Cervical Cancer Screening In Germany Research Articles

Impact of the Corona Pandemic on Cervical Cancer Screening Assessment.

The global impact of the COVID-19 pandemic resulted in disruptions to healthcare systems throughout the world. The numbers of cytology examinations, human papillomavirus (HPV) tests, and women referred for colposcopy decreased in many countries. There have been no reports on cervical cancer screening in Germany. This study aimed to describe changes in the numbers of colposcopies, cytology examinations, HPV tests, and histological results during the pandemic compared to the pre-pandemic years in order to evaluate the impact of the COVID-19 pandemic on cervical cancer screening. The numbers of colposcopies, cytology examinations, HPV tests, and histologic results were analyzed retrospectively for the period January 2018 to December 2022. The 2 years period before the pandemic (2018 and 2019) were compared with the 3 years period of the pandemic (2020-2022). In total, 6,518 colposcopies were performed in 5,579 women. The numbers of colposcopies, cytology examinations, and high-risk HPV (hrHPV) tests increased during the pandemic years. The number of biopsies per year taken was stable (range=450-554). The relative numbers of cervical intraepithelial neoplasia (CIN) III/HSIL findings were stable, while the numbers of cervical cancers identified increased slightly from 15 (6.6%) in 2018 to 22 (7.4%) in 2022. Increases in numbers of women examined and colposcopies were observed in the years 2021 and 2022 during the pandemic, in comparison to the preceding years. These also led to increases in the figures for cytology, hrHPV, histology, and operations. The onset of the pandemic occurred in the same year as a newly organized screening program started in Germany. The increases might therefore be due to the newly organized screening system.

Prevalence of higher-grade dysplasia in persistently high-risk human papillomavirus positive, cytology negative women after introduction of the new cervical cancer screening in Germany

PurposeAccording to the recently implemented organized cervical cancer screening program in Germany, women older than 35 years with negative cytology but persistent high-risk human papilloma virus (hrHPV) infection > 12 months should be referred to colposcopy for further evaluation. This study aimed to present and dissect colposcopic and histopathological findings with particular focus on associated hrHPV genotypes.MethodsThis study is a retrospective analysis of clinical data from 89 hrHPV positive patients with normal cytology who underwent colposcopic examination at a certified dysplasia outpatient clinic in Germany in 2021.ResultsWhile 38 (43%) women had a normal colposcopic finding, 45 (51%) had minor and 6 (7%) major changes. Thirty-one (35%) of the women were HPV 16 and/or HPV 18 positive and 58 (65%) women were positive for other hrHPV only. Among patients who underwent colposcopy with biopsies (in case of an abnormal finding or type 3 transformation zone, n = 68), eight (12%) had cervical intraepithelial neoplasia (CIN) 3 and six (9%) had CIN 2. The proportion of women diagnosed with CIN 3 varied among different hrHPV genotypes (HPV 16: 11%, HPV 18: 33%, HPV 31: 27%, HPV 33: 33%, HPV 52: 33%).ConclusionPersistently hrHPV positive women with negative cytology are at increased risk of being diagnosed with CIN 3. As CIN 3 prevalence seems to differ with regard to hrHPV strain, immediate HPV genotyping for risk stratification and subsequent early referral for colposcopy might constitute a feasible strategy.

Proposal for a descriptive and differentiated presentation of the longitudinal impact of the new organized cancer screening guideline and HPV vaccination in Germany

