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Background: Cancer burden in India is rapidly growing, with oral, breast, and uterine cervix being the three most commonly affected sites. It has a catastrophic epidemiological and financial impact on rural communities, the vast majority of whom are socio‐economically disadvantaged. Strengthening the health system is necessary to address challenges in the access and provision of cancer services, thus improving outcomes among vulnerable populations. Objective: To develop, test, and validate a health system capacity assessment (HSCA) tool that evaluates the capacity and readiness for cancer services provision in rural India. Methods: A multi‐method process was pursued to develop a cancer‐specific HSCA tool. Firstly, item generation entailed both a nominal group technique (to identify the health system dimensions to capture) and a rapid review of published and gray literature (to generate items within each of the selected dimensions). Secondly, tool development included the pre‐testing of questionnaires through healthcare facility visits, and item reduction through a series of in‐depth interviews (IDIs) with key local stakeholders. Thirdly, tool validation was performed through expert consensus. Results: A three‐step HSCA multi‐method tool was developed comprising: (a) desk review template, investigating policies and protocols at the state level, (b) facility assessment protocol and checklist, catering to the Indian public healthcare system, and (c) IDI topic guide, targeting policymakers, healthcare workforce, and other relevant stakeholders. Conclusions: The resulting HSCA tool assesses health system capacity, thus contributing to the planning and implementation of context‐appropriate, sustainable, equity‐focused, and integrated early detection interventions for cancer control, especially toward vulnerable populations in rural India and other low‐resource settings. [ABSTRACT FROM AUTHOR]

Background: This study presents the preliminary results of a randomized controlled trial (RCT) initiated in January 2006 in India to evaluate the effectiveness of clinical breast examination (CBE) in reducing breast cancer mortality as compared to a no‐screening control group reported significant downstaging in the intervention group. The present manuscript reports long‐term follow‐up outcomes. Methods: Women 30–69 years old from 133 intervention clusters and 141 control clusters were invited to participate. Women in the intervention arm underwent three rounds of CBE every 3 years. CBE‐positive women were reexamined by a physician, and triple‐assessment was performed on those confirmed to have abnormalities. All participants were followed through home visits and linkage with population‐based cancer registry. Results: Of the 55,843 eligible women in the intervention arm, 95.7% had CBE at least once and 11.5% were CBE‐positive. Breast cancers were diagnosed in 335 participants in the intervention group and 273 in the control group (N = 59,447). Age‐standardized incidence rate of early cancer was 30.4 of 100,000 in the intervention and 21.9 of 100,000 in the control group, with a rate ratio (RR) of 1.4 (95% confidence interval [CI], 1.1–1.8). The age‐standardized breast cancer mortality rates were 11.3 and 11.1 per 100,000 in intervention and control arms, respectively (RR, 1.1; 95% CI, 0.8–1.5) after 15 years. Five‐year breast cancer survival rates were 77.0% in the intervention and 71.2% in the control groups (overall p value =.043). Conclusions: Triennial CBE screening failed to demonstrate any mortality benefit despite achieving a shift toward earlier stage at detection and improved survival in the intervention arm. CBE is a valuable tool for diagnosis of breast cancer in symptomatic women especially in areas where mammography and/or breast cancer screening programs are not widely available. The authors demonstrated that an "early diagnosis" approach can be as effective as clinical breast examination screening in reducing breast cancer mortality. These observations have major policy implications. [ABSTRACT FROM AUTHOR]

We are reporting (a) updated incidence of cervical intraepithelial neoplasia (CIN) among women who did not have colposcopic or histopathological disease at baseline and (b) disease outcomes among women treated for CIN and their follow‐up HPV status; in a cohort of women living with HIV (WHIV). The median overall follow‐up was 3.5 years (IQR 2.8‐4.3). The incidence of any CIN and that of CIN 2 or worse disease was 16.7 and 7.0 per 1000 person‐years of observation (PYO), respectively. Compared with women who were HPV negative at baseline, women who cleared HPV infection had 23.95 times increased risk of incident CIN 2 or worse lesions (95% CI 2.40‐661.07). Women with persistent HPV infection had 138.18 times increased risk of CIN 2 or worse lesions (95% CI 20.30‐3300.22). Complete disease regression was observed in 65.6% of the HPV positive women with high‐grade CIN and were treated with thermal ablation but HPV persistence was seen in 44.8% of those with high‐grade disease. Among those who did not have any disease at baseline and were also HPV negative, about 87% (95% CI 83.79‐89.48) women remained HPV negative during consecutive HPV test/s with the median interval of 3.5 years. Long‐term surveillance of WHIV treated for any CIN is necessary for the prevention of cervical cancer among them. Our study provides an early indication that the currently recommended screening interval of 3 to 5 years among WHIV may be extended to at least 5 years among HPV negative women. Increasing the screening interval can be cost saving and improve scalability among WHIV to support WHO's cervical cancer elimination initiative. [ABSTRACT FROM AUTHOR]

Background: Colorectal cancer (CRC) incidence and mortality rates are increasing rapidly in many low‐income and middle‐income countries. A demonstration project was implemented in Morocco in collaboration with the Ministry of Health to assess the feasibility, acceptability, and challenges of implementing CRC screening through routine primary care facilities. Methods: The objective of the project was to screen 10,000 men and women aged 50 to 75 years through 10 primary health centers (PHCs) in 2 provinces. All eligible men and women attending the selected PHCs were offered the fecal immunochemical test (FIT). Stool specimens brought to the PHCs were tested immediately by trained nurses. FIT‐positive individuals were referred to the National Oncology Institute for colonoscopy. Results: In total, 9763 eligible men and women were screened by FIT between June 2017 and May 2019; most (73.3%) were women. The test was positive in 460 participants (4.7%). Among the individuals who had positive FIT results, 62.6% underwent colonoscopy. The main reasons for noncompliance to colonoscopy were competing life priorities (15.4%), other health problems (13%), and fear of getting a cancer diagnosis (12.3%). As the number of referrals to colonoscopy increased, the waiting time for the procedure increased, resulting in a drop in compliance. The detection rates of advanced adenomas and CRC were 4.0 in 1000 and 0.5 in 1000 individuals screened, respectively. Conclusions: An effective strategy to reach the target populations (especially men), a pragmatic assessment of the health system's capacity to deal with large numbers of referrals, and a formal cost‐effectiveness analysis are essential before making any decision to introduce CRC screening in Morocco. The performance of colorectal cancer screening with the fecal immunochemical test offered through existing health infrastructure in Morocco is described. The report highlights facilitators and challenges that must be considered before making any decision to introduce colorectal cancer screening in low‐income and middle‐income countries. [ABSTRACT FROM AUTHOR]

