Quality of care before and after initial certification at a German certified hereditary breast and ovarian cancer center.

PURPOSE: Genetic mutations contribute to around 10% of breast and 25% of ovarian cancers, with one third of patients having a familial cancer history. The German Consortium for Familial Breast and Ovarian Cancer was founded in 1996 to improve care for these patients. Certification of cancer centers, introduced in 2004, has been linked to improved survival rates and ensures adherence to evidence-based standards. This study investigates changes in care structures and quality before and after the initial certification of the HBOC center at the University Hospital Erlangen, certified from 2021 on.

METHODS

This retrospective study analyzed patient data from January 2018 to December 2023 at the certified Hereditary Breast and Ovarian Cancer center at the University Hospital Erlangen. Eligibility for genetic counseling and germline testing followed the German Cancer Society criteria. After informed consent, Next Generation Sequencing was performed, and variants were classified according to Human Genome Variation Society and American College of Medical Genetics and Genomics standards. Medical histories and genetic results were recorded in electronic case report forms.

RESULTS

From 2018 to 2023, a total of 2694 genetic tests were performed, increasing from 962 pre-certification to 1732 post-certification (+ 180%). Testing among affected female patients doubled. Genetic testing in breast cancer patients increased from 551 to 1,04, while testing for ovarian carcinoma rose from 117 to 159. Variants of uncertain significance were identified in approximately 9% of cases during both periods. Pathogenic findings were observed in 14.3% of cases pre-certification (with 9.2% involving BRCA1/2 mutations) and 11.5% post-certification (6.4% BRCA1/2 mutations). Enrollment in the intensified surveillance program (IBCS) increased by 182.5%, accompanied by a rise in recommendations for risk-reducing surgeries.

CONCLUSION

Certification of medical institutions ensures high-quality, evidence-based patient care and increases the utilization of preventive and counseling services, particularly for Hereditary Breast and Ovarian Cancer. Further studies are needed to confirm the long-term impact and necessity of certification.