Allergic patients and healthy controls selection
Patients with suggestive clinical history of NIDHR attending the Allergy Unit of the Hospital Regional Universitario de Málaga (HRUM) from 2013 until 2019 were prospectively evaluated. Only patients with confirmed diagnosis of NIDHRs following European Academy of Allergy and Clinical Immunology (EAACI) recommendations were included in the study.6,7,29 The diagnosis was based on STs (positive delayed-reading IDT or PT) and, if negative, on DPT. In cases reporting severe reactions or with a risky medical background in which DPT was contraindicated, the diagnosis was based on the causality algorithm of the Spanish Pharmacovigilance System (ASPS),17,30which classified reactions as not related (improbable (<0 score) and conditional (1-3 score)) or related (possible (4-5 score), probable (6-7 score) or defined (≥8 score)).
A group of healthy, sex- and age-matched subjects with no history of DHRs were included as controls. All subjects were correctly informed and those who decided to participate signed an informed consent. The study was conducted in accordance with the Declaration of Helsinki and it was approved by the Ethical Committee of Malaga.