The present study is the first systematic review of papers that have performed a full economic evaluation on oral cancer screening strategies using visual oral examination. The review questions were (1) Is screening a cost‐effective strategy in oral cancer? (2) What is the most cost‐effective strategy among the different screening approaches in oral cancer? The main outcome measure was the incremental cost‐effectiveness ratio. The study identifies and reviews seven full economic evaluations. The included studies scored 75%–100% on the methodological appraisal. Majority of the studies reports that oral cancer screening is a cost‐effective strategy, especially in an opportunistic setting and high‐risk subset of patients. The results were sensitive to cost and effectiveness parameters. Oral cancer screening, though found cost‐effective, the uncertainty around these parameters necessitates additional studies that include better estimates in the modeling assessments. The heterogeneity in studies limited comparison and generalization. [ABSTRACT FROM AUTHOR]

Thermal ablation is a point‐of‐care ablative treatment technique for cervical intraepithelial neoplasia (CIN). However, limited information is available about its efficacy in low‐ and middle‐income countries. We evaluated the efficacy of thermal ablation in treatment of CIN detected through high‐risk human papillomavirus (HPV) screening in China. Women positive on high‐risk HPV and having colposcopically suspected lesions eligible for ablation underwent colposcopy, biopsy and thermal ablation in one visit. Women ineligible were recalled for large loop excision of transformation zone (LLETZ) when histopathology results were high‐grade CIN. Posttreatment follow‐up at 6 months or more was with HPV test and cytology followed by colposcopy and biopsy for HPV and/or cytology‐positive women. Cure was defined as either negative cytology and HPV test or absence of histopathology proved CIN in any positive women. Of total 218 HPV‐positive women treated with thermal ablation (n = 170) or LLETZ (n = 48), 196 reported for follow‐up evaluation. For women with histologically confirmed CIN at baseline (thermal ablation‐104; LLETZ‐38), cure rates were 84.6% for thermal ablation and 86.8% for LLETZ. Cure rates after thermal ablation were 90.3% for CIN grade one (CIN1) and 76.2% for CIN grade two or worse (CIN2+). HPV clearance rate was 80.4% in women undergoing thermal ablation, which was lower for HPV16/18 compared to other oncogenic types (67.6% vs 85.7%). HPV test had a negative predictive value (NPV) of 98.7% to detect CIN2+ at follow‐up and the positive predictive value (PPV) was 40.4%. Thermal ablation is effective to treat CIN as well as to clear the high‐risk HPV infection. HPV test has high PPV and NPV in following up patients posttreatment. What's new? When premalignant cervical lesions are detected following HPV screening, thermal ablation (TA) may be an ideal point‐of‐care treatment option for lower‐income regions. But is it effective enough to warrant widespread use in these areas? In this prospective Chinese study, the authors found that the answer is yes, with the added benefit that TA may also clear high‐risk HPV infection. These results support the use of thermal ablation following colposcopy during a single clinic visit, in order to improve access to treatment of premalignant cervical lesions in regions with fewer resources. [ABSTRACT FROM AUTHOR]

Comparable performance indicators for breast cancer screening in the European Union (EU) have not been previously reported. We estimated adjusted breast cancer screening positivity rate (PR) and detection rates (DR) to investigate variation across EU countries. For the age 50–69 years, the adjusted EU‐pooled PR for initial screening was 8.9% (cross‐programme variation range 3.2–19.5%) while DR of invasive cancers was 5.3/1,000 (range 3.8–7.4/1,000) and DR of ductal carcinoma in situ (DCIS) was 1.3/1,000 (range 0.7–2.7/1,000). For subsequent screening, the adjusted EU‐pooled PR was 3.6% (range 1.4–8.4%), the DR was 4.0/1,000 (range 2.2–5.8/1,000) and 0.8/1,000 (range 0.5–1.3/1,000) for invasive and DCIS, respectively. Adjusted performance indicators showed remarkable heterogeneity, likely due to different background breast cancer risk and awareness between target populations, and also different screening protocols and organisation. Periodic reporting of the screening indicators permits comparison and evaluation of the screening activities between and within countries aiming to improve the quality and the outcomes of screening programmes. Cancer Screening Registries would be a milestone in this direction and EU Screening Reports provide a fundamental contribution to building them. What's new? Approximately half a million women in the European Union (EU) are afflicted with breast cancer but the screening process is not standardized across Europe. Here, the authors used data from the Second EU Screening Report to present adjusted breast cancer screening positivity and detection rates across Europe. They find large variability by country in detection rates, likely due to differences in background risk, awareness of the target populations, and different screening protocols, underscoring the need for periodic reporting of performance indicators in EU‐Member States. [ABSTRACT FROM AUTHOR]

