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28-11-2016

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

Auteurs: Zalmai Hakimi, Mike Herdman, Marco Pavesi, Nancy Devlin, Jameel Nazir, Chris Hoyle, Isaac A. O. Odeyemi

Gepubliceerd in: Quality of Life Research | Uitgave 5/2017

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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.
Literatuur
1.
go back to reference Abrams, P., Manson, J., & Kirby, M. G. (2012). Incidence and epidemiology of storage lower urinary tract symptoms. European Urological Review, 7, 50–54. Abrams, P., Manson, J., & Kirby, M. G. (2012). Incidence and epidemiology of storage lower urinary tract symptoms. European Urological Review, 7, 50–54.
2.
go back to reference Peters, T. J., Donovan, J. L., Kay, H. E., Abrams, P., de la Rosette, J. J., Porru, D., et al. (1997). The International Continence Society “benign prostatic hyperplasia” study: The bothersomeness of urinary symptoms. Journal of Urology, 157, 885–889.CrossRefPubMed Peters, T. J., Donovan, J. L., Kay, H. E., Abrams, P., de la Rosette, J. J., Porru, D., et al. (1997). The International Continence Society “benign prostatic hyperplasia” study: The bothersomeness of urinary symptoms. Journal of Urology, 157, 885–889.CrossRefPubMed
5.
go back to reference Garraway, W. M., Russell, E. B., Lee, R. J., Collins, G. N., McKelvie, G. B., Hehir, M., et al. (1993). Impact of previously unrecognized benign prostatic hyperplasia on the daily activities of middle-aged and elderly men. British Journal of General Practice, 43, 318–321.PubMedPubMedCentral Garraway, W. M., Russell, E. B., Lee, R. J., Collins, G. N., McKelvie, G. B., Hehir, M., et al. (1993). Impact of previously unrecognized benign prostatic hyperplasia on the daily activities of middle-aged and elderly men. British Journal of General Practice, 43, 318–321.PubMedPubMedCentral
6.
go back to reference McVary, K. T. (2006). BPH: Epidemiology and comorbidities. American Journal of Managed Care, 12, S122–S128.PubMed McVary, K. T. (2006). BPH: Epidemiology and comorbidities. American Journal of Managed Care, 12, S122–S128.PubMed
7.
go back to reference Schipper, H., Clinch, J. J., & Olweny, C. L. M. (1996). Quality of life studies: Definitions and conceptual issues. In B. Spilker (Ed.), Quality of life and pharmacoeconomics in clinical trials. Philadelphia: Lippincott-Raven Publishers. Schipper, H., Clinch, J. J., & Olweny, C. L. M. (1996). Quality of life studies: Definitions and conceptual issues. In B. Spilker (Ed.), Quality of life and pharmacoeconomics in clinical trials. Philadelphia: Lippincott-Raven Publishers.
8.
go back to reference Welch, G., Weinger, K., & Barry, M. J. (2002). Quality-of-life impact of lower urinary tract symptom severity: Results from the health professionals follow-up study. Urology, 59, 245–250.CrossRefPubMed Welch, G., Weinger, K., & Barry, M. J. (2002). Quality-of-life impact of lower urinary tract symptom severity: Results from the health professionals follow-up study. Urology, 59, 245–250.CrossRefPubMed
9.
go back to reference Coyne, K. S., Wein, A. J., Tubaro, A., Sexton, C. C., Thompson, C. L., Kopp, Z. S., et al. (2009). The burden of lower urinary tract symptoms: Evaluating the effect of LUTS on health-related quality of life, anxiety and depression: EpiLUTS. BJU International, 103, 4–11.CrossRefPubMed Coyne, K. S., Wein, A. J., Tubaro, A., Sexton, C. C., Thompson, C. L., Kopp, Z. S., et al. (2009). The burden of lower urinary tract symptoms: Evaluating the effect of LUTS on health-related quality of life, anxiety and depression: EpiLUTS. BJU International, 103, 4–11.CrossRefPubMed
10.
go back to reference Wein, A. J., Coyne, K. S., Tubaro, A., Sexton, C. C., Kopp, Z. S., & Aiyer, L. P. (2009). The impact of lower urinary tract symptoms on male sexual health: EpiLUTS. BJU International, 103, 33–41.CrossRefPubMed Wein, A. J., Coyne, K. S., Tubaro, A., Sexton, C. C., Kopp, Z. S., & Aiyer, L. P. (2009). The impact of lower urinary tract symptoms on male sexual health: EpiLUTS. BJU International, 103, 33–41.CrossRefPubMed
11.
