Kelly Helen, Jaafar Iman, Chung Michael, Michelow Pamela, Greene Sharon, Strickler Howard, Xie Xianhong, Schiffman Mark, Broutet Nathalie, Mayaud Philippe, Dalal Shona, Arbyn Marc, de Sanjosé Silvia
National Cancer Institute, National Institutes of Health, Rockville, MD, USA.
London School of Hygiene and Tropical Medicine, London, United Kingdom.
EClinicalMedicine. 2022 Sep 27;53:101645. doi: 10.1016/j.eclinm.2022.101645. eCollection 2022 Nov.
BACKGROUND: We systematically reviewed the diagnostic accuracy of cervical cancer screening and triage strategies in women living with HIV (WLHIV). METHODS: Cochrane Library, Embase, Global Health and Medline were searched for randomised controlled trials, prospective or cross-sectional studies published from database inception to 15 July 2022 reporting diagnostic accuracy of tests in cervical cancer screening and triage of screen-positive WLHIV. Studies were included if they reported the diagnostic accuracy of any cervical cancer screening or triage strategies for the detection of histologically-confirmed high-grade cervical intraepithelial neoplasia (CIN2+/CIN3+) among WLHIV. Summary data were extracted from published reports. Authors were contacted for missing data where applicable. Sensitivity and specificity estimates for CIN2/3+ were pooled using models for meta-analysis of diagnostic accuracy data. Study quality was assessed using the QUADAS-2 tool for the quality assessment of diagnostic accuracy studies. PROSPERO registration:CRD42020189031. FINDINGS: In 38 studies among 18,737 WLHIV, the majority (n=19) were conducted in sub-Saharan Africa. The pooled prevalence was 12.0% (95%CI:9.8-14.1) for CIN2+ and 6.7% (95%CI:5.0-8.4) for CIN3+. The proportion of screen-positive ranged from 3-31% (visual inspection using acetic acid[VIA]); 2-46% (high-grade squamous intraepithelial lesions, and greater [HSIL+] cytology); 20-64% (high-risk[HR]-HPV DNA). In 14 studies, sensitivity and specificity of VIA were variable limiting the reliability of pooled estimates. In 5 studies where majority had histology-confirmed CIN2+, pooled sensitivity was 56.0% (95%CI:45.4-66.1; ) for CIN2+ and 65.0% (95%CI:52.9-75.4; =42%) for CIN3+; specificity for <CIN2 was 73.8% (95%CI:59.8-84.2, ). Cytology was similarly variable (sensitivity of ASCUS+ for CIN2+ range: 58-100%; specificity: 9-96%). In 28 studies, sensitivity of tests targeting 14-HR-HPV types was high (91.6%, 95%CI:88.1-94.1; for CIN2+ and 92.5%, 95%CI:88.4-95.2; ) for CIN3+); but specificity for <CIN2 was low (62.2% (95%CI:57.9-66.4;). Restriction to 8-HR-HPV increased specificity (65.8%; Relative specificity[RSpec] vs. 14-HR-HPV=1.17; 95%CI:1.10-1.24) with no significant change in sensitivity (CIN2+:85.5%; Relative Sensitivity[RSens]=0.94, 95%CI: 0.89-1.00; CIN3+:90%; RSens=0.96, 95%CI:0.89-1.03). VIA triage of 14-HR-HPV positive women decreased sensitivity for CIN2+ compared to HPV-DNA test alone (64.4% vs. 91.6%; RSens=0.68, 95%CI:0.62-0.75). INTERPRETATION: HPV-DNA based approaches consistently showed superior sensitivity for CIN2+/CIN3+ compared to VIA or cytology. The low specificity of HPV-DNA based methods targeting up to 14-HR-HPV could be improved significantly by restricting to 8-HR-HPV with only minor losses in sensitivity, limiting requirement for triage for which optimal approaches are less clear. FUNDING: World Health Organisation; National Cancer Institute; European Union's Horizon 2020 and Marie Skłodowska-Curie Actions programme.
背景：我们系统回顾了人类免疫缺陷病毒（HIV）感染者（WLHIV）中宫颈癌筛查及分流策略的诊断准确性。 方法：检索Cochrane图书馆、Embase、全球健康数据库和Medline，查找从数据库建立至2022年7月15日发表的随机对照试验、前瞻性或横断面研究，这些研究报告了WLHIV宫颈癌筛查及筛查阳性者分流检测的诊断准确性。若研究报告了WLHIV中任何用于检测组织学确诊的高级别宫颈上皮内瘤变（CIN2+/CIN3+）的宫颈癌筛查或分流策略的诊断准确性，则纳入研究。从已发表报告中提取汇总数据。在适当时联系作者获取缺失数据。使用诊断准确性数据的Meta分析模型汇总CIN2/3+的敏感性和特异性估计值。使用QUADAS-2工具评估诊断准确性研究的质量。国际前瞻性系统评价注册库（PROSPERO）注册号：CRD42020189031。 结果：在针对18737名WLHIV的38项研究中，大多数研究（n = 19）在撒哈拉以南非洲进行。CIN2+的汇总患病率为12.0%（95%置信区间：9.8 - 14.1），CIN3+的汇总患病率为6.7%（95%置信区间：5.0 - 8.4）。筛查阳性比例范围为：3 - 31%（醋酸肉眼观察法[VIA]）；2 - 46%（高级别鳞状上皮内病变及以上[HSIL+]细胞学检查）；20 - 64%（高危[HR]-HPV DNA检测）。在14项研究中VIA的敏感性和特异性存在差异，限制了汇总估计值的可靠性。在5项大多数病例有组织学确诊CIN2+的研究中：CIN2+的汇总敏感性为56.0%（95%置信区间：45.4 - 66.1），CIN3+的汇总敏感性为65.0%（95%置信区间：52.9 - 75.4；I² = 42%）；<CIN2的特异性为73.8%（95%置信区间：59.8 - 84.2）。细胞学检查结果同样存在差异（不典型鳞状细胞及以上[ASCUS+]对CIN2+的敏感性范围：58 - 100%；特异性：9 - 96%）。在28项研究中，针对14种高危型HPV检测的敏感性较高（CIN2+为91.6%，95%置信区间：88.1 - 94.1；I² = 0），CIN3+为92.5%，95%置信区间：88.4 - 95.2；I² = 0）；但< CIN2的特异性较低（62.2%（95%置信区间：57.9 - 66.4）。将检测限制在8种高危型HPV可提高特异性（65.8%；相对特异性[RSpec]与14种高危型HPV相比 = 1.17；95%置信区间：1.10 - 1.24），而敏感性无显著变化（CIN2+：85.5%；相对敏感性[RSens] = 0.94，95%置信区间：0.89 - 1.00；CIN3+：90%；RSens = 0.96，95%置信区间：0.89 - 1.03）。与单独的HPV-DNA检测相比，对14种高危型HPV阳性女性进行VIA分流会降低CIN2+的敏感性（64.4%对91.6%；RSens = 0.68，95%置信区间：0.62 - 0.75）。 解读：与VIA或细胞学检查相比，基于HPV-DNA的方法对CIN2+/CIN3+始终显示出更高的敏感性。将基于HPV-DNA的方法检测范围限制在8种高危型HPV可显著提高其较低的特异性，且敏感性仅有轻微损失，减少了对分流的需求，而目前最佳分流方法尚不清楚。 资助：世界卫生组织；美国国立癌症研究所；欧盟“地平线2020”计划和玛丽·居里行动计划。
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