Behavioura l digit a l bioma rkers ena ble real-time monitoring of patient-reported outcomes: a substudy of the multicentre, prospective observational SafeHeart study

Aims Patient-reported outcome measures (PROMs) serve multiple purposes, including shared decision-making and patient communication, treatment monitoring, and health technology assessment. Patient monitoring using PROMs is con- strained by recall and non-response bias, respondent burden, and missing data. We evaluated the potential of behavioural digital biomarkers obtained from a wearable accelerometer to achieve personalized predictions of PROMs. Met hods a nd results Data from the multicentre, prospective SafeHeart study conducted at Amsterdam University Medical Center in the Netherlands and Copenhagen University Hospital, Rigshospitalet in Copenhagen, Denmark, were used. The study enrolled patients with an implantable cardioverter defibrillator between May 2021 and September 2022 who then wore wearable devices with raw acceleration output to capture digital biomarkers reflecting physical behaviour. To collect PROMs, patients received the Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQoL 5- Dimensions 5- Level (EQ5D-5L) questionnaire at two instances: baseline and after six months. Multivariable Tobit regression models were used to explore associations between digital biomarkers and PROMs, specifically whether digital biomarkers could enable PROM prediction. The study population consisted of 303 patients (mean age 62.9 ±10.9 years, 81.2% male). Digital biomarkers showed significant correlations to patient-reported physical and social limit ations , severity and frequency of symptoms, and quality of life. Prospective validation of the Tobit models indicated moderate correlations between the observed and predicted scores for KCCQ [concordance correlation coefficient (CCC) = 0.49, mean difference: 1.07 points] and EQ5D-5L (CCC = 0.38, mean difference: 0.02 points). Conclusion Wearable digital biomarkers correlate with PROMs, and may be leveraged for real-time prediction. These findings hold promise for monitoring of PROMs through wearable accelerometers.