The Reproducibility of Cerebrovascular Randomized Controlled Trials.

Area of Science:

• Neurosurgery
• Endovascular Surgery
• Clinical Trials

Background:

• Randomized controlled trials (RCTs) are crucial in cerebrovascular research.
• The fragility index is a novel metric to assess the robustness and reproducibility of RCT findings.
• Evaluating the fragility index in cerebrovascular RCTs is essential for reliable clinical decision-making.

Purpose of the Study:

• To evaluate the fragility index in key surgical and endovascular cerebrovascular RCTs.
• To propose a novel RCT classification system based on the fragility index.
• To enhance the interpretation of cerebrovascular trial results.

Main Methods:

• Review of cerebrovascular RCTs published between 2000 and 2018, focusing on stroke, carotid stenosis, cerebral aneurysms, and subarachnoid hemorrhage.
• Calculation and evaluation of the fragility index, number of patients lost to follow-up, and fragility quotient.
• Development of a 3-class RCT robustness classification system based on fragility index and patient follow-up data.

Main Results:

• Twenty RCTs with significant primary outcome differences were analyzed, showing a median fragility index of 5.5.
• A fragility quotient was derived from the fragility index and patient loss to follow-up.
• The proposed classification system effectively categorized RCT robustness based on reproducibility.

Conclusions:

• Neurosurgeons and neurointerventionalists must critically interpret cerebrovascular RCT results.
• Caution is advised for trials with small sample sizes, few events, and high patient attrition.
• The proposed fragility index-based classification system provides a quantitative tool for assessing study reliability.