Clinical Core

临床核心

• 批准号: 10765815
• 负责人: Afton L Hassett
• 金额: $ 58.61万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 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/10765815
• 关键词: Clinical; Core

PROJECT SUMMARY / ABSTRACT CLINICAL CORE The broad long-term objective of the UM BACPAC MRC Clinical Core will be to provide an enduring resource for the NIH BACPAC initiative. The data collected and cohorts established throughout the course of this project will remain a resource for a wide array of individuals and entities that conduct clinical pain research. The more immediate objective of the UM Clinical Core will be to provide the substrate for the successful completion of all four Specific Aims noted in the Overview for this application. The Interventional Response Phenotyping research project central to this effort will rely heavily on the patient population, existing registry, and research infrastructure of the Department of Anesthesiology’s Back and Pain Center at the University of Michigan and the experienced research team at the Chronic Pain and Fatigue Research Center (CPFRC). Both centers, working in concert, will make up the UM Clinical Core. The Michigan Medicine Back & Pain Center is a large tertiary care pain clinic that evaluates over 1500 new patients per year and conducts nearly three times as many return patient visits The Back & Pain Center has a pain patient registry (>8700) with rich pain phenotyping data, including numerous PROMIS measures, that are routinely collected from most of the new patients evaluated each year at the pain clinic. Further, there are nested cohort studies based on the data of registry patients, as well as randomized controlled trials that draw from them and are managed by the experienced study personnel. Similarly, the CPFRC has a long and rich history of successfully collecting the types of deep phenotyping data specified herein (e.g., neuroimaging, quantitative sensory testing [QST], inflammatory factors, ecological momentary assessment [EMA]) and has been a leader in the field of pain research for close to two decades. The UM Clinical Core will tap into our existing infrastructure and well- phenotyped patient population and address the following aims. First, the UM Clinical Core will provide the infrastructure and resources for the baseline assessment and both light and deep phenotyping data collection including the processing and analysis of neurobiological samples. Second, it will support the Interventional Response Phenotyping study through the recruitment, enrollment and retention of patient participants with chronic low back pain. Third, the UM Clinical Core will support the provision of the SMART design study interventions to be used in the Interventional Response Phenotyping study. Lastly, the clinical core will coordinate with the Informatics Core and Algorithm Development and Operations Management Center (DAC) for data management, statistical analysis and data sharing.

项目摘要 /摘要 临床核心 UM BACPAC MRC临床核心的广泛长期目标是提供持久的资源 对于NIH BACPAC倡议。收集的数据和在整个项目过程中建立的人群 将仍然是进行临床疼痛研究的各种个人和实体的资源。更多 UM临床核心的直接目标将是为成功完成的基板提供基质 此应用程序的概述中指出了四个具体目的。介入反应表型 这项工作中心的研究项目将在很大程度上依赖于患者群体，现有注册表和研究 密歇根大学麻醉学部门和疼痛中心的基础设施 慢性疼痛和疲劳研究中心（CPFRC）的经验丰富的研究团队。两个中心， 在音乐会上工作，将构成UM临床核心。密歇根州医学背部和疼痛中心很大 每年评估1500多名新患者的三级护理疼痛诊所，并进行近三倍 许多返回患者访问背部和疼痛中心有疼痛的患者注册表（> 8700），疼痛丰富 表型数据，包括大多数新的新型临时测量值 每年在疼痛诊所进行评估的患者。此外，基于数据的数据 注册患者以及从他们那里汲取的随机对照试验，并由 经验丰富的学习人员。同样，CPFRC拥有成功收集的悠久历史 本文指定的深度表型数据的类型（例如，神经成像，定量感觉测试[qST]， 炎症因素，生态瞬时评估[EMA]），一直是疼痛领域的领导者 研究近二十年。 UM临床核心将利用我们现有的基础设施和良好 表型的患者人群并解决以下目的。首先，UM临床核心将提供 基线评估的基础设施和资源以及光和深度表型数据收集 包括神经生物学样本的处理和分析。其次，它将支持介入 通过招聘，入学和保留患者参与者的反应预型研究 慢性下腰痛。第三，UM临床核心将支持智能设计研究的提供 用于干预反应表型研究中的干预措施。最后，临床核心将 与信息学核心和算法开发与运营管理中心（DAC）协调 用于数据管理，统计分析和数据共享。