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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 th...

Hayley Hutchings Orcid Logo, Kirsty Lanyon Orcid Logo, Gail Holland Orcid Logo, Raza Alikhan, Rhys Jenkins, Hamish Laing Orcid Logo, Arfon Hughes, Trudie Lobban, Kevin Pollock, Daniel Tod, Steven Lister

BMJ Open, Volume: 13, Issue: 10, Start page: e075335

Swansea University Authors: Hayley Hutchings Orcid Logo, Kirsty Lanyon Orcid Logo, Gail Holland Orcid Logo, Hamish Laing Orcid Logo, Daniel Tod

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Abstract

Objective: To 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.Design: Observational feasibility study. The study ai...

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Published in: BMJ Open
ISSN: 2044-6055 2044-6055
Published: BMJ 2023
Online Access: Check full text

URI: https://cronfa.swan.ac.uk/Record/cronfa64676
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Abstract: Objective: To 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.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 AF taking OATs who had experienced a recent major or minor bleed within the last 4 weeks.Primary and secondary outcome measures: Primary 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.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.Trial registration number: The study is registered in the Clinicaltrials.gov database, NCT04921176.
Keywords: Atrial fibrillation, oral anticoagulation therapies, quality of life, observational feasibility study
College: Faculty of Medicine, Health and Life Sciences
Funders: BMS/Pfizer (grant number: CV185-770).
Issue: 10
Start Page: e075335