Assessment of Efficacy and Accuracy of Cervical Cytology Screening With Artificial Intelligence Assistive System.

The role of artificial intelligence (AI) in pathology offers many exciting new possibilities for improving patient care. This study contributes to this development by identifying the viability of the AICyte assistive system for cervical screening, and investigating the utility of the system in assisting with workflow and diagnostic capability. In this study, a novel scanner was developed using a Ruiqian WSI-2400, trademarked AICyte assistive system, to create an AI-generated gallery of the most diagnostically relevant images, objects of interest (OOI), and provide categorical assessment, according to Bethesda category, for cervical ThinPrep Pap slides. For validation purposes, 2 pathologists reviewed OOIs from 32,451 cases of ThinPrep Paps independently, and their interpretations were correlated with the original ThinPrep interpretations (OTPI). The analysis was focused on the comparison of reporting rates, correlation between cytological results and histologic follow-up findings, and the assessment of independent AICyte screening utility. Pathologists using the AICyte system had a mean reading time of 55.14 seconds for the first 3000 cases trending down to 12.90 seconds in the last 6000 cases. Overall average reading time was 22.23 seconds per case compared with a manual reading time approximation of 180 seconds. Usage of AICyte compared with OTPI had similar sensitivity (97.89% vs 97.89%) and a statistically significant increase in specificity (16.19% vs 6.77%) for the detection of cervical intraepithelial neoplsia 2 and above lesions. When AICyte was run alone at a 50% negative cutoff value, it was able to read slides with a sensitivity of 99.30% and a specificity of 9.87%. When AICyte was run independently at this cutoff value, no sole case of high-grade squamous intraepithelial lesions/squamous cell carcinoma squamous lesion was missed. AICyte can provide a potential tool to help pathologists in both diagnostic capability and efficiency, which remained reliable compared with the baseline standard. Also unique for AICyte is the development of a negative cutoff value for which AICyte can categorize cases as "not needed for review" to triage cases and lower pathologist workload. This is the largest case number study that pathologists reviewed OOI with an AI-assistive system. The study demonstrates that AI-assistive system can be broadly applied for cervical cancer screening.

Atypical glandular cells in Pap tests: cytology-histology correlation and risk assessment with human papillopmavirus (HPV) testing.

INTRODUCTION: Atypical glandular cells (AGC) represent less than 1% of Pap test cases and include a variety of lesions in both the cervix and endometrium. The study aimed to investigate the cytology-histology correlation in AGC patients and to evaluate the clinical utility of hrHPV testing in this diagnostic context. MATERIALS AND METHODS: We identified 491 atypical glandular cells (AGC) cases in our quality analysis (QA) database of 336,064 Pap tests interpreted between March 1, 2013 and July 12, 2016. Of these, 251 cases had follow-up biopsies with hrHPV tests in 148 cases. RESULTS: The most common histologic diagnosis associated with AGC was normal/benign or low-grade lesions, comprising 55% of cervical biopsies and 24% of endometrial biopsies. High-grade lesions were identified in 21% of follow-up biopsies. In patients with AGC cytology, a positive hrHPV test significantly increased the likelihood of cervical HSIL or above lesions on biopsy by 26.4 times (OR = 26.4, 95% CI: 5.8-119.4, P < 0.0001). A positive genotyping result for HPV 16 dramatically increased the likelihood of cervical HSIL or above lesions on biopsy (OR = 84, 95% CI: 12.0-590.5, P < 0.0001). The HPV test had a negative predictive value of 97% (CI: 85%-100%). CONCLUSIONS: Our study confirms that AGC is a significant diagnosis with an overall risk for high-grade cervical or endometrial lesions as high as 21%. hrHPV testing with genotyping is an effective tool for identifying high-risk individuals within the AGC population, with excellent positive and negative predictive values. This approach is valuable for clinical risk stratification and differential diagnosis in patients with AGC cytology.

[Budget impact of self-testing in the national cervical cancer screening program]. / Impact budgétaire de l'utilisation de l'autotest dans le cadre du programme national de dépistage du cancer du col de l'utérus.

