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Breaking barriers: feasibility of a cluster randomised trial evaluating an instrument for identifying and ameliorating adverse drug reactions

Sue Jordan, Vera Logan, David Hughes, Adam Turner Orcid Logo, Neil Carter

BMJ Open, Volume: 16, Issue: 1

Swansea University Authors: Sue Jordan, Vera Logan, David Hughes, Adam Turner Orcid Logo, Neil Carter

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DOI (Published version): 10.1136/bmjopen-2025-099627

Abstract

Objectives We aimed to investigate the feasibility of a cluster randomised controlled trial (RCT) of the ADRe Profile in UK primary care. The ADRe Profile is a patient monitoring system to identify and address adverse drug reactions (ADR) and ADR-related issues to pre-empt clinical deterioration.Des...

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Published in: BMJ Open
ISSN: 2044-6055
Published: BMJ Publishing Group Ltd 2026
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URI: https://cronfa.swan.ac.uk/Record/cronfa71263
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The ADRe Profile is a patient monitoring system to identify and address adverse drug reactions (ADR) and ADR-related issues to pre-empt clinical deterioration.Design A preliminary study to test the feasibility of an RCT.Setting General practices (GPs) in South-West Wales, UK.Participants 20 patients aged &gt;64&#x2009;and prescribed &gt;4 long-term medicines.Interventions Participants reported their health-related problems using the ADRe-Profile. Participants completed the profile independently initially, then with researcher support, capturing vital signs, clinical observations and patient-reported symptoms.Main outcome measures Feasibility was assessed based on recruitment, retention, adherence to protocols, potential for clinical impact and staff costs.Results We recruited two GP practices (0.94% of 213 contacted), and 20 patients aged &gt;64 (51.3% of those approached). Retention was 100%. ADRe Profiles had a 98.29% completion rate, identifying 289 clinical problems, including pain (16 of 20 patients), dyspnoea (10/20), dizziness (8/20), bleeding/bruising (7/20) and falls (4/20). Most problems (90%) and vital signs (78%) recorded on ADRe Profiles were absent from existing patient records. Researchers recommended further investigations (164 instances) and interventions (126 suggestions). Despite the potential for clinical benefits, engagement from clinicians was limited. Cost estimates for ADRe administration ranged from &#xA3;40 to &#xA3;73, within the funding available from Health and Care Research Wales.Conclusions An RCT of the ADRe Profile was feasible, despite gatekeeping by clinicians. Recruitment of GP practices was challenging, with &lt;1% of eligible practices participating. In contrast, patient recruitment and retention were successful. 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spelling 2026-02-16T13:54:08.8841270 v2 71263 2026-01-16 Breaking barriers: feasibility of a cluster randomised trial evaluating an instrument for identifying and ameliorating adverse drug reactions 24ce9db29b4bde1af4e83b388aae0ea1 Sue Jordan Sue Jordan true false 89a4cb1af023b1d80dce90a417a94585 Vera Logan Vera Logan true false f1fbd458e3c75d8b597c0ac8036f2b88 David Hughes David Hughes true false 486394f1fb20386cbf02509e4a70ddd4 0000-0002-0721-7662 Adam Turner Adam Turner true false 9a3f8cbd9ad25966c489e44fabed844f Neil Carter Neil Carter true false 2026-01-16 Objectives We aimed to investigate the feasibility of a cluster randomised controlled trial (RCT) of the ADRe Profile in UK primary care. The ADRe Profile is a patient monitoring system to identify and address adverse drug reactions (ADR) and ADR-related issues to pre-empt clinical deterioration.Design A preliminary study to test the feasibility of an RCT.Setting General practices (GPs) in South-West Wales, UK.Participants 20 patients aged >64 and prescribed >4 long-term medicines.Interventions Participants reported their health-related problems using the ADRe-Profile. Participants completed the profile independently initially, then with researcher support, capturing vital signs, clinical observations and patient-reported symptoms.Main outcome measures Feasibility was assessed based on recruitment, retention, adherence to protocols, potential for clinical impact and staff costs.Results We recruited two GP practices (0.94% of 213 contacted), and 20 patients aged >64 (51.3% of those approached). Retention was 100%. ADRe Profiles had a 98.29% completion rate, identifying 289 clinical problems, including pain (16 of 20 patients), dyspnoea (10/20), dizziness (8/20), bleeding/bruising (7/20) and falls (4/20). Most problems (90%) and vital signs (78%) recorded on ADRe Profiles were absent from existing patient records. Researchers recommended further investigations (164 instances) and interventions (126 suggestions). Despite the potential for clinical benefits, engagement from clinicians was limited. Cost estimates for ADRe administration ranged from £40 to £73, within the funding available from Health and Care Research Wales.Conclusions An RCT of the ADRe Profile was feasible, despite gatekeeping by clinicians. Recruitment of GP practices was challenging, with <1% of eligible practices participating. In