ABSTRACT
Traumatic brain injury (TBI) is a leading cause of death and disability worldwide. Randomized controlled trials (RCTs) are the cornerstone to evaluate the efficacy of an intervention. In order to assess the methodology of clinical research, we performed a systematic review which evaluated the different outcomes used in RCTs targeting the early phase of moderate to severe adult TBI from 1983 to October 31, 2023. We extracted each outcome and organized them according to the COMET and OMERACT framework (core area, broad domains, target domains and finally outcomes). 190 RCTs were included, including 52,010 participants. 557 outcomes were reported and classified between the following core areas: pathophysiological manifestations (169 RCTs (88.9%)), life impact (117 RCTs (61.6%)), death (94 RCTs (49.5%)), resource use (72 RCTs (37.9%)) and adverse events (41 RCTs (21.6%)). We identified 29 broad domains and 89 target domains. Among target domains, physical functioning (111 (58.4%)), mortality (94 (49.5%)), intra-cranial pressure target domain (68 (35.8%)), hemodynamics (53 (27.9%)) were the most frequent. Outcomes were mostly clinician-reported (177 (93.2%)) while patient-reported outcomes were rarely reported (11 (5.8%)). In our review, there was significant heterogeneity in the choice of endpoints in TBI clinical research. There is an urgent need for consensus and homogeneity in order to improve the quality of clinical research in this area.