OBJECTIVES: A nationwide screening program for cervical cancer (CC) was organized in 2018 as part of the 2014-2019 French cancer plan, with the objective of reducing CC incidence and mortality in France by reaching an 80 % coverage rate. As an alternative to pap smear, vaginal self-sampling (VSS) aimed at identifying high-risk HPV carriage could help to achieve this goal. The objective of the present study is to compare the respective budgetary impacts of several self-sampling strategies. METHOD: A budget impact model was developed to compare non-use of self-sampling in CC screening to the 5-year costs of 5 VSS strategies viewed from an all-payer perspective. While the first strategy was based on mailing the VSS kit with a reminder to participate in the screening program, the second was based on accompanying the mailed kit with an invitation to participate. The third and fourth strategies were based on providing health professionals with the kit, and thereby offering self-sampling as an alternative to pap smears for women undergoing CC screening and having previously received the kits. Finally, the fifth strategy was based on self-sampling as the one and only CC screening modality. The parameters of the model were based on past screening participation data and experiments in France on organized screening and VSS use. The costs included those of procedures associated with screening and program organization. RESULTS: All in all, the costs associated with cervical cancer screening would represent approximately 1 billion euros over 5 years. All strategies would be associated with participation ranging from 81% to 84%, which would represent an increase of 4.7% to 5.2% of lesions diagnosed by screening and a cost reduction between €30M and €87M over 5 years, with the exception of the strategy based on sending the kit (with the reminder associated or not) to the health professionals offering this option (+€23M and +€6M). CONCLUSIONS: In conclusion, the use of self-sampling as an alternative to pap smears for non-participating women would increase participation, with only a moderate budgetary impact and could, in some cases, even induce savings.

Telecytologic diagnosis of cervical smears for triage of self-sampled human papillomavirus-positive women in a resource-limited setting: concept development before implementation.

INTRODUCTION: Cytology is an option for triaging human papillomavirus (HPV)-positive women. The interpretation of cytologic slides requires expertise and financial resources that are not always available in resource-limited settings. A solution could be offered by manual preparation and digitization of slides on site for real-time remote cytologic diagnosis by specialists. In the present study, we evaluated the operational feasibility and cost of manual preparation and digitization of thin-layer slides and the diagnostic accuracy of screening with virtual microscopy. MATERIALS AND METHODS: Operational feasibility was evaluated on 30 cervical samples obtained during colposcopy. The simplicity of the process and cellularity and quality of digitized thin-layer slides were evaluated. The diagnostic accuracy of digital versus glass slides to detect cervical intraepithelial neoplasia grade 2 or worse was assessed using a cohort of 264 HPV-positive Cameroonian women aged 30 to 49 years. The histologic results served as the reference standard. RESULTS: Manual preparation was found to be feasible and economically viable. The quality characteristics of the digital slides were satisfactory, and the mean cellularity was 6078 squamous cells per slide. When using the atypical squamous cells of undetermined significance or worse threshold for positivity, the diagnostic performance of screening digital slides was not significantly different statistically compared with the same set of slides screened using a light microscope (P = 0.26). CONCLUSIONS: We have developed an innovative triage concept for HPV-positive women. A quality-ensured telecytologic diagnosis could be an effective solution in areas with a shortage of specialists, applying a same day "test-triage-treat" approach. Our results warrant further on-site clinical validation in a large prospective screening trial.

Evaluation of PathTezt™, a Liquid-Based Cytology System.

