The Statistical Fragility of Outcomes on Breast Reconstruction with Acellular Dermal Matrix: A Systematic Review of Randomized Controlled Trials 

1. BACKGROUND

Acellular dermal matrices (ADMs) are often used in breast reconstruction

P-value reliance in ADM efficacy Randomized Controlled Trials (RCTs) can lead to misconceptions that affect patient and provider decision-making1

The Fragility Index (FI) is a metric to assess the statistical strength of RCTs and aid in interpreting P-values2,3

FI measures the minimum number of outcome changes needed to affect the study’s statistical significance2,3

Fragility analysis is common in other medical fields, but application in plastic and reconstructive surgery (PRS) remains understudied 

 

The study analyzed the statistical fragility of ADM outcomes in breast reconstruction RCTs within PRS literature