Addressing the challenges of integrating digital health technologies to measure patient-centred outcomes in clinical registries
Caroline Marra, Tim Chico, April I. Alexandrow, William G Dixon, Norman Briffa, Erin Rainaldi, Max A. Little, Kristin Size, Athanasios Tsanas, Joseph B. Franklin, Ritu Kapur, Helen Grice, Anwar Gariban, Joy Ellery, Cathie Sudlow, Amy P. Abernethy, Andrew H. Morris
Abstract
Longitudinal patient registries generate important evidence for advancing clinical care and the regulatory evaluation of health-care products. Most national registries rely on data collected as part of routine clinical encounters, an approach that does not capture real-world, patient-centred outcomes, such as physical activity, fatigue, ability to do daily tasks, and other indicators of quality of life. Digital health technologies that obtain such real-world data could greatly enhance patient registries but unresolved challenges have so far prevented their broad adoption. Based on our experience implementing digital health technologies in registries and observational studies, we propose potential solutions to three practical challenges we have repeatedly encountered: determining what to measure digitally, selecting the appropriate device, and ensuring representativeness and engagement over time. We describe the example of a hypothetical patient registry for valvular heart disease, a condition for which there is substantial variation in treatment selection and postintervention outcomes, and for which patient-centred outcome data are urgently needed to inform clinical care guidelines and health-service commissioning.