数字 VIA/VILI 联合传统裸眼检查用于 HPV 阳性女性的分诊：在资源匮乏环境中开展的一项研究。

Addition of digital VIA/VILI to conventional naked-eye examination for triage of HPV-positive women: A study conducted in a low-resource setting.

机构信息

Faculty of Medicine, University of Geneva, Geneva, Switzerland.

Faculty of Medicine and Pharmaceutical Science, University of Dschang, Dschang, Cameroon.

出版信息

PLoS One. 2022 May 12;17(5):e0268015. doi: 10.1371/journal.pone.0268015. eCollection 2022.

DOI:10.1371/journal.pone.0268015

PMID:35552564

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9098068/

Abstract

BACKGROUND

World Health Organization guidelines for cervical cancer screening recommend HPV testing followed by visual inspection with acetic acid (VIA) for triage if HPV positive. In order to improve visual assessment and identification of cervical intraepithelial neoplasia grade 2 and worse (CIN2+), providers may use visual aids such as digital cameras.

OBJECTIVES

To determine whether combined examination by naked-eye and digital VIA (D-VIA) and VILI (D-VILI) improves detection of CIN2+ as compared to the conventional evaluation.

MATERIALS AND METHODS

Women (30-49 years) living in Dschang (West Cameroon) were prospectively invited to a cervical cancer screening campaign. Primary HPV-based screening was followed by VIA/VILI and D-VIA/VILI if HPV-positive. Health care providers independently defined diagnosis (pathological or non-pathological) based on naked-eye VIA/VILI and D-VIA/VILI. Decision to treat was based on combined examination (VIA/VILI and D-VIA/VILI). Cervical biopsy and endocervical curettage were performed in all HPV-positive participants and considered as reference standard. Diagnostic performance of individual and combined naked-eye VIA/VILI and D-VIA/VILI was evaluated. A sample size of 1,500 women was calculated assuming a prevalence of 20% HPV positivity and 10% CIN2+ in HPV-positive women.

RESULTS

Due to the COVID-19 pandemic, the study had to terminate prematurely. A total of 1,081 women with a median age of 40 (IQR 35.5-45) were recruited. HPV positivity was 17.4% (n = 188) and 26 (14.4%) had CIN2+. Naked-eye VIA and D-VIA sensitivities were 80.8% (95% CI 60.6-93.4) and 92.0% (95% CI 74.0-99.0), and specificities were 31.2% (95% CI 24-39.1) and 31.6% (95% CI 24.4-39.6), respectively. The combination of both methods yielded a sensitivity of 92.3% (95% CI 74.9-99.1) and specificity of 23.2% (95% CI 16.8-30.7). A trend towards improved sensitivity was observed, but did not reach statistical significance.

CONCLUSION

Addition of D-VIA/VILI to conventional naked-eye examination may be associated with improved CIN2+ identification. Further studies including a larger sample size are needed to confirm these results.

摘要

背景

世界卫生组织的宫颈癌筛查指南建议，如果 HPV 检测呈阳性，则进行 HPV 检测后行醋酸视觉检查（VIA）进行分流。为了提高对宫颈上皮内瘤变 2 级及以上（CIN2+）的视觉评估和识别能力，医生可能会使用数字摄像头等视觉辅助工具。

目的

确定与传统评估相比，裸眼数字 VIA（D-VIA）和 VILI（D-VILI）联合检查是否能提高 CIN2+的检出率。

材料与方法

在喀麦隆西部的登巴萨（Dschang），前瞻性地邀请 30-49 岁的女性参加宫颈癌筛查活动。首先进行基于 HPV 的初级筛查，如果 HPV 阳性，则进行 VIA/VILI 和 D-VIA/VILI。医务人员根据裸眼 VIA/VILI 和 D-VIA/VILI 独立定义诊断（病理或非病理）。根据联合检查（VIA/VILI 和 D-VIA/VILI）来决定是否治疗。所有 HPV 阳性参与者均进行宫颈活检和宫颈管搔刮术，并作为参考标准。评估单独和联合使用裸眼 VIA/VILI 和 D-VIA/VILI 的诊断性能。假设 HPV 阳性妇女中 HPV 阳性率为 20%，CIN2+的患病率为 10%，计算出需要 1500 名女性的样本量。

结果

由于 COVID-19 大流行，该研究不得不提前终止。共招募了 1081 名中位年龄为 40（IQR 35.5-45）岁的女性。HPV 阳性率为 17.4%（n=188），26 人（14.4%）患有 CIN2+。裸眼 VIA 和 D-VIA 的敏感性分别为 80.8%（95%CI 60.6-93.4）和 92.0%（95%CI 74.0-99.0），特异性分别为 31.2%（95%CI 24-39.1）和 31.6%（95%CI 24.4-39.6）。两种方法联合使用的敏感性为 92.3%（95%CI 74.9-99.1），特异性为 23.2%（95%CI 16.8-30.7）。观察到敏感性有提高的趋势，但没有达到统计学意义。