Background
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.
Methods
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.
Outcomes
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.
Results
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.
Clinical implications
We established how to measure the COS for PVD, which will be useful for clinical trials.
Strengths and limitations
Strengths included the multidisciplinary team and the rigorous methodology. Limitations included overall lack of evidence of content validity for the instruments.
Conclusion
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.
To establish how to measure the COS, this systematic review presents the evidence base regarding the measurement properties of instruments for the COS.
Caroline Pukall, Christel Hellberg, Marie Österberg, Ann Kristine Jonsson, Susanna Kempe, Petter Gustavsson, Nina Bohm-Starke
Disease Category: Gynaecology
Disease Name: Provoked vestibulodynia
Age Range: 18 - 120
Sex: Female
Nature of Intervention: Any
- Recommendations for outcome measures (measurement/how)
- Systematic review