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和SC摘要 SARS-CoV-2感染与祖先基因组变异相互作用的研究 阿尔茨海默氏病(ISAVRAD)是一项国际性的多点研究，旨在确定个体的祖先特征 人口，包括来自安第斯山脉的美洲印第安人和来自尼日利亚的非洲人以及来自 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)的可变混血儿 美国人)和布朗克斯(西班牙裔/拉丁裔和非裔美国人)使用统一的协议。表征 基线包括对新冠肺炎疾病严重性、疫苗接种状态、记录日期的描述 感染时各部位流行病毒变异株和全基因组的感染和鉴定 测序，以及神经学、认知学和纵向随访的深层表型和纵向随访 神经成像特征可能会检测到认知能力下降或痴呆症作为SARS的长期后遗症- 冠状病毒2型感染。数据管理和统计核心(DM&SC)是支持 负责ISAVRAD计划四个项目的科研活动，负责管理， 报告和共享临床和神经成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，以便完成 拟议的目标和促进空间研发局网络内外的合作。以两个信息学为首 南得克萨斯州阿尔茨海默氏症中心的核心统计负责人，DM&SC配备了先进的 信息学、数据管理、统计基础设施和专门知识，以满足这些专门需求。 Zozus和Sanns博士拥有数十年的经验，为 临床研究，并提供监管级别的数据处理要求和 方法：研究方法。王博士和希马利博士提供设计和分析方面的专业知识。DM&SC将提供可靠的 用于记录、管理、存储和共享数据和元数据的过程 为支持其他核心的任务并促进完成项目目标和目标而建立的空间技术促进发展网络 协作努力，目标是使ISAVRAD数据与适当的标准保持一致，以最大限度地提高数据 再利用(目标1)；为数据和样本收集提供信息系统和专家支助 管理(目标2)；通过国家储存库查找和准备供外部共享的数据。