Philip Lambrechtse1,2, Victoria C Ziesenitz3,4, Andrew Atkinson5, Ernst Jan Bos6, Tatjana Welzel5, Yael Gilgen7, Nicolas Gürtler8, Simone Heuscher8, Adam Frederik Cohen6, Johannes N van den Anker5,9. 1. Division of Paediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel (UKBB), University of Basel, Basel, Switzerland. piplambrechtse@gmail.com. 2. Centre for Human Drug Research (CHDR), Zernikedreef 8 2333CL, Leiden, the Netherlands. piplambrechtse@gmail.com. 3. Division of Paediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel (UKBB), University of Basel, Basel, Switzerland. Ziesenitz.md@gmail.com. 4. Department of Pediatric Cardiology, Centre for Child and Adolescent Medicine, University Hospital Heidelberg, Heidelberg, Germany. Ziesenitz.md@gmail.com. 5. Division of Paediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel (UKBB), University of Basel, Basel, Switzerland. 6. Centre for Human Drug Research (CHDR), Zernikedreef 8 2333CL, Leiden, the Netherlands. 7. Practice for Otorhinolaryngology "at the Zoo", Basel, Switzerland. 8. Clinic for Otorhinolaryngology, University Hospital Basel, Basel, Switzerland. 9. Division of Clinical Pharmacology, Children's National Hospital, Washington, DC, USA.
Abstract
An observational prospective feasibility study in which children received a tracker 2 weeks before a tonsillectomy and were required to wear it until four weeks postoperatively. The parents used a diary to log the estimated steps of their child. As primary endpoint, the compliance of complete datasets was compared between the tracker and the diary. As secondary endpoints, the agreement of steps between tracker and diary, and the recovery time after tonsillectomy were analyzed.Twenty-four patients (50% male) with a median age of 6 years were recruited. The tracker had a complete dataset compliance of 91.7% in the pre-operative and 58.3% in postoperative period, whereas the diary's compliance was 62.5% in the pre-operative and 12.5% in the postoperative period. The difference of 29.2% and 45.8% in the pre-operative and postoperative periods between the tracker and the diary was significant (p < 0.005). The tracker and diary had a mean agreement difference of 1063 steps per day. Mean recovery time was 21 days after tonsillectomy. Conclusion: The results of this pilot study support the use of a tracker in terms of compliance and practicability. Consumer-level activity trackers are a viable alternative to conventional manual logging for clinical use in pediatric research.Trial registration: ClinicalTrials.gov Identifier: NCT03174496 What is known: • Consumer-level activity trackers are already used in clinical research to monitor steps and physical activity. • The use of consumer-level activity trackers in clinical studies has mostly been validated in the adult population. What is new: • This study proves the feasibility of using physical activity trackers in a pediatric population before and after a surgical intervention. • Recovery of a patient could be assessed with an activity tracker.
An observational prospective feasibility study in which children received a tracker 2 weeks before a tonsillectomy and were required to wear it until four weeks postoperatively. The parents used a diary to log the estimated steps of their child. As primary endpoint, the compliance of complete datasets was compared between the tracker and the diary. As secondary endpoints, the agreement of steps between tracker and diary, and the recovery time after tonsillectomy were analyzed.Twenty-four patients (50% male) with a median age of 6 years were recruited. The tracker had a complete dataset compliance of 91.7% in the pre-operative and 58.3% in postoperative period, whereas the diary's compliance was 62.5% in the pre-operative and 12.5% in the postoperative period. The difference of 29.2% and 45.8% in the pre-operative and postoperative periods between the tracker and the diary was significant (p < 0.005). The tracker and diary had a mean agreement difference of 1063 steps per day. Mean recovery time was 21 days after tonsillectomy. Conclusion: The results of this pilot study support the use of a tracker in terms of compliance and practicability. Consumer-level activity trackers are a viable alternative to conventional manual logging for clinical use in pediatric research.Trial registration: ClinicalTrials.gov Identifier: NCT03174496 What is known: • Consumer-level activity trackers are already used in clinical research to monitor steps and physical activity. • The use of consumer-level activity trackers in clinical studies has mostly been validated in the adult population. What is new: • This study proves the feasibility of using physical activity trackers in a pediatric population before and after a surgical intervention. • Recovery of a patient could be assessed with an activity tracker.
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