JMIR Publications

ABSTRACT

A scientific paradigm consists of a set of shared rules, beliefs, values, methods, and instruments for addressing scientific problems. Currently, healthcare embraces the paradigm of evidence-based healthcare. This paradigm prompts healthcare institutions to base decisions on the best available evidence, which is commonly generated in large-scale randomised controlled trials. We illustrate the application of evidence-based healthcare via the evaluation of drugs. We show how evidence-based healthcare is challenged when it is applied to the evaluation of digital therapeutics, which refers to technology and data to prevent, manage, or treat a medical disorder or disease. We conclude that amid the growing application of digital therapeutics, the paradigm of evidence-based healthcare is challenged on four domains: patient, intervention, control, and outcome. These domains are part of the PICO question, which is typically formulated as part of an evidence-based healthcare clinical evaluation process. In the second part of this viewpoint, we argue for a paradigm shift in healthcare so we can optimally evaluate and implement digital therapeutics, and we sketch out the contours of this novel paradigm. We address the need for considering design in healthcare and evaluation processes; studying user values so that healthcare can move from a focus on health to wellbeing; focusing on individual experiences rather than the average; addressing the need for evaluation in authentic use contexts; and stressing the need for continuous evaluation of the dynamic relations between users, context, and digital therapeutics. We conclude that the transition from evidence-based healthcare towards evidence-based wellbeing would improve the successful implementation of digital technologies in healthcare.