使用和不使用拉什评分的VFQ-25在试验中使用模拟数据进行评估,将激光与糖尿病视网膜病变的抗VEGF进行比较
Meet Panjwani1, Wesley Beaulieu2, Igor Kozak1
1Department of Ophthalmology and Vision Science, University of Arizona, Tucson, Arizona, United States.
Translational vision science & technology
|January 21, 2026
概括
在糖尿病视网膜病变试验中,视觉功能问卷-25 (VFQ-25) 的Rash校准得分与视觉敏度 (VA) 有着强烈的相关性. 这些精细的分数为评估患者报告的结果提供了更好的心理测量特性.
科学领域:
- 眼科医生 眼科 眼科
- 临床研究 临床研究
- 心理测量 心理测量 心理测量
背景情况:
- 糖尿病视网膜病变 (DR) 显著影响视力和生活质量.
- 在临床试验中评估与健康相关的生活质量 (HRQoL) 对于治疗评估至关重要.
- 视力敏度 (VA) 和患者报告的结果 (PROs) 是DR研究中的关键终点.
研究的目的:
- 为了比较Rasch校准和非Rasch校准的与视觉敏度 (VA) 相关的健康相关的生活质量域得分.
- 评估在多发性糖尿病视网膜病变 (PDR) 随机临床试验中治疗组在这些得分中的差异.
- 为了确定不同的评分方法在捕捉治疗效果的实用性.
主要方法:
- 模拟了10,000个随机对照试验 (RCT),使用来自糖尿病视网膜病理临床研究 (DRCR) 网络协议S数据的引导.
- 分析了VA和国家眼科研究所视觉功能问卷-25 (VFQ-25) 个体患者的反应.
- 在平均VA和平均域得分以及效果大小的治疗组差异之间计算了Pearson相关系数.
主要成果:
- 拉什校准的VFQ-25领域 (视觉功能,社会情绪,组合) 与VA差异的相关性最高.
- 原始的复合和近活动领域也表现出类似的相关性.
- 对于最初的复合,心理健康,依赖和外围视觉领域,观察到最大的效果大小.
结论:
- 拉什校准的VFQ-25领域,特别是视觉功能,社会情绪和综合分数,与PDR的VA变化有很强的相关性.
- 虽然拉什校准提供了卓越的心理测量,但原来的复合VFQ-25评分可能是可以接受的.
- 这些发现有助于在DR临床试验中选择适当的结果措施.
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