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

描述（由申请方提供）：CKiD研究是一项在1至16岁轻度至中度肾功能受损儿童中开展的多中心队列研究。两个临床协调中心（CCC）（费城儿童医院和堪萨斯城儿童慈善医院）、一个中心生物化学实验室（罗切斯特大学）和一个数据协调中心（约翰霍普金斯公共卫生学院）已达成合作协议，对儿童慢性肾脏疾病进行前瞻性研究。自2003年成立以来，CKiD的科学目标一直是确定肾功能下降的风险因素，并确定肾功能进行性下降如何影响心血管疾病风险因素的生物标志物;神经认知功能和行为;以及生长衰竭及其相关发病率。本申请的目的是申请资金， 从2013年8月至2018年7月继续进行队列研究。合作的核心共同承诺的申请中说明了实质性的科学目标。本申请描述了儿童肾脏疾病数据管理和分析中心（KIDMAC）将作为本研究的数据协调中心发挥的作用。我们将继续在研究设计、协调和实施、数据管理和分析方法方面发挥领导作用，从而提高CKiD的科学范围。KIDMAC的具体目标是：1）继续提供生物统计学和流行病学研究设计专业知识，包括适当嵌套病例队列子研究的方法; 2）继续为指导委员会、两个临床协调中心、中央生物化学实验室和科学小组委员会提供基础设施，以协调和开展CKiD研究活动，3）继续维持和改善由香港国际发展货币基金会发展的网上系统，以管理香港国际货币基金会的数据; 4）继续在分析中提供生物统计和流行病学领导，解释和介绍研究范围内的举措，包括开发适当分析CKiD数据的方法（例如，使用自CKD诊断以来的时间作为分析、非线性轨迹、联合生存和纵向数据分析的时间尺度，以及因果推断方法）;以及5）继续实施质量保证计划，该计划整合了数据管理、研究协调、统计方法和科学学科方面的专业知识。KIDMAC调查人员在研究设计、协调、数据管理、质量保证以及复杂纵向和生存数据的流行病学和生物统计方法方面具有专门知识。

DESCRIPTION (provided by applicant): The CKiD Study is a multi-center, cohort study of children aged 1 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 in Kansas City), a central biochemistry laboratory (at the University of Rochester), and a data coordinating center (at Johns Hopkins School of Public Health) have formed a cooperative agreement to conduct a prospective study of chronic kidney disease in children. 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 2013 to July 2018. 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 continue providing biostatistical and epidemiological study design expertise including methods to appropriately nest case-cohort sub- studies; 2) to continue providing the Steering Committee, the two clinical coordinating centers, the central biochemistry laboratory and the scientific subcommittees with an infrastructure to coordinate and conduct CKiD research activities, data acquisition and protocol and form development and revisions; 3) to continue maintaining and enhancing the KIDMAC-developed web-based system to manage the data of CKiD; 4) to continue providing 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, non-linear trajectories, joint survival and longitudinal data analysis, and methods fr causal inferences); and 5) to continue implementing 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.