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

Addition of digital VIA/VILI to conventional naked-eye examination for triage of HPV-positive women: A study conducted in a low-resource setting.
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DOI:
10.1371/journal.pone.0268015
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发表时间:
2022
期刊:
影响因子:
3.7
通讯作者:
--
中科院分区:
综合性期刊3区
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世界卫生组织宫颈癌筛查指南建议,如果HPV阳性,则应进行HPV检测,然后用乙酸目视检查(VIA)进行分类。为了改善宫颈上皮内瘤变2级及以上(CIN2+)的视觉评估和识别,医生可能会使用数码相机等视觉辅助设备。确定裸眼与数字VIA (D-VIA)和VILI (D-VILI)联合检查与常规评估相比是否能提高CIN2+的检测。居住在Dschang(西喀麦隆)的妇女(30-49岁)被前瞻性地邀请参加宫颈癌筛查运动。如果hpv阳性,则进行VIA/VILI和D-VIA/VILI筛查。医疗保健提供者根据裸眼VIA/VILI和D-VIA/VILI独立定义诊断(病理性或非病理性)。根据联合检查(VIA/VILI和D-VIA/VILI)决定治疗。所有hpv阳性的参与者都进行宫颈活检和宫颈内膜刮除,并作为参考标准。评估单独和联合裸眼VIA/VILI和D-VIA/VILI的诊断性能。假设HPV阳性女性中20%的HPV阳性和10%的CIN2+患病率,计算1500名女性的样本量。由于新冠肺炎大流行,该研究不得不提前终止。共招募了1081名中位年龄为40岁(IQR 35.5-45)的女性。HPV阳性18.4%(188例),CIN2+ 26例(14.4%)。裸眼VIA和D-VIA的灵敏度分别为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灵敏度为92.3% (95% CI 74.9-99.1),特异性为23.2% (95% CI 16.8-30.7)。观察到灵敏度有提高的趋势,但没有达到统计学意义。在常规裸眼检查中添加D-VIA/VILI可能与改进的CIN2+识别相关。需要进一步的研究,包括更大的样本量来证实这些结果。
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. 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. 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. 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. 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.
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