Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Nov 13, 2023
Open Peer Review Period: Nov 13, 2023 - Jan 8, 2024
Date Accepted: May 17, 2024
(closed for review but you can still tweet)
Key considerations for designing clinical studies to evaluate digital health solutions
ABSTRACT
Evidence of clinical impact is critical to unlock the potential of Digital Health Solutions (DHS), yet many solutions are failing to deliver positive clinical results. We argue this failure is linked to current approaches to DHS evaluation design, which neglect numerous key characteristics (KCs) requiring specific scientific and design considerations. We first delineate the KCs of DHS: they are implemented at healthcare system and patient level, can drive multiple clinical outcomes indirectly through a multitude of smaller clinical benefits, their mechanism of action can vary between individuals and change over time based on patient needs, and finally, they develop through short, iterative cycles - optimally within a real-world use context. Finally, we provide research design suggestions that better address these KCs, including tips on mechanism of action mapping, alternative randomization methods, control arm adaptations, and novel endpoint selection, as well as innovative methods utilizing real-world data and platform research.
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