Core--Biostatistics and Data Management

核心--生物统计与数据管理

• 批准号: 7344813
• 负责人: Sheryl F Kelsey
• 金额: $ 23.22万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-01 至 2009-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7344813
• 关键词: Acute; Agreement; Alabama; Algorithms; Allografting; Biometry; Biostatistics Core; Childhood; Chronic; Clinical; Clinical Data; Computer software; Count; Data; Data Analyses; Data Set; Databases; Disease; Epidemiology; Event; Gene Expression; Genetic; Heart Transplantation; Human Herpesvirus 4; Inflammatory; Laboratories; Leukocytes; Manuscripts; Measurement; Measures; Methodology; Morus; Numbers; Other Genetics; Outcome; Patients; Pharmacogenetics; Procedures; Process; Protocols documentation; Quality Control; Race; Records; Reporting; Research Design; Research Personnel; Research Project Grants; SAS; Sample Size; Site; Source; Standards of Weights and Measures; Statistical Models; Thymus Gland; Transplantation; Universities; Viral Load result; Work; data management; design; methionylmethionine; prospective; response

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.

生物统计和数据管理核心（核心 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。核心 C 将与所有 4 个项目和其他核心交互。统计分析策略包括： 对于项目 1“胸腺耐受性”，主要分析将侧重于排斥事件次数的累积，比较接受胸腺接种的人和未接受胸腺接种的人，以及 将使用计数过程方法。对于项目 2“移植 EBV 疾病”，将分析实验室测量和临床事件，比较 EBV 病毒载量高低的患者，并提供实验方案的结果数据。对于项目 3“移植物和患者结果的遗传贡献”，将创建统计模型来描述排斥结果与药物遗传学、炎症和 HLA 匹配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。除了遗传和其他因素之外，种族对排斥反应的影响也将被评估。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和预测的基因表达算法之间的一致性水平。 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匹兹堡处理的临床数据的 SAS 文件。 伯明翰阿拉巴马大学。儿科心脏移植研究 6 个地点的患者记录也将以 SAS 文件形式转发至匹兹堡进行项目 3。Core C 将在本地接收 ACCESS 文件中的实验室数据。流行病学数据中心开发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。核心研究人员将与项目研究人员合作准备研究结果报告。