Accessibility solutions for PRO management

描述（由申请人提供）：我们的最终项目目标是开发一个患者报告结局（PRO）管理系统，专门用于解决身体和神经认知障碍患者所经历的功能限制。我们认识到，有许多临床条件，可能会导致这些功能障碍，但打算证明我们的解决方案在第一阶段的技术可行性，重点放在一个单一的疾病，多发性硬化症（MS），为一个更实际和可管理的第一阶段范围考虑第一阶段的预算和时间限制。MS是理想的开始残疾相关的PRO解决方案的研究在一个良好的限制人口，因为MS的人经历的大多数功能限制与其他残疾。在第二阶段，我们将寻求扩大我们的项目范围，以验证我们的解决方案与其他残疾和康复人群。这一新产品将基于我们现有的PRO管理解决方案（称为“PROMIS Outcome”）开发，该解决方案已支持“自适应”PRO措施（包括PROMIS项目库）的管理、多个交付平台的支持、基于规则的定制患者教育内容的交付以及通过提醒/警报消息协调护理等高级功能。虽然ECONOTE结局系统最初是为肿瘤学实践设计的，但它为扩展到其他疾病领域提供了坚实的技术基础。然而，对于残疾和康复人口，目前的残疾人权利成果系统尚未提供全面的无障碍解决方案，而这正是第一阶段项目的重点。为了解决可及性问题，我们第一阶段的具体目标包括：1）使用不同的技术平台（例如，网络，触摸屏，语音/语音，和电话）通过个人访谈和迭代的以用户为中心的设计过程;和2）系统可用性和用户接受度的评估在两个监控（可用性工程师在场）和现实，无监控的条件。为了确保我们的解决方案不仅适用于MS患者，也适用于其他残疾和康复患者，我们将组建一个多学科专家小组（物理治疗，职业治疗，康复咨询，神经心理学，辅助技术和PRO），为我们的研究设计和分析提供建议。 公共卫生相关性：虽然很长一段时间以来，MS主要被认为是一种运动或运动功能疾病，但现在认识到视觉症状、疲劳、认知障碍、抑郁、疼痛和睡眠障碍对MS患者的疾病负担和整体功能有显著影响。“隐性残疾”对残疾程度的影响是显著的。然而，这些MS症状以及它们之间的复杂关系却知之甚少。患者报告的结局比客观指标（如通过MRI和其他生物物理指标评估的病变负荷）更能预测患者的健康状况和残疾。自我报告结果的简短而可靠的测量工具是必不可少的，以评估个人的疾病过程，或评估特定干预措施的治疗效益，药理学或其他。拟议的研究将生成和验证工具，以执行此类测量，并直接应用于MS人群的临床和研究。然而，PRO可及性的障碍并不限于MS人群。患有其他常见残疾的人，如癫痫、帕金森病和其他慢性身体功能障碍的人也支持无障碍的限制。例如，癫痫患者通常表现出广泛的脑部疾病，并伴有身体、认知、教育和经济疾病负担。癫痫具有重要的社会经济意义，PRO有望改善临床监测、药物依从性、整体临床护理并促进相关主题的研究。

DESCRIPTION (provided by applicant): Our ultimate project goal is to develop a patient-reported outcomes (PRO) management system specifically designed to address the functional limitations experienced by people with physical and neurocognitive disabilities. We recognize that there are many clinical conditions that could cause these functional impairments, but intend to demonstrate the technical feasibility of our solution in Phase I by focusing on a single disease, multiple sclerosis (MS), for a more practical and manageable Phase I scope considering the Phase I budget and timeframe constraints. MS is ideal to begin the study of disability-related PRO solutions in a well circumscribed population since people with MS experience most of the functional limitations associated with other disabilities. In Phase II we will seek to expand our project scope to validate our solutions with other disability and rehabilitation populations. This new product will be developed based on our existing PRO management solution called BrightOutcome", that already supports such advanced features as the administration of "adaptive" PRO measures (including PROMIS item banks), the support of multiple delivery platforms, the rules-based delivery of tailored patient education contents, and the coordination of care via reminder/alert messages. Although the BrightOutcome System was initially designed for oncology practices, it provided a solid technical foundation to expand to other disease domains. For the disability and rehabilitation populations, however, the current BrightOutcome System does not yet offer a comprehensive accessibility solution, which is the focus of this Phase I project. To address the accessibility issues, our Phase I specific aims include: 1) the design and development of a PRO assessment interface specifically for MS patients with various functional impairments using different technology platforms (e.g., Web, touch-screen, speech/voice, and phone) via personal interviews and an iterative user-centric design process; and 2) the evaluation of system usability and user acceptance in both monitored (with usability engineers present) and realistic, un-monitored conditions. To ensure that our solution will be adequate not just for MS patients but for other disability and rehabilitation patients as well, we will assemble a multidisciplinary Expert Panel (physical therapy, occupational therapy, rehabilitation counseling, neuropsychology, assistive technologies, and PRO) to advise on our study design and analysis. PUBLIC HEALTH RELEVANCE: Whereas for a long time, MS was primarily considered a disease of ambulation or motor function, it is now recognized that visual symptoms, fatigue, cognitive impairment, depression, pain and sleep disturbances significantly contribute to the burden of disease and the overall functioning of MS patients. The effects of the "hidden disabilities" on the level of disability are significant. However, these MS symptoms and even more their complex relationship to each other are poorly understood. Patient reported outcomes are more predictive of patient health status and disability than objective measures, such as lesion load assessed by MRIs and other biophysical measures. Brief, yet reliable measurement tools of self-reported outcomes are essential in order to evaluate an individual's disease course, or to assess therapeutic benefits of specific interventions, pharmacological or otherwise. The proposed research will generate and validate tools to perform such measurements with direct clinical and research applications for the MS population. Barriers of PRO accessibility, though, are not limited to the MS population. People with other common disabilities, such as epilepsy, Parkinson's disease and other chronic impairments of bodily function endorse limitations of accessibility as well. As an example, patients with epilepsy commonly display a wide range of brain disease with associated physical, cognitive, educational and economic disease burden. Epilepsy is of great socioeconomic importance and PRO is expected to have the potential to improve clinical monitoring, drug adherence, overall clinical care and facilitate research of related topics.