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的结果（PRO）管理系统，专门设计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导致这些功能障碍，但我们打算通过专注于单一疾病，多发性硬化症（MS）来证明我们的解决方案在I期的技术可行性，考虑到I期的预算和时间限制，这是一个更实际和可管理的I期范围。由于多发性硬化症患者经历了与其他残疾相关的大部分功能限制，因此在一个有良好限制的人群中开始残疾相关PRO解决方案的研究是理想的。在第二阶段，我们将设法扩大我们的项目范围，以便在其他残疾和康复人群中验证我们的解决方案。这款新产品将基于我们现有的PRO管理解决方案“BrightOutcome”开发，该解决方案已经支持诸如“适应性”PRO措施管理（包括PROMIS项目库），支持多个交付平台，基于规则的定制患者教育内容交付，以及通过提醒/警报消息协调护理等高级功能。虽然BrightOutcome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，对于残疾和康复人群，目前的BrightOutcome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。为了解决可访问性问题，我们的第一阶段具体目标包括：1)通过个人访谈和以用户为中心的迭代设计过程，设计和开发专门为具有各种功能障碍的MS患者使用不同技术平台（例如，Web，触摸屏，语音/语音和电话）的PRO评估界面；2)在监控（可用性工程师在场）和现实的、未监控的情况下，评估系统可用性和用户接受度。为了确保我们的解决方案不仅适用于多发性硬化症患者，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。

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.