Ninds/nih And Dod Sport-related Concussion Common Data Elements

Abstract

PURPOSE: In 2016, the National Institute of Neurological Disorders and Stroke (NINDS)/National Institutes of Health (NIH) and the Department of Defense (DOD) began development of Sport-related Concussion (SRC) Common Data Elements (CDEs) to develop data standards for all funded clinical research in neuroscience with goal of increasing the effectiveness of clinical research studies and treatment by facilitating data sharing across studies. The purpose of this abstract is to report the findings from the SRC-CDEs. METHODS: The initial NINDS Traumatic Brain Injury (TBI) CDE recommendations created in 2010 included limited sport-related brain injury recommendations. In August 2016, a new SRC-specific CDE working group (WG) began developing and identifying CDEs, template case report forms (CRFs), data dictionaries and guidelines to assist investigators initiating and conducting SRC-specific clinical research studies. Comprised of 34 experts from around the world, the WG met regularly to review current collection of SRC data. The WG was divided into three subgroups to examine SRC over time: (1) Acute Subgroup (time of injury until 72 hours); (2) Subacute Subgroup (after 72 hours to 3 months); and, (3) Persistent/Chronic Subgroup (3 months and greater post-concussion). RESULTS: The SRC CDEs were released to the NINDS CDE website in June 2017. The recommendations include Core and Supplemental - Highly Recommended CDEs for cognitive measures and symptom checklists, as well as other outcomes and endpoints (e.g., vestibular, oculomotor, balance, anxiety, depression) and sample case report forms (e.g., injury reporting, demographics, history of concussion, concussion history) across acute, sub-acute and persistent/chronic. CONCLUSION: NINDS encourages the use of SRC CDEs by the clinical research community to standardize data collection and reporting. The NINDS CDEs are a continually evolving resource, and these newly developed SRC CDEs serve as valuable starting points for investigators to streamline research that informs treatments for SRC. This material is based upon work supported by the U.S Army Medical Research and Materiel Command’s Combat Casualty Care Research Program and funded by NIH contracts HHSN271201700064C and HHSN271201200034C.