Preliminary assessment of using mobile point-of-care human papillomavirus (HPV) testing with the option of immediate colposcopy in a rural area in a high-income country: a case study.

AIM: Cervical cancer is now preventable with human papillomavirus (HPV) vaccination and HPV screening. However, structural health system barriers in rural areas can inhibit screening access. Inequitable access for rural Maori is exacerbated by social determinants and racism. Pro-equity tools, such as self-taken swabs point of care (POC) testing, now exist. This study aimed to investigate whether POC HPV testing and immediate offer of colposcopy by a mobile colposcopy service is possible at a rural community event. METHODS: This case study was a collaboration between a research centre, a women's health bus, a molecular diagnostics company, a Maori health provider and a community charity, and took place prior to the new cervical screening programme introduction at a 2-day community event-a shearathon. Eligible participants were offered a self-taken swab for HPV, which was analysed by POC testing. If high-risk HPV was detected, they were offered an immediate colposcopy. The Maori-centred qualitative component explored women's experiences of the process. RESULTS: Fourteen women undertook a self-test for HPV. High-risk HPV was detected in six women and all were offered immediate colposcopy. Six women were interviewed. All were supportive of the service. Culturally safe staff taking time to put women at ease contributed to acceptability and positive experiences. CONCLUSION: This case study shows that provision of POC HPV testing and colposcopy at a rural community event setting is possible through cross-sector collaboration. This service was acceptable to rural transient workers who face barriers to healthcare in a high-income country.

Time Differences From Abnormal Cervical Cancer Screening to Colposcopy Between Insurance Statuses.

OBJECTIVE: Screening and diagnostic follow-up to prevent cervical cancer are influenced by socioeconomic and systemic factors. This study sought to characterize intervals from abnormal cervical cancer screening to colposcopy between practices differing by insurance status at a large, urban academic center. MATERIALS AND METHODS: This retrospective cohort study included patients aged 21-65 who presented for colposcopy between January 1, 2021, and January 1, 2022, at the resident and faculty gynecology practices of a single large urban academic medical center. Patient characteristics were compared using t tests or Wilcoxon rank sum tests for continuous measures and χ 2 or Fisher exact tests for categorical measures. Intervals from abnormal cervical cancer screening to colposcopy were compared using the Wilcoxon rank sum test and linear regression analysis with multivariable models adjusted for age, cervical cytology result, human papillomavirus result, and HIV status. RESULTS: Resident practice patients were publicly insured and more likely to be Black or Hispanic ( p < .0001); rates of high-risk human papillomavirus and smoking were similar. Resident practice patients had longer intervals from abnormal cervical cancer screening to colposcopy compared with faculty practice patients (median 79.5 vs 34 d, p < .0001). On adjusted analysis, resident practice patients faced a 95% longer interval ( p < .0001). CONCLUSIONS: Publicly insured patients of a resident-based practice faced significantly longer intervals from abnormal cervical cancer screening to colposcopy than faculty practice patients at a single urban academic center. Effort to address these differences may be an area of focus in improving health disparities.

Cost-effectiveness of primary human papillomavirus triage approaches among vaccinated women in Norway: A model-based analysis.

As Norway considers revising triage approaches following their first adolescent cohort with human papillomavirus (HPV) vaccination entering the cervical cancer screening program, we analyzed the health impact and cost-effectiveness of alternative primary HPV triage approaches for women initiating cervical cancer screening in 2023. We used a multimodeling approach that captured HPV transmission and cervical carcinogenesis to evaluate the health benefits, harms and cost-effectiveness of alternative extended genotyping and age-based triage strategies under five-yearly primary HPV testing (including the status-quo screening strategy in Norway) for women born in 1998 (ie, age 25 in 2023). We examined 35 strategies that varied alternative groupings of high-risk HPV genotypes ("high-risk" genotypes; "medium-risk" genotypes or "intermediate-risk" genotypes), number and types of HPV included in each group, management of HPV-positive women to direct colposcopy or active surveillance, wait time for re-testing and age at which the HPV triage algorithm switched from less to more intensive strategies. Given the range of benchmarks for severity-specific cost-effectiveness thresholds in Norway, we found that the preferred strategy for vaccinated women aged 25 years in 2023 involved an age-based switch from a less to more intensive follow-up algorithm at age 30 or 35 years with HPV-16/18 genotypes in the "high-risk" group. The two potentially cost-effective strategies could reduce the number of colposcopies compared to current guidelines and simultaneously improve health benefits. Using age to guide primary HPV triage, paired with selective HPV genotype and follow-up time for re-testing, could improve both the cervical cancer program effectiveness and efficiency.

