@article {Von Niederh{\"a}usernA8, author = {Von Niederh{\"a}usern and Saccilotto and Sch{\"a}delin and Benkert and Summerer and Ziesenitz and Hammann and Bielicki and Pfister and Pauli-Magnus}, title = {O-18 Clinical studies at-home: feasibility of data and sample collection in paediatric pain management after tonsillectomy (tomachi)}, volume = {102}, number = {10}, pages = {A8--A8}, year = {2017}, doi = {10.1136/archdischild-2017-esdppp.18}, publisher = {BMJ Publishing Group Ltd}, abstract = {Background Clinical studies in children are challenging, yet they are necessary to improve current therapeutic strategies. The success of {\textquoteleft}care-at-home{\textquoteright} 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{\textquoteright}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{\textendash}4 days) and at-home phases. Data on pain scores and concomitant medication and saliva samples were collected by caregivers on 2{\textendash}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.}, issn = {0003-9888}, URL = {https://adc.bmj.com/content/102/10/A8.1}, eprint = {https://adc.bmj.com/content/102/10/A8.1.full.pdf}, journal = {Archives of Disease in Childhood} }