Clinical Outcomes Solutions, Canterbury, UK.
Clinical Outcomes Solutions, Canterbury, UK.
J Sex Med. 2019 Apr;16(4):569-576. doi: 10.1016/j.jsxm.2019.01.311. Epub 2019 Mar 2.
The Premature Ejaculation Profile (PEP) is a patient-reported outcome (PRO) measure that is widely used in clinical research in men with premature ejaculation (PE) but has not been fully validated for men meeting the current International Society for Sexual Medicine (ISSM) definition of lifelong PE.
To explore the content validity of the PEP (original 1-month recall version and new event-driven version) in men meeting current definitions of lifelong PE and to understand the relevance of the concept of ejaculation control.
In-depth individual interviews were conducted with 24 men in a stable heterosexual relationship, including 15 with lifelong PE, 4 with acquired PE (with intravaginal ejaculation latency time values confirmed during a 4-week period of no treatment), and 5 with no sexual dysfunction. Initial concept elicitation explored individual experiences of having PE (in those with PE), experiences of control, and impact on sexual life. This was followed by a cognitive debriefing of the PEP versions.
Thematic analysis was used to identify key concepts of PE, understand the experience of control in men with and without PE, and confirm understanding and relevance of questions from original and event-driven versions of the PEP.
The interviews confirmed substantial negative consequences for men with lifelong PE. Men with and without PE could describe ejaculation control (or lack of it). The PEP was shown to cover the key concepts in PE, and the questions were easily understood in both the original or event-driven versions. The items were comprehensive, and the concept of ejaculation control was confirmed. A 1- or 2-category change in each item of the PEP was considered clinically meaningful.
The PEP (original and per-event) has strong content validity for use in clinical research studies of men meeting the ISSM definition of lifelong PE.
STRENGTHS & LIMITATIONS: This study addressed gaps in previously published research on the development and validation of the PEP and also confirmed that a new event-driven version is also suitable for use in research. However, the study was limited mainly to men meeting a strict definition of lifelong PE; in addition, homosexual men and those not in stable long-term relationships were not studied.
Both the original and per-event PEP versions were shown to have strong content validity and be acceptable for use in men with lifelong PE. Burbridge C, Symonds T, Osterloh IH, et al. Content Validity of the Premature Ejaculation Profile, Original and Per-Event Formats, in Men with Lifelong Premature Ejaculation. J Sex Med 2019;16:569-576.
早泄状况量表（PEP）是一种患者报告的结局（PRO）测量工具，在早泄（PE）男性的临床研究中得到广泛应用，但尚未在符合当前国际性医学会（ISSM）终身 PE 定义的男性中得到充分验证。
探讨符合当前终身 PE 定义的男性中 PEP（原始 1 个月回忆版和新事件驱动版）的内容效度，并了解射精控制概念的相关性。
对 24 名处于稳定异性关系的男性进行深入的个体访谈，其中 15 名患有终身 PE，4 名患有获得性 PE（在无治疗的 4 周期间，阴道内射精潜伏期时间值得到确认），5 名无性功能障碍。初步概念发掘探索了有 PE（在有 PE 的人中）的个人经历、控制体验以及对性生活的影响。随后对 PEP 版本进行认知性审阅。
采用主题分析方法识别 PE 的关键概念，了解有和无 PE 的男性的控制体验，并确认原始和事件驱动版本的 PEP 问题的理解和相关性。
访谈证实了终身 PE 对男性的负面影响较大。有和无 PE 的男性都可以描述射精控制（或缺乏控制）。PEP 涵盖了 PE 的关键概念，且原始或事件驱动版本的问题都很容易理解。项目全面，射精控制概念得到确认。PEP 每项的 1 或 2 级变化被认为具有临床意义。
PEP（原始和每事件）具有很强的内容效度，可用于符合 ISSM 终身 PE 定义的男性临床研究。
本研究解决了之前关于 PEP 开发和验证的研究中的空白，也证实了新的事件驱动版本也适用于研究。然而，该研究主要局限于符合严格终身 PE 定义的男性；此外，未研究同性恋男性和非稳定长期关系的男性。
原始和每事件 PEP 版本均具有很强的内容效度，可用于终身 PE 男性。
