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

Received: 5 April 2022    Accepted: 23 April 2022    Published: 29 April 2022
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Abstract

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.

Published in Journal of Gynecology and Obstetrics (Volume 10, Issue 3)
DOI 10.11648/j.jgo.20221003.11
Page(s) 159-166
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

Vulvar Dermatosis, Vulvoscopy, Three Vulvar Rings, Three Rings Vulvoscopy, N-S-P Scheme

References
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[2] Harni V, Babic D, Barisic D. “Three Rings Vulvoscopy” – A New Approach to the Vulva. Gynaecol Perinatol 2015; 24: 37-45.
[3] Harni V, Babic D, Barisic D. “Three Rings Vulvoscopy” – A New Approach to the Vulva. Chapter in Watson L (ed.) Cryosurgery and Colposcopy: Practices, Outcomes, and Potential Complications. New York, Nova Science Publishers Inc; 2016. ISBN: 978-1-63484-507-6.
[4] van Beurden M, van der Vange N, de Craen AJM, Tjong-A-Hung SP, ten Kate FJW, ter Schegget J, et al. Normal findings in vulvar examination and vulvoscopy. J Br Obstet Gynaecol 1997; 104: 320-4.
[5] Audisio T, Zarazaga J, Vainer O. A Classification of Vulvoscopic Findings for Clinical Diagnosis. J Lower Genit Tract Dis 1999; 3: 7-18.
[6] McLean JM. Anatomy and physiology of the vulval area. Chapter in Ridley CM. The Vulva. Churchill Livingstone, Edinburgh London Melbourne and New York 1988; pp 39-65 and in Ridley CM, Neill SM. The Vulva. 2nd edition. Blackwell Science Ltd 1999; pp 37-63.
[7] Neill SM, Lewis FM. Basics of vulval embryology, anatomy and physiology. Chapter in Neill SM, Lewis FM. The Vulva. 3rd edition. Blackwell Publishing 2009; 1-33.
[8] Chren MM. Giving “scale” new meaning in dermatology: measurement matters. Arch Dermatol 2000; 136: 788-90.
[9] Simpson RC, Murphy R. Considerations for Disease Impact and Outcome Measures in Vulvar Disease. J Lower Genit Tract Dis 2012; 16: 460-3.
[10] Harni V, Babic D, Hadzavdic S, Barisic D. Diagnostic Accuracy of the Vulvoscopy Index for Detection of Vulvar Dermatosis (DATRIV Study, Part 1). Journal of Gynecology and Obstetrics. 2022; Vol. 10, No. 1, 39-47.
[11] ISSVD Vulvodynia Pattern Questionnaire. Available at: https://netforum.avectra.com/temp/ClientImages/ISSVD/3ef9c6ea-aac7-4d2b-a37f-058ef9f11a67.pdf Last accessed May 23, 2015.
[12] Haefner H, Collins M, Davis GD, Edwards L, Foster D, Hartmann E, et al. The Vulvodynia Guideline. J Lower Genit Tract Dis 2005; 9: 40-51.
[13] Stockdale CK, Lawson HW. 2013 Vulvodynia Guideline Update. J Lower Genit Tract Dis 2014; 18: 93-100.
[14] Bornstein J, Goldstein AT, Stockdale CK, Bergeron S, Pukall C, Zolnoun D, et al. 2015 ISSVD, ISSWSH, and IPPS Consensus Terminology and Classification of Persistent Vulvar Pain and Vulvodynia. J Lower Genit Tract Dis 2016; 20: 126-30.
[15] National Institute on Aging, National Institute of Health, U.S. Department of Health and Human Services. Why Population Aging Matters. A Global Perspective. Publication No. 07-6134. 2007.
[16] Surveillance, Epidemiology, and End Results. SEER Cancer Stat Facts: Vulvar Cancer. National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/statfacts/html/vulva.html.
[17] Baggish MS. Colposcopy of the cervix, vagina, and vulva: a comprehensive textbook. 1st ed. Mosby, Elsevier; 2003.
[18] Kesic V. Colposcopy of the vulva, perineum and anal canal. Chapter in Bosze P, Luesley DM. EACG Course Book on Colposcopy. Budapest, Primed-X-Press; 2003.
[19] Byrne MA, Walker MM, Leonard J, Pryce D, Taylor-Robinson D. Recognising covert disease in women with chronic vulval symptoms attending an STD clinic: value of detailed examination including colposcopy. Genitourin Med 1989; 65: 46-9.
[20] Foster DC, Stockdale CK, Simpson R, Kirtshhig G. Core Outcome Sets for Clinical Trials and Observational Studies in Vulvovaginal Disease. J Lower Genit Tract Dis 2017; 21: 163-5.
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Cite This Article
  • APA Style

    Vesna Harni, Damir Babic, Suzana Ljubojevic-Hadzavdic, Dubravko Barisic. (2022). Clinical Value of the N-S-P Scheme for Diagnosing Vulvar Dermatosis (DATRIV Study, Part 2). Journal of Gynecology and Obstetrics, 10(3), 159-166. https://doi.org/10.11648/j.jgo.20221003.11

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    ACS Style

    Vesna Harni; Damir Babic; Suzana Ljubojevic-Hadzavdic; Dubravko Barisic. Clinical Value of the N-S-P Scheme for Diagnosing Vulvar Dermatosis (DATRIV Study, Part 2). J. Gynecol. Obstet. 2022, 10(3), 159-166. doi: 10.11648/j.jgo.20221003.11

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    AMA Style

    Vesna Harni, Damir Babic, Suzana Ljubojevic-Hadzavdic, Dubravko Barisic. Clinical Value of the N-S-P Scheme for Diagnosing Vulvar Dermatosis (DATRIV Study, Part 2). J Gynecol Obstet. 2022;10(3):159-166. doi: 10.11648/j.jgo.20221003.11

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  • @article{10.11648/j.jgo.20221003.11,
      author = {Vesna Harni and Damir Babic and Suzana Ljubojevic-Hadzavdic and Dubravko Barisic},
      title = {Clinical Value of the N-S-P Scheme for Diagnosing Vulvar Dermatosis (DATRIV Study, Part 2)},
      journal = {Journal of Gynecology and Obstetrics},
      volume = {10},
      number = {3},
      pages = {159-166},
      doi = {10.11648/j.jgo.20221003.11},
      url = {https://doi.org/10.11648/j.jgo.20221003.11},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.jgo.20221003.11},
      abstract = {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.},
     year = {2022}
    }
    

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    T1  - Clinical Value of the N-S-P Scheme for Diagnosing Vulvar Dermatosis (DATRIV Study, Part 2)
    AU  - Vesna Harni
    AU  - Damir Babic
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    AU  - Dubravko Barisic
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    DO  - 10.11648/j.jgo.20221003.11
    T2  - Journal of Gynecology and Obstetrics
    JF  - Journal of Gynecology and Obstetrics
    JO  - Journal of Gynecology and Obstetrics
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    EP  - 166
    PB  - Science Publishing Group
    SN  - 2376-7820
    UR  - https://doi.org/10.11648/j.jgo.20221003.11
    AB  - 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.
    VL  - 10
    IS  - 3
    ER  - 

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Author Information
  • Department of Obstetrics and Gynaecology, Polyclinic Harni, Zagreb, Croatia

  • Department of Pathology and Cytology, University Hospital Center, Zagreb, Croatia

  • Department of Dermatovenereology, University Hospital Center, Zagreb, Croatia

  • Department of Obstetrics and Gynaecology, Kardinal Schwarzenberg Klinikum GmbH, Schwarzach im Pongau, Austria

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