Adding Legacy Clinical Data to the Federal Interagency Traumatic Brain Injury (FI

将遗留临床数据添加到联邦机构间创伤性脑损伤 (FI

• 批准号: 8744501
• 负责人: Huaqin Pan
• 金额: $ 14.66万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-15 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8744501
• 关键词: Address; Alzheimer' s Disease; Archives; Brain Injuries; Case Report Form; Cause of Death; Clinical Data; Clinical Research; Common Data Element; Costs and Benefits; Cytidine Diphosphate Choline; Data; Data Element; Data Set; Databases; Dementia; Double-Blind Method; Genomics; Goals; Image; Informatics; Measurement; Multicenter Trials; Natural History; Participant; Patients; Placebo Control; Process; Randomized; Research; Research Personnel; Risk Factors; System; Therapeutic; Traumatic Brain Injury; United States; Validation; Washington; Work; clinical research site; data format; disability; drug testing; functional outcomes; improved; public health relevance; repository; tool; treatment trial

DESCRIPTION (provided by applicant): Traumatic brain injury (TBI) is a major cause of death and disability. In the United States alone approximately 1.4 million people sustain a TBI each year, of which 50,000 people die and over 200,000 are hospitalized. In addition, new research suggests that TBI is an independent significant risk factor of developing dementia and Alzheimer's disease. Despite the scientific and cost benefits of cross-study analyses, variability in measurement across studies has limited the ability to combine TBI data. To address this, the Federal Interagency TBI Research (FITBIR) Informatics System was developed as a platform to define, refine, and standardize data definitions for performing cross-study TBI research and as a central repository for phenotypic, genomic, and imaging data from TBI studies. The goal of this proposed work is to accelerate the process of building FITBIR into a large, rich database for meta- and secondary analysis of TBI clinical research data by archiving legacy data from the Citicoline Brain Injury Treatment Trial (COBRIT). COBRIT is a randomized, double-blind, placebo- controlled, multicenter trial studying the effects of 90 days of Citicoline on improving functional outcome in patients with complicated mild, moderate, and severe TBI. A comprehensive TBI assessment and drug test data were collected using 43 Case Report Forms (CRFs) in 16 modules containing more than 1,600 variables from approximately 1,200 patients over a 4 year period across eight clinical sites. The archiving of COBRIT in a standardized and harmonized format will help TBI investigators perform cross-study analyses about the natural history of TBI and the feasibility of new TBI therapeutics. Specifically, we will standardize and harmonize COBRIT variables using FITBIR Common Data Elements (CDEs) and Unique Data Elements (UDEs) by (1) assigning CDEs/UDEs to COBRIT variables that are "Identical" to FITBIR CDEs/UDEs; (2) defining and annotating COBRIT variables that are "Comparable" to FITBIR CDE/UDE; (3) defining and harmonizing COBRIT variables that are "Related" to FITBIR CDE/UDEs; and (4) Creating new data elements for COBRIT variables not found in FITBIR CDEs/UDEs. Next, we will contribute the standardized and harmonized COBRIT data to FITBIR by (1) generating FITBIR Global Unique Identifiers (GUID) for COBRIT subjects; (2) validating data formats using the FITBIR Data Validation Tool; and (3) submitting standardized and harmonized COBRIT data using the FITBIR Upload Tool.

描述（由申请人提供）：创伤性脑损伤（TBI）是导致死亡和残疾的主要原因。仅在美国，每年就有大约140万人遭受脑外伤，其中5万人死亡，20多万人住院。此外，新的研究表明，创伤性脑损伤是发展为痴呆和阿尔茨海默病的一个独立的重要危险因素。尽管交叉研究分析具有科学和成本效益，但研究间测量的可变性限制了合并TBI数据的能力。为了解决这个问题，联邦机构间TBI研究（FITBIR）信息系统被开发为一个平台，用于定义、完善和标准化执行跨研究TBI研究的数据定义，并作为TBI研究的表型、基因组和成像数据的中央存储库。这项工作的目标是通过归档胞胆碱脑损伤治疗试验（COBRIT）的遗留数据，加速将FITBIR建立成一个大型、丰富的数据库，用于对TBI临床研究数据进行meta和二次分析。COBRIT是一项随机、双盲、安慰剂对照、多中心试验，研究90天胞磷胆碱对改善合并轻度、中度和重度TBI患者功能结局的影响。使用16个模块的43份病例报告表格（CRFs）收集了全面的TBI评估和药物测试数据，其中包含来自8个临床站点4年期间约1200名患者的1,600多个变量。以标准化和协调的格式存档COBRIT将有助于TBI研究人员对TBI的自然史和新的TBI治疗方法的可行性进行交叉研究分析。具体来说，我们将使用FITBIR通用数据元素（CDEs）和唯一数据元素（ude）来标准化和协调COBRIT变量，方法是：(1)将CDEs/ ude分配给与FITBIR CDEs/UDEs“相同”的COBRIT变量；(2)定义并标注与FITBIR CDE/UDE“可比”的COBRIT变量；(3)定义和协调与FITBIR CDE/UDEs“相关”的COBRIT变量；(4)为FITBIR CDEs/UDEs中没有的COBRIT变量创建新的数据元素。接下来，我们将通过以下方式为FITBIR提供标准化和协调的COBRIT数据：(1)为COBRIT受试者生成FITBIR全球唯一标识符（GUID）；(2)使用FITBIR数据验证工具对数据格式进行验证；(3)使用FITBIR上传工具提交标准化和协调的COBRIT数据。

项目成果

Using the PhenX Toolkit to Select Standard Measurement Protocols for Your Research Study.

• DOI: 10.1002/cpz1.149
• 发表时间: 2021-05
• 期刊: Current protocols
• 作者: Cox LA;Hwang S;Haines J;Ramos EM;McCarty CA;Marazita ML;Engle ML;Hendershot T;Pan HH;Hamilton CM
• 通讯作者: Hamilton CM