The Kidney Disease in Children Data Management and Analysis Center (KIDMAC)

儿童慢性肾脏疾病(CKiD)研究是一项针对6岁儿童的多中心队列研究 6个月至16岁，肾功能轻度至中度受损。两个临床协调中心 (在费城儿童医院和儿童慈悲医院)和一项数据 协调中心(在约翰霍普金斯大学彭博公共卫生学院)成立了一个合作社 同意对儿童慢性肾脏疾病进行前瞻性研究。从2003年到2018年，我们 已经与罗切斯特大学的中心生物化学实验室(CBL)建立了联系 如果他们被选为2018-2023年周期的成员，将保持这一点，但基础设施已经到位 与选定的任何一家机构合作。自2003年成立以来，CKiD的科学目标 已经确定了肾功能下降的危险因素，并确定了进展情况 肾功能下降影响心血管疾病危险因素的生物标志物；神经认知 功能和行为；生长障碍及其相关的发病率。本应用程序的目的是 是申请资金，从2018年8月到2023年7月继续进行队列研究。实质性的 科学目标在合作CCCS的申请中进行了描述。此应用程序描述 肾脏疾病在儿童数据管理与分析中心(KIDMAC)中的作用 作为研究的数据协调中心。我们将继续在学习方面发挥领导作用 设计、协调和执行、数据管理和分析方法，从而加强 CKiD的科学范围。KIDMAC的具体目标是：1)提供生物统计学和 流行病学研究设计专业知识，包括延长肾脏置换术后随访时间的方法 治疗和引入非侵入性设备以远程收集数据；2)提供转向 委员会、两个CCCS、CBL和具有基础设施的科学小组委员会 协调和开展CKiD研究活动；3)维护和加强KIDMAC开发的 基于Web的疾病数据管理系统；4)提供生物统计和流行病学 在分析、解释和介绍研究范围内的倡议方面发挥领导作用，包括 制定适当分析CKiD数据的方法(例如，CKD以来的时间使用情况 作为分析、关节存活率和纵向数据分析的时间尺度的诊断和方法 因果推论)；以及5)实施整合数据专业知识的质量保证计划 管理、研究协调、统计方法和科学学科。KIDMAC 调查人员在研究设计、协调、数据管理、质量保证和 用于复杂纵向和生存数据的流行病学和生物统计学方法。

The Chronic Kidney Disease in Children (CKiD) Study is a multi-center, cohort study of children aged 6 months to 16 years with mild to moderate impaired kidney function. Two clinical coordinating centers (CCCs) (at Children's Hospital of Philadelphia and at Children's Mercy Hospital) and a data coordinating center (at Johns Hopkins Bloomberg School of Public Health) have formed a cooperative agreement to conduct a prospective study of chronic kidney disease in children. From 2003 to 2018, we have established links with the central biochemistry laboratory (CBL) at the University of Rochester which will be maintained were they to be selected for the 2018-2023 cycle, but infastructure is in place to work with whichever institution is selected. Since its inception in 2003, the scientific aims of CKiD have been to determine the risk factors for decline in kidney function and to define how progressive decline in kidney function impacts biomarkers of risk factors for cardiovascular disease; neurocognitive function and behavior; and growth failure and its associated morbidity. The purpose of this application is to request funds to continue the cohort study from August 2018 to July 2023. The substantive scientific aims are described in the application from the collaborating CCCs. This application describes the role that the Kidney Disease in Children Data Management and Analysis Center (KIDMAC) will perform as the data coordinating center of the study. We will continue to provide leadership in study design, coordination and conduct, data management and analytical methodology and thereby enhance the scientific scope of CKiD. The specific aims of KIDMAC are: 1) to provide biostatistical and epidemiological study design expertise including methods to extend follow-up after renal replacement therapy and to introduce noninvasive devices to gather data remotely; 2) to provide the Steering Committee, the two CCCs, the CBL and the scientific subcommittees with an infrastructure to coordinate and conduct CKiD research activities; 3) to maintain and enhance the KIDMAC-developed web-based system to manage the data of CKiD; 4) to provide biostatistical and epidemiological leadership in the analysis, interpretation and presentation of study-wide initiatives including the development of methods for the appropriate analyses of the CKiD data (e.g., usage of time since CKD diagnosis as time scale for analysis, joint survival and longitudinal data analysis, and methods for causal inferences); and 5) to implement a quality assurance program that integrates expertise in data management, study coordination, statistical methodology and scientific disciplines. KIDMAC investigators have expertise in research design, coordination, data management, quality assurance and epidemiological and biostatistical methods for complex longitudinal and survival data.