The Center for Vulvovaginal Disorders, New York, NY, USA.
Grünenthal GmbH, Aachen, Germany.
J Sex Med. 2020 Oct;17(10):2055-2066. doi: 10.1016/j.jsxm.2020.07.010. Epub 2020 Sep 6.
Vulvodynia is defined as vulvar pain of at least 3 months duration without a clear identifiable cause. There are currently no validated questionnaires that assess the experience of women with localized vulvodynia of the vestibule (vestibulodynia, previously known as vulvar vestibulitis) that meet the requirements of the Food and Drug Administration's Patient Reported Outcome (PRO) Guidance.
To develop a new content-valid PRO assessment in accordance with the Food and Drug Administration's PRO guidance to assess the symptoms and impacts of localized vulvodynia.
Participants were recruited for concept elicitation interviews (ie, interviews with open-ended questions with the goal of eliciting volunteered data about the symptoms and impacts of vulvodynia). Participants were identified as having localized vulvodynia by clinicians who were experts in treating vulvar disorders. Eligibility was confirmed by the recruiting clinician, and informed consent was obtained; participants were then scheduled for in-person interviews. 25 participants were interviewed from United States (US). After concept elicitation interviews, the draft Vulvodynia Experience Questionnaire (VEQ) was developed based on the results. Cognitive interviews were conducted with 20 participants from US sites to assess the content validity of the VEQ (eg, interpretation and clarity of the items, relevance of concepts). The VEQ was further revised after cognitive interviews. All interviews were conducted face-to-face, audio-recorded, transcribed verbatim, anonymized, and analyzed using a qualitative data analysis software program.
17 unique symptoms and 32 unique impacts were reported during concept elicitation interviews. Pain (n = 25, 100%) and burning (n = 24, 96%) were the most frequently reported symptoms of localized vulvodynia, and negative impact on emotional well-being (n = 25, 100%) was the most frequently reported impact. After analysis, item generation, and cognitive interviews, the resulting VEQ v2.0 contains 3 parts (part 1, pain; part 2, associated symptoms; part 3, impacts) with a total of 25 items that measure the most frequently reported symptoms and impacts of localized vulvodynia.
The VEQ is a multidimensional assessment of the core symptoms and impacts of localized vulvodynia that, after additional psychometric testing including the ability to detect change, may be used in clinical trials to characterize the benefits of novel treatments. The VEQ requires additional testing to establish its cultural relevance and linguistic validity in other countries.
The VEQ is a novel method of collecting information on localized vulvodynia symptoms and impacts that may be suitable for use in clinical trials after psychometric testing. Goldstein AT, Diez PMQ, Kapanadze S, et al. The Vulvodynia Experience Questionnaire: Qualitative Development of a New Patient-Reported Outcome Measure for Vulvodynia. J Sex Med 2020;17:2055-2066.
外阴痛定义为外阴疼痛至少持续 3 个月，且无明确可识别的病因。目前尚无经过验证的问卷可以评估满足美国食品和药物管理局（FDA）患者报告结局（PRO）指南要求的前庭局部外阴痛（前庭痛，以前称为外阴前庭炎）女性患者的体验。
根据 FDA 的 PRO 指南，制定新的内容验证 PRO 评估，以评估局部外阴痛的症状和影响。
采用开放式问题进行概念发掘访谈（即访谈，目的是引出有关外阴痛症状和影响的自愿数据），以招募参与者。临床医生根据他们治疗外阴疾病的专业知识来确定参与者是否患有局部外阴痛。通过招聘临床医生确认参与者的资格，并获得知情同意，然后安排他们进行面对面访谈。从美国（US）招募了 25 名参与者。在概念发掘访谈之后，根据结果开发了外阴痛体验问卷（VEQ）草案。在美国进行了 20 名参与者的认知访谈，以评估 VEQ 的内容有效性（例如，对项目的解释和清晰度、概念的相关性）。在认知访谈后，对 VEQ 进行了进一步修订。所有访谈均为面对面进行，录音，逐字记录，匿名，并使用定性数据分析软件程序进行分析。
在概念发掘访谈中报告了 17 种独特的症状和 32 种独特的影响。疼痛（n=25，100%）和烧灼感（n=24，96%）是局部外阴痛最常报告的症状，而对情绪健康的负面影响（n=25，100%）是最常报告的影响。经过分析、项目生成和认知访谈，由此产生的 VEQ v2.0 包含 3 个部分（第 1 部分，疼痛；第 2 部分，相关症状；第 3 部分，影响），共有 25 个项目，用于衡量局部外阴痛最常报告的症状和影响。
VEQ 是对局部外阴痛核心症状和影响的多维评估，经过包括检测变化能力在内的进一步心理测量学测试后，可能会在临床试验中用于描述新疗法的益处。VEQ 需要进一步测试以确定其在其他国家的文化相关性和语言有效性。
VEQ 是一种收集局部外阴痛症状和影响信息的新方法，在经过心理测量学测试后，可能适用于临床试验。
