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.