Overview of randomized controlled trials of moderate to severe traumatic brain injury: A systematic review

BACKGROUND: Given the complexity of post-TBI medical, surgical, and rehabilitative care, research is critical to optimize interventions across the continuum of care and improve outcomes for persons with moderate to severe TBI. OBJECTIVE: To characterize randomized controlled trials (RCTs) of moderate to severe traumatic brain injury (TBI) in the literature. METHOD: Systematic searches of MEDLINE, PubMed, Scopus, CINAHL, EMBASE and PsycINFO for RCTs up to December 2022 inclusive were conducted in accordance with PRISMA guidelines. RESULTS: 662 RCTs of 91,946 participants published from 1978 to 2022 met inclusion criteria. The number of RCTs published annually has increased steadily. The most reported indicator of TBI severity was the Glasgow Coma Scale (545 RCTs, 82.3%). 432 (65.3%) RCTs focused on medical/surgical interventions while 230 (34.7%) addressed rehabilitation. Medical/surgical RCTs had larger sample sizes compared to rehabilitation RCTs. Rehabilitation RCTs accounted for only one third of moderate to severe TBI RCTs and were primarily conducted in the chronic phase post-injury relying on smaller sample sizes. CONCLUSION: Further research in the subacute and chronic phases as well as increasing rehabilitation focused TBI RCTs will be important to optimizing the long-term outcomes and quality of life for persons living with TBI.