Development and Validation of a Clinical Grading Scale to Assess the Vulvar Region: The Vulvar Architecture Severity Scale

Abstract

Background The vulva is composed of aesthetic units that can be affected differently by vulvar conditions. A reliable, comprehensive, and quick-to-use clinical scoring system is required to assess the disease extent in the vulvar area. Objectives The aim of this study was to develop and validate a grading scale based on the aesthetic unit principle to evaluate the extent of vulvar lichen sclerosus (VLS). Methods After reviewing photographs of 100 patients affected by VLS, the authors targeted the aesthetic units most frequently affected. The disease signs were recorded and graded in 4 levels of severity (none, mild, moderate, severe) taking into account the vulvar architecture and skin involvement. To validate the scale, 14 observers were asked to apply it to photographs of 25 VLS patients on 2 different occasions. Intra- and inter-observer reliabilities were determined employing Pearson’s and intraclass correlation coefficients. Results A 6-region, 4-point grading system was designed and identified as the Vulvar Architecture Severity Scale (VASS). In all 6 areas, the Pearson’s r was greater than 0.9 (mean, 0.994; 95% confidence interval [CI] = 0.992), indicating that the intra-observer reliability of the VASS was consistent over time (P < 0.001). Intraclass correlation at time 1 was 0.928 (95% CI = 0.910, 0.943) and at time 2 was 0.944 (95% CI = 0.931, 0.996), indicating a high reliability level among different observers. Conclusions The VASS is a reliable scale to assess the severity of VLS, and it might be considered as an outcome measure in future VLS trials. Level of Evidence: 4

Proposition of a severity scale for lichen sclerosus: The “Clinical Lichen Sclerosus Score”

“…However, comparability is strongly limited by methodology (50 pictures vs 5 cases, 6 vs 16 raters). Almadori et al 11 have recently developed a new severity score, the “VASS.” Interestingly, the authors also categorized between signs and architectural changes. However, in the final score these categories are abandoned in favor of “aesthetic units,” in which signs and architectural changes are combined.…”

“…10 Another very recently published study introduced a severity score for VLS, the "VASS," which is based on aesthetic units and was developed using vulvar photographs. 11 The items used in this study were not the ones suggested by the ISSVD, neither have the used items been evaluated in a clinical setting. Furthermore, the VASS lacks subjective items addressing symptoms and therefore may not capture LS in its complete manifestation.…”

“…The most elaborated attempt to address this issue was made in 2018 by a Delphi consensus group of the International Society for the Study of Vulvovaginal Disease (ISSVD) in selecting symptoms and clinical items for a future adult VLS severity scale followed by a recently published study evaluating the items using vulvar photographs 10 . Another very recently published study introduced a severity score for VLS, the “VASS,” which is based on aesthetic units and was developed using vulvar photographs 11 . The items used in this study were not the ones suggested by the ISSVD, neither have the used items been evaluated in a clinical setting.…”

The “CIV Classification,” a New Proposal for the Architectural Grading of Vulvar Lichen Sclerosus

“…This lack in literature represents an important challenge for the physician, both in clinical practice and in the research field. [26][27][28][29] To date, most studies focus on skin lesions, morphological modifications, or symptoms such as sexual impairment. 26,29,30 Hodges et al 30 tried to classify the influence of VLS on sexual functioning.…”

“…[26][27][28][29] To date, most studies focus on skin lesions, morphological modifications, or symptoms such as sexual impairment. 26,29,30 Hodges et al 30 tried to classify the influence of VLS on sexual functioning. The authors used a 7-item Female Genital Selfimage Scale to describe women's sexual function.…”