Dibbets Anna Caroline, Koldeweij Charlotte, Osinga Esra P, Scheepers Hubertina C J, de Wildt Saskia N
Division of Pharmacology and Toxicology, Department of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.
Department of Obstetrics and Gynaecology, Maastricht University Medical Center, Maastricht, The Netherlands.
Clin Pharmacol Ther. 2025 Mar;117(3):633-645. doi: 10.1002/cpt.3510. Epub 2024 Dec 10.
Model-informed precision dosing (MIPD) utilizes mathematical models to predict optimal medication doses for a specific patient or patient population. However, the factors influencing the implementation of MIPD have not been fully elucidated, hindering its widespread use in clinical practice. A systematic review was conducted in PubMed from inception to December 2022, aiming to identify barriers and facilitators for the implementation of MIPD into patient care. Articles with a focus on implementation of MIPD were eligible for this review. After screening titles and abstracts, full articles investigating the clinical implementation of MIPD were included for data extraction. Of 790 records identified, 15 publications were included. A total of 72 barriers and facilitators across seven categories were extracted through a hybrid thematic analysis. Barriers comprised limited data for model validation, unclear regulatory pathways for model endorsement and additional drug level measurements required for certain types of MIPD. Facilitators encompassed the development of user-friendly MIPD tools continuously updated based on user feedback and data. Collaborative efforts among diverse stakeholders for model validation and implementation, along with education of end-users, may promote the utilization of MIPD in patient care. Despite ongoing challenges, this systematic review revealed various strategies to facilitate the clinical implementation of MIPD.
模型指导的精准给药（MIPD）利用数学模型为特定患者或患者群体预测最佳药物剂量。然而，影响MIPD实施的因素尚未完全阐明，这阻碍了其在临床实践中的广泛应用。对PubMed数据库从建库至2022年12月进行了一项系统评价，旨在确定将MIPD应用于患者护理的障碍和促进因素。聚焦于MIPD实施的文章符合本评价的纳入标准。在筛选标题和摘要后，纳入调查MIPD临床实施情况的全文进行数据提取。在识别出的790条记录中，纳入了15篇出版物。通过混合主题分析共提取了七大类中的72个障碍和促进因素。障碍包括用于模型验证的数据有限、模型认可的监管途径不明确以及某些类型的MIPD需要额外的药物水平测量。促进因素包括开发基于用户反馈和数据不断更新的用户友好型MIPD工具。不同利益相关者之间为模型验证和实施所做的协作努力，以及对终端用户的教育，可能会促进MIPD在患者护理中的应用。尽管仍存在挑战，但这项系统评价揭示了促进MIPD临床实施的各种策略。
