Perioperative medicine & outcomes
Fragility Index of Randomized Clinical Trials in Perioperative Anesthesia: A Methodologic Survey of Guideline-supporting Evidence
Authors' conclusion
Randomized superiority trials underpinning contemporary perioperative guideline recommendations are generally small and demonstrate modest Fragility Index values, indicating that statistical conclusions often depend on relatively few outcome events.
Study context
- Population
- Parallel-group or factorial randomized controlled trial (RCTs) with binary outcomes cited in North American and European perioperative clinical practice guidelines published 2012–2022
- Participants
- 161 superiority RCTs
- Outcome
- FI of superiority trials
Methodological detailsstratified random sampling, prespecified exploratory negative binomial regression, Of 1,868 identified RCTs, 639 met eligibility criteria
- Stratified random sampling
- Prespecified exploratory negative binomial regression
- Of 1,868 identified RCTs, 639 met eligibility criteria
Main finding
As reported in the abstract
Median Fragility Index (FI) (IQR 2 to 8)
4
Median sample size, participants (IQR 80 to 310)
120
Cardiovascular trials, highest median FI (IQR 1 to 13)
6
Observational data: associations, not effects.
Further findings
| Outcome | IRR (95% CI) | |
|---|---|---|
| Trial characteristics associated with FI (exploratory multivariable analysis)Obstetric trials vs Adult trials · higher FI · exploratory | 1.63 (1.02–2.65) | |
| Trial characteristics associated with FI (exploratory multivariable analysis)Single-center trials vs Multicenter trials · lower FI · exploratory | 0.52 (0.35–0.76) | |
| 0.20.5125Incidence rate ratio (log scale) |
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Fragility Index of Randomized Clinical Trials in Perioperative Anesthesia: A Methodologic Survey of Guideline-supporting Evidence. Anesthesiology. Published 25 September 2026. doi:10.
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