Pukall Caroline, Hellberg Christel, Österberg Marie, Jonsson Ann Kristine, Kempe Susanna, Gustavsson Petter, Bohm-Starke Nina
Department of Psychology, Queen's University, Kingston, ON K7L 3N6, Canada.
Swedish Agency for Health Technology Assessment and Assessment of Social Services, Stockholm 102 33, Sweden.
J Sex Med. 2025 Jun 29;22(7):1253-1274. doi: 10.1093/jsxmed/qdaf120.
The inconsistency in outcome measures used in clinical trials for provoked vestibulodynia (PVD) makes it difficult to compare the effects of different interventions. In a previous study, we developed a core outcome set (COS) for PVD intervention studies, which determined what to measure.
To establish how to measure the COS, this systematic review presents the evidence base regarding the measurement properties of instruments for the COS.
The systematic review followed the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines and the Cochrane Handbook. A comprehensive search was conducted in PubMed, PsycInfo, and Embase.
Content validity for the outcomes was assessed using COSMIN guidelines and the methodological quality of studies, and quality of measurement properties were evaluated using the COSMIN checklist and criteria. The synthesized evidence was graded with the modified grading of recommendations, assessment, development, and evaluation approach.
No instrument showed high quality evidence for all measurement properties. Most development studies for the instruments were insufficient due to lack of patient involvement, and content validity was only investigated in the PVD population for one of the instruments assessed. Content validity was therefore largely based on expert opinion. No studies presented results for the structural validity or responsiveness of any of the instruments. For other measurement properties, aspects of construct validity (hypothesis testing) and reliability (including internal consistency) were the most studied.
We established how to measure the COS for PVD, which will be useful for clinical trials.
Strengths included the multidisciplinary team and the rigorous methodology. Limitations included overall lack of evidence of content validity for the instruments.
Based on limited evidence and expert opinion, the following instruments are the most promising for the PVD COS: Insertional pain (sexual), 11-point numerical rating scale (NRS) with specific question/anchors, Insertional pain (non-sexual), Tampon test, and 11-point NRS; Provoked pain by pressure/contact, Vulvalgesiometer; Pain related interference on one's life, the Activity Engagement subscale of the Chronic Pain Acceptance Questionnaire; Pain related interference on sexual life, the Sexual Function Interference subscale of the Vulvar Pain Assessment Questionnaire; Sexual function, Female Sexual Function Index, excluding pain subscale; Pain anxiety, Pain Anxiety Symptom Scale, or the Pain Catastrophizing Scale. No recommendations can be made for Pelvic floor function at this time. Future research is needed to establish strong measurement properties of instruments for the COS.
用于激发性前庭痛（PVD）临床试验的结局指标不一致，使得难以比较不同干预措施的效果。在之前的一项研究中，我们为PVD干预研究制定了一个核心结局集（COS），它确定了要测量的内容。
为了确定如何测量COS，本系统评价展示了关于COS测量工具测量特性的证据基础。
该系统评价遵循基于共识的健康测量工具选择标准（COSMIN）指南和Cochrane手册。在PubMed、PsycInfo和Embase中进行了全面检索。
没有一种工具对所有测量特性都显示出高质量证据。由于缺乏患者参与，大多数工具的开发研究都不充分，并且仅在PVD人群中对所评估的一种工具研究了内容效度。因此，内容效度很大程度上基于专家意见。没有研究给出任何工具的结构效度或反应度结果。对于其他测量特性，结构效度（假设检验）和信度（包括内部一致性）方面的研究最多。
我们确定了如何测量PVD的COS，这将对临床试验有用。
优点包括多学科团队和严谨的方法。局限性包括工具内容效度的证据总体缺乏。
基于有限的证据和专家意见，以下工具对PVD的COS最有前景：插入性疼痛（性方面），带有特定问题/锚定的11点数字评定量表（NRS），插入性疼痛（非性方面），棉塞试验，以及11点NRS；压力/接触激发的疼痛，外阴压力计；疼痛对生活的干扰，慢性疼痛接受问卷的活动参与子量表；疼痛对性生活的干扰，外阴疼痛评估问卷的性功能干扰子量表；性功能，女性性功能指数，不包括疼痛子量表；疼痛焦虑，疼痛焦虑症状量表，或疼痛灾难化量表。目前无法对盆底功能给出建议。未来需要开展研究以确定COS测量工具的强大测量特性。
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