Journal article 570 views 4 downloads
Breaking barriers: feasibility of a cluster randomised trial evaluating an instrument for identifying and ameliorating adverse drug reactions
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Neil Carter
BMJ Open, Volume: 16, Issue: 1
Swansea University Authors:
Sue Jordan, Vera Logan, David Hughes, Adam Turner , Neil Carter
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© 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.
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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...
| Published in: | BMJ Open |
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| ISSN: | 2044-6055 |
| Published: |
BMJ Publishing Group Ltd
2026
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| Online Access: |
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| URI: | https://cronfa.swan.ac.uk/Record/cronfa71263 |
| 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.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. |
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| College: |
Faculty of Medicine, Health and Life Sciences |
| Funders: |
Swansea University - RIO 034-20 |
| Issue: |
1 |