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

儿童慢性肾脏病（CKiD）研究是一项在6岁以下儿童中开展的多中心队列研究。 月至16岁，轻度至中度肾功能受损。两个临床协调中心 （CCCs）（在费城儿童医院和儿童慈善医院）和数据 协调中心（在约翰霍普金斯布隆伯格公共卫生学院）已经形成了一个合作 同意在儿童中进行慢性肾脏疾病的前瞻性研究。从2003年到2018年，我们 与罗切斯特大学的中心生物化学实验室（CBL）建立了联系 如果它们被选中参加2018-2023年周期，则将保留这些设施，但基础设施已经到位 与任何被选中的机构合作。自2003年成立以来，CKiD的科学目标 已经确定了肾功能下降的风险因素，并确定如何进行 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;以及生长障碍及其相关的发病率。本申请的目的 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 科学目标在合作的核心共同承诺的申请中有所描述。本申请描述 儿童肾脏疾病数据管理和分析中心（KIDMAC）将 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、协调和进行、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的方法 治疗和引入非侵入性设备远程收集数据; 2）提供指导 委员会、两个核心合作中心、能力建设实验室和科学小组委员会， 协调和开展CKiD研究活动; 3）维护和加强KIDMAC开发的 管理CKiD数据的网络系统; 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举措，包括领导 开发适当分析CKiD数据的方法（例如，CKD后的使用时间 作为分析时间尺度的诊断、关节存活和纵向数据分析，以及用于 因果推论）;以及5）实施质量保证计划，将专业知识整合到数据中 管理、研究协调、统计方法和科学学科。KIDMAC 研究人员在研究设计、协调、数据管理、质量保证和 复杂的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.