Liquid-based preparation (LBP) cytology is commonly used in most laboratories these days due to its convenience and reliable results for the cervical cancer screening program. The PathTezt™ Liquid-based Pap smear is a second-generation LBP, which uses a filter-based concentration technique in processing the sample. OBJECTIVE: This study was done to evaluate the cellular fixation, morphology, quality of smear in gynae cytology, and diagnostic interpretation of cervical cytological smears produced by the PathTezt liquid-based processor. MATERIALS AND METHODS: A total of 400 pap smear samples were taken and processed using the PathTezt 2000 processor. The slides were evaluated in terms of sample adequacy, percentage of the circle covered by epithelial cells, cellular distribution, obscuring factors, and cell fixation. RESULTS: About 95.25% (381) of the samples were satisfactory for the evaluation. In 19 (4.75%) of the samples, epithelial cells covered less than 50% of the circle. A sample with good cellular distribution was seen in 92% of the cases, while 354 (88.5%) samples showed minimal inflammatory background. Almost all the smears (95.75%) had no erythrocytes in the background. All smears showed good quality fixation features toward nuclear, cytoplasm, and microorganisms. The total performance rate was 99%. CONCLUSION: Although the PathTezt liquid-based processor is still new compared to other first-generation LBP, the smears produced by this method were of high quality and it was cost-effective.

Self-obtained vaginal samples for HPV DNA testing to detect HPV-related cervical disease.

OBJECTIVE: To investigate if a self-obtained vaginal sample (SOVAS) contains sufficient DNA for a human papillomavirus (HPV) test and if the results are comparable to those obtained via cervical samples (CS) collected by a physician. METHODS: One hundred and fifty-one women who had abnormal cervical smears or who were HPV-positive were enrolled. Self-sampling was done after reading instructions and watching a 2-min-long video, whereas CS was obtained with a cervical cytobrush during a gynecologic examination. RESULTS: A multiplex real-time polymerase chain reaction-based assay detected the prevalence of any type of HPV to be 67.5% in the SOVAS and 57.4% in the CS, and that of high-risk (HR-) HPV to be 58.7% in the SOVAS and 48.6% in the CS. The sensitivity of detection of HR-HPV in the SOVAS was 100% (95% confidence interval [CI] -0.09 to 0.32) for high-grade squamous intraepithelial lesion, 78% (95% CI -0.09 to 0.13) for atypical squamous cells of undetermined significance or worse, and 95% (95% CI -0.01 to 0.25) for low-grade squamous intraepithelial lesion or worse, which was statistically within the non-inferiority margin compared with that of CS. CONCLUSION: Our study shows that the collection of a SOVAS is feasible and it is comparable to a CS for HPV DNA testing. Future studies are required to investigate the feasibility and cost-effectiveness of a mail-delivered SOVAS for cervical cancer screening.

Assessment of cytological features of glandular lesions of the cervix on conventional smear preparations-a comprehensive study from a tertiary care hospital.

BACKGROUND: Atypical glandular cells (AGC) as a diagnostic category in cervicovaginal cytology remains as a challenge to cytopathologists. AIMS: The aim of the present study is to identify the cytological features helpful in categorizing AGC as reactive or neoplastic upon correlation with histology. MATERIALS AND METHODS: The study was a retrospective review of cervical smears, with histopathological follow up, reported as glandular lesions for a period of 9 years. The architectural and nuclear features studied were adapted from The Bethesda System (TBS) to stratify the lesions as AGC, AGC-FN (atypical glandular cells favour neoplasia) and adenocarcinoma. The cytological categories were correlated with histology. RESULTS: A total of 89 cases of which 67 (AGC NOS = 34, AGC FN = 19, adenocarcinoma = 14) with histology were reviewed. Neoplastic lesions were encountered in 14 cases (34.6%). Of the cases diagnosed as AGC-NOS, AGC-FN and adenocarcinoma, 26.5%, 68.4% and 100% respectively were neoplastic on histopathology. Squamous lesions accounted for 14.9% of all the glandular lesions. Rosette or acinar formation and loss of polarity frequently observed in neoplastic lesions as compared to reactive changes (p = 0.0004, p = 0.001). Of the nuclear features, nuclear hyperchromasia or coarse clumping of chromatin along with nuclear membrane irregularity and nuclear pleomorphism was frequently associated with neoplastic lesions as compared to reactive conditions (p = 0.007, p = 0.001, p = 0.0002). CONCLUSION: A diagnosis of AGC at cytology harbors significant number of malignant lesions when confirmed on biopsy. Architectural features complemented with nuclear characteristics helps in differentiating between reactive and neoplastic conditions. Hence stratifying glandular lesions at cytology according to TBS helps in the management.

