醋酸染色肉眼观察法筛查宫颈病变的效果及其误判的影响因素

[目的]分析醋酸染色肉眼观察(VIA)筛查宫颈病变的效果,并初步探讨其误判的影响因素。[方法]将3179名进行HPV检测、VIA检查的联合筛查妇女纳入分析,任意一种筛查方法阳性妇女和10%随机抽取的所有筛查试验阴性的1112名妇女进行阴道镜检查,阴道镜下可见病变处直接取活检,不可见病变且筛查阳性时四象限随机活检+宫颈管搔刮术(ECC),以病理诊断为金标准。[结果 ]在3179名纳入分析的筛查对象中,HPV感染率为24.6%(782/3179),VIA阳性率为6.2%(197/3179)。VIA检出宫颈高度以上病变(CIN2+)病变的灵敏度仅为31.5%,特异性为94.2%,漏诊率为68.5%,误诊率为5.8%。多因素分析结果显示,绝经妇女行VIA检查更容易被漏诊;而年龄小、鳞柱交界满意和有宫颈炎的妇女行VIA检查更容易被误诊。[结论]影响VIA检查准确性的因素较多,临床判断的主观性较大,需要对临床医生开展标准化培训,对于绝经和有生殖道炎症的妇女行VIA检查时更需慎重。     

醋酸染色法联合碘染色法在宫颈癌筛查中的应用

[目的]评价醋酸染色法（VIA）联合碘染色法（VILI）对农村地区宫颈癌筛查的可行性和价值。[方法]采用VIA/VILI在杭州市萧山区农村28-55岁的妇女人群中开展宫颈癌筛查。VIA或VILI阳性者行阴道镜检查,阴道镜检查阳性者转送上级医院进一步检查。[结果]2007-2009年期间,总筛查1697人次,其中低级别CIN17例、高级别CIN10例、浸润癌2例。[结论]在资源、设备有限的农村地区,VIA/VILI方法对妇女开展宫颈癌及癌前病变的筛查是可行的,有利于宫颈癌的早发现及早诊早治。     

肉眼观察法联合电子阴道镜检查在宫颈癌筛查中的应用

[目的]对新疆维吾尔族妇女肉眼观察宫颈（VIA,VILI）法联合电子阴道镜检查进行宫颈癌筛查,评价其对宫颈癌及癌前病变的应用价值。[方法]对新疆和田29～60岁的2005名维吾尔族农村妇女进行宫颈癌筛查。采取VIA、VILI法,对VIA、VILI异常者结合电子阴道镜检查,在异常阴道镜图象区取宫颈活检,病理诊断为金标准。[结果]2005名农村妇女中VIA阳性41例,占2.04%（41/2005）,其灵敏度、特异度、阳性预测值、阴性预测值分别为65.63%、98.98%、51.22%、99.44%;VILI阳性49例,占2.49%（49/1964）,其灵敏度、特异度、阳性预测值、阴性预测值分别为53.57%、98.24%、30.61%、99.32%;阴道镜转诊90例,占4.49%（90/2005）;宫颈活检65例,病理诊断为炎症33例、CIN24例、宫颈癌8例。[结论]在宫颈癌筛查中采用VIA、VILI法具有一定的阴性预测价值;结合阴道镜检查能够初步判断病变的程度,确保活检部位的准确性。     

