Experiences and Challenges Updating a Living Evidence-Based Review of Randomized Controlled Trials on Mental Health and Behavioral Disorders in Individuals With Moderate to Severe Traumatic Brain Injury.

Objective: To describe experiences and challenges when updating a living evidence-based review database of randomized controlled trials (RCTs) on mental health and behavioral disorders in moderate to severe traumatic brain injury (MSTBI).

Method: This commentary derives from our experience developing an extensive database of RCTs on MSTBI that has been conceptualized as a living evidence-based review. Our working group focused on mental health and behavior RCTs and reflected upon their experiences and challenges using the living systematic approach. We discuss challenges associated with metrics of study quality, injury etiology and severity, time post-injury, country of origin, and variability in outcome measures.

Results: RCTs were conducted almost solely in high income countries, with smaller sample sizes, and most conducted in the chronic phase post-TBI. Issues related to lack of transparency, unclear and incomplete reporting of injury severity, etiology, and time post-injury remain a concern and can lead to challenges associated with interpretation of results, validity, and reliability of the data. There was significant heterogeneity regarding the use of outcome measures and constructs, underscoring the need for standardization.

Conclusion: Lack of standardization and incomplete reporting of injury characteristics makes it difficult to compare data between RCTs of MSTBI, perform meta-analyses, and generate evidence-based clinical recommendations.