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阴道镜远程医疗:在检测CIN2+方面实时与静态瑞典评分及准确性的横断面试点研究

Colposcopy telemedicine: live versus static swede score and accuracy in detecting CIN2+, a cross-sectional pilot study.

作者信息

Taghavi Katayoun, Banerjee Dipanwita, Mandal Ranajit, Kallner Helena Kopp, Thorsell Malin, Friis Therese, Kocoska-Maras Ljiljana, Strander Björn, Singer Albert, Wikström Elisabeth

机构信息

Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland.

Department of Gynecologic Oncology, Chittaranjan National Cancer Institute, Kolkata, India.

出版信息

BMC Womens Health. 2018 Jun 11;18(1):89. doi: 10.1186/s12905-018-0569-1.

Abstract

BACKGROUND

This cross-sectional pilot study evaluates diagnostic accuracy of live colposcopy versus static image Swede-score evaluation for detecting significant precancerous cervical lesions greater than, or equal to grade 2 severity (CIN2+).

METHODS

VIA or HrHPV positive women were examined using a mobile colposcope, in a rural clinic in Kolkata, India. Live versus static Swede-score colposcopy assessments were made independently. All assessments were by gynecologists, junior or expert. Static image assessors were blinded to live scoring, patient information and final histopathology result. Primary outcome was the ability to detect CIN2+ lesions verified by directed biopsies. Diagnostic accuracy was calculated for live versus static Swede-score in detecting CIN2+ lesions, as well as for interclass correlation.

RESULTS

495 images from 94 VIA positive women were evaluated in this study. Thirteen women (13.9%) had CIN2+ on biopsy. No significant difference was found in the detection of CIN2+ lesions between live and static assessors (area under curve = 0.69 versus 0.71, p = 0.63). A Swede-score of 4+, had a sensitivity of 76.9% (95% CI 46.2-95.0%) and 84.6% (95% CI 54.6-98.1%), for live- and static-image assessment respectively. The corresponding positive predictive values were found to be 90.9% (95% CI 75.7-98.1%) and 92.6% (95% CI 75.7-99.1%). The interclass correlation was good (kappa statistic = 0.60) for the senior static assessors.

CONCLUSIONS

Swede-score evaluation of static colposcopy images was found to reliably detect CIN2+ lesions in this study. Larger studies are needed to further develop the colposcopy telemedicine concept which may offer reliable guidance in management where direct specialist input is not available.

TRIAL REGISTRATION

Ethical approval of the study was obtained by the Chittaranjan National Cancer Institute (CNCI) Human Research Ethics Committee (4.311/27/2014). The trial was retrospectively registered in the Clinical Trails Registry of India CTRI/2018/03/012470 .

摘要

背景

这项横断面试点研究评估了动态阴道镜检查与静态图像瑞典评分评估在检测严重程度大于或等于2级(CIN2+)的宫颈癌前病变方面的诊断准确性。

方法

在印度加尔各答的一家农村诊所,对醋酸肉眼观察(VIA)或高危型人乳头瘤病毒(HrHPV)阳性的女性使用移动阴道镜进行检查。分别进行动态和静态瑞典评分阴道镜评估。所有评估均由妇科医生(初级或专家)进行。静态图像评估人员对动态评分、患者信息和最终组织病理学结果不知情。主要结局是通过定向活检证实检测CIN2+病变的能力。计算动态与静态瑞典评分在检测CIN2+病变方面的诊断准确性以及组内相关性。

结果

本研究评估了94名VIA阳性女性的495张图像。13名女性(13.9%)活检显示为CIN2+。动态和静态评估人员在检测CIN2+病变方面未发现显著差异(曲线下面积分别为0.69和0.71,p = 0.63)。瑞典评分为4+时,动态图像评估和静态图像评估的敏感性分别为76.9%(95%置信区间46.2 - 95.0%)和84.6%(95%置信区间54.6 - 98.1%)。相应的阳性预测值分别为90.9%(95%置信区间75.7 - 98.1%)和92.6%(95%置信区间75.7 - 99.1%)。高级静态评估人员的组内相关性良好(kappa统计量 = 0.60)。

结论

在本研究中,发现对静态阴道镜图像进行瑞典评分评估能够可靠地检测CIN2+病变。需要开展更大规模的研究以进一步发展阴道镜远程医疗概念,这可能在无法获得专科医生直接指导的情况下为管理提供可靠指导。

试验注册

该研究获得了吉檀迦利国家癌症研究所(CNCI)人类研究伦理委员会的伦理批准(4.311/27/2014)。该试验在印度临床试验注册中心进行了回顾性注册CTRI/2018/03/012470 。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/db32/6040214/bc139afefe8b/12905_2018_569_Fig1_HTML.jpg

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