title: Health utilities lost and risk factors associated with HPV-induced diseases in men and women: the HPV Italian collaborative study group.
abstract: OBJECTIVE
  A complete economic evaluation requires accurate data concerning the resources used, outcomes, and utilities (patient's preferences) to properly value the cost utility of human papillomavirus (HPV) vaccination strategies. This study was designed to measure the utility loss in health states affected by a broad range of HPV-induced pathologies in both sexes in Italy. As a secondary objective, risk factors influencing the viral transmission and development of HPV infections were also investigated.
  
  
  METHODS
  Patients with a diagnosis of several HPV-induced pathologies including atypical squamous cells of undetermined significance (ASC-US), cervical intraepithelial neoplasia (CIN), cervical and anal-colorectal cancer, head and neck squamous cell carcinoma (HNSCC) and anogenital warts (AWs) were evaluated. Utilities, quality of life, and risk factors were elicited using a standardized and computer-guided administration of time trade-off, European Quality of Life 5 Dimensions (EQ-5D), 3 levels, and risk factor questionnaires. Utilities were measured at 6 clinical research centers across Italy. A group of healthy subjects was used as a control. A mean number of 20 healthy subjects was used as a control for each pathology group.
  
  
  RESULTS
  Overall, 600 respondents were eligible for analysis: 465 patients (mean [SD] age, 44.0 [16.3] years) and 135 controls (mean [SD] age, 44.0 [13.2] years). With the exception of anal and HNSCC cancer, no statistically significant differences were observed between case and control groups, in terms of either age or quality of life at the time of interview. The patients' perception of their health condition at baseline was equal to an EQ-5D score of 0.87 (0.22). The mean (SD) value of utilities associated with the HPV-induced pathologies corresponded to 0.83 (0.24), 0.78 (0.27), 0.83 (0.22), 0.81 (0.27), 0.58 (0.31), 0.51 (0.26), and 0.69 (0.30) for ASC-US, AWs, CIN 1 (mild), CIN 2-3 (moderate to severe), cervical cancer, anal cancer and HNSCC, respectively. Utility lost due to AWs was significantly higher in females compared with males (0.71 [0.29] vs 0.83 [0.25]; P = 0.018). Having >5 sexual partners increased the risk of acquiring HPV-induced infections as much as 2.52-fold (P = 0.004), whereas for smoking or the age at start of sexual activity younger than 18 years, the risk increased by ~1.62-fold (P = 0.034). High levels of education were associated with a statistically significant protective effect (P < 0.001).
  
  
  CONCLUSIONS
  Risk factors and utilities elicited in this study can be used as part of future economic assessments of other HPV vaccination strategies, including an immunization program for preadolescents of both sexes in Italy.
authors.affiliation: CEIS - Economic Evaluation and HTA, Faculty of Economics, University of Rome "Tor Vergata", Rome, Italy; Department of Demography, "Sapienza" University of Rome, Rome, Italy. Electronic address: andrea.marcellusi@uniroma2.it.
authors.forename: Andrea
authors.initials: A
authors.lastname: Marcellusi
authors.affiliation: Institute for Leadership and Management in Health, Kingston University London, London, United Kingdom.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Capone
authors.affiliation: Institute for Leadership and Management in Health, Kingston University London, London, United Kingdom.
authors.forename: Giampiero
authors.initials: G
authors.lastname: Favato
authors.affiliation: CEIS - Economic Evaluation and HTA, Faculty of Economics, University of Rome "Tor Vergata", Rome, Italy; Institute for Leadership and Management in Health, Kingston University London, London, United Kingdom.
authors.forename: Francesco Saverio
authors.initials: FS
authors.lastname: Mennini
authors.affiliation: Department of Statistical Science, University College London, London, United Kingdom.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Baio
authors.affiliation: Department of Statistical Science, University College London, London, United Kingdom.
authors.forename: Katrin
authors.initials: K
authors.lastname: Haeussler
authors.affiliation: Department of Surgery Pietro Valdoni, "Sapienza" University of Rome, Rome, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Bononi
mesh_terms: D000328:Adult; D001005:Anus Neoplasms / Q000191:economics / Q000517:prevention & control; D002294:Carcinoma, Squamous Cell / Q000191:economics / Q000517:prevention & control / Q000821:virology; D005006:Ethnicity; D005260:Female; D006258:Head and Neck Neoplasms / Q000191:economics / Q000517:prevention & control / Q000821:virology; D006304:Health Status; D006801:Humans; D017589:Immunization Programs / Q000191:economics*; D007558:Italy; D008297:Male; D008875:Middle Aged; D027383:Papillomaviridae; D030361:Papillomavirus Infections / Q000191:economics* / Q000517:prevention & control / Q000821:virology; D053918:Papillomavirus Vaccines / Q000191:economics*; D011788:Quality of Life; D012307:Risk Factors; D002583:Uterine Cervical Neoplasms / Q000191:economics / Q000517:prevention & control / Q000821:virology; D014611:Vaccination / Q000191:economics*; D002578:Uterine Cervical Dysplasia / Q000191:economics / Q000517:prevention & control / Q000821:virology
chemical_list: D053918:Papillomavirus Vaccines
keywords: CIN 1; CIN 2–3; HPV; TTO; anal cancer; anogenital warts; cervical cancer; head and neck squamous cell carcinoma; quality of life; utilities