Is high quality breast imaging and diagnosis possible in a decentralized system? The QuaMaDi project

A pilot project by the KVSH (Kassenärztliche Vereinigung Schleswig-Holstein), health insurance companies, gynecologists and radiologists in private practice together with the Breast Center, University Schleswig-Holstein, Campus Kiel and the Institute for Cancer Epidemiology, Campus Lübeck was started in May 2001 and finished in December 2005. 59,514 women with breast problems were diagnosed. A multidisciplinary comprehensive quality management following the EU Guidelines for Mammography Screening was implemented in combination with the national Early Breast Cancer Detection Guideline. Both guidelines afforded new structures and processes which had to be integrated into the existing health care system, most importantly complete documentation and outcome evaluation. This encompassed quality assurance of physical technical aspects, radiographical training and education, specialized training for radiologists, consecutive independent double readings, continuous multidisciplinary training and, in the case of dissent and BI-RADSTM 4 and 5 lesions, expert third readings and standardized assessment. The whole diagnostic chain had to be documented for evaluation and benchmarking purposes. With the use of quality indicators, the amelioration effects became measurable. Breast cancer incidence and stage distribution were determined. A total of 102,744 diagnostic processes were indicated, resulting in 24,470 (23.8%) third readings by the reference center. A recommendation for further assessment was initiated. 1,056 invasive/non-invasive breast cancer cases (10.3/1,000 examinations) were diagnosed. In comparison with the whole of Schleswig-Holstein, a much more favorable tumor stage distribution was achieved: 62.6% in situ and T1 vs. 48.6% in the remaining Schleswig-Holstein. These results indicate that comprehensive quality assurance measures are not only absolutely essential in the area of so-called curative medical care, but that they can also be effectively implemented in our decentralized medical care system.