Online Cost-Effectiveness ANalysis (OCEAN): a user-friendly interface to conduct cost-effectiveness analyses for cervical cancer.

BACKGROUND: Most cost-effectiveness analyses in the context of cervical cancer prevention involve the use of mathematical models to simulate HPV infection, cervical disease and prevention strategies. However, it is common for professionals who would need to perform these analyses to not be familiar with the models. This work introduces the Online Cost-Effectiveness ANalysis tool, featuring an easy-to-use web interface providing health professionals, researchers and decision makers involved in cervical cancer prevention programmes with a useful instrument to conduct complex cost-effectiveness analyses, which are becoming an essential tool as an approach for supporting decision-making that involves important trade-offs. RESULTS: The users can run cost-effectiveness evaluations of cervical cancer prevention strategies without deep knowledge of the underlying mathematical model or any programming language, obtaining the most relevant costs and health outcomes in a user-friendly format. The results provided by the tool are consistent with the existing literature. CONCLUSIONS: Having such a tool will be an asset to the cervical cancer prevention community, providing researchers with an easy-to-use instrument to conduct cost-effectiveness analyses.

Cervical cancer screening coverage, management of squamous intraepithelial lesions and related costs in France.

Until 2018, cervical cancer screening in France was an unorganized individual screening, with the exception of some pilot programs in some territories. We aimed to assess, before the implementation of organized cervical cancer screening and human papillomavirus (HPV) nonavalent vaccine introduction in the vaccination schedule in 2018, (i) the individual cervical cancer screening coverage, (ii) the management of squamous intraepithelial lesions (SIL) and (iii) the related costs. We used the Système National des Données de Santé (SNDS) (Echantillon Généraliste de Bénéficiaires [EGB] and Programme de Médicalisation des systèmes d'information [PMSI]) to assess the cervical screening coverage rate in France between January 1st, 2012 and December 31st, 2014, and to describe diagnostic investigations and therapeutic management of SIL in 2013. After extrapolation to the general population, a total of 10,847,814 women underwent at least one smear test over the 3-year study period, corresponding to a coverage rate of 52.4% of the women aged 25 to 64 included. In 2013, 126,095 women underwent HPV test, 327,444 women underwent colposcopy, and 9,653 underwent endocervical curettage; 31,863 had conization and 12,162 had laser ablation. Besides, 34,067 women experienced hospital stays related to management of SIL; 25,368 (74.5%) had high-grade lesions (HSIL) and 7,388 (21.7%) low-grade lesions (LSIL). Conization was the most frequent in-hospital therapeutic procedure: 89.5% (22,704) of women with an in-hospital procedure for HSIL and 64.7% (4,781) for LSIL. Mean cost of smear test, colposcopy and HPV tests were around 50€. Total cost for hospital stays in 2013 was estimated at M41€, or a mean cost of 1,211€ per woman; 76% were due to stays with HSIL. This study highlights the low coverage rate of individual cervical cancer screening and a high burden related to SIL management.

Acceptability and Feasibility of Community-Based, Lay Navigator-Facilitated At-Home Self-Collection for Human Papillomavirus Testing in Underscreened Women.

Objective: Women without regular health care providers or a medical home routinely fail to complete recommended cervical cancer screening. At-home self-collection of samples to test for high-risk strains of human papillomavirus (hrHPV) can improve screening rates. This study documents acceptability and feasibility of community lay navigator (LN)-facilitated at-home self-collection for underscreened women in Appalachian Virginia. Materials and Methods: This study used mixed methods in three phases. Phase I involved focus groups of LNs to ensure cultural acceptability of self-collection, and to enhance recruitment of medically underserved women. An environmental scan of community resources and climate was created in Phase II. During Phase III, underscreened women in Appalachian Virginia (the far southwest corner of Virginia) were recruited to complete hrHPV testing using LN-provided self-collection kits. Results: LN-facilitated at-home self-collection for HPV testing was deemed culturally acceptable and feasible to participants in this community-based pilot study. Self-kit training included 64 LNs, of which 35 engaged in the study and were provided 77 kits and instructions. A total of 59 self-kits were returned, of which 42 were correctly completed with valid HPV results, yielding a 16.6% hrHPV rate. Conclusions: Over a quarter of the women LNs recruited had no medical home, indicating this delivery model may have potential to reach women at increased risk of being underscreened for cervical cancer. Research is needed to identify optimal approaches to increase LN participation in outreach self-collection interventions.

