Core C--Biostatistics and Data Management

核心C--生物统计学和数据管理

• 批准号: 7062835
• 负责人: Sheryl F Kelsey
• 金额: $ 27.71万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-02-01 至 2009-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7062835
• 关键词: biomedical facility; clinical research; data management; heart transplantation; human data; medical records; pediatrics; statistics /biometry

The Biostatistics and Data Management Core (Core C) will support all of the pediatric heart transplantation research projects with statistical analysis and data management. The Core investigators, Drs. Sheryl Kelsey and Maria Mori Brooks, have met and will continue to meet with clinical and laboratory investigators and collaborate in the design of projects, including sample size calculation, definition of measurements and quality control. Core C will interact with all 4 projects and the other cores. Statistical Analysis Strategies include: For Project 1 "Thymic tolerance," primary analysis will focus on the accumulation of number of rejection episodes comparing those who did versus those who did not receive thymus inoculation, and counting process methodology will be used. For Project 2 "Transplant EBV disease," laboratory measures and clinical events will be analyzed comparing patients with high and low EBV viral loads, and outcome data from an experimental protocol will be presented. For Project 3, "Genetic contributions to graft and patient outcomes," statistical models will be created to describe the relationship between outcomes of rejection and explanatory factors of pharmacogenetic, inflammatory and HLA matching. Significant independent predictors of acute and chronic rejection will be sought. The effect of race on rejection over and above genetic and other factors will be evaluated. For Project 4 "Leukocyte gene expression," the Core will determine the level of agreement between gene expression algorithms for predicting allograft rejection and response to therapy versus the observed clinical outcomes. The Biostatistics and Data Management Core will manage and process clinical data received from local projects in Pittsburgh and receive SAS files of clinical data collected in Pittsburgh but initially processed at the University of Alabama in Birmingham. Patient records from 6 sites in the Pediatric Heart Transplant Study will also be forwarded in SAS files to Pittsburgh for Project 3. Core C will receive laboratory data in ACCESS files locally. Standard procedures developed at the Epidemiology Data Center will be used for editing, managing and integrating various data sets as well as for data quality control. SAS will be the primary statistical software used. The Core investigators will collaborate with project investigators to prepare reports of study results.

生物统计学和数据管理核心（核心C）将支持所有儿科心脏移植研究项目的统计分析和数据管理。核心研究者Sheryl凯尔西博士和Maria Mori布鲁克斯博士已经并将继续与临床和实验室研究者会面，并在项目设计方面进行合作，包括样本量计算、测量定义和质量控制。核心C将与所有4个项目和其他核心进行交互。统计分析策略包括：对于项目1“胸腺耐受性”，主要分析将侧重于比较接受胸腺接种的患者与未接受胸腺接种的患者的排斥事件数量的累积，以及 将采用点算程序方法。对于项目2“移植EBV病”，将分析实验室指标和临床事件，比较高和低EBV病毒载量的患者，并提供实验方案的结局数据。对于项目3，“基因对移植物和患者结局的贡献”，将创建统计模型来描述排斥结局与药物遗传学、炎症和HLA配型的解释因素之间的关系。将寻找急性和慢性排斥反应的重要独立预测因子。将评估种族对排斥反应的影响，而不是遗传和其他因素。对于项目4“白细胞基因表达”，核心将确定用于预测同种异体移植排斥反应的基因表达算法与 对治疗的反应与观察到的临床结果。生物统计和数据管理核心将管理和处理从匹兹堡当地项目收到的临床数据，并接收在匹兹堡收集但最初在 伯明翰的亚拉巴马大学。儿科心脏移植研究中6个研究中心的患者记录也将以SAS文件形式转发至匹兹堡，用于项目3。核心C将在本地接收ACCESS文件中的实验室数据。流行病学数据中心制定的标准程序将用于编辑、管理和整合各种数据集以及数据质量控制。SAS将是使用的主要统计软件。核心研究者将与项目研究者合作编写研究结果报告。