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

描述(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，200,000多人住院。此外，新的研究表明，脑外伤是患痴呆症和阿尔茨海默病的一个独立的重要风险因素。尽管交叉研究分析具有科学和成本效益，但不同研究之间测量的可变性限制了结合TBI数据的能力。为了解决这一问题，联邦跨机构脑损伤研究(FITBIR)信息学系统被开发为一个定义、改进和标准化数据定义的平台，用于执行交叉研究脑损伤研究，并作为来自脑损伤研究的表型、基因组和成像数据的中央存储库。这项拟议工作的目标是通过归档胞二磷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，用于对脑损伤临床研究数据进行元分析和二次分析。COBRIT是一项随机、双盲、安慰剂对照的多中心试验，研究90天胞二磷胆碱对复杂的轻、中、重度脑外伤患者的功能结局的改善作用。使用16个模块中的43个病例报告表(CRF)收集了全面的TBI评估和药物测试数据，这些模块包含来自8个临床站点的约1,200名患者的1,600多个变量，历时4年。以标准化和协调的格式存档COBRIT将有助于脑损伤研究人员对脑损伤的自然病史和新的脑损伤疗法的可行性进行交叉研究分析。具体地说，我们将使用FITBIR公共数据元素(CDE)和唯一数据元素(UDES)来标准化和协调COBRIT变量，方法是(1)将CDE/UDES赋值给与FITBIR CDE/UDES“相同”的COBRIT变量；(2)定义和注释与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；以及(4)为FITBIR CDE/UDES中找不到的COBRIT变量创建新的数据元素。接下来，我们将通过以下方式向FITBIR贡献标准化和协调的COBRIT数据：(1)为COBRIT对象生成FITBIR全球唯一标识符(GUID)；(2)使用FITBIR数据验证工具验证数据格式；以及(3)使用FITBIR上传工具提交标准化和协调的COBRIT数据。

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.