Village-Integrated Eye Worker trial II (VIEW II)

村庄综合眼科工作者试验 II (VIEW II)

基本信息

批准号：
10441468
负责人：
Jeremy David Keenan
金额：
$ 67.83万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-30 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10441468
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 Persons 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

项目摘要

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，但案件是未足够早期发现以防止视力丧失。为了解决这个全球伯恩，眼保健系统必须确定识别有视觉障碍或有风险的人的最佳方法。全球，系统利用各种基于社区的方法来识别此类情况，包括筛查早期疾病远程医疗和病例检测患有白内障营地或社区卫生工作者的病例检测。这些模型中的每一个都需要不同水平的资源和眼科技能，但是没有研究根据这些不同方法的比较有效性或成本效益进行了进行。该项目的总体目的是确定基于社区的方法的有效性通过群集随机试验来防止失明。尼泊尔的社区将被随机分为五个武器（1）使用远程医疗进行筛查和病例检测的最先进的移动筛查单元，（2）仅关注白内障和折射率错误的移动案例检测单元，（3）白内障营地采用眼科工作人员，（4）志愿者社区卫生工作者（CHW）计划，（5）不干预。干预武器（武器1-4）将针对所有居住在干预社区中的年龄≥50岁的成年人筛选和/或病例检测。符合推荐标准的人将转交给巴拉特布尔眼科医院确认性诊断和随访，并将受到研究人员的密切监控。四年实施后，将在所有研究社区和符合条件的成年人中进行基于人群的人口普查将进行视力评估。检查这些的有效性和成本效益方法，我们将追求三个具体目标：1）确定筛查是否有效减少相对于病例检测的视觉障碍（ARM 1 vs 2）； 2）确定CHW计划是否增加与白内障营地相比，白内障手术率（ARM 3 vs 4）； 3）比较每行的成本视觉障碍阻止了竞争性外展计划（ARM 1-5）。这种方法是创新的它使用最近开发的便携式诊断技术，该技术可实现移动，远程医疗大规模筛选。此外，仅基于测试后的基于人群的视力评估大型试验设计允许研究诸如失明之类的罕见事件，并消除了损失的问题 - 影响了以前的筛查试验。这项研究很重要，因为它将提供强大的类型指导国家眼保健计划的证据 - 随机对照试验的结果。最终，这个试验将使全球范围内的盲目预防计划受益，以决定如何分配有限的资源筛选或病例检测。