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)核心促进了与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，以及通过 创建与研究界共享数据的基础设施，以加深对 阿尔茨海默病和唐氏综合症。BDM核心人员，由Tudorascu博士领导(统计)和 安德鲁斯(数据管理)将支持ABC-DS核心领导和调查人员履行具体 研究项目1、2和3的目标是建立一个安全、集中的在线数据管理系统， 实施一项协议，以确保临床、神经影像、组学、遗传学 和神经病理数据，并提供高级统计支持，需要专业知识来测试每个声明 这个项目中的假设。这些职能将通过生物统计学的多学科小组执行 方法组(BMG)：统计学家、流行病学家和数据管理专家 小组，每个小组都有特定的专业知识和独特的技能，可以用于几个项目和核心。这个 将利用这一组织结构实施的具体目标如下：目标1：完成 通过协调和集成向统一的关系数据库和项目管理系统过渡 所有绩效站点的评估数据，整合了新的统一评估协议，并提供 用于计划和记录所有研究程序并集成来自 临床、神经病理学、OMICS、ADDORE和神经成像核心；目标2：创建一组分析数据文件 包含所需统计分析所需的所有来源的所有原始和派生数据元素 测试此建议书中每个研究项目的假设，并创建满足以下条件的数据集 本研究进行期间计划进行的任何二次和特别分析的规范；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学方面的专门知识；目标4： 开发和实施适当的统计模型，用于纵向分析来自所有 模式，以便对AD发展的每个阶段在我们的 成人DS患者队列；目标5：通过神经成像实验室促进ABC-DS数据的共享 (LONI)，作为ABC-DS内外有兴趣使用的研究人员的方法学资源 用于分析的ABC-DS数据库，并提供文件并确保出版的ABC-DS的再现性 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.