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The Sexual Event Diary (SED): Development and Validation of a Standardized Questionnaire for Assessing Female Sexual Functioning During Discrete Sexual Events

机译:性事件日记(SED):在离散性事件中评估女性性能的标准调查问卷的开发和验证

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Abstract Background 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. Aim To develop and validate an event log for measuring sexual satisfaction and sexual functioning of discrete sexual events. Methods 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. Outcomes 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. Results 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. Clinical Translation 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. Strengths and Limitations 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. Conclusions 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.
机译:摘要应使用验证的仪器进行评估,应评估低温性欲障碍障碍(HSDD)或女性性兴趣/唤醒障碍(FSIAD)的疗效。旨在开发和验证活动日志,以衡量离散性事件的性满意度和性功能。方法对在三项临床试验期间收集的10,959例性事件日记(SED)的数据进行了心理计量评估,共有421名患有HSDD的妇女。认知汇报访谈与16名妇女有16名妇女司。在事件水平和主题水平的情况下,在基线建立和积极治疗期间汇总妇女的项目分数,以及从基线建立到积极治疗的妇女的变化。结果初始16项SED项目的几项效果较弱。 16-Item Sed被精制到11项SED。确认了11项SED的可靠性,内容和收敛有效性。对于大多数11项SED项目分数,确认了已知组之间区分的能力。从基线建立期间的比分比得分更大的平均分数在没有已知的药物治疗中的那些中,并且Guyatt效应尺寸范围为0.73至1.58,从而证明了检测变化的能力。临床翻译SED是在离散性事件期间评估性功能的良好工具,以及评估女性的性功能超过更长的时间。优势和局限性SED的验证是对近11,000名性事件的数据进行的,作为HSDD和FSIAD的药物开发计划的一部分。与针对HSDD和FSIAD的药物使用有关时,此数据提供了非常强大的结果,但在将SED的有效性直接概括为其他研究领域(例如,休闲药物使用和性风险行为)时,请注意,因为此类数据未在此验证中使用。结论11项SED是可靠,有效和响应性的仪器,适用于评估HSDD或FSIAD妇女的需求药物的影响。 van nes y,bloemers j,van der heijden pgm,et?al。性事件日记(SED):用于评估离散性事件中女性性能的标准化问卷的开发和验证。 J SEX MED 2017; 14:1438-1450。

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