Introduction Premature ejaculation (PE) is the most common male sexual dysfunction affecting men and their partners. Lack of community-based data describing this condition limits understanding of PE and its outcomes. Aim To characterize PE in a large population of men with and without PE using patient-reported outcome (PRO) measures elicited from men and their partners. Methods 4-week, multicenter, observational study of males (≥18 years) and their female partners in monogamous relationships (≥6 months). Screening, baseline, and follow-up visits scheduled at 2-week intervals. Clinicians diagnosed PE utilizing DSM-IV-TR criteria. Intravaginal ejaculatory latency time (IELT), measured by a stopwatch held by the partner, was recorded for each sexual intercourse experience. Subject and partner independently assessed PROs: control over ejaculationand satisfaction with sexual intercourse(0 = very poor to 4 = very good), personal distressand interpersonal difficulty(0 = not at all to 4 = extremely), and severity of PE(0 = none to 3 = severe). Results Of the total study population (N = 1,587), 207 subjects were diagnosed with PE and 1,380 were assigned to the non-PE group. Median IELT (min) was 1.8 (range, 0–41) for PE and 7.3 (range, 0–53) for non-PE subjects (P < 0.0001). More PE vs. non-PE subjects gave ratings of “very poor” or “poor” for control over ejaculation(72% vs. 5%; P < 0.0001) and satisfaction with sexual intercourse(31% vs. 1%; P < 0.0001). More subjects in the PE vs. non-PE group gave ratings of “quite a bit” or “extremely” for personal distress(64% vs. 4%; P < 0.0001) and interpersonal difficulty(31% vs. 1%; P < 0.0001). Subject and partner assessments showed similar patterns and correlated moderately (0.36–0.57). Conclusions PE subjects reported significantly shorter IELT. Overlap in IELT distributions was observed between the PE and non-PE groups, indicating the need for additional PRO measures to characterize PE. Shorter IELT was significantly associated with reduced ejaculatory control and sexual satisfaction and increased distress and interpersonal difficulty.

OBJECTIVE To evaluate the reliability and validity of the Premature Ejaculation Profile (PEP), a self‐reported outcome instrument for evaluating domains of PE and its treatment, comprised of four single‐item measures, a profile, and an index score. SUBJECTS AND METHODS Data were from men participating in observational studies in the USA (PE, 207 men; non‐PE, 1380) and Europe (PE, 201; non‐PE, 914) and from men with PE (1238) participating in a phase III randomized, placebo‐controlled clinical trial of dapoxetine. The PEP contains four measures: perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse, and interpersonal difficulty related to ejaculation, each assessed on five‐point response scales. Test‐retest reliability, known‐groups validity, and ability to detect a patient‐reported global impression of change (PGI) in condition were evaluated for the individual PEP measures and a PEP index score (the mean of all four measures). Profile analysis was conducted using multivariate analysis of variance. RESULTS All PEP measures showed acceptable reliability (intraclass correlation coefficients ranged from 0.66 to 0.83) and mean scores for all measures differed significantly between PE and non‐PE groups (P < 0.001). Men who reported a reduction in PE with treatment in the phase III trial had significantly greater scores on each of the four measures. The PEP profiles of men with and without PE differed significantly (P < 0.001) in both observational studies; higher levels of PGI were associated with higher PEP profiles (P < 0.001). The PEP index score also showed acceptable reliability and was significantly different between the PE and non‐PE groups (P < 0.001). Men who reported an improvement in PE with treatment in the phase III trial had significantly greater PEP index scores. In the phase III trial, nausea was the most common adverse event with dapoxetine. CONCLUSION The PEP provides a reliable, valid, and interpretable measure for use in monitoring outcomes of men with PE.

The diabetic foot ulcer scale (DFS) questionnaire is a specific instrument designed to assess the impact of foot ulcers and their treatment on quality of life in people with diabetes. Based on the results of semi-structured interviews and focus-group discussions with foot ulcer patients and caregivers, the DFS consists of 58 items grouped into 11 domains: leisure, physical health, daily activities, emotions, noncompliance, family, friends, positive attitude, treatment, satisfaction, and financial.Two studies have been conducted to develop and validate the DFS. The first of these included 173 patients with diabetes and current foot ulcers (n = 48), healed foot ulcers (n = 54), or no history of foot ulcers (n = 71). A generic measure of health status, the SF-36, was used to test construct validity.The DFS had good internal consistency. Significant differences between patients with current ulcers and those with healed ulcers were observed in the mean scores for the leisure, emotions, and financial domains (p < 0.05). Marked differences were also observed in physical health, daily activities, and friends domains, indicating that the DFS is able to discriminate patients with healed ulcers from those with current ulcers.The DFS was further evaluated in a relevant clinical setting (n = 288); confirmatory factor analysis confirmed the hypothesised factor structure of the DFS, but with slight suggestions for improved scaling. The DFS scales also demonstrated adequate test-retest reliability and sensitivity to change in wound status over time KEYWORDSdiabetes; foot ulcer; quality of life; treatment; diabetic foot ulcer scale study conducted in the United Kingdom that involved face-to-face semi-structured interviews with ten patients (six men, four women; mean age, 61 years; range, 46 to 74 years) and three caregivers. All of these patients currently had diabetic foot ulcers, and were referred by either a neuropathy specialist/consultant or a diabetic foot ulcer nurse. Subsequent focus-group discussions with patients and caregivers were conducted to define further the domains of quality of life affected by diabetic foot ulcers. A total of 14 patients and 11 caregivers from the United Kingdom consented to participate in these discussions, consisting of two patient groups and two caregiver groups. The groups were not attended by anyone involved in treating the patients and were all facilitated by the same moderator. Following each focusgroup discussion, the research team reviewed the group responses to identify major issues. Themes arising in one group were presented to subsequent groups for further elucidation of the concepts and domains. These themes included the impact of ulcers on mobility and the resulting implications for daily activities and social activities, the impact of ulcers on leisure activities, and psychological issues, such as knowing that one is at high risk for ulceration, discovering the presence of an ulcer, having to obtain treatment for foot ulcers, or having a toe, foot, or leg amputated.The ...

No abstract