IDEAS home Printed from https://ideas.repec.org/a/spr/patien/v10y2017i6d10.1007_s40271-017-0262-8.html
   My bibliography  Save this article

Assessing Preference-Based Outcome Measures for Overactive Bladder: An Evaluation of Patient-Reported Outcome Data from the BESIDE Clinical Trial

Author

Listed:
  • Mike Herdman

    (The Office of Health Economics)

  • Jameel Nazir

    (Astellas Pharma Europe Ltd., Astellas Medical Affairs, EMEA, HEOR)

  • Zalmai Hakimi

    (Astellas Pharma Europe B.V., Astellas Medical Affairs, Global, HEOR)

  • Emad Siddiqui

    (Astellas Pharma Europe Ltd., Astellas Medical Affairs, EMEA, HEOR)

  • Moses Huang

    (Astellas Pharma Europe Ltd., Astellas Medical Affairs, EMEA, HEOR)

  • Marco Pavesi

    (European Foundation for the study of Chronic LIver Failure (EF-CLIF))

  • Scott MacDiarmid

    (Alliance Urology Specialists)

  • Marcus J. Drake

    (University of Bristol and Bristol Urological Institute)

  • Nancy Devlin

    (The Office of Health Economics)

Abstract

Objectives The aim of this study was to compare outcomes using two preference-based measures of health status (EQ-5D-5L and OAB-5D) in patients with overactive bladder (OAB) treated with solifenacin plus mirabegron or solifenacin monotherapy in the BESIDE trial. Methods Patients with OAB who remained incontinent after 4 weeks’ treatment with solifenacin 5 mg were randomized 1:1:1 to combination treatment (solifenacin 5 mg plus mirabegron [25 mg for the first 4 weeks/50 mg for the last 8 weeks]), solifenacin 5 mg, or solifenacin 10 mg. EQ-5D-5L and OAB-q were administered at baseline, weeks 4, 8, 12, and end of treatment (EoT). OAB-5D scores were derived from OAB-q results. Responder analysis was carried out using several definitions of minimally important difference. Results A total of 2054 patients received one or more doses of study treatment (combination, n = 694; solifenacin 5 mg, n = 684; solifenacin 10 mg, n = 676). EQ-5D-5L Index mean score changes (from baseline to EoT) were greater with combination (0.059) than with solifenacin 5 mg (0.040) and 10 mg (0.044) monotherapy, but the differences were not statistically significant. A significantly greater improvement was observed for combination on OAB-5D (0.107 vs 0.085 for 5 mg, and 0.087 for 10 mg; p ≤ 0.01). The dimensions most improved overall were anxiety/depression, pain/discomfort, and usual activities on EQ-5D-5L, and urge, urine loss, and coping on OAB-5D. The proportion of responders was significantly greater with combination compared with monotherapy using OAB-5D only. Conclusions Improvements were observed in all study arms on both the EQ-5D-5L and OAB-5D, although only the OAB-5D showed a statistically significant benefit for combination versus solifenacin monotherapy. Combining generic and condition-specific preference-based health status measures allowed for assessment of dimensions that were particularly relevant to this patient population, while permitting comparison with outcomes from other studies, treatments, and populations via EQ-5D.

Suggested Citation

  • Mike Herdman & Jameel Nazir & Zalmai Hakimi & Emad Siddiqui & Moses Huang & Marco Pavesi & Scott MacDiarmid & Marcus J. Drake & Nancy Devlin, 2017. "Assessing Preference-Based Outcome Measures for Overactive Bladder: An Evaluation of Patient-Reported Outcome Data from the BESIDE Clinical Trial," The Patient: Patient-Centered Outcomes Research, Springer;International Academy of Health Preference Research, vol. 10(6), pages 677-686, December.
    • Handle: RePEc:spr:patien:v:10:y:2017:i:6:d:10.1007_s40271-017-0262-8
    DOI: 10.1007/s40271-017-0262-8
    as

