How Digital Therapeutics Are Urging the Need for a Paradigm Shift: From Evidence-Based Health Care to Evidence-Based Well-being

Abstract

A scientific paradigm consists of a set of shared rules, beliefs, values, methods, and instruments for addressing scientific problems. Currently, health care embraces the paradigm of evidence-based health care (EBH). This paradigm prompts health care institutions to base decisions on the best available evidence, which is commonly generated in large-scale randomized controlled trials. We illustrate the application of EBH via the evaluation of drugs. We show how EBH 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 EBH is challenged in four domains: population, intervention, comparison, outcome. In the second part of this viewpoint, we argue for a paradigm shift in health care 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 health care and evaluation processes, studying user values so that health care can move from a focus on health to well-being, 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 EBH toward evidence-based well-being would improve the successful implementation of digital technologies in health care.

Exploring Health and Design Evidence Practices in Ehealth Systems’ Development

“…The absence of a clear understanding of evidence practices hampers eHealth systems development, as this brings uncertainty about what evidence is needed and how to generate it through the process (Lamé, 2018). Hence, it is essential to understand evidence practices in both fields since it could shed light on unexplored perspectives for evidence generation and ultimately lead to an evidence-based well-being paradigm in eHealth (Smits et al, 2022). This paper aims to dive deep into the epistemology behind health and design evidence practices and their implementation.…”

“…Within their development, evidence-based practices play a vital role in ensuring healthcare quality. However, the current evidence-based health paradigm fails to meet the needs and values of users during eHealth development (Smits et al, 2022). Design offers an approach to include users' needs and values in eHealth development, yet health sciences and design face the challenge of a shared understanding of their development practices.…”

Use of the Digital Assistant Vigo in the Home Environment for Stroke Recovery: Focus Group Discussion With Specialists Working in Neurorehabilitation

“…Tablet-based therapeutic programs present an alternative way to access rehabilitation services anytime and everywhere through the internet and technology under remote guidance of the therapist [ 11 - 13 ]. Tablet-based rehabilitation programs show a new paradigm for providing therapeutic interventions following a stroke [ 14 ]. Considering the complexity of the stroke recovery process, factors such as a suitable population, appropriate timing, setting, and the necessary patient-specialist support structure need to be thoroughly researched [ 15 , 16 ].…”

“…At the time of discharge from the hospital or inpatient rehabilitation center, approximately 74% of physical and occupational therapists hand out a written home program. Even though written recommendations are a widely used approach for continuing rehabilitation at home, they lack 2 key components, adherence and feedback [ 14 , 19 ]. The digital assistant Vigo provides an opportunity for a new, more integrative way of carrying out a home-based rehabilitation program compared to traditional written recommendations.…”

Game Digital Therapeutics for reducing perioperative anxiety in Children: Exploring Multi-Sensory Interaction Experience

“…As medicine shifts from a traditional biomedical to a psychological medical model [4], technological developments in non-pharmacological interventions provide a more accessible and comprehensive perspective [5]; increasingly, digital tools are used in prevention, treatment, and interventions. Several studies indicate that Digital therapy for children with perioperative anxiety is necessary for the health treatment process [6].…”