Archiving Common Data Element-Harmonized Pediatric Traumatic Brain Injury Data and Metadata

项目概要/摘要 创伤性脑损伤（TBI）是儿童死亡和后天残疾的主要原因。数据共享 对于最大限度地利用研究数据生成的可操作知识非常重要。共享 TBI 数据 是 NIH 的目标。为了实现这一目标，NIH 和美国国防部开发了 联邦跨机构 TBI 研究 (FITBIR) 信息系统作为中央存储库 对于 TBI 数据。然而，FITBIR 目前包含的有关需要关键治疗的儿童的信息很少 TBI 后的护理。该提案将显着扩展 FITBIR 中有关关键信息的可用数据： 患有 TBI 的陪审儿童。 NICHD 支持的 TBI 变量儿科验证 (PEDALFAST) 前瞻性队列研究连续招募了 395 名入住重症监护室的急性 TBI 儿童 PEDALFAST 是第一项研究，在美国两个大型 1 级儿科创伤中心的护理病房 (ICU) 进行 报告一项重要的新结果测量——功能状态量表（FSS）在儿童中的使用情况。 德伦患有 TBI。 PEDALFAST 收集有关患者、损伤和影像特征的信息，并 院前、急诊室 (ED)、ICU 和康复护理阶段的事件。目标 1 是将 PEDALFAST 数据与 NIH 开发的 TBI 通用数据元素 (CDE) 协调一致， 开发完整的元数据，并将去识别化的数据和元数据存入 FITBIR。目标 2 是去 开发并分发一个免费的开源 R 数据包，其中包含去识别化的、CDE 协调的 PEDALFAST 数据和元数据。这一目标将利用结构、元数据和文档 内置于 R 统计编程环境中的“包”中，以提供易于使用且良好的 CDE 协调的 PEDALFAST 数据的记录来源。这个提议意义重大，因为它 将大大增加有关患有 TBI 的重伤儿童的数据量，可供秒 一般使用。这些数据将与当前儿科 TBI 的黄金标准 CDE 相协调，并将 附有完整的元数据。该提案具有创新性，因为 PEDALFAST 数据将 可在美国最大的 TBI 数据存储库 (FITBIR) 中获取，也可免费下载 R数据包。这种开源包格式的创新使用将使数据立即 可供分析团队重复使用。预计 PEDALFAST 数据可以重复使用，因为它 将以两种不同的记录良好的格式提供。

PROJECT SUMMARY/ABSTRACT Traumatic brain injury (TBI) is the leading cause of death and acquired disability in children. Data shar- ing is important to maximize the actionable knowledge generated from research data. Sharing TBI data is a goal of the NIH. To achieve that goal, NIH and the U.S. Department of Defense have developed the Federal Interagency TBI Research (FITBIR) Informatics System to serve as a central repository for TBI data. However, FITBIR currently contains little information about children who require critical care after TBI. This proposal will significantly expand the data available in FITBIR about critically in- jured children with TBI. The NICHD-supported PEDiatric vAlidation oF vAriableS in TBI (PEDALFAST) prospective cohort study enrolled 395 consecutive children with acute TBI admitted to the intensive care unit (ICU) at two large level 1 pediatric trauma centers in the U.S. PEDALFAST was the first study to report the use of an important new outcome measure, the Functional Status Scale (FSS), in chil- dren with TBI. PEDALFAST collected information about patient, injury, and imaging characteristics and events from the pre-hospital, Emergency Department (ED), ICU, and rehabilitation phases of care. Aim 1 is to harmonize the PEDALFAST data to the TBI common data elements (CDEs) developed by NIH, develop complete metadata, and deposit the de-identified data and metadata in FITBIR. Aim 2 is to de- velop and distribute a free, open source R data package containing the de-identified, CDE-harmonized PEDALFAST data and metadata. This aim will leverage the structure, metadata, and documentation built into “packages” in the R statistical programming environment to provide an easy-to-use and well- documented source for the CDE-harmonized PEDALFAST data. This proposal is significant because it will substantially increase the amount of data about critically injured children with TBI available for sec- ondary use. The data will be harmonized to the current gold standard CDEs for pediatric TBI and will be accompanied by complete metadata. This proposal is innovative because the PEDALFAST data will be made available in the largest U.S. TBI data repository (FITBIR) and also as a free and downloadable R data package. This innovative use of an open-source package format will make the data immediately available for reuse by analytic teams. Ready reuse of the PEDALFAST data is anticipated because it will be available in two different well-documented formats.