Chatbot-interfaced and cognitive-affective barrier-driven messages to improve colposcopy adherence after abnormal Pap test results in underserved urban women: A feasibility pilot study.

Challenges in ensuring adherence to colposcopy and follow-up recommendations, particularly within underserved communities, hinder the delivery of appropriate care. Informed by our established evidence-based program, we sought to assess the feasibility and acceptability of a novel cognitive-affective intervention delivered through a Chatbot interface, aimed to enhance colposcopy adherence within an urban inner-city population. We developed the evidence-based intervention, CervixChat, to address comprehension of colposcopy's purpose, human papillomavirus (HPV) understanding, cancer-related fatalistic beliefs, procedural concerns, and disease progression, offered in both English and Spanish. Females aged 21-65, with colposcopy appointments at an urban OBGYN clinic, were invited to participate. Enrolled patients experienced real-time counseling messages tailored via a Chatbot-driven barriers assessment, dispatched via text one week before their scheduled colposcopy. Cognitive-affective measures were assessed at baseline and through a 1-month follow-up. Participants also engaged in a brief post-intervention satisfaction survey and interview to capture their acceptance and feedback on the intervention. The primary endpoints encompassed study adherence (CervixChat response rate and follow-up survey rate) and self-evaluated intervention acceptability, with predefined feasibility benchmarks of at least 70% adherence and 80% satisfaction. Among 48 eligible women scheduled for colposcopies, 27 (56.3%) agreed, consented, and completed baseline assessments. Participants had an average age of 34 years, with 14 (52%) identifying as non-Hispanic White. Of these, 21 (77.8%) engaged with the CervixChat intervention via mobile phones. Impressively, 26 participants (96.3%) attended their diagnostic colposcopy within the specified timeframe. Moreover, 22 (81.5%) completed the follow-up survey and a brief interview. Barriers assessment revealed notable encodings in the Affect and Values/Goals domains, highlighting concerns and understanding around HPV, as well as its impact on body image and sexual matters. Persistent and relatively high intrusive thoughts and lowered risk perceptions regarding cervical cancer were reported over time, unaffected by the intervention. Post-intervention evaluations documented high satisfaction and perceived usefulness, with recommendations for incorporating additional practical and educational content. Our findings underscore the robust satisfaction and practicality of the CervixChat intervention among a diverse underserved population. Moving forward, our next step involves evaluating the intervention's efficacy through a Sequential Multiple Assignment Randomized Trial (SMART) design. Enhanced by personalized health coaching, we aim to further bolster women's risk perception, address intrusive thoughts, and streamline resources to effectively improve colposcopy screening attendance.

Our study focused on helping underserved women, especially from ethnic minorities, with abnormal Pap test results. We aimed to break down barriers preventing them from seeking necessary follow-up care. Using Chatbot-facilitated text messages, we reached out to offer timely support. Starting with a warm text, we asked participants to share their thoughts on their abnormal Pap results. We then sent targeted messages addressing concerns about colposcopy, cervical health, emotions, appointment importance, and coping strategies. Participants engaged actively, finding value in the messages for information and encouragement. Their responses highlighted concerns about the test and emotional challenges. We also identified the need to address worries about human papillomavirus (HPV), body image, and discomfort during the test. In conclusion, our study showcased the feasibility and acceptability of using Chatbot messages to provide tailored support after abnormal Pap tests. By addressing unique concerns, we aimed to alleviate distress and enhance adherence to follow-up care for better cervical cancer screening outcomes.

2019 ASCCP Risk-Based Management Consensus Guidelines: Updates Through 2023.

ABSTRACT: This Research Letter summarizes all updates to the 2019 Guidelines through September 2023, including: endorsement of the 2021 Opportunistic Infections guidelines for HIV+ or immunosuppressed patients; clarification of use of human papillomavirus testing alone for patients undergoing observation for cervical intraepithelial neoplasia 2; revision of unsatisfactory cytology management; clarification that 2012 guidelines should be followed for patients aged 25 years and older screened with cytology only; management of patients for whom colposcopy was recommended but not completed; clarification that after treatment for cervical intraepithelial neoplasia 2+, 3 negative human papillomavirus tests or cotests at 6, 18, and 30 months are recommended before the patient can return to a 3-year testing interval; and clarification of postcolposcopy management of minimally abnormal results.

Developing and piloting an intervention to reduce colposcopy non-attendance and corresponding inequalities: a mixed-methods study.