Cervical screening in Western Kazakhstan: Liquid-based cytology 'Cell Scan' versus azur-eosin staining.

OBJECTIVE: To assess the effectiveness of the current cervical cancer screening tools in Western Kazakhstan. METHODS: Smears taken through (i) conventional cytology using azur-eosin staining and (ii) liquid-based cytology (LBC) 'Cell Scan' in the general female population and in women first diagnosed with cervical cancer were collected throughout the region. ROC-analysis with curve construction and weighted Cohen's κ calculation were applied. A total of 494 cytological pairs were collected, including 94 sets with histology findings. RESULTS: The conventional (azur-eosin staining) technique contained 0.2% non-informative material and LBC 'Cell Scan' had 5.9%. Area under the curve was 0.95 for the conventional technique and 0.92 for 'Cell Scan' (p > 0.05). The conventional smears showed κ 0.62, sensitivity 90.4% at specificity 90.0% for CIN2+, while LBC 'Cell Scan' smears showed κ 0.47, sensitivity 83.3% at specificity 92.5%. CONCLUSIONS: In this analysis it was not possible to prove that the LBC 'Cell Scan' technique was superior to its predecessor, azur-eosin staining. These findings highlight the need to modify the current screening programme according to updated international scientific evidence on effective screening design, such as the use of HPV DNA testing with Pap smear triage in women aged 30 or older. Further research, and a Health Technology Assessment, are necessary if we wish to establish a national standardized screening programme using the available technology appropriately.

Reducing overtreatment associated with overdiagnosis in cervical cancer screening-A model-based benefit-harm analysis for Austria.

A general concern exists that cervical cancer screening using human papillomavirus (HPV) testing may lead to considerable overtreatment. We evaluated the trade-off between benefits and overtreatment among different screening strategies differing by primary tests (cytology, p16/Ki-67, HPV alone or in combinations), interval, age and diagnostic follow-up algorithms. A Markov state-transition model calibrated to the Austrian epidemiological context was used to predict cervical cancer cases, deaths, overtreatments and incremental harm-benefit ratios (IHBR) for each strategy. When considering the same screening interval, HPV-based screening strategies were more effective compared to cytology or p16/Ki-67 testing (e.g., relative reduction in cervical cancer with biennial screening: 67.7% for HPV + Pap cotesting, 57.3% for cytology and 65.5% for p16/Ki-67), but were associated with increased overtreatment (e.g., 19.8% more conizations with biennial HPV + Papcotesting vs. biennial cytology). The IHBRs measured in unnecessary conizations per additional prevented cancer-related death were 31 (quinquennial Pap + p16/Ki-67-triage), 49 (triennial Pap + p16/Ki-67-triage), 58 (triennial HPV + Pap cotesting), 66 (biennial HPV + Pap cotesting), 189 (annual Pap + p16/Ki-67-triage) and 401 (annual p16/Ki-67 testing alone). The IHBRs increased significantly with increasing screening adherence rates and slightly with lower age at screening initiation, with a reduction in HPV incidence or with lower Pap-test sensitivity. Depending on the accepted IHBR threshold, biennial or triennial HPV-based screening in women as of age 30 and biennial cytology in younger women may be considered in opportunistic screening settings with low or moderate adherence such as in Austria. In organized settings with high screening adherence and in postvaccination settings with lower HPV prevalence, the interval may be prolonged.

Design and Outcomes of a Community Trial to Increase Pap Testing in Pacific Islander Women.

