Validation of a patient decision aid for choosing between dabigatran and warfarin for atrial fibrillation.

BACKGROUND: Decision aids have been helpful to support patients in decision-making including anticoagulation. With the introduction of new oral anticoagulants (NOACs), it will be important to assist patients and physicians in shared decision-making about NOACs and warfarin. OBJECTIVES: To validate a patient decision aid (DA) for warfarin versus dabigatran, the first NOAC approved for atrial fibrillation (AF). METHODS: Participants without AF and not taking anticoagulants were recruited for the validation exercise. The decision aid described AF, stroke, and hemorrhagic events in terms of incidence, clinical presentation, and prognosis. Warfarin and dabigatran were then compared on multiple clinical and process outcomes as outlined in the pivotal clinical trial. Our primary outcome was confidence in making a treatment decision, using a decisional conflict scale. Secondary outcomes were change in knowledge scores and ratings of clarity, helpfulness and comprehensiveness. RESULTS: 35 patients (mean age 62.7 [SD 9.68], 37.1% female) participated. After use of the decision aid, the mean total decisional conflict score was low at 18.9 (SD: 14.2). Mean knowledge score improved significantly from 4.60 (SD 1.48) to 6.42 (SD 0.80) out of a total score of 7. Only one participant (2.9%) found the decision aid difficult to understand. All 35 participants rated the DA as helpful for making a decision about anticoagulant treatment for AF. Two participants (5.7%) requested more information on adverse effects of the two drugs. CONCLUSION: Our DA to allow patients to make an informed decision with their physician regarding dabigatran versus warfarin in AF, proved understandable, comprehensive and helpful.