Background Clinical studies in children are challenging, yet they are necessary to improve current therapeutic strategies. The success of ‘care-at-home’ initiatives sug-gests their potential to be adapted to paediatric clinical trial settings. This pilot aims to study the feasibility of such a patient-centred, innovative model for clinical research in children.
Methods This was a single-centre, prospective pilot study in children undergoing elective tonsillectomy at the University of Basel Children’s Hospital. Tonsillectomy as a model population had been chosen due to the fre-quency of this surgical procedure performed in this age group requiring standardised pain management with distinct inpatient (2–4 days) and at-home phases. Data on pain scores and concomitant medication and saliva samples were collected by caregivers on 2–4 inpatient study days with the support of study nurses and on 3 consequent study days at home. A specifically developed mobile application supported data collection. The prima-ry endpoint was the proportion of complete and correct caregiver-collected clinical data (pain score) and saliva samples in the at-home setting. Secondary endpoints included practicability, and the proportion of caregivers consenting to take part in the study (incl. reasons asso-ciated with non-consent), and the cost-effectiveness of the study.
Results A total number of 23 children were included in the study of which 16 children, median age 6.0 years (IQR 4.8, 7.5), provided evaluable data. During the at-home phase, 76.2% of the saliva samples and 91.8% of the pain score data were complete. At home, 42.5% of the saliva samples and 80.7% of the pain scores were collected cor-rectly. Overall, 56.7% of all saliva sample and pain score data were complete and correct in the at-home setting. Most parents supported the concept of conducting stud-ies at home, but the most-common reason for non-par-ticipation was lack of time. Study costs for a sample size of 100 patients were calculated 20% lower for the at-home than for a traditional in-patient study setting.
Conclusion At-home study conduction might be a feasible approach in paediatric clinical trials when certain circumstances are met. While this method seems to work well for data entry (e.g. questionnaires or diaries), it clear-ly does not for collection of samples within narrow time frames.
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