Abstract：
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.
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.
摘要：
背景：神经外科治疗指南通常基于从随机对照试验（RCTs）获得的证据。
目的：通过计算脆性指数（FI）来评估支持当前中枢神经肿瘤和脑血管病指南的RCT的稳健性-从事件转归到非事件转归以改变重要试验主要结局所需的最小患者人数。
方法：我们分析了神经外科医师大会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指南中引用的RCT。试验特点,发现有利于实验干预的主要终点有统计学意义的差异，FI,评估了FI减去随访损失的数量。
结果：在确定的312个RCT中，从2000年到2010年发布了158篇（50.6%），在2010年之后发布了106篇（34%）。63项试验（19.2%）被归类为手术试验，其余研究药物治疗(82.0%)或经皮介入治疗(8.33%)。试验的中位功效为80.0%(IQR80.0-90.0)。其中,120项试验符合FI计算条件。中位FI为7.0（IQR2.0-16.25）。44项(36.6%)试验的FI≤3表明稳健性非常低。在调整协变量后，与较早的试验和比较手术方法的试验相比，最近发表的试验和研究经皮介入治疗的试验与较高的FI相关，分别。仅限于单个中心的试验与FI显着降低相关。
结论：支持当前神经肿瘤和神经血管外科干预指南的试验具有较低的稳健性。虽然试验的稳健性随着时间的推移而提高，未来的指导方针必须在他们的建议中考虑到这一指标。
目的：通过计算脆性指数（FI）来评估支持当前中枢神经肿瘤和脑血管病指南的RCT的稳健性-从事件转归到非事件转归以改变重要试验主要结局所需的最小患者人数。
方法：我们分析了神经外科医师大会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指南中引用的RCT。试验特点,发现有利于实验干预的主要终点有统计学意义的差异，FI,评估了FI减去随访损失的数量。
结果：在确定的312个RCT中，从2000年到2010年发布了158篇（50.6%），在2010年之后发布了106篇（34%）。63项试验（19.2%）被归类为手术试验，其余研究药物治疗(82.0%)或经皮介入治疗(8.33%)。试验的中位功效为80.0%(IQR80.0-90.0)。其中,120项试验符合FI计算条件。中位FI为7.0（IQR2.0-16.25）。44项(36.6%)试验的FI≤3表明稳健性非常低。在调整协变量后，与较早的试验和比较手术方法的试验相比，最近发表的试验和研究经皮介入治疗的试验与较高的FI相关，分别。仅限于单个中心的试验与FI显着降低相关。
结论：支持当前神经肿瘤和神经血管外科干预指南的试验具有较低的稳健性。虽然试验的稳健性随着时间的推移而提高，未来的指导方针必须在他们的建议中考虑到这一指标。
