Vulvar Lichen Sclerosus: Outcomes Important to Patients in Assessing Disease Severity

Abstract

Objective The aim of the study was to determine outcome measures that women with vulvar lichen sclerosus (LS) rate as important in assessing disease severity with the ultimate goal of including these items in a disease severity rating tool. Methods An online survey of women older than 18 years with a diagnosis of vulvar LS was performed. The survey was posted in Facebook LS support groups. Participants rated items on a scale from 1 to 5 (not important to include to essential to include) in a disease severity scale. Participants also rated how often they were affected by various symptoms on a scale from 1 to 5 (never to daily). Mean rating of importance and mean rating of frequency for each sign and symptom were calculated. T tests were used to compare patients with biopsy-proven disease with those with a clinical diagnosis of LS. Results Nine hundred fifty-eight participants completed the survey (86% completion rate). Patients felt that the most important items to assess disease severity were irritation (4.39), fusion of the labia (4.38), soreness (4.37), itch (4.34), change in vulvar skin (4.34), and decrease in quality of life (4.33). The most frequently experienced items by those with LS were irritation (3.92), changes in appearance of vulvar skin (3.92), and discomfort (3.89). There were no differences between patients with biopsy-proven LS versus those diagnosed on clinical examination. Conclusions Future LS severity assessment tools will need to include a combination of patient-rated symptoms, clinical rated signs and anatomical changes, and quality of life measures.

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.…”

“…An agreement to measure VLS's severity in a standard way is yet to be defined, and to our knowledge, no standardized clinical classification of architectural modifications in VLS has been validated. This lack in literature represents an important challenge for the physician, both in clinical practice and in the research field 26–29 …”

“…In our opinion, defining in advance the criteria on which global experts would have had to agree on was of utmost importance. As outlined in the online survey by Green et al, 28 the anatomical changes represent one of the most important aspects considered by patients.…”

Outcome Measures in Adult Vulvar Lichen Sclerosus: A Systematic Review

“…Within this scale type, 6 tools were found. Gunthert's clinical score for VLS, 20,22 the Adult Vulvar Lichen Sclerosus Severity Scale (AVLSSS), 27,32,34 and the Clinical Lichen Sclerosus Score (CLISSCO) 36 cover the CODs clinical (visible) signs and symptoms. The Vulvar Architecture Severity Scale (VASS) 28 and the "Clitoral phimosis, Interlabial sulci involvement, Vulvar introitus narrowing-classification" (CIV-classification) 35 cover the COD clinical (visible) signs, and the Electronic Personal Health Questionnairevulva (ePAQ-vulva) 26 covers the COD symptoms but has not yet been applied in VLS research.…”

“…The Vulvar Architecture Severity Scale (VASS) 28 and the "Clitoral phimosis, Interlabial sulci involvement, Vulvar introitus narrowing-classification" (CIV-classification) 35 cover the COD clinical (visible) signs, and the Electronic Personal Health Questionnairevulva (ePAQ-vulva) 26 covers the COD symptoms but has not yet been applied in VLS research. The AVLSSS has been applied 3 times, 27,32,34 Gunthert's clinical score for VLS twice, 20,22 and the CLISSCO, 36 VASS, 28 and CIV-classification, 35 each only once. Beyond validation studies, only the AVLSSS 27,32,34 and Gunthert's clinical scores for VLS 20,22 have been applied in VLS research.…”