• HameedN U FarrukhNUFDepartment of Neurosurgery, University of Pittsburgh Medical Center, Pittsburgh , Pennsylvania , USA.Hillman Cancer Center, University of Pittsburgh Medical Center, Pittsburgh , Pennsylvania , USA., Xiaoran Zhang, Omar Sajjad, Sam Sathyamurthi, Maadeha H Zaidi, Nicolina Jovanovich, Ahmed Habib, Mamindla Priyadharshini, and Pascal O Zinn.
• Department of Neurosurgery, University of Pittsburgh Medical Center, Pittsburgh , Pennsylvania , USA.
• Neurosurgery. 2023 Sep 1; 93 (3): 539545539-545.

BackgroundTreatment guidelines in neurosurgery are often based on evidence obtained from randomized controlled trials (RCTs).ObjectiveTo 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.MethodsWe 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.ResultsOf 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.ConclusionTrials 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.

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