The Fragility of Statistically Significant Findings in Pediatric Critical Care Randomized Controlled Trials*

This study aimed to assess the robustness of statistically significant results from pediatric critical care randomized controlled trials with dichotomous outcomes.
Data Sources:
A previously published scoping review of pediatric critical care randomized controlled trials (www.PICUtrials.net).
Study Selection:
A total of 342 trials were screened for inclusion. After applying inclusion/exclusion criteria, 43 fulfilled eligibility criteria and were included in the analysis.
Data Extraction:
Calculation of Fragility Index for trials reporting a statistically significant dichotomous outcome, and analysis of the relationship between trial characteristics and Fragility Index.
Data Synthesis:
The median Fragility Index was 2 (interquartile range, 1–6). The median sample size was 98 (interquartile range, 50–148) and sample size demonstrated a strong correlation with the Fragility Index (r = 0.729; n = 43; p

Source: Pediatric Critical Care Medicine - June 1, 2019 Category: Pediatrics Tags: Online Clinical Investigations Source Type: research