title: Assessing cost-effectiveness of HPV vaccines with decision analytic models: what are the distinct challenges of low- and middle-income countries? A protocol for a systematic review.
abstract: BACKGROUND
  Cervical cancer poses a huge health burden, both to developed and developing nations, making prevention and control strategies necessary. However, the challenges of designing and implementing prevention strategies differ for low- and middle-income countries (LMICs) as compared to countries with fully developed health care systems. Moreover, for many LMICs, much of the data needed for decision analytic modelling, such as prevalence, will most likely only be partly available or measured with much larger uncertainty. Lastly, imperfect implementation of human papillomavirus (HPV) vaccination may influence the effectiveness of cervical cancer prevention in unpredictable ways. This systematic review aims to assess how decision analytic modelling studies of HPV cost-effectiveness in LMICs accounted for the particular challenges faced in such countries. Specifically, the study will assess the following: (1) whether the existing literature on cost-effectiveness modelling of HPV vaccines acknowledges the distinct challenges of LMICs, (2) how these challenges were accommodated in the models, (3) whether certain parameters systemically exhibited large degrees of uncertainty due to lack of data and how influential were these parameters on model-based recommendations, and (4) whether the choice of modelling herd immunity influences model-based recommendations, especially when coverage of a HPV vaccination program is not optimal.
  
  
  METHODS
  We will conduct a systematic review to identify suitable studies from MEDLINE (via PubMed), EMBASE, NHS Economic Evaluation Database (NHS EED), EconLit, Web of Science, and CEA Registry. Searches will be conducted for studies of interest published since 2006. The searches will be supplemented by hand searching of the most relevant papers found in the search. Studies will be critically appraised using Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement checklist. We will undertake a descriptive, narrative, and interpretative synthesis of data to address the study objectives.
  
  
  CONCLUSIONS
  The proposed systematic review will assess how the cost-effectiveness studies of HPV vaccines accounted for the distinct challenges of LMICs. The gaps identified will expose areas for additional research as well as challenges that need to be accounted for in future modelling studies.
  
  
  BACKGROUND
  PROSPERO CRD42015017870.
authors.affiliation: Cooperative Research Group for Evidence-Based Public Health, Department of Prevention and Evaluation, Leibniz Institute for Prevention Research and Epidemiology-BIPS, Bremen, Germany. ekwunife@uni-bremen.de.|Department of Clinical Pharmacy and Pharmacy Management, Nnamdi Azikiwe University, Awka, Nigeria. ekwunife@uni-bremen.de.
authors.forename: Obinna I
authors.initials: OI
authors.lastname: Ekwunife
authors.affiliation: Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany. andreas.gerber@iqwig.de.
authors.forename: Andreas Gerber
authors.initials: AG
authors.lastname: Grote
authors.affiliation: Institute for Research in Operative Medicine (IFOM), Universität Witten/Herdecke, Witten, Germany. Christoph.Mosch@uni-wh.de.
authors.forename: Christoph
authors.initials: C
authors.lastname: Mosch
authors.affiliation: Department of Health Policy and Management, School of Medicine, Trinity College Dublin, Dublin, Ireland. jfomahon@tcd.ie.
authors.forename: James F
authors.initials: JF
authors.lastname: O'Mahony
authors.affiliation: Cooperative Research Group for Evidence-Based Public Health, Department of Prevention and Evaluation, Leibniz Institute for Prevention Research and Epidemiology-BIPS, Bremen, Germany. Stefan.Lhachimi@uni-bremen.de.|Institute for Public Health and Nursing Research-IPP, Health Sciences Bremen, University of Bremen, Bremen, Germany. Stefan.Lhachimi@uni-bremen.de.
authors.forename: Stefan K
authors.initials: SK
authors.lastname: Lhachimi
mesh_terms: D002985:Clinical Protocols; D003362:Cost-Benefit Analysis / Q000191:economics*; D003661:Decision Support Techniques; D003906:Developing Countries; D005260:Female; D006801:Humans; D053918:Papillomavirus Vaccines / Q000191:economics*; D000078202:Systematic Reviews as Topic; D002583:Uterine Cervical Neoplasms / Q000191:economics / Q000517:prevention & control*
chemical_list: D053918:Papillomavirus Vaccines