BACKGROUND: Cervical cancer incidence and mortality is higher in lower income populations. Non-attendance for colposcopy following cervical screening is higher in deprived areas and younger patients. Diagnostic delays reduce the benefits of screening, increasing risk of pre-cancerous cells being undetected or treated later. We aimed to better understand drivers of colposcopy non-attendance and pilot a targeted intervention. Women and people with a cervix (referred to as patients in this paper) access colposcopy services. METHODS: For the service improvement audit, we collected qualitative data from Jan 24 to April 22, 2022, via telephone calls and interviews. The sample included patients who cancelled or did not attend their appointment and patients who attended their appointment. Interviews explored attendance barriers and enablers. Data were analysed thematically and reported, aligning with Consolidated Criteria for reporting Qualitative Studies' principles. The analysis informed development of a pilot intervention, implemented from Aug 8 to Oct 6, 2022, for all scheduled appointments. Patients were contacted by telephone pre-appointment as both a reminder and opportunity to identify and address attendance barriers. Barrier-specific pathways were developed to support attendance (eg, transport assistance). We compared descriptive non-attendance rates during the intervention period and pre-intervention. Audit permission was granted by Northumbria Clinical Audit Team and Caldicott approval obtained. FINDINGS: Data were collected from 20 of the 36 patients who did not attend between Jan 24, and April 22, 2022. Further data were gathered from 88 patients cancelling appointments and four colposcopy attendees. During the audit, ethnicity and gender identity were not routinely collected. Themes identified were administrative, forgetting, anxiety, work, childcare, and transport. During the pilot, 383 (65%) of all 595 patients with an appointment were successfully contacted. The overall non-attendance in 2022 pre-telephone intervention was 10% (195 of 1736 appointments). During the intervention, non-attendance was 8% (45 of 539 appointments). Non-attendance during the intervention was 12% (10 of 87 appointments) for patients aged 25-39 years in the 20% most deprived areas was, compared with 20% (64 of 319 appointments) before the intervention. INTERPRETATION: Identifying and addressing attendance barriers might improve non-attendance, particularly in younger and more deprived populations. This offers the prospect of improving the effectiveness of screening programmes alongside reducing inequalities in health-care access. The findings of this small-scale study are limited to NHS trust colposcopy service in the northeast of England, thus further formalised research is necessary. FUNDING: None.

Examining the association of clinician characteristics with perceived changes in cervical cancer screening and colposcopy practice during the COVID-19 pandemic: a mixed methods assessment.

Background: The COVID-19 pandemic led to reductions in cervical cancer screening and colposcopy. Therefore, in this mixed method study we explored perceived pandemic-related practice changes to cervical cancer screenings and colposcopies. Methods: In 2021, a national sample of 1251 clinicians completed surveys, including 675 clinicians who performed colposcopy; a subset (n=55) of clinicians completed qualitative interviews. Results: Nearly half of all clinicians reported they were currently performing fewer cervical cancer screenings (47%) and colposcopies (44% of those who perform the procedure) than before the pandemic. About one-fifth (18.6%) of colposcopists reported performing fewer LEEPs than prior to the pandemic. Binomial regression analyses indicated that older, as well as internal medicine and family medicine clinicians (compared to OB-GYNs), and those practicing in community health centers (compared to private practice) had higher odds of reporting reduced screening. Among colposcopists, internal medicine physicians and those practicing in community health centers had higher odds of reporting reduced colposcopies. Qualitative interviews highlighted pandemic-related care disruptions and lack of tracking systems to identify overdue screenings. Conclusions: Reductions in cervical cancer screening and colposcopy among nearly half of clinicians more than 1 year into the pandemic raise concerns that inadequate screening and follow-up will lead to future increases in preventable cancers. Funding: This study was funded by the American Cancer Society, who had no role in the study's design, conduct, or reporting.

Designing Guidelines for Those Who Do Not Follow Them: The Impact of Adherence Assumptions on Optimal Screening Guidelines.

OBJECTIVES: Model-based cost-effectiveness analyses can inform decisions about screening guidelines by quantifying consequences of alternative algorithms. Although actual screening adherence is imperfect, incorporating nonadherence into analyses that aim to determine optimal screening may affect the policy recommendations. We evaluated the impact of nonadherence assumptions on the optimal cervical cancer screening in Norway. METHODS: We used a microsimulation model of cervical carcinogenesis to project the long-term health and economic outcomes under alternative screening algorithms and adherence patterns. We compared 18 algorithms involving primary human papillomavirus testing (5-yearly) that varied follow-up management of different human papillomavirus results. We considered 12 adherence scenarios: perfect adherence, 8 high- and low-coverage "random-complier" scenarios, and 3 "systematic-complier" scenarios that reflect conditional screening behavior over a lifetime. We calculated incremental cost-effectiveness ratios and considered a strategy with the highest incremental cost-effectiveness ratio < 55 000 US dollars/quality-adjusted life-year as "optimal." RESULTS: Under perfect adherence, the least intensive screening strategy was optimal; in contrast, assuming any nonadherence resulted in a more intensive optimal strategy. Accounting for lower adherence resulted in both lower costs and health benefits, which allowed for a more intensive strategy to be considered optimal, but more harms for women who screen according to guidelines (ie, up to 41% more colposcopies when comparing the optimal strategy in the lowest-adherence scenario with the optimal strategy under perfect adherence). CONCLUSIONS: Assuming nonadherence in analyses designed to inform national guidelines may lead to a relatively more intensive recommendation. Designing guidelines for those who do not adhere to them may lead to over-screening of those who do.

