The Spine Phenome Project: Enabling Technology for Personalized Medicine

脊柱表型组项目：个性化医疗的支持技术

• 批准号: 10375971
• 负责人: Safdar N. Khan
• 金额: $ 307.49万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-26 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10375971
• 关键词: Address; Adoption; Affect; Aftercare; Back; Caring; Characteristics; Chronic low back pain; Clinical; Clinical Data; Clinical Research; Clinical Treatment; Collaborations; Complex; Computer software; Data; Data Collection; Development; Diagnostic; Disease; Environment; Feasibility Studies; Feedback; Goals; Intervention; Low Back Pain; Measures; Medical; Medical Care Costs; Monitor; Motion; Outcome; Pain management; Pathway interactions; Patient Outcomes Assessments; Patient Preferences; Patient-Focused Outcomes; Patients; Performance; Phase; Phenotype; Pilot Projects; Positioning Attribute; Prediction of Response to Therapy; Prevalence; Probability; Process; Provider; Reporting; Reproducibility; Research; Research Personnel; Safety; Sampling; Security; Series; Site; Spinal; System; Technology; Testing; Time; Translations; Treatment outcome; Use Effectiveness; Vertebral column; Visualization; biopsychosocial; biopsychosocial factor; clinical decision-making; clinical practice; cost; design; digital health; disability; effectiveness validation; feasibility testing; imaging modality; improved; improved outcome; individual patient; motion sensor; multidisciplinary; novel; optimal treatments; pain patient; patient stratification; personalized decision; personalized medicine; phenome; prototype; research clinical testing; research study; response; system architecture; technology development; tool; treatment response; usability; validation studies

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.

项目总结/摘要 慢性腰痛（cLBP）是一种使人衰弱的疾病，影响着全球数百万人。尽管 随着干预措施的使用增加和医疗费用的上升，cLBP患病率继续增加。这 由于cLBP是复杂的、异质的，并且目前的诊断和治疗主要依赖于 主观指标，并不针对所有的多维生物心理社会机制， cLBP。具体地，大多数诊断不定量地考虑患者功能测量。这 多学科的努力提出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，使临床评价的综合方法成为可能， 治疗cLBP该平台将有助于使用定量脊柱运动指标（功能）、PRO 和患者偏好信息，以实现深度患者表型分析并告知临床决策， 个性化治疗，以改善治疗效果。这项工作将涉及软件和硬件 开发，使数据收集，分析和可视化的临床设置。技术开发 将与Switchbox Inc.合作开展这项工作。（软件战略）和优先设计公司。（监管 战略）。UH 2阶段的具体目标是：1）开发数字健康平台，用于收集，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 原型; UH 3阶段的具体目标是：1）优化数字健康平台以进行翻译 通过BACPAC用于临床研究; 2）验证数字健康平台识别cLBP的实用性 患者表型，并为个体患者的最佳治疗途径提供临床决策。 该项目的成果将是一个数字健康平台，其中的数据可支持监管提交， 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，用于整合临床研究 由BACPAC财团支持。