First Results for the Evaluation of the Cervical Cancer Screening Carried Out in 2021 and 2022 in the Context of the Organized Cancer Screening Program (oKFE): Part 1 - Primary Screening.

Abstract

Organized cancer screening programs (oKFE) aim to detect and treat various cancers in their early stages. The German oKFE Directive has set out the requirements for evaluating the efficacy, quality, and safety of such programs. The first evaluation report on the cervical cancer screening program in Germany was published in May 2024 and covers the years 2021 and 2022. Women with statutory health insurance who are above the age of 20 and live in Germany are entitled to be screened for cervical cancer. Between the ages of 20 and 34 years, women are offered an annual cytology-based examination. From the age of 35 years and above, screening consists of a cytology examination and an HPV test (co-testing). The current evaluable data consists of pseudonymized data obtained from statutory health insurance companies and service providers as defined by the specifications of the IQTIG. The evaluation shows that around three million women between 20 and 34 years of age undergo cervical cancer screening every year, which corresponds to a response rate of 45%. As regards the co-testing carried out in women aged 35 years and above, around 2.3 million women with statutory health insurance had cytological examinations and co-testing in 2021 and 1.3 million women were similarly examined in 2022. The participation rate for this cohort cannot yet be determined as the three-year interval for persons eligible for this type of screening cannot be depicted using only two years of data. 97% of cytology smears were unremarkable. Fewer than 0.1% of smears resulted in cytological findings indicating precancerous cervical lesions or cervical malignancies. The average positive rate for HPV tests carried out as part of co-testing was 8.56%. The high-risk human papilloma viruses 16/18 were identified in 30% of cases with positive HPV tests, and the presence of these high-risk viruses increased in parallel with an increase in the severity of cytological findings. More than 30% of insured women aged between 20 and 34 years have been fully vaccinated against HPV. The limitations of this evaluation are the short observation period, some data gaps, and the not yet implemented combination of screening data with data from the cancer registries of the German federal states. It is not yet possible to make valid statements about the acceptance of the screening program and the long-term impact of this program.