宫颈癌早诊早治农村示范基地研究报告

[目的]通过对9176名妇女采用醋酸或碘染色肉眼筛查方法（VIA/VILI）筛查宫颈癌的早诊早治结果分析,评价在农村高发区宫颈癌采用该筛查方式推广应用的可行性。[方法]以山西省襄垣县30～59岁的妇女作为研究对象进行以自然人群为基础的宫颈癌筛查,用醋酸染色后肉眼观察（VIA）和碘染色后肉眼观察（VILI）进行宫颈检查,VIA或VILI阳性者进行阴道镜检查,阴道镜异常者在病变处取活检进行病理学诊断。采用同样方法对该人群连续复查两年。[结果]首次筛查人群参与率为73.92%,二次复查率为84.3%。2005年首次筛查了1287例妇女,最终经病理确诊的CINⅠ10例、CINⅡ9例、CINⅢ13例、宫颈癌3例。该方法与已往该地区采用液基细胞学和HPV检测联合筛查方法相比较,CINⅡ和≥CINⅢ病变的检出率略低,但差异无统计学意义。连续两年复查出5例CINⅠ,3例CINⅡ,1例CINⅢ。2006～2008年共筛查7889例,首次筛查最终病理确诊116例CINⅠ,36例CINⅡ,35例CINⅢ,4例早期浸润癌,浸润性鳞癌5例。第二次复查,经病理确诊75例CINⅠ,24例CINⅡ,15例CINⅢ,1例早期浸润癌。[结论]在资源有限．经济不发达的农村地区．用VIA／VILI方法对宫颈癌及其癌前病变的筛查是可行的．建议进一步在农村地区进行推广。     

河南省新密市2010~2013年农村女性宫颈癌筛查结果分析

摘 要：［目的］ 根据2010～2013年河南省新密市农村地区宫颈癌筛查数据,分析当地女性宫颈癌筛查的参与率,宫颈炎、宫颈癌前病变及宫颈癌的检出率,为当地制定宫颈癌筛查策略提供依据。［方法］ 2010～2013年对新密市35～64岁农村妇女进行宫颈癌筛查,绝经前女性使用醋酸/碘染色肉眼观察法（VIA/VILI）初筛,绝经后女性使用巴氏涂片法初筛。VIA/VILI异常及巴氏涂片结果≥ASC-US者召回行阴道镜检查,并对镜下检查异常处取活检。病理结果为金标准,CIN2及以上妇女转诊进行手术治疗。［结果］ 2010~2013年共筛查115 789名农村女性,总体顺应性为59.50%;VIA/VILI筛查84 762人,阳性率为20.0%;巴氏涂片筛查31 027人,阳性率为4.81%。13 914人进行阴道镜检查,取活检4438例(31.90%)。病理诊断宫颈炎症3830例(3.31%),CIN1 126例(0.11%),CIN2 125例(0.11%),CIN3/原位癌204例(0.18%),宫颈癌67例(0.06%),另发现5例内膜癌(0.004%)、2例外阴癌(0.002%)。［结论］ 2010~2013年新密市CIN2+的整体检出水平较高。农村女性参加筛查的整体顺应性不高,VIA/VILI筛查的假阳性率高,应加强对基层医生技术水平的培训。     

2006-2009年山西省襄垣县VIA/VILI筛查宫颈癌的检出效果评价

目的：通过对2006—2009年山西省襄垣县宫颈癌筛查早诊早治结果分析,评价醋酸或碘染色肉眼观察法（visual inspection with acetic acid/Lugol’s iodine,VIA/VILI）宫颈癌筛查方案在农村高发区推广应用的可行性。方法2006—2009年在山西省襄垣县对30~59岁的妇女进行宫颈癌筛查。用VIA和VILI作为初筛方法,VIA/VILI阳性者进行阴道镜检查,阴道镜异常者在病变处取活检进行病理诊断。对VIA和VILI阴性、VIA/VILI阳性但阴道镜检查正常、VIA/VILI阳性同时阴道镜检查异常且病理活检结果为轻度宫颈上皮内瘤样病变（cervical intraepithelial neoplasia grade 1,CIN1）或正常的妇女一年后用与初筛同样的方法进行复查。结果2006—2010年累计筛查16703人次,其中初筛9618人,复查7085人。4年初筛人群累计阴道镜转诊率、中度CIN及以上（CIN2+）检出率、重度CIN及以上（CIN3+）检出率分别为4.6%（438/9618）、0.9%（82/9618）、0.5%（44/9618）;复查人群上述指标分别为3.1%（221/7085）、0.6%（42/7085）、0.2%（19/7085）;筛查人群累计（包括初筛和复查）上述指标分别为4.0%（659/16703）、1.3%（124/9618）、0.7%（63/9618）。初筛人群阴道镜转诊率、CIN2+检出率和CIN3+检出率均随方案的持续开展呈升高趋势（P<0.001）;复查阴道镜转诊率、CIN2+检出率则呈下降趋势（P<0.001）。结论随着VIA/VILI筛查方案在示范基地的推广,筛查效果越来越显著。VIA/VI-LI是一种经济有效的宫颈癌及其癌前病变筛查方法,适宜在资源有限、经济欠发达的农村地区推广。持续的培训和实践是VIA/VILI筛查方案有效实施的关键措施。     

