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The purpose of the study was to evaluate the feasibility of recruiting participants diagnosed with atrial fibrillation (AF) taking oral anticoagulation therapies (OACs) and recently experiencing a bleed to collect health-related quality of life (HRQoL) information. Design Observational 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. Setting Primary care, secondary care, and via an online patient forum. Participants The study population was adult patients (≥ 18) with Atrial Fibrillation (AF) taking oral anticoagulation therapies (OATs) who had experienced a recent major or minor bleed within the last four weeks. Primary and Secondary outcome measures Primary outcome: Patient reported outcome measures (PROMs): EuroQol 5 dimensions-5 levels (EQ-5D-5L); Perception of anticoagulant treatment questionnaire, part 2 only (PACT-Q, part 2); Atrial fibrillation effect on quality of life (AFEQT) Secondary outcomes: Location of bleed; bleed severity; current treatment; patient perceptions of HRQoLin relation to bleeding events. Results We 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. Conclusions Primary 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. Registration The study was adopted onto the NIHR Portfolio (I.D. #47771) and registered with www.ClinicalTrials.gov (#NCT04921176) in February 2021. Dataset contains all anonymised data for the participants who completed the survey including demographics, details of bleeds, co-morbidities and completed patient reported outcomes
quality of life, patient reported outcome measures, atrial fibrillation, bleeding, feasibility
quality of life, patient reported outcome measures, atrial fibrillation, bleeding, feasibility
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