Quality Standards for Allergen Immunotherapy Clinics in Spain: Consensus Document.

BACKGROUND AND OBJECTIVE: Allergen immunotherapy clinics (AITCs) in Spain differ widely in terms of structure, organization, resources, and portfolio of services. Therefore, it is essential to unify treatment criteria and define quality standards for the most complex AITCs. Objective: To establish a series of recommendations that make it possible to guarantee quality and safety in the administration of immunotherapy and define quality standards for the most complex AITCs. METHODS: This project began with an online survey of 65 allergy departments/units throughout Spain in 2013. Next, a 2-phase consensus process was carried out. In the first phase, 10 experts defined and agreed on the standards using the RAND/UCLA Appropriateness method; in the second, the agreements were validated by means of a 2-round Delphi consultation with 84 experts. RESULTS: Consensus was reached on minimum safety and quality criteria in the administration of allergen immunotherapy, and 2 levels of highly complex AITCs were defined: accredited AITCs and accredited AITCs with excellence. Consensus was also reached on quality standards and accreditation criteria for both levels. CONCLUSIONS: This project is pioneering in terms of its purpose (the definition of quality standards for AITCs) and of the use of structured participation techniques (combination of the RAND/UCLA and Delphi methods). It enabled the design of minimum standards for quality and safety in administering AIT, as well as quality criteria for accreditation of AITCs supported by a broad panel of experts from the Spanish Society of Allergology and Clinical Immunology.

Esophageal dysfunction and immunological changes induced by grass sublingual immunotherapy.

Sublingual immunotherapy frequently causes local oropharyngeal adverse events which are usually of mild severity, and tend to be self-limited and disappear within the first weeks of therapy. The mechanism of action involves changes in the specific humoral response to allergens, with increases in allergen-specific immunoglobulin G4 (IgG4) and blunting of the seasonal increase in allergen-specific IgE. We describe the case of a 25-year-old man diagnosed with grass pollen induced allergic rhinoconjunctivitis, who was treated with a lyophilisate of Phleum pratense by sublingual route. After 5 weeks of therapy he developed repeatedly intense symptoms of esophageal dysfunction immediately after the administration. Symptoms recurred every day, subsided in some hours without treatment and disappeared with the termination of therapy. The episode coincided with a marked elevation of total and specific IgE. The immunological changes gradually declined during the three years of follow up. The reported case suggests the need to evaluate the role of the immunological changes detected after the first weeks of sublingual therapy with Phleum pratense, in the induction of esophageal disorders.