Core C--Biostatistics and Data Management

生物统计和数据管理核心(核心C)将为所有儿科心脏移植研究项目提供统计分析和数据管理。核心研究人员谢丽尔·凯尔西博士和玛丽亚·莫里·布鲁克斯博士已经并将继续与临床和实验室研究人员会面，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”，初步分析将侧重于排斥发作的累积数量，比较接受胸腺接种的人和没有接受胸腺接种的人，以及 将使用计数过程方法。对于项目2“移植EBV疾病”，将分析实验室措施和临床事件，比较高和低EBV病毒载量的患者，并将提供来自实验方案的结果数据。对于项目3，“基因对移植和患者结局的贡献”，将建立统计模型来描述排斥反应的结局与药物遗传、炎症和人类白细胞抗原配型的解释因素之间的关系。将寻求急性和慢性排斥反应的重要独立预测因子。除了遗传和其他因素外，还将评估种族对排斥的影响。对于项目4“白细胞基因表达”，核心将确定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 位于伯明翰的阿拉巴马大学。儿科心脏移植研究中6个地点的患者记录也将以SAS文件的形式转发到匹兹堡，用于项目3。核心C将以本地Access文件的形式接收实验室数据。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将是主要使用的统计软件。核心调查员将与项目调查员合作编写研究结果报告。

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.