• Ranjit D Singh, van DijckJeroen T J MJTJMDepartment of Neurosurgery, University Neurosurgical Center Holland, Leiden University Medical Centre, Haaglanden Medical Center, and Haga Teaching Hospital, Leiden University, The Hague, The Netherlands., MaasAndrew I RAIRDepartment of Neurosurgery, Antwerp University Hospital and University of Antwerp, Edegem, Belgium., Wilco C Peul, and Thomas A van Essen.
• Department of Neurosurgery, University Neurosurgical Center Holland, Leiden University Medical Centre, Haaglanden Medical Center, and Haga Teaching Hospital, Leiden University, The Hague, The Netherlands. Electronic address: r.d.singh@lumc.nl.
• World Neurosurg. 2022 May 1; 161: 410-417.

BackgroundInvestigating neurosurgical interventions for traumatic brain injury (TBI) involves complex methodological and practical challenges. In the present report, we have provided an overview of the current state of neurosurgical TBI research and discussed the key challenges and possible solutions.MethodsThe content of our report was based on an extensive literature review and personal knowledge and expert opinions of senior neurosurgeon researchers and epidemiologists.ResultsCurrent best practice research strategies include randomized controlled trials (RCTs) and comparative effectiveness research. The performance of RCTs has been complicated by the heterogeneity of TBI patient populations with the associated sample size requirements, the traditional eminence-based neurosurgical culture, inadequate research budgets, and the often acutely life-threatening setting of severe TBI. Statistical corrections can mitigate the effects of heterogeneity, and increasing awareness of clinical equipoise and informed consent alternatives can improve trial efficiency. The substantial confounding by indication, which limits the interpretability of observational research, can be circumvented by using an instrumental variable analysis. Traditional TBI outcome measures remain relevant but do not adequately capture the subtleties of well-being, suggesting a need for multidimensional approaches to outcome assessments.ConclusionsIn settings in which traditional RCTs are difficult to conduct and substantial confounding by indication can be present, observational studies using an instrumental variable analysis and "pragmatic" RCTs are promising alternatives. Embedding TBI research into standard clinical practice should be more frequently considered but will require fundamental modifications to the current health care system. Finally, multimodality outcome assessment will be key to improving future surgical and nonsurgical TBI research.Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.

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