Safety, quality & education

The Fragility Index of randomized controlled trials in pediatric anesthesiology

Can J AnaesthPublished Systematic review

Authors' conclusion

The FI of published trials in pediatric anesthesiology is similarly low as in other medical specialties. Larger trials with more events and P values ≤ 0.01 were associated with a higher FI.

Study context

Population
Pediatric anesthesiology randomized controlled trials (RCTs) comparing an intervention between two groups with a statistically significant P value (< 0.05) for a dichotomous outcome
Outcome
Fragility Index (FI): number of outcome events that would need to change to nonevents to render a significant P value nonsignificant (P ≥ 0.05)
Methodological detailsmeta-research study of Fragility Index, comprehensive systematic search, high-impact anesthesia, surgical and medical journals, last 25 years
  • Meta-research study of Fragility Index
  • Comprehensive systematic search
  • High-impact anesthesia, surgical and medical journals
  • Last 25 years

Pooled result

As reported in the abstract

Fragility Index

Median [IQR] Fragility Index (FI)

3

1–7

Further pooled results

Association of FI with trial characteristics

Positive correlation with number of participants (rS)
0.41; P < 0.001
Positive correlation with number of events (rS)
0.42; P < 0.001
Negative correlation with P value (rPB)
−0.36; P < 0.001
Other measures of trial quality and impact or importance not strongly associated with FI

Original publication

The Fragility Index of randomized controlled trials in pediatric anesthesiology. Can J Anaesth. Published 8 June 2023. doi:10.1007/s12630-023-02513-3

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