Abstract

The fragility index (FI) is an objective measure of robustness in statistically significant binary outcomes and is calculated as the minimum number of event conversions to change the results from statistically significant to nonsignificant. The FI can also be applied to nonsignificant trials to assess the number of events needed to change the results from statistically nonsignificant to significant. Many randomized controlled trials (RCTs) in vascular surgery comparing endovascular techniques to open surgery have found statistically nonsignificant primary outcomes.

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