BACKGROUND: Pap tests remain an essential cervical cancer detection method in the United States, yet they are underutilized among Pacific Islanders (PI) who experience elevated cervical cancer incidence and mortality. This study describes the design, methods, participants, and outcomes of a multiyear (2010-2016), community-based randomized intervention trial in southern California. Based upon strong collectivistic norms, the trial tested the efficacy of a unique social support intervention targeting Chamorro, Samoan, and Tongan women and their male husbands/partners. METHODS: A single-session educational intervention was designed and tailored for ethnic- and gender-specific groups to increase men's social support for their female wives/partners to receive a Pap test, and for women to receive a Pap test. The comparison group received preexisting brochures on Pap testing (for women) or general men's health (for men). Pretest and 6-month follow-up data were analyzed. RESULTS: Intervention and comparison groups were mostly equivalent on pretest demographics and outcome variables. Intervention women who were not compliant with Pap screening recommendations at pretest were significantly more likely to have scheduled and received a Pap test at 6-month follow-up. However, 6-month follow-up results indicated no intervention effect on changes in women's Pap testing knowledge, fatalistic attitudes, or perceived social support from their male partner. CONCLUSIONS: Ethnic- and gender-tailored community interventions can successfully increase Pap test behaviors for PI women, although more research is needed on the specific pathways leading to behavior change. IMPACT: Collaborative community-based interventions lead to increases in women's cancer prevention and early detection for Pacific Islander and other collectivistic communities.

Exploring women's preferences for HPV-based cervical cancer screening in South Africa.

OBJECTIVE: To determine preferences for HPV-based cervical cancer screening among South African women. METHODS: A discrete choice experiment survey was conducted among 298 women who attended two public-sector clinics in South Africa from February 1 to May 31, 2018. Participants chose between hypothetical screening scenarios: method of swab collection (self or provider); timing of treatment (same day or return visit); type of clinic (static or mobile); cost of services (US $0 or US $4); and time spent at the clinic (30, 60, or 120 minutes). A logistic regression model was generated to evaluate the importance of each attribute. A market simulation analysis was performed to determine potential uptake of the various screening strategies. RESULTS: The participants expressed strong preferences for free services (ß=0.50; P<0.001) and same-day HPV testing and treatment (ß=0.40; P<0.001). The market simulation indicated that 83.8% of women would be willing to undergo screening if services were free; the swab was collected by the provider; and treatment was offered at a return visit. Including same-day testing and treatment in the model increased uptake to 96.4%. CONCLUSION: Offering same-day HPV testing and treatment could substantially improve uptake of cervical cancer screening in the South African public healthcare sector.

Cost-effectiveness evaluation of HPV self-testing offered to non-attendees in cervical cancer screening in Switzerland.

OBJECTIVE: About 30% of women who are eligible for cervical cancer (CC) screening remain un-screened or under-screened in Switzerland. HPV testing on self-collected vaginal samples (Self-HPV) has shown to be more sensitive than cytology while also reaching non-attendees. The objective of this study was to explore the cost-effectiveness of offering Self-HPV to non-attendees in Switzerland. METHODS: A recursive decision-tree with one-year cycles was used to model the life-long natural HPV history. Markov cohort simulations were used to assess the expected outcomes from the model. The outcomes of three strategies were compared with the absence of screening: Self-HPV and triage with colposcopy (Self-HPV/colpo), Self-HPV and triage with Pap cytology (Self-HPV/PAP), cytological screening and triage with HPV (PAP/HPV). Sensitivity analyses for the key parameters of the model were conducted to check the robustness of findings. RESULTS: Offering a Self-HPV screening to non-attendees could prevent 90% of CC and 94% of CC-related deaths in the study population. The current cytology-based program could reduce by 83% the number of CC cases and by 88% the number of CC-related deaths over the population's lifetime. Compared to the absence of screening, incremental cost-effectiveness ratios (ICER) were estimated to be, per saved Quality Adjusted Life Year (QALY), 12413US$ for the strategy Self-HPV/colpo, 11138US$ for the strategy Self-HPV/Pap and 22488US$ for the strategy PAP/HPV. CONCLUSIONS: Offering Self-HPV as a CC screening strategy to non-attendees in Switzerland is a cost-effective solution that is associated with a reduction of CC cases and related deaths. Self-HPV is more cost-effective than the currently used cytology-based screening.

