Abstract 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. <Table Float="No" ID="Taba"> <tgroup cols="2"> <colspec align="left" colname="c1" colnum="1" /> <colspec align="left" colname="c2" colnum="2" /> <tbody> <row> <entry align="left" nameend="c2" namest="c1"> 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. </entry> </row> </tbody> </tgroup> </Table>

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

期刊论文
发表日期：

2026年4月26日

查看全文

Anna Zanin,
Elisa Poletto,
Santiago Mencia,
Orsola Gawronski,
Gilles Jourdain

摘要

Abstract

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.