go back to reference Trueman, P., Hood, S. C., Nayak, U. S., & Mrazek, M. F. (1999). Prevalence of lower urinary tract symptoms and self-reported diagnosed ‘benign prostatic hyperplasia’, and their effect on quality of life in a community-based survey of men in the UK. BJU International, 83, 410–415.CrossRefPubMed Trueman, P., Hood, S. C., Nayak, U. S., & Mrazek, M. F. (1999). Prevalence of lower urinary tract symptoms and self-reported diagnosed ‘benign prostatic hyperplasia’, and their effect on quality of life in a community-based survey of men in the UK. BJU International, 83, 410–415.CrossRefPubMed
12.
go back to reference Girman, C. J., Jacobsen, S. J., Tsukamoto, T., Richard, F., Garraway, W. M., Sagnier, P. P., et al. (1998). Health-related quality of life associated with lower urinary tract symptoms in four countries. Urology, 51, 428–436.CrossRefPubMed Girman, C. J., Jacobsen, S. J., Tsukamoto, T., Richard, F., Garraway, W. M., Sagnier, P. P., et al. (1998). Health-related quality of life associated with lower urinary tract symptoms in four countries. Urology, 51, 428–436.CrossRefPubMed
13.
go back to reference Boyle, P., Robertson, C., Mazzetta, C., Keech, M., Hobbs, R., Fourcade, R., et al. (2003). The relationship between lower urinary tract symptoms and health status: The UREPIK study. BJU International, 92, 575–580.CrossRefPubMed Boyle, P., Robertson, C., Mazzetta, C., Keech, M., Hobbs, R., Fourcade, R., et al. (2003). The relationship between lower urinary tract symptoms and health status: The UREPIK study. BJU International, 92, 575–580.CrossRefPubMed
14.
go back to reference Lukacs, B., Cornu, J. N., Aout, M., Tessier, N., Hodée, C., Haab, F., et al. (2013). Management of lower urinary tract symptoms related to benign prostatic hyperplasia in real-life practice in France: A comprehensive population study. European Urology, 64, 493–501.CrossRefPubMed Lukacs, B., Cornu, J. N., Aout, M., Tessier, N., Hodée, C., Haab, F., et al. (2013). Management of lower urinary tract symptoms related to benign prostatic hyperplasia in real-life practice in France: A comprehensive population study. European Urology, 64, 493–501.CrossRefPubMed
15.
go back to reference Drummond, M. F., Sculpher, M. J., Torrance, G. W., O’Brien, B. J., & Stoddart, G. L. (2005). Methods for the economic evaluation of health care programmes (3rd ed.). Oxford: Oxford University Press. Drummond, M. F., Sculpher, M. J., Torrance, G. W., O’Brien, B. J., & Stoddart, G. L. (2005). Methods for the economic evaluation of health care programmes (3rd ed.). Oxford: Oxford University Press.
17.
go back to reference Castro-Díaz, D., Callejo, D., Cortés, X., & Pérez, M. (2014). Study of quality of life in patients with benign prostatic hyperplasia under treatment with silodosin. Actas Urológicas Españolas, 38, 361–366.PubMed Castro-Díaz, D., Callejo, D., Cortés, X., & Pérez, M. (2014). Study of quality of life in patients with benign prostatic hyperplasia under treatment with silodosin. Actas Urológicas Españolas, 38, 361–366.PubMed
18.
go back to reference Fourcade, R. O., Lacoin, F., Rouprêt, M., Slama, A., Le Fur, C., Michel, E., et al. (2012). Outcomes and general health-related quality of life among patients medically treated in general daily practice for lower urinary tract symptoms due to benign prostatic hyperplasia. World Journal of Urology, 30, 419–426.CrossRefPubMed Fourcade, R. O., Lacoin, F., Rouprêt, M., Slama, A., Le Fur, C., Michel, E., et al. (2012). Outcomes and general health-related quality of life among patients medically treated in general daily practice for lower urinary tract symptoms due to benign prostatic hyperplasia. World Journal of Urology, 30, 419–426.CrossRefPubMed
19.
go back to reference Coyne, K., Revicki, D., Hunt, T., Corey, R., Stewart, W., Bentkover, J., et al. (2002). Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: The OAB-q. Quality of Life Research, 11, 563–574.CrossRefPubMed Coyne, K., Revicki, D., Hunt, T., Corey, R., Stewart, W., Bentkover, J., et al. (2002). Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: The OAB-q. Quality of Life Research, 11, 563–574.CrossRefPubMed
20.
go back to reference Young, T., Yang, Y., Brazier, J. E., Tsuchiya, A., & Coyne, K. (2009). The first stage of developing preference-based measures: Constructing a health-state classification using Rasch analysis. Quality of Life Research, 18, 253–265.CrossRefPubMed Young, T., Yang, Y., Brazier, J. E., Tsuchiya, A., & Coyne, K. (2009). The first stage of developing preference-based measures: Constructing a health-state classification using Rasch analysis. Quality of Life Research, 18, 253–265.CrossRefPubMed
21.
