Diagnostic accuracy of hand-held colposcope (Gynocular) in comparison with standard colposcope in patients with abnormal cervical cytology or visual inspection with acetic acid positivity: a cross over randomized controlled study.
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引用次数: 0
Abstract
Objective: To compare the diagnostic accuracy of a handheld colposcope (Gynocular) versus a standard colposcope in women with abnormal cervical cytology or visual Inspection with acetic acid positivity.
Methods: This crossover randomized clinical trial was conducted in Pondicherry, India, and included 230 women who were referred for colposcopy. Swede scores were calculated using both colposcopes, and a cervical biopsy was performed from the most visually abnormal areas. Swede scores were compared with the histopathological diagnosis, which was used as the reference standard. The level of agreement between the two colposcopes was calculated using Kappa (κ) statistics.
Results: The level of agreement of Swede scores between the standard and Gynocular colposcopes was 62.56%, and the κ statistic was 0.43 (P<0.001). Cervical intraepithelial neoplasia (CIN) 2+ (CIN 2, CIN 3, CIN 3+) was diagnosed in 40 (17.4%) women. There were no significant differences between the two colposcopes in terms of sensitivity, specificity, or predictive value for detecting CIN 2+ lesions.
Conclusion: The diagnostic accuracy of Gynocular colposcopy was similar to that of standard colposcopy for detecting CIN 2+ lesions. Gynocular colposcopes showed a good level of agreement with standard colposcopes when the Swede score was used.
期刊介绍:
Obstetrics & Gynecology Science (NLM title: Obstet Gynecol Sci) is an international peer-review journal that published basic, translational, clinical research, and clinical practice guideline to promote women’s health and prevent obstetric and gynecologic disorders. The journal has an international editorial board and is published in English on the 15th day of every other month. Submitted manuscripts should not contain previously published material and should not be under consideration for publication elsewhere. The journal has been publishing articles since 1958. The aim of the journal is to publish original articles, reviews, case reports, short communications, letters to the editor, and video articles that have the potential to change the practices in women''s health care. The journal’s main focus is the diagnosis, treatment, prediction, and prevention of obstetric and gynecologic disorders. Because the life expectancy of Korean and Asian women is increasing, the journal''s editors are particularly interested in the health of elderly women in these population groups. The journal also publishes articles about reproductive biology, stem cell research, and artificial intelligence research for women; additionally, it provides insights into the physiology and mechanisms of obstetric and gynecologic diseases.