Resampling Fragility in the MUTTON-HF Randomized Clinical Trial of an Indigenous Food Is Medicine Intervention

Abstract

Statistical fragility is not a single quantity. Resampling fragility estimates the probability that a trial's significance classification would reverse in a new sample of the same size, while perturbation fragility measures the minimum change to the recorded data that reverses the classification in the observed table. The primary endpoint of the Medically Utilized Tailored Traditional Foods to Optimize Nutrition in Heart Failure (MUTTON-HF) randomized clinical trial carries a resampling fragility of 0.38 under a within-arm binomial replication model, and a global fragility quotient of 0.0097 (unstable). These fragility metrics indicate that the significance classification behind this clinically promising result is easily reversed and therefore warrants cautious interpretation.