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Updated: Jun 30, 2025

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开发一套核心结局,用于治疗诱发性阴道的治疗研究
Nina Bohm-Starke1, Caroline Pukall2, Marie Österberg3
1Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital, 171 77 Stockholm, Sweden.
The journal of sexual medicine
|March 22, 2024
概括
研究人员建立了一个核心结果集 (COS) 诱发性静脉动力症 (PVD) 临床试验. 这将使结果测量标准化,以便更好地进行治疗比较和建议.
科学领域:
- 妇科 妇科 妇科 妇科
- 疼痛医学 医学 疼痛医学
- 临床试验方法论 临床试验方法论
背景情况:
- 诱发性静脉动力症 (PVD) 的临床试验缺乏一致的结果测量,阻碍了治疗比较.
- 标准化结果对于有效评估PVD干预措施至关重要.
研究的目的:
- 建立PVD临床试验的核心结果集 (COS).
- 确定在PVD研究中进行一致测量的基本结果.
主要方法:
- 对PVD临床试验和注册协议的系统审查.
- 两轮的德尔菲调查与不同的利益相关者 (患者,临床医生,研究人员).
- 修改名义组技术共识会议,以最终确定COS.
主要成果:
- 审查了40篇文章和92条协议,确定了402个结果,分为63个独特的措施.
- 319和213名参与者对Delphi调查做出了回应.
- 对PVD试验的6个关键结果达成共识:插入疼痛 (性和非性),接触引起的部疼痛,疼痛干扰生命和性功能以及性功能.
结论:
- 开发的COS为PVD临床试验中的标准化测量提供了关键的结果.
- 这种标准化将使干预措施能够准确地比较,并为治疗建议提供信息.
- 需要进一步的研究来确定测量这些结果的准确方法和时间.
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