Clinical validation of digital biomarkers for paediatric patients with asthma and cystic fibrosis: potential for clinical trials and clinical care.

Kruizinga MD, Essers E, Stuurman FE, Yavuz Y, de Kam ML, Zhuparris A, Janssens HM, Groothuis I, Sprij AJ, Nuijsink M, Cohen AF, Driessen GJA

Digital biomarkers are a promising novel method to capture clinical data in a home setting. However, clinical validation prior to implementation is of vital importance. The aim of this study was to clinically validate physical activity, heart rate, sleep and forced expiratory volume in 1 s (FEV) as digital biomarkers measured by a smartwatch and portable spirometer in children with asthma and cystic fibrosis (CF).