Core B-Clinical Data Collection and Management Core

核心 B-临床数据收集和管理核心

• 批准号: 10555683
• 负责人: Peggy Mannen Cawthon
• 金额: $ 638.93万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2028-02-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10555683
• 关键词: Address; Adherence; Alabama; Blood; Calcium; Clinic; Clinical; Clinical Data; Collection; Complex; Crystal Formation; Data; Data Collection; Databases; Degenerative polyarthritis; Deposition; Disease Progression; Elderly; Enrollment; Ensure; Exclusion Criteria; Exercise; Fright; Goals; Image; Impairment; Incentives; Incidence; Infrastructure; Institutional Review Boards; Iowa; Joints; Knee Osteoarthritis; Knowledge; Lead; Leadership; Life; Monitor; Nervous System; Observational Study; Outcome; Outcome Study; Pain; Participant; Patient Recruitments; Phase; Physical activity; Prevalence; Procedures; Proteins; Proteomics; Protocols documentation; Reporting; Research; Risk Factors; Safety; Site; Specimen; Synovial Fluid; Universities; Visit; Work; advanced disease; clinical center; data access; data cleaning; data management; data standards; disability; disabling disease; ethnic minority population; experience; follow-up; high risk; inclusion criteria; insight; mineralization; novel; participant safety; quality assurance; racial minority population; retention rate; sample collection; success; timeline

ABSTRACT Clinical Data Collection and Management Core Knee osteoarthritis (OA) is among the world's most disabling diseases, and it accounts for a substantial percentage of the increase in disability life years. The Multicenter Osteoarthritis (MOST) Study has made major contributions to our understanding of the course of OA and identification of risk factors for its incidence and progression. Beginning in 2003, the MOST initially enrolled 3026 participants with or at high risk of knee OA. In the most recent phase (MOST3), an additional 1525 participants who were slightly younger and unlikely to have advanced disease were enrolled. Despite the insights provided by the previous phases of MOST, there are still no treatments available that slow progression of OA. The next phase (MOST4) focuses on three major scientific projects that address key gaps in knowledge in OA. These projects include: Impaired Exercise-Induced Hypoalgesia (Project 1); Synovial Fluid Proteomics (Project 2); and Intra-articular Mineralization (Project 3). These projects will be supported by four Cores – the Administrative Core, the Imaging Core, the Analysis Core, and the Clinical Data Collection and Management Core (CDCMC). The overarching goal of the CDCMC is to ensure the success of the MOST projects by providing an outstanding infrastructure for visit enrollment, study procedures and data collection, and longitudinal ascertainment of critical outcomes. This core includes the Coordinating Center (led by Peggy Cawthon at UCSF) and the MOST clinical centers: University of Iowa (UI clinic center lead: James Torner) and University of Alabama, Birmingham (UAB clinic center lead: Cora E. Lewis). Specially, the aims of the CDCMC are to: 1) To enroll 2143 existing MOST participants, and 150 newly recruited participants from underrepresented racial and ethnic minority groups, for the MOST4 V1 examination (2293 total), and follow those participants for the MOST4 V2 examination, 2) Ensure the collection of high-quality research data and specimens, 3) To maintain a high rate of retention of study participants and complete ascertainment of study outcomes, 4) To ensure the safety of participants and to meet regulatory standards, 5) Collect, clean, document and integrate MOST data across all projects and cores.

摘要 临床数据收集和管理核心 膝骨关节炎 (OA) 是世界上最严重的致残疾病之一，占相当大的比例。 多中心骨关节炎 (MOST) 研究取得了重大进展。 有助于我们了解 OA 的病程并识别其发病率和风险因素 MOST 于 2003 年开始进展，最初招募了 3026 名患有膝关节骨关节炎或膝关节骨关节炎高风险的参与者。 在最近的阶段（MOST3）中，另外有 1525 名参与者，他们年龄稍小，不太可能有 尽管 MOST 的前几阶段提供了见解，但仍然存在晚期疾病。 没有可用的治疗方法可以减缓 OA 的进展 下一阶段 (MOST4) 的重点是三个主要科学领域。 解决 OA 知识差距的项目包括： 运动引起的障碍。 痛觉减退（项目 1）；滑液蛋白质组学（项目 2）和关节内矿化（项目 3）。 这些项目将由四个核心支持——管理核心、成像核心、分析核心、 临床数据收集和管理核心 (CDCMC) CDCMC 的总体目标是： 通过提供出色的访问注册、学习基础设施，确保 MOST 项目的成功 该核心包括程序和数据收集以及关键结果的纵向确定。 协调中心（由 UCSF 的 Peggy Cawthon 领导）和 MOST 临床中心：爱荷华大学 (UI 临床中心负责人：James Torner）和阿拉巴马大学伯明翰分校（UAB 临床中心负责人：Cora E. Lewis）特别指出，CDCMC 的目标是： 1) 招募 2143 名现有 MOST 参与者，以及 150 名新参与者。 招募来自代表性不足的种族和少数民族群体的参与者，参加 MOST4 V1 考试 （共2293个），并跟踪参加MOST4 V2考试，2）确保收集高质量的 研究数据和标本，3）保持研究参与者的高保留率并完成 确定研究结果，4) 确保参与者的安全并满足监管标准，5) 收集、清理、记录和集成所有项目和核心的大部分数据。