DATA COORDINATING CENTER FOR SLEEP HEART STUDY

本申请提供了一个计划，用于在约翰霍普金斯大学卫生与公共卫生学院的临床试验中心和流行病学与生物统计学系内移动并维护睡眠心脏健康研究（SHHS）的数据协调中心（DCC）。 SHHS始于1994年，是一项多中心前瞻性队列研究，研究睡眠呼吸障碍（SDB）的心血管后果。 在最初的五年里，SHHS的研究人员已经完成了6,440人的夜间睡眠研究（多导睡眠图），这些人是通过美国各地的多个临床中心招募的。 在此DCC申请所涵盖的五年期间（对应于SHHS资助的第6-10年），SHHS将继续随访参与者，收集第二份PSG并将随访延长五年。 除了监测额外的数据收集和数据管理外，DCC还将负责继续对已收集的数据进行横断面分析，并利用已从母队列收集的数据和在SHHS受试者随访期间收集的数据进行纵向分析。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DCC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。 具体任务包括：1）将数据和操作从当前DCC顺利转移到新的DCC; 2）通过监测数据收集过程和数据质量，继续支持SHHS临床中心的数据收集;第三章维护和扩展SHHS数据管理系统，以确保高质量数据的有效存档和分析数据库的开发供DCC和临床中心使用; 4）与指导委员会一起制定分析计划，用于纵向分析，包括使用来自母研究的预先存在的数据; 5）与睡眠阅读中心一起制定和实施数据收集和分析协调计划; 6）为SHHS调查人员提供后勤支持，包括协调会议和电话会议，跟踪出版物和其他SHHS活动; 7）与指导委员会合作，建立分布式分析的安排，并在适当时由DCC复制，并根据需要向编写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.