Data Analysis and Coordination Center for the MACS-WIHS Combined Cohort Study

MACS-WIHS 联合队列研究数据分析和协调中心

• 批准号: 10376145
• 负责人: Gypsyamber D'Souza
• 金额: $ 453.41万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-09 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10376145
• 关键词: AIDS/HIV problem; Adherence; Adult; American; Archives; Basic Science; Biological; Biostatistics Core; Child; Child Health; Chronic Disease; Clinical; Clinical Sciences; Cohort Studies; Collaborations; Communication; Data; Data Analyses; Data Collection; Data Set; Database Management Systems; Databases; Discipline; Epidemiology; Event; Faculty; Funding; HIV; HIV Infections; Institutes; Joints; Kidney Diseases; Knowledge; Lung; Lung diseases; Methodology; Methods; Modeling; Monitor; National Heart, Lung, and Blood Institute; National Institute of Allergy and Infectious Disease; National Institute of Child Health and Human Development; National Institute of Diabetes and Digestive and Kidney Diseases; National Institute of Drug Abuse; National Institute of Mental Health; Online Systems; Outcome; Participant; Pathogenesis; Periodicity; Prospective cohort study; Protocols documentation; Public Health Schools; Publications; Recording of previous events; Research; Research Design; Research Personnel; Research Project Grants; Resources; Science; Site; Specimen; Standardization; System; The Multicenter AIDS Cohort Study; Training; United States National Institutes of Health; Visit; Woman; Women' s Interagency HIV Study; adjudication; clinical research site; cohort; comorbidity; data centers; data integration; data management; data standards; experience; men; operation; programs; quality assurance; recruit; repository; working group

ABSTRACT The Multicenter AIDS Cohort Study (MACS) and the Women's Interagency HIV Study (WIHS) Combined Cohort Study (CCS) is a large, comprehensive, prospective cohort study designed to investigate a spectrum of questions relating to the basic science, clinical science, and epidemiology of HIV infection in the US, with a focus on comorbidities among men and women living with HIV. The purpose of this application is to support the Data Analysis and Coordination Center (DACC) for the CCS. The specific aims of the DACC are: 1) To optimize the contributions of the MACS and the WIHS to the understanding of the pathogenesis and treated history of HIV infection in U.S. adults by providing epidemiological and statistical expertise, and initiating and sustaining successful scientific partnerships, to support the unified science agenda; 2) To coordinate the recruitment of 2,500 new MACS/WIHS-CCS participants, including coordination of the administration of standardized baseline visits across all clinical research sites and integration of data from new recruits with the existing combined database; 3) To coordinate research initiatives and scientific presentations; to facilitate communication amongst CCS and external investigators, Working Groups and committees; to orchestrate study protocol and form revision; to coordinate outcome ascertainment and adjudication of clinical events; and to disseminate key scientific findings; 4) To develop and maintain a web-based data management system to harmonize and integrate data from the MACS and WIHS, as well as manage new data collected per the CCS protocol. We will continue our systems for: tracking the storage and transfer of biological specimens at national repositories, producing annual public data sets, and conducting training in methods that facilitate the appropriate use of study data for local research; and 5) To continue our quality assurance program in partnership with the clinical research sites that integrates expertise in data management, study coordination, statistical methodology, and scientific disciplines.

摘要 多中心艾滋病队列研究（MACS）和妇女机构间艾滋病研究（WIHS）联合 队列研究（CCS）是一项大型、综合性、前瞻性队列研究，旨在调查一系列 与美国艾滋病感染的基础科学、临床科学和流行病学有关的问题， 重点关注男性和女性艾滋病毒感染者的合并症。此应用程序的目的是支持 数据分析和协调中心（DACC）。 DACC的具体目标是：1）优化MACS和WIHS对 通过提供信息，了解美国成年人艾滋病毒感染的发病机制和治疗史 流行病学和统计学专门知识，并发起和维持成功的科学伙伴关系， 支持统一的科学议程; 2）协调招募2，500名新的MACS/WIHS-CCS 参与者，包括协调所有临床研究中的标准化基线访视的管理 研究地点以及新招募人员的数据与现有组合数据库的整合; 3）协调 研究计划和科学报告;促进CCS与外部 研究者、工作组和委员会;协调研究方案和表格修订;协调 临床事件的结果确定和裁定;以及传播关键的科学发现; 4） 开发和维护一个基于网络的数据管理系统，以协调和整合来自MACS的数据 和WIHS，以及管理根据CCS协议收集的新数据。我们将继续我们的系统： 跟踪国家储存库生物标本的储存和转移情况，编制年度公共数据 以及就促进适当使用研究数据进行本地研究的方法进行培训;以及 5)继续我们的质量保证计划，与临床研究中心合作， 数据管理、研究协调、统计方法和科学学科方面的专业知识。