Human papillomavirus (HPV) test, self‐sampling and thermal ablation for cervical intraepithelial neoplasia (CIN) have been developed separately to increase screening coverage and treatment compliance of cervical cancer screening programmes. A large‐scale study in rural China screened 9,526 women with their combinations to explore the optimal cervical cancer‐screening cascade in the real‐world. Participants received careHPV and polymerase chain reaction (PCR) HPV tests on self‐collected samples. Women positive on either HPV test underwent colposcopy, biopsy and thermal ablation in a single visit. Samples positive on either HPV test were retested for genotyping. Absolute and relative performance of HPV tests, triage strategies, 'colposcopy and thermal ablation' approach were statistically evaluated. PCR HPV test detected 33.3% more CIN grade two or worse (CIN2+) at a cost of 28.1% more colposcopies compared to careHPV. Sensitivities of PCR HPV and careHPV tests to detect CIN2+ were 96.7 and 72.5%. Specificities for the same disease outcome were 82.1 and 86.0%. Triaging HPV‐positive women with HPV16/18 genotyping considerably improved the positive predictive value for CIN2+ (4.8–5.0 to 18.2–19.2%). Ninety‐six women positive on HPV and having abnormal colposcopy were eligible for thermal ablation and all accepted same‐day treatment, contributing to 64.6% being treated appropriately (CIN1+ on histopathology), which reached up to 84.8% among women positive on HPV 16/18 triage. No serious side‐effects/complications were reported. The combination of PCR HPV test followed by HPV 16/18 triaging on self‐collected samples and colposcopy of triage positive women followed by immediate thermal ablation might be the appropriate screening cascade for rural China. What's new? To be effective, cervical cancer screening programs must be tailored to the needs of the target population. In rural China, screening coverage is low, and women may not return for separate diagnosis and treatment visits. Here, the authors evaluated various screening protocols under real world conditions. They found that self‐sampling, PCR HPV test and triage based on HPV16/18 genotyping, followed by colposcopy and immediate thermal ablation in a single visit, could be the most efficient screening cascade for this rural population. This plan reduced costs while increasing compliance for follow up care. [ABSTRACT FROM AUTHOR]

The 2003 European Council recommendation urging the Member States to introduce or scale up breast, cervical and colorectal cancer screening through an organized population‐based approach has had a remarkable impact. We argue that the recommendation needs to be updated for at least two sets of reasons. First, some of the current clinical guidelines include new tests or protocols that were not available at the time of the Council document. Some have already been adopted by organized screening programs, such as newly defined age ranges for mammography screening, Human Papillomavirus (HPV)‐based cervical cancer screening, fecal immunochemical test (FIT) and sigmoidoscopy for colorectal cancer screening. Second, the outcomes of randomized trials evaluating screening for lung and prostate cancer have been published recently and the balance between harms and benefits needs to be pragmatically assessed. In the European Union, research collaboration and networking to exchange and develop best practices should be regularly supported by the European Commission. Integration between primary and secondary preventive strategies through comprehensive approaches is necessary not only to maximize the reduction in cancer burden but also to control the rising trend of other noncommunicable diseases sharing the same risk factors. [ABSTRACT FROM AUTHOR]

We report the incidence of cervical intraepithelial neoplasia (CIN) among HIV‐infected women who did not have any colposcopic or histopathological evidence of CIN at baseline. Of the 1,023 women without any CIN at baseline, 855 (83.6%) have been followed up to a maximum of 6.4 years contributing 2,875 person years of observation (PYO). Among these 855 women, 54 cases of any CIN were observed resulting in incidence rate of any CIN of 1.9 per 100 PYO. The median time for follow‐up for women with any CIN was 3.0 (IQR 1.6–3.7) years. The cumulative incidence rate per 100 PYO of CIN 2 or worse lesion in women with HPV‐18 infection at baseline was 13.3% (95% CI 5.1–26.8); in women with HPV‐16 infection was 10.8% (95% CI 4.4–20.9); in women with HPV‐31 infection was 4.2% (95% CI 0.9–11.7); and in women with other high‐risk HPV infections was 5.4% (95% CI 2.6–9.7). HPV‐18 infection at baseline contributed highest frequency of incident CIN 2 or worse lesions followed by HPV‐16 infection; however, other high‐risk HPV types were also responsible for substantial number of incident CIN. The elevated risk of CIN2+ disease in the study cohort was non‐significant in women with CD4 count <200, possibly because of the small number of cases. Our results emphasize the need for regular cervical cancer screening of HIV‐infected women and urgent implementation of cervical cancer screening services in HIV programs in India and other low and middle‐income countries. What's new? The regions in the world with high cervical cancer burden are also the regions with a high burden of human immunodeficiency virus (HIV) infection. Here the authors report incidence rates of cervical abnormalities in HIV‐infected women in India. HIV‐infected women with human papillomavirus infection at baseline had a 57 times increased risk of developing cervical intraepithelial neoplasia during follow‐up, underscoring the urgent need for regular cervical cancer screening in HIV treatment platforms. [ABSTRACT FROM AUTHOR]

Breast Cancer Screening Program was introduced and rolled out in Morocco in 2010. Women between 40 and 69 years are screened at the primary health centers (PHC) with clinical breast examination (CBE). A comprehensive evaluation of the program was conducted in 2016–2017 for quality assurance and mid‐term course correction. The evaluation process involved: in‐depth interviews of program managers; focus group discussions with service‐providers of screening, diagnosis and treatment; supportive supervisory visits to randomly selected PHCs and diagnostic centers; desk review of the national guidelines and other published documents; and analysis of the performance data compiled by the program‐in‐charge. We found that the program has strong political support, a well‐organized management structure and documented national policy and protocol. In absence of a mechanism to identify and invite the eligible women individually, the program is opportunistic in nature. Every PHC is provided with an annual target to be screened. A highly visible annual campaign to educate and motivate women has a major impact on participation. Record keeping and data collection are paper‐based. In the years 2015 and 2016, 1.1 and 1.5 million women were screened, respectively. In the year 2015, 62.8% of the annual target population was covered, CBE positivity was 3.2%, a further assessment rate of screen‐positive women was 34.1% and the breast cancer detection rate was 1.0/1000 women. Systematic paper‐based data collection enabled the assessment of some of the process and outcome indicators. The screening coverage was moderate and the cancer detection rate was low. What's new? The rising incidence of breast cancer is a tremendous public health challenge in the developing world. Clinical breast examination is a promising approach provided effective diagnosis, timely treatment, and adequate resources. Here, the authors conducted a comprehensive evaluation of the Breast Cancer Screening Program in Morocco, where systematic data collection is challenging in absence of a computerized information system. They found that the program has strong political support and a well‐organized management structure. Systematic paper‐based data collection showed a moderate screening coverage and low cancer detection rate. The experience will be useful for all developing countries implementing clinical breast examination. [ABSTRACT FROM AUTHOR]

