EVENT RECORDINGS OF HIGH RISK INFANTS ON APNEA MONITORS

这是波士顿大学医学中心(BUMC)为 开展数据协调和分析中心(DCAC) 高危婴儿事件记录的多中心协作研究 在呼吸暂停监护仪上。该提案的目标是：为DCAC配备工作人员 拥有高素质的新生儿科专业技术人员， 流行病学、生物统计学和数据管理；提供 将这些技能编织在一起的组织框架 领导力；并创建一个DCAC，对 研究的其他组成部分的需要，这构成了一个真正的 团队协作。该提案澄清了几个 研究设计中的困难和关键问题， 特别是在DCAC可以进行重大合作的情况下 贡献。该提案记录了对以下角色的理解 DCAC通过列出DCAC要承担的具体任务清单 在研究的三个指定阶段中的每一个阶段，以及 详细说明拟议的DCAC在数据管理方面的活动。这些 DCAC的主要活动包括：合作研究设计， 协议、操作手册和数据表格的制定；设计和 实施数据库管理系统和质量保证及质量 控制系统；培训现场人员进行数据收集；协作 在改进和修改研究程序的过程中，研究不断发展；提供 在规划和剥离方面的统计和数据管理专业知识 卫星研究；回应来自不同组成部分的数据请求 研究；计划和进行数据分析；合作撰写报告 并展示研究结果。该建议书记录了 拟议研究小组在以下方面的资格：其深度 和广泛的临床研究经验；他们在 设计、实施和分析随机临床试验和 观察性流行病学研究；他们最近的合作努力 在临床研究方面，特别是在孕产妇和儿童方面 健康；他们作为有效的团队成员在协作、 多学科研究；以及丰富的学术资源 在研究过程中，如果需要，团队可以要求部署。

This is a proposal from Boston University Medical Center (BUMC) for the conduct of the Data Coordinating and Analysis Center (DCAC) of the multicenter collaborative study of Event Recordings of High Risk Infants on Apnea Monitors. The goals of the proposal are: to staff the DCAC with highly qualified professionals with skills in neonatology, epidemiology, biostatistics and data management; to provide an organizational framework that weaves together these skills under strong leadership; and to create a DCAC that in responsive and sensitive to the needs of the other components of the study and that constitutes a truly collaborative team effort. The proposal elucidates several of the difficulties and key issues entailed in the design of the study, particularly those in which the DCAC can make a major collaborative contribution. The proposal documents an understanding of the role of the DCAC by outlining lists of specific tasks for the DCAC to undertake in each of the three designated phases of the study, and with an elaboration of the proposed DCAC's activities in data management. These major activities of the DCAC include: collaborate in study design, development of protocol, Manual of operations and data forms; design and implement database management system and quality assurance and quality control systems; train field personnel in data collection; collaborate in refining and modifying study procedures an the study evolves; provide statistical and data management expertise in planning spinoff and satellite studies; respond to data requests from various components of the study; plan and conduct data analyses; collaborate in report writing and presention of study results. The proposal documents the qualifications of the proposed research team in regard to: their depth and breadth of clinical research experience; their achievements in the design, conduct and analysis of randomized clinical trials and observational epidemiologic studies; their recent collaborative efforts in clinical research, particularly in regard to maternal and child health; their track records as effective team players in collaborative, multidisciplinary research; and the rich academic resources that the team can call upon to deploy if needed during the course of the study.