Evidence map›Paper›PMID 37666558›Full record

ArticleBMJ open2023

Penicillin allergy status and its effect on antibiotic prescribing, patient outcomes and antimicrobial resistance (ALABAMA): protocol for a multicentre, parallel-arm, open-label, randomised pragmatic trial.

Kelsey Fiona Armitage, Catherine E Porter, Shadia Ahmed, Johanna Cook, Jenny Boards, Emily Bongard, Christopher C Butler, Kate Corfield, Mina Davoudianfar, Ushma Galal and 12 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Open forum infectious diseases · 2026
    Article
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  7. Review
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

22 authors.

Kelsey Fiona Armitage *Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK.ORCID 0000-0001-5438-5290
Catherine E Porter *Dental Translational and Clinical Research Unit, School of Dentistry, University of Leeds, Leeds, West Yorkshire, UK.
Shadia AhmedLeeds Teaching Hospitals NHS Trust, Leeds, Leeds, UK.
Johanna CookNuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK.
Jenny BoardsLeeds Teaching Hospitals NHS Trust, Leeds, Leeds, UK.
Emily BongardNuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK.ORCID 0000-0001-5957-6280
Christopher C ButlerNuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK.ORCID 0000-0002-0102-3453
Kate CorfieldNuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK.
Mina DavoudianfarNuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK.
Ushma GalalNuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK.
Philip HowardSchool of Healthcare, University of Leeds, Leeds, UK.
Ruben Mujica-MotaAcademic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Razan SamanLeeds Teaching Hospitals NHS Trust, Leeds, Leeds, UK.ORCID 0000-0002-0733-9344
Marta SantilloNuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK.ORCID 0000-0001-6345-7612
Sinisa SavicClinical Immunology and Allergy, University of Leeds Leeds Institute of Medical Research at St James's, Leeds, UK.
Bethany ShinkinsAcademic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
Sarah Tonkin-CrineNuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK.ORCID 0000-0003-4470-1151
Marta WanatNuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK.ORCID 0000-0002-0163-1547
Robert M WestLeeds Institute of Health Sciences, University of Leeds, Leeds, UK.ORCID 0000-0001-7305-3654
Ly-Mee YuNuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK.
Sue PavittDental Translational and Clinical Research Unit, School of Dentistry, University of Leeds, Leeds, West Yorkshire, UK.
Jonathan A T SandoeLeeds Institute of Medical Research, School of Medicine, University of Leeds, Leeds, UK J.Sandoe@leeds.ac.uk.

Funding

Department of Health RP-PG-1214-20007
6 · The paper itself

Abstract

introductionIncorrect penicillin allergy records are recognised as an important barrier to the safe treatment of infection and affect an estimated 2.7 million people in England. Penicillin allergy records are associated with worse health outcome and antimicrobial resistance. The ALlergy AntiBiotics And Microbial resistAnce (ALABAMA) trial aims to determine if an intervention package, centred around a penicillin allergy assessment pathway (PAAP) initiated in primary care, is safe and effective in improving patient health outcomes and antibiotic prescribing. METHODS AND ANALYSIS: The ALABAMA trial is a multicentre, parallel-arm, open-label, randomised pragmatic trial with a nested pilot study. Adults (≥18 years) with a penicillin allergy record and who have received antibiotics in the previous 24 months will be eligible for participation. Between 1592 and 2090 participants will be recruited from participating National Health Service general practices in England. Participants will be randomised to either usual care or intervention to undergo a pre-emptive PAAP using a 1:1 allocation ratio. The primary outcome measure is the percentage of treatment response failures within 28 days of an index prescription. 2090 and 1592 participants are estimated to provide 90% and 80% power, respectively, to detect a clinically important absolute difference of 7.9% in primary outcome at 1 year between groups. The trial includes a mixed-methods process evaluation and cost-effectiveness evaluation. ETHICS AND DISSEMINATION: This trial has been approved by London Bridge Research Ethics Committee (ref: 19/LO/0176). It will be conducted in compliance with Good Clinical Practice guidelines according to the Declaration of Helsinki. Informed consent will be obtained from all subjects involved in the study. The primary trial results will be submitted for publication to an international, peer-reviewed journal.

trial registrationISRCTN20579216.

Indexed as

Drug HypersensitivityHypersensitivityAdultAlabamaAnti-Bacterial AgentsDrug Resistance, BacterialHumansMulticenter Studies as TopicPenicillinsPilot ProjectsPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicState MedicineAnti-Bacterial AgentsPenicillinsclinical trialimmunologyinfectious diseasesprimary care

Identifiers

PMID37666558
PMCPMC10481831

What OpenQuestion holds

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Registered trials

None linked

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.