Fokom-Domgue Joël, Combescure Christophe, Fokom-Defo Victoire, Tebeu Pierre Marie, Vassilakos Pierre, Kengne André Pascal, Petignat Patrick
Department of Gynecology and Obstetrics, Faculty of Medicine and Biomedical Sciences, University of Yaoundé, Yaoundé, Cameroon Division of Gynecology, Department of Gynecology and Obstetrics, Geneva University Hospitals, 1211 Geneva 14, Switzerland
Division of Clinical Epidemiology, Geneva University Hospitals, Geneva, Switzerland.
BMJ. 2015 Jul 3;351:h3084. doi: 10.1136/bmj.h3084.
To assess and compare the accuracy of visual inspection with acetic acid (VIA), visual inspection with Lugol's iodine (VILI), and human papillomavirus (HPV) testing as alternative standalone methods for primary cervical cancer screening in sub-Saharan Africa.
Systematic review and meta-analysis of diagnostic test accuracy studies.
Systematic searches of multiple databases including Medline, Embase, and Scopus for studies published between January 1994 and June 2014.
Inclusion criteria for studies were: alternative methods to cytology used as a standalone test for primary screening; study population not at particular risk of cervical cancer (excluding studies focusing on HIV positive women or women with gynaecological symptoms); women screened by nurses; reference test (colposcopy and directed biopsies) performed at least in women with positive screening results. Two reviewers independently screened studies for eligibility and extracted data for inclusion, and evaluated study quality using the quality assessment of diagnostic accuracy studies 2 (QUADAS-2) checklist. Primary outcomes were absolute accuracy measures (sensitivity and specificity) of screening tests to detect cervical intraepithelial neoplasia grade 2 or worse (CIN2+).
15 studies of moderate quality were included (n=61,381 for VIA, n=46,435 for VILI, n=11,322 for HPV testing). Prevalence of CIN2+ did not vary by screening test and ranged from 2.3% (95% confidence interval 1.5% to 3.3%) in VILI studies to 4.9% (2.7% to 7.8%) in HPV testing studies. Positivity rates of VILI, VIA, and HPV testing were 16.5% (9.8% to 24.7%), 16.8% (11.0% to 23.6%), and 25.8% (17.4% to 35.3%), respectively. Pooled sensitivity was higher for VILI (95.1%; 90.1% to 97.7%) than VIA (82.4%; 76.3% to 87.3%) in studies where the reference test was performed in all women (P<0.001). Pooled specificity of VILI and VIA were similar (87.2% (78.1% to 92.8%) v 87.4% (77.1% to 93.4%); P=0.85). Pooled sensitivity and specificity were similar for HPV testing versus VIA (both P ≥ 0.23) and versus VILI (both P ≥ 0.16). Accuracy of VIA and VILI increased with sample size and time period.
For primary screening of cervical cancer in sub-Saharan Africa, VILI is a simple and affordable alternative to cytology that demonstrates higher sensitivity than VIA. Implementation studies are needed to assess the effect of these screening strategies on the incidence and outcomes of cervical cancer in the region.
评估并比较醋酸肉眼观察法（VIA）、卢戈氏碘肉眼观察法（VILI）以及人乳头瘤病毒（HPV）检测作为撒哈拉以南非洲地区宫颈癌初筛独立替代方法的准确性。
诊断试验准确性研究的系统评价和荟萃分析。
对多个数据库进行系统检索，包括Medline、Embase和Scopus，检索1994年1月至2014年6月发表的研究。
研究的纳入标准为：用作初筛独立检测的细胞学替代方法；研究人群无宫颈癌特定风险（不包括聚焦于HIV阳性女性或有妇科症状女性的研究）；由护士进行筛查的女性；至少对筛查结果阳性的女性进行参考检测（阴道镜检查和定向活检）。两名研究者独立筛选研究的合格性并提取纳入数据，使用诊断准确性研究质量评估2（QUADAS - 2）清单评估研究质量。主要结局是筛查试验检测宫颈上皮内瘤变2级或更严重病变（CIN2 +）的绝对准确性指标（敏感性和特异性）。
纳入15项中等质量的研究（VIA研究n = 61381，VILI研究n = 46435，HPV检测研究n = 11322）。CIN2 +的患病率不因筛查试验而异，在VILI研究中为2.3%（95%置信区间1.5%至3.3%），在HPV检测研究中为4.9%（2.7%至7.8%）。VILI、VIA和HPV检测的阳性率分别为16.5%（9.8%至24.7%）、16.8%（11.0%至23.6%）和25.8%（17.4%至35.3%）。在对所有女性进行参考检测的研究中，VILI的合并敏感性（95.1%；90.1%至97.7%）高于VIA（82.4%；76.3%至87.3%）（P < 0.001）。VILI和VIA的合并特异性相似（87.2%（78.1%至92.8%）对87.4%（77.1%至93.4%）；P = 0.85）。HPV检测与VIA（P均≥0.23）以及与VILI（P均≥0.16）的合并敏感性和特异性相似。VIA和VILI的准确性随样本量和时间段增加。
对于撒哈拉以南非洲地区的宫颈癌初筛，VILI是一种简单且经济的细胞学替代方法，其敏感性高于VIA。需要开展实施研究以评估这些筛查策略对该地区宫颈癌发病率和结局的影响。
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