4 种不同检查方法在宫颈癌筛查中的临床应用价值*

目的:了解4 种不同检查方法在宫颈癌筛查中的临床应用价值。方法:采用第二代杂交捕获技术（hybrid capture 2,HC-II）检测13种高危型人乳头瘤病毒（human papillomavirus ,HPV ）、薄层液基细胞学技术（Liquid-based cytology test,LCT ）检测宫颈脱落细胞、醋酸肉眼检查（visual inspection with acetic acid,VIA）和阴道镜检查4 种方法对2004年11月～2004年12月深圳南山区华侨城区域15～59岁有性生活女性共1 137 例进行盲法同步宫颈癌筛查。对阴道镜检查异常或可疑异常者行阴道镜下直接活检;对HPV 阳性并且LCT ≥未明确诊断意义的不典型鳞状上皮细胞（atypical squamous cells of undetetemined sign,ASCUS ）,或HPV 阴性但LCT ≥低度鳞状上皮内病变（low grade squamous intraepithelial lesion ,LSIL ）的妇女再次行阴道镜下活组织病理学检查,以病理结果作为验证4种检查方法的金标准。结果:共取病理122 例。病理结果证实该人群中无宫颈癌病例:子宫颈上皮内瘤变（cervical intraepithelial neoplasia ,CIN）Ⅲ级3 例,CIN Ⅱ级11例,CIN Ⅰ级36例;慢性宫颈炎和鳞状上皮化生69例;正常宫颈3 例。人群的高危HPV 总检出率为14.0% ;LCT 阳性率为12.6% ;VIA 阳性率为12.5% ;阴道镜阳性率为13.6% 。随宫颈病变级别升高,高危HPV 感染率及LCT 阳性率均呈趋势性增加（P<0.005）;VIA 和阴道镜阳性率在各级宫颈病变中无统计学差异,但在宫颈病变组阳性检出率明显高于正常宫颈组。高危HPV 对宫颈高度病变的敏感性、特异性、准确性、阳性预测值、阴性预测值、阳性似然比和阴性似然比分别为100% 、87.1% 、87.3% 、8.8% 、100% 、7.6% 和0;LCT 以上各指标分别为92.9% 、88.4% 、88.5% 、9.1% 、99.9% 、8.0% 和8.0% ;VIA 以上各指标分别为35.7% 、96.0% 、95.3% 、10.0% 、99.2% 、8.9% 和67.0% ;阴道镜以上各指标分别为50.0% 、86.8% 、86.4% 、4.5% 、99.3% 、3.8% 和58.0% 。结论:高危HPV 检测和LCT 检查均为目前宫颈癌筛查较好的方法,VIA 和阴道镜检查敏感性较差,漏诊率高,不适合大范围筛查,但二者阴性预测值均较高,可应用于临床病例诊断。      

