Scheie Eye Institute, Perelman School of Medicine, Department of Ophthalmology, University of Pennsylvania, Philadelphia.
Center for Preventative Ophthalmology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
JAMA Ophthalmol. 2020 Mar 1;138(3):237-242. doi: 10.1001/jamaophthalmol.2019.4577.
Visit adherence has been shown to play a significant role in patient health outcomes. The effect of missing visits on visual acuity (VA) in individuals with neovascular age-related macular degeneration has yet to be characterized.
To quantify the association between patients' adherence to randomized clinical trial visits and VA in individuals with neovascular age-related macular degeneration based on 4 visit adherence metrics.
DESIGN, SETTING, AND PARTICIPANTS: This is a secondary analysis of the Comparison of Age-Related Macular Degeneration Treatment Trial randomized clinical trial. Individuals with age-related macular degeneration were recruited from 44 clinical centers in the United States between February 2008 and December 2009. The 2-year study protocol required 1 visit every 4 weeks (every 21-35 days for a total of 26 visits) for monthly vs pro re nata treatments of bevacizumab vs ranibizumab. Analysis took place from November 2018 through May 2019.
Visit adherence was measured in 4 ways: total number of missed visits, average number of days (avg days) between each visit, longest duration in days (max days) between visits, and visit constancy (the tally of 3-month periods with at least 1 visit attended). Average and max days were also categorized as on time (28-35 days), late (36-60 days), and very late (>60 days).
Change in Early Treatment Diabetic Retinopathy Study VA between the baseline and the last visit. Linear multivariate regression models were applied to analyze the association between visit adherence and change in VA, controlling for age, sex, baseline VA, anti-vascular endothelial growth factor drug, number of injections, and dosing regimen.
Of 1178 patients, the mean (SD) age was 79.1 (7.3) years, and 727 (61.7%) were women. The mean (SD) number of missed visits was 2.4 (3.1). Overall, 1091 patients (92.6%) had complete visit constancy during the entire study period. Average days were categorized with 1060 patients (90.0%) classified as on time, 108 (9.2%) were late, and 10 (0.8%) were very late. For max days between visits, 197 patients (16.7%) were on time, 773 (65.6%) were late, and 208 (17.7%) were very late. After controlling for covariates, the late (avg days = -6.1; max days = -2.0) and very late (avg days = -12.5; max days = -5.9) groups saw fewer letters in both the avg and max days categories than patients in the on-time group (P < .001).
These results provide evidence to support the concept that visit adherence contributes to VA outcomes in neovascular age-related macular degeneration. The magnitude of the association of visit adherence with VA outcomes in this clinical scenario suggests that substantial effort should be expended to strive for visit adherence or therapeutic strategies that reduce the visit burden without compromising VA outcomes.
ClinicalTrials.gov Identifier: NCT00593450.
已有研究表明，就诊依从性对患者的健康结果有着重要的影响。然而，尚不清楚错过就诊对新生血管性年龄相关性黄斑变性患者的视力（VA）的影响。
根据 4 种就诊依从性指标，量化个体就诊依从性与新生血管性年龄相关性黄斑变性患者 VA 之间的关联。
设计、地点和参与者：这是一项对年龄相关性黄斑变性治疗试验比较（Comparison of Age-Related Macular Degeneration Treatment Trial）随机临床试验的二次分析。2008 年 2 月至 2009 年 12 月期间，在美国的 44 个临床中心招募了年龄相关性黄斑变性患者。为期 2 年的研究方案要求每月或按需治疗，每月治疗使用贝伐珠单抗，按需治疗使用雷珠单抗，每 4 周（21-35 天）就诊一次，共 26 次就诊。分析于 2018 年 11 月至 2019 年 5 月进行。
就诊依从性通过 4 种方式进行测量：总错过就诊次数、每次就诊之间的平均天数（avg days）、就诊之间最长持续时间（max days）以及就诊稳定性（至少有 1 次就诊的 3 个月时间段计数）。平均天数和最长天数也分为按时（28-35 天）、延迟（36-60 天）和非常延迟（>60 天）。
基线和最后一次就诊之间的早期治疗糖尿病视网膜病变研究 VA 变化。应用线性多元回归模型分析就诊依从性与 VA 变化之间的关联，控制年龄、性别、基线 VA、抗血管内皮生长因子药物、注射次数和给药方案。
在 1178 例患者中，平均（标准差）年龄为 79.1（7.3）岁，727 例（61.7%）为女性。平均（标准差）错过就诊次数为 2.4（3.1）次。总体而言，在整个研究期间，有 1091 例（92.6%）患者的就诊稳定性完全一致。平均天数中，有 1060 例（90.0%）患者按时就诊，108 例（9.2%）患者延迟就诊，10 例（0.8%）患者非常延迟就诊。对于就诊之间的最长天数，有 197 例（16.7%）患者按时就诊，773 例（65.6%）患者延迟就诊，208 例（17.7%）患者非常延迟就诊。在控制了协变量后，延迟（avg days = -6.1；max days = -2.0）和非常延迟（avg days = -12.5；max days = -5.9）组的患者在平均天数和最长天数类别中看到的字母都比按时就诊组少（P<0.001）。
这些结果为就诊依从性对新生血管性年龄相关性黄斑变性患者的 VA 结果有影响的观点提供了证据。就诊依从性与 VA 结果之间的关联程度表明，应大力努力确保就诊依从性，或采用减少就诊负担而不影响 VA 结果的治疗策略。
ClinicalTrials.gov 标识符：NCT00593450。
