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 膝骨性关节炎(OA)是世界上致残率最高的疾病之一，它占世界上 伤残寿命年增加的百分比。多中心骨关节炎(MOST)研究取得了重大进展 有助于我们了解骨性关节炎的病程和确定其发生和发展的风险因素 进步。从2003年开始，最初入选人数最多的3026名患有或高危膝骨性关节炎的参与者。在……里面 最近的阶段(MOST3)，额外的1525名参与者，他们略年轻，不太可能有 晚期疾病入选。尽管MOST的前几个阶段提供了见解，但仍有 没有治疗方法可以延缓骨性关节炎的进展。下一阶段(MOST4)侧重于三个主要的科学研究 解决开放式获取知识中的关键差距的项目。这些项目包括：运动导致的受损 痛觉减退(项目1)；滑液蛋白质组学(项目2)；关节内矿化(项目3)。 这些项目将得到四个核心的支持--管理核心、成像核心、分析核心、 和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、学习提供出色的基础设施，确保大多数项目的成功 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(由加州大学旧金山分校的Peggy Cawthon领导)和最多的临床中心：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 刘易斯)。具体来说，CDCMC的目标是：1)现有最多的参与者2143人，新增150人 从代表性不足的种族和少数民族群体中招募参与者参加MOST4 V1考试 (共2293名)，并跟踪那些参与者进行MOST4 V2考试，2)确保收集到的高质量 研究数据和样本，3)保持研究参与者的高保留率和完成率 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多数数据。