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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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DOI (Published version): 10.1136/bmjopen-2023-075335

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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ISSN: 2044-6055 2044-6055
Published: BMJ 2023
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An observational feasibility study in primary and secondary care in Wales and through a UK online forum</title><swanseaauthors><author><sid>bdf5d5f154d339dd92bb25884b7c3652</sid><ORCID>0000-0003-4155-1741</ORCID><firstname>Hayley</firstname><surname>Hutchings</surname><name>Hayley Hutchings</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>a3f45c952158fb8d56dc7dbff5a4cf2d</sid><ORCID>0000-0002-4227-6852</ORCID><firstname>Kirsty</firstname><surname>Lanyon</surname><name>Kirsty Lanyon</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>b9f3a8bf7478db012c8856b7bbbc7597</sid><ORCID>0000-0002-6924-2521</ORCID><firstname>Gail</firstname><surname>Holland</surname><name>Gail Holland</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>be60df55bc8e44cf2aacf7230876588d</sid><ORCID>0000-0002-5661-7937</ORCID><firstname>Hamish</firstname><surname>Laing</surname><name>Hamish Laing</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>fbb6764a346f9e12b7978d67130240f7</sid><firstname>Daniel</firstname><surname>Tod</surname><name>Daniel Tod</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2023-10-09</date><deptcode>HDAT</deptcode><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. 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spelling v2 64676 2023-10-09 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 bdf5d5f154d339dd92bb25884b7c3652 0000-0003-4155-1741 Hayley Hutchings Hayley Hutchings true false a3f45c952158fb8d56dc7dbff5a4cf2d 0000-0002-4227-6852 Kirsty Lanyon Kirsty Lanyon true false b9f3a8bf7478db012c8856b7bbbc7597 0000-0002-6924-2521 Gail Holland Gail Holland true false be60df55bc8e44cf2aacf7230876588d 0000-0002-5661-7937 Hamish Laing Hamish Laing true false fbb6764a346f9e12b7978d67130240f7 Daniel Tod Daniel Tod true false 2023-10-09 HDAT 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. Journal Article BMJ Open 13 10 e075335 BMJ 2044-6055 2044-6055 Atrial fibrillation, oral anticoagulation therapies, quality of life, observational feasibility study 6 10 2023 2023-10-06 10.1136/bmjopen-2023-075335 http://dx.doi.org/10.1136/bmjopen-2023-075335 COLLEGE NANME Health Data Science COLLEGE CODE HDAT Swansea University SU Library paid the OA fee (TA Institutional Deal) BMS/Pfizer (grant number: CV185-770). 2023-11-07T13:58:39.6733536 2023-10-09T11:35:39.5492989 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Hayley Hutchings 0000-0003-4155-1741 1 Kirsty Lanyon 0000-0002-4227-6852 2 Gail Holland 0000-0002-6924-2521 3 Raza Alikhan 4 Rhys Jenkins 5 Hamish Laing 0000-0002-5661-7937 6 Arfon Hughes 7 Trudie Lobban 8 Kevin Pollock 9 Daniel Tod 10 Steven Lister 11 64676__28728__4e44cda71b264ab3adca292ac96afab9.pdf e075335.full.pdf 2023-10-09T11:41:11.6621106 Output 1289423 application/pdf Version of Record true © Author(s) (or their employer(s)) 2023. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. true eng http://creativecommons.org/licenses/by-nc/4.0/
title 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
spellingShingle 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
Hayley Hutchings
Kirsty Lanyon
Gail Holland
Hamish Laing
Daniel Tod
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
author_id_str_mv bdf5d5f154d339dd92bb25884b7c3652
a3f45c952158fb8d56dc7dbff5a4cf2d
b9f3a8bf7478db012c8856b7bbbc7597
be60df55bc8e44cf2aacf7230876588d
fbb6764a346f9e12b7978d67130240f7
author_id_fullname_str_mv bdf5d5f154d339dd92bb25884b7c3652_***_Hayley Hutchings
a3f45c952158fb8d56dc7dbff5a4cf2d_***_Kirsty Lanyon
b9f3a8bf7478db012c8856b7bbbc7597_***_Gail Holland
be60df55bc8e44cf2aacf7230876588d_***_Hamish Laing
fbb6764a346f9e12b7978d67130240f7_***_Daniel Tod
author Hayley Hutchings
Kirsty Lanyon
Gail Holland
Hamish Laing
Daniel Tod
author2 Hayley Hutchings
Kirsty Lanyon
Gail Holland
Raza Alikhan
Rhys Jenkins
Hamish Laing
Arfon Hughes
Trudie Lobban
Kevin Pollock
Daniel Tod
Steven Lister
format Journal article
container_title BMJ Open
container_volume 13
container_issue 10
container_start_page e075335
publishDate 2023
institution Swansea University
issn 2044-6055
2044-6055
doi_str_mv 10.1136/bmjopen-2023-075335
publisher BMJ
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
url http://dx.doi.org/10.1136/bmjopen-2023-075335
document_store_str 1
active_str 0
description 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.
published_date 2023-10-06T13:58:42Z
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