Twelve-Year Real-World Evaluation of a Regulated Guideline-Based Warfarin Dosing and Care Automation System
Year: 2026
Type: preprint
Study design: Observational Study
Abstract: Background Warfarin therapy requires repetitive dose adjustments based on INR (International Normalised Ratio) monitoring. We evaluated the long-term real-world performance of Forsante Warfarin Advisor (WA), a CE-marked class IIb guideline-based decision support and care automation medical device used in anticoagulation management. Methods Retrospective real-world data from routine clinical use between 2014 and 2026 were analysed. Treatment quality was assessed using Time in Therapeutic Range (TTR). Recommendation performance was evaluated by comparing achievement of target INR after clinician acceptance or modification of Warfarin Advisor recommendations. Results Among 1348 patients in March 2026 median TTR was 83%, compared with 70% in March 2016. Dosages congruent with Warfarin Advisor recommendations were strongly associated with achieving target INR at follow-up in INR target ranges of 2.0-3.0 and 2.5-3.5. Treatment quality remained consistently high across years of deployment. No serious device-attributable safety incidents, regulatory incident reports, or CAPA cases were identified during 12 calendar years and 82,709 patient years of routine use. Conclusions The findings provide real-world long-term evidence that a guideline-based warfarin dosing and care automation system can support sustained high-quality anticoagulation control in routine clinical practice. They support the feasibility of deploying workflow-integrated execution of selected guideline-driven clinical processes, while the causal effects on clinical outcomes require prospective confirmation.
Source: medRxiv
Author: Mikko T. Tiihonen
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7202302392