首页> 外文期刊>The journal of sexual medicine >The HSDD registry for women: a novel patient registry for women with generalized acquired hypoactive sexual desire disorder.
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The HSDD registry for women: a novel patient registry for women with generalized acquired hypoactive sexual desire disorder.

机译:妇女的HSDD注册表:针对患有广泛性获得性机能减退性欲障碍的女性的新型患者注册表。

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INTRODUCTION: Hypoactive sexual desire disorder (HSDD) is a clinically challenging disorder in women. Little is known about the natural history of the disorder and long-term consequences. A longitudinal registry can address these needs. AIM: To design and implement a registry study of HSDD in women to characterize the natural history of HSDD and current treatment practices. METHODS: A longitudinal multicenter registry study has been initiated at clinical sites across the United States. A total of 1,500 women (approximately 1,000 premenopausal, 500 postmenopausal) with clinically-diagnosed HSDD, confirmed by the Decreased Sexual Desire Screener, will be recruited over 24 months at up to 40 clinical sites. Participants will be followed with in-clinic or remote, computer-assisted follow-up. Data from the initial implementation phase was analyzed to assess feasibility of the protocol. A qualitative substudy (N = 40) was conducted to assess content validity of the participant questionnaire. MAIN OUTCOME MEASURES: The primary outcome measure for the Registry study is a patient-based global impression of change in HSDD. Secondary outcome measures are derived from two sources: (i) self-administered questionnaire completed by the participant, and (ii) medical history review completed by the clinician. The questionnaire includes validated measures of sexual function, quality of life, relationship factors, and physical and mental health, as well as newly developed questions on treatments and medications. RESULTS: As of February 12, 2009, 290 women (209 premenopausal, 81 postmenopausal) had been recruited from 15 clinical sites. Results of the initial implementation phase and qualitative substudy on the participant questionnaire show that the Registry protocol is highly feasible and the questionnaire consisting of previously validated scales and selected new items has high content validity. CONCLUSIONS: As the first longitudinal registry study in female sexual dysfunction, the HSDD Registry will contribute to a broader understanding of the impact and treatment needs of women with clinically diagnosed HSDD.
机译:简介:性欲减退症(HSDD)是女性的一项具有临床挑战性的疾病。对于这种疾病的自然病史和长期后果知之甚少。纵向注册表可以满足这些需求。目的:设计和实施女性HSDD登记研究,以表征HSDD的自然病史和当前的治疗方法。方法:一项纵向多中心注册表研究已在美国各地的临床场所启动。经减少的性欲筛查者确认,将有1,500名妇女(绝经前约1,000名,绝经后500名)经临床诊断为HSDD,将在24个月内招募多达40个临床地点。参加者将接受诊所内或远程的计算机辅助随访。分析了初始实施阶段的数据,以评估该协议的可行性。进行了定性子研究(N = 40)以评估参与者问卷的内容有效性。主要观察指标:注册研究的主要观察指标是患者对HSDD变化的总体印象。次要结局指标来自两个来源:(i)参与者自行填写的问卷,以及(ii)临床医师完成病史回顾。该问卷包括性功能,生活质量,关系因素以及身心健康的经过验证的量度,以及有关治疗和药物的新开发问题。结果:截至2009年2月12日,已从15个临床地点招募了290名妇女(绝经前209名,绝经后81名)。参与者问卷的初始实施阶段和定性子研究的结果表明,Registry协议是高度可行的,并且由先前验证的量表和选定的新项目组成的问卷具有较高的内容效度。结论:作为第一个针对女性性功能障碍的纵向登记研究,HSDD登记将有助于更广泛地了解临床诊断为HSDD的妇女的影响和治疗需求。

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