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.

IF 2 Q2 OBSTETRICS & GYNECOLOGY Obstetrics and Gynecology Science Pub Date : 2023-07-01 DOI:10.5468/ogs.23089
Sowmiya Jayabalan, Murali Subbaiah, Latha Chaturvedula
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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.

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手持式阴道镜(Gynocular)与标准阴道镜在宫颈细胞学异常或目测醋酸阳性患者中的诊断准确性:一项交叉随机对照研究。
目的:比较手持式阴道镜(妇科)与标准阴道镜对宫颈细胞学异常或目视检查为醋酸阳性的妇女的诊断准确性。方法:这项交叉随机临床试验在印度本地治里进行,纳入230名接受阴道镜检查的妇女。使用阴道镜计算瑞典评分,并从最视觉异常的区域进行宫颈活检。将瑞典评分与组织病理学诊断进行比较,作为参考标准。采用Kappa (κ)统计计算两组阴道镜的一致性水平。结果:标准阴道镜与阴道镜瑞典评分的一致性为62.56%,κ统计量为0.43 (p)。结论:阴道镜对CIN 2+病变的诊断准确率与标准阴道镜相近。当使用瑞典评分时,阴道镜与标准阴道镜显示出良好的一致性。
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来源期刊
Obstetrics and Gynecology Science
Obstetrics and Gynecology Science Medicine-Obstetrics and Gynecology
CiteScore
3.80
自引率
15.80%
发文量
58
审稿时长
16 weeks
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.
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