Methodological Shortcomings of Wrist-Worn Heart Rate Monitors Validations (Preprint)

UNSTRUCTURED Wearable sensor technology could have an important role for clinical research and in delivering health care. Accordingly, such technology should undergo rigorous evaluation prior to market launch, and its performance should be supported by evidence-based marketing claims. Many studies have been published attempting to validate wrist-worn photoplethysmography (PPG)-based heart rate monitoring devices, but their contrasting results question the utility of this technology. The reason why many validations did not provide conclusive evidence of the validity of wrist-worn PPG-based heart rate monitoring devices is mostly methodological. The validation strategy should consider the nature of data provided by both the investigational and reference devices. There should be uniformity in the statistical approach to the analyses employed in these validation studies. The investigators should test the technology in the population of interest and in a setting appropriate for intended use. Device industries and the scientific community require robust standards for the validation of new wearable sensor technology.