Is a delay in the introduction of human papillomavirus-based cervical screening affordable?
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ABSTRACT: Objective
It often takes considerable time for sufficient evidence to accumulate to support implementation of new methods in routine screening. Where national screening programmes are already effective, switching to a more sensitive screening test may not be a priority. Although risk associated with overly rapid implementation exists, postponement is also associated with a (to date unquantified) missed opportunity to prevent deaths. This risk tends not to be addressed where effective screening methods are already in use. We here estimate the monetary value of a one-year delay in replacing cytology cervical screening with human papillomavirus testing.Methods
Using a previously validated model, we calculated the number of incident and fatal cervical cancers that would be diagnosed by 2030 in England, under the assumption that human papillomavirus testing replaces cytology in 2020 rather than 2019, and the monetary value of the quality-adjusted life years lost in preventable cases.Results
A one-year delay in the implementation of human papillomavirus screening would miss the opportunity to prevent 581 cases of cervical cancer, and lead to a loss of 1595 quality-adjusted life years (3.5% discount rate) with a monetary value of £32 million (at £20,000 per quality-adjusted life year).Conclusion
This is a measurable loss and should be considered in prioritising decision-making in screening.
SUBMITTER: Castanon A
PROVIDER: S-EPMC6376595 | biostudies-literature | 2019 Mar
REPOSITORIES: biostudies-literature
Publications
Is a delay in the introduction of human papillomavirus-based cervical screening affordable?
Castañon Alejandra A Rebolj Matejka M Sasieni Peter P
Journal of medical screening 20181003 1
<h4>Objective</h4>It often takes considerable time for sufficient evidence to accumulate to support implementation of new methods in routine screening. Where national screening programmes are already effective, switching to a more sensitive screening test may not be a priority. Although risk associated with overly rapid implementation exists, postponement is also associated with a (to date unquantified) missed opportunity to prevent deaths. This risk tends not to be addressed where effective scr ...[more]
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Project description:BackgroundClinical trials in the research setting have demonstrated that primary human papillomavirus (HPV)-based screening results in greater protection against cervical cancer compared with cytology, but evidence from real-life implementation was missing. To evaluate the effectiveness of HPV-based cervical screening within a real-life screening program, the organized, population-based cervical screening program in the capital region of Sweden offered either HPV- or cytology-based screening in a randomized manner through a randomized healthcare policy (RHP).Methods and findingsA total of 395,725 women aged 30 to 64 years that were invited for their routine cervical screening visit were randomized without blinding to either cytology-based screening with HPV triage (n = 183,309) or HPV-based screening, with cytology triage (n = 212,416 women) between September 1, 2014 and September 30, 2016 and follow-up through June 30, 2017. The main outcome was non-inferior detection rate of cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Secondary outcomes included superiority in CIN2+ detection, screening attendance, and referral to histology. In total, 120,240 had a cervical screening sample on record in the study period in the HPV arm and 99,340 in the cytology arm and were followed for the outcomes of interest. In per-protocol (PP) analyses, the detection rate of CIN2+ was 1.03% (95% confidence interval (CI) 0.98 to 1.10) in the HPV arm and 0.93% (0.87 to 0.99) in the cytology arm (p for non-inferiority <0.0001; odds ratio (OR) 1.11 (95% CI 1.02 to 1.22)). There were 46 cervical cancers detected in the HPV arm (0.04% (0.03 to 0.06)) and 48 cancers detected in the cytology arm (0.05% (0.04 to 0.07)) (p for non-inferiority <0.0001; OR 0.79 (0.53 to 1.18)). Intention-to-screen (ITS) analyses found few differences. In the HPV arm, there was a modestly increased attendance after new invitations (68.56% (68.31 to 68.80) vs. 67.71% (67.43 to 67.98); OR 1.02 (1.00 to 1.03)) and increased rate of referral with completed biopsy (3.89% (3.79 to 4.00) vs. 3.53% (3.42 to 3.65); OR 1.10 (1.05 to 1.15)). The main limitations of this analysis are that only the baseline results are presented, and there was an imbalance in invitations between the study arms.ConclusionsIn this study, we observed that a real-life RHP of primary HPV-based screening was acceptable and effective when evaluated against cytology-based screening, as indicated by comparable participation, referral, and detection rates.Trial registrationClinicalTrials.gov NCT01511328.
