Can we collect health-related quality of life information from anticoagulated atrial fibrillation participants who have recently experienced a bleed? An observational feasibility study in primary and secondary care in Wales and through a UK online forum

Abstract

ObjectiveTo evaluate the feasibility of recruiting participants diagnosed with atrial fibrillation (AF) taking oral anticoagulation therapies (OATs) and recently experiencing a bleed to collect health-related quality of life (HRQoL) information.DesignObservational feasibility study. The study aimed to determine the feasibility of recruiting participants with minor and major bleeds, the most appropriate route for recruitment and the appropriateness of the patient-reported outcome measures (PROMs) selected for collecting HRQoL information in AF patients, and the preferred format of the surveys.SettingPrimary care, secondary care and via an online patient forum.ParticipantsThe study population was adult patients (≥18) with AF taking OATs who had experienced a recent major or minor bleed within the last 4 weeks.Primary and secondary outcome measuresPrimary outcomes– PROMs: EuroQol 5 Dimensions-5 Levels, Perception of Anticoagulant Treatment Questionnaire, part 2 only (part 2), atrial fibrillation effect on quality of life.Secondary outcomes– Location of bleed, bleed severity, current treatment, patient perceptions of HRQoL in relation to bleeding events.ResultsWe received initial expressions of interest from 103 participants. We subsequently recruited 32 participants to the study—14 from primary care and 18 through the AF forum. No participants were recruited through secondary care. Despite 32 participants consenting, only 26 initial surveys were completed. We received follow-up surveys from 11 participants (8 primary care and 3 AF forum). COVID-19 had a major impact on the study.ConclusionsPrimary care was the most successful route for recruitment. Most participants recruited to the study experienced a minor bleed. Further ways to recruit in secondary care should be explored, especially to capture more serious bleeds.Trial registration numberThe study is registered in the Clinicaltrials.gov database,NCT04921176.