IntroductionSince 01/01/2020, the cervical cancer screening in Germany has been carried out due to the organized early cancer diagnosis guideline (oKFE-RL). In 2007, HPV vaccination was initiated in Germany. The main goal of both initiatives is to further reduce the incidence of invasive cervical cancer. To assess the effect of the new screening strategy in a timely manner, monitoring of short-term changes need to be considered. Ideally, the effects of both prevention methods would be presented together in one model.Materials and methodsBecause no change in the incidence of invasive cervical cancer is initially expected, the incidence of CIN 3 is used as a surrogate parameter to assess the effects of the prevention efforts. Based on expected additional effects of vaccination and co-testing, a model-based estimation of the expected CIN 3 incidence during the evaluation of the screening program is performed using the CIN 3 incidence in the Saarland population.Modeling resultsThe oKFE-RL provides for two groups: Primary cytodiagnosis continues until 35 years of age. Here, in the next few years, CIN 3 incidence will be reduced not by the oKFE-RL but by the increasing proportion of vaccinated women. In the group over 35 years, co-testing was introduced with a stringent algorithm. Due to the higher sensitivity of the HPV test, significantly more CIN 3 are detected in the first round of 3 years and thus, the CIN 3 incidence initially increases. As these CIN 3 are absent in the second round, significantly fewer CIN 3 cases will be detected then. These effects suggest a global decrease in CIN 3 incidence of 25.8% after 6 years.ConclusionObservation of the age distribution curve of CIN 3 allows both effects of prevention to be assessed in a timely manner and separately. In the future, data from epidemiologic cancer registries should be incorporated into the model to replace modeling with real data.

Implementation of the Program for Early Detection of Cervical Cancer in the Federal Republic of Germany.

Introduction:There are many cervical cancer screening programs in the world. Germany, as well as a number of other countries in the world, carry out its national cervical cancer screening program.Aim:In order to improve screening results, new guidelines for cervical cancer screening are in force in Germany.Methods:Auhors used descriptive-analytical method to described advantages and disadvantages of new adopted Guidelines for screnning program according eperiences of used previous program in Germany.Discussion:These guidelines have been adopted and approved by the competent Federal Committee for the implementation of cervical cancer screening in Germany. The committee is under the independent management of doctors and health insurance companies. The Committee is also under the legal control of the German Federal Ministry of Health.Conclusion:New Guidelines for Cervical Cancer Screening in Germany has an unchanged part relating to cervical cytodiagnostics. In addition, HPV typizatiion has been integrated in the new screening guidelines to further improve the quality of cervical cancer screening in Germany.

Cervical cancer screening in Germany

Cytological examination for the early detection of cervical cancer (CCS) has been available in Germany since 1971. Women over the age of 20 are entitled to aPap smear every year; however, thus far an organized screening program and personal invitations have been missing.The incidence rate of cervical carcinoma declined dramatically in the decades following the introduction of CCS, but the incidence rate has stagnated in recent years. The cause of cervical cancer is apersistent infection with high-risk types of human papillomavirus (HPV). HPV tests have been approved by the American Food and Drug Administration (FDA) for CCS for several years. Furthermore, since 2006, the HPV vaccination has been offered as aform of primary prevention.As part of the German National Cancer Plan, the European Guideline for Cervical Cancer Screening was implemented and adopted into the 2013 Law on Cancer Screening and Registration. The Federal Joint Committee (G-BA) was commissioned with the implementation of an organized cervical cancer screening program.In April 2018, the G‑BA published updated key points for the implementation of an organized nationwide screening program in Germany. While annual cytological screening for women between the ages of 20 and 34 will continue, women over the age of 34years will be given aco-test comprising a Pap smear and an HPV test, every threeyears. Women between the ages of 20 and 60 will be contacted by their health insurance provider every fiveyears and receive an information leaflet. After atest phase of at least sixyears, the new program will be evaluated.

Invitation to cervical cancer screening does increase participation in Germany: Results from the MARZY study.

The effect of different invitation models on participation in cervical cancer screening (CCS) was investigated in a randomized population-based cohort study in Germany. Participants were randomly selected via population registries and randomized into intervention Arm A (invitation letter) and Arm B (invitation letter and information brochure) or control Arm C (no invitation). The intervention and control arms were compared with regard to 3-year participation and the two invitation models were compared between intervention arms. Of the 7,758 eligible women aged 30-65 years, living in the city of Mainz and in the rural region of Mainz-Bingen, 5,265 were included in the analysis. Differences in proportions of women attending CCS were investigated and logistic regression was performed to analyze various factors influencing participation. In the intervention group, 91.8% participated in CCS compared to 85.3% in the control group (p < 0.0001), with a 6.6 percentage point increase in participation [95% confidence interval (CI) 4.6-8.6] and an adjusted odds ratio (OR) of 2.69 (95% CI 2.15-3.37). Effect estimators increased to 21.9 percentage points (95% CI 16.7-27.1) and an OR of 3.64 (95% CI 2.74-4.82), respectively, when women who participated in screening annually were excluded from the analysis. The invitation letter was particularly effective among women with lower school education, migrant women and older women. No difference in participation was found between the intervention Arm A and Arm B. An accompanying information brochure did not motivate more women to undergo CCS. However, a written invitation statistically significantly increased participation in CCS in Germany.