Precancerous cervical lesions and HPV genotypes identified in previously unsatisfactory cervical smear tests after inexpensive glacial acetic acid processing.

OBJECTIVE: To determine the effectiveness of using glacial acetic acid (GAA) to convert unsatisfactory bloody ThinPrep (TP) cervical smear test to satisfactory, and identify associated missed diagnoses and high-risk HPV (hrHPV) genotypes. METHODS: In a retrospective descriptive cross-sectional analysis, all TP tests performed in Mississippi, USA, 2012-2016, were evaluated for unsatisfactory results owing to blood. Tests that were converted to satisfactory by GAA treatment, and corresponding anomalies and HPV genotypes were identified. RESULTS: Among 106 384 TP tests, there were 1460 (1.37%) unsatisfactory results, of which 1442 (98.77%) were converted to satisfactory after GAA treatment. Laboratory preprocessing with GAA increased costs minimally. Precancerous lesions were detected in 166 (11.51%) of 1442 GAA-treated samples, of which 12 (7.2%) were high-grade lesions, 110 (66.3%) were atypical squamous cells of undetermined significance, and 63 (57.3%) tested positive for hrHPV. Of 60 genotyped samples, 39 (65%) had non-HPV16 and non-HPV18. Including mixed infections, 48 (80%) contained less-common hrHPV types, reflecting an unexpected distribution in bloody specimens. CONCLUSIONS: GAA pretreatment of bloody TP tests would reduce the incidence of unsatisfactory results and missed high-grade lesions, and prevent the cost of repeat tests and delayed treatment. Clinicians without access to GAA should consider HPV testing.

Nuevas estrategias de prevención y control de cáncer de cuello uterino en Chile / New strategies for the prevention and control of cervical cancer in Chile

Resumen: Objetivos: Discutir el cáncer cervicouterino (CC), el virus del papiloma humano (VPH), el programa de control del CC y proponer alternativas para Chile. Material y métodos: Se analiza el programa nacional del CC 1966-2015 y la guía clínica 2015-2020, la prevalencia de VPH en mujeres y en casos de CC; la infección y serología de VPH; la autotoma; la precisión y rentabilidad del tamizaje con VPH contra el Papanicolaou y las opciones de triaje en VPH AR positivas. Resultados: En Chile mueren 600 mujeres (principalmente de bajos recursos) al año por CC. La cobertura del Papanicolaou es < 70%, sensibilidad muy inferior al test de VPH, por lo que el cambio es rentable. Desde 2015 se vacuna contra VPH a niñas menores de 13 años. Conclusiones: Las condiciones técnicas y económicas existen en Chile para lograr una mejoría sustancial del CC: se sugiere el reemplazo del Papanicolaou por el examen de VPH; tamizaje cada cinco años con opción de autotoma; triaje con base en la tipificación de VPH 16/18 o Papanicolaou.

Abstract: Objective: To discuss cervical cancer (CC), Human Papilloma Virus (HPV), CC control program and propose alternatives for Chile. Materials and methods: We analyzed the national program of CC 1966-2015 and the clinical CC guideline 2015-2020; HPV prevalence in women and in cases of CC; HPV infection and serology; the self-vaginal sample; the accuracy and cost-effectiveness of screening with HPV versus Papanicolaou, and triage options among HPV-AR positives. Results: 600 women die of CC each year in Chile, mainly from low resources. Papanicolaou coverage is <70%; Papanicolaou sensitivity is much lower than HPV test. Change from Papanicolaou to HPV test is cost-effective. Since 2015, girls under 13 have been vaccinated against HPV. Conclusions: There are the technical and economic conditions for a substantial improvement of CC in Chile: replacement of the Papanicolaou by HPV; screening every five years, with the option of self-sampling, and triage based on HPV 16/18 or Papanicolaou typing.

[New strategies for the prevention and control of cervical cancer in Chile.] / Nuevas estrategias de prevención y control de cáncer de cuello uterino en Chile.

