Village-Integrated Eye Worker trial II (VIEW II)

村庄综合眼科工作者试验 II (VIEW II)

• 批准号: 10200055
• 负责人: Jeremy David Keenan
• 金额: $ 42.21万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10200055
• 关键词: Address; Adult; Affect; Age; Age related macular degeneration; Blindness; Caring; Cataract; Cataract Extraction; Censuses; Clinic; Cluster randomized trial; Communities; Community Health Aides; Counseling; Detection; Developing Countries; Diabetic Retinopathy; Diagnosis; Disease; Early Diagnosis; Economics; Effectiveness; Equation; Event; Eye; Eye diseases; Fees; Glaucoma; Goals; Health; Health Care Costs; Hospitals; Human Resources; Improve Access; Individual; Intervention; Mass Screening; Methods; Modeling; Monitor; National Eye Institute; Nepal; Operative Surgical Procedures; Patients; Population; Prevention; Prevention program; Public Health; Quality of life; Randomized; Randomized Controlled Trials; Refractive Errors; Research; Resources; Risk; Running; System; Technology; Telemedicine; Testing; Time; Travel; Vision; Visual Acuity; Visual impairment; World Health Organization; aged; arm; base; care systems; community intervention; comparative effectiveness; cost; cost effective; cost effectiveness; cost-effectiveness ratio; diagnostic technologies; early screening; effective therapy; effectiveness evaluation; follow-up; improved; incremental cost-effectiveness; innovation; local economy; meetings; mobile computing; outreach; outreach program; population based; portability; post intervention; prevent; programs; screening; screening program; skills; tool; treatment arm; trial design; volunteer

PROJECT SUMMARY/ABSTRACT The World Health Organization estimates that 80% of blindness worldwide is avoidable, yet cases are not detected early enough to prevent vision loss. To address this global burden, eye care systems must determine optimal methods for identifying people with or at risk for visual impairment. Worldwide, systems utilize a variety of community-based approaches to identify such cases, including screening for early disease with telemedicine and case detection of prevalent disease with cataract camps or community health workers. Each of these models requires varying levels of resources and ophthalmic skill, but no studies have been conducted on the comparative effectiveness or cost effectiveness of these different approaches. The overall objective of this project is to determine the effectiveness of community-based approaches to prevent blindness through a cluster-randomized trial. Communities in Nepal will be randomized to one of five arms (1) a state-of-the-art mobile screening unit employing telemedicine for screening and case detection, (2) a mobile case detection unit focused on cataract and refractive error only, (3) a cataract camp employing ophthalmic personnel, (4) a volunteer community health worker (CHW) program, and (5) no intervention. Intervention arms (arms 1-4) will target all adults aged ≥50 years residing in intervention communities for screening and/or case detection. Those meeting referral criteria will be referred to Bharatpur Eye Hospital for a confirmatory diagnosis and follow-up care as needed, and will be closely monitored by study staff. Four years after implementation, a population-based census will be conducted in all study communities, and eligible adults will undergo a visual acuity assessment. To examine effectiveness and cost-effectiveness of these approaches, we will pursue three specific aims: 1) to determine whether screening is effective for reducing visual impairment relative to case detection (arm 1 vs 2); 2) to determine whether a CHW program increases the rate of cataract surgery compared to cataract camp (arm 3 vs 4); and 3) to compare the costs per line of visual impairment prevented between competing outreach programs (arms 1-5). The approach is innovative in its use of recently developed portable diagnostic technology that enables mobile, telemedicine-based screening on this large scale. In addition, the post-test only population-based assessment of visual acuity in a large trial design allows for the study of a rare event like blindness and eliminates the problem of loss to follow- up that affected previous screening trials. This research is significant because it will provide the strongest type of evidence to guide national eye health programs – results from a randomized controlled trial. Ultimately, this trial will benefit blindness prevention programs worldwide in deciding how to allocate limited resources to screening or case detection.

项目摘要/摘要 世界卫生组织估计，全球80%的失明是可以避免的，但病例却是 没有及早发现以防止视力丧失。为了应对这一全球负担，眼科护理系统必须 确定识别视力受损或有视力受损风险的人的最佳方法。世界范围内，系统 利用各种以社区为基础的方法来确定这类病例，包括筛查早期疾病 与白内障训练营或社区卫生工作者一起进行远程医疗和流行疾病病例检测。 这些模型中的每一个都需要不同水平的资源和眼科技能，但还没有研究 对这些不同方法的比较效果或成本效益进行了评估。 该项目的总体目标是确定基于社区的方法的有效性。 通过整群随机试验预防失明。尼泊尔的社区将被随机分为五个 ARMS(1)最先进的流动筛查装置，采用远程医疗进行筛查和病例侦测；(2) 一个只专注于白内障和屈光不正的流动病例检测小组，(3)一个白内障训练营 眼科人员，(4)志愿社区卫生工作者(CHW)计划，(5)不干预。 干预武器(武器1-4)将以居住在干预社区的所有50岁≥成年人为目标 筛查和/或病例检测。符合转诊标准的患者将被转介到Bharatpur眼科医院进行 根据需要进行确证诊断和后续护理，并将由研究人员密切监测。四年 实施后，将在所有研究社区进行以人口为基础的普查，符合条件的成年人 将接受视力评估。检查这些措施的有效性和成本效益 方法，我们将追求三个具体目标：1)确定筛查是否对减少 与病例发现相关的视力损害(ARM 1对2)；2)确定CHW计划是否增加 白内障手术率与白内障训练营的比较(第3组对第4组)；以及3)比较每行白内障手术的成本 在相互竞争的外展计划之间防止视力损害(第1-5号武器)。该方法在以下方面具有创新性 它使用了最近开发的便携式诊断技术，使基于移动、远程医疗的 如此大规模的放映。此外，测试后仅基于人群的视力评估在一个 大型试验设计允许对像失明这样的罕见事件进行研究，并消除了后续的损失问题- 这影响了之前的筛查试验。这项研究具有重要意义，因为它将提供最强的类型 指导国家眼睛健康计划的证据--来自随机对照试验的结果。归根结底，这 试验将使世界各地的防盲项目在决定如何将有限的资源分配给 筛查或病例检测。