A Mixed Method Study in Young Children Participating in Clinical Research During A Kidney Transplantation Trajectory.

Abstract

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.