A common data language for biomechanical devices used in TBI clinical research: The National Institute of Neurological Disorders and Stroke (NINDS) and Department of Defense (DoD) CDE recommendations

Abstract

ObjectiveThe NINDS Common Data Element (CDE) project provides data standards for clinical research in neuroscience. NINDS/NIH and DoD collaborated to develop CDE recommendations for Biomechanical Devices in TBI. CDEs increase efficiency of clinical research studies by reducing study start-up time and cost, increasing data quality, facilitating data sharing and aggregation, and helping educate new clinical investigators.BackgroundIn January 2017, a working group (WG) of subject matter experts from academia, industry and the military convened to develop CDE recommendations for blast, blunt head impact and inertial-loading exposures measured by biomechanical devices. These CDEs are available as a subset of the TBI recommendations under the Disease/Injury Related Events Domain and Biomechanical Devices Sub-Domain on the NINDS CDE website.Design/methodsThe WG divided into 3 subgroups: Head Accelerometry, Impact Video and Blast Exposure to review commonly collected data and analysis methods. The Head Accelerometry subgroup focused on data captured by kinematic sensors in sports/activities. The Impact Video subgroup addressed the use of video information to confirm device measurements. The Blast Exposure subgroup compared data from research sources using blast overpressure sensors. Subgroup recommendations were reviewed internally across the WG before being posted for public review.ResultsThe WG's end products are summaries, CDE metadata and template case report forms. Assigned classifications guide researchers in selecting CDEs: Supplemental-Highly Recommended (essential for specified conditions, study types or designs), Supplemental (commonly collected, but not required), and Exploratory (reasonable to use, but require further validation). Version 1.0 recommendations were made available for use through the NINDS CDE website in late February 2018.ConclusionThese new CDE recommendations will facilitate robust metadata analysis and data-sharing. NINDS encourages use of CDEs for all clinical research in neuroscience. NINDS CDEs are a dynamic resource, which is updated periodically based on the current state of science.