Diagnostic Accuracy of the Vulvoscopy Index for Detection of Vulvar Dermatosis (DATRIV Study, Part 1)

Abstract

Three rings vulvoscopy (TRIV) has previously been described to facilitate the diagnosis and treatment of vulvar discomfort. The distinction between outer, middle, and inner vulvar rings is based on differences in anatomy, histology, and embryology. The vulvoscopy index was designed considering the patient's history, clinical exam, and assessment of the specificity and localization of the lesion relative to the vulvar ring. This paper evaluated the sensitivity, specificity, and diagnostic accuracy of the vulvoscopy index in detecting vulvar dermatosis compared with histopathology as a reference test. Structured ISSVD vulvodynia pattern questionnaire and TRIV form data were utilized for the study. The data obtained were analyzed using StatSoft (Dell, Austin, Texas), Statistica 12 (TIBCO®, Palo Alto, CA), and SPSS 20 (IBM, Armonk, NY). Ethical approval for the study was obtained from the Institutional Review Board of Polyclinic Harni, and all patients provided written informed consent. The histopathological diagnosis of vulvar dermatosis was confirmed in 72 patients at first biopsy. Lesions specific for vulvar dermatosis were visible by TRIV in 82 patients. The resulting difference of ten patients were participants with early vulvar dermatosis. In six of them, vulvar dermatosis was confirmed at a later biopsy during the study period. There was no statistically significant difference between the scores of points (median and range), frequency and relative frequency of vulvar findings within one item of the vulvoscopy index and histopathology, except for ten patients with early forms of vulvar dermatoses. The sensitivity, specificity, and diagnostic accuracy of the vulvoscopy index for detecting vulvar dermatosis were 100%, 96.1%, and 96.9%, respectively. The positive and negative predictive values were 0.88 and 1.00, respectively. The vulvoscopy index represents a compelling clinical test for detecting vulvar dermatoses. Differences between vulvoscopic and histopathological diagnostics implicate the impossibility of histopathology in recognizing early forms of vulvar dermatoses. Accordingly, early dermatoses could represent a key area for applying this test. ClinicalTrials.gov Identifier: NCT02732145.

Clinical Value of the N-S-P Scheme for Diagnosing Vulvar Dermatosis (DATRIV Study, Part 2)

“…The problem of aging in the general population, with a predominance of older women in whom vulvar dermatosis is most often revealed, is another remarkable issue [15][16]. This condition is responsible for chronic vulvar discomfort that further degrades the life quality, and progression to differentiated vulvar intraepithelial neoplasia may pose a risk of developing vulvar cancer [10].…”

“…The vulvoscopy index considers the patient's medical history, clinical examination, and cotton swab test, as well as the specificity and localization of lesions towards the three vulvar rings according to TRIV. The work so far has shown the immense potential of the vulvoscopy index in the detection of vulvar dermatoses with a diagnostic accuracy of 96.9% [10]. Since the test result is a sum of points, a feasible option is to monitor the failing and improvement of treatment and compare the findings by corresponding to the outcome.…”

“…Therefore, the DATRIV study was developed to build the basis for creating standard outcome measures in vulvoscopy. For that objective, two index tests founded on the specificity and localization of the vulvar findings according to the three vulvar rings were developed as outcome parameters, the vulvoscopy index and the N-S-P scheme [10]. The diagnostic accuracy of both tests was evaluated in concordance with histopathology as a reference test.…”

Basic Characteristics and Demographic Data in Patients with Chronic Vulvar Discomfort: A Detailed Analysis of DATRIV Study

“…The DATRIV study (Diagnostic Accuracy of Three Rings Vulvoscopy) aimed to improve the diagnosis and treatment of vulvar discomfort and establish standard outcome measures in vulvoscopy, particularly Three Rings Vulvoscopy (TRIV) [36,37].…”

“…Dermatological lesions with secondary morphological presentation were termed "specific lesions" [40,41]. Their localization was described concerning the three vulvar rings [42,43].…”