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

Cappelleri JC, Althof SE, O'Leary MP, Glina S, King R, Stecher VJ, Carlsson M, Siegel RL

Pfizer Inc, Global Research & Development, MS 8260-2222, Eastern Point Road, Groton, CT 06340-8030, USA. joseph.c.cappelleri@pfizer.com

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.

Published 31 August 2007 in Qual Life Res, 16(7): 1203-10.
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