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

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.