Trial reportBMJ open2026
Breaking barriers: feasibility of a cluster randomised trial evaluating an instrument for identifying and ameliorating adverse drug reactions.
Trial report in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04663360 (Medication Monitoring in General Practice), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Medication Monitoring in General Practice: Clinical Impact of Implementing a Nurse-led Adverse Drug Reaction (ADRe) Profile in Older Adults With 5 or More Prescribed Medicines
Who cites it
1 citing paper in PubMed.
- Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesWe 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.
designA preliminary study to test the feasibility of an RCT.
settingGeneral practices (GPs) in South-West Wales, UK.
participants20 patients aged >64 and prescribed >4 long-term medicines.
interventionsParticipants 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 measuresFeasibility was assessed based on recruitment, retention, adherence to protocols, potential for clinical impact and staff costs.
resultsWe 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.
conclusionsAn 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. TRIAL REGISTRATION NUMBER: NCT04663360; Pre-Results.
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