Fragility of randomized clinical trials comparing surgical approaches for inguinal hernia repair: a systematic review.
Maria Clara Morais, Denise Padilha Abs de Almeida, Beatriz Laus Pereira Lima et al.
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In 30 seconds
This systematic review assessed the fragility of dichotomous findings in randomized trials comparing inguinal hernia repair approaches. Searches identified 42 RCTs involving 14,505 patients and 44 primary comparisons; all eligible comparisons were laparoscopic versus open repair. Twelve comparisons were statistically significant, with a median Fragility Index of 4 (IQR, 3-5.25), and one-third had an index of 3 or less. Among nonsignificant comparisons, the median Reverse Fragility Index was 5 (IQR, 3.5-6.5). The authors recommend interpreting these post hoc measures alongside other trial evidence.
Key findings
- Of 12 significant primary comparisons, the median Fragility Index was 4 (IQR, 3-5.25); 4 (33.3%) had an FI of 3 or less.
- Among 31 nonsignificant primary comparisons, the median Reverse Fragility Index was 5 (IQR, 3.5-6.5).
- All 4 significant individual-complication results had an FI of 3 or less (median, 1).
- FI was not significantly correlated with sample size; significance classification differed between reported and recalculated P values in 4 of 78 extracted comparisons.
Why it matters
Fragility measures show how few outcome-status changes could alter whether a trial result crosses a statistical-significance threshold. This offers clinicians and evidence reviewers additional context when interpreting dichotomous outcomes in surgical trials, while not replacing assessment of effect estimates, confidence intervals, trial design, missing data, or clinical importance.
What to keep in mind
The review’s eligible comparisons were limited to laparoscopic versus open repair, so its findings do not address randomized comparisons involving robotic repair.