Recommendations for Self-Report Outcome Measures in Vulvodynia Clinical Trials.
Recommendations for Self-Report Outcome Measures in Vulvodynia Clinical Trials.
复制标题
外阴痛临床试验中自我报告结果测量的建议。
DOI：
10.1097/ajp.0000000000000453
复制
发表时间：
2017
期刊：
影响因子：
--
通讯作者：
VulvodyniaCollaborativeResearchGroup
中科院分区：
文献类型：
--
作者：
Pukall,CarolineF;Bergeron,Sophie;Brown,Candace;Bachmann,Gloria;Wesselmann,Ursula;VulvodyniaCollaborativeResearchGroup
目的：外阴疼痛（特发性慢性外阴疼痛）是一种常见的疾病，与许多功能领域的重大和负面影响有关。尽管近年来对外阴痛的研究兴趣增加，但临床试验中使用的结局指标的建议仍然缺失。因此，本文的目的是为外阴痛临床试验的结局指标提供建议，以便在各试验中使用一致的指标，以促进研究间比较和大型多中心试验的进行，并改善外阴痛多个维度的测量。方法：鉴于诱发性前庭痛（PVD）--特征在于阴道口局部的诱发性疼痛--是外阴痛最常见的亚型，也是目前临床试验的主要焦点，这篇文章集中于PVD临床试验中推荐的结果测量。用于指导选择的结果措施的框架是基于一个倡议提出的方法，测量和疼痛评估的临床试验（IMMPACT）。结果：IMMPACT框架提供了一个非常适合的指南，结果措施的建议，在PVD临床试验。然而，由于挑起介绍PVD和它对性的重大影响，修改一些IMMPACT的建议和具体的额外measurements were suggested.Discussion：措施，具体到外阴阴道疼痛是理想的，通过PVD临床试验，目前存在许多这样的措施，允许相关的IMMPACT域被捕获。
Objectives:Vulvodynia (idiopathic chronic vulvar pain) is a prevalent condition associated with significant and negative impacts in many areas of function. Despite the increased research interest in vulvodynia in recent years, recommendations for outcome measures for use in clinical trials are missing. The purpose of this paper, therefore, was to provide recommendations for outcome measures for vulvodynia clinical trials so that consistent measures are used across trials to facilitate between-study comparisons and the conduct of large multicenter trials, and to improve measurement of the multiple dimensions of vulvodynia.Methods:Given that provoked vestibulodynia (PVD)—characterized by provoked pain localized to the vaginal opening—is the most common subtype of vulvodynia and the current main focus of clinical trials, this paper focused on recommended outcome measures in PVD clinical trials. The framework used to guide the selection of outcome measures was based on the one proposed by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT).Results:The IMMPACT framework provided a well-suited guideline for outcome measure recommendations in PVD clinical trials. However, given the provoked presentation of PVD and the significant impact it has on sexuality, modifications to some of the IMMPACT recommendations were made and specific additional measures were suggested.Discussion:Measures that are specific to vulvovaginal pain are ideal for adoption in PVD clinical trials, and many such measures currently exist that allow the relevant IMMPACT domains to be captured.