Clinical Core

临床核心

• 批准号: 9898112
• 负责人: Afton L Hassett
• 金额: $ 169.57万
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9898112
• 关键词: Address; Algorithms; Anesthesiology; Back Pain; Biological; Characteristics; Chronic low back pain; Clinic; Clinical; Clinical Research; Clinical Trials; Cohort Studies; Data; Data Collection; Development; Ecological momentary assessment; Enrollment; Ensure; Ethics; Family Practice; Fatigue; General Population; Human Resources; Human Subject Research; Individual; Inflammatory; Informatics; Information Management; Infrastructure; Institutional Review Boards; Intervention; Intervention Studies; Light; Measures; Medicine; Michigan; Neurobiology; Pain; Pain Clinics; Pain Research; Participant; Patient Recruitments; Patients; Performance; Phenotype; Physical Medicine; Physical Rehabilitation; Population; Procedures; Protocols documentation; Quality Control; Ramp; Randomized Controlled Trials; Recording of previous events; Registries; Research; Research Design; Research Infrastructure; Research Personnel; Research Project Grants; Resources; Sampling; Sensory; Site; Specific qualifier value; Statistical Data Interpretation; System; Testing; Time; United States National Institutes of Health; Universities; Update; Visit; Work; base; chronic pain; clinical pain; cohort; data management; data registry; data sharing; experience; neuroimaging; operation; pain patient; patient population; patient registry; patient safety; phenotypic data; programs; recruit; response; sample collection; success; tertiary care; training opportunity

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.

项目总结/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 关于NIH BACPAC的倡议。在整个项目过程中收集的数据和建立的队列 将仍然是进行临床疼痛研究的各种个人和实体的资源。越 UM临床核心的直接目标将是为成功完成所有 本申请概述中提到的四个具体目标。干预反应表型分析 这项工作的核心研究项目将在很大程度上依赖于患者人群、现有登记和研究 密歇根大学麻醉科背部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， 协同工作，将组成UM临床核心。密歇根医学背部和疼痛中心是一个大型的 三级护理疼痛诊所，每年评估超过1500名新患者，并进行近三次， 背部和疼痛中心有一个疼痛患者登记处（>8700）， 表型数据，包括许多PROMIS措施，这是例行收集的大多数新的 每年在疼痛诊所接受评估的患者。此外，还有基于以下数据的嵌套队列研究： 登记的患者，以及随机对照试验，从他们和管理 经验丰富的研究人员。同样，CPFRC在成功收集 在此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]， 炎症因子，生态瞬时评估[EMA]），并一直是疼痛领域的领导者 近二十年的研究。UM临床核心将利用我们现有的基础设施，以及- 表型分型的患者群体，并解决以下目标。首先，UM临床核心将提供 用于基线评估以及轻度和深度表型数据收集的基础设施和资源 包括神经生物学样本的处理和分析。第二，支持干预 通过招募、入组和保留患者参与者的缓解表型研究 慢性下背痛。第三，UM临床核心将支持SMART设计研究的提供 干预反应表型研究中使用的干预措施。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。