Einfluss einer schriftlichen oder mündlichen Patientenerinnerung unter Alltagsbedingungen auf die Compliance hinsichtlich der Einnahme eines Aromatasehemmers in der adjuvanten Therapie des primären Mammakarzinoms im Vergleich zur Standardaufklärung, im Rahmen der Versorgungsforschung

Background An important precondition for the effectiveness of a therapy is patient compliance. The level of adherence of various pharmacological therapies in chronic diseases is predominantly low and is often only 40% to 50% after a few months. Regarding the decreasing compliance over the time in the adjuvant anti--‐hormonal breast cancer therapy, it seems appropriate, to remind patients regularly to take the prescribed medication, to achieve an improved understanding of the disease and increased motivation. Methods We included and randomized 181 patients who had received surgery for their primary breast cancer at our hospital and thereafter had been assigned to an adjuvant endocrine treatment. Our study is a single-center, three-armed, partially blind, randomized parallel group comparison over 12 months. The diagnosis and treatment occurred independently of the study, according to current guidelines for breast cancer therapy and close in time to randomization. This is the first study investigating, whether a written or oral intervention with information content and as a reminder, can improve compliance. Reminders and information were performed at 1, 2, 10, 20 and 33 weeks in the first year. The adherence rate has been evaluated by a patient-self-report-questionnaire and by checking prescriptions of the hospital and local physician medical charts. A patient was considered as adherent if a tablet intake of 80% or more was achieved. Results We observed no significant mean differences between the groups regarding the baseline characteristics. 96.9% of the patient population reported to be compliant at the 1-year visit (patient self report). According to the prescription check and the GAPs, only 47.1% (control group) vs. 64.7% (written intervention) and 62.3% (oral intervention) of the patients were still classified as compliant after 12 months of aromatase inhibitor therapy. We report a marginally 85 significant increase in the compliance of almost 37% and 18 percentage points in the written intervention group (c2 = 2.86, p = 0.090), 15% and 15 percentage points in the oral group (c2 = 1.88, p = 0.170) compared to the control group. Between the oral and written intervention groups the Chi2--‐test shows (c2 = 11, p = 0.739) showed no significant differences. We found a significant difference (p = 0.028) in the items ‘anxiety’ with regard to compliant and non--‐compliant patients. Compliant patients were more anxious. Conclusion The present study investigated the impact of a written and an oral intervention on compliance. We state a marginally significant increase in compliance, as well as a significant rise in persistence in the written intervention group compared to the control group. These new findings require a critical clinical interpretation and implementation in evidence--‐ based care approaches.