醋酸染色肉眼观察在子宫颈癌筛查分流中的应用价值

目的:评价醋酸染色肉眼观察(VIA)在宫颈癌筛查中分流自我取样人乳头瘤病毒(HPV) DNA阳性人群的可行性及应用价值.方法:对2 500名河南省新密市25～65岁的妇女进行宫颈癌筛查.初次访视时每位妇女均接受了自我取样HPV DNA检测和VIA.任何筛查阳性及随机10％阴性的妇女进行第2次VIA和阴道镜检查.阴道镜下可见病变处直接活检;无可见病变但筛查阳性时行四象限随机活检+宫颈管搔刮术(ECC).以病理诊断为金标准.结果:最终有2 463名妇女纳入分析.目标人群自我取样HPV的阳性率为17.3％(427/2 463),检出CINⅡ+的灵敏度为89.2％(33/37),特异度为83.8％(2 032/2 426),阳性预测值(PPV)为7.7％(33/427).用VIA对自我取样HPV DNA阳性者进行分流,阴道镜转诊率由17.3％(427/2 463)降至2.5％(61/2 463),x2=304.7,P＜0.001;特异度和PPV可分别达到98.3％(2 384/2 426)(x2=350.0,P＜0.001)和31.2％(19/61),x2=30.7,P＜0.001,灵敏度为51.4％.结论:用VIA分流自我取样HPV DNA阳性妇女,可以显著提高宫颈癌筛查的特异度和PPV值,明显降低阴道镜转诊率,对于未绝经妇女,意义更为显著.这种分流方法可以有效节约卫生资源,有望成为宫颈癌筛查分流的一种新选择.     

我国农村地区宫颈癌筛查中人乳头瘤病毒检测阳性女性的分流策略

目的探讨适用于我国农村地区宫颈癌筛查人乳头瘤病毒(HPV)阳性女性的分流策略。方法选取2015年7月至2015年10月间,在山西省襄垣县和阳城县招募35~64岁女性进行宫颈癌及其癌前病变筛查,采用宫颈癌快速筛查技术(care HPV检测法)进行初筛,后采用随机数表法将初筛结果阳性女性(248例)分成三组:细胞学分流(82例)、醋酸或碘染色肉眼观察法(VIA/VILI)分流(83例)和不分流直接转诊阴道镜(83例)。细胞学和VIA/VILI检查阳性者转诊阴道镜。阴道镜异常者在病变处取活检进行病理诊断。结果共有1 503名女性参加筛查,HPV阳性检出率为16.5%(248/1503),中度及以上宫颈上皮内瘤样病变(CIN2+)的检出率为0.7%(11/1503),248例中有237例完成分流检查,依从率为95.6%(237/248),细胞学分流组、VIA/VILI分流组和不分流直接阴道镜组检查的人数分别为81例、79例和77例。细胞学分流组中,分流结果阳性率、CIN2+检出率和阳性预测值依次为:19.8%、1.2%和11.1%;VIA/VILI分流组中上述指标依次为:17.5%、3.6%和21.4%;不分流直接阴道镜组中上述指标依次为:19.5%、8.4%和9.5%。上述阳性检出率和CIN2+检出率差异均无统计学意义(均P>0.05)。随着年龄的增加,HPV阳性率趋于上升趋势,而直接阴道镜组阳性检出率趋于下降趋势,差异均有统计学意义(均P<0.05)。细胞学分流组和VIA/VILI分流组随年龄的增加未发现显著的变化趋势,差异无统计学意义(P>0.05)。结论三组方法中,VIA/VILI较适用于我国农村地区宫颈癌筛查HPV阳性女性的分流。     

肉眼观察(VIA、VILI)在中国农村地区宫颈癌筛查中的应用评价

目的评价醋酸、碘着色肉眼观察在中国农村地区宫颈癌筛查中的应用价值及可行性。方法对子宫颈癌高发区江西省修水县大桥乡妇女进行以人群为基础的研究,对2499例年龄为30～49岁农村已婚妇女进行了人乳头瘤病毒(HPV)的检测,薄层液基细胞学(TCT),醋酸、碘染色后肉眼观察(VIA、VILI)以及电子阴道镜检查。各种方法独立进行,均为双盲。对VIA、VILI或电子阴道镜中任何一项存在阳性病变进行宫颈组织活检,或行颈管刮术(ECC),另HPV或TCT阳性的妇女也给予活检。宫颈组织病理诊断均经国际癌症研究所病理检查确诊,将CIN2以上(含CIN2)病变纳入阳性结果。结果2499例受检妇女中有2432例列入研究,共检出CIN237例,CIN359例,宫颈癌3例。HPV,TCT,HPV TCT,VIA,VILI,VIA VILI和阴道镜检查等筛查方法的敏感度分别是96.67%,89.47%,97.98%,56.57%,36.36%,63.64%和39.39%;特异度分别为85.00%,96.91%,86.97%,94.60%,96.23%,92.97%和98.14%。结论VIA、VILI的灵敏度低于HPV或TCT,但因其简单、廉价、易掌握等特点,故更适合在农村地区推广应用。     

