Pre-Clinical Common Data Elements for Traumatic Brain Injury Research: Progress and Use Cases
Pre-Clinical Common Data Elements for Traumatic Brain Injury Research: Progress and Use Cases
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DOI：
10.1089/neu.2020.7328
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发表时间：
2021-02-24
影响因子：
4.2
通讯作者：
Zai, Laila J.
中科院分区：
文献类型：
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作者：
LaPlaca, Michelle C.;Huie, J. Russell;Zai, Laila J.
创伤性脑损伤（TBI）是一种极其复杂的情况，由于损伤机制，基础条件和继发性损伤的异质性。临床前和临床研究人员面临着重现性的挑战，这对翻译和治疗开发产生了负面影响，从而改善了TBI患者的预后。为了应对这一挑战，TBI临床前工作组扩展了以前的工作，并开发了通用数据元素（CDE）来描述最常用的实验参数。工作组创建了913个CDE来描述研究元数据、动物特征、动物病史、损伤模型和行为测试。用例应用了一组常用的CDE，以解决和评价因合并来自不同实验室的两种不同结局指标（Morris水迷宫[MWM]; RotorRod/Rotarod）的遗留数据而导致的缺失数据的程度。对数据进行清理并协调至包含相关CDE的表格结构，并进行缺失值分析。对于MWM数据集（来自5项研究的358只动物，44个CDE），50%的CDE包含至少一个缺失值，而对于Rotarod数据集（来自3项研究的97只动物，48个CDE），超过60%的CDE包含至少一个缺失值。总体而言，MWM数据集有35%的值缺失，Rotarod数据集有33%的值缺失，这表明使用CDE组合传统数据集的可行性和挑战性。这里创建的CDE和相关表格可供更广泛的临床前研究社区使用，以促进一致和全面的数据采集，并促进数据共享和数据存储库的形成。除了解决TBI临床前研究标准化的挑战外，这项工作还旨在引起人们对临床前实验室之间评估和结果指标差异的关注，并最终加速转化为临床研究。
Traumatic brain injury (TBI) is an extremely complex condition due to heterogeneity in injury mechanism, underlying conditions, and secondary injury. Pre-clinical and clinical researchers face challenges with reproducibility that negatively impact translation and therapeutic development for improved TBI patient outcomes. To address this challenge, TBI Pre-clinical Working Groups expanded upon previous efforts and developed common data elements (CDEs) to describe the most frequently used experimental parameters. The working groups created 913 CDEs to describe study metadata, animal characteristics, animal history, injury models, and behavioral tests. Use cases applied a set of commonly used CDEs to address and evaluate the degree of missing data resulting from combining legacy data from different laboratories for two different outcome measures (Morris water maze [MWM]; RotorRod/Rotarod). Data were cleaned and harmonized to Form Structures containing the relevant CDEs and subjected to missing value analysis. For the MWM dataset (358 animals from five studies, 44 CDEs), 50% of the CDEs contained at least one missing value, while for the Rotarod dataset (97 animals from three studies, 48 CDEs), over 60% of CDEs contained at least one missing value. Overall, 35% of values were missing across the MWM dataset, and 33% of values were missing for the Rotarod dataset, demonstrating both the feasibility and the challenge of combining legacy datasets using CDEs. The CDEs and the associated forms created here are available to the broader pre-clinical research community to promote consistent and comprehensive data acquisition, as well as to facilitate data sharing and formation of data repositories. In addition to addressing the challenge of standardization in TBI pre-clinical studies, this effort is intended to bring attention to the discrepancies in assessment and outcome metrics among pre-clinical laboratories and ultimately accelerate translation to clinical research.