Research AppraisalSystematic Review

Evaluating the impact of simulation on patient outcomes in pediatric and neonatal critical care: a systematic review and critical appraisal of the evidence

European journal of pediatricsZanin, Anna, Poletto, Elisa, Mencia, Santiago et al.26 Apr 2026DOI

Clinical Snapshot

60CEBM
Evidence: ModerateSystematic Review

PICO Framework

P — PopulationHealthcare professionals working in pediatric and neonatal critical care settings
I — InterventionSimulation-based education (SBE) programs
C — ComparatorStandard training methods or pre-intervention baseline
O — OutcomesKirkpatrick Level 4 outcomes: system-level processes (Level 4a) and direct patient outcomes (Level 4b) including mortality, complication rates, protocol adherence, and response times

Bottom Line

This systematic review reveals a critical evidence gap in simulation-based education research for pediatric and neonatal critical care. While simulation effectively improves system processes like protocol adherence and response times (75% of studies), evidence for direct patient benefit remains limited (50% of studies). Importantly, all included studies had high or critical risk of bias, predominantly due to non-randomized designs and single-center limitations. The distinction between Level 4a (system) and Level 4b (patient) outcomes is crucial for clinicians considering simulation investments. Current evidence supports simulation for process improvement but cannot definitively establish patient outcome benefits. Future research requires multicenter randomized trials with robust patient-centered endpoints. For Australian intensive care units, simulation programs remain valuable for training and system optimization, but expectations regarding direct patient outcome improvements should be tempered pending higher-quality evidence.

Evidence: Moderate

Key Findings

  • P Value: Not reported for pooled analysis

  • Effect Size: 75% of studies showed positive Level 4a outcomes; 50% showed positive Level 4b outcomes

  • Primary Outcome: Kirkpatrick Level 4 outcomes (system processes and direct patient outcomes)

  • Nnt Or Sensitivity: Not calculated due to heterogeneity of interventions and outcomes

  • Confidence Interval: Not reported - no meta-analysis performed

Clinical Application

Simulation programs are feasible but require significant resource investment and institutional commitment Relevant to Australian PICUs and NICUs; aligns with ANZPIC-RC training requirements and could inform CICM fellowship simulation components Healthcare professionals in pediatric and neonatal intensive care units globally

Abstract

UNLABELLED: While the literature widely supports a positive relationship between simulation-based education (SBE) and learning outcomes, its impact on patient outcomes remains less clearly understood. Our aim was to comprehensively survey the landscape of simulation-based research (SBR) that evaluates patient outcomes (Kirkpatrick Level 4) in the context of pediatric and neonatal critical care. A systematic search of MEDLINE, Cochrane Library, CINAHL, and ERIC was conducted through December 2024. We included RCTs, non-RCTs, and before-after studies focusing on Kirkpatrick Level 4 outcomes. Quality was appraised using the RoB 2 and ROBINS-I tools. A total of 2481 articles were screened. Sixteen studies met the inclusion criteria. Most were prospective (63%) and single-center (69%), with only three RCTs (19%). All included studies (100%) reported Level 4 outcomes; however, a critical distinction emerged between system-level and patient-level results. While 75% (12/16) of studies reported positive impacts on Level 4a (system processes), such as protocol adherence or response times, only 50% (8/16) demonstrated significant improvements in Level 4b (direct patient outcomes), such as mortality or complication rates. In addition, all included studies were judged to have a high or critical risk of bias. CONCLUSIONS: Although SBE effectively optimizes clinical processes (Level 4a), a significant evidence gap remains regarding its direct impact on patient health (Level 4b). Current SBR often lacks the methodological rigor-specifically the use of randomized designs-needed to isolate SBE as the primary driver of clinical improvement. Future research must prioritize high-quality, multicenter trials targeting patient-oriented metrics to bridge this translational gap. WHAT IS KNOWN: • SBE has been extensively developed in pediatric and neonatal critical care settings; however, its impact on healthcare professional training and on patient outcomes remains less well understood. WHAT IS NEW: • There is a scarcity of rigorous Level 4 evidence linking SBE to patient outcomes in pediatric and neonatal critical care. • We provide a methodological roadmap advocating for mixed-methods and multicenter designs to bridge this clinical evidence gap.

References

  1. 1.Zanin, A., Poletto, E., Mencia, S., Gawronski, O., & Jourdain, G. (2026). Evaluating the impact of simulation on patient outcomes in pediatric and neonatal critical care: a systematic review and critical appraisal of the evidence. European Journal of Pediatrics. https://doi.org/10.1186/s12912-025-03059-z
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