Accuracy of concurrent visual and cytology screening in detecting cervical cancer precursors in rural India

The high burden of cervical cancer and inadequate/suboptimal cytology screening in developing countries led to the evaluation of visual screening tests, like visual inspection with acetic acid (VIA) and Lugol's iodine (VILI). We describe the performance of VIA, VILI and cytology, carried out in a multinational project called "Screening Technologies to Advance Rapid Testing" in 5,519 women aged 30-49 years, in detecting cervical intraepithelial neoplasia (CIN). VIA, VILI and cytology were positive in 16.9%, 15.6% and 6.1% women, respectively. We found 57 cases of CIN2, 55 of CIN3 and 12 of cervical cancer; 90% of CIN3 and 43% CIN2 cases were positive for p16 overexpression and high-risk HPV infection, indicating a high validity of histological diagnosis. The sensitivity of VIA, VILI and cytology to detect high-grade CIN were 64.5%, 64.5% and 67.7%, respectively; specificities were 84.2%, 85.5% and 95.4%. A high proportion of p16 positive CIN 3 (93.8%) and 2 (76.9%) were positive on cytology compared with visual tests (68.8% and 53.8%, respectively) indicating a higher sensitivity of cytology to detect p16 positive high-grade CIN. However, the immediate availability of the results from the visual tests permits diagnosis and/or treatment to be performed in the same sitting, which can potentially reduce loss to follow-up when women must be recalled following positive cytology. Organizing visual screening services in low-resource countries may facilitate the gradual building of an infrastructure committed to screening allowing the eventual introduction of more sensitive, highly objective, reproducible and affordable human papillomavirus screening tests in future.     

Comparison between Visual Inspection of Cervix and Cytology Based Screening Procedures in Bangladesh

Background: Cervical cancer continues to be a major problem in Bangladesh with approximately 18,000 newcases annually of which over 10,000 women die from it. Visual inspection of the cervix after 3-5% acetic acid(VIA) application is a simple and easy to learn method for cervical cancer screening, although cytology-basedscreening is more often applied in developed countries where it has successfully reduced the prevalence of cervicalcancer. Objective: To compare the efficacy of VIA and cytology-based primary methods for cervical cancerscreening in Bangladesh. Materials and Methods: This hospital based comparative study was conducted at theVIA centre and Colposcopy Clinic of Bangabandhu Sheikh Mujib Medical University (BSMMU) from October2008 to October 2010. Results: Among 650 women, 74 (11.4%) were VIA+ve and 8 (1.2%) had abnormalitiesin their Pap smear reports. During colposcopy, 38 (7.7%) women had different grades of CIN and 4 (0.6%)had cervical cancer. The gold standard histology findings proved 20 women had CIN I, 14 had CIN II/II and 4had cervical cancer. Among the 38 histology diagnosed abnormalities, VIA test could identify 30 abnormalitiesincluding two cervical cancers. However, Pap smear could detect only 8 cases of histological abnormalities (2low grade and 6 had high grade lesion) and it missed all the cervical cancer cases. The sensitivity and specificityof VIA were 88.9% and 52.1%. The positive predictive value (PPV) and negative predictive value (NPV) were41.0%, and 92.6% respectively. Moreover, the sensitivity, specificity, PPV and NPV of Pap smear were 33.3%,95.8%, 75.0% and 79.3%, respectively. Conclusions: VIA test should be used as the primary screening tool evenwith its low sensitivity and specificity in low resource countries like Bangladesh. False positive results may begreater, but overtreatment can be minimized by colposcopy evaluation of the VIA positive women.     

