The Premature Ejaculation Profile: validation of self-reported outcome measures for research and practice.
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.


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.


CONCLUSIONS
The PEP provides a reliable, valid, and interpretable measure for use in monitoring outcomes of men with PE.
Patrick
Donald L
DL
Department of Health Services and Epidemiology, University of Washington, Seattle, WA 98195-7660, USA. donald@u.washington.edu
Giuliano
François
F
Ho
Kai Fai
KF
Gagnon
Dennis D
DD
McNulty
Pauline
P
Rothman
Margaret
M
D000328:Adult; D001596:Benzylamines / Q000009:adverse effects / Q000627:therapeutic use*; D003075:Coitus / Q000502:physiology* / Q000523:psychology; D004542:Ejaculation / Q000502:physiology*; D006801:Humans; D007398:Interpersonal Relations; D008297:Male; D009281:Naphthalenes / Q000009:adverse effects / Q000627:therapeutic use*; D017060:Patient Satisfaction; D015203:Reproducibility of Results; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D012735:Sexual Dysfunction, Physiological / Q000188:drug therapy / Q000503:physiopathology* / Q000523:psychology; D016896:Treatment Outcome
D001596:Benzylamines; D009281:Naphthalenes; D017367:Selective Serotonin Reuptake Inhibitors; C080598:dapoxetine