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Using EQ-5D-3L and OAB-5D to assess changes in the health-related quality of life of men with lower urinary tract symptoms associated with benign prostatic hyperplasia

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Abstract

Objectives

To assess changes in the health status of men with lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) using the EQ-5D-3L and OAB-5D instruments and to evaluate the sensitivity of the instruments.

Methods

Data were available from a large randomised phase III trial of men with moderate-to-severe storage and voiding LUTS/BPH (NEPTUNE). Men received a fixed-dose combination of solifenacin 6 mg plus oral controlled absorption system (OCAS™) formulation of tamsulosin (TOCAS, 0.4 mg), TOCAS monotherapy or placebo and completed the EQ-5D-3L and OAB-5D at baseline and weeks 4, 8 and 12. Analysis of covariance was used to estimate changes in EQ-5D-3L Index, EQ-VAS and OAB-5D. Changes in dimension level were summarised using the Paretian Classification of Health Change (PCHC).

Results

Improved health-related quality of life from baseline was seen in all treatment arms on EQ-5D-3L and OAB-5D at week 12, although only OAB-5D showed statistically significant differences between active treatment and placebo, both on the index score and using the PCHC approach. Effect sizes in the active treatment groups were large (>0.8) on OAB-5D but small (≈0.2) on EQ-5D-3L. EQ-5D-3L showed a very high ceiling effect (45% of men reported full health at baseline) and a substantial proportion of these men reported improvements at week 12 in several dimensions of OAB-5D.

Conclusions

A large ceiling effect on EQ-5D-3L substantially limited its sensitivity in this population. OAB-5D proved more sensitive to changes in health status and could be considered a complement to ED-5D-3L as a source of utilities for health economic modelling.

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Acknowledgements

Medical writing support was provided by Tyrone Daniel of Bioscript Medical and was funded by Astellas Pharma Europe Ltd.

Funding

Astellas funded the research, but the publication of study results was not contingent on the sponsor’s approval or censorship of the manuscript.

Author contributions

ZH, IO and CH contributed to the concept and design of the study; all authors contributed to the analysis and interpretation of the data; all authors provided direction for the content, critically revised the publication for intellectual content and approved the final version for submission. This research was funded by Astellas.

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Authors and Affiliations

  1. Astellas Pharma Europe B.V., Astellas Medical Affairs, Global, HEOR, Sylviusweg 62, 2300 AH, Leiden, The Netherlands

    Zalmai Hakimi

  2. Office of Health Economics, London, UK

    Mike Herdman, Nancy Devlin & Chris Hoyle

  3. Data Management Centre, European Foundation for the Study of Chronic Liver Failure (EF-CLIF), Barcelona, Spain

    Marco Pavesi

  4. Astellas Pharma Europe Ltd., Astellas Medical Affairs, EMEA, HEOR, Chertsey, UK

    Jameel Nazir & Isaac A. O. Odeyemi

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  1. Zalmai Hakimi
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  5. Jameel Nazir
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  7. Isaac A. O. Odeyemi
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Correspondence to Zalmai Hakimi.

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Conflict of interest

ZH, JH and IO are employees of Astellas Pharma. MH and ND are employees of Office of Health Economics, which was contracted by Astellas Pharma to support the conduct of this study. CH was employed by Office of Health Economics at the time of the analysis and is now employed by AstraZeneca.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the Institutional and/or National Research Committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Hakimi, Z., Herdman, M., Pavesi, M. et al. Using EQ-5D-3L and OAB-5D to assess changes in the health-related quality of life of men with lower urinary tract symptoms associated with benign prostatic hyperplasia. Qual Life Res 26, 1187–1195 (2017). https://doi.org/10.1007/s11136-016-1460-x

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