POPULATION-BASED PATIENT-CARE STUDY FOR BREAST-CANCER

Background: Different approaches for an effective quality management a re funded by the Ministry of Health to verify, to assess and, if neces sary to optimize the quality of health care using the tracer diagnoses of breast, rectal, and lung cancer in eight regions in Germany. The c onception of these observational studies and initial findings are show n here, using breast cancer in the region of Munich (population 2.4 mi llion) as an example. Patients and Methods: The study started on April 1, 1996. The recruitment phase for all primary boast cancer patients in this region is planned for 2 years with a 3-5-year follow-up. Estab lished documentation sheets are used to document basic medical informa tion of each patient, along with the original reports (pathology: radi otherapy, doctors' reports, etc.), follow-up reports and quality of li fe questionnaires (QLQ, including the EORTC QLQ C30). Results: In 1996 , the Munich region has a crude incidence of 125/100,000 women (world standard 71.5). After almost complete documentation the incidence is 1 0-15% higher. In the period from April 1 1996 to June 30, 1997 1,360 p atients have been recruited into the study. 79% of the patients were 5 0 years of age or older. pT stages are distributed as follows: pTIS 5% , pT1 54%, pT2 32%, pT3 4%, pT4 6%. 4.5% had primary metastases. Breas t-conserving therapy (BCT) was performed in 57% of patients. Five of t he 46 departments involved recruited more than 50 patients each within these 14 months. These larger departments treat 59% of all patients. The proportion of older patients and pT4 stages is significantly highe r in the smaller departments. BCT is performed significantly more ofte n in the larger departments. First results of quality of life show dep endencies on age, but no differences between mastectomy and BCT 3 mont hs after operation. Not only the addressed patients (response rate to QLQ over 80%) but also almost all hospitals and many physicians are mi lling to support and to partake in quality assurance. 35 hospitals, 46 surgical departments. 80 heads of department and surgically: active g eneral practioners, 330 general practioners. 7 radiotherapy department s, and 13 pathology departments have so far documented for this study. Conclusions: An effective quality management in oncology needs a mode rn cancer registry which uses documentation sheets as well as original reports and organizes the complicated infrastructure for an interdisc iplinary cooperation. To be able to evaluate the health care reality i t is necessary to carry out a data analysis and assess each individual case. A feedback of the results have to be available for each physici an and each department. The cost of this information management is app roximately 0.3% of the health care cost for this group of patients.