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Recommended Methods for the Collection of Health State Utility Value Evidence in Clinical Studies

Author

Listed:
  • Roberta Ara

    (School of Health and Related Research (ScHARR), University of Sheffield)

  • John Brazier

    (School of Health and Related Research (ScHARR), University of Sheffield)

  • Tracey Young

    (School of Health and Related Research (ScHARR), University of Sheffield)

Abstract

A conceptual model framework and an initial literature review are invaluable when considering what health state utility values (HSUVs) are required to populate health states in decision models. They are the recommended starting point early within a research and development programme, and before development of phase III trial protocols. While clinical trials can provide an opportunity to collect the required evidence, their appropriateness should be reviewed against the requirements of the model structure taking into account population characteristics, time horizon and frequency of clinical events. Alternative sources such as observational studies or registries may be more appropriate when evidence describing changes in HSUVs over time or rare clinical events is required. Phase IV clinical studies may provide the opportunity to collect additional longitudinal real-world evidence. Aspects to consider when designing the collection of the evidence include patient and investigator burden, whom to ask, the representativeness of the population, the exact definitions of health states within the economic model, the timing of data collection, sample size, and mode of administration. Missing data can be an issue, particularly in longitudinal studies, and it is important to determine whether the missing data will bias inferences from analyses. For example, respondents may fail to complete follow-up questionnaires because of a relapse or the severity of their condition. The decision on the preferred study type and the particular quality of life measure should be informed by any evidence currently available in the literature, the design of data collection, and the exact requirements of the model that will be used to support resource allocation decisions (e.g. reimbursement).

Suggested Citation

  • Roberta Ara & John Brazier & Tracey Young, 2017. "Recommended Methods for the Collection of Health State Utility Value Evidence in Clinical Studies," PharmacoEconomics, Springer, vol. 35(1), pages 67-75, December.
  • Handle: RePEc:spr:pharme:v:35:y:2017:i:1:d:10.1007_s40273-017-0549-6
    DOI: 10.1007/s40273-017-0549-6
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    References listed on IDEAS

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    1. John Brazier & Roberta Ara & Donna Rowen & Helene Chevrou-Severac, 2017. "A Review of Generic Preference-Based Measures for Use in Cost-Effectiveness Models," PharmacoEconomics, Springer, vol. 35(1), pages 21-31, December.
    2. Roberta Ara & Donna Rowen & Clara Mukuria, 2017. "The Use of Mapping to Estimate Health State Utility Values," PharmacoEconomics, Springer, vol. 35(1), pages 57-66, December.
    3. Bernie J. O'Brien & Marian Spath & Gordon Blackhouse & J.L. Severens & Paul Dorian & John Brazier, 2003. "A view from the bridge: agreement between the SF‐6D utility algorithm and the Health Utilities Index," Health Economics, John Wiley & Sons, Ltd., vol. 12(11), pages 975-981, November.
    4. Philip M. Clarke & Chris Ryan, 2006. "Self‐reported health: reliability and consequences for health inequality measurement," Health Economics, John Wiley & Sons, Ltd., vol. 15(6), pages 645-652, June.
    5. Maria Alva & Alastair Gray & Borislava Mihaylova & Philip Clarke, 2014. "The Effect Of Diabetes Complications On Health‐Related Quality Of Life: The Importance Of Longitudinal Data To Address Patient Heterogeneity," Health Economics, John Wiley & Sons, Ltd., vol. 23(4), pages 487-500, April.
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