Cost-Conscious Colposcopy: A Single-Institution Review of Biopsy Submission Practices and Outcomes.

OBJECTIVE: Distribution of cervical dysplasia may influence approach for excisional procedures. Separating colposcopy biopsies into multiple specimen cups for pathologic evaluation incurs additional costs. The authors aimed to determine whether the practice of separating biopsy specimens impacts patient outcomes. METHODS: A retrospective review of all colposcopy cases from a single institution was performed. A total of 1,331 cases were reviewed from January 1, 2017, to December 31, 2019. Multibiopsy cohorts were separated by number of specimen cups received by pathology (single or multiple). Cohorts were compared for histology, need for excisional procedure, and final excisional pathology results. Specimen processing fees were acquired from the Department of Pathology ($70/specimen). Statistical analysis performed on MINITAB using Pearson chi-square and Fisher exact tests. RESULTS: Excisional procedures were required by 30.4% (86/283) of multiple specimen submissions compared with 28.2% (154/547) of single specimen cup submissions ( p = .50). There was a higher, although not statistically significant, rate of additional procedures in the multiple specimen cup cohort (8.8 vs 2.9% [ p = .08]). Malignancy diagnosis was equivalent in each cohort. Cost analysis revealed adopting a single specimen cup model would reduce costs up to approximately $30,000/year. CONCLUSIONS: Patient outcomes were not improved by the practice of submitting multiple specimen cups. Given the additional cost associated with separating specimens, the authors recommend during routine colposcopy that all cervical biopsies be sent for evaluation as a single pathology specimen unless a lesion of concern is identified in an area not normally excised during traditional excisional procedures.

Performance of standardised colposcopy to detect cervical precancer and cancer for triage of women testing positive for human papillomavirus: results from the ESTAMPA multicentric screening study.

BACKGROUND: Colposcopy, currently included in WHO recommendations as an option to triage human papillomavirus (HPV)-positive women, remains as the reference standard to guide both biopsy for confirmation of cervical precancer and cancer and treatment approaches. We aim to evaluate the performance of colposcopy to detect cervical precancer and cancer for triage in HPV-positive women. METHODS: This cross-sectional, multicentric screening study was conducted at 12 centres (including primary and secondary care centres, hospitals, laboratories, and universities) in Latin America (Argentina, Bolivia, Colombia, Costa Rica, Honduras, Mexico, Paraguay, Peru, and Uruguay). Eligible women were aged 30-64 years, sexually active, did not have a history of cervical cancer or treatment for cervical precancer or a hysterectomy, and were not planning to move outside of the study area. Women were screened with HPV DNA testing and cytology. HPV-positive women were referred to colposcopy using a standardised protocol, including biopsy collection of observed lesions, endocervical sampling for transformation zone (TZ) type 3, and treatment as needed. Women with initial normal colposcopy or no high-grade cervical lesions on histology (less than cervical intraepithelial neoplasia [CIN] grade 2) were recalled after 18 months for another HPV test to complete disease ascertainment; HPV-positive women were referred for a second colposcopy with biopsy and treatment as needed. Diagnostic accuracy of colposcopy was assessed by considering a positive test result when the colposcopic impression at the initial colposcopy was positive minor, positive major, or suspected cancer, and was considered negative otherwise. The main study outcome was histologically confirmed CIN3+ (defined as grade 3 or worse) detected at the initial visit or 18-month visit. FINDINGS: Between Dec 12, 2012, and Dec 3, 2021, 42 502 women were recruited, and 5985 (14·1%) tested positive for HPV. 4499 participants with complete disease ascertainment and follow-up were included in the analysis, with a median age of 40·6 years (IQR 34·7-49·9). CIN3+ was detected in 669 (14·9%) of 4499 women at the initial visit or 18-month visit (3530 [78·5%] negative or CIN1, 300 [6·7%] CIN2, 616 [13·7%] CIN3, and 53 [1·2%] cancers). Sensitivity was 91·2% (95% CI 88·9-93·2) for CIN3+, whereas specificity was 50·1% (48·5-51·8) for less than CIN2 and 47·1% (45·5-48·7) for less than CIN3. Sensitivity for CIN3+ significantly decreased in older women (93·5% [95% CI 91·3-95·3] in those aged 30-49 years vs 77·6% [68·6-85·0] in those aged 50-65 years; p<0·0001), whereas specificity for less than CIN2 significantly increased (45·7% [43·8-47·6] vs 61·8% [58·7-64·8]; p<0·0001). Sensitivity for CIN3+ was also significantly lower in women with negative cytology than in those with abnormal cytology (p<0·0001). INTERPRETATION: Colposcopy is accurate for CIN3+ detection in HPV-positive women. These results reflect ESTAMPA efforts in an 18-month follow-up strategy to maximise disease detection with an internationally validated clinical management protocol and regular training, including quality improvement practices. We showed that colposcopy can be optimised with proper standardisation to be used as triage in HPV-positive women. FUNDING: WHO; Pan American Health Organization; Union for International Cancer Control; National Cancer Institute (NCI); NCI Center for Global Health; National Agency for the Promotion of Research, Technological Development, and Innovation; NCI of Argentina and Colombia; Caja Costarricense de Seguro Social; National Council for Science and Technology of Paraguay; International Agency for Research on Cancer; and all local collaborative institutions.

