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

描述（由申请人提供）： 预计到2010年，美国ESRD病例数将增加一倍以上。为了制定有效的干预措施，需要描述儿童慢性肾病的自然史。前瞻性队列研究是实现更好地了解肾脏疾病进展及其对神经认知发育，生长和心血管疾病风险因素的影响的科学目标的最佳选择。本申请旨在建立儿童肾脏疾病前瞻性研究的数据协调中心。我们将在数据管理、研究协调和分析方法方面发挥领导作用，从而提高拟议研究的科学范围。具体目标是：1）为整个队列研究的设计提供生物统计学和流行病学专业知识，以实现其科学目标; 2）提供协调和开展研究的基础设施，包括：在NIDDK的主持下建立中心实验室和与中心储存库的链接;制定和修订研究方案;跟踪正在进行的研究范围内的研究;促进各委员会和工作组之间的沟通; 3）利用网上数据管理系统管理研究中收集的数据，以便输入、编辑、合并、储存和备份数据; 4）在分析中提供生物统计和流行病学领导，研究报告的解释和介绍-广泛的举措，并制定适用于本研究的科学研究举措的新的统计和流行病学方法; 5）实施质量保证计划，整合数据管理，研究协调，统计方法和科学学科的专业知识。我们建议的中心将是KIDMAC（儿童肾脏疾病数据管理和分析中心）。我们建议我们指导数据管理、分析和质量控制小组委员会，并根据研究建立的组织机制积极参与指导委员会和其他委员会。KIDMAC将密切互动，并向外部咨询委员会提供报告。KIDMAC将采购进行数据管理和分析所需的硬件并开发软件。KIDMAC将与指导委员会协调，执行各种程序（例如，公共数据磁带）与外部调查人员共享数据。

DESCRIPTION (provided by applicant): 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.