ArticlePLOS digital health2025
Assessment of digital therapeutics in decentralized clinical trials: A scoping review.
Article in PLOS digital health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
- Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health.Sensors (Basel, Switzerland) · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This scoping review aims to identify the necessary and practical considerations for the design, conduct and safety of decentralized clinical trials (DCTs) that test digital therapeutics (DTx) or software as a medical device (SaMD). The review follows the framework of Arksey & O'Malley. A search strategy with the keywords "Digital therapeutics" or "Software as Medical Device" AND "decentralized clinical trial" or synonyms was applied to Cochrane CENTRAL, EMBASE, MEDLINE and Web of Science databases with the latest search on the 25th of April 2025. We selected peer-reviewed articles reporting about fully or partly DCTs using apps or devices that were classified as DTx or SaMD. Studies using general health software or not focusing on the design or experiences of the DCT were excluded. Main study characteristics were extracted and the articles thematically coded with the qualitative software Atlas.ti. 335 results were assessed for title and abstract screening and 113 articles were identified for full-text screening, of those 41 fulfilled inclusion criteria. DTx used in the trials were mainly targeting depression. The clinical trial design differed significantly in the number of study arms (1-16), participants (11─5602) and blinding. E-recruitment (78%), e-eligibility screening (73%), e-informed consent (68%), inclusion of electronic-patient reported outcomes (e-PROs) (88%), passive data collection (59%) and use of reminders (59%) were key reoccurring features of the studies. Effective access and inclusion of participants, but low adherence and engagement is highlighted in most studies. In some cases, only 40% of participants installed the app and significant drop-out rates of about 50% are reported. A framework for DCTs evaluating DTx is provided. In summary, DCTs for DTx are unstandardized, heterogenous and characterized by low adherence. Further research on how to tackle the engagement problem, along with clearer guidance and regulatory frameworks, is required to standardize this trial type in the future.
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.