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Introduction <p>Model-Informed Precision Dosing (MIPD) is increasingly used to optimize vancomycin therapy in critically ill patients. However, process evaluations randomized controlled trials (RCTs) of MIPD remain rare, particularly in neonatal and pediatric intensive care. They provide however valuable insights about how and why interventions work.</p> Aim <p>This study explored healthcare professionals’ (HCPs) experiences with using the MIPD software for vancomycin during the BENEFICIAL-RCT in critically ill children and examined contextual factors influencing its use.</p> Method <p>A qualitative descriptive exploratory study was conducted after the BENEFICIAL-RCT in 8 Belgian hospitals. Semi-structured interviews and focus groups were held between January and May 2025 with physicians, clinical pharmacists, clinical biologists, and trial nurses. Data were analyzed thematically.</p> Results <p>Twenty-one HCPs participated. Four overarching themes emerged: enhanced clinical confidence and professional empowerment, experienced workflow barriers, clinical and healthcare-system implications and conditions for sustained MIPD-adoption. Participants described that beyond faster attainment of target AUC, the software fostered professional empowerment through its visualizations and the ability to retain final decision authority. Experiences also underscored how infrequent clinical exposure to adopting MIPD hindered continuity of MIPD expertise. This was pertinent in settings with low vancomycin case volumes or frequent rotating medical staff. As experienced workflow barriers especially the pivotal role of nurses in ensuring accurate documentation of sampling and infusion times was mentioned. These documentation uncertainties were perceived as affecting trust in the dosing workflow. Participants also highlighted night-time operational challenges for which workarounds set up during the RCT would not be feasible for routine practice. Concerning conditions for sustained MIPD-implementation, HCPs emphasized the importance of MIPD integration in electronic health records and automated dose calculation. The need for local MIPD champions was recurrently emphasized, particularly to support onboarding of new HCPs in MIPD.</p> Conclusion <p>The results highlight that to support broader implementation of MIPD in pediatric critical care, hospitals should prioritize electronic record integration, streamline workflows, and appoint internal MIPD champions. These measures may reduce workload and errors, and support sustainable use in daily practice.</p>

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A qualitative process evaluation of a clinical trial on bedside model-informed precision dosing of vancomycin in critically ill children

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  • 发表日期：

    2026年3月19日

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  • Lise-Marie Kinnaer,
  • Anca Amza,
  • Pieter De Cock

摘要

Introduction

Model-Informed Precision Dosing (MIPD) is increasingly used to optimize vancomycin therapy in critically ill patients. However, process evaluations randomized controlled trials (RCTs) of MIPD remain rare, particularly in neonatal and pediatric intensive care. They provide however valuable insights about how and why interventions work.

Aim

This study explored healthcare professionals’ (HCPs) experiences with using the MIPD software for vancomycin during the BENEFICIAL-RCT in critically ill children and examined contextual factors influencing its use.

Method

A qualitative descriptive exploratory study was conducted after the BENEFICIAL-RCT in 8 Belgian hospitals. Semi-structured interviews and focus groups were held between January and May 2025 with physicians, clinical pharmacists, clinical biologists, and trial nurses. Data were analyzed thematically.

Results

Twenty-one HCPs participated. Four overarching themes emerged: enhanced clinical confidence and professional empowerment, experienced workflow barriers, clinical and healthcare-system implications and conditions for sustained MIPD-adoption. Participants described that beyond faster attainment of target AUC, the software fostered professional empowerment through its visualizations and the ability to retain final decision authority. Experiences also underscored how infrequent clinical exposure to adopting MIPD hindered continuity of MIPD expertise. This was pertinent in settings with low vancomycin case volumes or frequent rotating medical staff. As experienced workflow barriers especially the pivotal role of nurses in ensuring accurate documentation of sampling and infusion times was mentioned. These documentation uncertainties were perceived as affecting trust in the dosing workflow. Participants also highlighted night-time operational challenges for which workarounds set up during the RCT would not be feasible for routine practice. Concerning conditions for sustained MIPD-implementation, HCPs emphasized the importance of MIPD integration in electronic health records and automated dose calculation. The need for local MIPD champions was recurrently emphasized, particularly to support onboarding of new HCPs in MIPD.

Conclusion

The results highlight that to support broader implementation of MIPD in pediatric critical care, hospitals should prioritize electronic record integration, streamline workflows, and appoint internal MIPD champions. These measures may reduce workload and errors, and support sustainable use in daily practice.