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

渗出性黄斑脱位发生后优化患者就诊速度的工具

基本信息

批准号：
7912553
负责人：
Mark C Roser
金额：
$ 51.37万
依托单位：
RESULTS GROUP
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-07-01 至 2012-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7912553
关键词：
Address Adherence Adult Advertising Age Age related macular degeneration Appointment Awareness Blindness Books Businesses Caring Charge Clinical Research Communication Data Defect Diagnosis Disease Disease Progression Drops Education Effectiveness Electronics Elements Ensure Evaluation Eye Feedback Focus Groups Fostering Glass Gold Group Interviews Health Professional Hearing Home environment Homes for the Aged Individual Injectable Internet Knowledge Learning Legal patent Location Macular degeneration Measures Medicare Methods Monitor Newly Diagnosed Ophthalmic examination and evaluation Outcome Pamphlets Paper Patient Education Patient Preferences Patient Schedules Patients Performance Phase Population Principal Investigator Printing Provider Quality of life Regimen Reporting Research Design Retinal Risk Sales Schedule Self Care Sensitivity and Specificity Series Solutions Speed Spottings Staging Symptoms Target Populations Technology Testing Variant Vision Visit Visual Visual Acuity Visual impairment advanced disease base bevacizumab clinical Diagnosis compliance behavior cost experience improved macula novel outreach patient population phase 1 study programs prototype public health relevance research clinical testing response socioeconomics standard of care tool usability web site

项目摘要

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.

描述（由申请人提供）：具体目标： 1 - 完善一套新颖的低成本、正在申请专利的交互式家庭 AMD 教育和监控工具，该工具将第一阶段评价良好的测试与目前原型中的其他新颖工具结合起来。 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，从而有可能最大限度地减少视力丧失。意义：黄斑变性是导致 60 岁以上老年人失明的主要原因。2005 年推出的新型抗 VEGF 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 个月才去看医疗保健专业人员，从而导致不必要的视力丧失。这导致护理成本增加（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以及当前护理标准的重大差距。我们的解决方案以经济高效的方式解决了患者延误的最重要原因，能够分发给数百万患者，如果成功，将加速就诊并最大限度地减少大量患者的视力丧失。背景：美国有近 1000 万早期 AMD 患者，预计到 2050 年这一数字将增至 1780 万。2,3 在这一人群中，10% 至 15% 的干性 AMD 患者最终将转化为湿性 AMD。4从干性 AMD 到湿性 AMD 的转变可能会突然发生，并且历史上患者很难识别和应对。延迟就诊长达 5 个月的情况很常见。8 在最近一项针对新诊断的湿性 AMD 患者的研究中，患者最常见的延迟原因是对症状缺乏信心，以及对治疗的紧迫性缺乏认识。问题。目前家庭监测的黄金标准是 1940 年代开发的阿姆斯勒网格，它并没有解决延迟的主要原因，也没有解决患者在疾病进展过程中遇到的各种症状。用于改善家庭监控的新电子技术 AMD 已表现出敏感性和特异性，但其成本和学习曲线可能会限制大规模推广。需要一种解决方案，1) 解决延迟的多种原因，2) 成本低且易于在大量人群中分发，3) 包括满足患者依从性和个人需求的多个互动元素，4) 促进适当和及时的行动。研究设计和方法：1）对当前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 发病后出现的视力下降情况。如果成功，这些工具将实现大规模推广，减少教育差异，促进常规眼科检查，帮助加快患者就诊速度，帮助减少视力丧失，并帮助减轻 AMD 的社会经济负担。公共卫生相关性：年龄相关性黄斑变性 (AMD) 是 60.1 岁以上成年人失明的主要原因 2005 年推出的新注射疗法如果尽早注射即可有效，但患者通常在症状出现后等待长达 5 个月看医疗保健专业人员，导致不必要的视力丧失。这导致护理成本增加（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。目前的研究改进了一组正在申请专利的新型低成本工具，并评估了它们减少呈现延迟的能力。