ArticleHealthcare informatics research2022
Clinical Evaluation of Digital Therapeutics: Present and Future.
Article in Healthcare informatics research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 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
27 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Magnitude of the Digital Placebo Effect and Its Moderators on Generalized Anxiety Symptoms: Systematic Review and Meta-Analysis.Journal of medical Internet research · 2025Pooled it
- Digital Therapeutics in China: Comprehensive Review.Journal of medical Internet research · 2025Pooled it
- Economic Evaluation Associated With Clinical-Grade Mobile App-Based Digital Therapeutic Interventions: Systematic Review.Journal of medical Internet research · 2023Pooled it
- Developing and Evaluating Guidelines to Prevent Overdependence on Digital Therapeutics in Children and Adolescents: Randomized Controlled Trial.Journal of medical Internet research · 2025Trial
- Predicting Long-Term Engagement in mHealth Apps: Comparative Study of Engagement Indices.Journal of medical Internet research · 2024Trial
- Trial
- Selection of Outcomes and Measurement Methods in Clinical Trials for Digital Therapeutics: Qualitative Analysis.JMIR formative research · 2026Article
- Landscape of regulatory clinical investigations status of traditional and digital medical devices in the Republic of Korea (2003-mid 2024).NPJ digital medicine · 2026Article
- Diving into the Regulatory Landscape of Digital Therapeutics.Therapeutic innovation & regulatory science · 2026Review
- Digital health technologies in medicine: evidence, artificial intelligence integration, and ethical challenges.Infectious agents and cancer · 2026Review
- The Italian landscape of digital therapeutics in a European context.Frontiers in digital health · 2026Review
- Analysis of the challenges in ensuring robust and effective clinical evaluation of AI-based digital medical devices.BMJ digital health & AI · 2026Review
- Assessment of digital therapeutics in decentralized clinical trials: A scoping review.PLOS digital health · 2025Article
- Digital Therapeutic Combining Hypnosis and Diaphragmatic Breathing Intervention for Functional Abdominal Bloating: A Feasibility Study.Clinical and translational gastroenterology · 2025Article
- Developing interactive VR-based digital therapeutics for Acceptance and Commitment Therapy (ACT): a structured framework for the digital transformation integrating gamification and multimodal arts.Frontiers in psychiatry · 2025Article
- Designing and developing a prescription digital therapeutic for at-home heart rate variability biofeedback to support and enhance patient outcomes in post-traumatic stress disorder treatment.Frontiers in digital health · 2025Article
- Co-Creation in the Development of Digital Therapeutics: A Narrative Review.International journal of environmental research and public health · 2024Review
- The Revolution of Digital Therapeutics (DTx) in the Pharmaceutical Industry and Their Quality Impacts.Cureus · 2024Review
- Implementing a digital solution for patients with migraine-Developing a methodology for comparing digitally delivered treatment with conventional treatment: A study protocol.PLOS digital health · 2024Article
- Adoption of Digital Therapeutics in Europe.Therapeutics and clinical risk management · 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
4 authors.
Funding
Abstract
objectivesDigital therapeutics (DTx) are software-based therapeutic interventions based on clinical evidence. Randomized clinical trials (RCTs) are often the source of clinical evidence, similar to conventional drugs or medical devices. However, novel approaches such as the use of real-world data or digital biomarkers are also utilized. This article aimed to review how DTx products have been clinically evaluated.
methodsDTx products approved by the US Food and Drug Administration as of 2020 were reviewed and products with sufficient published information were selected. Pivotal clinical trials were analyzed according to the elements of the Consolidated Standards of Reporting Trials (CONSORT) guideline. Case reviews were presented for other clinical evaluation strategies, considering the small number of publications.
resultsMost approved DTx products used RCTs for clinical evaluations. Similar to conventional RCTs, parallel-group designs with statistical hypothesis testing were adopted. However, DTx trials were often not blinded due to practical issues and involved various comparator groups. In addition, DTx products could be readily evaluated in home-based settings and delivered through the internet. Other evaluation approaches included retrospective analyses using insurance claims data or usage data, which enabled long-term evaluations of effectiveness. Digital biomarkers obtained from real-time and continuous log data were also used to improve the objectiveness of endpoints.
conclusionsRCTs accounted for the majority of DTx evaluations. The designs of DTx trials were comparable to those of drug or device trials, but blinding and comparator elements were often different. Furthermore, the use of real-world data and digital biomarkers are also being tried.
Indexed as
Identifiers
What OpenQuestion holds
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.