title: Estimating Health-State Utility for Economic Models in Clinical Studies: An ISPOR Good Research Practices Task Force Report.
abstract: Cost-utility models are increasingly used in many countries to establish whether the cost of a new intervention can be justified in terms of health benefits. Health-state utility (HSU) estimates (the preference for a given state of health on a cardinal scale where 0 represents dead and 1 represents full health) are typically among the most important and uncertain data inputs in cost-utility models. Clinical trials represent an important opportunity for the collection of health-utility data. However, trials designed primarily to evaluate efficacy and safety often present challenges to the optimal collection of HSU estimates for economic models. Careful planning is needed to determine which of the HSU estimates may be measured in planned trials; to establish the optimal methodology; and to plan any additional studies needed. This report aimed to provide a framework for researchers to plan the collection of health-utility data in clinical studies to provide high-quality HSU estimates for economic modeling. Recommendations are made for early planning of health-utility data collection within a research and development program; design of health-utility data collection during protocol development for a planned clinical trial; design of prospective and cross-sectional observational studies and alternative study types; and statistical analyses and reporting.
authors.affiliation: RTI Health Solutions, Manchester, UK.
authors.forename: Sorrel E
authors.initials: SE
authors.lastname: Wolowacz
authors.affiliation: Health Economics and Health Technology Assessment Research Group, Institute of Health & Wellbeing, Glasgow University, Glasgow, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Briggs
authors.affiliation: Global Health Economics, Amgen, Inc, Thousand Oaks, CA, USA.
authors.forename: Vasily
authors.initials: V
authors.lastname: Belozeroff
authors.affiliation: Centre for Health Policy, School of Population and Global Health, University of Melbourne, Melbourne, Australia.
authors.forename: Philip
authors.initials: P
authors.lastname: Clarke
authors.affiliation: RTI Health Solutions, Manchester, UK.
authors.forename: Lynda
authors.initials: L
authors.lastname: Doward
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada; Goeree Consulting Limited, Hamilton, Ontario, Canada.
authors.forename: Ron
authors.initials: R
authors.lastname: Goeree
authors.affiliation: Bladon Associates Ltd., Oxford, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Lloyd
authors.affiliation: School of Public Health, Curtin University, Curtin, West Australia, Australia.
authors.forename: Richard
authors.initials: R
authors.lastname: Norman
mesh_terms: D026683:Advisory Committees; D003362:Cost-Benefit Analysis; D003430:Cross-Sectional Studies; D003625:Data Collection / Q000379:methods; D017048:Health Care Costs; D006304:Health Status; D006801:Humans; D018803:Models, Economic; D057240:Patient Preference / Q000523:psychology; D011446:Prospective Studies
keywords: economic model; health-utility; recommendations