Evaluation of Several Screening Approaches for Detection of Cervical Lesions in Rural Shandong,China

Purpose: The study was designed to: (1) investigate the prevalence of high-risk human papillomavirus (HRHPV)infection and cervical neoplasia; and (2) evaluate clinical performance of visual inspection with aceticacid/ Lugol’s iodine (VIA /VILI), Pap smear, high-risk human papillomavirus (HR-HPV) DNA test for detectingcervical intraepithelial neoplasia grade 2 or worse (CIN2+) and (3) explore appropriate screening approach inrural areas of Shandong Province. Materials and Methods: A total of 3,763 eligible women from Yiyuan Countyin Yimeng mountainous areas of rural Shandong, China, were enrolled and underwent Pap smear, HR-HPVDNA testing by Hybrid Capture 2 (HC2), and VIA /VILI tests. Women positive in any test were referred tocolposcopy and biopsy as indicated. Results: The prevalence of HR-HPV infection among all enrolled womenwas 11.1% and that in healthy women was 9.9%. In total 33 cases of CIN1, 16 cases of CIN2, 6 cases of CIN3 butnone of cervical cancer were detected and the crude prevalence of CIN2+ was 0.58%. For detecting CIN2+, thesensitivity of HR-HPV DNA testing, VIA/VILI, Pap smear was 90.9%, 77.3%, 81.8%, respectively. Pap smearhad the best specificity of 98.2%, followed by HR-HPV DNA testing with specificity of 89.4%, VIA/VILI hadthe lowest specificity of 81.2%. Colposcopy referral rate of HR-HPV DNA testing, VIA/VILI, Pap smear was11.1%, 18.5%, 2.3%, respectively. Conclusions: Our results suggest that HR-HPV DNA testing alone might beappropriate for primary cervical cancer screening in rural low-resource areas of Shandong Province, China.     

山西省襄垣县2009~2015年农村女性宫颈癌筛查项目结果分析

[目的]通过分析襄垣县2009～2015年农村妇女宫颈癌筛查结果,为国家宫颈癌筛查项目的评价和优化提供理论依据.[方法]对襄垣县35～64岁妇女开展宫颈癌筛查.2009～2013年采用醋酸/碘染色后肉眼观察(VIA/VILI),2014年开始部分引入人乳头状瘤病毒(HPV)检测,2015年又引入新柏氏液基细胞学(TCT)检测,根据卫生资源情况在不同人群中分别使用三种方法.任意筛查结果阳性者转诊阴道镜,镜下有病变时取活检,以病理诊断为金标准.通过评价不同方法对宫颈上皮内瘤变(CIN)2级及以上病变的检出率评价不同方法对宫颈癌的筛查效果.[结果] 2009～2015年共筛查62 618名女性,其中CIN2级及以上(CIN2+)病变的患病率为0.76％,早诊率为90.53％,下生殖道感染率为25.68％,其中滴虫性阴道炎、细菌性阴道炎和宫颈炎与HPV感染相关.根据2014及2015年数据,VIA/VILI的CIN2+病变检出率为0.74％,TCT的病变检出率为0.70％,两者相似,但均低于HPV检测,其病变检出率为1.37％.[结论]HPV检测是首选的宫颈癌初筛方法,在资源匮乏地区,培训合格的基层医生使用VIA/VILI或TCT方法对适龄妇女开展宫颈癌筛查是有效的备选方案.     

