Emotional Brain BV, Almere, The Netherlands.
Emotional Brain BV, Almere, The Netherlands; Utrecht University, Utrecht Institute for Pharmaceutical Sciences and Rudolf Magnus Institute of Neuroscience, Utrecht, The Netherlands.
J Sex Med. 2017 Nov;14(11):1438-1450. doi: 10.1016/j.jsxm.2017.09.008. Epub 2017 Oct 6.
The efficacy of on-demand drugs for hypoactive sexual desire disorder (HSDD) or female sexual interest/arousal disorder (FSIAD) should be assessed using a validated instrument that assesses the discrete sexual events during which the on-demand drug is taken.
To develop and validate an event log for measuring sexual satisfaction and sexual functioning of discrete sexual events.
Psychometric assessment was carried out on data of 10,959 Sexual Event Diaries (SEDs) collected during three clinical trials in a total of 421 women with HSDD. Cognitive debriefing interviews were held with 16 women with HSDD.
Item scores of the SED at the event level and at the subject level, summarized item scores of women during the baseline establishment and active treatment periods, and score changes in women from baseline establishment to active treatment.
Several items of the initial 16-item SED items showed weak validity. The 16-item SED was refined to the 11-item SED. The reliability, content, and convergent validity of the 11-item SED were confirmed. For most 11-item SED item scores, the ability to discriminate between known groups was confirmed. Larger mean score changes from the baseline establishment period were found in those with than in those without known benefit from the medication, and Guyatt effect sizes ranged from 0.73 to 1.58, thereby demonstrating the ability to detect change.
The SED is a good tool for assessing sexual function during a discrete sexual event and for assessing the sexual function of women over longer periods.
The validation of the SED was performed on data from nearly 11,000 sexual events, gathered as part of a drug development program for HSDD and FSIAD. This amount of data provides very robust results when related to drug use for HSDD and FSIAD, but caution is advised when generalizing the validity of the SED directly to other areas of research (eg, recreational drug use and sexual risky behaviors), because such data were not used in this validation.
The 11-item SED is a reliable, valid, and responsive instrument and suitable for use in evaluating the effects of on-demand drugs in women with HSDD or FSIAD. van Nes Y, Bloemers J, van der Heijden PGM, et al. The Sexual Event Diary (SED): Development and Validation of a Standardized Questionnaire for Assessing Female Sexual Functioning During Discrete Sexual Events. J Sex Med 2017;14:1438-1450.
按需药物治疗低性欲障碍（HSDD）或女性性兴趣/唤起障碍（FSIAD）的疗效应使用评估特定性事件的有效性工具进行评估，在此期间使用按需药物。
开发和验证用于测量离散性事件中性满意度和性功能的事件日志。
对三项临床试验中 421 名 HSDD 女性共 10959 份性事件日记（SED）的数据进行了心理测量评估。对 16 名 HSDD 女性进行了认知深度访谈。
事件水平和受试者水平的 SED 项目得分、基线建立和积极治疗期间女性综合项目得分、以及女性从基线建立到积极治疗的评分变化。
SED 是一种评估离散性事件期间女性性功能的有效工具，也适用于评估女性较长时期的性功能。
SED 的验证是基于近 11000 次性行为事件的数据进行的，这些数据是作为 HSDD 和 FSIAD 药物开发项目的一部分收集的。与 HSDD 和 FSIAD 药物使用相关的这些数据提供了非常可靠的结果，但在将 SED 的有效性直接推广到其他研究领域（例如，娱乐性药物使用和性行为风险）时需谨慎，因为在验证中未使用此类数据。
