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O-18 Clinical studies at-home: feasibility of data and sample collection in paediatric pain management after tonsillectomy (tomachi)
  1. Von Niederhäusern1,
  2. Saccilotto1,
  3. Schädelin1,
  4. Benkert1,
  5. Summerer2,
  6. Ziesenitz2,
  7. Hammann1,
  8. Bielicki2,
  9. Pfister2,
  10. Pauli-Magnus1
  1. 1University Hospital Basel, BASEL, Switzerland
  2. 2University of Basel Children’s Hospital, BASEL, Switzerland

Abstract

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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