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

Abstract：

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.

journal_name

BJU Int

journal_title

BJU international

authors

Patrick DL,Giuliano F,Ho KF,Gagnon DD,McNulty P,Rothman M

doi

10.1111/j.1464-410X.2008.08041.x

subject

Has Abstract

pub_date

2009-02-01 00:00:00

pages

358-64

issue

eissn

1464-4096

issn

1464-410X

pii

BJU8041

journal_volume

103

pub_type

杂志文章,多中心研究,随机对照试验

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