEI-VFQ 25，EuroQoL健康问卷（EQ-5D）的挪威语翻译，在基线，3、6和12个月时患者可接受的症状状态（PASS 5）。此外，对照组人群填写了相同的问卷。使用LogMar评估视力最佳/治疗的视力。有效性测试包括关于NEI-VFQ 25相关性的0-10数字评分量表的面部有效性，以及NEI-VFQ 25与其他相关变量之间的回归分析和相关性。使用类内相关系数（ICC）检验了可靠性，并进行了内部一致性的Cronbach's alpha。还探讨了响应能力，歧视能力和预测价值。基线，3、6和12个月后的受访者人数分别为197、186、176和168。对照人群包括26个人。NEI-VFQ 25的面部有效性平均值（SD）为7.8（1.7）（n = 84）。在基线时，NEI-VFQ与视敏度和PASS 5以及EQ-5D显着相关。患者/对照的总体和次级评分的可靠性（ICC）为0.49–0.97 / 0.59–0.97。克朗巴赫（Cronbach）的alpha为0.61-0.85。对照者和患者之间的总体评分存在显着差异，从而证实了歧视能力（P <0.001）。NEI-VFQ 25表示从基线到3个月，总体评分显着改善（P≤0.001）。NEI-VFQ 25，基线的总体健康状况和视敏度是6个月随访后患者如何报告视力的最强预测指标。NEI-VFQ 25表现出可接受的心理测验性能，这支持挪威版本可用于监测接受nAMD治疗的患者。患者/对照的总体和次级评分的可靠性（ICC）为0.49–0.97 / 0.59–0.97。克朗巴赫（Cronbach）的alpha为0.61-0.85。对照者和患者之间的总体评分存在显着差异，从而证实了歧视能力（P <0.001）。NEI-VFQ 25表示从基线到3个月，总体评分显着改善（P≤0.001）。NEI-VFQ 25，基线的总体健康状况和视敏度是6个月随访后患者如何报告视力的最强预测指标。NEI-VFQ 25表现出可接受的心理测验性能，这支持挪威版本可用于监测接受nAMD治疗的患者。患者/对照的总体和次级评分的可靠性（ICC）为0.49–0.97 / 0.59–0.97。克朗巴赫（Cronbach）的alpha为0.61-0.85。对照者和患者之间的总体评分存在显着差异，从而证实了歧视能力（P <0.001）。NEI-VFQ 25表示从基线到3个月，总体评分显着改善（P≤0.001）。NEI-VFQ 25，基线的总体健康状况和视敏度是6个月随访后患者如何报告视力的最强预测指标。NEI-VFQ 25表现出可接受的心理测量性能，这支持挪威版本可用于监测接受nAMD治疗的患者。对照者和患者之间的总体评分存在显着差异，从而证实了歧视能力（P <0.001）。NEI-VFQ 25表示从基线到3个月，总体评分显着改善（P≤0.001）。NEI-VFQ 25，基线的总体健康状况和视敏度是6个月随访后患者如何报告视力的最强预测指标。NEI-VFQ 25表现出可接受的心理测验性能，这支持挪威版本可用于监测接受nAMD治疗的患者。对照者和患者之间的总体评分存在显着差异，从而证实了歧视能力（P <0.001）。NEI-VFQ 25表示从基线到3个月，总体评分显着改善（P≤0.001）。NEI-VFQ 25，基线的总体健康状况和视敏度是6个月随访后患者如何报告视力的最强预测指标。NEI-VFQ 25表现出可接受的心理测验性能，这支持挪威版本可用于监测接受nAMD治疗的患者。基线后的总体健康状况和视敏度是6个月随访后患者如何报告视力的最强预测指标。NEI-VFQ 25表现出可接受的心理测验性能，这支持挪威版本可用于监测接受nAMD治疗的患者。基线后的总体健康状况和视敏度是6个月随访后患者如何报告视力的最强预测指标。NEI-VFQ 25表现出可接受的心理测量性能，这支持挪威版本可用于监测接受nAMD治疗的患者。