Planning a Clinical Trial on Low Vision Rehabilitation

描述(由申请人提供)：美国目前提供的低视力康复服务的有效性仍然没有可靠的科学证据，尽管美国视力障碍的发病率很高，服务的普及，以及公众对低视力的认识不断提高。需要有关这些服务有效性的信息，以便：(1)提供证据基础，证明低视力服务在以视力为目标的健康相关生活质量和视觉任务执行方面的有效性，以便向客户提供关于潜在个人利益的真实信息。(2)提供关于哪些类型或水平的服务对以视力为目标的健康相关生活质量和视觉任务执行的有效性的信息。(3)提供有助于医疗保险和医疗补助服务中心(CMS)制定有关这些服务覆盖范围的政策的信息。这项研究计划的长期目标是对低视力康复服务的有效性进行随机临床试验，因为低视力康复服务在美国为寻求治疗的成年客户进行。在合理设计这样的随机临床试验之前，首先必须解决几个问题。这项规划补助金为我们提供了一种机制，使我们能够开展这些必要的初步活动。这个规划阶段的具体目标就是回答这些问题。(1)什么是日常护理？美国为成年人提供的低视力康复服务应该如何描述？提供的服务范围是什么？(2)最近开发的以视力为目标的健康相关生活质量问卷对低视力康复有反应吗？(3)在临床试验中，什么是有效、可靠和有响应性的视觉表现任务测量可以作为结果测量？(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，开发程序手册，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.