Improving Colposcopy Education Through Images: A Preliminary Assessment of an Image-Based Mobile App for Colposcopic Education.

OBJECTIVES: Colposcopy is an indispensable part of cervical cancer screening. However, in most training programs, there is little by way of a formalized curriculum. We created an image-based teaching tool and hypothesized that this tool, in a mobile app format, would increase resident comfort with colposcopic practice and quantitatively increase their ability to correlate colposcopic images with impressions. MATERIALS AND METHODS: This was a pilot study conducted among ObGyn residents during March 2021. Thirty-eight residents participated and were randomized to either an app user or an independent study control group. Both groups were surveyed before and after their assigned training and completed a postintervention standardized cognitive examination. The primary end points were subjective improvements in comfort with colposcopy. The secondary end point was performance on a standardized image quiz. RESULTS: Of the 46 targeted residents, 38 participated and 26 completed all elements of the study. On the image examination, app users performed slightly better when compared with the independent study group (mean score, 14.9/25 [SD = 2.15] vs 14.0/25 [SD = 3.27], p = .39). App users also were more likely to be confident in providing an overall colposcopic impression (73% vs 30%, p = .111). One hundred percent of the participants in the app user group said that they would recommend the tool to other residents and residency programs. CONCLUSIONS: Image-based teaching tools, such as the ICE-TI app, are valued by learners and can be a useful adjunct to standardized colposcopy curricula. In addition, making use of a mobile platform facilitated convenience learning.

Temporal Trends in Cervical Cancer Screening Practices and Associated Downstream Abnormalities and Procedures Among Women With Insurance in the United States.

OBJECTIVE: To examine temporal trends in cervical cancer screening practices and associated downstream abnormalities and procedures. METHODS: Women aged 18-64 years with commercial insurance or Medicaid insurance from 2008 to 2019 were identified using the IBM MarketScan databases. The annual rates of screening overall and by type of test (cytology, co-testing, or primary human papillomavirus testing) were examined. Downstream abnormal cytologic and histologic test results, colposcopies, and excisional procedures were examined, and rates were reported for the population of eligible patients with continuous insurance and for those who underwent screening. Changes over time in testing and outcomes were compared using χ2 tests and Spearman's correlation. RESULTS: From 2008 to 2019, the annual screening prevalence decreased from 42.6% to 29.4% in women with commercial insurance (P<.001) and from 27.9% to 12.4% among women with Medicaid insurance (P<.001). In the cohort of women with commercial insurance, cytology usage decreased from 79.4% to 38.9% and co-testing increased from 20.1% to 59.6% (P<.001). Per 1,000 women screened, the rate of abnormal histologic and cytologic test results rose from 96 to 119 (P<.001) and colposcopies rose from 33 to 42 (P<.001); excisional procedures remained relatively constant. Per 1,000 eligible women, the rate of abnormal histologic and cytologic test results decreased from 41 to 35 (P<.001), colposcopies declined from 14 to 12, and excisional procedures decreased from 3 to 2. CONCLUSION: Human papillomavirus testing has been rapidly incorporated into cervical cancer screening and is associated with an increasing trend of downstream abnormalities and procedures among screened women but a declining trend at the population level.

