McGuinness Myra B, Finger Robert P, Wu Zhichao, Luu Chi D, Chen Fred K, Arnold Jenifer J, Chakravarthy Usha, Guymer Robyn H
Centre for Eye Research Australia, Royal Victorian Eye & Ear Hospital, Melbourne, Australia; Centre for Biostatistics and Epidemiology, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.
Centre for Eye Research Australia, Royal Victorian Eye & Ear Hospital, Melbourne, Australia; Department of Ophthalmology, University of Bonn, Bonn, Germany.
Ophthalmol Retina. 2020 Sep;4(9):881-888. doi: 10.1016/j.oret.2020.03.015. Epub 2020 Mar 30.
To investigate the relationship between patient-reported outcome (PRO) questionnaire responses and time to late age-related macular degeneration (AMD; neovascular AMD [nAMD] or multimodal imaging [MMI]-defined atrophy) among individuals with bilateral large drusen, and the prognostic value of baseline PROs for 36-month AMD status.
Exploratory analyses from a multicenter randomized controlled trial of an AMD intervention (Australian New Zealand Clinical Trials Registry identifier, ACTRN12612000704897).
Sham treatment group of the Laser Intervention in Early Stages of Age-Related Macular Degeneration (LEAD) Study (n = 141; age, 50-88 years; 77% female).
The 28-item Impact of Vision Impairment (IVI-28) and 10-item Night Vision Questionnaire (NVQ-10) were administered at the baseline visit. The PRO scores were derived using rating scale models. Multivariate Cox regression adjusting for demographics and clinical measures of vision (low-luminance visual acuity, low-luminance deficit, and microperimetric sensitivity) from the poorer-performing eye was used to investigate the association between PRO scores and time to late AMD in either eye. Multivariate competing-risk regression was used to estimate cause-specific subhazard ratios for nAMD and atrophy in either eye. Cross-validated logistic lasso models were used to estimate the predicted probability of AMD at 36 months. The area under the receiver operating characteristic curve was assessed to compare prognostic accuracy between models with and without PROs.
Time until nAMD or atrophy in either eye.
The PRO scores were skewed toward higher functional vision. Higher IVI-28 scores were associated with a lower risk of progression to MMI-defined atrophy (20 events: adjusted hazard ratio, 0.65/logit increase; P = 0.002) but not nAMD (10 events; P = 0.562). Insufficient evidence was found of an association between NVQ-10 score and rate of progression to late AMD (P ≥0.149). Baseline IVI-28 scores were found to contribute to the prognosis of atrophy at the 36-month visit (P = 0.010).
On average, PROs were associated with an increased risk of progression from intermediate AMD to MMI-defined atrophy. Continuing development of instruments to record PROs in the early stages of AMD have the potential to produce inexpensive and efficient tools to assist in the assessment of disease severity and risk of AMD progression.
研究双侧大玻璃膜疣患者自我报告结局（PRO）问卷回答与晚期年龄相关性黄斑变性（AMD；新生血管性AMD [nAMD]或多模态成像[MMI]定义的萎缩）发生时间之间的关系，以及基线PRO对36个月AMD状态的预后价值。
一项AMD干预多中心随机对照试验的探索性分析（澳大利亚新西兰临床试验注册标识符，ACTRN12612000704897）。
年龄相关性黄斑变性早期激光干预（LEAD）研究的假治疗组（n = 141；年龄50 - 88岁；77%为女性）。
在基线访视时发放28项视力损害影响问卷（IVI - 28）和10项夜间视力问卷（NVQ - 10）。PRO分数通过评分量表模型得出。采用多变量Cox回归，对较差眼的人口统计学和视力临床指标（低亮度视力、低亮度缺陷和微视野敏感度）进行调整，以研究PRO分数与任一眼晚期AMD发生时间之间的关联。采用多变量竞争风险回归来估计任一眼nAMD和萎缩的特定病因亚风险比。使用交叉验证的逻辑套索模型来估计36个月时AMD的预测概率。评估受试者工作特征曲线下面积，以比较有和没有PRO的模型之间的预后准确性。
任一眼发生nAMD或萎缩的时间。
PRO分数倾向于更高的功能性视力。较高的IVI - 28分数与进展为MMI定义的萎缩的较低风险相关（20例事件：调整后风险比，0.65/对数增加；P = 0.002），但与nAMD无关（10例事件；P = 0.562）。未发现足够证据表明NVQ - 10分数与进展为晚期AMD的速率之间存在关联（P≥0.149）。发现基线IVI - 28分数有助于36个月访视时萎缩的预后评估（P = 0.010）。
平均而言，PRO与中度AMD进展为MMI定义的萎缩的风险增加相关。继续开发在AMD早期记录PRO的工具有可能产生廉价且有效的工具，以协助评估疾病严重程度和AMD进展风险。
