Psychometric validation of the Confidence in Performing Sexual Intercourse Questionnaire and Difficulty in Performing Sexual Intercourse Questionnaire.

The objective of this study was to perform psychometric testing of two new patient-reported outcome instruments (PROs), the Confidence in Performing Sexual Intercourse Questionnaire (CPSIQ) and the Difficulty in Performing Sexual Intercourse Questionnaire (DPSIQ). The new PROs were administered at non-drug, run-in, baseline and end point in men with erectile dysfunction (ED) participating in a randomized clinical trial of ED treatment (Study 1, n=291) and two times within 2 weeks to men with ED participating in a web-based survey (Study 2, n=71). Psychometric tests included factor analysis, internal consistency and test-retest reliability, construct validity and responsiveness. Analysis of data from Study 1 participants (74% ≤65 years, 83% Caucasian and 75% with moderate ED) suggested one-factor solutions for both PROs with Cronbach's α >0.88. CPSIQ and DPSIQ total scores discriminated between ED severity groups showed worsening after a 4-week non-drug, run-in period, and showed improvement after 12 weeks of ED treatment (all, P<0.05). Intraclass correlation coefficients calculated for the CPSIQ and DPSIQ, using data from Study 2 participants (82% ≤65 years, 90% Caucasian and 66% with mild ED), were 0.56 and 0.83, respectively. The CPSIQ and DPSIQ show potential for augmenting existing treatment outcome measures used in the evaluation of ED treatment.

RCT Entities:   Population Interventions Outcomes