ArticleJournal of medical Internet research2024
The Digital Therapeutics Real-World Evidence Framework: An Approach for Guiding Evidence-Based Digital Therapeutics Design, Development, Testing, and Monitoring.
Article in Journal of medical Internet research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Conversational Agents Supporting Self-Management in People With a Chronic Disease: Systematic Review.Journal of medical Internet research · 2025Pooled it
- Application of Chatbots to Help Patients Self-Manage Diabetes: Systematic Review and Meta-Analysis.Journal of medical Internet research · 2024Pooled it
- Behavioral Modification as a Putative Mediator of Digital Therapeutic Response in Temporomandibular Disorders: Secondary Analysis of a Multicenter Sham-Controlled Randomized Trial.JMIR mHealth and uHealth · 2026Trial
- An Early-Stage Digital Therapeutic Intervention to Enhance Affective Response During Physical Activity Among Adults With Overweight or Obesity: Benchmark-Driven Formative Testing Study.JMIR human factors · 2026Trial
- A Responsible AI Readiness Framework for Digital Self-Management Platforms: Illustrative Application to a Rule-Based GERD Platform.Healthcare (Basel, Switzerland) · 2026Article
- Digital Therapeutic Content for Substance Use Disorder Treatment: Development and Evaluation Study.JMIR formative research · 2026Article
- Comparing mental health professionals' willingness to use digital therapeutics: a cross-national survey in South Korea and Germany.BMC health services research · 2026Article
- Bridging the divide in digital therapeutics (DTx): Partnership strategies for broader representation across DTx development and deployment.PLOS digital health · 2026Article
- Real-world multicenter assessment of sustained clinical outcomes after digital deep brain stimulation.NPJ digital medicine · 2026Article
- Digital therapeutics for stress in health science students at under-resourced universities: A narrative review.Health SA = SA Gesondheid · 2026Review
- Musculoskeletal Digital Therapeutics and Digital Health Rehabilitation: A Global Paradigm Shift in Orthopedic Care.Journal of clinical medicine · 2025Review
- Multimodal and Multidimensional Artificial Intelligence Technology in Obesity.Journal of obesity & metabolic syndrome · 2025Review
- Understanding Economic Decision-Making in Digital Therapeutics Development: Qualitative Approach.Journal of medical Internet research · 2025Article
- Artificial intelligence-enhanced pain management: the NXTSTIM EcoAI platform.Pain management · 2025Review
- Toward a Smartphone-Based and Conversational Agent-Delivered Just-in-Time Adaptive Holistic Lifestyle Intervention for Older Adults Affected by Cognitive Decline: Two-Week Proof-of-Concept Study.JMIR formative research · 2025Article
- Designing a Visual Analytics Tool to Support Data Analysis Tasks of Digital Mental Health Interventions: Case Study.JMIR human factors · 2025Article
- Article
- A Holistic Digital Health Framework to Support Health Prevention Strategies in the First 1000 Days.JMIR pediatrics and parenting · 2025Article
- Personalized cardiometabolic care powered by artificial intelligence.Frontiers in endocrinology · 2025Article
- Mobile Health Interventions for Substance Use Disorders.Annual review of clinical psychology · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
Digital therapeutics (DTx) are a promising way to provide safe, effective, accessible, sustainable, scalable, and equitable approaches to advance individual and population health. However, developing and deploying DTx is inherently complex in that DTx includes multiple interacting components, such as tools to support activities like medication adherence, health behavior goal-setting or self-monitoring, and algorithms that adapt the provision of these according to individual needs that may change over time. While myriad frameworks exist for different phases of DTx development, no single framework exists to guide evidence production for DTx across its full life cycle, from initial DTx development to long-term use. To fill this gap, we propose the DTx real-world evidence (RWE) framework as a pragmatic, iterative, milestone-driven approach for developing DTx. The DTx RWE framework is derived from the 4-phase development model used for behavioral interventions, but it includes key adaptations that are specific to the unique characteristics of DTx. To ensure the highest level of fidelity to the needs of users, the framework also incorporates real-world data (RWD) across the entire life cycle of DTx development and use. The DTx RWE framework is intended for any group interested in developing and deploying DTx in real-world contexts, including those in industry, health care, public health, and academia. Moreover, entities that fund research that supports the development of DTx and agencies that regulate DTx might find the DTx RWE framework useful as they endeavor to improve how DTxcan advance individual and population health.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.