Transforming Research and Clinical Knowledge in Spinal Cord Injury (TRACK-SCI): an overview of initial enrollment and demographics
Tsolinas Rachel E, John F Burke, Anthony M DiGiorgio, Leigh H Thomas, Xuan Duong-Fernandez, Mark H Harris, John K Yue, Ethan A Winkler, Catherine G Suen, Lisa U Pascual, Adam R Ferguson, J Russell Huie, Jonathan Z Pan, Debra D Hemmerle, Vineeta Singh, Abel Torres-Espin, Cleopa Omondi, Nikos Kyritsis, Jenny Haefeli, Philip R Weinstein, Carlos A de Almeida Neto, Yu-Hung Kuo, Derek Taggard, Jason F Talbott, William D Whetstone, Geoffrey T Manley, Jacqueline C Bresnahan, Michael S Beattie, Sanjay S Dhall
Objective: Traumatic spinal cord injury (SCI) is a dreaded condition that can lead to paralysis and severe disability. With few treatment options available for patients who have suffered from SCI, it is important to develop prospective databases to standardize data collection in order to develop new therapeutic approaches and guidelines. Here, the authors present an overview of their multicenter, prospective, observational patient registry, Transforming Research and Clinical Knowledge in SCI (TRACK-SCI).
Methods: Data were collected using the National Institute of Neurological Disorders and Stroke (NINDS) common data elements (CDEs). Highly granular clinical information, in addition to standardized imaging, biospecimen, and follow-up data, were included in the registry. Surgical approaches were determined by the surgeon treating each patient; however, they were carefully documented and compared within and across study sites. Follow-up visits were scheduled for 6 and 12 months after injury.
Results: One hundred sixty patients were enrolled in the TRACK-SCI study. In this overview, basic clinical, imaging, neurological severity, and follow-up data on these patients are presented. Overall, 78.8% of the patients were determined to be surgical candidates and underwent spinal decompression and/or stabilization. Follow-up rates to date at 6 and 12 months are 45% and 36.3%, respectively. Overall resources required for clinical research coordination are also discussed.
Conclusions: The authors established the feasibility of SCI CDE implementation in a multicenter, prospective observational study. Through the application of standardized SCI CDEs and expansion of future multicenter collaborations, they hope to advance SCI research and improve treatment.
Keywords: AIS = ASIA Impairment Scale; ASIA = American Spinal Injury Association; BASIC = Brain and Spinal Injury Center; CDE = common data element; CMS = Centers for Medicare & Medicaid Services; CRC = clinical research coordinator; GCS = Glasgow Coma Scale; IRB = institutional review board; ISCI = International Spinal Cord Injury; ISCoS = International Spinal Cord Society; ISNCSCI = International Standard for Neurological Classification of Spinal Cord Injury; ISS = Injury Severity Score; LAR = legally authorized representative; NINDS = National Institute of Neurological Disorders and Stroke; REDCap = Research Electronic Data Capture; SCI; SCI = spinal cord injury; TBI = traumatic brain injury; TRACK-SCI = Transforming Research and Clinical Knowledge in SCI; UCSF = University of California San Francisco; ZSFGH = Zuckerberg San Francisco General Hospital; data registries; spine trauma.