title: The International development of PROQOL-HCV: An instrument to assess the health-related quality of life of patients treated for Hepatitis C virus.
abstract: Hepatitis C virus (HCV) compromises Health-related Quality of Life (HRQL) with detriments to Physical, Mental and Social health domains. Treatment with interferon and ribavirin is associated with side effects which further impair HRQL. New treatments appear potent, effective and tolerable. However, Patient Reported Outcomes instruments that capture the impact on HRQL for people with hepatitis C are largely non-specific and will be needed in the new treatment era. Therefore, we developed a conceptually valid multidimensional model of HCV-specific quality of life and pilot survey instrument, the Patient Reported Outcome Quality of Life survey for HCV (PROQOL-HCV).
  
  
  
  HCV patients from France (n = 30), Brazil (n = 20) and Australia (n = 20) were interviewed to investigate HCV-HRQL issues raised in the scientific literature and by treatment specialists. Interviews were recorded, transcribed and translated into English and French.
  
  
  
  Fifteen content dimensions were derived from the qualitative analysis, refined and fitted to four domains: (1) Physical Health included: fatigue, pain, sleep, sexual impairment and physical activity; (2) Mental Health: psychological distress, psychosocial impact, and cognition; (3) Social Health: support, stigma, social activity, substance use; (4) TREATMENT: management, side effects, and fear of treatment failure. The impact of some dimensions extended beyond their primary domain including: physical activity, cognition, sleep, sexual impairment, and the three treatment dimensions. A bank of 300 items was constructed to reflect patient reports and, following expert review, reduced to a 72-item pilot questionnaire.
  
  
  
  We present a conceptually valid multidimensional model of HCV-specific quality of life and the pilot survey instrument, PROQOL-HCV. The model is widely inclusive of the experience of hepatitis C and the first to include the treatment dimension.
authors.affiliation: EA 7334 REMES, Patient-Centered Outcomes Research, University Paris-Diderot, Sorbonne Paris Cité, Paris, France. Andrew74.psy@gmail.com.|Australian Institute of Family Studies, Melbourne, Australia. Andrew74.psy@gmail.com.
authors.forename: Andrew Richard
authors.initials: AR
authors.lastname: Armstrong
authors.affiliation: Institute for Immunology and Infectious Diseases, Murdoch University, Murdoch, Western Australia, Australia.
authors.forename: Susan Elizabeth
authors.initials: SE
authors.lastname: Herrmann
authors.affiliation: EA 7334 REMES, Patient-Centered Outcomes Research, University Paris-Diderot, Sorbonne Paris Cité, Paris, France.|URC-ECO, Hopital Hotel-Dieu, AP-HP, Paris, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Chassany
authors.affiliation: EA 7334 REMES, Patient-Centered Outcomes Research, University Paris-Diderot, Sorbonne Paris Cité, Paris, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Lalanne
authors.affiliation: Centro de Referência e Treinamento DST/Aids, Rue santa Cruz, Sao Paulo, Brazil.
authors.forename: Mariliza Henrique
authors.initials: MH
authors.lastname: Da Silva
authors.affiliation: Centro de Referência e Treinamento DST/Aids, Rue santa Cruz, Sao Paulo, Brazil.
authors.forename: Eliana
authors.initials: E
authors.lastname: Galano
authors.affiliation: U912 (SE4S), INSERM, Marseille, France.
authors.forename: Patrizia M
authors.initials: PM
authors.lastname: Carrieri
authors.affiliation: Université Paris Descartes, Paris, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Estellon
authors.affiliation: Service d'Hépatologie, Hopital Cochin, AP-HP, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Sogni
authors.affiliation: EA 7334 REMES, Patient-Centered Outcomes Research, University Paris-Diderot, Sorbonne Paris Cité, Paris, France.|URC-ECO, Hopital Hotel-Dieu, AP-HP, Paris, France.|Service de Médecine Interne et d'Immunologie Clinique, Hopital Bicetre, AP-HP, Kremlin-Bicetre, France.
authors.forename: Martin
authors.initials: M
authors.lastname: Duracinsky
mesh_terms: D000328:Adult; D001315:Australia; D001938:Brazil; D005221:Fatigue; D005260:Female; D005602:France; D006305:Health Status Indicators; D016174:Hepacivirus / Q000502:physiology; D006526:Hepatitis C / Q000523:psychology* / Q000628:therapy*; D006801:Humans; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011594:Psychometrics / Q000379:methods* / Q000592:standards; D011788:Quality of Life / Q000523:psychology; D011795:Surveys and Questionnaires / Q000592:standards
keywords: Health status; Hepatitis c; Quality of life; Questionnaires; Research methods