研究动态
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支持当前神经外科指南的随机对照试验的鲁棒性。

Robustness of Randomized Control Trials Supporting Current Neurosurgery Guidelines.

发表日期:2023 Mar 21
作者: N U Farrukh Hameed, Xiaoran Zhang, Omar Sajjad, Sam Sathyamurthi, Maadeha H Zaidi, Nicolina Jovanovich, Ahmed Habib, Mamindla Priyadharshini, Pascal O Zinn
来源: NEUROSURGERY

摘要:

神经外科治疗指南通常基于随机对照试验(RCT)获得的证据。通过计算脆弱性指数(FI)-转换为无事件结果所需的最小患者数量来评估支持目前中枢神经肿瘤和脑血管疾病指南的RCT的强度,并改变显著试验主要结果。我们分析了《神经外科医师和美国神经外科医师协会关于中枢神经肿瘤和脑血管疾病管理的指南》中引用的RCT。评估了试验特征,对实验干预有利的主要终点的统计显着差异发现,FI和减去失访人数的FI。在确定的312个RCT中,有158个(50.6%)是2000年至2010年发表的,106个(34%)是在2010年之后。有63个试验(19.2%)被归类为手术试验,其余研究医疗治疗(82.0%)或经皮介入(8.33%)。这些试验的中位数功率为80.0%(IQR 80.0-90.0)。其中,有120个试验符合FI计算的条件。中位数FI为7.0(IQR 2.0-16.25)。44项(36.6%)试验FI≤3,表示非常低的稳健性。在调整协变量后,近期发表的试验和研究经皮介入的试验与老试验和比较手术方法的试验相比,与显着较高的FI相关。限于单个中心的试验与FI显着较低相关。支持当前神经肿瘤和神经血管外科干预指南的试验稳健性较低。虽然试验的稳健性随着时间的推移而改善,但未来的指南在其建议中必须考虑这一指标。版权 ©2023年神经外科医师协会。保留所有权利。
Treatment guidelines in neurosurgery are often based on evidence obtained from randomized controlled trials (RCTs).To evaluate the robustness of RCTs supporting current central nervous tumor and cerebrovascular disease guidelines by calculating their fragility index (FI)-the minimum number of patients needed to switch from an event to nonevent outcome to change significant trial primary outcome.We analyzed RCTs referenced in the Congress of Neurological Surgeons and American Association of Neurological Surgeons guidelines on central nervous tumor and cerebrovascular disease management. Trial characteristics, finding of a statistically significant difference in the primary endpoint favoring the experimental intervention, the FI, and FI minus number lost to follow-up were assessed.Of 312 RCTs identified, 158 (50.6%) were published from 2000 to 2010 and 106 (34%) after 2010. Sixty-three trials (19.2%) were categorized as surgical trials, and the rest studied medical treatment (82.0%) or percutaneous intervention (8.33%). The trials had a median power of 80.0% (IQR 80.0-90.0). Of these, 120 trials were eligible for FI calculation. The median FI was 7.0 (IQR 2.0-16.25). Forty-four (36.6%) trials had FI ≤ 3 indicating very low robustness. After adjusting for covariates, recently published trials and trials studying percutaneous interventions were associated with significantly higher FI compared with older trials and trials comparing surgical approaches, respectively. Trials limited to single centers were associated with significantly lower FI.Trials supporting current guidelines on neuro-oncological and neurovascular surgical interventions have low robustness. While the robustness of trials has improved over time, future guidelines must take into consideration this metric in their recommendations.Copyright © Congress of Neurological Surgeons 2023. All rights reserved.