Pelvic Floor Disorders Network Data Coordinating Center

项目摘要 RTI International建议继续担任NICHD骨盆数据协调中心(DCC) 地板疾病网络(PFDN)支持其改善盆底妇女护理的使命 通过进行精心设计的多中心观察性研究和临床试验来告知 诊断、预防和治疗。RTI在担任民阵DCC的10年经验基础上，将提供 在研究设计和数据分析方面具有统计领导作用的网络，并通过数据提供操作支持 管理和后勤服务。具体来说，DCC将(1)领导创新的研究设计和分析 应对PFD研究的具体挑战，包括床位到床边的翻译研究，通过提供 生物统计学、统计遗传学、心理计量学、卫生经济学、机器学习等方面的专业知识 并与临床研究人员合作，开发设计严谨的研究结果 对患有人格障碍的妇女很重要的措施；(2)提供沟通和协作工具，以促进 快速开发协议和基于网络的电子数据捕获系统(包括直接捕获 患者通过移动应用程序报告的结果)、生物量监测、组学数据管道和培训； (3)在每项研究的整个生命周期内进行数据管理、质量保证和监控程序； 利用集中和远程监控功能高效利用网络资源；(4)报告 关于数据质量、协议遵从性和安全性，并执行统计分析以提交给国家和 国际会议，并在顶级期刊上发表文章；以及(5)协调远程和面对面 会议、管理分包合同、向站点提供自动资费支付以及管理生物质学 运输和储存，研究药品采购，并根据需要分发设备和用品，以支持 网络研究。玛丽·甘茨博士担任DCC首席研究员(PI)，索尼娅·托马斯博士担任候补PI Will 为下一个PFDN周期提供经过验证的DCC领导地位的连续性。他们得到了一支拥有 丰富的PFD研究经验，可以灵活地调整人员配置并引入额外的专业知识，如 支持人阵不断变化的需求所需的资源。

Project Summary RTI International proposes to continue to serve as the data coordinating center (DCC) for the NICHD Pelvic Floor Disorders Network (PFDN) in support of its mission to improve the care of women with pelvic floor disorders (PFDs) by conducting well-designed multicenter observational studies and clinical trials to inform diagnosis, prevention, and treatment. Building on 10 years of experience as PFDN DCC, RTI will provide the Network with statistical leadership in study design and data analysis and operational support through data management and logistical services. Specifically, the DCC will (1) lead innovative study designs and analyses to address challenges specific to PFD research, including bench-to-bedside translational studies, by providing expertise in biostatistics, statistical genetics, psychometrics, health economics, machine learning, and other fields and collaborating with clinical investigators to develop rigorously designed studies with outcome measures important to women with PFDs; (2) provide tools for communication and collaboration to facilitate rapid development of protocols and web-based systems for electronic data capture (including direct capture of patient-reported outcomes via mobile applications), biospecimen tracking, omics data pipelines, and training; (3) conduct data management, quality assurance, and monitoring procedures throughout the life of each study, capitalizing on centralized and remote monitoring capabilities for efficient use of network resources; (4) report on data quality, protocol adherence, and safety, and perform statistical analysis for presentation at national and international conferences, and publication in top-tiered journals; and (5) coordinate remote and in-person meetings, manage subcontracts, provide automatic capitation payments to sites, and manage biospecimen transport and storage, study drug acquisition, and equipment and supplies distribution as needed to support network studies. Dr. Marie Gantz as DCC Principal Investigator (PI) and Dr. Sonia Thomas as Alternate PI will provide continuity of proven DCC leadership into the next PFDN cycle. They are supported by a team with extensive PFD research experience, with flexibility to adjust staffing and bring in additional expertise as needed to support the evolving needs of the PFDN.