| S-EPMC8423359 | biostudies-literature
Project description:INTRODUCTION:Since 2006, human papillomavirus vaccine has been recommended for young females in the U.S. This study aimed to compare cervical cancer incidence among young women before and after the human papillomavirus vaccine was introduced. METHODS:This cross-sectional study used data from the National Program for Cancer Registries and Surveillance, Epidemiology, and End Results Incidence-U.S. Cancer Statistics 2001-2014 database for U.S. females aged 15-34 years. This study compared the 4-year average annual incidence of invasive cervical cancer in the 4 years before human papillomavirus vaccine was introduced (2003-2006) and the 4 most recent years in the vaccine era (2011-2014). Joinpoint regression models of cervical incidence from 2001 to 2014 were fitted to identify the discrete joints (year) that represent statistically significant changes in the direction of the trend after the introduction of human papillomavirus vaccination in 2006. Data were collected in 2001-2014, released, and analyzed in 2017. RESULTS:The 4-year average annual incidence rates for cervical cancer in 2011-2014 were 29% lower than that in 2003-2006 (6.0 vs 8.4 per 1,000,000 people, rate ratio=0.71, 95% CI=0.64, 0.80) among females aged 15-24 years, and 13.0% lower among females aged 25-34 years. Joinpoint analyses of cervical cancer incidence among females aged 15-24 years revealed a significant joint at 2009 for both squamous cell carcinoma and non-squamous cell carcinoma. Among females aged 25-34 years, there was no significant decrease in cervical cancer incidence after 2006. CONCLUSIONS:A significant decrease in the incidence of cervical cancer among young females after the introduction of human papillomavirus vaccine may indicate early effects of human papillomavirus vaccination.
| S-EPMC6054889 | biostudies-literature
Project description:Current US cervical cancer screening guidelines do not differentiate recommendations based on a woman's human papillomavirus (HPV) vaccination status. Changes to cervical cancer screening policies in HPV-vaccinated women should be evaluated. We utilized an individual-based mathematical model of HPV and cervical cancer in US women to project the health benefits, costs, and harms associated with screening strategies in women vaccinated with the bivalent, quadrivalent, or nonavalent vaccine. Strategies varied by the primary screening test, including cytology, HPV, and combined cytology and HPV "cotesting"; age of screening initiation and/or switching to a new test; and interval between routine screens. Cost-effectiveness analysis was conducted from the societal perspective to identify screening strategies that would be considered good value for money according to thresholds of $50 000 to $200 000 per quality-adjusted life-year (QALY) gained. Among women fully vaccinated with the bivalent or quadrivalent vaccine, optimal screening strategies involved either cytology or HPV testing alone every five years starting at age 25 or 30 years, with cost-effectiveness ratios ranging from $34 680 to $138 560 per QALY gained. Screening earlier or more frequently was either not cost-effective or associated with exceedingly high cost-effectiveness ratios. In women vaccinated with the nonavalent vaccine, only primary HPV testing was efficient, involving decreased frequency (ie, every 10 years) starting at either age 35 years ($40 210 per QALY) or age 30 years ($127 010 per QALY); with lower nonavalent vaccine efficacy, 10-year HPV testing starting at earlier ages of 25 or 30 years was optimal. Importantly, current US guidelines for screening were inefficient in HPV-vaccinated women. This model-based analysis suggests screening can be modified to start at later ages, occur at decreased frequency, and involve primary HPV testing in HPV-vaccinated women, providing more health benefit at lower harms and costs than current screening guidelines.
