A Review of Traumatic Brain Injury Randomized Controlled Trials

Abstract

<h3>Objective(s)</h3> To describe the landscape of traumatic brain injury (TBI) randomized controlled trial (RCT) publications, in terms of number of studies, country of origin, and time post injury. <h3>Data Sources</h3> Scopus, PubMed, CINAHL, EMBASE and PsycINFO. <h3>Study Selection</h3> Articles published up to and including June 30, 2021 meeting the following criteria were included: (1) human subjects with a mean age of ≥18 years, (2) ≥50% of the sample had moderate to severe TBI, (3) the study design was a RCT, and (4) written in English. Protocols and post-hoc analyses of RCTs were not included. <h3>Data Extraction</h3> Author(s), year, journal, country (based on primary authors affiliation), sample size, time post injury, and primary study objective. <h3>Data Synthesis</h3> A total of 674 TBI RCTs met inclusion; 45 different countries were represented. The largest volume of RCTs originated in North America (n=246; 36.5%), predominately the United States (n=234). Over half of the RCTs (53.6%) were published in the last 10 years (2011-2021). The majority of RCTs studied medical outcomes (55%), followed by cognition and cognitive-communication (17.5%). Of those articles that provided data on time post injury (n=496), interventions were studied most frequently within the first 72 hours post injury (50.0%), and after 6 months post injury (34.3%). <h3>Conclusions</h3> By examining high level trends we are able to see where research efforts have been focused across the continuum of TBI rehabilitation care. While there has been an increase in the number of RCTs published in recent years, there is a lack of RCTs in the subacute rehabilitation phase between 3 days and 6 months. <h3>Author(s) Disclosures</h3> None.