The death of a neurotrauma trial lessons learned from the prematurely halted randomized evaluation of surgery in elderly with traumatic acute subdural hematoma (RESET-ASDH) trial.

Autor:	Singh RD; University Neurosurgical Center Holland (UNCH), Leiden University Medical Center (LUMC), Haaglanden Medical Center (HMC) and Haga Teaching Hospital, Department of Neurosurgery, Leiden and The Hague, the Netherlands., van Dijck JTJM; University Neurosurgical Center Holland (UNCH), Leiden University Medical Center (LUMC), Haaglanden Medical Center (HMC) and Haga Teaching Hospital, Department of Neurosurgery, Leiden and The Hague, the Netherlands., van Essen TA; University Neurosurgical Center Holland (UNCH), Leiden University Medical Center (LUMC), Haaglanden Medical Center (HMC) and Haga Teaching Hospital, Department of Neurosurgery, Leiden and The Hague, the Netherlands.; Department of Surgery, Division of Neurosurgery, QEll Health Sciences Centre and Dalhousie University, Halifax, Nova Scotia, Canada., Nix HP; Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada., Vreeburg RJG; University Neurosurgical Center Holland (UNCH), Leiden University Medical Center (LUMC), Haaglanden Medical Center (HMC) and Haga Teaching Hospital, Department of Neurosurgery, Leiden and The Hague, the Netherlands., den Boogert HF; University Neurosurgical Center Holland (UNCH), Leiden University Medical Center (LUMC), Haaglanden Medical Center (HMC) and Haga Teaching Hospital, Department of Neurosurgery, Leiden and The Hague, the Netherlands., de Ruiter GCW; University Neurosurgical Center Holland (UNCH), Leiden University Medical Center (LUMC), Haaglanden Medical Center (HMC) and Haga Teaching Hospital, Department of Neurosurgery, Leiden and The Hague, the Netherlands., Depreitere B; University Hospital Leuven (UZ Leuven), Department of Neurosurgery, Leuven, Belgium., Peul WC; University Neurosurgical Center Holland (UNCH), Leiden University Medical Center (LUMC), Haaglanden Medical Center (HMC) and Haga Teaching Hospital, Department of Neurosurgery, Leiden and The Hague, the Netherlands.
Jazyk:	angličtina
Zdroj:	Brain & spine [Brain Spine] 2024 Jul 18; Vol. 4, pp. 102903. Date of Electronic Publication: 2024 Jul 18 (Print Publication: 2024).
DOI:	10.1016/j.bas.2024.102903
Abstrakt:	Introduction: Acute subdural hematoma (ASDH) due to traumatic brain injury (TBI) constitutes an increasing global health problem, especially in the elderly population. Treatment decisions on surgical versus conservative management pose a neurosurgical dilemma. Large practice variation exists between countries, hospitals, and individual neurosurgeons, illustrating the presence of 'clinical equipoise'. The RESET-ASDH trial aimed to address this dilemma but was terminated prematurely due to insufficient patient recruitment. Research Question: What factors may have contributed to the premature discontinuation of the RESET-ASDH trial? Materials and Methods: The RESET-ASDH was a multicenter randomized controlled trial (RCT) comparing functional outcome at 1 year after early surgery or an initial conservative treatment in elderly patients (≥65 years) with a traumatic ASDH. Logs of registry data, medical-ethical approval timelines and COVID-19 related research documents were analyzed. Furthermore, non-structured interviews with involved clinical research personnel were conducted. Results: The concept of clinical equipoise was broadly misinterpreted by neurosurgeons as individual uncertainty, hampering patient recruitment. Also, the elderly target population complicated the inclusion process as elderly and their informal caregivers were hesitant to participate in our acute surgical trial. Moreover, the COVID-19 pandemic added additional hurdles like delayed medical-ethical approval, a decline in eligible patients and repeated trial halts during the peaks of the pandemic. Discussion and Conclusion: The premature termination of the RESET-ASDH study may have been related to the trial's methodology and target population with an additional impact of COVID-19. Future acute neurosurgical trials in elderly may consider these challenges to prevent premature trial termination. Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (© 2024 The Authors.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu