CORE--HUMAN ASSESSMENT AND BIOSTATISTICS

核心——人体评估和生物统计学

• 批准号: 6349179
• 负责人: GREG MAISLIN
• 金额: $ 21.99万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-01 至 2001-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6349179
• 关键词: biomedical facility; computer data analysis; data management; patient /disease registry; psychometrics; statistics /biometry

The Human Assessment and Biostatistical Core (HABC Core) will play an integral role as part of the proposed Special Center of Research in Neurobiology of Sleep and Sleep Apnea. The Core's specific aims (functions) are: 1) to provide innovative biostatistical solutions to data analysis challenges arising from clinical and basic science SCOR projects; 2) to provide centralized statistical programming and data management resource to the human projects (Projects 01 and 05) and the animal clinical trial component of Project 03 and to implement non-routine statistical methodology for Project 04 (adenosine); 3) to research, develop, and assess the utility of new and existing: a) human assessment instruments, b) measurement modalities, and c) follow-up strategies; and 4) to maintain and expand the Clinical Research Support Data Base (CRSD) to facilitate subject recruitment and to provide a means for methodological and technology transfer. The Clinical Research Support Data Base (CRSD) is a multi-center patient registry used in a number of distinct but inter-related ways. Its four primary functions are: 1) to help in the process of screening patients for inclusion and exclusion criteria for Projects 01 and 05; 2) to support the human projects by providing access to demographic information, symptom reports, physical assessments, and results from overnight polysomnography for all study participants; 3) to support the human projects by providing access to a large population for psychometric evaluation of existing and new measurement instruments, and to facilitate ancillary analyses; 4) to foster technology transfer of research results into clinical practice. Core C puts together an experienced data analysis team including a biostatistician with extensive experience collaborating with Project Leaders, a senior statistical programmer, data manager, and data clerk all using state-of-the-art statistical software (SAS/TM). The Core will serve as the primary mechanism of the implementation of statistical analyses of data arising from Project 01 and Project 05, from the clinical trial component of Project 03, and will implement the harmonic regression analyses for Project 04 as well as provide biostatistical to all Projects.

人类评估和生物统计核心（HABC核心）将发挥重要作用， 作为拟议的特别研究中心的一部分， 睡眠和睡眠呼吸暂停的神经生物学。核心的具体目标 （职能）是：1）提供创新的生物统计解决方案，以数据 临床和基础科学SCOR项目带来的分析挑战; 2)提供集中的统计规划和数据管理 人类项目（项目01和05）和动物资源 项目03的临床试验部分，并实施非常规 项目04（腺苷）的统计方法; 3）研究， 开发和评估新的和现有的：a）人类评估 工具，B）测量模式，以及c）后续战略;以及 4)维持和扩充临床研究支援数据库 促进受试者招募，并提供一种方法， 方法和技术转让。临床研究支持数据 Base（CRSD）是一项多中心患者登记研究，用于许多 不同但相互关联的方式。它的四个主要职能是：（1） 帮助筛选患者以进行入选和排除 项目01和05的标准; 2）支持人类项目， 提供访问人口统计信息，症状报告，身体检查， 评估和所有研究的夜间多导睡眠图结果 3）通过提供一个 现有和新的心理测量评估的大人口 测量仪器，并促进辅助分析; 4） 促进研究成果向临床实践的技术转移。 Core C组建了一个经验丰富的数据分析团队， 与项目合作经验丰富的生物统计学家 领导，一个高级统计程序员，数据经理，和数据办事员都 使用最先进的统计软件（SAS/TM）。核心将服务于 统计分析的主要机制， 来自临床试验的项目01和项目05的数据 项目03的组成部分，并将实施谐波回归 为项目04提供生物统计分析，并为所有项目提供生物统计。