Robustness of Randomized Control Trials Supporting Current Neurosurgery Guidelines.

Area of Science:

• Neurosurgery
• Clinical Trials
• Evidence-Based Medicine

Background:

• Neurosurgical treatment guidelines rely heavily on evidence from randomized controlled trials (RCTs).
• The robustness of these RCTs is critical for the validity of current guidelines.
• Assessing the strength of evidence is essential for informed clinical decision-making.

Purpose of the Study:

• To evaluate the robustness of RCTs underpinning central nervous system tumor and cerebrovascular disease guidelines.
• To calculate the fragility index (FI) for these RCTs.
• To determine the minimum number of patients needed to alter trial outcomes.

Main Methods:

• Analysis of RCTs cited in CNS tumor and cerebrovascular disease guidelines.
• Assessment of trial characteristics, primary endpoint significance, and FI.
• Calculation of FI adjusted for patients lost to follow-up.

Main Results:

• Of 312 identified RCTs, 120 were eligible for FI calculation.
• The median FI was 7.0, with 36.6% of trials having an FI of 3 or less, indicating low robustness.
• Recently published trials and those studying percutaneous interventions showed higher FI; single-center trials had lower FI.

Conclusions:

• RCTs supporting current neuro-oncological and neurovascular surgical guidelines demonstrate low robustness.
• While trial robustness has improved, it remains a concern.
• Future neurosurgery guidelines should incorporate trial robustness metrics into their recommendations.