The paradigm shift in cervical cancer screening in Germany.

With the adoption of the Cancer Screening and Registration Law (KFRG, 2013) based on the National Cancer Plan, the so far opportunistic cervical cancer screening in Germany is to be converted to an organized screening program. This decision in Germany is consistent with the new EU Guidelines and, in anticipation of the upcoming German S3 guideline for cervical cancer screening.

Cervical cancer screening in Germany: group-specific participation rates in the state of Niedersachsen (Lower Saxony). A study with health insurance data.

The participation rates in cervical screenings are varying over different countries. This is only partly due to the availability of organized screening programs, as the rates are also varying between countries were such programs were implemented. For Germany the level of knowledge is low, and information are outdated. In order to improve the level of knowledge, we examined whether the participation rates in cervical screenings in a large German insurance population were changing over time, and whether these changes were different with respect to age and qualification of the participating women. The analyses were based on the complete anonymised dataset of a large statutory health insurance in Lower Saxony, Germany, with case numbers between 940,827 (2006) and 1,044,797 (2011) women aged 20 years and older. Between 2006 and 2011 the overall annual participation rates were increasing from 44.8 to 47.6%. The highest rates occurred in women with the highest qualification level, thus leading to increasing social differences over time. There was a peak in the age group of 25-29 years from annually 60.3 (2006) to 60.2% (2011), and bi-annually from 77 to 77.1% with constantly decreasing rates up to the age of 60. No substantial differences occurred between a 2- and a 3-year observation period. Over time only small increases of participation rates in cervical screenings occurred. These findings may be interpreted in favor of population-based screenings within an invitation program.

Decision-analytic modeling to evaluate the long-term effectiveness and cost-effectiveness of HPV-DNA testing in primary cervical cancer screening in Germany.

BackgroundPersistent infections with high-risk types of human papillomavirus (HPV) are associated with the development of cervical neoplasia. Compared to cytology HPV testing is more sensitive in detecting high-grade cervical cancer precursors, but with lower specificity. HPV based primary screening for cervical cancer is currently discussed in Germany. Decisions should be based on a systematic evaluation of the long-term effectiveness and cost-effectiveness of HPV based primary screening.Research questionsWhat is the long-term clinical effectiveness (reduction in lifetime risk of cervical cancer and death due to cervical cancer, life years gained) of HPV testing and what is the cost-effectiveness in Euro per life year gained (LYG) of including HPV testing in primary cervical cancer screening in the German health care context? How can the screening program be improved with respect to test combination, age at start and end of screening and screening interval and which recommendations should be made for the German health care context?MethodsA previously published and validated decision-analytic model for the German health care context was extended and adapted to the natural history of HPV infection and cervical cancer in order to evaluate different screening strategies that differ by screening interval, and tests, including cytology alone, HPV testing alone or in combination with cytology, and HPV testing with cytology triage for HPV-positive women. German clinical, epidemiological and economic data were used. In the absence of individual data, screening adherence was modelled independently from screening history. Test accuracy data were retrieved from international meta-analyses. Predicted outcomes included reduction in lifetime-risk for cervical cancer cases and deaths, life expectancy, lifetime costs, and discounted incremental cost-effectiveness ratios (ICER). The perspective of the third party payer and 3% annual discount rate were adopted. Extensive sensitivity analyses were performed in order to evaluate the robustness of results and identify areas of future research.ResultsIn the base case analysis screening resulted in a 53% to 97% risk reduction for cervical cancer with a discounted ICER between 2,600 Euro/LYG (cytology alone every five years) and 155,500 Euro/LYG (Annual cytology age 20 to 29 years, and annual HPV age 30 years and older). Annual cytology, the current recommended screening strategy in Germany, was dominated. In sensitivity analyses variation in the relative increase in the sensitivity of HPV testing as compared to cytology, HPV test costs, screening adherence, HPV incidence, and annual discount rate influenced the ICER results. Variation in the screening start age also influenced the ICER. All cytology strategies were dominated by HPV screening strategies, when relative sensitivity increase by HPV testing compared to cytology was higher (scenario analysis with data for test accuracy from German studies). HPV testing every one, two or three years was more effective than annual cytology. With increased screening adherence a longer screening interval and with low screening adherence a shorter interval would be more cost-effective. With a reduction in HPV incidence of more than 70% triennial HPV screening in women aged 30 years and older (and biennial Pap screening in women aged 20 to 29 years) is cost-effective. The discounted ICER increases with increasing annual discount rate. Increasing screening start age to 25 years had no relevant loss in effectiveness but resulted in lower costs. An optimal strategy may be biennial HPV testing age 30 years and older with biennial cytology at age 25 to 29 years (ICER of 23,400 Euro/LYG).ConclusionsBased on these results, HPV-based cervical cancer screening is more effective than cytology and could be cost-effective if performed at intervals of two years or greater. Increasing the age at screening start to 25 years causes no relevant loss in effectiveness but saves resources. In the German context an optimal screening strategy could be biennial HPV testing at age 30 years and older with biennial cytology at the age of 25 to 29 years. An extension to a three-yearly screening interval requires substantially improved screening adherence or a higher relative increase in the sensitivity of HPV testing as compared to cytology. The implementation of an organised screening program for quality-controlled introduction of HPV-screening and -vaccination with continued systematic outcome evaluation is recommended.