| S-EPMC5068562 | biostudies-literature
Project description:ObjectiveTo provide the first report on the main outcomes from the prevalence and incidence rounds of a large pilot of routine primary high risk human papillomavirus (hrHPV) testing in England, compared with contemporaneous primary liquid based cytology screening.DesignObservational study.SettingThe English Cervical Screening Programme.Participants578 547 women undergoing cervical screening in primary care between May 2013 and December 2014, with follow-up until May 2017; 183 970 (32%) were screened with hrHPV testing.InterventionsRoutine cervical screening with hrHPV testing with liquid based cytology triage and two early recalls for women who were hrHPV positive and cytology negative, following the national screening age and interval recommendations.Main outcome measuresFrequency of referral for a colposcopy; adherence to early recall; and relative detection of cervical intraepithelial neoplasia grade 2 or worse from hrHPV testing compared with liquid based cytology in two consecutive screening rounds.ResultsBaseline hrHPV testing and early recall required approximately 80% more colposcopies, (adjusted odds ratio 1.77, 95% confidence interval 1.73 to 1.82), but detected substantially more cervical intraepithelial neoplasia than liquid based cytology (1.49 for cervical intraepithelial neoplasia grade 2 or worse, 1.43 to 1.55; 1.44 for cervical intraepithelial neoplasia grade 3 or worse, 1.36 to 1.51) and for cervical cancer (1.27, 0.99 to 1.63). Attendance at early recall and colposcopy referral were 80% and 95%, respectively. At the incidence screen, the 33 506 women screened with hrHPV testing had substantially less cervical intraepithelial neoplasia grade 3 or worse than the 77 017 women screened with liquid based cytology (0.14, 0.09 to 0.23).ConclusionsIn England, routine primary hrHPV screening increased the detection of cervical intraepithelial neoplasia grade 3 or worse and cervical cancer by approximately 40% and 30%, respectively, compared with liquid based cytology. The very low incidence of cervical intraepithelial neoplasia grade 3 or worse after three years supports extending the screening interval.
| S-EPMC6364146 | biostudies-literature
Project description:BACKGROUND:Cervical cancer is the fourth most common cancer affecting women worldwide. In the 1980s, it was found that the sexually transmitted disease human papillomavirus causes over 90% of all cervical cancer cases. Since that discovery, diagnostic technologies have been developed for the detection of human papillomavirus DNA in cervical samples. However, significant sociocultural and structural barriers remain. Considerable strides have taken place in recent years to address these barriers, such as the self-collection for human papillomavirus-based cervical screening method. OBJECTIVE:The purpose of this review is to synthesize qualitative evidence around the self-collection method and identify strategies to increase acceptability and feasibility in different settings. This qualitative synthesis will be used to better understand how to conceptualize and implement more effective, accessible, and socially and culturally acceptable cervical screening programs and policies globally. METHODS:A systematic search will be conducted in Global Health, Cochrane, CINAHL (Cumulative Index to Nursing and Allied Health Literature), ProQuest, ScienceDirect, EMBASE, EMCARE, Medline (OVID), Scopus, and Web of Science. Published and peer-reviewed articles will be included. Two reviewers will independently screen and assess the studies. The data will be coded and analyzed using a thematic synthesis process. The socioecological model will be used to organize emergent themes at the micro and macro levels. The results will be presented in narrative and tabular form. RESULTS:The article search and data extraction were completed in May 2020. The data were analyzed in June 2020. The review will be submitted for publication in Fall 2020. CONCLUSIONS:This review will present the global evidence of the perspectives and experiences of various key stakeholders and how these perspectives and experiences impact their decision-making process to perform or accept self-collection for human papillomavirus-based cervical screening. The review will provide guidance to implementation researchers as well as implications for future research. TRIAL REGISTRATION:PROSPERO International Prospective Register of Systematic Reviews CRD42019109073; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=109073. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/21093.
| S-EPMC7644378 | biostudies-literature
Project description:PurposeTo describe changes in knowledge of cervical cancer prevention, human papillomavirus (HPV), and HPV vaccination among women at high risk for cervical cancer in the first five years after introduction of HPV vaccination.MethodsIn 2007, 2008-9, and 2011, women in a multicenter U.S. cohort study completed 44-item self-report questionnaires assessing knowledge of cervical cancer prevention, HPV, and HPV vaccination. Results across time were assessed for individuals, and three study enrollment cohorts were compared. Knowledge scores were correlated with demographic variables, measures of education and attention, and medical factors. Associations were assessed in multivariable models.ResultsIn all, 974 women completed three serial questionnaires; most were minority, low income, and current or former smokers. The group included 652 (67%) HIV infected and 322 (33%) uninfected. Summary knowledge scores (possible range 0-24) increased from 2007 (12.8, S.D. 5.8) to 2008-9 (13.9, S.D. 5.3, P < 0.001) and to 2011 (14.3, S.D 5.2, P < 0.0001 vs 2007 and <0.04 vs 2008-9). Higher knowledge scores at first and follow-up administration of questionnaires, higher income, and higher education level were associated with improved knowledge score at third administration. Women not previously surveyed had scores similar to those of the longitudinal group at baseline.ConclusionSubstantial gaps in understanding of HPV and cervical cancer prevention exist despite years of health education. While more effective educational interventions may help, optimal cancer prevention may require opt-out vaccination programs that do not require nuanced understanding.
