Quality of Erection Questionnaire Correlates: Change in Erection Quality with Erectile Function, Hardness, and Psychosocial Measures in Men Treated with Sildenafil for Erectile Dysfunction

Abstract

Introduction The validated Quality of Erection Questionnaire (QEQ) is a six-question, patient-reported outcome measure for comprehensively evaluating satisfaction with the quality of erections in terms of hardness, onset, and duration, which can be used to develop and monitor individualized treatment goals. Aims To further validate the QEQ by determining responsiveness/sensitivity to change in erectile function, erection hardness grade, and psychosocial outcomes in men treated with sildenafil for erectile dysfunction (ED). Methods This open-label, noncomparative, multicenter trial of sildenafil (50 or 100 mg as needed for 10 weeks) enrolled men with ED who were in a stable, sexual relationship for at least 6 months. Previous phosphodiesterase type 5 inhibitor use must have been no more than 6 doses ever and no doses more recently than the previous 4 weeks. Main Outcome Measures The baseline to week 10 change in the QEQ total score and its correlations with the end-of-treatment Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) score and with changes in: (i) International Index of Erectile Function (IIEF) domain scores; (ii) Self-Esteem And Relationship (SEAR) questionnaire component scores; and (iii) the frequency of erections graded hard enough for penetration (grade 3) or completely hard (grade 4) on the event log Erectile Hardness Grading Scale. Results The mean ± standard deviation transformed QEQ total score tripled from 22.0 ± 21.1 to 69.9 ± 35.9 (P <0.0001), and correlated positively with the end-of-treatment EDITS index score (r = 0.71) and with changes in IIEF domain scores (r =0.29–0.86), SEAR component scores (r = 0.37–0.78), and the percentage of occasions that grade 3 or 4 erections were achieved (r =0.66). Conclusion The brief, easy-to-administer QEQ is responsive to the benefits of sildenafil treatment of men for ED and has convergent validity with measures of clinical and psychosocial outcomes.

Clinically meaningful improvement on the quality of erection questionnaire in men with erectile dysfunction

“…2 In prospective trials of flexible-dose sildenafil citrate (25,50 or 100 mg) for the treatment of men with ED, the mean ± s.d. transformed QEQ total score increased by more than 40 points, from baseline values of 22 1 and 34 4 points, in men treated with sildenafil. Furthermore, the QEQ had convergent validity with measures of sexual function (International Index of Erectile Function (IIEF) 5,6 ), erection hardness (Erection Hardness Score 7 ), satisfaction (Erectile Dysfunction Inventory of Treatment Satisfaction 8 ) and emotional well-being (Self-Esteem And Relationship Questionnaire (SEAR) 9,10 ).…”

“…1,2 Although the past decade has seen the development of many PROs to evaluate ED, 3 the QEQ is unique in that it is the only psychometrically validated assessment tool designed to solely and specifically evaluate satisfaction with the quality of erections. 2,3 The development and validation of the QEQ were described previously.…”

“…Furthermore, the QEQ had convergent validity with measures of sexual function (International Index of Erectile Function (IIEF) 5,6 ), erection hardness (Erection Hardness Score 7 ), satisfaction (Erectile Dysfunction Inventory of Treatment Satisfaction 8 ) and emotional well-being (Self-Esteem And Relationship Questionnaire (SEAR) 9,10 ). 1,4 Health-status measures have become a standard and essential part of validated PROs in many different types of diseases. However, to understand the relevance of outcomes on a health-status measure, it is crucial to be able to interpret the scores and have established criteria for determining the meaningfulness of changes in scores.…”

An assessment of patient-reported outcomes for men with erectile dysfunction: Pfizer's perspective

“…Among men in a stable relationship-those who had the regular opportunity to engage in sexual activity-who attempted sexual intercourse and activity in the past 4 weeks, levels of ED severity on the EF domain have been classified as follows: normal (no ED; score, 26-30); mild ED (22)(23)(24)(25); mild-to-moderate (17-21); moderate (11)(12)(13)(14)(15)(16)) and severe (6)(7)(8)(9)(10). 19,[41][42] For men in a stable relationship whose ED is so poor that they do not even attempt sexual activity, the severe ED scores range from 1 to 10.…”

“…16 The International Index of Erectile Function (IIEF)-and especially its Erectile Function (EF) domain-is widely accepted as the standard PRO to assess erectile function of men in clinical trials of ED. [16][17][18][19] Other well-known PROs in clinical trials include the Sexual Health Inventory for Men (SHIM), [20][21] Quality of Erection Questionnaire (QEQ), [22][23] the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), 24 the Self-Esteem And Relationship questionnaire (SEAR) [25][26][27] and the Erection Hardness Score (EHS). [28][29][30] A recent member to the list of PROs is the Sexual Experience Questionnaire (SEX-Q).…”