Allergy · 2026
Development of Betalactam-Predictor: A Clinical Decision Tool for Delabeling Low-Risk Betalactam Allergy Patients. Initial Validation in Penicillin Allergy.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Labella Marina, Nuñez Rafael, Doña Inmaculada, de Guzmán Julia Rodríguez, Moreno Esther, Garvey Lene Heise, Laguna Jose Julio, Barbaud Annick, Bonnadona Patrizia, Boel Jonas Bredtoft, Mosbech Holger, Sfriso Giovanna, Castells Mariana, Phillips Elizabeth, Torres María José
Аннотация
BACKGROUND: A label of betalactam (BL) allergy is estimated in around 10% of the population in their medical records. Second-line choices carry significant negative consequences, including reduced efficacy, effectiveness, and safety. This study aimed to develop a new highly specific score constructed by selecting variables assisted by artificial intelligence to identify low-risk BL-allergic patients.
METHODS: In this study, derivation and validation of the BL-predictor score were performed on a retrospective cohort of 2207 patients who underwent penicillin allergy testing at Málaga University Hospital (Spain). The development of the BL-predictor encompassed expert drafting and a two-step variable selection process consisting of univariate analysis and variable filtering, followed by stepwise logistic regression with resampling. To assess the efficiency, a multicentric retrospective external validation was performed in 4261 patients from six populations: Salamanca and Madrid, Spain; Nashville, United States of America; Verona, Italy; Paris, France; and Copenhagen, Denmark.
RESULTS: The definitive questionnaire consisted of eight items and risk points were computed from the logistic regression model as follows: +1 for reactions after first dose or in less than 1 h (ITEM-1), +2 for anaphylaxis (ITEM-2); +1 for previous reaction with the culprit (ITEM-3); -1 for resolution in > 24 h (ITEM-4); +2 for spontaneous resolution (ITEM-5); -2 for unknown symptoms (ITEM-6); -2 for reaction occurred > 5 years (ITEM-7), and -1 for another reported drug allergy (ITEM-8). After establishing a threshold of ≤ 0 points to classify individuals with low risk, internal validation showed a specificity of 86% and a negative predictive value (NPV) of 83%. Overall multicenter external validation showed a specificity of 93%, which implies a 25% increase in specificity compared to the previously published BL decision tool.
CONCLUSION: This score would simplify diagnostic procedures in low-risk patients, enabling rapid delabeling, potentially in non-specialty settings, and reducing diagnostic costs and the negative consequences associated with incorrect antibiotic allergy labels.
METHODS: In this study, derivation and validation of the BL-predictor score were performed on a retrospective cohort of 2207 patients who underwent penicillin allergy testing at Málaga University Hospital (Spain). The development of the BL-predictor encompassed expert drafting and a two-step variable selection process consisting of univariate analysis and variable filtering, followed by stepwise logistic regression with resampling. To assess the efficiency, a multicentric retrospective external validation was performed in 4261 patients from six populations: Salamanca and Madrid, Spain; Nashville, United States of America; Verona, Italy; Paris, France; and Copenhagen, Denmark.
RESULTS: The definitive questionnaire consisted of eight items and risk points were computed from the logistic regression model as follows: +1 for reactions after first dose or in less than 1 h (ITEM-1), +2 for anaphylaxis (ITEM-2); +1 for previous reaction with the culprit (ITEM-3); -1 for resolution in > 24 h (ITEM-4); +2 for spontaneous resolution (ITEM-5); -2 for unknown symptoms (ITEM-6); -2 for reaction occurred > 5 years (ITEM-7), and -1 for another reported drug allergy (ITEM-8). After establishing a threshold of ≤ 0 points to classify individuals with low risk, internal validation showed a specificity of 86% and a negative predictive value (NPV) of 83%. Overall multicenter external validation showed a specificity of 93%, which implies a 25% increase in specificity compared to the previously published BL decision tool.
CONCLUSION: This score would simplify diagnostic procedures in low-risk patients, enabling rapid delabeling, potentially in non-specialty settings, and reducing diagnostic costs and the negative consequences associated with incorrect antibiotic allergy labels.