Top

Gepubliceerd in:

01-09-2007

Clinically meaningful improvement on the Self-Esteem And Relationship questionnaire in men with erectile dysfunction

Auteurs: Joseph C. Cappelleri, Stanley E. Althof, Michael P. O’Leary, Sidney Glina, Rosie King, Vera J. Stecher, Martin Carlsson, Richard L. Siegel

Gepubliceerd in: Quality of Life Research | Uitgave 7/2007

Abstract

Purpose

To estimate the minimal clinically meaningful improvement (MCMI) on the Self-Esteem And Relationship (SEAR) questionnaire.

Methods

Using combined data from the 2 pivotal SEAR trials of men treated with sildenafil for erectile dysfunction (ED), MCMIs were estimated as the lower limit of the 2-sided 95% confidence intervals of SEAR mean change scores (from baseline to end of study) for 2 anchor groups: (1) men who improved 1 ED severity category on the Erectile Function domain of the International Index of Erectile Function, and (2) men who improved 5–60% (inclusive) on these erectile function scores.

Results

Both anchors gave comparable results. A 10-point MCMI was proposed because the estimates of 95% lower bounds centered on around 10 points for most SEAR components (Sexual Relationship, Confidence, Self-Esteem, Overall Score). An exception was the Overall Relationship whose 95% lower bounds were too low to recommend them as an MCMI.

Conclusions

Two anchor-based approaches suggest that a change of about 10 points represents an MCMI on most components of the SEAR questionnaire.

vorige artikel Validity of patient-reported health-related quality of life global ratings of change using structural equation modeling

volgende artikel The effects of response bias on self-reported quality of life among childhood cancer survivors

Cappelleri, J. C., Althof, S. E., Siegel, R. L., Shpilsky, A., Bell, S. S., & Duttagupta, S. (2004). Development and validation of the Self-Esteem And Relationship (SEAR) questionnaire in erectile dysfunction. International Journal of Impotence Research, 16, 30–38.PubMedCrossRef

Althof, S. E., Cappelleri, J. C., Shpilsky, A., Stecher, V., Diuguid, C., Sweeney, M., et al. (2003). Treatment responsiveness of the Self-Esteem And Relationship questionnaire in erectile dysfunction. Urology, 61, 888–892.PubMedCrossRef

Steidle, C. P., Stecher, V. J., Pace, C., & Tseng, L. J. (2006). Correlation of improved erectile function and rate of successful intercourse with improved emotional well-being assessed with the Self-Esteem And Relationship questionnaire in men treated with sildenafil for erectile dysfunction and stratified by age. Current Medical Research and Opinion, 22, 939–948.PubMedCrossRef

O’Leary, M. P., Althof, S. E., Cappelleri, J. C., Crowley, A., Sherman, N., Duttagupta, S., et al (2006). Self-esteem, confidence, and relationship satisfaction in men with erectile dysfunction treated with sildenafil citrate: A multicenter, randomized, parallel-group, double-blind, placebo-controlled study in the United States. Journal of Urology, 175, 1058–1062.PubMedCrossRef

Althof, S. E., O’Leary, M. P., Cappelleri, J. C., Hvidsten, K., Stecher, V. J., Glina, S., et al. (2006). Sildenafil citrate improves self-esteem, confidence, and relationships in men with erectile dysfunction: Results from an international, multi-center, double-blind, placebo-controlled trial. Journal of Sexual Medicine, 3, 521–529.PubMedCrossRef

Althof, S. E., O’Leary, M. P., Cappelleri, J. C., Glina, S., King, R., Tseng, L.-J., et al. (2006). Self-esteem, confidence, and relationships in men with erectile dysfunction treated with sildenafil citrate: Pooled analysis of two double-blind, placebo-controlled trials. Journal of General Internal Medicine, 21, 1069–1074.PubMedCrossRef

Cappelleri, J. C., Althof, S. E., Siegel, R. L., Stecher, V. J., Tseng, L. J., & Duttagupta, S. (2005). Association between the Erectile Dysfunction Inventory of Treatment Satisfaction and the Self-Esteem and Relationship Questionnaire following treatment with sildenafil citrate for men with erectile dysfunction. Value in Health, 8(suppl 1), S54–S60.PubMedCrossRef

Althof, S. E., O’Leary, M. P., Cappelleri, J. C., Crowley, A. R., Tseng, L.-J., & Collins, S. (2006). Impact of erectile dysfunction on confidence, self-esteem, and relationship satisfaction after 9 months of sildenafil citrate treatment. Journal of Urology, 176, 2132–2137.PubMedCrossRef

Symonds, T., Berzon, R., Marquis, P., & Rummans, T. A. (2002). The clinical significance of quality-of-life results: Practical considerations for specific audiences. Mayo Clinic Proceedings, 77, 572–583.PubMed

10.

Crosby, R. D., Kolotkin, R. L., & Williams, G. R. (2003). Defining clinically meaningful change in health-related quality of life. Journal of Clinical Epidemiology, 56, 395–407.PubMedCrossRef

11.