The second report on the implementation status of cancer screening in European Union (EU) was published in 2017. The report described the implementation status, protocols and organization (updated till 2016) and invitation coverage (for index year 2013) of breast, cervical and colorectal cancer screening in the EU. Experts in screening programme monitoring ( N = 80) from the EU Member States having access to requisite information in their respective countries provided data on breast, cervical and colorectal cancer screening through online questionnaires. Data was collected for screening performed in the framework of publicly mandated programmes only. Filled in questionnaires were received from 26 Member States for all three sites and from one Member State for breast cancer only. Substantial improvement in screening implementation using population-based approach was documented. Among the age-eligible women, 94.7% were residents of Member States implementing or planning population-based breast cancer screening in 2016, compared to 91.6% in 2007. The corresponding figures for cervical cancer screening were 72.3 and 51.3% in 2016 and 2007, respectively. Most significant improvement was documented for colorectal cancer screening with roll-out ongoing or completed in 17 Member States in 2016, compared to only five in 2007. So the access to population-based screening increased to 72.4% of the age-eligible populations in 2016 as opposed to only 42.6% in 2007. The invitation coverage was highly variable, ranging from 0.2-111% for breast cancer, 7.6-105% for cervical cancer and 1.8-127% for colorectal cancer in the target populations. In spite of the considerable progress, much work remains to be done to achieve optimal effectiveness. Continued monitoring, regular feedbacks and periodic reporting are needed to ensure the desired impacts of the programmes. [ABSTRACT FROM AUTHOR]

E6 oncoprotein is a necessary agent of HPV driven oncogenic transformation. This study is aimed at evaluating the risk stratification potency of HPV 16/18 E6 oncoprotein (E6) as a triage method for HPV positivity. Moreover, it also acts as a predictor of cervical intraepithelial neoplasia grade 3 or worse (CIN3+). The screening cohort of 1,997 women was followed for a 15 year period in approximate five-year intervals. Participants were concurrently screened by HPV DNA testing (HC2), liquid based cytology (LBC), visual inspection with acetic acid (VIA) and were referred to colposcopy and biopsy if any tests reflected positive. E6 was performed on cervical samples collected from this cohort in 2005 and 2014. The ability of E6 to predict CIN3+ risk after the five- and ten-year interval was evaluated. Among HPV positive women in 2005, E6 indicated the lowest positive rate (9.9%) compared to LBC (48.4%) and VIA (28.0%), however, a higher prevalence rate (10.3%) and 10-year cumulative incidence rate (53.0%) of CIN3+ were detected among women who were E6 positive. Meanwhile, only 4.2% and 2.9% of women with abnormal LBC and positive VIA were diagnosed as prevalent CIN3+ in 2005, 23.0% and 16.5% developed to CIN3+ after year 10, respectively. Strong associations were found between precedent and subsequent HPV persistence and E6 oncoprotein expression (ORadjusted = 40.0 and 21.2, respectively). E6 oncoprotein could serve as a low-cost, highly specific, strongly indicative point-of-care method in the triage and treatment of HPV positive women. [ABSTRACT FROM AUTHOR]

Infection with high-risk human papillomavirus (HR-HPV) is transient and clears on its own in majority of the women. Only a few women who have persistent infection may finally develop cervical intraepithelial neoplasia (CIN) or cervical cancer in later years. The risk of progression in the HR-HPV-positive women with normal cervix or low-grade lesion on colposcopy and histopathology at baseline is less studied. We performed a longitudinal study on 650 HR-HPV-positive women with colposcopy and/or histopathology-proved normal or CIN1 diagnosis at baseline to assess the cumulative risk of development of high-grade CIN. After a mean follow-up of 2.1 person years of observation (PYO) (range 0.1-5.1), the cumulative incidence of CIN2+ (6.4%; 3.0/100 PYO) was significantly higher in women who had persistent HR-HPV infection compared to those who cleared the infection (adjusted HR 6.28; 95% CI 2.87-13.73). The risk of viral persistence in women aged 50-60 years was two times higher compared to women aged 40-49 years and three times higher compared to women aged 30-39 years. The probability of having persistent infection increased progressively with higher viral load at baseline (adjusted HR 3.29, 95% CI 2.21-4.90 for RLU ≥100; adjusted HR 2.69, 95% CI 1.71-4.22 for RLU 10-100). Women with increasing viral load at follow-up had four times higher risk of developing CIN2 or worse lesions as compared to those with decreasing load (20.9% vs 4.8%; p < 0.001). In the context of developing countries where cytology or genotyping triaging is not feasible, colposcopy referral of HR-HPV-positive women with advancing age, viral persistence, and increasing viral load may be considered. [ABSTRACT FROM AUTHOR]

By using data from the International Agency for Research on Cancer publication Cancer Incidence in 5 Continents and GLOBOCAN, this report provides the first consolidated global estimation of the subsite distribution of new cases of lip, oral cavity, and pharyngeal cancers by country, sex, and age for the year 2012. Major geographically based, sex-based, and age-based variations in the incidence of lip, oral cavity, and pharyngeal cancers by subsite were observed. Lip cancers were highly frequent in Australia (associated with solar radiation) and in central and eastern Europe (associated with tobacco smoking). Cancers of the oral cavity and hypopharynx were highly common in south-central Asia, especially in India (associated with smokeless tobacco, bidi, and betel-quid use). Rates of oropharyngeal cancers were elevated in northern America and Europe, notably in Hungary, Slovakia, Germany, and France and were associated with alcohol use, tobacco smoking, and human papillomavirus infection. Nasopharyngeal cancers were most common in northern Africa and eastern/southeast Asia, indicative of genetic susceptibility combined with Epstein-Barr virus infection and early life carcinogenic exposures (nitrosamines and salted foods). The global incidence of lip, oral cavity, and pharyngeal cancers of 529,500, corresponding to 3.8% of all cancer cases, is predicted to rise by 62% to 856,000 cases by 2035 because of changes in demographics. Given the rising incidence of lip, oral cavity, and pharyngeal cancers and the variations in incidence by subsites across world regions and countries, there is a need for local, tailored approaches to prevention, screening, and treatment interventions that will optimally reduce the lip, oral cavity, and pharyngeal cancer burden in future decades. CA Cancer J Clin 2017;67:51-64. © 2016 American Cancer Society. [ABSTRACT FROM AUTHOR]

