Remote digital smart device follow-up in prospective clinical trials: early insights from ORBITA-2, ORBITA-COSMIC, and ORBITA-STAR.

Abstract

Smart devices are a fundamental media for acquisition, processing, storage, and transfer of digital health data. The global penetration and high frequency usage of smart devices such as smartphones and fitness monitors provide us an opportunity for incorporation into clinical trials to generate more clinically meaningful data. Reporting of angina can significantly vary between patients and also within patients at different timepoints. Furthermore, the nature of angina can lead to variation in ways patients adapt their activities of daily living and hence reporting of symptoms and quality of life. Current clinical trials investigating the effects of intervention on angina do not accurately incorporate these patient centred outcomes and considerations. Hence, methods to contemporaneously assess daily angina burden in a convenient, patient focused, and cost-effective manner are priorities for contemporary clinical trials to address. In this article, we provide our insights into the use of remote digital smart devices in clinical trials of stable coronary artery disease conducted by our research group. We discuss how our experiences from previous trials necessitated its incorporation and will provide us with important data that will inform clinical practice. We discuss the benefits and current challenges and limitations of smart device incorporation while providing our procedural workflow for how we incorporated smart devices into our clinical trials for others to consider. We hope that this approach will allow us to understand the perceptions and implications of angina on patient lives with greater granularity than previously explored.