contrast, patient recruitment and retention were successful. ADRe aligns with WHO patient safety goals and could improve healthcare by addressing ADR-related problems proactively in this vulnerable population. Journal Article BMJ Open 16 1 BMJ Publishing Group Ltd 2044-6055 27 1 2026 2026-01-27 10.1136/bmjopen-2025-099627 COLLEGE NANME COLLEGE CODE Swansea University SU Library paid the OA fee (TA Institutional Deal) Swansea University - RIO 034-20 2026-02-16T13:54:08.8841270 2026-01-16T15:43:09.0627500 Faculty of Medicine, Health and Life Sciences School of Health and Social Care - Nursing Sue Jordan 1 Vera Logan 2 David Hughes 3 Adam Turner 0000-0002-0721-7662 4 Neil Carter 5 71263__36240__1814b0be433d414f827a0419a28fc017.pdf 71263.VoR.pdf 2026-02-16T13:52:29.7607958 Output 761981 application/pdf Version of Record true © Author(s) (or their employer(s)) 2026. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license. true Eng https://creativecommons.org/licenses/by/4.0/
title Breaking barriers: feasibility of a cluster randomised trial evaluating an instrument for identifying and ameliorating adverse drug reactions
spellingShingle Breaking barriers: feasibility of a cluster randomised trial evaluating an instrument for identifying and ameliorating adverse drug reactions
Sue Jordan
Vera Logan
David Hughes
Adam Turner
Neil Carter
title_short Breaking barriers: feasibility of a cluster randomised trial evaluating an instrument for identifying and ameliorating adverse drug reactions
title_full Breaking barriers: feasibility of a cluster randomised trial evaluating an instrument for identifying and ameliorating adverse drug reactions
title_fullStr Breaking barriers: feasibility of a cluster randomised trial evaluating an instrument for identifying and ameliorating adverse drug reactions
title_full_unstemmed Breaking barriers: feasibility of a cluster randomised trial evaluating an instrument for identifying and ameliorating adverse drug reactions
title_sort Breaking barriers: feasibility of a cluster randomised trial evaluating an instrument for identifying and ameliorating adverse drug reactions
author_id_str_mv 24ce9db29b4bde1af4e83b388aae0ea1
89a4cb1af023b1d80dce90a417a94585
f1fbd458e3c75d8b597c0ac8036f2b88
486394f1fb20386cbf02509e4a70ddd4
9a3f8cbd9ad25966c489e44fabed844f
author_id_fullname_str_mv 24ce9db29b4bde1af4e83b388aae0ea1_***_Sue Jordan
89a4cb1af023b1d80dce90a417a94585_***_Vera Logan
f1fbd458e3c75d8b597c0ac8036f2b88_***_David Hughes
486394f1fb20386cbf02509e4a70ddd4_***_Adam Turner
9a3f8cbd9ad25966c489e44fabed844f_***_Neil Carter
author Sue Jordan
Vera Logan
David Hughes
Adam Turner
Neil Carter
author2 Sue Jordan
Vera Logan
David Hughes
Adam Turner
Neil Carter
format Journal article
container_title BMJ Open
container_volume 16
container_issue 1
publishDate 2026
institution Swansea University
issn 2044-6055
doi_str_mv 10.1136/bmjopen-2025-099627
publisher BMJ Publishing Group Ltd
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 School of Health and Social Care - Nursing{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}School of Health and Social Care - Nursing
document_store_str 1
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description Objectives We aimed to investigate the feasibility of a cluster randomised controlled trial (RCT) of the ADRe Profile in UK primary care. The ADRe Profile is a patient monitoring system to identify and address adverse drug reactions (ADR) and ADR-related issues to pre-empt clinical deterioration.Design A preliminary study to test the feasibility of an RCT.Setting General practices (GPs) in South-West Wales, UK.Participants 20 patients aged >64 and prescribed >4 long-term medicines.Interventions Participants reported their health-related problems using the ADRe-Profile. Participants completed the profile independently initially, then with researcher support, capturing vital signs, clinical observations and patient-reported symptoms.Main outcome measures Feasibility was assessed based on recruitment, retention, adherence to protocols, potential for clinical impact and staff costs.Results We recruited two GP practices (0.94% of 213 contacted), and 20 patients aged >64 (51.3% of those approached). Retention was 100%. ADRe Profiles had a 98.29% completion rate, identifying 289 clinical problems, including pain (16 of 20 patients), dyspnoea (10/20), dizziness (8/20), bleeding/bruising (7/20) and falls (4/20). Most problems (90%) and vital signs (78%) recorded on ADRe Profiles were absent from existing patient records. Researchers recommended further investigations (164 instances) and interventions (126 suggestions). Despite the potential for clinical benefits, engagement from clinicians was limited. Cost estimates for ADRe administration ranged from £40 to £73, within the funding available from Health and Care Research Wales.Conclusions An RCT of the ADRe Profile was feasible, despite gatekeeping by clinicians. Recruitment of GP practices was challenging, with <1% of eligible practices participating. In contrast, patient recruitment and retention were successful. ADRe aligns with WHO patient safety goals and could improve healthcare by addressing ADR-related problems proactively in this vulnerable population.
published_date 2026-01-27T05:39:20Z
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