一项神经创伤试验的死亡教训：从针对老年创伤性急性硬膜下血肿患者手术的随机评估（RESET-ASDH）试验过早中止中吸取的经验教训
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.
作者信息
Singh R D, van Dijck J T J M, van Essen T A, Nix H P, Vreeburg R J G, den Boogert H F, de Ruiter G C W, Depreitere B, Peul W C
机构信息
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.
出版信息
Brain Spine. 2024 Jul 18;4:102903. doi: 10.1016/j.bas.2024.102903. eCollection 2024.
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.
引言
创伤性脑损伤（TBI）所致急性硬膜下血肿（ASDH）在全球范围内构成了日益严重的健康问题，尤其是在老年人群体中。手术治疗与保守治疗的决策给神经外科医生带来了两难困境。国家、医院和个体神经外科医生之间存在很大的实践差异，这表明存在“临床 equipoise”。RESET-ASDH 试验旨在解决这一两难困境，但由于患者招募不足而提前终止。
研究问题
哪些因素可能导致了 RESET-ASDH 试验的提前终止？
材料与方法
RESET-ASDH 是一项多中心随机对照试验（RCT），比较老年患者（≥65 岁）创伤性 ASDH 早期手术后 1 年或初始保守治疗后的功能结局。分析了注册数据日志、医学伦理批准时间表和与 COVID-19 相关的研究文件。此外，还对参与的临床研究人员进行了非结构化访谈。
结果
神经外科医生广泛地将临床 equipoise 的概念误解为个体不确定性，这阻碍了患者招募。此外，老年目标人群使纳入过程变得复杂，因为老年人及其非正式护理人员对参与我们的急性外科试验犹豫不决。此外，COVID-19 大流行增加了额外的障碍，如医学伦理批准延迟、符合条件的患者数量下降以及在大流行高峰期试验多次暂停。
讨论与结论
RESET-ASDH 研究的提前终止可能与试验方法和目标人群有关，COVID-19 也产生了额外影响。未来针对老年人的急性神经外科试验可能需要考虑这些挑战，以防止试验提前终止。
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