The Spine Phenome Project: Enabling Technology for Personalized Medicine

项目摘要/摘要 慢性下腰痛(CLBP)是一种影响全球数百万人的衰弱疾病。尽管 由于干预措施使用率的增加和医疗费用的上升，慢性下腰痛的患病率继续上升。这 出现问题是因为慢性腰痛是复杂的、异质性的，而目前的诊断和治疗主要依赖于 关于主观指标，而不是针对与以下方面相关的所有多维生物心理社会机制 CLBP。具体地说，大多数诊断没有定量地考虑患者的功能测量。这 多学科的努力建议通过开发和验证数字健康平台来解决这个问题 并提供有意义的数据驱动指标，以支持对临床评估和 慢性腰痛的治疗。该平台将促进使用定量脊柱运动度量(功能)、PROS 和患者偏好信息，以实现深入的患者表型鉴定并为临床决策提供信息 个性化治疗，以改善结果。这项工作将涉及软件和硬件 开发以实现临床环境中的数据收集、分析和可视化。技术发展 这项工作将与Switchbox Inc.(软件战略)和Priority Designs Inc.(监管)合作完成 战略)。UH2阶段的具体目标是：1)开发数字健康平台，收集、分析、 并报告核心cLBP指标；2)进行可行性研究，以测试临床可操作性、可用性和实用性 UH3阶段的具体目标是：1)优化数字健康平台的翻译 通过bacpac用于临床研究；2)验证数字健康平台识别cLBP的效用 患者表型并为临床决策提供信息，为个别患者的最佳治疗路径提供信息。 该项目的成果将是一个数字健康平台，具有支持监管提交的数据 临床应用。在这项工作结束时，我们将有一个经过验证的工具来整合临床研究研究 由BACPAC财团支持。

Project Summary/Abstract Chronic Low Back Pain (cLBP) is a debilitating condition that affects millions of people globally. Despite increased utilization of interventions and rising medical costs, cLBP prevalence has continued to increase. This problem arises because cLBP is complex, heterogeneous and current diagnostics and treatments rely primarily on subjective metrics and do not target all the multidimensional biopsychosocial mechanisms associated with cLBP. Specifically, most diagnostics do not quantitively consider patient functional measures. This multidisciplinary effort proposes to address this problem by developing and validating a digital health platform and provide meaningful data-driven metrics that enable an integrated approach to clinical evaluation and treatment of cLBP. This platform will facilitate the use of quantitative spinal motion metrics (function), PROs and patient preference information to enable deep patient phenotyping and inform clinical decision-making on personalized treatments in order to improve outcomes. This effort will involve software and hardware development to enable data collection, analysis and visualization in clinical settings. Technology development effort will be done in partnership with Switchbox Inc. (Software Strategy) and Priority Designs Inc. (Regulatory Strategy). The specific aims for UH2 phase are to: 1) Develop a Digital health platform for collecting, analyzing, and reporting core cLBP metrics; 2) Conduct a feasibility study to test the clinical operability, usability and utility of the prototype; and the specific Aims for UH3 phase are to: 1) Optimize Digital Health Platform for translation to clinical research use through BACPAC; 2) Validate the utility of the Digital Health Platform to identify cLBP patient phenotypes and inform clinical decision-making on optimal treatment pathways for individual patients. The outcome of this project will be a digital health platform with data to support regulatory submission for clinical use. At the end of this effort, we will have a validated tool for integration in clinical research studies supported by the BACPAC consortium.