Streamlining clinical research: The National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH) and Department of Defense (DoD) sport-related concussion common data element (CDE) recommendations

Objective The purpose of the NINDS CDE project is to educate new clinical investigators, increase efficiency and effectiveness of clinical research studies and treatment, increase data quality, facilitate data sharing, significantly reduce study start-up time, and more effectively aggregate information into significant metadata results. In 2016, as part of the NINDS CDE project to develop data standards for all clinical neuroscience research, NINDS, NIH and the DoD initiated the development of Sport-Related Concussion (SRC) CDEs. Background TBI CDE recommendations were published on the NINDS CDE website in 2010, but lacked a thorough inclusion of SRC. In August 2016, a new SRC-specific working group (WG) began developing and identifying CDEs, template case report forms (CRFs), and guidelines to assist investigators conducting SRC-specific clinical research studies. Design/methods The CDE WG, which consisted of 34 worldwide SRC research experts, met regularly via teleconference over several months. The WG was divided into 3 subgroups to examine SRC during defined periods relative to time of injury: Acute (72 hours post-concussion), Sub-Acute (3 days-3 months post-concussion) and Persistent/Chronic (3 months and greater post-concussion). Results Version 1.0 of the SRC CDEs were available on the NINDS CDE website in June 2017. These include Core and Supplemental, Highly Recommended CDEs or instruments for cognitive measures and symptom checklists, as well as, other outcomes and endpoints, and sample CRFs for domains typically included in clinical research studies (e.g., vestibular, oculomotor, balance, anxiety, depression). Conclusion The NINDS CDEs are reviewed and updated regularly as research advancements or changes to specific recommendations are deemed appropriate. Because the CDEs are an evolving resource, continued feedback is important for improved use and utility. The use of SRC CDE recommendations is highly encouraged for SRC related researchers as they serve as a valuable starting point and facilitate streamlining and sharing data.