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- Title
Development and Validation of a Penicillin Allergy Clinical Decision Rule.
- Authors
Trubiano, Jason A.; Vogrin, Sara; Chua, Kyra Y. L.; Bourke, Jack; Yun, James; Douglas, Abby; Stone, Cosby A.; Yu, Roger; Groenendijk, Lauren; Holmes, Natasha E.; Phillips, Elizabeth J.
- Abstract
<bold>Importance: </bold>Penicillin allergy is a significant public health issue for patients, antimicrobial stewardship programs, and health services. Validated clinical decision rules are urgently needed to identify low-risk penicillin allergies that potentially do not require penicillin skin testing by a specialist.<bold>Objective: </bold>To develop and validate a penicillin allergy clinical decision rule that enables point-of-care risk assessment of patient-reported penicillin allergies.<bold>Design, Setting, and Participants: </bold>In this diagnostic study, a multicenter prospective antibiotic allergy-tested cohort of 622 patients from 2 tertiary care sites in Melbourne, Australia (Austin Health and Peter MacCallum Cancer Centre) was used for derivation and internal validation of a penicillin allergy decision rule. Backward stepwise logistic regression was used to derive the model, including clinical variables predictive of a positive penicillin allergy test result. Internal validation of the final model used bootstrapped samples and the model scoring derived from the coefficients. External validation was performed in retrospective penicillin allergy-tested cohorts consisting of 945 patients from Sydney and Perth, Australia, and Nashville, Tennessee. Patients who reported a penicillin allergy underwent penicillin allergy testing using skin prick, intradermal, or patch testing and/or oral challenge (direct or after skin testing). Data were collected from June 26, 2008, to June 3, 2019, and analyzed from January 9 to 12, 2019.<bold>Main Outcomes and Measures: </bold>The primary outcome for the model was any positive result of penicillin allergy testing performed during outpatient or inpatient assessment.<bold>Results: </bold>From an internal derivation and validation cohort of 622 patients (367 female [59.0%]; median age, 60 [interquartile range{IQR}, 48-71] years) and an external validation cohort of 945 patients (662 female [70.1%]; median age, 55 [IQR, 38-68] years), the 4 features associated with a positive penicillin allergy test result on multivariable analysis were summarized in the mnemonic PEN-FAST: penicillin allergy, five or fewer years ago, anaphylaxis/angioedema, severe cutaneous adverse reaction (SCAR), and treatment required for allergy episode. The major criteria included an allergy event occurring 5 or fewer years ago (2 points) and anaphylaxis/angioedema or SCAR (2 points); the minor criterion (1 point), treatment required for an allergy episode. Internal validation showed minimal mean optimism of 0.003 with internally validated area under the curve of 0.805. A cutoff of less than 3 points for PEN-FAST was chosen to classify a low risk of penicillin allergy, for which only 17 of 460 patients (3.7%) had positive results of allergy testing, with a negative predictive value of 96.3% (95% CI, 94.1%-97.8%). External validation resulted in similar findings.<bold>Conclusions and Relevance: </bold>In this study, PEN-FAST was found to be a simple rule that accurately identified low-risk penicillin allergies that do not require formal allergy testing. The results suggest that a PEN-FAST score of less than 3, associated with a high negative predictive value, could be used by clinicians and antimicrobial stewardship programs to identify low-risk penicillin allergies at the point of care.
- Subjects
RESEARCH; RESEARCH methodology; EVALUATION research; MEDICAL cooperation; PENICILLIN; RISK assessment; COMPARATIVE studies; RESEARCH funding; DRUG allergy; ANTIBIOTICS; LONGITUDINAL method
- Publication
JAMA Internal Medicine, 2020, Vol 180, Issue 5, p745
- ISSN
2168-6106
- Publication type
journal article
- DOI
10.1001/jamainternmed.2020.0403