title: Quantitative benefit-risk assessment by MCDA of the quadrivalent HPV vaccine for preventing anal cancer in males.
abstract: OBJECTIVE
  To quantify the benefit-risk (BR) balance of the quadrivalent human papillomavirus (qHPV) vaccine for use in males, including anal cancer prevention, by using the multicriteria decision analysis (MCDA).
  
  
  METHODS
  Value tree and an effect table were compiled using relevant qHPV vaccine efficacy/safety data. An expert panel validated the final model inputs.
  
  
  RESULTS
  On a scale of 0-100, the MCDA qHPV vaccine score (66) was superior to the no vaccination score (46), indicating a more favorable BR balance for the qHPV vaccine. Significant changes in weight of individual outcomes were needed to change BR balance in sensitivity analyses. The qHPV vaccine maintained a better BR profile in all alternative models.
  
  
  CONCLUSIONS
  MCDA can be used to transparently evaluate BR balance of vaccines. The qHPV vaccine had a favorable BR balance in males. Including anal cancer as a new indication further improves the BR profile of the qHPV vaccine.
authors.affiliation: a Epidemiology Department , Sanofi Pasteur MSD , Lyon Cedex 07 , France.
authors.forename: Lydie
authors.initials: L
authors.lastname: Marcelon
authors.affiliation: a Epidemiology Department , Sanofi Pasteur MSD , Lyon Cedex 07 , France.|b Epidemiology and Pharmacovigilance Consulting and Services , P95 , Leuven , Belgium.
authors.forename: Thomas
authors.initials: T
authors.lastname: Verstraeten
authors.affiliation: a Epidemiology Department , Sanofi Pasteur MSD , Lyon Cedex 07 , France.
authors.forename: Geraldine
authors.initials: G
authors.lastname: Dominiak-Felden
authors.affiliation: a Epidemiology Department , Sanofi Pasteur MSD , Lyon Cedex 07 , France.
authors.forename: François
authors.initials: F
authors.lastname: Simondon
mesh_terms: D000293:Adolescent; D001005:Anus Neoplasms / Q000191:economics* / Q000453:epidemiology / Q000517:prevention & control*; D002648:Child; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 / Q000008:administration & dosage / Q000191:economics* / Q000276:immunology*; D006801:Humans; D008297:Male; D030361:Papillomavirus Infections / Q000150:complications* / Q000517:prevention & control*; D018570:Risk Assessment; D055815:Young Adult
chemical_list: D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
keywords: Benefit-risk assessment; anal cancer; human papillomavirus (HPV); multicriteria decision analysis; vaccine