Tamización primaria con prueba ADN-VPH en mujeres menores de 30 años: evaluación de tecnología sanitaria / Primary HPV-DNA screening in women under 30 years of age: health technology assessment

Antecedentes A partir del 2014 en Colombia se incorporó la Tamización primaria con prueba de Virus del Papiloma Humano (VPH) desde los 30 hasta los 65 años, cuando la prueba es positiva se hace triage con citología para remisión a colposcopia. Actualmente se discute la conveniencia de iniciar la tamización con prueba de ADN de VPH a partir de los 25 años. De esta manera, el objetivo de esta evaluación de tecnologías sanitarias es analizar la evidencia disponible en torno a la seguridad, efectividad, costoefectividad, valores y preferencias, dilemas éticos y aspectos relacionados con la implementación para el contexto colombiano de la prueba ADN-VPH como estrategia de tamización cervical en mujeres menores de 30 años. Dominios a evaluar Eficacia clínica y seguridad 1. Tasa acumulada de neoplasia intraepitelial cervical (NIC) grado 2 o más avanzado luego de 2 rondas de tamización. 2. Tasas acumuladas de cáncer invasor de cérvix luego de 2 rondas de tamización. 3. Seguridad: remisión a colposcopia. Costo-efectividad Costo efectividad para Colombia. Otros dominios considerados Aspectos éticos asociados a la tamización cervical en mujeres menores de 30 años. Aspectos organizacionales y del individuo. Barreras y facilitadores relacionados con la implementación en el contexto colombiano de la tamización cervical en mujeres menores de 30 años. Métodos Evaluación de efectividad y seguridad clínicas Se realizó una búsqueda sistemática de la literatura en MEDLINE, Embase y CENTRAL de revisiones sistemáticas y ensayos clínicos. Se calificó el cuerpo de la evidencia con la aproximación GRADE. Posteriormente, se convocó a un grupo interdisciplinario a una mesa de trabajo en donde se presentó la evidencia recuperada, dando paso a la discusión y a la construcción de las conclusiones, siguiendo los lineamientos de un consenso formal acorde a la metodología RAND/UCLA. Estudio económico Se hizo una búsqueda sistemática de la literatura de estudios que hubieran evaluado el costo-efectividad para Colombia. Resultados De 7.659 referencias recuperadas se incluyeron 8 estudios. Resultados clínicos Se realizó un análisis integrativo de 5 ensayos clínicos aleatorizados que cumplieron con los citerios de inclusión. Cuando se compara frente a la citología, la tamización primaria con ADN-VPH en mujeres menores de 30 años, podría asociarse con una mayor frecuencia de detección de lesiones NIC2+ durante la primera ronda de cribado (RR: 1.57; IC: 1,20 a 2,04; certeza en la evidencia baja), con una menor incidencia de NIC2+ (RR:0,67; IC: 0,48 a 0,92; certeza en la evidencia baja) y se asocia con una menor frecuencia de carcinoma invasor al término del seguimiento (RR: 0,19; IC: 0,07 a 0,53; certeza en la evidencia alta). Resultados económicos Desde el punto de vista económico, la alternativa de ADN-VPH y triage con citología desde los 25 años quizás representa la alternativa más costo-efectiva para Colombia (razón costo-efectividad incremental $8.820.980 COP año 2013). Otras implicaciones Dos estudios sugieren que las barreras de implementación, atribuibles a circunstancias de intermediación, de orden público y de carácter geográfico, podrían ser solventadas por nuevas tecnologías o estrategias de cribado. Es importante considerar alternativas de forma de administración y de prestación de servicios para solventar algunas barreras de aceptabilidad y acceso. Todo programa de tamización cervical debe contemplar los principios éticos de no maleficencia, beneficencia, autonomía y equidad. Futuros estudios deben enfocarse en analizar nuevas tecnologías de cribado con énfasis en población menor de 30 años. Conclusiones El uso de la prueba ADN-VPH como estrategia de tamización en mujeres menores de 30 años es una intervención probablemente efectiva y costoefectiva para Colombia. Futuros estudios deben enfocarse en analizar nuevas tecnologías de cribado con énfasis en población menor de 30 años.

