CORE--HUMAN ASSESSMENT AND BIOSTATISTICS

核心——人体评估和生物统计学

• 批准号: 6109971
• 负责人: GREG MAISLIN
• 金额: $ 15.38万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-01 至 1999-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6109971
• 关键词: biomedical facility; human subject; patient /disease registry; sleep apnea; sleep disorders; statistics /biometry

The Human Assessment and Biostatistical Core (HABC) will provide support to all projects in the Program Specifically, this support will include: 1) the screening and recruitment of human subjects for the clinic projects, 2) biostatistical consulting to all of the projects, 3,) statistical programming consulting to all of the projects, and 4) data analysis resources as needed. The Clinical Research Support Data Base (CRSDB) will continue to serve as a subject registry and research tool. Data are collected from all subjects registered for an initial visit to the multidisciplinary Penn Center for Sleep Disorders as well as from collaborating sleep centers. Data collected include patient demographics, subjective symptom reports, physician physical assessments, polysomnography results, final diagnosis, and treatment modalities. The CRSDB is available to all Program investigators interested in obtaining information on the relationships among collected variables, prevalence of specific characteristics, etc. It is maintained on the VAX 4000 of the Clinical Research Center using the SAS statistical and data management software. The data can be accessed by way of modem by any Program investigator or the statistical programmer can respond to specific information requests. Currently, information on approximately 700 patients has been collected from 3 sleep centers (Penn, Hopkins, and West Penn in Pittsburgh). Research into the relationships among the variables included in the CRSDB was initiated by the director/biostatistician. This research will be extended. The Core will be staffed by a director/biostatistician, a nurse researcher, a statistical programmer, and data entry/collection personnel. The Core will work in close collaboration with physicians involved in patient care in the area of subject recruitment and in close collaboration with clinical physicians and other Program investigators in the area of its own research initiatives utilizing the CRSDB.

人类评估和生物统计核心将提供支持 具体而言，这种支持将包括：1） 为临床项目筛选和招募人类受试者， 2)所有项目的生物统计咨询，3）统计 对所有项目进行编程咨询，以及4）数据分析 所需的资源。临床研究支持数据库（CRSDB）将 继续作为主题登记和研究工具。数据 从登记参加首次访视的所有受试者中收集 多学科宾州睡眠障碍中心以及来自 睡眠中心合作收集的数据包括患者人口统计学资料， 主观症状报告，医生身体评估， 多导睡眠图结果、最终诊断和治疗方式。的 CRSDB可供所有有兴趣获得 关于所收集变量之间关系的信息， 具体特性等。它是在VAX 4000上维护的， 临床研究中心使用SAS进行统计和数据管理 软件任何程序都可以通过调制解调器访问数据 调查员或统计程序员可以对特定的 信息请求。 目前，约有700名 从3个睡眠中心（宾夕法尼亚、霍普金斯和西 Pittsburgh）。研究变量之间的关系 包括在CRSDB中，由负责人/生物统计学家发起。这 研究将扩大。 核心将配备一名主管/生物统计学家、一名护士 研究员、统计程序员和数据输入/收集人员。 核心将与参与的医生密切合作， 受试者招募领域的患者护理，并与 与临床医生和其他计划研究人员在该地区的 利用CRSDB进行自己的研究计划。