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-完善一套新的低成本正在申请专利的交互式家庭AMD教育和监测工具，将在第一阶段评估良好的测试与目前处于原型中的其他新工具相结合。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，从而潜在地将视力损失降至最低。意义：黄斑变性是60岁以上人群失明的主要原因。2005年推出的新的抗血管内皮生长因子治疗如果及早给予是有效的，但患者通常在症状出现后等待长达5个月的时间才能看医疗保健专业人员，导致不必要的视力丧失。这导致了医疗成本的增加(通常是由联邦医疗保险产生的)，增加了社会负担，降低了患者的生活质量。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中的重大差距。我们的解决方案以一种能够分发给数百万患者的经济高效的形式解决了导致患者延迟的最主要原因，如果成功，将加快演示速度，并将大量患者的视力损失降至最低。背景：美国有近1000万早期AMD患者，预计到2050年这一数字将上升到1780万。2、3在这一人群中，10%至15%的干性AMD患者最终会转变为湿性AMD。4干性AMD转变为湿性AMD可能突然发生，患者历来难以识别和应对。在最近对新诊断的湿性AMD患者进行的一项研究中，患者提到的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。目前家庭监护的黄金标准，安斯勒网格，开发于20世纪40年代的S，没有解决延迟的主要原因，也没有解决患者在病情进展时经历的各种症状。用于改善家庭监测AMD的新电子技术已显示出敏感性和特异性，但其成本和学习曲线可能会限制广泛的分布。需要一种解决方案，1)解决延误的多种原因，2)低成本，并易于在大量人群中分发，3)包括满足患者遵从性和个人需求的多种互动元素，以及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)根据患者反馈提炼原型。3)对新工具的性能进行临床评估，测量湿性AMD发病后出现之前的视力下降。如果成功，工具将实现广泛的推广，减少教育差距，促进常规眼科检查，帮助加快患者的陈述，帮助减少视力损失，并有助于降低AMD的社会经济负担。 公共卫生相关性：老年性黄斑变性(AMD)是60.1岁以上成年人失明的主要原因。2005年推出的新的注射疗法如果及早给予治疗是有效的，但患者通常在症状出现后等待长达5个月的时间才能看医疗专业人员，导致不必要的视力丧失。这导致了医疗成本的增加(通常是由联邦医疗保险产生的)，增加了社会负担，降低了患者的生活质量。目前的研究提炼了一组正在申请专利的低成本工具，并评估了它们减少呈现延迟的能力。

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.