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.

项目总结/摘要 世界卫生组织估计，全世界80%的失明是可以避免的， 没有及早发现以防止视力丧失。为了解决这一全球负担，眼科护理系统必须 确定识别视力障碍或有视力障碍风险的人的最佳方法。在世界范围内，系统 利用各种以社区为基础的方法来识别此类病例，包括早期疾病筛查 远程医疗和流行病病例检测与白内障营地或社区卫生工作者。 这些模型中的每一个都需要不同水平的资源和眼科技能，但还没有研究表明， 这些不同的方法的相对有效性或成本效益进行。 本项目的总体目标是确定以社区为基础的方法的有效性 通过集群随机试验来预防失明。尼泊尔的社区将被随机分配到五个社区之一 （1）采用远程医疗进行筛查和病例检测的最先进的移动的筛查单元，（2） 一个移动的病例检测单元，其仅关注白内障和屈光不正，（3）一个白内障营地， 眼科人员，（4）志愿者社区卫生工作者（CHW）计划，和（5）无干预。 干预组（1-4组）将针对居住在干预社区的所有年龄≥50岁的成年人， 筛查和/或病例检测。符合转诊标准的患者将被转诊至巴拉特布尔眼科医院， 根据需要进行确诊和随访治疗，并由研究工作人员密切监测。四年 实施后，将在所有研究社区进行以人口为基础的人口普查， 将接受视力评估研究这些措施的成效和成本效益， 方法，我们将追求三个具体目标：1）确定是否筛选是有效的减少 与病例检测相关的视力损害（第1组vs第2组）; 2）确定CHW计划是否增加 白内障手术率与白内障营地相比（第3组与第4组）;以及3）比较 在竞争性外展计划之间预防视力损害（组1-5）。该方法具有创新性， 它使用最近开发的便携式诊断技术，使移动的，基于远程医疗， 如此大规模的筛选。此外，测试后仅基于人群的视力评估， 大型试验设计允许研究像失明这样的罕见事件，并消除了失访的问题- 这影响了之前的筛查试验。这项研究意义重大，因为它将提供最强的类型 指导国家眼健康计划的证据-来自随机对照试验的结果。最终这 这项试验将有利于全世界的防盲项目决定如何分配有限的资源， 筛查或病例检测。