Core G: Biostatistics and Data Management

生物统计学和数据管理核心摘要 生物统计和数据管理 (BDM) 核心促进与 ABC-DS 的研究和合作 通过提供数据管理、流行病学、分析设计和统计支持，以及 创建与研究界共享数据的基础设施，以进一步了解 阿尔茨海默病和唐氏综合症。 BDM 核心人员，由博士领导。图多拉斯库（统计）和 Andrews（数据管理）将支持 ABC-DS 核心领导者和研究人员完成具体任务 通过建立安全、集中的在线数据管理系统来实现研究项目 1、2 和 3 的目标， 实施协议以确保临床、神经影像、组学、遗传的整合和记录 和神经病理学数据，并提供高水平的统计支持，以及测试每个陈述所需的专业知识 本项目中的假设。这些职能将通过生物统计学的多学科团队来执行 方法组 (BMG)：统计学家、流行病学家和数据管理专家组成 每个小组都拥有特定的专业知识和独特的技能，可以在多个项目和核心中使用。的 使用该组织结构将实现的具体目标如下： 目标 1：完成 通过协调和集成过渡到统一的关系数据库和项目管理系统 所有性能站点的评估数据，纳入新的统一评估协议，并提供 用于安排和记录所有研究程序以及集成来自研究的关键数据元素的功能 临床、神经病理学、组学、ADDORE 和神经影像核心；目标 2：创建一组分析数据文件 包含统计分析所需的所有来源的所有原始和派生数据元素 测试本提案中每个研究项目的假设，并创建数据集 本研究进行期间计划的任何二次和临时分析的规范；目标 3：领先 统计数据分析，协作准备所有核心和研究项目的报告，并提供 ABC-DS 研究项目统计分析的设计和方法方面的专业知识；目标 4： 开发并实施适当的统计模型，对来自所有来源的生物标志物进行纵向分析 模式，以便就我们的 AD 发展的每个阶段的影响做出推断 DS 成人队列；目标 5：通过神经影像实验室促进 ABC-DS 数据共享 (LONI)，为 ABC-DS 内部和外部有兴趣使用的研究人员提供方法资源 ABC-DS 数据库进行分析，并提供文档并确保已发布的 ABC-DS 的可重复性 DS 研究。

Biostatistics and Data Management Core Abstract The Biostatistics and Data Management (BDM) Core facilitates research and collaboration with ABC-DS investigators by providing data management, epidemiological, analytic design and statistical support, and by creating an infrastructure for data sharing with the research community to further the understanding of Alzheimer’s Disease and Down syndrome. BDM Core personnel, lead by Drs. Tudorascu (statistics) and Andrews (data management) will support the ABC-DS Cores leaders and investigators in fulfilling the specific aims of Research Projects 1, 2 and 3 by establishing a secure, centralized online data management system, implementing a protocol to ensure the integration and documentation of clinical, neuroimaging, omics, genetic and neuropathology data and providing high-level statistical support, with expertise required to test each stated hypothesis in this project. These functions will be carried out through a multidisciplinary team of Biostatistics Methodology Groups (BMGs): statisticians, epidemiologists, and data management experts organized into groups, each with specific expertise and unique skills that can be used across several Projects and Cores. The Specific Aims that will be implemented using this organizational structure are as follows: Aim 1: Complete the transition to a unified relational database and project management system by harmonizing and integrating evaluation data across all Performance sites, incorporating the new, unified evaluation protocol, and providing functionality for scheduling and documenting all study procedures and integrating key data elements from the Clinical, Neuropathology, Omics, ADDORE and Neuroimaging Core; Aim 2: Create a set of analytic data files containing all original and derived data elements from all sources necessary for the statistical analysis required to test the hypotheses of each Research Project in this proposal, as well as create data sets meeting specifications for any secondary and ad hoc analyses planned during the conduct of this research; Aim 3: Lead the statistical data analyses, collaborate in report preparation for all Cores and Research Projects, and provide expertise on design and methodological aspects of statistical analyses for ABC-DS Research Projects; Aim 4: Develop and implement appropriate statistical models for longitudinal analyses of derived biomarkers from all modalities in order to make inferences with respect to impact at each stage of the development of AD in our cohort of adults with DS; Aim 5: Facilitate sharing of ABC-DS data through the Laboratory of Neuroimaging (LONI), serve as a methodological resource for researchers within and outside of ABC-DS interested in using the ABC-DS database for analyses, and provide documentation and ensure reproducibility of published ABC- DS research.