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

摘要 我们建议开发后端接口和互操作功能的“背部疼痛跟踪”，智能手机 基于NIH慢性背痛研究标准和PROMIS计算机自适应测试的应用程序。的 拟议的工作将为这项创新的商业化做好准备。商业化的考虑因素 战略是定制或与临床实践、EMR公司、综合健康 系统或国家协会来衡量和比较患者的结果。主要可替代产品， 已经存在的是GeoPain（MoxyTech，Inc.），My Pain Diary & Symptom Tracker（DamoLab，LLC），PainScale （Boston Scientific，Inc.），像素年（Valley Software）、Flaredown（Flaredown）、CatchMyPain（Sanovation AG.），管理我的疼痛（ManagingLife，Inc.），WebMD移动的疼痛教练（WebMD LLC）和iBeatPain for 《风中的少年》（Take The Wind，Lda.）与该公司技术最接近的竞争对手是My Pain Diary & DamoLab LLC的症状跟踪器。该产品可以跟踪患者疼痛的位置和强度， 更新用药日志，记录天气，回顾所有过去的条目，并绘制一段时间内的趋势图。 我们的价值主张是一流的PRO（患者报告结局）评估，符合 NIH为cLBP临床研究制定的最高标准。我们的产品，背部疼痛跟踪器，是 旨在使患者能够直接了解他们的疼痛和功能评分，与其他类似患者相比， 年龄和性别。该知识产权受两项专利保护：美国专利申请，名称为： 和交互式医疗保健方法，申请号15/470，819，提交日期2017年3月27日;以及 美国专利申请，名称为：交互式健康护理系统，用于背部或颈部 疼痛，文件编号408/0002 R，存档日期2018年9月5日。通过使用该应用程序，PRO趋势反映了观察结果 通过一段时间，不受最近记忆的依赖性的限制。应用程序有实用性在所有 治疗阶段：诊断、术前物理治疗（PT）、药物治疗（pharma）、手术 准备、术后PT、药物和随访评价。最后，该应用程序在 个性化医疗，以患者为中心的结果的记录和分析，依赖于 医疗保健提供者和患者对治疗目标的定义; 共享决策，特别是关于手术;以及可应用于其他骨科手术的基本设计。 条件我们在患者报告的疼痛结局监测领域拥有专业知识， 疼痛治疗（包括外科手术）的临床需求和要求。查明的主要问题 利用当前用于跟踪和报告患者疼痛结果的技术， 调查中的治疗数据和与结局相关的数据，可靠性和再现性问题，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。本目标 项目是（1）为诊所开发一个仪表板，以管理患者和分析组，（2）开发 诊所能够自定义应用程序功能，以创建个性化体验，以及（3）集成 使用EMR系统。

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.