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01-09-2007 | Uitgave 7/2007

Quality of Life Research 7/2007

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

Tijdschrift:
Quality of Life Research > Uitgave 7/2007
Auteurs:
Joseph C. Cappelleri, Stanley E. Althof, Michael P. O’Leary, Sidney Glina, Rosie King, Vera J. Stecher, Martin Carlsson, Richard L. Siegel

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.

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