OBJECTIVE: To discuss cervical cancer (CC), Human PapillomaVirus (HPV),CC control program and propose alternatives for Chile. MATERIALS AND METHODS: We analyzed the national program of CC 1966-2015 and the clinical CC guideline 2015-2020;HPV prevalence in women and in cases of CC; HPV infection and serology; the self-vaginal sample; the accuracy and cost-effectiveness of screening with HPV versus Papanicolaou,and triage options among HPV-AR positives. RESULTS: 600 women die of CC each year in Chile, mainly from low resources. Papanicolaou coverage is <70%; Papanicolaou sensitivity is much lowerthan HPV test.Change from Papanicolaou to HPV test is cost-effective. Since 2015, girls under 13 have been vaccinated against HPV. CONCLUSIONS: .There are the technical and economic conditions for a substantial improvement of CC in Chile: replacement of the Papanicolaou by HPV; screening every five years, with the option of self-sampling, and triage based on HPV 16/18 or Papanicolaou typing.

OBJETIVO: Discutir el cáncer cervicouterino (CC), el virus del papiloma humano (VPH),el programa de control del CC y proponer alternativas para Chile. MATERIAL Y MÉTODOS: Se analiza el programa nacional del CC 1966-2015 y la guía clínica 2015-2020, la prevalencia deVPH en mujeres y en casos de CC; la infección y serología deVPH; la autotoma; la precisión y rentabilidad del tamizaje con VPH contra el Papanicolaou y las opciones de triaje enVPH AR positivas. RESULTADOS: En Chile mueren 600 mujeres (principalmente de bajos recursos) al año por CC. La cobertura del Papanicolaou es <70%, sensibilidad muy inferior al test de VPH, por lo que el cambio esrentable.Desde 2015 se vacuna contraVPH a niñas menores de 13 años. CONCLUSIONES: Las condiciones técnicas y económicas existen en Chile para lograr una mejoría sustancial del CC:se sugiere el reemplazo del Papanicolaou por el examen deVPH;tamizaje cada cinco años con opción de autotoma; triaje con base en la tipificación deVPH 16/18 o Papanicolaou.

Barriers to HPV self-sampling and cytology among low-income indigenous women in rural areas of a middle-income setting: a qualitative study.

BACKGROUND: Data is needed about barriers to self-collection of Human Papillomavirus (HPV) samples and cytology among low-income, disadvantaged women living in rural areas of lower-income countries as these women are at increased risk of cervical cancer mortality. METHODS: Individual interviews (n = 29), focus groups (n = 7, 5-11 participants) and discussion groups (n = 2, 18-25 participants) were organized with women from three indigenous ethnic groups residing in rural areas in Mexico, after they were provided with free, self-sampled HPV tests. These groups are low-income, underserved by healthcare and have historically been on the receiving end of racism and social exclusion. Descriptive, qualitative content analysis was done, including two cycles of coding. RESULTS: Interview and focus/discussion group data indicate women had limited understanding of HPV's role in cervical cancer etiology. They identified HPV's existence, that cytology detects cervical cancer, the need for regular testing and that cervical cancer is sexually transmitted. Organizational barriers to clinic-based cytology included irregular supplies of disposable speculums, distance to clinics and lack of clear communication by healthcare personnel. Women considered self-collected HPV-testing easy, less embarrassing and less painful than cytology, an opportunity for self-care and most felt they understood how to take a self-sample after a 20-min explanation. Some women feared hurting themselves when taking the self-sample or that they would take the sample incorrectly, which they worried would make the test useless. Attending HPV-testing in groups facilitated use by allowing women to discuss their doubts and fears before doing self-collection of the sample or to ask other women who were the first to do the self-sampling what the experience had been like (whether it hurt and how easy it was). Lack of indoor bathrooms was a barrier to doing HPV self-sampling at home, when those homes were resource-poor (one-room dwellings). CONCLUSIONS: Low-income, indigenous Mexican women residing in rural, underserved areas identified their need for cervical cancer screening but encountered multiple barriers to cytology-based screening. They found a number of advantages of HPV self-sampled tests. Employing self-collected HPV-testing instead of cytology could resolve some but not all gender-related, organizational or technical quality-of-care issues within cervical cancer detection and control programs.