Core--Biostatistics and Data Management

生物统计学和数据管理核心（Core C）将通过统计分析和数据管理支持所有儿科心脏移植研究项目。核心研究小组的研究人员，博士。Sheryl Kelsey和Maria Mori Brooks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。Core 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”，主要分析将集中于比较那些接种了胸腺疫苗和没有接种胸腺疫苗的人的排斥事件的累积次数

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.