A Scoping Review of Treatment Outcome Measures for Vulvar Intraepithelial Neoplasia.

OBJECTIVE: The goal of this study is to identify a list of clinician-reported outcome measures (CROMs) and patient-reported outcome measures (PROMs) through a review of published studies reporting on any therapeutic interventions for vulvar intraepithelial neoplasia (VIN). MATERIALS AND METHODS: A systematic search of published studies reporting on any therapeutic interventions for VIN was performed on MEDLINE, Embase, Cochrane Database, PsychInfo, and CINAHL from inception to September 20, 2021, based on predetermined study selection criteria. Data were extracted and analyzed by 2 authors independently using Covidence software. RESULTS: Thirty two of 2386 studies identified met study selection criteria. None of the 32 studies provided an explicit definition of VIN treatment "success." The most common CROM was "clinical response to treatment." The most common scale used to measure this outcome was "complete response/partial response/no response"; however, 17 of 23 studies (73.9%) did not define these values. Laboratory CROMs were reported in 12/32 (37.5%) studies. Patient-reported outcome measures were reported in only 10 of 32 studies(31.3%) -the most common PROM was "symptoms." Only 2 of 32 studies measured PROMs related to "quality of life" domains. Adverse events/treatment-related adverse effects were reported in 24 of 32 studies (75%), although 71% of studies provided no details on how these data were collected. CONCLUSIONS: There is a large variation in outcome measures, instruments, and scales used for any clinician-reported treatment outcome such as "clinical response." Most studies do not include patient-reported outcome measures assessing quality of life domains. A Core Outcome Set for the treatment of VIN is needed to improve the quality of VIN research.

A Systematic Review of Risk Factors for Development, Recurrence, and Progression of Vulvar Intraepithelial Neoplasia.

OBJECTIVE: Vulvar intraepithelial neoplasia (VIN) is a premalignant condition with high recurrence rates despite treatment. Vulvar intraepithelial neoplasia develops through separate etiologic pathways relative to the presence or absence of human papillomavirus (HPV) and TP53 mutations. This systematic review was conducted (1) to identify historical risk factors for the development, recurrence, and progression of VIN and (2) to critique these risk factors in the context of advances made in the stratification of VIN based on HPV or TP53 status. MATERIALS AND METHODS: A systematic search was performed on MEDLINE, Embase, Cochrane Database, PsychInfo, and CINAHL from inception to July 5, 2021. Three gynecologic oncologists independently evaluated the eligibility of studies based on predetermined inclusion and exclusion criteria, abstracted data, and then analyzed the relevant data. RESULTS: A total of 1,969 studies (involving 6,983 patients) were identified. Twenty-nine studies met inclusion criteria. The quality of evidence was low; primarily level 2b (Oxford Centre for Evidence-Based Medicine). Risk factors associated with the development of VIN include: smoking and coexisting vulvar dermatoses. Risk factors associated with recurrence include: smoking, multifocal disease, and positive surgical margins. Recent studies identified the presence of differentiated VIN/TP53 mutation as the most significant risk factor for both VIN recurrence and malignant progression. CONCLUSIONS: The current body of evidence consists primarily of small retrospective observational studies. Well-designed retrospective case-control series and/or prospective observational studies are urgently needed. Ideally, future studies will collect standardized data regarding associated risk factors and stratify women with VIN based on HPV and TP53 status.