| S-EPMC4392650 | biostudies-literature
Project description:BackgroundTo be effective, population-based cervical cancer prevention programs must be tailored to meet the needs of the target population. One important factor in cervical cancer screening may include male involvement. To iteratively improve a screening program employing self-collected vaginal swabs for human-papillomavirus (HPV) testing in western Kenya, we examined the role of male partners and community leaders in decision-making and accessing screening services.MethodsWe carried out 604 semi-structured, in-depth interviews (IDIs) with women and community health volunteers who took part in a multiphase trial of implementation strategies for HPV-based cervical cancer screening. IDIs were coded and themes related to decision-making, screening and treatment barriers, and influence of male partners and community leaders were identified and analyzed.ResultsWomen experienced both support and opposition from their male partners. Partner support took the form of financial support for transportation and emotional support and encouragement, while opposition ranged from anticipated negative reactions to lack of permission, isolation, and abandonment. Though most women described their own partners as supportive, many felt that other male partners would not be supportive. Most participants believed that increased HPV and cervical cancer knowledge would increase partner support. Women reported a general acceptance of involvement of community leaders in education and screening campaigns, in a setting where such leaders may hold influence over men in the community.ConclusionThere was a clear interest in involving male partners in the cervical cancer prevention process, specifically in increasing knowledge and awareness. Future research should explore the feasibility and effectiveness of engaging male partners in cervical cancer screening and prevention programs.
| S-EPMC6688365 | biostudies-literature
Project description:Background and objectiveHuman papillomavirus (HPV) testing has become a preferred cervical cancer screening. However, most HPV infections are harmless and additional tests are required to screen HPV positive women. The objective of this study is to determine the optimal triage strategies for HPV positive women in China's rural population.MethodsA population-based screening was performed at seven rural counties of Jiangxi province, between October 2014 to January 2016. A total of 18,000 women aged 35-64 years were enrolled in this study. The primary screening was performed using CareHPV, HC-2, Cobas ®4,800 or HybriMax. Positive women were further screened with five triage tests: (1) Liquid-based cytology test (LBC); (2) conventional Pap cytology test (Pap smear); (3) HPV16, 18 detection; (4) viral load; and (5) visual inspection with acetic acid and Lugol's iodine (VIA/VILI). Women who were tested positive were referred for colposcopy. The five triage tests were compared with respect to sensitivity, specificity, referral rate, cost and diagnostic time.ResultsComplete data were available for 17,782 women. The HPV prevalence was 13.6%. Referral rates for colposcopy were 4.5%, 2.8%, 2.8%, 6.6%, and 3.7% with LBC, Pap smear, HPV16/18, viral load, and VIA/VILI, respectively. The sensitivity of the above triage tests was 65.8%, 51.9%, 86.8%, 73.3%, and 41.7%, respectively. The specificity was 69.8%, 81.0%, 85.8%, 52.2% and 65.3%, respectively. The average time to diagnosis was significantly lower with HPV16/18, viral load and VIA/VILI than LBC and Pap smear. In addition, screening cost that leads to identify one HSIL+ woman was the lowest with viral load.ConclusionOur data indicate that HPV16/18 and viral load are the optimal triage strategies for HPV screening in China's rural population.
