The statistical significance of a meta-analysis of a binary outcome could be changed if the outcomes of a few patients were modified within the randomized controlled trials included in it.
The Fragility Index for meta-analyses of randomized controlled trials is an intuitive measure for the confidence we have in the statistical significance of a meta-analysis.
It is defined as the minimum number of patients from one or more trials included in the meta-analysis for which a modification on the event status (ie, changing events to non-events, or non-events to events) would change the statistical significance of the pooled treatment effect.
After specific event-status modifications, a statistically significant pooled treatment effect could be turned non-significant, and a statistically non-significant treatment effect could be turned significant.
Evaluate the fragility of the statistical significance of your own meta-analysis!
The method used to evaluate the Fragility Index of meta-analyses is based on an iterative re-evaluation of the statistical significance of the pooled treatment effect of modified meta-analyses, iteratively derived from the original meta-analysis by performing single event-status modifications in each arm of each trial in turn.
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Evaluate the Fragility Index of your own meta-analysis!