title: An EAACI "European Survey on Adverse Systemic Reactions in Allergen Immunotherapy (EASSI)": the methodology.
abstract: At present, there is no European report on clinically relevant systemic reactions due to the regular use of allergen immunotherapy (AIT), administered either subcutaneously or sublingually (SCIT and SLIT, respectively) outside clinical trials. Using an electronic survey and a "harmonised terminology" according to MedDRA, we aimed to prospectively collect systemic adverse reactions due to AIT from real life clinical settings. Under the framework of the EAACI, a team of European specialists in AIT, pharmacovigilance, epidemiology and drugs regulation set up a web-based prospective pilot survey to be conducted in three European countries (France, Germany and Spain). A designated "national coordinator" was responsible for following ethics requirements relative to each country and to select at least 30 doctors per country. Patients were recruited the same day they received their first dose of either SCIT or SLIT. Patient inclusion criteria were: adults and children, with IgE mediated pollen, house dust mite, Alternaria, and/or animal dander respiratory allergies who will initiate AIT. A list of 31 symptoms terms were extracted from the MedDRA (Medical Dictionary for Regulatory Activities) dictionary to harmonize the reporting of all adverse systemic reactions in this survey. The SurveyMonkey® online instrument was used by participant doctors to submit information directly to a blinded central database.
  i) the Doctor Questionnaire, ii) the Patient Questionnaire and iii) the Adverse Reaction Questionnaire. A handbook and a mistake report form were given to each doctor. In this paper, we describe the methodology followed.
authors: Section of Allergy and Clinical Immunology, Imperial College London, National Heart and Lung Institute, Royal Brompton Hospital, London, UK.
authors: Moises A
authors: MA
authors: Calderón
authors: Allergy Section, Hospital Infantil Universitario Niño Jesús, Madrid, Spain.
authors: Pablo
authors: P
authors: Rodríguez Del Río
authors: Allergy Department, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.
authors: Carmen
authors: C
authors: Vidal
authors: Allergology Department, Centre de l'Asthme et des Allergies. Hôpital d'Enfants Armand-Trousseau (APHP)-Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Equipe EPAR, Paris, F-75013 75571 Cedex 12, France.
authors: Jocelyne
authors: J
authors: Just
authors: Center for Rhinology and Allergology, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, Wiesbaden, Germany.
authors: Oliver
authors: O
authors: Pfaar
authors: Research Centre for Prevention and Health, the Capital Region of Denmark, Glostrup, Denmark ; Department of Clinical Experimental Research, Glostrup University Hospital, Glostrup, Denmark ; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
authors: Allan
authors: A
authors: Linneberg
authors: Département de Pneumologie et Addictologie, Hôpital Arnaud de Villeneuve, University Hospital of Montpellier, Sorbonne Universités, UPMC Paris 06, UMR-S 1136, IPLESP, Equipe EPAR, 75013 Paris, France.
authors: Pascal
authors: P
authors: Demoly
keywords: Adverse systemic reactions; Allergen; Allergen immunotherapy; Subcutaneous; Sublingual