Planning a Clinical Trial on Low Vision Rehabilitation

描述（由申请人提供）：尽管美国视力障碍的患病率很高，服务的广泛可用性以及公众对低视力的认识提高，但目前在美国提供的低视力康复服务的有效性的可靠科学证据仍然不可用。需要关于这些服务的有效性的信息，以便：（1）提供证据基础，证明低视力服务对视力目标健康相关生活质量和视觉任务性能的有效性，以便为客户提供有关潜在个人利益的现实信息。(2)提供关于哪些类型或水平的服务对视觉目标健康相关生活质量和视觉任务表现有效的信息。(3)提供可以协助医疗保险和医疗补助服务中心（CMS）制定这些服务覆盖范围政策的信息。这项研究计划的长期目标是进行一项随机临床试验，研究低视力康复服务的有效性，因为它们是在美国为寻求它们的成年客户进行的。在合理设计这样一个随机临床试验之前，有几个问题必须首先解决。这项规划补助金为我们提供了一个机制，使我们能够开展这些重要的初步活动。这一规划阶段的具体目标是回答这些问题。(1)什么是常规护理？美国成年人可获得的低视力康复服务应如何描述？提供的服务范围是什么？(2)最近开发的视力健康相关生活质量问卷对低视力康复有反应吗？(3)什么是有效的，可靠的，和响应的视觉性能任务的测量，可用于临床试验的结果措施？(4)利用这些信息，我们将设计一项多中心随机临床试验，提交给国家眼科研究所，制定一份程序手册，并设计一个电子数据库。

DESCRIPTION (provided by applicant): Sound scientific evidence about the effectiveness of low vision rehabilitation services as provided today in the U.S. remains unavailable despite the high prevalence of visual impairment in this country, the widespread availability of services, and increased public awareness about low vision. Information about the effectiveness of these services is needed in order to: (1) Provide an evidence-base demonstrating the effectiveness of low vision services on vision-targeted health-related quality of life and performance of visual tasks so clients are offered realistic information about potential personal benefits. (2) Provide information about what types or levels of services have effectiveness on vision-targeted health-related quality of life and performance of visual tasks. (3) Provide information that could assist the Center for Medicare and Medicaid Services (CMS) in formulating policy on coverage of these services. The long-term goal of this program of research is to conduct a randomized clinical trial on the effectiveness of low vision rehabilitation services as they are carried out in the U.S. for adult clients who seek them. Before such a randomized clinical trial can be reasonably designed, there are several issues that first must be addressed. This Planning Grant affords us a mechanism by which we can carry out these essential preliminary activities. The specific aims of this planning phase are to answer these questions. (1) What is usual care? How should the low vision rehabilitation services available to adults in the U.S. be characterized? What is the range of services offered? (2) Is a recently developed vision-targeted health related quality of life questionnaire responsive to low vision rehabilitation? (3) What are valid, reliable, and responsive visual performance task measurements that could be used as outcome measures in the clinical trial? (4) Using this information, we will design a multi-center randomized clinical trial for submission to the National Eye Institute, develop a manual of procedures, and design an electronic database.