Evidence map›Paper›PMID 39363246›Full record

ArticleTrials2024

Utilising primary care electronic health records to deliver the ALABAMA randomised controlled trial of penicillin allergy assessment.

Shadia Ahmed, Joanne Fielding, Catherine E Porter, Kelsey F Armitage, Marta Wanat, Chris Bates, Lazarina Engonidou, Robert M West, Ly-Mee Yu, Ushma Galal and 9 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04108637 (Penicillin Allergy Status And Its Effect On Antibiotic Prescribing, Patient Outcomes, and Antimicrobial Resistance), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT04108637 nacompletednot on this map

Penicillin Allergy Status And Its Effect On Antibiotic Prescribing, Patient Outcomes, and Antimicrobial Resistance

TypeinterventionalSponsorUniversity of LeedsRan2019 to 2024Enrolled823ConditionsInfectionArmspenicillin allergy assessment pathway
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Shadia Ahmed *Leeds Institute of Medical Research, University of Leeds, Leeds, UK. s.ahmed1@leeds.ac.uk.ORCID http://orcid.org/0000-0002-5841-2804
Joanne Fielding *Dental Translational and Clinical Research Unit, School of Dentistry, University of Leeds, Leeds, UK.
Catherine E PorterDental Translational and Clinical Research Unit, School of Dentistry, University of Leeds, Leeds, UK.
Kelsey F ArmitageThe Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Marta WanatThe Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Chris BatesThe Phoenix Partnership, Leeds, UK.
Lazarina EngonidouThe Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Robert M WestLeeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Ly-Mee YuThe Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Ushma GalalThe Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Philip HowardNorth-East Yorkshire, NHS England, Newcastle, UK.
Christopher C ButlerThe Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Sinisa SavicLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
Jenny BoardsSMILE AIDER PPI Group, Leeds Clinical Research Facility, The Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Sarah Tonkin-CrineThe Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
John Parry *The Phoenix Partnership, Leeds, UK.
Sue A Pavitt *Dental Translational and Clinical Research Unit, School of Dentistry, University of Leeds, Leeds, UK.
Jonathan T Sandoe *Leeds Institute of Medical Research, University of Leeds, Leeds, UK.
ALABAMA research team

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUse of electronic health records (EHR) to provide real-world data for research is established, but using EHR to deliver randomised controlled trials (RCTs) more efficiently is less developed. The Allergy AntiBiotics And Microbial resistAnce (ALABAMA) RCT evaluated a penicillin allergy assessment pathway versus usual clinical care in a UK primary care setting. The aim of this paper is to describe how EHRs were used to facilitate efficient delivery of a large-scale randomised trial of a complex intervention embracing efficient participant identification, supporting minimising GP workload, providing accurate post-intervention EHR updates of allergy status, and facilitating participant follow up and outcome data collection. The generalisability of the EHR approach and health economic implications of EHR in clinical trials will be reported in the main ALABAMA trial cost-effectiveness analysis.

methodsA descriptive account of the adaptation of functionality within SystmOne used to deliver/facilitate multiple trial processes from participant identification to outcome data collection.

resultsAn ALABAMA organisation group within SystmOne was established which allowed sharing of trial functions/materials developed centrally by the research team. The 'ALABAMA unit' within SystmOne was also created and provided a secure efficient environment to access participants' EHR data. Processes of referring consented participants, allocating them to a trial arm, and assigning specific functions to the intervention arm were developed by adapting tools such as templates, reports, and protocols which were already available in SystmOne as well as pathways to facilitate allergy de-labelling processes and data retrieval for trial outcome analysis.

conclusionsALABAMA is one of the first RCTs to utilise SystmOne EHR functionality and data across the RCT delivery, demonstrating feasibility and applicability to other primary care RCTs.

trial registrationClinicalTrials.gov: NCT04108637, registered 05/03/2019. ISRCTN: ISRCTN20579216.

Indexed as

Drug HypersensitivityElectronic Health RecordsPenicillinsPrimary Health CareAlabamaAnti-Bacterial AgentsCost-Benefit AnalysisHumansRandomized Controlled Trials as TopicAnti-Bacterial AgentsPenicillinsClinical trialsEHRElectronic health recordEMISPenicillin allergyPenicillin allergy de-labellingPrimary careRCTSystmOneTPP

Identifiers

PMID39363246
PMCPMC11450982

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.