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.
The DATRIV study aimed to create a basis for developing standard outcome measures in vulvoscopy to facilitate the diagnosis and treatment of vulvar discomfort. For this purpose, the three rings vulvoscopy (TRIV) was introduced, and the vulvoscopy index and N-S-P scheme were designed as outcome parameters. In this paper, the clinical value of collecting and managing data obtained during TRIV in normal and patients with chronic vulvar distress was carefully examined by introducing the N-S-P scheme. Complex ISSVD vulvodynia pattern questionnaire and TRIV form data were methodically performed for data gathering. The collected data were explored using StatSoft (Dell, Austin, Texas), Statistica 12 (TIBCO®, Palo Alto, CA) and SPSS 20 (IBM, Armonk, NY). Ethical permission for the study was acquired from the Institutional Review Board of the Polyclinic Harni, and all patients gave written informed consent. In addition to TRIV, lesions specific to vulvar dermatosis were detected in 82 patients. Histopathology diagnosed vulvar dermatosis at the first biopsy in 72 patients. The resulting difference of ten patients consisted of patients with early vulvar dermatosis. Six of these ten subjects were diagnosed with vulvar dermatosis on a second biopsy during the study period. Statistical tests did not show a significant difference between normal findings or the presence of any type of lesion (nonspecific and specific) concerning the three vulvar rings, except in ten patients with early vulvar dermatoses. The N-S-P scheme accurately recognized the disease in all patients showing 100% sensitivity in detecting vulvar dermatoses. Patients without histopathological verified vulvar dermatosis at the first biopsy were classified as false positives, so the specificity of the test was 96.1%. Overall, the diagnostic accuracy of the N-S-P scheme in detecting vulvar dermatosis was 96.9%. Positive and negative predictive values were 0.88 and 1.00, respectively. The N-S-P scheme and TRIV are convincing clinical tests to detect vulvar dermatoses. Differences between vulvoscopy and histopathological diagnostics imply a lack of specificity of tissue transformations within early forms of vulvar dermatoses sufficient to distinguish them microscopically from normal findings. Consequently, early dermatoses could be a critical area for proposing this test. ClinicalTrials.gov Identifier: NCT02732145.
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