Abstract

In 2003, a certification system was introduced to ensure high standards of oncological care in breast cancer patients in Germany. Certified breast cancer centers (BCCs) must fulfill specific requirements including quality indicators (QI) derived from the clinical guidelines that are evaluated in annual audits. When target values for QIs are not fulfilled, centers need to give explanations. We analyzed data from BCCs for a selected indicator: the recommendation of trastuzumab for patients with early HER-2-positive invasive breast cancer. We investigated explanations given in cases when trastuzumab was not recommended to see whether this was justified. Patient data from 274 BCCs treating 53,777 primary cases in 2015 were analyzed using descriptive statistics. In the 274 BCC sites, 5700 primary patients with early HER-2-positive breast cancer were treated in 2015. 128 sites (46.7%) did not reach the target value of 95% trastuzumab recommendation and thus had to give explanations. In these 128 sites, 2663 primary HER-2-positive breast cancer patients were treated, 343 (12.9%) of whom did not receive a recommendation for adjuvant trastuzumab treatment. All 128 sites delivered explanations. Overall, 450 explanations were given, allowing multiple explanations for single patients. No explanation was given for 8 of the 343 patients (2.3%). The most common given explanation was multi-/comorbidity (45.5%). The analysis suggests thorough decision-making when quality indicator target values for a trastuzumab recommendation were not fulfilled. Our data do not provide information on whether such decisions have an impact on treatment outcome for these patients.

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