Universal Clinician Device for improving risk prediction and management of patients with atrial fibrillation: an assumed benefit analysis.

Aim: Atrial fibrillation (AF) management guidelines advise using risk tools to optimize AF treatment. This study aims to develop a dynamic and clinically applicable digital device to assess stroke and bleeding risk, and to facilitate outcome improvements in AF patients. The device will provide tailored treatment recommendations according to easily attainable individual patient data. Methods and Results: This Universal Clinician Device (UCD) was created using the GARFIELD-AF registry using a split sample approach. The GARFIELD-AF risk tool was adapted with two modifications. First, predictors with ≥1000 missing data points were separated, allowing expected risks estimation. Second, recommendations for modifiable risk factors and associated 2-year outcome estimates were incorporated. Outcomes of interest were all-cause mortality, non-haemorrhagic stroke/systemic embolism (SE), and major bleeding. All patients were randomized to a derivation ( Conclusion: The UCD simultaneously predicts mortality, stroke, and bleeding risk in patients using easily attainable individual clinical data and guideline-based optimized treatment plans. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier for GARFIELD-AF: NCT01090362.