Visual inspection after acetic acid application (VIA) and human papillomavirus (HPV) detection tests have been recommended to screen women for cervical cancer in low and middle income countries. A demonstration project in rural India screened 39,740 women with both the tests to compare their accuracies in real population setting. The project also evaluated the model of screening women in the existing primary health care facilities, evaluating the screen positive women with colposcopy (and biopsy) in the same setup and recalling the women diagnosed to have disease for treatment at tertiary center. Accuracy of VIA and HPV test used sequentially was also studied. VIA was performed by trained health workers and Hybrid Capture II (HC II) assay was used for oncogenic HPV detection. Test positivity was 7.1% for VIA and 4.7% for HC II. Detection rate of CIN 3+ disease was significantly higher with HC II than VIA. Sensitivities of VIA and HC II to detect 162 histology proved CIN 3+ lesions were 67.9 and 91.2%, respectively after adjusting for verification bias. Specificity for the same disease outcome and verification bias correction was 93.2% for VIA and 96.9% for HC II. Triaging of VIA positive women with HPV test would have considerably improved the positive predictive value (4.0 to 37.5% to detect CIN 3+) without significant drop in sensitivity. All VIA positive women and 74.0% of HC II positive women had colposcopy. There was high compliance to treatment and significant stage-shift of the screen-detected cancers towards more early stage. [ABSTRACT FROM AUTHOR]

Although virtually all cervical cancers and most cervical intraepithelial neoplasia (CIN) are caused by persistent human papillomavirus (HPV) infection, only a small proportion of HPV-positive women have or will develop CIN. Triaging HPV-positive women has been suggested to reduce the false-positive rate and proportion of women referred for CIN confirmation and/or treatment. In two cross-sectional studies and one randomized trial in India, we evaluated the impact of using cytology or visual inspection with acetic acid (VIA) to triage HPV-positive women on the proportion of women who would be referred for CIN confirmation and on the detection rates of high-grade CIN. We present the numbers of HPV test-positive women found and the CIN detected among them. We further assess the proportions that would be referred for CIN confirmation with colposcopy/biopsy and CIN that would be detected if cytology triage or VIA triage were used. Using cytology triage at atypical squamous cells of undetermined significance threshold or VIA triage reduced referrals for colposcopy by about 62% and 59%, respectively ( p-value = 0.012), but missed around 16% and 18%, respectively, of the high-grade CIN ( p-value = 0.539) indicating similar performance of both triaging approaches. The choice of a triage test in different low- and middle-income countries (LMIC) would depend on the availability and affordability in the particular setting. Cytology triage may be considered in settings where adequate infrastructure exists, whereas VIA triage may be suitable in settings with limited or no cytology infrastructure. [ABSTRACT FROM AUTHOR]

Population prevalence of human papillomavirus (HPV) and cervical intraepithelial neoplasias (CIN) is an important indicator to judge the disease burden in the community, to monitor the performance of cervical cancer screening program and to assess the impact of HPV vaccination program. India being a country without any cervical cancer screening program has no published data on the population prevalence of CIN and only a few large community-based studies to report the high-risk HPV prevalence. The objective of our study was to study HPV and CIN prevalence in a previously unscreened population. We pooled together the results of three research studies originally designed to assess the performance of visual inspection after acetic acid application and Hybrid Capture 2 (HC 2). Nearly 60% of the screened women had colposcopy irrespective of their screening test results. The diagnosis and grading of cervical neoplasias were based on histology. The age standardized prevalence of HPV by HC 2 test was 6.0%. Age-adjusted prevalence of CIN1 and CIN2 was 2.3% and 0.5%, respectively. The age-adjusted prevalence of CIN3 was 0.4% and that of invasive cancer was 0.2%. The prevalence of high-risk HPV was relatively low in the population we studied, which is reflected in the low prevalence of high-grade CIN. The prevalence of CIN3 remained constant across age groups due to absence of screening. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To describe phase 1 of an organized cytology screening project initiated in Thailand by the Ministry of Public Health and the National Health Security Office. Methods: Women aged 35–60years were encouraged to undergo cervical screening in primary care units and hospitals through awareness programs. Papanicolaou smears were processed and reported at district or provincial cytology laboratories. Women with normal test results were advised to undergo repeat screening after 5years, while those with precancerous and cancerous lesions were referred for colposcopy, biopsy, and treatment. Information on screening, referral, investigations, and therapy were logged in a computer database. Results: Between 2005 and 2009, 69.2% of the 4030833 targeted women were screened. In all, 20991 women had inadequate smears; 27253 had low-grade squamous intraepithelial lesions; 15706 had high-grade squamous intraepithelial lesions; and 2920 had invasive cancers. Information on the management of precancerous lesions was available for only 17.4% of women referred for colposcopy. Conclusion: Although follow-up data on women with positive test results were inadequately documented, the present findings indicate that provision of cytology services through the existing healthcare system is feasible. [Copyright &y& Elsevier]

Cervical cancer is the most common cancer among women in many areas of India which contributes for a fifth of the global burden of disease. Persistent infection with one of the high-risk human papillomaviruses (HPV) has been established as the cause for cervical cancer and the documentation of the prevalence of HPV types in cervical cancer in different regions of India is useful for a prevention program combining both screening and vaccination. In this study, the HPV type distribution and the frequency of p16INK4a immunoexpression have been determined in 125 cases of inflammatory lesions or grade 1 cervical intraepithelial neoplasia, 74 cases of grade 2, 72 cases of grade 3, and 113 cervical cancer cases diagnosed among women from rural Solapur and Osmanabad districts, Maharashtra. The overall prevalence of high-risk HPV was 37.6% in inflammatory lesions or grade 1 cervical intraepithelial neoplasia, 63.5% in grade 2, 97.2% in grade 3 and 92% in cervical cancer cases. HPV 16 and HPV 18 were detected in 80.6% of grade 3 cervical intraepithelial neoplasia and 86.5% of cervical cancer cases. 94.7% of the cervical cancer and 84.4% of the high grade lesions with a strong and full thickness staining for p16INK4a were positive for HPV infection; p16INK4a immunoexpression increased with worsening grade of cervical intraepithelial neoplasia. The HPV genotyping data showing a high HPV 16 and 18 prevalence in cancer specimens indicate that prophylactic HPV 16/18 vaccination would have a significant impact on the prevention of cervical cancer in India. J. Med. Virol. 84: 1054-1060, 2012. © 2012 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

