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Clinically meaningful improvement on the quality of erection questionnaire in men with erectile dysfunction

International Journal of Impotence Research volume 22, pages 45–50 (2010)Cite this article

Abstract

Defining the minimal clinically meaningful improvement (MCMI) is crucial to understanding the treatment effects on health-status measures. We estimated the MCMI on the quality of erection questionnaire (QEQ), a validated measure specific to assess erectile quality during sexual intercourse. Data were from two controlled trials of an investigational phosphodiesterase type 5 inhibitor. Improvement on the Erectile Function domain of the International Index of Erectile Function was used as the anchor. For men who improved by exactly 1 erectile dysfunction severity category (anchor group (n=95)), clinically meaningful improvement (CMI, estimated with mean QEQ total change score from baseline to end of treatment) and MCMI (estimated with the lower limit of the 95% confidence interval of the mean) were 22.4 (s.d., 2.2) and 18.0 points, respectively. For the difference between the anchor group and men with no change in severity category (n=116), CMI and MCMI were 17.7 (s.d., 2.9) and 12 points, respectively. Distribution-based analyses (baseline s.e. of measurement (s.e.m.)=7.99, end-of-treatment s.e.m.=8.22 and s.e. of difference=11.46) supported a proposed MCMI of 12 points. Convergence of anchor-based and distribution-based criteria supports at least a 12-point difference in QEQ scores between treatments as clinically important.

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Acknowledgements

The study was funded by Pfizer. Editorial support was provided by Deborah M Campoli-Richards, BSPHA, RPh, of Complete Healthcare Communications, and was funded by Pfizer. All authors participated in the conception and design of the study, helped to draft and revise the paper, and read and approved of the final version. Martin Carlsson performed the statistical analysis.

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Authors and Affiliations

  1. Pfizer, New York, NY, USA

    K Hvidsten, M Carlsson, V J Stecher & I Levinson

  2. Pfizer Global Research and Development, Sandwich, Kent, UK

    T Symonds

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  1. K Hvidsten
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  2. M Carlsson
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  3. V J Stecher
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  4. T Symonds
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  5. I Levinson
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Correspondence to T Symonds.

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Hvidsten, K., Carlsson, M., Stecher, V. et al. Clinically meaningful improvement on the quality of erection questionnaire in men with erectile dysfunction. Int J Impot Res 22, 45–50 (2010). https://doi.org/10.1038/ijir.2009.47

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