Senior Clinical Trials Specialist Center for Neuroscience and Regenerative Medicine, HJF Bethesda, Maryland
Abstract Text: Background Traumatic Brain Injury (TBI) occurs in 3-4 million people annually in the U.S. Certain populations such as military service members are at higher risk due to exposures, behaviors, or beliefs that increases the probability of injury and affect recovery outcomes. Symptoms related to TBI is complicated due to heterogenous presentations and the absence of objective assessment methods. The majority of individuals recover; however, it is estimated that 15 – 25% experience chronic (> 3 months) neurological and psychological symptoms such as headache, fatigue, sleep disturbances, vestibular and oculomotor dysfunction, mental health changes, and disruptions in cognitive function. Often, many mild TBIs are undiagnosed or overlooked in the clinical setting due to various other medical concerns that take precedence. The identification of symptoms and TBI sequalae , especially the impact on mild cases continues to remain a challenge when solely relying on self-reported clinical data. The objective of this abstract is to present on the development of an epidemiological study that will utilize retrospective research data from a curated database managed by the Center for Neuroscience and Regenerative Medicine (CNRM) to conduct an epidemiologic cohort analysis of military TBI baseline indicators to identify and model risk factors and outcome expectancies. Methods Between 2010 and 2020, the CNRM sponsored protocol NCT03191357 in which service members and those eligible for clinical care in military treatment facilities and DoD related care centers were recruited into an observational natural history protocol. Within this study, data collected included TBI presentation, TBI history, combat exposure, imaging findings, and various health measures capturing TBI symptoms including sleep, headache, and behavioral changes. Upon completion, this data was validated, coded, and transferred to the CNRM data repository. To conduct this retrospective cohort analysis, an exempt protocol will be submitted to the USUHS IRB for exempt determination. Upon approval, coded data with no identifiers will be accessed from the repository and analyzed. Data will include categorical data: non-identifying demographics, service history, TBI history from Ohio State University TBI Identification tool, clinical presentation information collected from the baseline visit, imaging reads based on key image indicators from CT and MRI when available including intercranial hemorrhage, and TBI severity; and quantifiable outcome results from validated symptom collection tools: Neurobehavioral Symptom Inventory, Patient Health Questionnaire 9, and Glasgow Outcome Scale Extended; collected at 6, 12, 24, 36, and 48 months as available. Statistical analysis will be conducted on variables to assess risk ratios for outcomes based on categorical presentation data related to TBI. Outcome The primary outcome for this epidemiological study will be to identify TBI exposure risks in a population known for high TBI incidence. Through the analysis, the determination of the relationship of exposure and various outcomes related to TBI in service member related populations will be inferred and summarized. By identifying risk ratios related to presentation factors such as demographics, past injury, TBI severity, symptoms at presentation, and imaging findings to outcome, recovery expectations can be improved, and clinical treatment can be optimized to the specific needs of the patient. Furthermore, this study will provide additional evidence and groundwork for the feasibility and efficacy of the CNRM data repository as a unique public health tool available to researchers and students in expanding the understanding and care for TBI, especially in the warfighter population.
Disclaimer: The authors have no conflicts of interest to disclose. The views, information or content, and conclusions presented do not necessarily represent the official position or policy of, nor should any official endorsement be inferred on the part of, the Uniformed Services University, the Department of Defense, the U.S. Government or the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.
