Ophthalmic Epidemiol. 2007 Jul-Aug;14(4):205-15. doi: 10.1080/09286580701502970.
To evaluate responsiveness of the National Eye Institute Visual Function Questionnaire (NEI-VFQ) to changes in visual acuity and to provide estimates of minimum clinically meaningful changes in NEI-VFQ scores.
Data were combined from three clinical trials of submacular surgery for subfoveal choroidal neovascularization. Patients who completed NEI-VFQ interviews and visual acuity measurements at baseline and 2 years later contributed data for analysis. Data were analyzed using anchor-based (relating 2-year change in NEI-VFQ to 2-year change in visual acuity using correlation and linear regression) and distribution-based (standardized response mean) methods.
Of 1,015 patients enrolled, 828 patients completed NEI-VFQ interviews and had visual acuity measurements at baseline and 2 years later. Median age of patients was 75 years (range 18 to 94); all patients had subfoveal choroidal neovascularization in at least one eye. Median overall NEI-VFQ score at baseline was 69.9 (mean, 66.5). Based on anchor-based methods, a 2-line change in visual acuity of the better-seeing eye translated to a 3.4-point change in the overall NEI-VFQ score and from 2.4-point to 7.0-point changes in most subscale scores. The NEI-VFQ was sensitive to both gains and losses in visual acuity; the standardized response mean for the overall NEI-VFQ score in patients with a 2-line gain was 0.6 and for patients with 2-line loss was -0.3. In the subgroup of patients with a 2-line loss of visual acuity in the better-seeing eye, patients who had overall NEI-VFQ scores at baseline greater than the median (59.8) had an standardized response mean of -0.9 for the overall NEI-VFQ score and patients who had overall NEI-VFQ scores at baseline at or below the median had a standardized response mean of 0.2 for the overall NEI-VFQ score. A 4-point change in the overall NEI-VFQ and a 5-point change in individual subscale scores corresponded to a small clinically meaningful change.
The NEI-VFQ was responsive to 2-year changes in visual acuity but was less responsive to changes among patients with poorer NEI-VFQ scores at baseline. Based on this analysis, a 4-point change in the overall NEI-VFQ and a 5-point change in individual subscale scores may be considered minimum clinically meaningful within-person changes in NEI-VFQ scores.
评估美国国立眼科研究所视觉功能问卷（NEI-VFQ）对视敏度变化的反应性，并提供NEI-VFQ评分中最小临床有意义变化的估计值。
数据来自三项针对黄斑下脉络膜新生血管的黄斑下手术临床试验。在基线和2年后完成NEI-VFQ访谈和视敏度测量的患者提供数据用于分析。使用基于锚定的方法（通过相关性和线性回归将NEI-VFQ的2年变化与视敏度的2年变化相关联）和基于分布的方法（标准化反应均值）进行数据分析。
在1015名登记患者中，828名患者完成了NEI-VFQ访谈，并在基线和两年后进行了视敏度测量。患者的中位年龄为75岁（范围18至94岁）；所有患者至少一只眼睛患有黄斑下脉络膜新生血管。基线时NEI-VFQ总评分中位数为69.9（均值为66.5）。基于锚定法，视力较好眼视敏度变化2行相当于NEI-VFQ总评分变化3.4分，大多数子量表评分变化2.4分至7.0分。NEI-VFQ对视敏度的提高和降低均敏感；视敏度提高2行患者的NEI-VFQ总评分标准化反应均值为0.6，视敏度降低2行患者为-0.3。在视力较好眼视敏度降低2行的患者亚组中，基线时NEI-VFQ总评分高于中位数（59.8）的患者，NEI-VFQ总评分标准化反应均值为-0.9，基线时NEI-VFQ总评分等于或低于中位数的患者，NEI-VFQ总评分标准化反应均值为0.2。NEI-VFQ总评分变化4分和单个子量表评分变化5分相当于较小的临床有意义变化。
NEI-VFQ对视敏度的2年变化有反应，但对基线时NEI-VFQ评分较差的患者的变化反应较小。基于此分析，NEI-VFQ总评分变化4分和单个子量表评分变化5分可被视为NEI-VFQ评分中个体内最小临床有意义变化。