    Download full text from publisher

    File URL: http://link.springer.com/10.1007/s40271-017-0262-8
    File Function: Abstract
    Download Restriction: Access to the full text of the articles in this series is restricted.
    File URL: https://libkey.io/10.1007/s40271-017-0262-8?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. Yan Feng & Nancy J. Devlin & Koonal K. Shah & Brendan Mulhern & Ben van Hout, 2018. "New methods for modelling EQ‐5D‐5L value sets: An application to English data," Health Economics, John Wiley & Sons, Ltd., vol. 27(1), pages 23-38, January.
    Full references (including those not matched with items on IDEAS)

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Kristina Ludwig & J.-Matthias Graf von der Schulenburg & Wolfgang Greiner, 2018. "German Value Set for the EQ-5D-5L," PharmacoEconomics, Springer, vol. 36(6), pages 663-674, June.
    2. Anna Selivanova & Erik Buskens & Paul F. M. Krabbe, 2018. "Head-to-Head Comparison of EQ‐5D‐3L and EQ‐5D‐5L Health Values," PharmacoEconomics, Springer, vol. 36(6), pages 715-725, June.
    3. Sullivan, Trudy & Hansen, Paul & Ombler, Franz & Derrett, Sarah & Devlin, Nancy, 2020. "A new tool for creating personal and social EQ-5D-5L value sets, including valuing ‘dead’," Social Science & Medicine, Elsevier, vol. 246(C).
    4. Brendan Mulhern & Yan Feng & Koonal Shah & Mathieu F. Janssen & Michael Herdman & Ben Hout & Nancy Devlin, 2018. "Comparing the UK EQ-5D-3L and English EQ-5D-5L Value Sets," PharmacoEconomics, Springer, vol. 36(6), pages 699-713, June.
    5. Micah Rose & Stephen Rice & Dawn Craig, 2018. "Does Methodological Guidance Produce Consistency? A Review of Methodological Consistency in Breast Cancer Utility Value Measurement in NICE Single Technology Appraisals," PharmacoEconomics - Open, Springer, vol. 2(2), pages 97-107, June.
    6. Yiu, Hei Hang Edmund & Buckell, John & Petrou, Stavros & Stewart-Brown, Sarah & Madan, Jason, 2023. "Derivation of a UK preference-based value set for the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) to allow estimation of Mental Well-being Adjusted Life Years (MWALYs)," Social Science & Medicine, Elsevier, vol. 327(C).
    7. Brendan Mulhern & Richard Norman & Deborah J. Street & Rosalie Viney, 2019. "One Method, Many Methodological Choices: A Structured Review of Discrete-Choice Experiments for Health State Valuation," PharmacoEconomics, Springer, vol. 37(1), pages 29-43, January.
    8. Spencer, Anne & Rivero-Arias, Oliver & Wong, Ruth & Tsuchiya, Aki & Bleichrodt, Han & Edwards, Rhiannon Tudor & Norman, Richard & Lloyd, Andrew & Clarke, Philip, 2022. "The QALY at 50: One story many voices," Social Science & Medicine, Elsevier, vol. 296(C).
    9. Nancy Devlin & John Brazier & A. Simon Pickard & Elly Stolk, 2018. "3L, 5L, What the L? A NICE Conundrum," PharmacoEconomics, Springer, vol. 36(6), pages 637-640, June.
    10. Eliza L. Y. Wong & Juan Manuel Ramos-Goñi & Annie W. L. Cheung & Amy Y. K. Wong & Oliver Rivero-Arias, 2018. "Assessing the Use of a Feedback Module to Model EQ-5D-5L Health States Values in Hong Kong," The Patient: Patient-Centered Outcomes Research, Springer;International Academy of Health Preference Research, vol. 11(2), pages 235-247, April.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:spr:patien:v:10:y:2017:i:6:d:10.1007_s40271-017-0262-8. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sonal Shukla or Springer Nature Abstracting and Indexing (email available below). General contact details of provider: http://www.springer.com .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.