The number of cases of ESRD in the US is expected to more than double by the year 2010. In order to develop effective interventions, a description of the natural history of Chronic Kidney Disease in children is needed. A prospective cohort study is optimal to achieve the scientific goals to better understand the progression of kidney disease and its consequences on neurocognitive development, growth and risk factors for cardiovascular disease. The purpose of this application is to establish the Data Coordinating Center for the prospective study of Kidney Disease in Children. We will provide leadership in data management, study coordination, and analytical methodology and thereby enhance the scientific scope of the proposed study.
The specific aims are to: 1) provide biostatistical and epidemiologic expertise for the design of the overall cohort study to achieve its scientific goals;2) provide an infrastructure to coordinate and conduct the study including: establishment of central laboratories and links to a central repository under the auspices of the NIDDK;the development and revision of study protocols;tracking of ongoing study-wide research;facilitation of communication among committees and working groups 3) manage the data collected in the study using a web-based data management system for entering, editing, merging, storing and backing up data;4) provide biostatistical and epidemiological leadership in the analysis, interpretation and presentation of study-wide initiatives and develop novel statistical and epidemiological methodology applicable to the scientific research initiatives of the study;5) implement a quality assurance program that integrates expertise in data management, study coordination, statistical methodology and scientific disciplines. Our proposed center will be the KIDMAC (Kidney Disease in children Data Management and Analysis Center). We propose that we direct the Data Management, Analysis and Quality Control subcommittee as well as actively participate in the Steering and other committees according to the organizational mechanisms established by the study. KIDMAC will closely interact and provide reports to the External Advisory Committee. KIDMAC will procure hardware and develop software needed to carry out the management and analysis of the data. In coordination with the Steering Committee, KIDMAC will implement procedures (e.g., a public data tape) to share data with external investigators.
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