Department of Anaesthesiology, Pain and Palliative Care, Radboud University Medical Center, GA Nijmegen, the Netherlands.
Department of Clinical Psychology, Amalia Children's Hospital Radboud University Medical Center, Nijmegen, the Netherlands.
Prog Transplant. 2024 Sep;34(3):89-95. doi: 10.1177/15269248241268718. Epub 2024 Aug 14.
Regulations designed to protect children participating in clinical research often restrict the availability of research data necessary for the development of age-specific therapies and drug dosing. Few data exist on how children experience participation in clinical research, and studies investigating young children undergoing an intensive medical treatment are lacking.
Mixed methods with semi-structured interviews and DISCO-RC questionnaires were used to explore young children's and their parents' experiences in clinical research participation during a kidney transplantation trajectory.
Nine children and their parents were interviewed. Children's median age at kidney transplantation was 4 years (IQR 4,7); age at interview was 7 years (IQR 6,9). Thematic content analysis of interviews revealed that most children were unaware of having participated in a study. Both children and their parents frequently were unaware whether procedures were standard care or research related. The additional burden attributed to study participation varied from not at all to heavy in combination with intensive medical treatment. Positive experiences included kind healthcare professionals, effective distraction techniques, educational aspects, contributing to science and extra check-ups. Most reported negative experiences were conflicting communication, spending much time in the hospital, missing school and suboptimal planning. Venous puncture was stressful for all children, whereas the discomfort of other procedures varied.
Pediatric clinical research design should focus on education and fun during research procedures, smart planning, consistent communication, close collaboration between clinical and research team and age appropriate distraction techniques.
旨在保护参与临床研究的儿童的法规通常限制了特定年龄治疗方法和药物剂量开发所需的研究数据的可用性。关于儿童参与临床研究的体验的数据很少，并且缺乏对接受密集医疗治疗的幼儿进行的研究。
采用混合方法，使用半结构化访谈和 DISCO-RC 问卷，探讨了儿童在肾移植过程中参与临床研究的经历及其父母的经历。
对 9 名儿童及其父母进行了访谈。儿童在肾移植时的中位年龄为 4 岁（IQR 4，7）；访谈时的年龄为 7 岁（IQR 6，9）。访谈的主题内容分析显示，大多数儿童不知道自己参与了一项研究。儿童及其父母经常不知道程序是标准护理还是与研究相关。与密集的医疗治疗相结合，研究参与带来的额外负担从无到有不等。积极的体验包括友善的医护人员、有效的分散注意力的技巧、教育方面、为科学做出贡献和额外的检查。大多数人报告的负面体验是沟通不一致、在医院花费大量时间、缺课和计划不佳。静脉穿刺对所有儿童来说都很有压力，而其他程序的不适则因人而异。
儿科临床研究设计应注重研究过程中的教育和乐趣、巧妙的规划、一致的沟通、临床和研究团队之间的密切合作以及适合年龄的分散注意力技巧。
