Participant Engagement and Preference Study for Clinical Outcomes Associated With Atrial Fibrillation: The PEARL-AF...

Area of Science:

• Health outcomes research
• Patient preference assessment
• Atrial fibrillation (AF) treatment evaluation

Background:

• Quantifying patient preferences for health outcomes in atrial fibrillation (AF) is crucial for regulatory decision-making.
• Incorporating patient perspectives ensures treatments align with individual values.

Purpose of the Study:

• To estimate the relative importance of AF-related health events.
• To inform clinical trial analyses for net health benefit calculations of anticoagulants.

Main Methods:

• A preference survey was conducted with 1028 AF patients.
• Best-worst scaling was used to assess the seriousness of various AF-related events, including different stroke severities, bleeding events, myocardial infarction (MI), and death.

Main Results:

• Death was ranked as the most serious event, followed by severe disabling stroke and major bleeding or MI with heart failure (HF).
• Minor stroke, MI without HF, and clinically relevant nonmajor bleeding were ranked as least serious.
• Event importance rankings were consistent across demographics, but relative weights varied by sex and race.

Conclusions:

• Patients express significant concern regarding major bleeding, comparable to moderate stroke or systemic embolism.
• Estimated patient preference weights can facilitate patient-centered net-benefit assessments for AF therapies.