go back to reference Desroziers, K., Aballéa, S., Maman, K., Nazir, J., Odeyemi, I., & Hakimi, Z. (2013). Estimating EQ-5D and OAB-5D health state utilities for patients with overactive bladder. Health and Quality of Life Outcomes, 11, 200.CrossRefPubMedPubMedCentral Desroziers, K., Aballéa, S., Maman, K., Nazir, J., Odeyemi, I., & Hakimi, Z. (2013). Estimating EQ-5D and OAB-5D health state utilities for patients with overactive bladder. Health and Quality of Life Outcomes, 11, 200.CrossRefPubMedPubMedCentral
22.
go back to reference van Kerrebroeck, P., Chapple, C., Drogendijk, T., Klaver, M., Sokol, R., Speakman, M., et al. (2013). Combination therapy with solifenacin and tamsulosin oral controlled absorption system in a single tablet for lower urinary tract symptoms in men: Efficacy and safety results from the randomised controlled NEPTUNE trial. European Urology, 64, 1003–1012.CrossRefPubMed van Kerrebroeck, P., Chapple, C., Drogendijk, T., Klaver, M., Sokol, R., Speakman, M., et al. (2013). Combination therapy with solifenacin and tamsulosin oral controlled absorption system in a single tablet for lower urinary tract symptoms in men: Efficacy and safety results from the randomised controlled NEPTUNE trial. European Urology, 64, 1003–1012.CrossRefPubMed
24.
go back to reference Chapple, C. R., Drake, M. J., van Kerrebroeck, P., Cardozo, L., Drogendijk, T., Klaver, M., et al. (2014). Total urgency and frequency score as a measure of urgency and frequency in overactive bladder and storage lower urinary tract symptoms. BJU International, 113, 696–703.CrossRefPubMed Chapple, C. R., Drake, M. J., van Kerrebroeck, P., Cardozo, L., Drogendijk, T., Klaver, M., et al. (2014). Total urgency and frequency score as a measure of urgency and frequency in overactive bladder and storage lower urinary tract symptoms. BJU International, 113, 696–703.CrossRefPubMed
25.
go back to reference Drake, M. J., Sokol, R., Coyne, K., Hakimi, Z., Nazir, J., Dorey, J., et al. (2016). Responder and health-related quality of life analyses in men with lower urinary tract symptoms treated with a fixed-dose combination of solifenacin and tamsulosin oral-controlled absorption system: Results from the NEPTUNE study. BJU International, 117, 165–172.CrossRefPubMed Drake, M. J., Sokol, R., Coyne, K., Hakimi, Z., Nazir, J., Dorey, J., et al. (2016). Responder and health-related quality of life analyses in men with lower urinary tract symptoms treated with a fixed-dose combination of solifenacin and tamsulosin oral-controlled absorption system: Results from the NEPTUNE study. BJU International, 117, 165–172.CrossRefPubMed
26.
go back to reference Matza, L. S., Thompson, C. L., Krasnow, J., Brewster-Jordan, J., Zyczynski, T., & Coyne, K. S. (2005). Test-retest reliability of four questionnaires for patients with overactive bladder: The overactive bladder questionnaire (OAB-q), patient perception of bladder condition (PPBC), urgency questionnaire (UQ), and the primary OAB symptom questionnaire (POSQ). Neurourology and Urodynamics, 24, 215–225.CrossRefPubMed Matza, L. S., Thompson, C. L., Krasnow, J., Brewster-Jordan, J., Zyczynski, T., & Coyne, K. S. (2005). Test-retest reliability of four questionnaires for patients with overactive bladder: The overactive bladder questionnaire (OAB-q), patient perception of bladder condition (PPBC), urgency questionnaire (UQ), and the primary OAB symptom questionnaire (POSQ). Neurourology and Urodynamics, 24, 215–225.CrossRefPubMed
27.
go back to reference Coyne, K. S., Matza, L. S., & Thompson, C. L. (2005). The responsiveness of the Overactive Bladder Questionnaire (OAB-q). Quality of Life Research, 14, 849–855.CrossRefPubMed Coyne, K. S., Matza, L. S., & Thompson, C. L. (2005). The responsiveness of the Overactive Bladder Questionnaire (OAB-q). Quality of Life Research, 14, 849–855.CrossRefPubMed
28.
go back to reference Yang, Y., Brazier, J., Tsuchiya, A., & Coyne, K. (2009). Estimating a preference-based single index from the Overactive Bladder Questionnaire. Value in Health, 12, 159–166.CrossRefPubMed Yang, Y., Brazier, J., Tsuchiya, A., & Coyne, K. (2009). Estimating a preference-based single index from the Overactive Bladder Questionnaire. Value in Health, 12, 159–166.CrossRefPubMed
29.
go back to reference Gudex, C. (2005). The descriptive system of the EuroQol instrument. In P. Kind, R. Brooks, & R. Rabin (Eds.), EQ-5D concepts and methods: A developmental history. Berlin: Springer. Gudex, C. (2005). The descriptive system of the EuroQol instrument. In P. Kind, R. Brooks, & R. Rabin (Eds.), EQ-5D concepts and methods: A developmental history. Berlin: Springer.
