Back Pain Tracker Smartphone App for Longitudinal Assessment of Patient Reported Outcomes

摘要 我们计划为智能手机“Back Pain Tracker”开发后端接口和互操作功能 APP基于美国国立卫生研究院慢性背痛和PROMIS计算机适应性测试研究标准。这个 拟议的工作将为这项创新的商业化做准备。商业化的几点思考 战略是定制或许可与临床实践、EMR公司、综合健康 系统，或衡量和比较患者结果的国家社会。主要的可替代产品 已经存在的有GeoPain(MoxyTech，Inc.)、My Pain Diary&Symptom Tracker(DamoLab，LLC)、PainScale (波士顿科学公司)，Year in Pixels(山谷软件)，Flaredown(Flaredown)，CatchMyPain(Sanvation 公司)、Manage My Pain(管理生活公司)、WebMD Mobile Pain Coach(WebMD LLC)和iBeatPain for 《青少年》(《乘风破浪》)。与该公司技术最接近的竞争对手是我的痛苦日记& 症状跟踪器由DamoLab LLC提供。该产品可以跟踪患者疼痛的位置和强度， 更新用药记录，记录天气，回顾过去的所有条目，并绘制一段时间的趋势图。 我们的价值主张是一流的PROS(患者报告的结果)评估，符合 美国国立卫生研究院为慢性下腰痛的临床研究设立的最高标准。我们的产品，背痛追踪器，是 旨在让患者直接了解他们与其他类似患者相比的疼痛和功能评分 年龄和性别。该知识产权受两项专利保护：美国专利申请：系统 和互动保健的方法，申请号15/470,819，提交日期为3/27/17；以及 题为：用于管理背部或颈部的交互式医疗保健系统的美国专利申请 Pain，文件号408/0002R，申请日期2018年9月5日。通过使用这款应用，专业人士的趋势反映了观察结果 通过一段时间，不受对最近记忆的依赖的限制。这个应用程序完全有实用程序 治疗阶段：诊断、术前物理治疗(PT)、药物治疗(药物治疗)、手术治疗 准备、术后PT、用药及随访评价。最后，该应用程序在 个性化医疗，记录和分析以患者为中心的结果，依赖于 医疗保健提供者和患者对治疗目标的定义；共同的基于数据的基础 共享决策，特别是关于手术的决策；以及可以应用于其他整形外科的基本设计 条件。我们在患者报告结果监测疼痛方面拥有专业知识，并在 疼痛治疗的临床需求和要求，包括外科手术。确定的关键问题 目前用于跟踪和报告患者疼痛结果的技术包括收集患者 调查中的治疗数据并与结果相关，可靠性和重复性问题，以及所有主要的EMR 美国使用的系统不支持患者自我报告的疼痛管理数据。这样做的目标是 项目是(1)开发一个用于诊所管理患者和分析群体的仪表板，(2)开发 诊所能够定制应用程序功能以创建个性化体验，以及(3)集成 使用电子病历系统的应用程序。

Abstract We propose to develop back-end interface and interoperability features for “Back Pain Tracker”, a smart-phone app based on the NIH Research Standards for Chronic Back Pain and PROMIS Computer Adaptive Tests. The proposed work will prepare this innovation for commercialization. Considerations for commercialization strategy are customizations or licensing partnerships with clinical practices, EMR companies, integrated health systems, or national societies that measure and compare patient outcomes. Major substitutable products that already exists are GeoPain (MoxyTech, Inc.), My Pain Diary & Symptom Tracker (DamoLab, LLC), PainScale (Boston Scientific, Inc.), Year in Pixels (Valley Software), Flaredown (Flaredown), CatchMyPain (Sanovation AG.), Manage My Pain (ManagingLife, Inc.), WebMD Mobile Pain Coach (WebMD LLC), and iBeatPain for Teens (Take The Wind, Lda.). The closest competitor to the company's technology is My Pain Diary & Symptom Tracker by DamoLab LLC. The product can track the location and intensity of the patient's pain, update a medication log, note the weather, look back at all past entries, and graph trends over time. Our value proposition is best-in-class PROs (Patient Reported Outcomes) assessment that complies with the highest standards established by the NIH for clinical research on cLBP. Our product, Back Pain Tracker, is designed to allow patients to directly understand their pain and function scores compared to others of similar age and sex. This intellectual property is protected by two patents: U.S. Patent Application entitled: SYSTEM AND METHODS FOR INTERACTIVE HEALTH CARE, Application No. 15/470,819, Filing Date 3/27/17; and U.S Patent Application entitled: INTERACTIVE HEALTH CARE SYSTEM FOR MANAGING BACK OR NECK PAIN, File No. 408/0002R, Filing Date 9/5/2018. By using the app the PROs trends reflect the observations through a time period, not restricted by dependence on the most recent memory. The app has utility at all treatment phases: diagnosis, pre-surgical physical therapy (PT), pharmacological therapy (pharma), surgical preparation, and post-surgical PT, pharma and follow-up evaluation. Finally, the app has applications in personalized medicine, recording and analysis of patient centered outcomes relying on an interaction between healthcare provider and patient on the definitions of treatment goals; a common data-based foundation for shared decision making, particularly about surgery; and a basic design that can be applied to other orthopedic conditions. We have expertise in the area of patient reported outcomes monitoring for pain and expertise in the clinical needs and requirements for treatment of pain including surgical procedures. Key problems identified with current technologies for tracking and reporting patient outcomes for pain include collection of patient treatment data in surveys and related to outcomes, issues with reliability and reproducibility, and all major EMR systems used in the USA do not support self-reported pain management data from patients. Goals of this project are (1) to develop a dashboard for clinics to manage patients and analyze groups, (2) develop the ability for clinics to customize app functions to create a personalized experience, and (3) integrate the application with an EMR system.