| S-EPMC6927345 | biostudies-literature
Project description:ImportanceCervical cancer screening is a lifesaving intervention, with an array of approaches, including liquid-based cytology (LBC), molecular testing for human papillomavirus (HPV) infection, and combinations via parallel cotesting or sequential triage. Maximizing screening efficacy while minimizing overtreatment is vital, especially when considering how the HPV vaccine will affect the interpretation of results.ObjectivesTo estimate the likely outcomes of different screening modalities and to model how the increasing uptake of the HPV vaccine could affect the interpretation of screening results.Design, setting, and participantsThis decision analytic model established a simple Markov model to compare the outcomes of different cervical cancer screening modalities on a simulated population of women (aged ≥25 years), considering different levels of HPV vaccination.Main outcomes and measuresThe number of cases of cervical intraepithelial neoplasia (CIN) grade 2 and 3 detected and missed, the number of false positives, and the number of tests required to achieve a given level of accuracy. Positive and negative predictive values of different modalities were simulated under varying levels of HPV vaccination and therefore HPV prevalence.ResultsIn a simulated population of 1000 women aged 25 years and older with an HPV prevalence of 2%, HPV-based modalities outperformed LBC-based approaches, detecting 19% more true positives (HPV test sensitivity, 89.9% [95% CI, 88.6%-91.1%]; LBC test sensitivity, 75.5% [95% CI, 66.6%-82.7%]). While cotesting markedly reduced missed cases, detecting 29% more true positives than LBC alone (19.5 [95% CI, 19.3-19.7] per 1000 women screened vs 15.1 [95% CI, 13.3-16.5] per 1000 women screened), it unacceptably increased excess colposcopy referral by 94% (184.4 [95% CI, 181.8-188.0] false positives per 1000 women screened vs 95.1 [95% CI, 93.1-97.0] false positives per 1000 women screened). By contrast, triage testing with reflex screening substantially reduced false positives by a factor of approximately 10 (eg, HPV with LBC triage, 9.6 [95% CI, 9.3-10.0] per 1000 women screened). Over a lifetime of screening, reflex approaches with appropriate test intervals maximized therapeutic efficacy; as HPV vaccination rates increased, HPV-based screening approaches resulted in fewer unnecessary colposcopies than LBC approaches (HPV testing, 80% vaccine coverage: 44.1 [95% CI, 40-45.9] excess colposcopies; LBC testing, 80% vaccine coverage: 96.9 [95% CI, 96.8-97.0] excess colposcopies).Conclusions and relevanceIn this decision analytic model, the effectiveness of cervical cancer screening was dependent on the prevalence of cervical dysplasia and/or HPV infection or vaccination in a population as well as the sensitivity and specificity of various modalities. Although screening is lifesaving, overtesting or modalities inappropriate to the target population may cause significant harm, including overtreatment.
| S-EPMC8246311 | biostudies-literature
Project description:ObjectiveTo determine the most cost-effective screening programme for cervical cancer.DesignCost-effectiveness analysis from a societal perspective.SettingThe Netherlands.PopulationDutch women who have not been invited for human papillomavirus (HPV) vaccination.MethodsWe calibrated the microsimulation screening analysis (MISCAN) model to Dutch epidemiological data. We used this model to consider nine screening strategies that use: (i) cytological testing with cytology triage for borderline/mildly abnormal smears; (ii) HPV testing with cytology triage for HPV-positive smears; or (iii) cytological testing with HPV triage for borderline/mildly abnormal smears. For each strategy, we varied the number of screening rounds, the time interval, the age of the first screening, and the type of cytological testing (conventional or liquid-based cytology).Main outcome measuresQuality-adjusted life years (QALYs) gained and costs from a societal perspective.ResultsUnder the base-case assumptions, primary HPV testing with cytology triage is the most cost-effective strategy. Using cost-effectiveness thresholds of € 20,000 and € 50,000 per QALY gained yields optimal screening programmes with three and seven screening rounds, respectively. The results are sensitive to several uncertain model inputs, most importantly the costs of the HPV test. For women aged 32 years or younger, primary cytology screening is more cost-effective than primary HPV testing.ConclusionsIncreasing the interval between screening rounds and changing the primary test from cytology to HPV testing can improve the effectiveness and decrease the costs of cervical cancer screening in the Netherlands.
| S-EPMC3489039 | biostudies-literature