The Fragility Index of Randomized Controlled Trials for Preterm Neonates.

ABSTRACT:

Background

As a metric to determine the robustness of trial results, the fragility index (FI) is the number indicating how many patients would be required to reverse the significant results. This study aimed to calculate the FI in randomized controlled trials (RCTs) involving premature.

Methods

Trials were included if they had a 1:1 study design, reported statistically significant dichotomous outcomes, and had an explicitly stated sample size or power calculation. The FI was calculated for binary outcomes using Fisher's exact test, and the FIs of subgroups were compared. Spearman's correlation was applied to determine correlations between the FI and study characteristics.

Results

Finally, 66 RCTs were included in the analyses. The median FI for these trials was 3.00 (

SUBMITTER: Li H 

PROVIDER: S-EPMC9124941 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature