The usage of over-the-counter products by private insured patients in Germany - a claims data analysis with focus on complementary medicine.

BACKGROUND: An important contribution to well-being of human beings can be observed by the use of self-medication products that is reflected in the constantly growing volume of over-the-counter (OTC) drugs. The aim of the current study was to extend the measurement concept for OTCs by exploring the relevance of the peripheral assortment provided by the widely accepted framework of the Anatomical Therapeutical and Chemical (ATC) classification of the WHO. METHODS: The focus was on the prescriptions and drug-related receipts submitted by privately insured persons to 18 private health insurers (PHIs) in Germany from the year 2016. The age- and gender-specific average claims amount per risks of outpatient drug expenditure were used as weights to scale up the relative distributions of the item amounts. The ATC-classification defines the commodity groups and discriminates between the main and the peripheral assortment. A descriptive analysis assessed the OTC frequencies and sum scores of the product groups within the main and peripheral assortment whereby the study group explored and assessed the relevance of each category independently according to the OTCs and integrative medicines. RESULTS: The analysis included 22.1 Mio. packages from the main assortment and examined 10.1 Mio. packages from the peripheral assortment. The latter was examined thoroughly and the commodity groups "Pharmaceutical food products", "Medicinal products for special therapy options" and particular "Hygiene and body care products" meet the defined requirements for OTCs relevant for integrative medicines. A high proportion of OTC products from the peripheral assortment was associated with the categories "medicinal products for special therapy options". Homeopathy and anthroposophy present two special therapy options, which are relevant for the extended OTC measurement. CONCLUSIONS: The analysis of OTC drugs is feasible when the main and the peripheral assortment is available and enable to integrate about 18% of all OTCs, which are neglected by the common ATC-based approach. The presented extended approach may help to identify potential users of OTCs or people in need of OTC use. In case of the highly disputed homeopathy and anthroposophy products, more research among interactions with prescriptions drugs (Rx), nutrition's and other potentially harmful exposures is recommended.

[DNVF Memorandum Health Services Research in Oncology]. / DNVF-Memorandum Versorgungsforschung in der Onkologie.

Health services research in oncology deals with all situations which cancer patients face. It looks at the different phases of care, i. e. prevention / early detection, prehabilitation, diagnostics, therapy, rehabilitation and palliative care as well as the various actors, including those affected, the carers and self-help. It deals with healthy people (e. g. in the context of prevention / early detection), patients and cancer survivors. Due to the nature of cancer and the existing care structures, there are a number of specific contents for health services research in oncology compared to general health services research while the methods remain essentially identical. This memorandum describes the subject, illustrates the care structures and identifies areas of health services research in oncology. This memorandum has been prepared by the Oncology Section of the German Network for Health Services Research and is the result of intensive discussions.

[S3 guideline breast cancer: update on early detection, and mammography screening]. / S3-Leitlinie Mammakarzinom: Aktuelles zur Früherkennung und zum Mammographie-Screening.

Based on the update of the S3-Guideline Early Detection, Diagnosis, Treatment and Follow-up Care of Breast Cancer (Version 4.0, December 2017, AWMF registry number 032-045OL, www.leitlinienprogramm-onkologie.de ), evolving topics and relevant changes to the former 2012 version concerning early detection and mammography screening are presented. The outline and figures follow the original text.

[DNVF-Memorandum III - Methods for Health Services Research, Part 4 - Concept and Methods for Organizational Health Services Research. Chapter 3 - Methodological Approaches for the Evaluation and Implementation of Complex Interventions in Healthcare Organizations]. / DNVF-Memorandum III ­ Methoden für die Versorgungsforschung, Teil 4 ­ Konzept und Methoden der organisationsbezogenen Versorgungsforschung. Kapitel 3 ­ Methodische Ansätze zur Evaluation und Implementierung komplexer Interventionen in Versorgungsorganisationen.

Organizational health services research is still a relatively young field of research in Germany which is of increasing interest. The German Network Health Services Research e.V. (DNVF e.V.) published in 2009 - supported by expert associations and individual members of the DNVF - a guide on "Methods for organizational health services research" of the Memorandum III, part 1 [1]. Originating from this publication and facilitated by the increasing relevance of the field, a necessity to refine the conceptual and methodological basis became evident. The update and extension of the publication from 2009 consists of three chapters: (1) Definition and concept of organizational health services research, (2) Methodological approaches in organizational health services research: indicators, data sources, data collection and data analysis, (3) Methodological approaches for the design, evaluation and implementation of complex interventions in health care organizations. The aim of the third chapter is to present methods for intervention design, evaluation of effectiveness and efficacy as well as implementation research with particular regard to the organizational context of interventions to improve health care.

[DNVF-Memorandum III - Methods for Health Services Research, Part 4 - Concept and Methods for Organizational Health Services Research: Short Version]. / DNVF-Memorandum III ­ Methoden für die Versorgungsforschung, Teil 4 ­ Konzept und Methoden der organisationsbezogenen Versorgungsforschung: Kurzfassung.

Organizational health services research in Germany is of increasing relevance. Based on the guide on methods for organizational health services research of the Memorandum III, part 1 from the year 2009, the fundamentals and standards have now been refined. The memorandum captures the theoretical framework, basic methodological approaches and methods in health services research for the design, evaluation and implementation of complex interventions in healthcare organizations.

Facilitating adherence to endocrine therapy in breast cancer: stability and predictive power of treatment expectations in a 2-year prospective study.

PURPOSE: To identify modifiable factors predictive of long-term adherence to adjuvant endocrine therapy (AET). METHODS: As part of a 2-year cohort study in primary care (n = 116), we investigated whether initial treatment expectations predict adherence at 24 months after controlling for demographic, medical, and psychosocial variables. Treatment expectations were measured as necessity-concern beliefs, expected side-effect severity, and expected coping with side effects. Their stability over time and differences of trajectories between the adherent and nonadherent group were examined. RESULTS: Nonadherence at 24 months was 14.7% (n = 17). Side-effect severity at 3 months [OR 0.25, 95% CI (0.08, 0.81), p = 0.02] and necessity-concern beliefs [OR 2.03, 95% CI (1.11, 3.72), p = 0.02] were the sole predictors of adherence. Necessity-concern beliefs remained stable over 2 years, whereas expected side-effect severity (p = 0.01, η p2  = 0.07) and expected coping with side effects became less optimistic over time (p < 0.001, η p2  = 0.19), the latter particularly among nonadherers (p < 0.01, η p2  = 0.10). CONCLUSIONS: Patients' initial necessity-concern beliefs about the AET and early severity of side effects affect long-term adherence. Expecting poor management of side effects may also facilitate nonadherence. We suggest that discussing benefits, addressing concerns of AET, and providing side-effect coping strategies could constitute a feasible and promising option to improve adherence in clinical practice.

What do women with breast cancer expect from their treatment? Correlates of negative treatment expectations about endocrine therapy.

OBJECTIVES: Patients' negative treatment expectations can lead to nocebo-related side effects and non-initiation of treatment. This study aims to identify correlates of treatment expectations in patients with breast cancer before the start of endocrine therapy. METHODS: Expectations were assessed in a cross-sectional sample of 166 patients with breast cancer after receiving treatment information. Side effect expectations (one item) and treatment necessity-concern balance (Beliefs about Medicines Questionnaire) were assessed. Correlates were analyzed using regression analyses. The structure of treatment expectations was investigated using a network analysis. RESULTS: About 25% of patients expressed negative expectations. Higher side effect expectations were associated with lower treatment efficacy expectations (ß = -0.20, p = 0.01), higher medication overuse beliefs (ß = 0.17, p = 0.01), and a negative treatment appraisal before study treatment information (ß = -0.17, p = 0.02). A negative necessity-concern balance was associated with lower treatment efficacy expectations (ß = 0.36, p < 0.001), lower adherence intention (ß = 0.21, p < 0.001), and no knowledge of tumor's receptor status (ß = 0.21, p < 0.001); furthermore, it was associated with higher medication harmfulness beliefs (ß = -0.16, p = 0.02), negative treatment pre-appraisal (ß = 0.15, p = 0.01), higher somatosensory amplification (ß = -0.14, p = 0.02), and higher education (ß = -0.12, p = 0.02). The most important network node was the concern that endocrine therapy disrupts life. CONCLUSION: Negative treatment expectations before treatment start are mainly associated with psychological variables. These results are relevant for patient education in clinical settings. To improve expectations, clinicians might emphasize treatment efficacy and discuss general and specific medication concerns. Improving treatment knowledge could also be beneficial. Copyright © 2016 John Wiley & Sons, Ltd.

Impact of disease management programs on women with breast cancer in Germany.

The aim of the study was to analyze the impact of disease management programs (DMPs) on adherence in women with breast cancer (BC) in Germany. Data on 4915 BC patients [1874 DMP and 3041 standard care (SC)] who started hormone therapy between 2008 and 2013 in 234 gynecological practices in Germany were analyzed retrospectively. The primary outcome measure was the rate of discontinuation of hormone therapy within 3 years of the start of treatment. Discontinuation of therapy was defined as a period of at least 90 days without treatment. A multivariate Cox regression model was created to determine the effect of DMPs on the risk of discontinuation. Region (western vs. eastern Germany), patient age, and concomitant diagnoses (depression, osteoporosis, thrombosis, and diabetes) were included as covariates. There was a significant difference between DMPs and SC in terms of age (63 ± 12 years vs. 64 ± 12 years, p value = 0.0012) and region (79.2% of patients living in western Germany vs. 88.6%, p value < 0.0001), but not initial therapy (51.8% vs. 52%, p value = 0.8696). Depression was also more common in patients in DMPs than those in SC (26.8% vs. 17.3%, p value < 0.0001). Within 3 years of therapy initiation, 32.7% of DMP patients and 39.6% of SC patients had discontinued their treatment (p < 0.001). Women with BC who were enrolled in a DMP had a lower risk of discontinuing therapy (HR = 0.91, 95% CI: 0.85-0.98, p value = 0.0092). This risk was also slightly higher in western Germany (HR = 1.13, 95% CI: 1.02-1.24, p value = 0.0143). Involvement in DMPs has a positive impact on the adherence of BC patients.

Informing women with breast cancer about endocrine therapy: effects on knowledge and adherence.

OBJECTIVE: Adherence to adjuvant endocrine therapy in women with breast cancer is low, and patients are not informed sufficiently. This study analyzes the effects of a structured treatment information on patients' satisfaction, knowledge, and adherence. METHODS: An interventional single cohort study of postoperative women with estrogen-receptor-positive breast cancer was conducted to study the effects of enhanced information about endocrine therapy given additionally to clinical routine information. Knowledge and satisfaction with additional information given 1-3 weeks after surgery were assessed before and after informing patients; adherence and knowledge were measured 3 months after start of treatment. RESULTS: A total of 137 patients were analyzed before and after provision of enhanced treatment information as well as 3 months after start of endocrine therapy. Enhanced information increased satisfaction with information and knowledge. The percentage of patients who knew their estrogen receptor status increased from 50% to 93%. At 3 months follow-up, 60% still had correct knowledge. Patients who learned their receptor status were older, and those who forgot had lower cognitive abilities and lower educational level. Patients with higher satisfaction, better learning, and comprehension directly after enhanced information showed better adherence at 3 months follow-up. CONCLUSION: Patients, especially older ones, can benefit from enhanced treatment information given additionally to routine care. Enhanced information about mode of action and potential side effects of endocrine therapy when included into clinical routine might foster patient autonomy and prevent early disruptions in adherence.

Treatment persistence evaluation of tamoxifen and aromatase inhibitors in breast cancer patients in early and late stage disease.

BACKGROUND: The aim of our study was to analyze the persistence with tamoxifen (TAM) and aromatase inhibitors (AIs) in postmenopausal women with hormone-receptor-positive breast cancer (BC) in early and late stage disease. METHODS: This study based on data from The IMS Oncology Analyzer (OA) including retrospective longitudinal patient treatment histories from diagnosis for all cancer types. 4,626 patients with a diagnosis of breast cancer with current or terminated treatment with TAM or AIs between January 2003 and March 2012 in Germany were included. RESULTS: Our results indicate a significantly increased risk for treatment discontinuation for patients in the age groups of 41 - 50 and 51 - 60 years compared to older patients as well as in patients with a stage IV tumor compared to patients with lower stage tumors. If treatment was initiated by a gynecologist, patients are less likely to discontinue their therapy compared to treatment initiated by an oncologist. Furthermore, the risk of therapy break up was significantly lower in patients treated in an office-based setting compared to the reference group of patients treated in general hospitals. CONCLUSION: In conclusion, persistence with endocrine treatment in woman with hormone-receptor-positive breast cancer is low, especially in later stage disease, and needs to be significantly increased to improve outcome in clinical practice. Further research is required to understand this complex, but important aspect.

Arbeitsgemeinschaft Gynäkologische Onkologie Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2024.

Introduction: Each year the interdisciplinary AGO (Arbeitsgemeinschaft Gynäkologische Onkologie, German Gynecological Oncology Group) Breast Committee on Diagnosis and Treatment of Breast Cancer provides updated state-of-the-art recommendations for early and metastatic breast cancer. Methods: The updated evidence-based treatment recommendations for early and metastatic breast cancer have been released in March 2024. Results and Conclusion: This paper concisely captures the updated recommendations for early breast cancer chapter by chapter.

Arbeitsgemeinschaft Gynäkologische Onkologie Recommendations for the Diagnosis and Treatment of Patients with Locally Advanced and Metastatic Breast Cancer: Update 2024.

The Breast Committee of the Arbeitsgemeinschaft Gynäkologische Onkologie (German Gynecological Oncology Group, AGO) presents the 2024 update of the evidence-based recommendations for the diagnosis and treatment of patients with locally advanced and metastatic breast cancer.

Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial.