The German Cervical Cancer Screening Model: development and validation of a decision-analytic model for cervical cancer screening in Germany

We sought to develop and validate a decision-analytic model for the natural history of cervical cancer for the German health care context and to apply it to cervical cancer screening. We developed a Markov model for the natural history of cervical cancer and cervical cancer screening in the German health care context. The model reflects current German practice standards for screening, diagnostic follow-up and treatment regarding cervical cancer and its precursors. Data for disease progression and cervical cancer survival were obtained from the literature and German cancer registries. Accuracy of Papanicolaou (Pap) testing was based on meta-analyses. We performed internal and external model validation using observed epidemiological data for unscreened women from different German cancer registries. The model predicts life expectancy, incidence of detected cervical cancer cases, lifetime cervical cancer risks and mortality. The model predicted a lifetime cervical cancer risk of 3.0% and a lifetime cervical cancer mortality of 1.0%, with a peak cancer incidence of 84/100,000 at age 51 years. These results were similar to observed data from German cancer registries, German literature data and results from other international models. Based on our model, annual Pap screening could prevent 98.7% of diagnosed cancer cases and 99.6% of deaths due to cervical cancer in women completely adherent to screening and compliant to treatment. Extending the screening interval from 1 year to 2, 3 or 5 years resulted in reduced screening effectiveness. This model provides a tool for evaluating the long-term effectiveness of different cervical cancer screening tests and strategies.

Cervical cancer screening in Germany

Cervical cancer is one of the target cancers covered by the statutory German cancer screening programme which was introduced in West Germany in 1971 and expanded to the eastern part of the country in 1991. Women covered by statutory health insurance (over 90% of the female population) are eligible to receive an annual cervical examination including a Papanicolaou (PAP) smear beginning at age 20 years. Annual uptake currently slightly exceeds 50% of the eligible population. Shortly after implementation of the national screening programme in the early 1970s the incidence of invasive cervical cancer decreased moderately and the incidence of cervical carcinoma in situ increased substantially in the state of Saarland. These observations would be expected as a result of a cervical cancer screening programme with substantial uptake. Although quality assurance guidelines for cervical cancer screening have been adopted and updated since the inception of the screening programme, only minor changes have been made in the cross-sectional programme documentation. Implementation of population-based documentation and evaluation of screening activities is currently being developed for the German cancer screening programme in pilot studies implementing the European guidelines on the quality assurance of mammography screening. After demonstration of feasibility and effectiveness, improvements in the quality management of breast cancer screening will subsequently be applied to the cervical cancer screening programme.