Establishing the content validity of the confidence in performing sexual intercourse and difficulty in performing sexual intercourse questionnaires.

The aim of this qualitative analysis was to establish the content validity of two new patient-reported outcome (PRO) measures, Confidence in Performing Sexual Intercourse Questionnaire (CPSIQ) and Difficulty in Performing Sexual Intercourse Questionnaire (DPSIQ). Six separate qualitative studies (interviews/focus groups) were conducted from December 2009 to August 2010 by a single moderator and included 227 men with erectile dysfunction (ED; mean age: 54 years, 58% Caucasian). In the first three studies, concepts about ED and its treatment that were important and relevant to men with ED were identified. They included: getting and controlling erection; erection hardness; maintaining erection for desired duration; achieving and controlling ejaculation; satisfying partner; changing sexual positions; and frequency and spontaneity of sexual intercourse. In the subsequent two studies, concepts were confirmed and transformed into CPSIQ and DPSIQ items. The last study entailed a cognitive interview of the CPSIQ and DPSIQ to ensure that respondents' interpretation of the PRO items were consistent with their intended meaning and that both recall periods and response sets were acceptable. After psychometric testing, the CPSIQ and DPSIQ could serve as complementary tools to existing PROs used in ED clinical trials.