Quintillá Jose Maria, de la Gala Carmen, Berrueco Ruben, Claverol Joana, Figueres Bibiana, Bergós Anna, Rodríguez Lourdes, Mora Anna, DiBiaso Victoria, Llanos Cristina, Nafria Begonya
Clinical Simulation Unit, Hospital Sant Joan de Déu, Passeig de Sant Joan de Déu 2, 08950, Esplugues de Llobregat, Spain.
Co-director of the Fellowship in Clinical Simulation and Patient Security, Laboratorio de Simulación Clínica de la Facultad de Medicina y Ciencias de la Salud, Universitat de Barcelona, Barcelona, Spain.
Paediatr Drugs. 2025 Jan;27(1):73-84. doi: 10.1007/s40272-024-00660-8. Epub 2024 Nov 25.
Clinical trials entail complex processes that are more challenging when they are addressed to pediatric patients and include a decentralized design. High-realistic simulation allows for the testing and refining of procedures, organizational systems, and interactions between professionals and patients/families, narrowing the gap between work-as-imagined and work-as-done.
The aim of this research was to analyze the impact of simulation in three key moments of a clinical trial: the baseline visit, home administration of the investigational drug by parents, and the drawing and processing of pharmacokinetics samples by a home nurse.
Multidisciplinary meetings were held between the team of Barcelona Children's Hospital and the sponsor to define the simulation objectives. Three simulation scenarios were executed in 2 days. Subsequently, a post-process analysis was performed, including the assessment of the patient/family experience.
In the baseline visit scenario, minimum duration was calculated, and main aspects related to task dynamics, materials, and training were identified. In the drug administration scenario, the family was able to carry out the infusion within the time established in the protocol, but with some difficulties. In the home nursing scenario, some recommendations for improving safety and patient experience were suggested.
High-realistic clinical simulation can contribute to anticipate risks, refine the design of activities, and to identify specific needs prior to the protocol finalization, a timepoint in the process when modifications can still be made that constitutes a significant return on investment and return on the engagement, in the experience of the patients that will participate in the study.
NCT04644575.
临床试验涉及复杂的流程，当针对儿科患者并采用去中心化设计时，这些流程更具挑战性。高度逼真的模拟能够对程序、组织系统以及专业人员与患者/家庭之间的互动进行测试和优化，缩小设想中的工作与实际完成的工作之间的差距。
本研究旨在分析模拟在临床试验的三个关键环节中的影响：基线访视、家长在家中给予研究药物以及家庭护士采集和处理药代动力学样本。
巴塞罗那儿童医院团队与申办方召开多学科会议，以确定模拟目标。在两天内执行了三个模拟场景。随后进行了事后分析，包括对患者/家庭体验的评估。
在基线访视场景中，计算出了最短持续时间，并确定了与任务动态、材料和培训相关的主要方面。在药物给药场景中，家庭能够在方案规定的时间内完成输液，但存在一些困难。在家庭护理场景中，提出了一些改善安全性和患者体验的建议。
高度逼真的临床模拟有助于预测风险、优化活动设计，并在方案最终确定之前识别特定需求，此时仍可进行修改，这在参与研究的患者体验中构成了显著的投资回报率和参与回报率。
NCT04644575。
