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.

临床数据收集和管理核心 膝关节骨关节炎（OA）是世界上最致残的疾病之一，它占了相当大的比例， 残疾寿命年增长的百分比。多中心骨关节炎（MOST）研究已经取得了重大进展， 有助于我们理解OA的病程和识别其发病的风险因素， 进展从2003年开始，MOST最初招募了3026名患有膝关节OA或膝关节OA高风险的参与者。在 最近一个阶段（MOST 3），另外1525名参与者，他们稍微年轻，不太可能有 入组了晚期疾病。尽管社会变革管理计划的前几个阶段提供了深刻的见解， 没有可用的治疗方法来减缓OA的进展。下一阶段（MOST 4）的重点是三个主要的科学 解决开放式获取知识方面的关键差距的项目。这些项目包括： 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）。 这些项目将得到四个核心的支持-行政核心，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 通过为访问、注册、学习和培训提供出色的基础设施，确保MOST项目的成功 程序和数据收集，以及关键结果的纵向确定。该核心包括 协调中心（由UCSF的Peggy Cawthon领导）和MOST临床中心：爱荷华州大学（UI 临床中心负责人：James Torner）和伯明翰亚拉巴马大学（UAB临床中心负责人：Cora E. 刘易斯）。具体而言，CDCMC的目标是：1）招募2143名现有MOST参与者，150名新参与者 从代表性不足的种族和少数民族群体中招募参与者，参加MOST 4 V1考试 (2293 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和完整性 确定研究结果，4）确保参与者的安全并符合监管标准，5） 收集、清理、记录和整合所有项目和核心的MOST数据。