Relationship between patient self-assessment of erectile dysfunction and the Sexual Health Inventory for Men

Background: The Sexual Health Inventory for Men (SHIM) has been shown to po ssess favorable statistical properties in diagnosing the presence and sever ity of erectile dysfunction (ED). However, the SHIM has not been compared w ith patient self-assessment of ED. Objective: This article describes an independent-validation study examining the correlation and agreement between the SHIM and patient self-assessment of ED with respect to the severity of ED at baseline and after treatment, and in terms of change from baseline. Methods: The study population consisted of 247 male outpatients with ED par ticipating in a multicenter, double-blind, placebo-controlled, flexible-dos e (25-100 mg/d) Phase IIIb clinical trial in which they were randomized equ ally to sildenafil citrate or placebo. Patients assessed their degree of ED as severe, moderate, minimal/mild, or no problem at baseline and after 12 weeks of treatment. They also responded to the 5 questions on the SHIM, aft er which their degree of ED was calculated based on the SHIM total score. Results: In general, the SHIM and the single-item self-assessment question produced similar descriptive profiles of the severity of ED. Kendall tau -b correlations were 0.66 (95% Cl, 0.58-0.74) at baseline, 0.86 (95% Cl, 0.82 -0.90) after treatment, and 0.72 (95% Cl, 0.67-0.77) for change from baseli ne. Agreement between instruments, measured by the weighted kappa statistic , mirrored the correlations at baseline and after treatment. As expected, b oth measures correlated moderately with improvement in erections and treatm ent satisfaction of both patient and partner. Conclusion: The moderate-to-high correlation and agreement between the SHIM and patient self-assessment of ED validate the SHIM for use in the diagnos tic classification of ED severity.