Accuracy of visual inspection with acetic acid to detect cervical cancer precursors among HIV‐infected women in Kenya

Visual inspection with acetic acid (VIA) is becoming a more widely recommended and implemented screening tool for cervical cancer prevention programs in low‐resource settings. Many of these settings have a high prevalence of HIV‐infected women. We carried out a cross‐sectional validation study to define the sensitivity, specificity and predictive values of VIA among HIV‐infected women. Women enrolled in HIV care at the Family AIDS Care and Education Services clinic in Kisumu, Kenya, were recruited for participation. All participants underwent VIA followed by colposcopy performed by a second blinded clinician. At colposcopy, lesions suspicious for cervical intraepithelial neoplasia 2 or greater (CIN2+) were biopsied. Disease status was determined by final histopathologic diagnosis in women who underwent biopsies. A satisfactory colposcopy with no lesions was considered a negative result. From October 2010 to June 2012, 1,432 women underwent VIA and colposcopy. A total of 514 (35.7%) women had a positive VIA, and 179 (12.2%) had CIN2+ confirmed by colposcopically directed biopsy. Sensitivity, specificity, positive and negative predictive values of VIA for CIN2+ were 86.6, 71.6, 30.3 and 97.4%, respectively. Specificity, but not sensitivity, increased with older age. Among older women, sensitivity was affected by CD4+ count and use of antiretroviral therapy. Although they are impacted by age and immune status, test characteristics for VIA among HIV‐infected women are similar to what has been reported for general populations. Recommendations to use VIA as a screening tool should not vary by HIV status.     

Effectiveness of a two‐stage strategy with HPV testing followed by visual inspection with acetic acid for cervical cancer screening in a low‐income setting

The World Health Organization recently advocated a two‐stage strategy with human papillomavirus (HPV) testing followed by visual inspection of the cervix with acetic acid (VIA) as a suitable option for cervical cancer screening. However, its accuracy has never been directly assessed in the context of primary screening. To evaluate effectiveness of HPV testing on self‐obtained specimens (self‐HPV) followed by VIA (sequential testing) in a low‐income setting, we recruited 540 women aged between 30 and 65 years in two Cameroonian periurban areas. Eligible women were counseled about cervical cancer and how to perform self‐sampling. HPV positive and a random sample of HPV‐negative women were called back for VIA and biopsy. Disease was defined by interpretation of cervical intraepithelial neoplasia Grade 2 or worse (CIN2+). Performances of VIA, self‐HPV and sequential testing were determined after adjustment for verification bias. HPV prevalence was 27.0%. VIA positivity was 12.9% and disease prevalence was 5%. Sensitivity and specificity of VIA for CIN2+ were 36.4% [95% confidence interval (CI): 15.2–64.6%] and 90.4% (95% CI: 85.4–93.7%), respectively. Sensitivity of self‐HPV [100.0% (95% CI: 79.6–100.0%)] was 66% higher than that of sequential testing [33.3% (95% CI: 15.2–58.3%)]. Meanwhile, specificity of self‐HPV [74.5% (95% CI: 70.6–78.1%)] was 22% lower than that of sequential testing [96.7% (95% CI: 94.8–97.9%)]. A two‐stage screening strategy with self‐HPV followed by VIA improves specificity of cervical cancer screening, but at the cost of an important loss of sensitivity. Ways to improve VIA performance or other tools are needed to increase positive predictive value of HPV testing.     

Screening for cervical cancer in India: How much will it cost? A trial based analysis of the cost per case detected

The cost and cost effectiveness of screening previously unscreened women by VIA, cytology or HPV testing was investigated within a large cluster randomised trial involving 131,178 women in rural India. All resources involved in implementation, training, management, recruitment, screening and diagnosis were identified and costed. We estimated the total costs and detection rates for each cluster and used these data to calculate an average cluster cost and detection rate for each screening approach. These estimates were combined to estimate a cost per case of cervical intraepithelial neoplasia grade 2/3 or invasive cancer (CIN 2/3+) detected. The average total costs per 1,000 women eligible for screening were US dollar 3,917, US dollar 6,609 and US dollar 11,779 with VIA, cytology and HPV respectively. The cost of detecting a case of CIN2/3+ using VIA was dollar 522 (95% CI dollar 429- dollar 652). Our results suggest that more CIN2/3+ cases would be detected in the same population if cytology were used instead of VIA and each additional case would cost US dollar 1065 (95% CI dollar 713- dollar2175). Delivering cervical cancer screening is potentially expensive in a low-income country although costs might be lower outside a trial setting. We found screening with VIA to be the least expensive option, but it also detected fewer cases of CIN2/3+ than other methods; its long-term cost-effectiveness will depend on the long-term benefits of early detection. Cytology was more effective at detecting cases than VIA but was also more expensive. Our findings indicate that HPV may not be a cost effective screening strategy in India at current consumable prices.     

