Clinically Meaningful Change Estimates for the National Eye Institute Visual Function Questionnaire-25 in Patients With Diabetic Macular Edema.

IF 2.6 3区 医学 Q2 OPHTHALMOLOGY Translational Vision Science & Technology Pub Date : 2024-12-02 DOI:10.1167/tvst.13.12.27
Neil Bressler, Zdenka Haskova, Audrey Kapre, Brittany Gentile
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Abstract

Purpose: To derive estimates of clinically meaningful change (improvement) on the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) in patients with diabetic macular edema (DME) using anchor- and distribution-based methods.

Methods: In this exploratory post hoc analysis of data from the RIDE/RISE (NCT00473382/NCT00473330) clinical trials of ranibizumab for DME, the NEI VFQ-25 was completed at baseline and six, 12, 18, and 24 months. Anchor-based (≥5-, ≥10-, and ≥15-letter gain in best-corrected visual acuity [BCVA]) and distribution-based estimates were calculated. Subgroup analyses included outcomes when the study eye was the better- or worse-seeing eye.

Results: Baseline characteristics were balanced between the trials (RIDE, N = 382; RISE, N = 377). Anchor-based estimates of clinically meaningful improvement in composite scores (for ≥15-letter gain in BCVA) were 3.78 and 2.23 for RIDE and RISE, respectively. Estimates appeared similar for most subscales: near activities (4.11 and 3.31), distance activities (3.53 and 3.74), driving difficulties (5.15 and 3.15), and vision-specific dependency (4.70 and 1.83). Supportive distribution-based meaningful change composite score estimates also were similar between RIDE and RISE for values based on 0.5 standard deviation (9.85 and 9.70, respectively) or standard error of the mean (5.10 and 4.82, respectively).

Conclusions: These analyses suggest improvement of three to five points on the NEI VFQ-25 composite score and four individual subscales as clinically meaningful in patients with DME.

Translational relevance: This analysis supports considering these thresholds when assessing the clinical risk-benefit of DME treatment from the patient perspective using the NEI VFQ-25.

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国家眼科研究所视力功能问卷-25对糖尿病黄斑水肿患者的临床意义变化估计。
目的:采用锚点和分布为基础的方法,对糖尿病性黄斑水肿(DME)患者25项美国国家眼科研究所视力功能问卷(NEI VFQ-25)的临床意义变化(改善)进行估计。方法:在这项对雷尼单抗治疗DME的RIDE/RISE (NCT00473382/NCT00473330)临床试验数据的探索性事后分析中,NEI VFQ-25在基线和6个月、12个月、18个月和24个月完成。计算基于锚点(最佳矫正视力[BCVA]中≥5、≥10和≥15个字母增益)和基于分布的估计值。亚组分析包括研究眼视力较好或较差时的结果。结果:基线特征在试验之间是平衡的(RIDE, N = 382;上升,n = 377)。基于锚定的综合评分临床意义改善(BCVA≥15个字母增益)估计RIDE和RISE分别为3.78和2.23。大多数子量表的估计相似:近距离活动(4.11和3.31),远距离活动(3.53和3.74),驾驶困难(5.15和3.15),以及视觉特异性依赖(4.70和1.83)。基于支持性分布的有意义变化综合评分估计值在RIDE和RISE之间也相似,其值基于0.5标准差(分别为9.85和9.70)或平均标准误差(分别为5.10和4.82)。结论:这些分析表明,NEI VFQ-25综合评分和四个单独亚量表的3至5分的改善对DME患者具有临床意义。翻译相关性:该分析支持在使用NEI VFQ-25从患者角度评估二甲醚治疗的临床风险-收益时考虑这些阈值。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Translational Vision Science & Technology
Translational Vision Science & Technology Engineering-Biomedical Engineering
CiteScore
5.70
自引率
3.30%
发文量
346
审稿时长
25 weeks
期刊介绍: Translational Vision Science & Technology (TVST), an official journal of the Association for Research in Vision and Ophthalmology (ARVO), an international organization whose purpose is to advance research worldwide into understanding the visual system and preventing, treating and curing its disorders, is an online, open access, peer-reviewed journal emphasizing multidisciplinary research that bridges the gap between basic research and clinical care. A highly qualified and diverse group of Associate Editors and Editorial Board Members is led by Editor-in-Chief Marco Zarbin, MD, PhD, FARVO. The journal covers a broad spectrum of work, including but not limited to: Applications of stem cell technology for regenerative medicine, Development of new animal models of human diseases, Tissue bioengineering, Chemical engineering to improve virus-based gene delivery, Nanotechnology for drug delivery, Design and synthesis of artificial extracellular matrices, Development of a true microsurgical operating environment, Refining data analysis algorithms to improve in vivo imaging technology, Results of Phase 1 clinical trials, Reverse translational ("bedside to bench") research. TVST seeks manuscripts from scientists and clinicians with diverse backgrounds ranging from basic chemistry to ophthalmic surgery that will advance or change the way we understand and/or treat vision-threatening diseases. TVST encourages the use of color, multimedia, hyperlinks, program code and other digital enhancements.
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