Koldeweij C J M, Dibbets A C, Ceulemans M, de Vries L C, Franklin B D, Scheepers H C J, de Wildt S N
Division of Pharmacology and Toxicology, Department of Pharmacy, Radboud University Medical Center, Nijmegen, Netherlands.
Department of Obstetrics and Gynaecology, Maastricht University Medical Centre, Maastricht, Netherlands.
Front Pharmacol. 2024 Aug 15;15:1403747. doi: 10.3389/fphar.2024.1403747. eCollection 2024.
Physiological changes in pregnancy may affect drug safety and efficacy, sometimes requiring dose adjustments. Pregnancy-adjusted doses, however, are missing for most medications. Increasingly, pharmacokinetic models can be used for antenatal dose finding. Given the novelty of this technique and questions regarding dose credibility, the acceptability of model-informed antenatal doses should be explored. We aimed to assess the willingness-to-use and preferred features for model-informed antenatal doses among healthcare practitioners (HCPs) and pregnant women in European countries. A cross-sectional, web-based study drawing on two open surveys was performed between 8 September and 30 November 2022. Each survey comprised statements drawn from prior focus groups, associated with Likert-scales. Themes included respondents' information needs, search behaviours along with their willingness-to-use and preferred features for model-informed antenatal doses. The surveys were disseminated through professional societies, pregnancy websites and social media. A descriptive analysis was performed. In total, 608 HCPs from different specialties and 794 pregnant women across 15 countries participated, with 81% of respondents across both groups in the Netherlands or Belgium. Among pregnant women, 31% were medical professionals and 85% used medication during pregnancy. Eighty-three percent of HCPs found current antenatal pharmacotherapy suboptimal and 97% believed that model-informed antenatal doses would enhance the quality of antenatal care. Most HCPs (93%) and pregnant women (75%) would be willing to follow model-informed antenatal doses. Most HCPs desired access to the evidence (88%), including from pharmacokinetic modelling (62%). Most pregnant women (96%) wanted to understand antenatal dosing rationales and to be involved in dosing decisions (97%). The willingness-to-use model-informed antenatal doses is high among HCPs and pregnant women provided that certain information needs are met.
孕期的生理变化可能会影响药物的安全性和疗效，有时需要调整剂量。然而，大多数药物都没有针对孕期调整的剂量。越来越多的药代动力学模型可用于产前剂量确定。鉴于这项技术的新颖性以及关于剂量可信度的问题，应探讨基于模型的产前剂量的可接受性。我们旨在评估欧洲国家医疗保健从业者（HCP）和孕妇对基于模型的产前剂量的使用意愿及偏好特征。2022年9月8日至11月30日期间，基于两项开放式调查开展了一项横断面网络研究。每项调查都包含从先前焦点小组中提取的陈述，并与李克特量表相关联。主题包括受访者的信息需求、搜索行为以及他们对基于模型的产前剂量的使用意愿和偏好特征。调查通过专业协会、孕期网站和社交媒体进行传播。进行了描述性分析。共有来自不同专业的608名HCP和来自15个国家的794名孕妇参与，两组中81%的受访者来自荷兰或比利时。在孕妇中，31%是医疗专业人员，85%在孕期使用过药物。83%的HCP认为当前的产前药物治疗并不理想，97%的人认为基于模型的产前剂量将提高产前护理质量。大多数HCP（93%）和孕妇（75%）愿意遵循基于模型的产前剂量。大多数HCP希望获取相关证据（88%），包括来自药代动力学建模的证据（62%）。大多数孕妇（96%）希望了解产前给药原理并参与给药决策（97%）。如果某些信息需求得到满足，HCP和孕妇对基于模型的产前剂量的使用意愿很高。
