Adeeb Nimer, Terrell Danielle L, Whipple Stephen Garrett, Thakur Jai Deep, Griessenauer Christoph J, Adeeb Abdallah, Aslan Asala, Mamilly Ahmed, Mortazavi Martin M, Dossani Rimal H, Guthikonda Bharat, Ogilvy Christopher S, Thomas Ajith J, Moore Justin M
Department of Neurosurgery, Ochsner LSU Medical Center, Louisiana State University, Shreveport, Louisiana, USA.
Department of Neurosurgery, Ochsner LSU Medical Center, Louisiana State University, Shreveport, Louisiana, USA.
World Neurosurg. 2020 Aug;140:e46-e52. doi: 10.1016/j.wneu.2020.04.106. Epub 2020 May 8.
Numerous randomized controlled trials (RCTs) relevant to the cerebrovascular field have been performed. The fragility index was recently developed to complement the P value and measure the robustness and reproducibility of clinical findings of RCTs.
In this study, we evaluate the fragility index for key surgical and endovascular cerebrovascular RCTs and propose a novel RCT classification system based on the fragility index.
Cerebrovascular RCTs reported between 2000 and 2018 were reviewed. Six key areas were specifically targeted in relation to stroke, carotid stenosis, cerebral aneurysms, and subarachnoid hemorrhage. The correlation between fragility index, number of patients lost to follow-up, and fragility quotient were evaluated to propose a classification system for the robustness of the studies.
A total of 20 RCTs that reported significant differences between both study groups in terms of the primary outcome were included. The median fragility index for the trials was 5.5. An additional 30 randomly selected RCTs were added to propose a classification system with high reliability. The difference between the number of patients lost to follow-up and fragility index inversely correlated with the fragility quotient and was used to divide the robustness of the RCTs into 3 classes reflecting the reproducibility of the trial.
Neurosurgeons and neurointerventionalists should exercise caution with interpreting the results of cerebrovascular RCTs, especially when the sample size and events numbers are small and there is a high number of patients who were lost to follow-up, as quantitatively identified using the proposed classification system.
已经开展了许多与脑血管领域相关的随机对照试验（RCT）。最近开发了脆弱性指数以补充P值，并衡量RCT临床研究结果的稳健性和可重复性。
在本研究中，我们评估关键的脑血管外科手术和血管内治疗RCT的脆弱性指数，并基于脆弱性指数提出一种新的RCT分类系统。
回顾了2000年至2018年期间报道的脑血管RCT。特别针对中风、颈动脉狭窄、脑动脉瘤和蛛网膜下腔出血的六个关键领域。评估脆弱性指数、失访患者数量和脆弱性商数之间的相关性，以提出研究稳健性的分类系统。
总共纳入了20项RCT，这些研究报告了两个研究组在主要结局方面存在显著差异。这些试验的中位脆弱性指数为5.5。另外增加了30项随机选择的RCT以提出具有高可靠性的分类系统。失访患者数量与脆弱性指数之间的差异与脆弱性商数呈负相关，并用于将RCT的稳健性分为3类，反映试验的可重复性。
神经外科医生和神经介入医生在解释脑血管RCT的结果时应谨慎，特别是当样本量和事件数量较少且失访患者数量较多时，如使用所提出的分类系统进行定量识别。
