Pykonsult, LLC, New Fairfield, CT, USA.
Sex Med Rev. 2021 Apr;9(2):186-193. doi: 10.1016/j.sxmr.2020.12.001. Epub 2021 Jan 27.
In 2000, the FDA began issuing advice about treatments for hypoactive sexual desire disorder (HSDD) in women. How its recommendations have evolved has not been reviewed. Its consistent preference for self-rating by patients over evaluation by an examining clinician has not been addressed.
Recount the changes in FDA's proposals about patient-reported outcomes and diagnostics. Compare the value of patient-reported measures and clinical interviews.
Historical review is based on draft guidances, publications, meetings, and prescribing information.
The FDA has avoided clinician input into diagnosis and evaluation of the severity of HSDD in women. It abandoned its initial (2000) insistence on counts of satisfying sexual events to define efficacy in favor of symptom-related scales to evaluate desire and distress with daily self-ratings. By 2015, the FDA accepted the self-rated Female Sexual Function Index-Desire Domain (FSFI-D) to measure desire and the most relevant item of the Female Sexual Distress Scale-Revised (FSDS-R) to measure distress; retrospection for both is one month. The FDA rejected the one clinician-rated broad measure of HSDD, the Sexual Interest and Desire Inventory (SIDI-F), although well-validated and treatment-sensitive. Since 2005, the FDA has accepted the Decreased Sexual Desire Screener (DSDS) to diagnose HSDD by non-expert clinicians using self-ratings and exploring them in more depth in a clinical interview.
FDA's decisions on how to measure HSDD in women may have stabilized on accepting 2 co-primary measures: the FSFI-D and the FSDS-R item on bother about low desire, and on accepting the DSDS for diagnosis. FDA's rejection of clinician ratings of severity through interviews in clinical trials seems unsound because interviews can give broader assessments than (brief) self-ratings, although the agency's logic was to avoid diagnostic controversies and help avoid overcommercialization. Semistructured clinical interviews for diagnosis (DSDS) and severity-rating (SIDI-F) are well validated and are recommended for clinical practice. Pyke RE. FDA Decisions on Measures of Hypoactive Sexual Desire Disorder in Women: A History, With Grounds to Consider Clinical Judgment. Sex Med Rev 2021;9:186-193.
2000 年，FDA 开始发布有关女性性欲减退障碍（HSDD）治疗的建议。其建议如何演变尚未得到审查。它一直倾向于让患者自我评估，而不是让检查医生评估，这一点也没有得到解决。
描述 FDA 关于患者报告结果和诊断的建议的变化。比较患者报告的测量值和临床访谈的价值。
历史回顾基于草案指南、出版物、会议和处方信息。
FDA 避免了临床医生对女性 HSDD 的诊断和严重程度的评估。它放弃了最初（2000 年）坚持以令人满意的性事件次数来定义疗效的做法，转而采用与症状相关的量表，以每日自我评估来评估欲望和困扰。到 2015 年，FDA 接受了自我评估的女性性功能指数-欲望域（FSFI-D）来衡量欲望，以及女性性困扰量表修订版（FSDS-R）中最相关的项目来衡量困扰；两者的回顾期均为一个月。FDA 拒绝了一种由单一医生评估的广泛的 HSDD 测量方法，即性兴趣和欲望量表（SIDI-F），尽管它是经过良好验证和治疗敏感的。自 2005 年以来，FDA 接受了非专家临床医生使用自我评估和更深入的临床访谈来诊断 HSDD 的性欲减退筛查器（DSDS）。
FDA 决定如何衡量女性 HSDD 的方法可能已经稳定，接受了 2 个主要指标：FSFI-D 和 FSDS-R 中对低欲望的困扰项目，以及接受 DSDS 进行诊断。FDA 在临床试验中拒绝接受访谈对严重程度的临床医生评估似乎不合理，因为访谈可以提供比（简短）自我评估更广泛的评估，尽管该机构的逻辑是避免诊断争议，并帮助避免过度商业化。用于诊断（DSDS）和严重程度评估（SIDI-F）的半结构化临床访谈经过了充分验证，建议在临床实践中使用。
