WIHS Data Management and Analysis Center(WDMAC)

产品说明：妇女机构间艾滋病毒研究（WIHS）是一项大型综合性队列研究，旨在调查在高度活跃的抗逆转录病毒治疗时代妇女艾滋病毒感染的发病机制和自然史相关问题。本申请的目的是扩大对WIHS数据管理和分析中心（WDMAC）的支持，该中心将继续领导为WIHS研究议程贡献“流行病学和统计学专业知识，提供稳定有效的数据管理系统，并提供研究方案和WIHS研究者倡议的协调，以提高WIHS中数据和科学研究的质量和有效性。“WDMAC的具体目标是（1）在WIHS研究数据的设计，分析和呈现方面提供领导，并开发适用于WIHS科学研究计划的新型统计和流行病学方法。这一目标的一个核心组成部分将是区分与正常衰老过程相关的因素与艾滋病毒感染和抗病毒治疗的使用;（2）建立、实施和维护一个数据管理系统，包括数据输入、传输、记录、编辑、存储和总结。这一目标的组成部分将是建立一个跟踪国家储存库生物标本储存和转移的系统，并制作年度公共数据磁带;（3）建立和实施协调研究计划和科学报告的方法，促进WIHS研究者，工作组和委员会之间的沟通，协调研究方案和表格的修订，并制作研究范围内的队列特征概况（WIHS档案）、研究数据库和正在进行的研究计划（WDMAC报告）以及科学出版物（WIHS档案）;（4）实施质量保证计划，整合数据管理、研究协调、统计方法学和科学学科方面的专业知识。该计划将促进标准化数据收集和管理计划的遵守和培训。一项关键的科学举措将建立在我们现有的经验，以开发适当评价观察性研究中治疗效果的方法。

DESCRIPTION: The Women's Interagency HIV Study (WIHS) is a large, comprehensive cohort study designed to investigate a spectrum of questions relating to the pathogenesis and natural history of HIV infection among women in the era of highly active antiretroviral therapy. The purpose of this application is to extend support of the WIHS Data Management and Analysis Center (WDMAC) which will continue to provide leadership in contributing "epidemiological and statistical expertise to the WIHS research agenda, provide a stable and efficient data management system, and provide coordination of study protocols and WIHS investigator initiatives to enhance the quality and validity of the data and the scientific research in the WIHS." The specific aims of WDMAC are (1) To provide leadership in the design, analysis, and presentation of WIHS study data and to develop novel statistical and epidemiologic methodology applicable to the scientific research initiatives of the WIHS. A core component of this aim will be to distinguish factors associated with the normal aging process from HIV infection and the use of anti-viral therapies; (2) To establish, implement, and maintain a data management system encompassing data entry, transmission, documentation, editing, storage, and summarization. Components of this aim will be to establish a system for tracking the storage and transfer of biological specimens at the national repository, and produce annual public data tapes; (3) To establish and implement methods to coordinate research initiatives and scientific presentations, to facilitate communication among WIHS investigators, Working Groups, and Committees, to orchestrate revisions of study protocols and forms, and to produce study-wide profiles of cohort characteristics (WIHS Dossier), the study database and ongoing research initiatives (WDMAC Report), and scientific publications (WIHS Archives); (4) To implement a quality assurance program that integrates expertise in data management, study coordination, statistical methodology, and scientific disciplines. This program will promote adherence and training for standardized data collection and management programs. A key scientific initiative will build upon our existing experience to develop methods for the appropriate evaluation of the effects of therapies in observational studies.