ORCID
- Debasish Kar: 0000-0002-1524-1312
Abstract
Objective: To summarize the key intervention characteristics and evaluate the effectivenessand safety of digital therapeutics (DTx) in patients receiving oral anticoagulation, witheffectiveness evaluated using time in therapeutic range (TTR), thromboembolic events (TEE),and mortality, and safety evaluated based on bleeding events.Patients and Methods: We searched PubMed, Embase, Web of Science, and the CochraneLibrary from inception to June 20, 2025, and identified ten randomized controlled trialsinvolving 7,237 patients. The criteria required studies to assess software-based DTxsupporting anticoagulation management and report effectiveness or safety outcomes. Studyquality was evaluated using the Grading of Recommendations, Assessment, Development,and Evaluation (GRADE) framework, and random-effects models were applied.Results: DTx interventions were associated with a lower incidence of major bleeding thanusual care; no clear differences in TTR, TEE, or mortality. Evidence quality ranged from verylow to high. Secondary analyses showed more INR testing with DTx; rehospitalization ratesdid not differ significantly between groups. Sensitivity analysis changed TTR effect afterexcluding a study with enhanced control, but other outcomes remained unchanged.Conclusion: DTx interventions for anticoagulation management improve safety outcomes,particularly reducing major bleeding, and with greater monitoring intensity. Larger, long-termtrials are needed to confirm the clinical benefits and evaluate cost-effectiveness.Trial Registration: PROSPERO (CRD420251107441)
DOI Link
Publication Date
2026-01-20
Publication Title
Mayo Clinic Proceedings: Digital Health
Acceptance Date
2026-01-13
Deposit Date
2026-01-26
Funding
LY was funded by the Innovation Project of CAMS (2021-I2M-1-046). JJ was funded by NHMRC (GNT1192469, GNT 2038330) and MRFF (MRF2036251). DK received the UK NIHR Clinical Lecturer award (CL-001-2023-24).
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
Recommended Citation
Guo, J., You, L., Liu, L., Jiao, X., Kar, D., & Jonnagaddala, J. (2026) 'The Effectiveness of Digital Therapeutics Intervention in Oral Anticoagulation Management: A Systematic Review and Meta-analysis', Mayo Clinic Proceedings: Digital Health, . Available at: 10.1016/j.mcpdig.2026.100336