Objective: To provide an updated estimation of the accuracy of visual inspection with acetic acid (VIA) in detecting true disease.Methods: A PubMed search provided original studies on VIA accuracy in which the gold standard for confirmatory testing was histology alone or colposcopy followed by biopsy. The numbers of true-positive, false-positive, false-negative, and true-negative results were extracted from each study. Meta-analyses were then performed with different categories of studies according to confirmatory diagnosis threshold, category of women who received confirmatory testing, and whether a medical condition that could affect VIA accuracy was present at screening. The reference category consisted of 26 studies in which VIA was performed on asymptomatic women who all underwent confirmatory testing and in which the disease threshold was cervical intraepithelial neoplasia grade 2.Results: We report an 80% sensitivity (range, 79%-82%) and a 92% specificity (range, 91%-92%) for VIA. Study region, capacity of screener, or size of the study population did not modify VIA accuracy. The positive predictive value was 10% (range, 9%-10%).Conclusion: Screening for precancerous and cancerous cervical lesions using VIA is a simple, low-cost, and efficient alternative to cytologic testing in low-resource areas. [ABSTRACT FROM AUTHOR]

Objective: To report the organization and early results of a visual inspection with acetic acid (VIA) screening program for cervical cancer prevention in Bangladesh.Methods: Opportunistic VIA screening was offered by trained medical personnel to healthy women attending healthcare facilities in 44 districts. Colposcopy and/or directed biopsies were performed on VIA-positive women at Bangabandhu Sheikh Mujib Medical University (BSMMU) or medical college hospitals. The numbers of screened and VIA-positive women as well as the results of colposcopy, biopsy, and treatment of those with cervical intraepithelial neoplasia (CIN) attending BSMMU are reported.Results: From January, 2005, to June, 2008, 104098 women underwent VIA screening. Among them, 5013 (4.8%) women were positive, of whom 4371 (87.2%) attended colposcopy clinics in different hospitals. Of the 2188 who underwent colposcopy at BSMMU, 157 were diagnosed with CIN 2-3 and 123 with invasive cancer. For 2065 women (excluding the cancer cases), results for sensitivity, specificity, and positive predictive value of VIA to detect CIN 2-3 lesions were 93.6%, 58.3%, and 15.6%, respectively. Almost half the women with CIN 2 or 3 lesions had treatment.Conclusion: A VIA-based program would facilitate the development of screening, diagnosis, and treatment of cervical neoplasia and improve awareness of cervical cancer prevention in Bangladesh. [ABSTRACT FROM AUTHOR]

Abstract: Objective: A cross-sectional study in Angola to evaluate the feasibility of cervical screening using visual inspection with acetic acid (VIA) or Lugol''s iodine (VILI) to detect and treat cervical intraepithelial neoplasia (CIN). Methods: All 8851 women screened by trained nurses received colposcopy and/or colposcopically-directed biopsies. The final disease status was based on histopathology or colposcopy when no or inadequate biopsies were done. The sensitivity, specificity, and predictive values of tests to detect CIN 2–3 were calculated. Results: VIA was positive in 6.6% and VILI in 32.0% of the women. The positivity rates increased with time only for VILI. CIN 2–3 was diagnosed in 75 women and invasive cancer in 57. The sensitivity and specificity was 70.7% (95% CI, 59.0%–80.6%) and 94.5% (95% CI, 94.0%–95.0%) respectively for VIA, and 88.0% (95% CI, 78.4%–94.4%) and 68.9% (95% CI, 67.9%–69.9%) for VILI. Ninety percent of women detected with CIN received treatment. Treatment was given on the same day as screening to one-third of the 374 women treated with cryotherapy/LEEP. No major complications or adverse effects were associated with treatment. Conclusion: It was feasible to screen with both visual tests and treat women with CIN in Angola. VILI was less specific than VIA, implying subjectivity in interpreting test results. [Copyright &y& Elsevier]

Abstract: Objective: To evaluate the feasibility and performance of screening for cervical cancer using visual inspection with acetic acid (VIA) or with Lugol''s iodine (VILI) in Dar es Salaam, Tanzania. Methods: The accuracy of tests for detecting cervical intraepithelial neoplasia (CIN) was assessed in a cross-sectional study of 10378 women. All women who were screened underwent colposcopy, and biopsies were offered to those with abnormal colposcopy results. Results: The positivity rates were 3.8% for VIA and 4.8% for VILI. The peak positivity rates for both visual tests were observed just after training or re-training and gradually declined thereafter. CIN 1 was diagnosed in 41 women, CIN 2–3 in 33 women, and invasive cancer in 200 women, showing high detection rates of invasive cancer. The sensitivity and specificity for the detection of CIN 2–3 lesions were 60.6% (95% confidence interval [CI], 42.1–77.1) and 98.2% (95% CI, 97.9–98.4), respectively, for VIA; and 93.9% (95% CI, 79.8–99.3) and 97.3% (95% CI, 97.0–97.6), respectively, for VILI. Two-thirds of the women detected with CIN 2–3 lesions were treated. Conclusion: Both visual screening tests are useful and accurate, especially in low-income settings. Standardization of assessment of the visual inspection techniques, continual training and supervision, and quality control measures are important for successful visual screening programs. [Copyright &y& Elsevier]

