临床上有意义的变化估计国家眼科研究所视觉功能问卷-25在患有糖尿病黄斑的患者
Neil Bressler1, Zdenka Haskova2, Audrey Kapre2
1Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Translational vision science & technology
|December 16, 2024
概括
使用国家眼科视觉功能问卷 (NEI VFQ-25) 的糖尿病黄斑 (DME) 患者的临床上有意义的改善估计为3-5分. 这些发现有助于评估患者的治疗效益.
科学领域:
- 眼科医生 眼科 眼科
- 临床试验 临床试验
- 患者报告的结果
背景情况:
- 糖尿病黄斑 (DME) 显著影响视觉功能和生活质量.
- 国家眼科研究所视觉功能问卷 (NEI VFQ-25) 是患者报告的关键结果指标.
- 确定NEI VFQ-25临床上有意义的变化值对于评估DME治疗至关重要.
研究的目的:
- 确定NEI VFQ-25在患有DME的患者中具有临床意义的改善估计.
- 使用基于和基于分布的方法来导出这些估计.
- 为患者提供以患者为中心的观点,以了解DME的治疗疗效.
主要方法:
- 来自RIDE/RISE临床试验中对DME治疗拉尼比祖马布的数据的分析.
- 使用最佳校正视敏度 (BCVA) 收益 (≥5,≥10,≥15个字母) 来计算基于的估计值.
- 使用平均值的标准偏差和标准误差计算基于分布的估计.
主要成果:
- 对于≥15个字母的BCVA增值,基于基的估计表明NEI VFQ-25复合分数有意义地提高了3.78 (RIDE) 和2.23 (RISE).
- 对于关键子尺度也观察到类似的估计,包括近距离活动,远距离活动,驾驶困难和依赖.
- 基于分布的有意义变化估计在试验之间是一致的.
结论:
- 在NEI VFQ-25综合评分和特定子尺度上,建议对DME患者来说,3-5点的改善具有临床意义.
- 这些值可以为评估DME治疗的风险益处概况提供信息.
- 这些发现强调了患者报告结果在评估DME干预措施中的重要性.
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