BACKGROUND: Adjuvant endocrine therapy can improve disease-free survival and time before recurrence in breast cancer patients. However, it is associated with considerable side effects that negatively affect patients' quality of life and cause non-adherence. The recently demonstrated effect of individual expectations on side-effect development (nocebo effect) suggests that psychological factors play a role in the prevention of side effects. The aim of this study is to evaluate cognitive-behavioral side-effect prevention training (SEPT) for breast cancer patients. This article describes the study protocol and applied research methods. METHODS/DESIGN: In a randomized controlled trial, 184 female breast cancer patients are assigned to receive either SEPT, standard medical care or a manualized supportive therapy at the start of adjuvant endocrine treatment. SEPT consists of three sessions of cognitive-behavioral training including psychoeducation to provide a realistic view of endocrine therapy, imagination-training to integrate positive aspects of medication into daily life, and side-effect management to enhance expectations about coping ability. Side effects three months after the start of endocrine therapy serve as primary outcomes. Secondary outcomes include quality of life, coping ability and patients' medication adherence. Patients' expectations (i.e., expectations about side effects, coping ability, treatment and illness) are analyzed as mediators. DISCUSSION: The optimization of expectations might be a potential pathway in health care to improve patients' quality of life during long-term medication intake. The results will provide implications for a possible integration of evidence-based prevention training into clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov, (NCT01741883).

AGO Recommendations for the Diagnosis and Treatment of Patients with Locally Advanced and Metastatic Breast Cancer: Update 2023.

The Breast Committee of the Arbeitsgemeinschaft Gynäkologische Onkologie (German Gynecological Oncology Group, AGO) presents the 2023 update of the evidence-based recommendations for the diagnosis and treatment of patients with locally advanced and metastatic breast cancer (mBC).

Arbeitsgemeinschaft Gynäkologische Onkologie Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2023.

Background: Each year the interdisciplinary Arbeitsgemeinschaft Gynäkologische Onkologie (AGO), German Gynecological Oncology Group Breast Committee on Diagnosis and Treatment of Breast Cancer provides updated state-of-the-art recommendations for early and metastatic breast cancer. Summary: The updated evidence-based treatment recommendation for early and metastatic breast cancer has been released in March 2023. Key Messages: This paper concisely captures the updated recommendations for early breast cancer chapter by chapter.

[Psychological distress of breast cancer patients: screening and patients' request for psycho-oncological care as indicators of health-related quality of life]. / Psychische Belastung von Brustkrebspatientinnen: Screening und psychoonkologischer Unterstützungswunsch als Indikatoren der Lebensqualität.

Health-related quality of life (QoL) in breast cancer patients strongly depends on emotional well-being. QoL (EORTC-QLQ-C30), psychological distress (HADS), and patient's request for psycho-oncological care were assessed in 103 breast cancer patients during initial hospitalization. Clinical diagnoses according to ICD-10-F were made by clinical interview. As expected, both positive HADS screens (>13) and clinical diagnoses of mental disorders were inversely related to QoL. However, in multivariate analysis of variance only positive HADS scores but not clinical diagnoses of mental disorders significantly predicted QoL. The performance of psychological screening instruments should therefore not only be judged by their ability to detect clinical diagnoses but also by their relevance for reflecting patients' QoL.

Prepubertal Idiopathic Unilateral Gynecomastia: Case Report and Literature Review.

Introduction: Gynecomastia is a benign proliferation of the glandular tissue of the breast in males. Depending on the age, it can be considered a physiological condition. Prepubertal unilateral gynecomastia is a rare phenomenon. There are only a few case reports described through the last few years. Case Presentation: We report the clinical appearance and management of prepubertal idiopathic unilateral gynecomastia in a 9-year-old boy. We further include a literature review of 14 cases from 2011 to 2021. In contrast to pubertal gynecomastia, prepubertal gynecomastia and especially unilateral prepubertal gynecomastia are extremely rare conditions. Most cases remain idiopathic. Conclusion: Chromosomal and genetic testing, as well as oncological, endocrine diagnostic and tests for liver and kidney function should be performed. In case of idiopathic prepubertal gynecomastia, surgery is an important part of therapy since patients suffer from their atypical and rare phenotype.

AGO Recommendations for the Diagnosis and Treatment of Patients with Locally Advanced and Metastatic Breast Cancer: Update 2022.

The Breast Committee of the Arbeitsgemeinschaft Gynäkologische Onkologie (German Gynecological Oncology Group, AGO) presents the 2022 update of the evidence-based recommendations for the diagnosis and treatment of patients with locally advanced and metastatic breast cancer.

AGO Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2022.

Introduction: The AGO (Arbeitsgemeinschaft Gynäkologische Onkologie, German Gynecological Oncology Group) Task Force on Diagnosis and Treatment of Breast Cancer as an interdisciplinary team consists of specialists from gynecological oncology, pathology, diagnostic radiology, medical oncology, and radiation oncology with a special focus on breast cancer. Methods: The updated evidence-based treatment recommendation 2022 for early breast cancer (EBC) and metastatic breast cancer of the AGO Task Force has been released. Results and Conclusion: This paper captures the update of EBC.