Case Western Reserve University Medical School, Cleveland, OH, USA; Center for Marital and Sexual Health of South Florida, West Palm Beach, FL, USA.
New England Research Institutes, Watertown, MA, USA.
J Sex Med. 2020 Apr;17(4):634-644. doi: 10.1016/j.jsxm.2020.01.002. Epub 2020 Feb 20.
Clinical trials evaluating new treatments for premature ejaculation (PE) should ideally include both objective end points and patient reported outcomes (PROs), but there is no consensus currently over the optimal measures or combination of outcomes. In addition, many PROs use a 1-month recall period, despite concerns about potential recall bias.
Data from a clinical trial of men with lifelong PE were used to examine the consistency of 2 core items of the Premature Ejaculation Profile (PEP), a widely used PRO for assessing subjective aspects of PE. The specific aim was to assess the level of agreement between the original 1-month recall version compared with a new event-based version of the scale in men meeting current definitions of lifelong PE. A further aim was to investigate the convergent validity between an objective end point of intravaginal ejaculatory latency time (IELT), subjective PEP responses, and a patient's Clinical Global Impression of Change (CGIC) measure.
For assessment of consistency of PEP responses (short-term [ie, sexual event driven] vs 1-month recall), descriptive statistics, correlation coefficients (Pearson and Spearman), and Bland-Altman plots are presented for each time interval. For assessment of convergent validity, descriptive statistics and correlation coefficients (Pearson and Spearman) are presented for each assessment with geometric mean IELT values. Results are also depicted graphically. Geometric mean IELT over the last 4 weeks of treatment and change from baseline (absolute and fold change) were estimated via a general linear model for each category of change in PEP and CGIC, adjusting for baseline IELT.
PEP items administered via 1-month recall and short-term event-driven responses gave virtually identical results. There was a strong correlation (very good convergent validity) between IELT and responses to PEP and the CGIC.
Men with lifelong PE can accurately recall their level of sexual functioning over the previous month. The PEP and CGIC are appropriate instruments to measure the subjective response of men with PE to new treatments.
Our analyses address gaps in previously published research on PE assessment methodology. Men with acquired PE, men without partners, and men in homosexual relationships were not studied.
In a clinical trial setting, PEP and CGIC are appropriate end points and are likely the optimal combination of PROs for use with IELT to enable a global assessment of patient response to new PE treatments. Althof S, Rosen R, Harty B, et al. Objective and Subjective Measures of Premature Ejaculation: How Closely Do They Correspond and How Well Are the Subjective Measures Recalled? J Sex Med 2020;17:634-644.
评估早泄（PE）新疗法的临床试验理想情况下应同时包含客观终点和患者报告的结局（PROs），但目前对于最佳的措施或结局组合尚未达成共识。此外，尽管存在潜在的回忆偏倚，许多 PROs 仍使用 1 个月的回顾期。
使用一项针对终身 PE 男性的临床试验数据，研究广泛用于评估 PE 主观方面的早泄问卷（PEP）的 2 个核心项目的一致性。具体目的是评估符合当前终身 PE 定义的男性中，原始 1 个月回顾版本与新的基于事件的量表版本之间的一致性。进一步的目的是调查客观终点阴道内射精潜伏期时间（IELT）、主观 PEP 反应和患者临床总体印象变化（CGIC）测量之间的收敛效度。
为了评估 PEP 反应的一致性（短期[即，性事件驱动]与 1 个月回顾），呈现了每个时间间隔的描述性统计、相关系数（皮尔逊和斯皮尔曼）和 Bland-Altman 图。为了评估收敛效度，呈现了每个评估的描述性统计和相关系数（皮尔逊和斯皮尔曼），以及几何均数 IELT 值。结果以图形方式呈现。通过广义线性模型，根据基线 IELT ，估计每个 PEP 和 CGIC 类别变化的最后 4 周治疗期间和从基线的变化（绝对值和倍数变化）的几何均数 IELT 值。
通过 1 个月回顾和短期事件驱动反应进行的 PEP 项目给出了几乎相同的结果。IELT 与 PEP 和 CGIC 的反应之间存在很强的相关性（具有很好的收敛效度）。
患有终身 PE 的男性可以准确地回忆起他们过去一个月的性功能水平。PEP 和 CGIC 是测量新疗法治疗后 PE 男性主观反应的合适工具。
我们的分析解决了之前关于 PE 评估方法研究中的空白。获得性 PE 男性、没有伴侣的男性和同性恋关系中的男性未被研究。
在临床试验环境中，PEP 和 CGIC 是合适的终点，并且可能是与 IELT 结合使用的最佳 PRO 组合，可实现对新 PE 治疗患者反应的全面评估。
