title: The hereditary angioedema burden of illness study in Europe (HAE-BOIS-Europe): background and methodology.
abstract: BACKGROUND
  Hereditary angioedema (HAE) is a rare but serious disease marked by swelling attacks in the extremities, face, trunk, airway, or abdominal areas that can be spontaneous or the result of trauma and other triggers. It can be life-threatening due to the risk of asphyxiation. While there have been major advancements in our understanding of the immunogenetics of HAE, there are significant gaps in the literature regarding understanding of the humanistic and economic impact of the disease, particularly in Europe. The purpose of the HAE Burden of Illness Study-Europe (HAE-BOIS-Europe), the development and methodology of which is described here, is to better understand the management and impact of HAE from the patient perspective in Europe.
  
  
  METHODS
  This is a cross-sectional study in which retrospective data were also collected being conducted in Denmark, Germany and Spain. The study is open to patients ages 12 and older with a diagnosis of HAE-I or HAE-II. Data collection includes: (i) a survey on individuals' health care resource use, direct and indirect medical costs, impact on work and school, treatment satisfaction, and emotional functioning (via the Hospital Anxiety and Depression Scale); and (ii) one-on-one interviews to collect detailed descriptive data and patient testimonials on the impact of HAE on patients' health-related quality of life.
  
  
  CONCLUSIONS
  The present manuscript describes the development and plans for implementing a multi-country European study with the aim of characterizing the humanistic and economic burden of HAE from the patient perspective. This study will help raise awareness of HAE as a rare but debilitating condition with wide-ranging impacts.
authors.affiliation: HAE Centre Denmark, Department of Dermatology and Allergy Centre, Odense University Hospital, 5000 Odense C, Denmark. Anette.Bygum@ouh.regionsyddanmark.dk
authors.forename: Anette
authors.initials: A
authors.lastname: Bygum
authors.forename: Emel
authors.initials: E
authors.lastname: Aygören-Pürsün
authors.forename: Teresa
authors.initials: T
authors.lastname: Caballero
authors.forename: Kathleen
authors.initials: K
authors.lastname: Beusterien
authors.forename: Shadi
authors.initials: S
authors.lastname: Gholizadeh
authors.forename: Patience
authors.initials: P
authors.lastname: Musingarimi
authors.forename: Suzanne
authors.initials: S
authors.lastname: Wait
authors.forename: Henrik
authors.initials: H
authors.lastname: Boysen
mesh_terms: D000293:Adolescent; D000328:Adult; D054179:Angioedemas, Hereditary / Q000150:complications / Q000453:epidemiology / Q000523:psychology; D002648:Child; D017281:Cost of Illness; D003430:Cross-Sectional Studies; D003718:Denmark / Q000453:epidemiology; D005260:Female; D005858:Germany / Q000453:epidemiology; D017048:Health Care Costs; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012189:Retrospective Studies; D013030:Spain / Q000453:epidemiology; D011795:Surveys and Questionnaires; D055815:Young Adult