Key result
Operative management robustly outperforms non-operative management as the standard of care for acute uncomplicated appendicitis.
Why the study?
The robustness of randomized controlled trials comparing non-operative and operative management of acute uncomplicated appendicitis had not been assessed using fragility metrics.
Is the evidence from RCTs comparing non-operative management to operative management for acute uncomplicated appendicitis robust based on fragility index?
Systematic Review (n=5)
Is the evidence from RCTs comparing non-operative management to operative management for acute uncomplicated appendicitis robust based on fragility index?
RCTs comparing operative and non-operative management of acute uncomplicated appendicitis are robust, favoring operative management as the standard of care.
Answers are grounded in this paper and cite their sources.
Supports operative management as standard for acute uncomplicated appendicitis; confirms statistical robustness of RCT evidence.
Background The fragility index (FI) is a statistical evaluation of the robustness of randomized controlled trials (RCTs) and quantifies how many patient outcomes would need to change to alter statistical significance. A FI of ≤3 is considered a fragile study. This study assessed the fragility of RCTs comparing non-operative management (NOM) and operative management (OM) of acute uncomplicated appendicitis (AUA). Methods A systematic search of PubMed and Google Scholar was conducted to identify RCTs published between January 2000 and September 2025 that reported a statistically significant dichotomous primary outcome ( P < 0.05) and featured 2 parallel arms (NOM vs OM). The FI, reverse FI (RFI), fragility quotient (FQ), and reverse FQ (RFQ) were calculated. Results Five RCTs met criteria for inclusion: 4 negative non-inferiority (NI) RCTs and 1 positive superiority RCT. The superiority RCT assessed treatment success at 6 months and found OM to be superior (FI = 10, FQ = 0.056). For negative NI RCTs, median (range) RFI scores were 30 (4-55); none of these trials confirmed NI. The median RFQ scores were 0.050 (0.017-0.189). The NI RCT with the highest RFI (RFI = 55, RFQ = 0.065) analyzed treatment at 12 months, and the absolute difference in failure rates was 26.7% (90% CI: 22.4-30.9), failing to demonstrate non-inferiority of antibiotic management. Discussion All examined RCTs were robust, favoring OM as the standard of care for AUA. Fragility calculations can help interpret the quality of RCTs, supplementing traditional statistical calculations and providing an additional metric for readers to assess study robustness.
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Walker et al. (2026) conducted a systematic review in Acute uncomplicated appendicitis (n=5). Non-operative management vs. Operative management was evaluated on Fragility index (FI) and reverse fragility index (RFI). A fragility analysis of 5 RCTs comparing non-operative and operative management for acute uncomplicated appendicitis found all trials to be robust, favoring operative management as the standard of care.
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