Abstract: Objective: To compare the utility of cytology and HPV testing in women from Mumbai, India, suspected of having cervical intraepithelial neoplasia (CIN) on visual inspection with acetic acid (VIA), Lugol''s iodine (VILI), or both. Method: The sensitivity, specificity, and predictive values of these tests for the detection of CIN 2 and/or 3 were evaluated in this cross-sectional study with 756 women suspected of having CIN on visual inspection. Results: There were 25 women with CIN 2, 20 with CIN 3, and 21 with invasive cancer. The sensitivity to detect CIN 3 lesions was 85.0% (95% CI, 62.1–96.8) and 70.0% (95% CI, 45.7–88.1) for cytology testing at the ASCUS and LSIL thresholds, respectively, and it was 89.5% (95% CI, 66.9–98.7) for HPV testing. The specificity to detect CIN 3 lesions was 94.5% (95% CI, 92.5–96.1) and 96.1% (95% CI, 94.4–97.5) for cytology testing at the ASCUS and LSIL thresholds, and it was 91.1% (95% CI, 88.5–93.2) for HPV testing. Conclusion: Cytology and HPV testing were both found to be accurate triaging methods for women suspected of having CIN on visual inspection, especially for those with CIN 3 lesions. [Copyright &y& Elsevier]

Objective: The aim of the study was to evaluate the role of alcohol drinking and patterns of consumption in oral cancer incidence and mortality in a cohort study using data from the Trivandrum Oral Cancer Screening Study, India. Methods: At baseline, the study participants completed a lifestyle questionnaire including items on frequency and duration of alcohol consumption. They were followed up for oral cancer incidence and mortality. Data from 32 347 subjects, of whom 134 eventually developed oral cancer, were analysed to estimate risk of oral cancer incidence and mortality according to drinking patterns, using a Cox regression model adjusted for age, religion, education, occupation, body mass index (BMI), standard of living index, chewing habits, smoking habits, and vegetable and fruit intake. Results: Current and past drinkers were each associated with significantly increased risk of developing oral cancer. The hazard ratio increased significantly by 49% (95% CI = 1–121%) among current drinkers and 90% (95% CI = 13–218%) among past drinkers. A significant dose–response relationship between intake frequency, duration and oral cancer risk (incidence and mortality) was observed. Conclusions: As with other lifestyle factors, alcohol intake plays an important role in oral carcinogenesis in this population, and understanding this role is relevant to developing public health policies targeting at-risk population. [ABSTRACT FROM AUTHOR]

Objective: To assess the accuracy of cervical screening with visual inspection and cytology testing, and the cure rate of cervical intraepithelial neoplasia (CIN) after treatment, in a rural population in North India.Methods: A cross-sectional study evaluated the detection rates of CIN 2 and CIN 3 lesions by cytology testing and by visual inspection of the cervix following the application of 5% acetic acid (VIA) or Lugol's iodine (VILI). It also evaluated the cure rates following treatment of CIN.Results: Of 5050 women approached in 17 villages, 3000 (59.4%) participated (range, 41%-91%). Of these, 14.2% were positive by VIA, 15.6% by VILI, and 5.4% by cytology testing at ASCUS threshold, and 37 women were diagnosed as having CIN 1 and 20 as having CIN 2 or CIN 3. Detection rates of CIN 2 or 3 using VIA, VILI, and cytologic findings of ASCUS and LSIL were 3.7, 3.3, 4.5, and 4.2 per 1000 women, respectively, and 91.4% of the treated women were cured.Conclusion: Both VIA and VILI were found to be accurate screening tests and the cure rates for CIN were satisfactory. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness and safety of loop electrosurgical excision procedure (LEEP) to treat cervical intraepithelial neoplasia (CIN) in rural India.Method: Women with CIN colposcopic features unsuitable for cryotherapy were treated with LEEP using a "see-and-treat" approach. Women with unsatisfactory colposcopy had diagnostic LEEP. Cure was defined as no clinical or histologic evidence of CIN at 1-year follow-up. Factors influencing cure rates were evaluated by chi(2) tests.Results: Of the 1,141 women who underwent LEEP (569 see-and-treat; 572 unsatisfactory colposcopy), 634 had histologically proven CIN. Of those, 489 reported for follow-up and 459 (93.9%) had no evidence of disease. Cure rates were 98.1% for women with CIN 1, 93.6% for CIN 2, and 85.0% for CIN 3. Patients with CIN 2-3 had significantly lower cure rates.Conclusion: Cure rates for LEEP provided by newly trained doctors in rural India were similar to those reported in the gynecological literature. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness, safety, and acceptability of cryotherapy for cervical intraepithelial neoplasia (CIN) when provided by trained midwives in rural India.Method: Women with colposcopic findings of CIN lesions suitable for ablative treatment received cryotherapy from trained midwives before the biopsy results were known. Cure rates, adverse effects, and complications were assessed and factors influencing cure rates were evaluated by chi(2) tests. Cure was defined as no clinical or histologic evidence of CIN lesions 6 or more months after treatment.Results: Of 1068 women treated with cryotherapy, 728 had histologically proven CIN in their pretreatment biopsy specimens; of the 574 reporting for follow-up, 538 (93.7%) were cured (95% confidence interval [CI], 92.1%-96.3%). Cure rates were 96.4% (95% CI, 94.6%-98.1%) for CIN 1 and 82.1% (95% CI, 74.7%-89.4%) for CIN 2 and CIN 3 lesions combined. Minor adverse effects were documented in 5.2% of the women.Conclusion: Cryotherapy provided by midwives was found to be safe, effective, and acceptable by the women. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness and safety of the loop electrosurgical excision procedure (LEEP) to treat cervical intraepithelial neoplasia (CIN) in a low-resource setting.Methods: Women participating in a cervical screening study in India with histologically confirmed CIN unsuitable for cryotherapy were advised to undergo LEEP. One year after treatment the cervix was visually inspected with acetic acid, followed by colposcopy and biopsy taken from abnormal areas. Cure was defined as no clinical or histologic evidence of CIN. Factors influencing cure rates were evaluated by chi(2) tests.Results: Of the 311 women who underwent LEEP, 283 reported for 1-year follow-up and 248 (87.6%) were disease free. Cure rates were 93.0% for CIN 1, 85.5% for CIN 2, and 72.7% for CIN 3. Minor adverse effects were observed in 34 women and complications were seen in 5 women.Conclusion: LEEP was associated with minimal complications and acceptable cure rates in a low-resource setting, although women with larger lesions had lower cure rates. [ABSTRACT FROM AUTHOR]

