Core Outcome Sets for Clinical Trials and Observational Studies in Vulvovaginal Disease

Foster, David C.; Stockdale, Colleen K.; Simpson, Rosalind; Kirtschig, Gudula

doi:10.1097/lgt.0000000000000320

Cited by 7 publications

(5 citation statements)

References 14 publications

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“…In a recent editorial, Foster et al (2017) highlighted the absence of core outcome sets, which they define as “a minimum set of outcomes that is used in clinical trials and observational studies… that will enable trials or studies to be compared in meta-analyses”, within the field of vulvovaginal disease, making the production of high-quality research trials next to impossible. 71 Although there is a long way to go toward the completion of a validated scale for measuring adult vulvar lichen sclerosus severity and creating an internationally accepted core outcome set for adult vulvar lichen sclerosus, this study brings us one step closer toward achieving this goal.…”

Section: Discussionmentioning

confidence: 98%

Development of the Adult Vulvar Lichen Sclerosus Severity Scale—A Delphi Consensus Exercise for Item Generation

Sheinis

Selk

2018

J Low Genit Tract Dis

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Section: Discussionmentioning

confidence: 98%

Development of the Adult Vulvar Lichen Sclerosus Severity Scale—A Delphi Consensus Exercise for Item Generation

Sheinis

Selk

2018

J Low Genit Tract Dis

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“…The most influential prior observations that seemingly identical lesions in various regions of the vulva have different importance required deeper immersion in the histological and embryological characteristics of individual anatomical parts of the vulva [1,[17][18][19][20]. By modifying the viewing point and using an annular instead of a linear approach, the qualities of each of the three types of vulvar tissue were recognized and correlated, and three separate rings were identified as the ground for vulvar observation [2][3].…”

Section: Discussionmentioning

confidence: 99%

“…An essential segment of the present work is to heighten consideration regarding developing suitable implements for evaluating test outcomes, as formerly advised [20]. The DATRIV study assessed the clinical value of the vulvoscopy index and the N-S-P scheme as parameters of the TRIV outcome to facilitate data management and gain the possibility of measurability and comparison of vulvoscopy results.…”

Section: Discussionmentioning

confidence: 99%

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

Harni¹,

Babić²,

Ljubojevic-Hadzavdic³

et al. 2022

JGO

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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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“…Evidence-based practice delays in the field of vulvovaginal conditions and the lack of validated outcome measures obstruct the implementation of interventional clinical trials for vulvovaginal diseases [9].…”

Section: Introductionmentioning

confidence: 99%

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

Harni¹,

Babić²,

Ljubojevic-Hadzavdic³

et al. 2022

JGO

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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.

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Core Outcome Sets for Clinical Trials and Observational Studies in Vulvovaginal Disease

Cited by 7 publications

References 14 publications

Development of the Adult Vulvar Lichen Sclerosus Severity Scale—A Delphi Consensus Exercise for Item Generation

Development of the Adult Vulvar Lichen Sclerosus Severity Scale—A Delphi Consensus Exercise for Item Generation

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

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

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