Background Primary screening with Human Papilloma Virus (HPV) testing was introduced in Colombia in 2014 for individuals between 30 and 65 years of age. When the result is positive, cytology triage is performed for colposcopy referral. The convenience of initiating HPV-DNA testing for screening at 25 years of age is currently a subject of discussion. Therefore, the objective of this health technology assessment (HTA) is to analyze the available evidence regarding safety, efficacy, cost-effectiveness, values and preferences, ethical dilemmas and considerations pertaining to the implementation of the HPV-DNA test as a cervical screening strategy in women under 30 years of age in the Colombian context. Domains to be assessed Clinical efficacy and safety 1. Cumulative rate of cervical intraepithelial neoplasia (CIN) grade 2 or high-er after 2 screening rounds. 2. Cumulative rates of invasive cancer of the uterine cervix after 2 screening rounds. 3. Safety: referral to colposcopy Cost-effectiveness Cost-effectiveness for Colombia. Other domains considered Ethical considerations associated with cervical screening in women under 30 years of age. Organizational and individual considerations. Barriers and facilitators pertaining to the implementation of cervical screening in women under 30 years of age in the Colombian context. Methods Clinical efficacy and safety assessment A systematic literature search of systematic reviews and clinical trials was conducted in MEDLINE, Embase and CENTRAL. The body of evidence was rated using the GRADE approach. An interdisciplinary team was then convened to create a working group to review the retrieved evidence. This led to the discussion and construction of the conclusions following the guidelines of a formal consensus in accordance with the RAND/UCLA methodology. Economic study Systematic literature research of studies that had assessed cost-effectiveness for Colombia. Results Out of the 7,659 references retrieved, 8 studies were included. Clinical outcomes An integrative analysis of 5 randomized clinical trials that met the inclusion critera was performed. Compared with cytology, primary HPV-DNA testing in women under 30 years of age could be associated with a lower frequency of CIN+2 lesions during the first screening round (RR: 1.57; CI: 1.20 to 2.04; low evidence certainty), and a lower incidence of CIN+2 (RR: 0.67; CI: 0.48 to 0.92; low evidence certainty). Moreover, it is associated with a lower frequency of invasive carcinoma at the end of follow-up (RR: 0.19; CI: 0.07 to 0.53; high evidence certainty). Economic results From the financial point of view, the use of HPVDNA testing plus cytology-based triage starting at 25 years of age is perhaps the most cost-effective option for Colombia (incremental cost-effectiveness ratio, COP 8,820,980 in 2013). Other implications Two studies suggest that barriers to implementation attributable to intermediation, public unrest and geographic considerations could be overcome with the use of new screening technologies or strategies. It is important to consider administration and service provision alternatives in order to overcome some acceptability and access barriers. Any cervical screening program must take into consideration ethical principles of nonmaleficence, beneficence, autonomy and equity. Future studies should focus on analyzing new screening techniques with emphasis on the population under 30 years of age. Conclusions The use of HPV-DNA testing as a screening strategy in women under 30 years of age is a potentially efficacious and cost-effective intervention for Colombia. Future studies should focus on analyzing new screening technologies, with emphasis on the population under 30 years of age.

Evidence to Support Change of Clinical Pathway Following Colposcopy Treatment for Cervical Intraepithelial Neoplasia in Canada.

OBJECTIVES: Human papillomavirus (HPV) testing can be incorporated into the post-treatment pathway of cervical intraepithelial neoplasia (CIN) to confirm disease-free status. To inform a post-treatment strategy based on risk of recurrence, we modelled disease and economic outcomes. METHODS: The current Alberta, Canada, post-treatment care pathway-cytology testing with colposcopy assessment-was compared with 6 other scenarios incorporating cytology, HPV testing, or both tests at different time points in a modelling study based on a microsimulation program. Input parameter values for the screening participation, screening age groups, and follow-up options and test compliance for HPV, cytology, and colposcopy were varied, based on Alberta cervical cancer screening program data. Health outcomes over the short- and long-term were projected, which incorporated the increasing population-level coverage of HPV vaccination. Lifetime incremental cost-effectiveness ratios (ICERs) were used to evaluate economic outcomes and descriptive statistics compared with numbers of tests, visits, and procedures as well as changes in incidence and mortality rates between the scenarios. RESULTS: At 5 years after implementation of the "HPV testing alone at 6 and 18 months" post-treatment pathway, the number of colposcopies dropped by 36% and the number of pre-cancer treatments, by 6%. Lifetime ICERs were CAD $6170 versus $248,495 per quality-adjusted life-year compared with the status quo pathway. Cervical cancer incidence and mortality rates decreased significantly and similarly in all scenarios. CONCLUSION: Strategies that involve HPV testing in CIN post-treatment follow-up care are expected to be more cost effective with improved clinical outcomes than traditional cytology and colposcopy-based follow-up.

Risk Assessment of Human Papillomavirus-Positive Cytology-Negative Cervical Cancer Screening in Black and White Women.

