Overview of Medical, Surgical, and Rehabilitation Outcome Measures Used in Randomized Controlled Trials of Moderate to Severe Traumatic Brain Injury.

Abstract: Optimal reporting of outcomes is critical for the interpretation of research findings. This review aimed to examine the utilization of outcome measures in randomized controlled trials of moderate to severe traumatic brain injury. Systematic searches were conducted up to December 2022 in MEDLINE, PubMed, Scopus, CINAHL, Embase, and PsycINFO, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Randomized controlled trials were included if the population studied had ≥18 yrs and ≥50% had moderate to severe traumatic brain injury. A total of 662 met inclusion criteria. There was a total of 839 unique outcome measures across all included randomized controlled trials. Of these, only 195 (23.2%) were used in ≥4 randomized controlled trials. On average, randomized controlled trials included 1.26 outcome measures (range 1-23). A total of 495 (59%) of outcome measures were classified in the recovery and rehabilitation category, and 344 (41%) in the medical and surgical measures category. There was a more equal representation of outcome measures in high-income countries compared to low to middle income countries, with the latter using fewer recovery and rehabilitation outcome measures. Outcome measures used in randomized controlled trials of moderate to severe traumatic brain injury have significant heterogeneity and variable clinical relevance, which limits the impact and generalizability of research in moderate to severe traumatic brain injury, and the ability to compare across studies.