Risk assessment to guide cervical screening strategies in a large Chinese population

Three different cervical screening methods [cytology, human papillomavirus(HPV) testing and visual inspection with acetic acid(VIA)] are being considered in China for the national cervical screening program. Comparing risks of CIN3 and cervical cancer (CIN3+) for different results can inform test choice and management guidelines. We evaluated the immediate risk of CIN3+ for different screening results generated from individual and combined tests. We compared tests using a novel statistic designed for this purpose called Mean Risk Stratification (MRS), in a pooled analysis of 17 cross sectional population‐based studies of 30,371Chinese women screened with all 3 methods and diagnosed by colposcopically‐directed biopsies. The 3 tests combined powerfully distinguished CIN3+ risk; triple‐negative screening conferred a risk of 0.01%, while HPV‐positive HSIL+ that was VIA‐positive yielded a risk of 57.8%. Among the three screening tests, HPV status most strongly stratified CIN3+ risk. Among HPV‐positive women, cytology was the more useful second test. In HPV‐negative women, the immediate risks of CIN3+ ranged from 0.01% (negative cytology), 0.00% (ASC‐US), 1.1% (LSIL), to 6.6 (HSIL+). In HPV‐positive women, the CIN3+ risks were 0.9% (negative cytology), 3.6% (ASC‐US), 6.3% (LSIL) and 38.5% (HSIL+). VIA results did not meaningful stratify CIN3+ risk among HPV‐negative women with negative or ASC‐US cytology; however, positive VIA substantially elevated CIN3+ risk for all other, more positive combinations of HPV and cytology compared with a negative VIA. Because all 3 screening tests had independent value in defining risk of CIN3+, different combinations can be optimized as pragmatic strategies in different resource settings.     

Initial results from a randomized trial of cervical visual screening in rural south India

The impact of a single round of screening of visual inspection with acetic acid (VIA) on cervical cancer incidence and mortality was investigated in a cluster randomized trial in south India. Women 30-59 years of age in 113 clusters in Dindigul District were randomized to VIA screening (57 clusters, 48,225 women) by nurses and to a control group (56 clusters, 30,167 women). 30,577 eligible women were screened between May 2000 and April 2003; 2,939 (9.6%) screen-positive women were investigated with colposcopy by nurses and 2,777 (9.1%) women had biopsy. CIN 1 was diagnosed in 1,778 women, CIN 2-3 lesions were found in 222, and there were 69 screen detected invasive cervical cancers. The detection rates of lesions per 1,000 screened women were 58.2 for CIN 1, 7.3 for CIN 2-3, and 2.3 for invasive cancer. The detection rate of high-grade lesions in our study was 2-3-fold higher than those observed in repeatedly screened populations in developed countries. 71% of women with CIN 1 and 80% of those with CIN 2-3 lesions accepted cryotherapy provided by nurses and surgical treatment by mid-level clinicians. Overall, 97 and 34 incident cervical cancer cases were observed in the intervention and control arms, respectively. The intervention arm accrued 124,144 person years and the control arm accrued 90,172 during the study period. The age standardized cervical cancer incidence rates were 92.4/100,000 person-years in the intervention and 43.1/100,000 in the control arms. In the screened arm, 35.0% of cases were in Stage I as opposed to none in the control arm. The preliminary findings from our study indicate that not only is a VIA-based screening programme feasible, safe and acceptable to a population in rural settings, it also results in early detection of cervical neoplasia.