Tools to Optimize Patient Presentation Speed after Onset of Exudative Macular Deg

描述（由申请人提供）：具体目标：1 -改进一套新颖的低成本正在申请专利的交互式家用AMD教育和监控工具，该工具将第一阶段评估良好的测试与目前处于原型中的其他新颖工具相结合。2 -临床评估这些工具在减少症状出现和表现之间的延迟方面的有效性，从而潜在地减少视力丧失。意义：黄斑变性是60岁以上人群致盲的主要原因。2005年推出的新的抗vegf治疗方法如果早期使用是有效的，但患者通常在症状出现后等待长达5个月去看医疗专业人员，导致不必要的视力丧失。这导致了医疗费用的增加（通常由医疗保险承担）、更高的社会负担和更低的患者生活质量。在早期的研究中，我们已经确定了患者延误的关键原因和当前护理标准的重大差距。我们的解决方案以具有成本效益的方式解决了患者延误的最重要原因，能够向数百万患者分发，如果成功，将加速呈现并最大限度地减少大量患者的视力丧失。背景：美国有近1000万人患有早期AMD，预计到2050年这一数字将上升到1780万。在这一人群中，10 - 15%的干性AMD患者最终会转变为湿性AMD。4从干性AMD转变为湿性AMD可能突然发生，历史上很难被患者识别和反应。出现延迟长达5个月是很常见的在最近一项对新诊断为湿性AMD的患者的研究中，患者最常见的延迟原因是对症状缺乏信心，以及对问题的紧迫性缺乏认识。目前家庭监测的黄金标准，即20世纪40年代开发的Amsler网格，并没有解决导致延迟的主要原因，也没有解决患者在疾病进展中遇到的各种症状。改善家庭监控AMD的新电子技术已经证明了其敏感性和特异性，但其成本和学习曲线限制了其大规模分布。需要一种解决方案：1)解决造成延误的多种原因；2)成本低，可在大量人群中分配；3)包括多种互动要素，解决患者依从性和个人需求；4)促进适当和及时的行动。研究设计与方法：1)对现有原型工具进行焦点小组评估。2)根据患者反馈完善原型。3)对新工具的性能进行临床评估，测量湿性AMD发病后出现症状前的视力下降。如果成功，这些工具将实现大规模推广，减少教育差距，促进常规眼科检查，帮助加快患者就诊，帮助减少视力丧失，并帮助降低AMD的社会经济负担。

DESCRIPTION (provided by applicant): Specific Aims: 1 - to refine a novel set of low cost patent pending interactive home AMD education and monitoring tools that combine tests evaluated favorably in Phase I together with additional novel tools currently in prototype. 2 - To clinically evaluate the effectiveness of these tools in reducing the delay between onset of symptoms and presentation, thus potentially minimizing vision loss. Significance: Macular degeneration is the leading cause of blindness in those over 60. New anti-VEGF treatments introduced in 2005 are effective if given early but patients typically wait for up to 5 months after the onset of symptoms to see a healthcare professional, leading to unnecessary vision loss. This results in incremental costs of care (which most often accrue to Medicare), a higher societal burden and lower patient quality of life. In earlier studies, we have identified critical reasons for patient delay and significant gaps in the current standard of care. Our solutions address the most significant reasons for patient delay in a cost-effective format capable of distribution to millions of patients, that, if successful, will accelerate presentation and minimize vision loss for a significant population of patients. Background: There are almost 10 million people with early AMD in the US, with the number expected to rise to 17.8 million by 2050. 2,3 of this population, 10 to 15% of dry patients will eventually convert to wet AMD.4 The conversion from dry to wet AMD can occur suddenly and has been historically difficult to recognize and respond to by patients. Delays in presentation of up to 5 months are common.8 In a recent study of patients with newly diagnosed wet AMD, the most common patient-cited reasons for delay were lack of confidence in symptoms, and a lack of appreciation of the urgency of the problem. The current gold standard of home monitoring, the Amsler Grid, developed in the 1940's, does not address the top reasons for delay, nor does it address the variety of symptoms that patients experience with advancing disease. New electronic technologies for improving home monitoring AMD have demonstrated sensitivity and specificity, but their cost and learning curve can limit broad-scale distribution. A solution is required that 1) addresses the multiple reasons for delay, 2) is low-cost and amenable to distribution across large populations, 3) includes multiple interactive elements that address patient compliance and individual needs, and 4) fosters appropriate and timely action. Research design and methods: 1) conduct focus group evaluation of current prototype tools. 2) Refine the prototypes based upon patient feedback. 3) Conduct a clinical evaluation of the performance of the novel tools, measuring drop in visual acuity prior to presentation after onset of wet AMD. If successful, tools will enable broad-scale outreach, reduce educational disparities, foster routine eye exams, help accelerate patient presentation, help reduce vision loss, and help lower the socioeconomic burden of AMD. PUBLIC HEALTH RELEVANCE: Age-related macular degeneration (AMD) is the leading cause of blindness in adults over the age of 60.1 New injectable treatments introduced in 2005 are effective if given early but patients typically wait for up to 5 months after the onset of symptoms to see a healthcare professional, leading to unnecessary vision loss. This results in incremental costs of care (which most often accrue to Medicare), a higher societal burden and lower patient quality of life. The current study refines a patent pending novel group of low cost tools and assesses their ability to reduce presentation delay.