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

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.

conclusionsAlthough 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.