Biostatistics Core

生物统计学核心

• 批准号: 10628508
• 负责人: Meredith Nahm Zozus
• 金额: $ 47.43万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-15 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10628508
• 关键词: 2019-nCoV; Admixture; African; African American population; Alzheimer' s Disease; Alzheimer' s disease risk; Amerindian; Biological; Biological Markers; Biostatistics Core; Books; COVID-19; COVID-19 severity; Case Report Form; Clinical; Clinical Data; Clinical Research; Code; Cognitive; Collaborations; Data; Data Analyses; Data Collection; Data Set; Decision Making; Dementia; Elderly; Evaluation; Faculty; Fostering; Funding; Genetic Variation; Goals; Good Clinical Practice; Hispanic; Impaired cognition; Individual; Infection; Informatics; Information Systems; Infrastructure; International; Knowledge; Latino Population; Laws; Medical History; Metadata; Methods; Mexican Americans; Mission; Molecular; Native Americans; Neurologic; Neuropsychology; Nigeria; Participant; Phenotype; Population; Post-Acute Sequelae of SARS-CoV-2 Infection; Practice Management; Process; Protocols documentation; Regulation; Reporting; Reproducibility; Research; Research Activity; Resource Sharing; Risk; SARS-CoV-2 infection; SARS-CoV-2 infection history; Sampling; Site; South Texas; Specific qualifier value; Standardization; System; Terminology; Texas; Time; Tribes; Underrepresented Minority; Urate; Vaccination; Variant; Virus; World Health Organization; computer program; data handling; data management; data reuse; data sharing; data standards; dementia risk; design; ethnic minority population; experience; follow-up; genome sequencing; genomic variation; human subject protection; neuroimaging; programs; repository; sample collection; statistics; whole genome

DM&SC Abstract The Study on Interactions between SARS-CoV-2 infection and Ancestral genomic Variations in the Risk of Alzheimer’s Disease (ISAVRAD) is an international, multi-site study to characterize individuals from ancestral populations, including Amerindians from the Andes mountains and Africans from Nigeria, as well as from individuals with variable admixture from Southern Texas (Mexican Americans), Seattle (no-tribal Native Americans) and the Bronx (Hispanic/Latinos and African Americans) using a uniform protocol. Characterization at baseline includes descriptions of the COVID-19 disease severity, vaccination status, date of documented infection and identity of the prevalent virus variant at each site at the time of infection and whole genome sequencing, as well as deep phenotyping and longitudinal follow up of neurological, cognitive and neuroimaging signatures that may detect cognitive decline or dementia as long-term sequelae of the SARS- CoV-2 infection. The Data Management and Statistics Core (DM&SC) is one of 4 Cores supporting the scientific research activities of the four ISAVRAD Program Projects and is responsible for management, reporting and sharing of raw and meta-data generated by the Clinical and Neuroimaging Cores; from NIA ADSP components (NCRAD, NIAGADS and GCAD); and from ISAVRAD Projects, to allow completion of the proposed aims and foster collaboration within and outside the ISVRAD network. Led by the two Informatics and Statistics Core leaders for the South Texas Alzheimer’s Center, the DM&SC is equipped with advanced informatics, data management, and statistical infrastructure and expertise to meet these specialized needs. Drs Zozus and Sanns boast decades of experience providing comprehensive coordinating center support for clinical studies and offer extensive practical knowledge of regulatory-grade data handling requirements and methods. Drs. Wang and Himali provide design and analysis expertise. The DM&SC will provide reliable processes for the recording, management, storing and sharing of data and metadata within and outside the ISAVRAD network to support the mission of the other cores and foster the completion of the Projects aims and collaborative efforts, with the goals of aligning ISAVRAD data with appropriate standards to maximize data reuse (Aim 1); providing information systems and expert support for data and sample collection and management (Aim 2); and urating and preparing data for external sharing through national repositories.

DM&SC摘要 SARS-CoV-2感染与祖先基因组变异在SARS发病风险中的交互作用研究 阿尔茨海默氏病（ISAVRAD）是一项国际性的多地点研究，以表征来自祖先的个体。 人口，包括美洲印第安人从安第斯山脉和非洲人从尼日利亚，以及从 来自德克萨斯州南部（墨西哥裔美国人）、西雅图（非部落原住民） 美国人）和布朗克斯（西班牙裔/拉丁美洲人和非洲裔美国人）使用统一的协议。表征 包括对COVID-19疾病严重程度、疫苗接种状态、记录日期 感染和感染时每个位点的流行病毒变体的身份以及全基因组 测序，以及深度表型和纵向随访的神经，认知和 神经影像学特征，可以检测认知能力下降或痴呆症作为SARS的长期后遗症- CoV-2感染。数据管理和统计核心（DM&SC）是支持 四个ISAVRAD计划项目的科学研究活动，并负责管理， 报告和共享临床和神经影像核心生成的原始数据和元数据;来自NIA ADSP组件（NCRAD，NIAGADS和GCAD）;以及ISAVRAD项目，以完成 提出的目标，并促进ISVRAD网络内外的合作。由两个信息学 和统计核心领导人南得克萨斯州阿尔茨海默氏症中心，DM&SC配备了先进的 信息学、数据管理和统计基础设施和专门知识，以满足这些专门需求。 Drs Zozus和Sanns拥有数十年的经验，为以下方面提供全面的协调中心支持： 临床研究，并提供监管级数据处理要求的广泛实践知识， 方法. Wang博士和Himali博士提供设计和分析专业知识。DM&SC将提供可靠的 数据和元数据的记录、管理、存储和共享流程 ISAVRAD网络，以支持其他核心的使命并促进完成项目目标， 协同工作，目标是使ISAVRAD数据与适当的标准相一致，以最大限度地利用数据 再利用（目标1）;为数据和样本收集提供信息系统和专家支持， 管理（目标2）;以及收集和准备数据，通过国家储存库对外分享。