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)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
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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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.