OBJECTIVES: As we move toward human papillomavirus (HPV) only as the preferred cervical cancer screening method, we performed a retrospective analysis of Black and White women with negative cytology (Papanicolaou negative [PAPneg]) and positive high-risk HPV (hrHPV) (HPVpos) results and determined follow-up. METHODS: We searched our pathology data system for patients with PAPneg/HPVpos results (2017-2019). Follow-up data were reviewed (39 months), and a comparison among race was performed. RESULTS: In total, 1,728 patients were identified (Black, 53%; White, 47%). Twenty-nine percent of the patients had no follow-up with no difference among the races. HPV 16 was more common among Whites (P < .01), while non-16/18 hrHPV was more common among Black patients (P = .01). A total of 30 (3.3%) Black and 26 (3.2%) White patients were diagnosed with cervical intraepithelial neoplasia grade 2/3 (CIN 2/3). More White women were diagnosed on biopsy alone (negative endocervical curettage) compared with Black women (20 vs 9, P < .01). Meanwhile, there were 21 Black and 6 White women with CIN 2/3 on endocervical curettage (P = .01). CONCLUSIONS: Follow-up of women with PAPneg/HPVpos remains a challenge. There was no disparity in follow-up when cohorts were compared. However, Black women had higher numbers of high-grade intraepithelial lesions on endocervical curettage.

Patterns of cervical cancer screening among Medicaid beneficiaries.

OBJECTIVE: Cervical cancer screening guidelines have evolved over time with the incorporation of human papillomavirus (HPV) testing along with cytology. Current screening guidelines recommend cytological screening every 3 years or HPV testing with or without cytology every 5 years in women age 30-65 years. We examined the use of cervical cancer screening among average-risk Medicaid beneficiaries. DESIGN: Retrospective cohort study. POPULATION: Women age 30-64 years at average risk for cervical cancer who underwent cervical cancer screening with cytology, co-testing or primary HPV testing from 2013 to 2016. METHODS: The IBM Watson Health Multi-State Medicaid MarketScan Database was used. Subsequent screening rates within 3 years of the index test were examined. MAIN OUTCOME MEASURE: The rate of repeat cervical cancer screening was analysed using a cumulative incidence function. RESULTS: A total of 265 083 patients were identified. Overall, 43.1% (n = 114 312) had index co-testing, 55.2% (n = 146 309) had cytology and 1.7% (n = 4462) had primary HPV testing. The cumulative incidence of early, repeat cervical cancer screening was 3.9% at 12 months, 22.7% at 24 months and 33.3% at 36 months. During the period from 12 to 24 months after follow up, 20.9% of women underwent repeat screening while 19.4% underwent repeat screening 24-36 months after the index test. Among women who did not undergo repeat cervical cancer screening, a yearly gynaecological examination was performed in only 16 627 (10.7%) during year 2 and in 11 116 (8.8%) during year 3. CONCLUSION: Among average-risk Medicaid beneficiaries, cervical cancer screening is frequently overused. Women who do not undergo cervical cancer screening are unlikely to undergo routine gynaecological examination. TWEETABLE ABSTRACT: Among average-risk Medicaid beneficiaries, cervical cancer screening is frequently overused.

Colposcopic assessment by Swedescore, evaluation of effectiveness in the Swedish screening programme: a cross-sectional study.

OBJECTIVE: To evaluate the effectiveness and performance of Swedescore in the Swedish screening programme. DESIGN: Cross-sectional register study. SETTING AND POPULATION: All Swedish women aged over 18 years with a colposcopic assessment linked to a biopsy in the Swedish National Cervical Screening Registry, 2015-20. METHODS: Colposcopies with Swedescore were compared with the histopathological diagnosis of cervical intraepithelial neoplasia grade 2 or higher (CIN2+). The respective influence of cytology and human papillomavirus (HPV) testing, at referral for colposcopy and concurrently with colposcopy, were investigated in regression models. MAIN OUTCOME MEASURES: CIN2+. RESULTS: A total of 11 317 colposcopic assessments with Swedescore were included. Odds ratios for CIN2+ increased for every step in the Swedescore scale. At Swedescore ≥0-1, the proportion of CIN2+ was 9.8%. At Swedescore ≥8, the specificity was 93.3% and the positive predictive value was 60.1%, Area under the receiver operating characteristics curve (AUC) was 0.71. If the smear had been abnormal at referral, a normal colposcopy (Swedescore 0-1) was still associated with a CIN2+ risk of more than 5%. In the regression model, cytology and HPV had higher odds ratio for CIN2+ than colposcopy; the combination resulted in an AUC of 0.88. CONCLUSIONS: Swedescore works well in a routine clinical setting but colposcopy assessed with Swedescore was inferior to that reported in previous clinical studies. No safe cutoff level was identified for refraining from biopsy. See-and-treat at Swedescore 8-10 is feasible only if referral cytology showed high-grade squamous intraepithelial lesion. TWEETABLE ABSTRACT: No safe cutoff level for refraining from biopsy nor for see-and-treat with Swedescore.