Cervical cancer is the main cancer among women in sub-Saharan Africa, India and other parts of the developing world. Evaluation of screening performance of effective, feasible and affordable early detection and management methods is a public health priority. Five screening methods, naked eye visual inspection of the cervix uteri after application of diluted acetic acid (VIA), or Lugol's iodine (VILI) or with a magnifying device (VIAM), the Pap smear and human papillomavirus testing with the high-risk probe of the Hybrid Capture-2 assay (HC2), were evaluated in 11 studies in India and Africa. More than 58,000 women, aged 25-64 years, were tested with 2-5 screening tests and outcome verification was done on all women independent of the screen test results. The outcome was presence or absence of cervical intraepithelial neoplasia (CIN) of different degrees or invasive cervical cancer. Verification was based on colposcopy and histological interpretation of colposcopy-directed biopsies. Negative colposcopy was accepted as a truly negative outcome. VIA showed a sensitivity of 79% (95% CI 73-85%) and 83% (95% CI 77-89%), and a specificity of 85% (95% CI 81-89%) and 84% (95% CI 80-88%) for the outcomes CIN2+ or CIN3+, respectively. VILI was on average 10% more sensitive and equally specific. VIAM showed similar results as VIA. The Pap smear showed lowest sensitivity, even at the lowest cutoff of atypical squamous cells of undetermined significance (57%; 95% CI 38-76%) for CIN2+ but the specificity was rather high (93%; 95% CI 89-97%). The HC2-assay showed a sensitivity for CIN2+ of 62% (95% CI 56-68%) and a specificity of 94% (95% CI 92-95%). Substantial interstudy variation was observed in the accuracy of the visual screening methods. Accuracy of visual methods and cytology increased over time, whereas performance of HC2 was constant. Results of visual tests and colposcopy were highly correlated. This study was the largest ever done that evaluates the cross-sectional accuracy of screening tests for cervical cancer precursors in developing countries. The merit of the study was that all screened subjects were submitted to confirmatory investigations avoiding to verification bias. A major finding was the consistently higher sensitivity but equal specificity of VILI compared with VIA. Nevertheless, some caution is warranted in the interpretation of observed accuracy measures, since a certain degree of gold standard misclassification cannot be excluded. Because of the correlation between visual screening tests and colposcopy and a certain degree of over-diagnosis of apparent CIN2+ by study pathologists, it is possible that both sensitivity and specificity of VIA and VILI were overestimated. Gold standard verification error could also explain the surprisingly low sensitivity of HC2, which contrasts with findings from other studies. © 2008 Wiley-Liss, Inc. [ABSTRACT FROM AUTHOR]

The knowledge that cervical neoplasia are caused by human papillomavirus (HPV) infection has led to the evaluation of its role in screening. We evaluated the accuracy of HPV testing by Hybrid capture II (HC II) method in detecting cervical intraepithelial neoplasia grade 2 and 3 (CIN 2 and 3) lesions in 4 cross-sectional studies with common protocol and questionnaire in 3 different locations (Kolkata, Mumbai and Trivandrum) in India. These studies involved 18,085 women aged 25-65 years. The reference standard for final diagnosis was a combination of colposcopy/biopsy. All women were investigated with colposcopy and 3,116 received directed biopsy. The sensitivity of HPV testing for detecting CIN 2-3 lesions varied from 45.7% to 80.9% across the study sites; the specificity varied from 91.7% to 94.6% and the positive predictive value from 6.7% to 13.7%. Retesting of 298 randomly chosen denatured samples in France revealed an agreement rate of 85.9% and a κ-value of 0.72. Although HPV testing seems to be a promising approach for cervical cancer prevention, a large range in sensitivity was observed in our study, possibly due to variations in the quality of specimen collection and reference standards. A higher sensitivity was associated with the center performing the test well. Further developments in terms of more reproducible, less expensive and less sophisticated testing are essential to make the test feasible and effective in low-resource settings. © 2004 Wiley-Liss, Inc. [ABSTRACT FROM AUTHOR]

Visual inspection-based screening tests, such as visual inspection with 4% acetic acid (VIA) and with Lugol's iodine (VILI), have been proposed as alternatives to cytology in mass screening programs. To date, there is only limited information on the accuracy of these tests in detecting High-grade Squamous Intraepithelial Lesions (HSIL). Eleven cross-sectional studies involving 56,939 women aged 25-65 years were conducted in Burkina Faso, Congo, Guinea, India, Mali and Niger to evaluate the accuracy of VIA and VILI performed by health workers. A common protocol and questionnaire was used. For final diagnosis, all women were investigated with colposcopy and biopsies were taken when necessary. Data from the studies were pooled to calculate sensitivity, specificity and predictive values of the tests for the detection of HSIL. Of the screened women, 16.1% and 16.4% were positive on examination using, respectively, VIA and VILI; 1,063 were diagnosed with HSIL. The pooled sensitivity, specificity, positive and negative predictive values for VIA were 76.8% (95% CI: 74.2-79.4%), 85.5% (95% CI: 85.2-85.8%), 9.4% (95% CI:8.8-10.8%) and 99.5% (95% CI:99.4-99.6%), respectively. The values were 91.7% (95% CI: 89.7-93.4%), 85.4% (95% CI: 85.1-85.7%), 10.9% (95% CI: 10.2-11.6%) and 99.8% (95% CI:99.7-99.9%), respectively for VILI. The range of sensitivity and specificity for VIA was 56.1-93.9% and 74.2-93.8%, respectively, between studies and were 76.0-97.0 % and 73.0-91.3% for VILI. VILI had a significantly higher sensitivity than VIA in detecting HSIL, but specificity was similar. VILI appears to be a more accurate visual test for use in screening and treatment programs in low-resource settings. © 2004 Wiley-Liss, Inc. [ABSTRACT FROM AUTHOR]