Guyatt, G. H., Osoba, D., Wu, A. W., Wyrwich, K. W., & Norman, G. R. (2002). Methods to explain the clinical significance of health status measures. Mayo Clinic Proceedings, 77, 371–383.PubMed

12.

Food and Drug Administration (2006). Guidance for industry. Patient-reported outcome measures: Use in medical product development to support labeling claims. http://www.fda.gov/cder/guidance/5460dft.pdf

13.

Hays, R. D., Farivar, S. S., & Liu, H. (2005). Approaches and recommendations for estimating minimally important differences for health-related quality of life measures. COPD: Journal of Chronic Obstructive Lung Disease, 2, 63–67.CrossRef

14.

Cappelleri, J. C., Siegel, R. L., Osterloh, I. H., & Rosen, R. C. (2000). Relationship between patient self-assessment of erectile function and the erectile function domain of the International Index of Erectile Function. Urology, 56, 477–481.PubMedCrossRef

15.

Cappelleri, J. C., Rosen, R. C., Smith, M. D., Mishra, A., & Osterloh, I. H. (1999). Diagnostic evaluation of the erectile function domain of the International Index of Erectile Function. Urology, 54, 346–351.PubMedCrossRef

16.

Rosen, R. C., Riley, A., Wagner, G., Osterloh, I. H., Kirkpatrick, J., & Mishra, A. (1997). The International Index of Erectile Function (IIEF): A multidimensional scale for assessment of erectile dysfunction. Urology, 49, 822–830.PubMedCrossRef

17.

Sloan, J. A., Cella, D., Frost, M., Guyatt, G. H., Sprangers, M., & Symonds, T. (2002). Assessing clinical significance in measuring oncology patient quality of life: Introduction to the symposium, content overview, and definition of terms. Mayo Clinic Proceedings, 77, 367–370.PubMedCrossRef

18.

Hays, R. D., & Woolley, J. M. (2000). The concept of clinically meaningful difference in health-related quality-of-life research. How meaningful is it? Pharmacoeconomics, 18, 419–423.PubMedCrossRef

19.

Fitzpatrick, R., Norquist, J. M., & Jenkinson, C. (2004). Distribution-based criteria for change in health-related quality of life in Parkinson’s disease. Journal of Clinical Epidemiology, 57, 40–44.PubMedCrossRef

20.

Eton, D. T., Cella, D., Yost, K. J., Yount, S. E., Peterman, A. H., Neuberg, D. S., et al. (2004). A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale. Journal of Clinical Epidemiology, 57, 898–910.PubMedCrossRef

21.

Cella, D., Eton, D. T., Fairclough, D. L., Bonomi, P., Heyes, A. E., Silberman, C., et al. (2002). What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592. Journal of Clinical Epidemiology, 55, 285–295.PubMedCrossRef

22.

Osoba, D., Rodrigues, G., Myles, J., Zee, B., & Pater, J. (1998). Interpreting the significance of changes in health-related quality-of-life scores. Journal of Clinical Oncology, 16, 139–144.PubMed

23.

Coyne, K., Matza, L., Thomspon, C., Kopp, Z., & Khullar, V. (2006). Determining the importance of change in the Overactive Bladder Questionnaire. Journal of Urology, 176, 627–632.PubMedCrossRef

24.

McLeod, L. D., Fehnel, S. E., Brandman, J., & Symonds, T. (2003). Evaluating minimal clinically important differences for the acne-specific quality of life questionnaire. Pharmacoeconomics, 21, 1069–1079.PubMedCrossRef

25.

Althof, S. E., Corty, E. W., Levine, S. B., Levine, F., Burnett, A. L., McVary, K., et al. (1999). EDITS: Development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction. Urology, 53, 793–799.PubMedCrossRef

Titel: Clinically meaningful improvement on the Self-Esteem And Relationship questionnaire in men with erectile dysfunction
Auteurs: Joseph C. Cappelleri
Stanley E. Althof
Michael P. O’Leary
Sidney Glina
Rosie King
Vera J. Stecher
Martin Carlsson
Richard L. Siegel
Publicatiedatum: 01-09-2007
Uitgeverij: Springer Netherlands
Gepubliceerd in: Quality of Life Research / Uitgave 7/2007
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-007-9232-2

Bohn Stafleu van Loghum

Deel dit onderdeel of sectie (kopieer de link)

Abstract

Purpose

Methods

Results

Conclusions

Log in om toegang te krijgen

Andere artikelen Uitgave 7/2007

How can quality of life researchers make their work more useful to health workers and their patients?

Emergency physicians’ pain judgments: cluster analyses on scenarios of acute abdominal pain

Utilities and disutilities for type 2 diabetes treatment-related attributes

Two questionnaires for Parkinson’s disease: are the PDQ-39 and PDQL equivalent?

Reliability and validity of the Pediatric Quality of Life Inventory™ (PedsQL™) Short Form 15 Generic Core Scales in Japan

The effect of walking and vitamin B supplementation on quality of life in community-dwelling adults with mild cognitive impairment: a randomized, controlled trial