DATA COORDINATING CENTER FOR SLEEP HEART STUDY

该应用程序为临床试验中心和约翰·霍普金斯大学卫生与公共卫生学院的流行病学和生物统计学系内的睡眠心脏健康研究(SHHS)提供了一个移动和然后维护数据协调中心(DCC)的计划。SHHS始于1994年，是一项关于睡眠呼吸障碍(SDB)心血管后果的多中心前瞻性队列研究。在最初的五年里，SHHS的调查人员在家中完成了6440人的夜间睡眠研究(多导睡眠图)，这些研究是通过美国各地的多个临床中心登记的。在本申请所涵盖的五年期间(相当于卫生及康乐服务资助计划的第六至第十年)，卫生及社会保障局将继续跟进参加者，收集第二份综合服务计划，并将跟进工作延长五年。除了监测额外的数据收集和数据管理外，疾病预防控制中心将负责继续对已经收集的数据进行横断面分析，并利用已经从父母队列中收集的数据和从卫生和社会保障制度参与者的后续行动中收集的数据进行纵向分析。将需要最先进的纵向分析方法来检验SHHS的主要假设。为了应对这些挑战，将组建一个多学科团队，为疾病预防控制中心配备工作人员，包括肺部和睡眠医学、流行病学、生物统计学以及数据收集和管理方面的专业知识。将执行的具体任务包括：1)顺利地将数据和业务从现有的疾病控制中心转移到新的疾病控制中心；2)通过监测数据收集过程和数据质量，继续支持卫生和社会保障制度临床中心收集数据；3)维护和扩展卫生和社会服务数据管理系统，以确保有效地存档高质量的数据，并开发供疾病控制中心和临床中心使用的分析数据库；4)与指导委员会合作，制定一项分析计划，用于纵向分析，包括使用来自母研究的先前存在的数据；5)制定和实施与睡眠阅读中心协调数据收集和分析的计划；6)向卫生与公众服务部调查人员提供后勤支持，包括协调会议和电话会议、出版物的跟踪以及卫生与公众服务部的其他活动；7)与指导委员会合作，为分布式分析作出安排，并在适当时由疾病预防控制中心复制，并根据需要向撰写报告的小组提供生物统计咨询。

This application presents a plan for moving and then maintaining the Data Coordinating Center (DCC) for the Sleep Heart Health Study (SHHS) within the Center for Clinical Trials and the Departments of Epidemiology and Biostatistics of the Johns Hopkins University School of Hygiene and Public Health. The SHHS was started in 1994 as a multicenter prospective cohort study of the cardiovascular consequences of sleep-disordered breathing (SDB). During its initial five years, the SHHS investigators have completed overnight sleep studies (polysomnography) at home for 6,440 persons, enrolled through multiple clinical centers across the United States. During the five years (corresponding to Years 6-10 of funding for the SHHS) covered by this application for a DCC, the SHHS will continue follow-up of the participants with collection of a second PSG and extension of follow-up by five additional years. In addition to the monitoring of the additional data collection and the management of the data, the DCC will have responsibility for continuing cross-sectional analysis of the already collected data and for implementing longitudinal analyses, drawing on the already collected data from the parent cohorts and from the data collected during follow-up of the SHHS participants. State-of-art methods for longitudinal analysis will be needed to test the primary hypotheses of the SHHS. To meet these challenges, a multidisciplinary team will be assembled to staff the DCC, including expertise in pulmonary and sleep medicine, epidemiology, biostatistics, and data collection and management. The specific tasks to be carried out include: 1) a smooth transfer of data and operations from the current DCC to the new DCC; 2) continued support of data collection by the SHHS clinical centers through monitoring of the data collection process and of data quality; 3) maintaining and extending the SHHS data management system in order to assure efficient archiving of high quality data and the development of analytic databases for use by the DCC and the clinical centers; 4) development of an analytic plan, in conjunction with the Steering Committee, for longitudinal analyses, including the use of pre-existing data from the parent studies; 5) development and implementation of a plan for coordination of data collection and analyses with the Sleep Reading Center; 6) provision of logistical support to the SHHS investigators, including the coordination of meetings and conference calls, the tracking of publications, and other SHHS activities and; 7) working with the Steering Committee, to establish arrangements for distributed analyses, with replication by the DCC when appropriate, and for providing biostatistical consultation to writing groups, as needed.