Center for Public Health, Queen's University Belfast, Belfast, United Kingdom.
NIHR Moorfields Biomedical Research Center, Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom.
JAMA Ophthalmol. 2024 Jun 1;142(6):512-520. doi: 10.1001/jamaophthalmol.2024.0918.
Most neovascular age-related macular degeneration (nAMD) treatments involve long-term follow-up of disease activity. Home-monitoring would reduce the burden on patients and their caregivers and release clinic capacity.
To evaluate 3 vision home-monitoring tests for patients to use to detect active nAMD compared with diagnosing active nAMD at hospital follow-up during the after-treatment monitoring phase.
DESIGN, SETTING, AND PARTICIPANTS: This was a diagnostic test accuracy study wherein the reference standard was detection of active nAMD by an ophthalmologist at hospital follow-up. The 3 home-monitoring tests evaluated included the following: (1) the KeepSight Journal (KSJ [International Macular and Retinal Foundation]), which contains paper-based near-vision tests presented as word puzzles, (2) the MyVisionTrack (mVT [Genentech]) vision-monitoring mobile app, viewed on an Apple mobile operating system-based device, and (3) the MultiBit (MBT [Visumetrics]) app, viewed on an Apple mobile operating system-based device. Participants were asked to test weekly; mVT and MBT scores were transmitted automatically, and KSJ scores were returned to the research office every 6 months. Raw scores between hospital follow-ups were summarized as averages. Patients were recruited from 6 UK hospital eye clinics and were 50 years and older with at least 1 eye first treated for active nAMD for at least 6 months or longer to a maximum of 42 months before approach. Participants were stratified by time since starting treatment. Study data were analyzed from May to September 2021.
The KSJ, mVT, and MBT were compared with the reference standard (in-hospital ophthalmologist examination).
Estimated area under receiver operating characteristic curve (AUROC). The study had 90% power to detect a difference of 0.06, or 80% power to detect a difference of 0.05, if the AUROC for 2 tests was 0.75.
A total of 297 patients (mean [SD] age, 74.9 [6.6] years; 174 female [58.6%]) were included in the study. At least 1 hospital follow-up was available for 312 study eyes in 259 participants (1549 complete visits). Median (IQR) home-monitoring testing frequency was 3 (1-4) times per month. Estimated AUROC was less than 0.6 for all home-monitoring tests, and only the KSJ summary score was associated with lesion activity (odds ratio, 3.48; 95% CI, 1.09-11.13; P = .04).
Results suggest that no home-monitoring vision test evaluated provided satisfactory diagnostic accuracy to identify active nAMD diagnosed in hospital eye service follow-up clinics. Implementing any of these evaluated tests, with ophthalmologists only reviewing test positives, would mean most active lesions were missed, risking unnecessary sight loss.
大多数新生血管性年龄相关性黄斑变性（nAMD）的治疗都需要对疾病活动进行长期随访。家庭监测可以减轻患者及其护理人员的负担，并释放诊所的能力。
评估 3 种用于患者在家中监测以检测活跃性 nAMD 的视力测试，与在治疗后监测阶段在医院随访时通过眼科医生诊断活跃性 nAMD 进行比较。
设计、设置和参与者：这是一项诊断测试准确性研究，参考标准是眼科医生在医院随访时检测到的活跃性 nAMD。评估的 3 种家庭监测测试包括以下内容：（1）KeepSight 日记（KSJ[国际黄斑和视网膜基金会]），其中包含纸质近视力测试，以字谜的形式呈现，（2）MyVisionTrack（mVT[基因泰克]）视力监测移动应用程序，在苹果移动操作系统设备上查看，（3）MultiBit（MBT[Visumetrics]）应用程序，在苹果移动操作系统设备上查看。参与者被要求每周进行测试；mVT 和 MBT 分数自动传输，KSJ 分数每 6 个月返回研究办公室一次。两次医院随访之间的原始分数汇总为平均值。患者从英国 6 家医院眼科诊所招募，年龄在 50 岁及以上，至少有 1 只眼睛在开始治疗后至少 6 个月至最长 42 个月内首次接受活跃性 nAMD 治疗。参与者按治疗开始后的时间分层。研究数据于 2021 年 5 月至 9 月进行分析。
KSJ、mVT 和 MBT 与参考标准（医院眼科医生检查）进行比较。
估计接收器操作特征曲线下的面积（AUROC）。该研究有 90%的效能可检测到 0.06 的差异，如果 2 项测试的 AUROC 为 0.75，则有 80%的效能可检测到 0.05 的差异。
共有 297 名患者（平均[标准差]年龄，74.9[6.6]岁；174 名女性[58.6%]）纳入研究。在 259 名参与者（1549 次完整就诊）的 312 只研究眼中，至少有 1 次医院随访。家庭监测测试的中位（IQR）频率为每月 3（1-4）次。所有家庭监测测试的估计 AUROC 均低于 0.6，只有 KSJ 总结分数与病变活动相关（优势比，3.48；95%CI，1.09-11.13；P=0.04）。
结果表明，评估的任何家庭监测视力测试都无法提供令人满意的诊断准确性来识别在医院眼科服务随访诊所中诊断的活跃性 nAMD。实施任何这些经过评估的测试，仅由眼科医生审查测试阳性结果，意味着大多数活跃病变都会被遗漏，从而导致不必要的视力丧失。
Zotero 插件
