title: Psychometric validation of the Confidence in Performing Sexual Intercourse Questionnaire and Difficulty in Performing Sexual Intercourse Questionnaire.
abstract: 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.
authors: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors: R P
authors: RP
authors: Hayes
authors: Cooper University Hospital-Cooper Medical School of Rowan University, Camden, NJ, USA.
authors: A
authors: A
authors: Seftel
authors: New England Research Institutes, Watertown, MA, USA.
authors: R C
authors: RC
authors: Rosen
authors: Case Western Reserve University School of Medicine, Cleveland, OH, USA.
authors: S
authors: S
authors: Althof
authors: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
authors: W
authors: W
authors: Shen
authors: inVentiv Health, Burlington, MA, USA.
authors: T
authors: T
authors: Shih
authors: Lilly USA, LLC, Indianapolis, IN, USA.
authors: A
authors: A
authors: Sontag
mesh_terms: D000368:Aged; D002985:Clinical Protocols; D003075:Coitus / Q000523:psychology*; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D006801:Humans; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors / Q000627:therapeutic use; D010919:Placebos; D011594:Psychometrics; D015203:Reproducibility of Results; D012649:Self Concept; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D058986:Phosphodiesterase 5 Inhibitors; D010919:Placebos