Clinically meaningful improvement on the Self-Esteem And Relationship questionnaire in men with erectile dysfunction.
OBJECTIVE
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.
Cappelleri
Joseph C
JC
Pfizer Inc, Global Research & Development, MS 8260-2222, Eastern Point Road, Groton, CT 06340-8030, USA. joseph.c.cappelleri@pfizer.com
Althof
Stanley E
SE
O'Leary
Michael P
MP
Glina
Sidney
S
King
Rosie
R
Stecher
Vera J
VJ
Carlsson
Martin
M
Siegel
Richard L
RL
D007172:Erectile Dysfunction / Q000188:drug therapy / Q000523:psychology*; D006304:Health Status; D006305:Health Status Indicators; D006306:Health Surveys; D006801:Humans; D008297:Male; D008875:Middle Aged; D015233:Models, Statistical; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D010879:Piperazines / Q000627:therapeutic use*; D011594:Psychometrics; D011687:Purines / Q000627:therapeutic use; D011788:Quality of Life; D012649:Self Concept; D012725:Sexual Behavior; D012747:Sexual Partners / Q000523:psychology*; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000627:therapeutic use*; D011795:Surveys and Questionnaires
D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate