Current state of Russian rcts in anesthesiology and intensive care: methodological characteristics and statistical fragility of mortality outcomes (a systematic review)

Introduction. Randomized controlled trials (RCTs) are a cornerstone of evidence-based assessment of medical interventions; however, the statistical significance of their results may depend on a small number of events. The Fragility Index (FI) and Reverse Fragility Index (RFI) provide additional measures of the robustness of conclusions based on binary outcomes. This study aimed to assess the methodological characteristics and statistical robustness of mortality outcomes in RCTs published In Russian journals in anesthesiology and intensive care medicine. Material and methods. A systematic review was performed of RCTs published in 2016–2025 in four Russian specialty journals. The study was conducted in accordance with PRISMA 2020. Methodological characteristics and mortality data were extracted. Statistical significance was recalculated using the two-sided Fisher exact test. FI was calculated for statistically significant results, and RFI for non-significant results. Results. Of 2.347 publications, 43 RCTs reporting mortality data were included, accounting for 1.8% of all publications. The total number of randomized patients was 3.750; the median sample size was 60 [47.5; 90]. Four RCTs (9.3%) were multicenter studies, sample size calculation was reported in 9 studies (20.9%), and trial registration in 5 studies (11.6%). Statistically significant differences in mortality were identified in 2 RCTs; in both cases, FI was 1. The median RFI was 5 [4; 6], and RFI ≤5 was observed in 61.0% of studies. Conclusion. The findings indicate a shortage of RCTs reporting mortality data In Russian specialty journals in anesthesiology and intensive care medicine, as well as insufficient statistical robustness of their results. The development of the national evidence base in this field requires a shift from predominantly small single-center studies to prospectively planned, registered, and methodologically transparent multicenter RCTs.