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.

INTRODUCTION: Incorrect 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 REGISTRATION: ISRCTN20579216.

Clinician and Patient Factors Influencing Treatment Decisions: Ethnographic Study of Antibiotic Prescribing and Operative Procedures in Out-of-Hours and General Dental Practices.

Operative treatment is indicated for most toothache/dental abscesses, yet antibiotics instead of procedures are often prescribed. This ethnographic study aimed to identify clinician and patient factors influencing urgent dental care for adults during actual appointments; and to identify elements sensitive to context. Appointments were observed in out-of-hours and general dental practices. Follow-up interviews took place with dentists, dental nurses, and patients. Dentist and patient factors were identified through thematic analysis of observation records and appointment/interview transcripts. Dentist factors were based on a published list of factors influencing antibiotic prescribing for adults with acute conditions across primary health care and presented within the Capability-Opportunity-Motivation-Behaviour model. Contextually sensitive elements were revealed by comparing the factors between settings. In total, thirty-one dentist factors and nineteen patient factors were identified. Beliefs about antibiotics, goals for the appointment and access to dental services were important for both dentists and patients. Dentist factors included beliefs about the lifetime impact of urgent dental procedures on patients. Patient factors included their communication and negotiation skills. Contextual elements included dentists' concerns about inflicting pain on regular patients in general dental practice; and patients' difficulties accessing care to complete temporary treatment provided out of hours. This improved understanding of factors influencing shared decisions about treatments presents significant opportunity for new, evidence-based, contextually sensitive antibiotic stewardship interventions.