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

Abstract

BackgroundDigital 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 FEV1 as digital biomarkers measured by a smartwatch and portable spirometer in children with asthma and cystic fibrosis (CF).MethodsThis was a prospective cohort study including 60 children with asthma and 30 children with CF (age 6–16). Participants wore a smartwatch, performed daily spirometry at home and completed a daily symptom questionnaire for 28-days. Physical activity, heart rate, sleep and FEV1 were considered candidate digital endpoints. Data from 128 healthy children was used for comparison. Reported outcomes were compliance, difference between patients and controls, correlation with disease-activity and potential to detect clinical events. Analysis was performed with linear mixed effect models.ResultsMedian compliance was 88%. On average, patients exhibited lower physical activity and FEV1 compared to healthy children, whereas the heart rate of children with asthma was higher compared to healthy children. Days with a higher symptom score were associated with lower physical activity for children with uncontrolled asthma and CF. Furthermore, FEV1 was lower and (nocturnal) heart rate was higher for both patient groups on days with more symptoms. Candidate biomarkers and showed a distinct pattern before- and after a pulmonary exacerbation.ConclusionPortable spirometer- and smartwatch-derived digital biomarkers show promise as candidate endpoints for use in clinical trials or clinical care in pediatric lung disease.

DIGIPREDICT: physiological, behavioural and environmental predictors of asthma attacks—a prospective observational study using digital markers and artificial intelligence—study protocol

“…Digital technologies offer dual opportunities of monitoring in real-time (a) factors that increase the risk of an attack (eg, environmental triggers, individual history of attacks, poor adherence to preventer medication) to promote strategies to reduce risk and (b) objective measures that enable early detection of an imminent attack that can be captured by digital sensors 8 (eg, heart rate, [9][10][11] sleep quality 12 and peak expiratory flow 13 ), which can trigger an alert for immediate action to avert further deterioration. However, there has been no research to date that bring together the range of factors.…”

Home monitoring in asthma: towards digital twins

“…An evaluation of 100 patients with chronic lung diseases showed that heart rate and oxygen saturation values measured by the Apple Watch 6 were highly correlated with those measured by validated commercial devices, with Pearson coefficients of 0.99 and 0.81, respectively [21]. Physical activity can also be measured by smartwatches and connected bracelets, and it was shown that on average, children with asthma exhibited lower physical activity compared to their healthy peers [22 ▪▪ ]. In younger children, a connected bracelet worn on the arm is being validated (Gabi SmartCare, Liège, Belgium).…”

New trends in pediatric pulmonology: our experience

“…The study of omics science is closely related to that of biomarker. One of the medical areas most affected by these innovations is certainly childhood respiratory disorders, including asthma and cystic fibrosis (CF) (3,4). Asthma is a complex disease, mostly characterized by chronic airway inflammation and airway hyperresponsiveness and obstruction with a prominent role of T helper type 2 (Th2) cells that eventually lead to airway epithelial remodelling (5)(6)(7)(8)(9).…”

“…All of this evidence suggests that the study of VOCs might by a promising, non-invasive tool for monitoring children with respiratory diseases, but further studies are needed (3).…”