Center for Health Outcomes Research, United BioSource Corporation, Bethesda, Maryland 20814, USA.
Invest Ophthalmol Vis Sci. 2010 Feb;51(2):712-7. doi: 10.1167/iovs.09-3766. Epub 2009 Sep 24.
To evaluate the psychometric characteristics of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) in patients with age-related macular degeneration (AMD) who participated in two clinical trials.
A secondary analysis of data from two randomized clinical trials was performed. NEI VFQ-25 data were collected from 1134 of 1146 patients with subfoveal choroidal neovascularization due to AMD with minimally classic or occult with no classic types and predominantly classic type. The NEI VFQ-25 was administered at baseline and months 1, 2, 3, 6, 9, and 12, and the SF-36 Health survey was administered at baseline and months 6 and 12. Visual acuity assessments were completed monthly throughout the studies. Internal consistency reliability and construct validity were examined.
The average age was 77 years (SD = 7.5; range, 52-96) with 59% women. At baseline, internal consistency reliability was 0.96 for the NEI VFQ-25 total score and ranged from 0.62 (ocular pain) to 0.91 (near activities) for the subscales. NEI VFQ-25 total and subscale scores correlated significantly with SF-36 scores (P < 0.05), and total, near activities, distance activities, and dependency scores correlated significantly with best corrected visual acuity (BCVA) in the better (P < 0.0001) and worse seeing eye (P < 0.0001). Mean NEI VFQ-25 total and subscale scores, except for ocular pain and general health, varied by BCVA group (P < 0.001), with higher impairment scores seen in the lower visual acuity groups.
The NEI VFQ-25 demonstrated good reliability and construct validity as a measure of vision-related functioning outcomes in patients with AMD.
评估国家眼科研究所视觉功能问卷-25(NEI VFQ-25)在参加两项临床试验的年龄相关性黄斑变性(AMD)患者中的心理测量学特征。
对两项随机临床试验的数据进行二次分析。从 1146 名患有因 AMD 导致的脉络膜新生血管性黄斑下病变的患者中收集了 1134 名患者的数据,这些患者的病变类型为最小型经典或隐匿型且无典型型,或主要为典型型。在基线和第 1、2、3、6、9 和 12 个月时,对 NEI VFQ-25 进行了评估,在基线和第 6 和 12 个月时,对 SF-36 健康调查进行了评估。在整个研究过程中,每月进行视力评估。检查了内部一致性可靠性和结构有效性。
平均年龄为 77 岁(SD=7.5;范围,52-96),女性占 59%。在基线时,NEI VFQ-25 总分的内部一致性可靠性为 0.96,子量表的范围从 0.62(眼痛)到 0.91(近距活动)。NEI VFQ-25 总分和子量表得分与 SF-36 得分显著相关(P<0.05),并且总分、近距活动、远距活动和依赖得分与较好眼(P<0.0001)和较差眼(P<0.0001)的最佳矫正视力(BCVA)显著相关。除眼痛和总体健康外,NEI VFQ-25 总分和子量表评分在 BCVA 组之间存在差异(P<0.001),较低的视力组的评分较高。
NEI VFQ-25 作为 AMD 患者视力相关功能结果的测量工具,具有良好的可靠性和结构有效性。