30.
31.
go back to reference Walters, S. J., & Brazier, J. E. (2005). Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Quality of Life Research, 14, 1523–1532.CrossRefPubMed Walters, S. J., & Brazier, J. E. (2005). Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Quality of Life Research, 14, 1523–1532.CrossRefPubMed
32.
go back to reference Hays, R. D., & Revicki, D. (2005). Reliability and validity (including responsiveness). In P. Fayers & R. Hays (Eds.), Assessing quality of life in clinical trials: Methods and practice (2nd ed.). New York: Oxford University Press. Hays, R. D., & Revicki, D. (2005). Reliability and validity (including responsiveness). In P. Fayers & R. Hays (Eds.), Assessing quality of life in clinical trials: Methods and practice (2nd ed.). New York: Oxford University Press.
33.
go back to reference Cohen, J. (1998). Statistical power analysis for the behavioural sciences (2nd ed.). Hillsdale, NJ: L. Erlbaum Associates. Cohen, J. (1998). Statistical power analysis for the behavioural sciences (2nd ed.). Hillsdale, NJ: L. Erlbaum Associates.
34.
go back to reference Devlin, N. J., Parkin, D., & Browne, J. (2010). Patient-reported outcome measures in the NHS: New methods for analysing and reporting EQ-5D data. Health Economics, 19, 886–905.CrossRefPubMed Devlin, N. J., Parkin, D., & Browne, J. (2010). Patient-reported outcome measures in the NHS: New methods for analysing and reporting EQ-5D data. Health Economics, 19, 886–905.CrossRefPubMed
35.
go back to reference Parkin, D., Devlin, N., & Rice, N. (2010). Statistical analysis of EQ-5D profiles: Does the use of value sets bias inference? Medical Decision Making, 30, 556–565.CrossRefPubMed Parkin, D., Devlin, N., & Rice, N. (2010). Statistical analysis of EQ-5D profiles: Does the use of value sets bias inference? Medical Decision Making, 30, 556–565.CrossRefPubMed
36.
go back to reference Pavesi, M., Devlin, N., Hakimi, Z., Nazir, J., Herdman, M., Hoyle, C., et al. (2013). Understanding the effects on HR-QoL of treatment for overactive bladder: A detailed analysis of EQ-5D clinical trial data for mirabegron. Journal of Medical Economics, 16, 866–876.CrossRefPubMed Pavesi, M., Devlin, N., Hakimi, Z., Nazir, J., Herdman, M., Hoyle, C., et al. (2013). Understanding the effects on HR-QoL of treatment for overactive bladder: A detailed analysis of EQ-5D clinical trial data for mirabegron. Journal of Medical Economics, 16, 866–876.CrossRefPubMed
37.
go back to reference Buckley, B.S., Lapitan, M.C., Glazener, C.M.; MAPS Trial Group. (2012). The effect of urinary incontinence on health utility and health-related quality of life in men following prostate surgery. Neurourology and Urodynamics, 31, 465–469.CrossRef Buckley, B.S., Lapitan, M.C., Glazener, C.M.; MAPS Trial Group. (2012). The effect of urinary incontinence on health utility and health-related quality of life in men following prostate surgery. Neurourology and Urodynamics, 31, 465–469.CrossRef
38.
go back to reference Patrick, D. L., & Deyo, R. A. (1989). Generic and disease-specific measures in assessing health status and quality of life. Medical Care, 27, S217–S232.CrossRefPubMed Patrick, D. L., & Deyo, R. A. (1989). Generic and disease-specific measures in assessing health status and quality of life. Medical Care, 27, S217–S232.CrossRefPubMed
39.
go back to reference Wiebe, S., Guyatt, G., Weaver, B., Matijevic, S., & Sidwell, C. (2003). Comparative responsiveness of generic and specific quality-of-life instruments. Journal of Clinical Epidemiology, 56, 52–60.CrossRefPubMed Wiebe, S., Guyatt, G., Weaver, B., Matijevic, S., & Sidwell, C. (2003). Comparative responsiveness of generic and specific quality-of-life instruments. Journal of Clinical Epidemiology, 56, 52–60.CrossRefPubMed
Metagegevens
Titel
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
Auteurs
Zalmai Hakimi
Mike Herdman
Marco Pavesi
Nancy Devlin
Jameel Nazir
Chris Hoyle
Isaac A. O. Odeyemi
Publicatiedatum
28-11-2016
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 5/2017
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-016-1460-x

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