Current clinical practice and outcome of neoadjuvant chemotherapy for early breast cancer: analysis of individual data from 94,638 patients treated in 55 breast cancer centers.

Neoadjuvant chemotherapy (NACT) is frequently used in patients with early breast cancer. Randomized controlled trials have demonstrated similar survival after NACT or adjuvant chemotherapy (ACT). However, certain subtypes may benefit more when NACT contains regimes leading to high rates of pathologic complete response (pCR) rates. In this study we analyzed data using the OncoBox research from 94,638 patients treated in 55 breast cancer centers to describe the current clinical practice of and outcomes after NACT under routine conditions. These data were compared to patients treated with ACT. 40% of all patients received chemotherapy. The use of NACT increased over time from 5% in 2007 up to 17.3% in 2016. The proportion of patients receiving NACT varied by subtype. It was low in patients with HR-positive/HER2-negative breast cancer (5.8%). However, 31.8% of patients with triple-negative, 31.9% with HR-negative/HER2-positive, and 26.5% with HR-positive/HER2-positive breast cancer received NACT. The rates of pCR were higher in patients with HR-positive/HER2-positive, HR-negative/HER2-positive and triple-negative tumors (36, 53 and 38%) compared to HR-positive/HER2-negative tumors (12%). PCR was achieved more often in HER2-positive and triple-negative tumors over time.This is the largest study on use and effects of NACT in German breast cancer centers. It demonstrates the increased use of NACT based on recommendations in current clinical guidelines. An improvement of pCR was shown in particular in HER2-positive and triple-negative breast cancer, which is consistent with data from randomized controlled trails.

Quality assurance and improvement in oncology using guideline-derived quality indicators - results of gynaecological cancer centres certified by the German cancer society (DKG).

PURPOSE: Based on the example of Gynaecological Cancer Centres (GCCs) certified by the German Cancer Society, this study evaluates the results of medical-guideline-derived quality indicators (QIs) for cervical cancer (CC) and ovarian cancer (OC), examines the development of indicator implementation over time as well as the status of guideline-compliant care and identifies improvement measures. METHODS: QI results for patients with CC and OC treated in GCCs between 2015 and 2019 are analysed. The median, overall proportion and standard deviation of each QI were calculated. Two-sided Cochran-Armitage tests were applied. RESULTS: QIs are divided into two categories: process-organization (PO-QIs) and treatment-procedures (TP-QIs), to allow a differentiated analysis for identifying improvement measures. PO-QIs that reflect the implementation of processes and structures show a high degree of application. PO-QIs have a tremendous influence on the quality of care and are easy to implement through SOPs. TP-QIs report on treatments that are performed in the GCC. TP-QIs that report on systemic therapies reach a plateau where the guideline is known, but patient-related-factors meaningfully prevent further increase. TP-QIs that report on surgical interventions fluctuate. The most relevant factors are practitioners' personal skills. Besides the discussion of results amongst peers during the audit, improvement measures could include surgical courses or coaching. CONCLUSION: The analysis shows that a combination of different measures is necessary to anchor quality sustainably in health care and thus improve it.

[Surgical Therapy for Lung Cancer: Why it Should be Performed in High Volume Centres]. / Chirurgische Therapie des Lungenkarzinoms: Argumente für die Behandlung in großen Zentren.

Data on surgical lung cancer cases were extracted from the German Federal Statistics on Diagnosis-related groups (DRG) and a possible association between hospital volume and surgical mortality was explored. All treatment cases documented between 2005 and 2015 with the main diagnosis of lung cancer (International Classification of Disease code C34) and the German Operations and Procedure Key (OPS) codes 5-323 to 5-328 for anatomical lung resections were analysed. The treatment cases were assigned to hospital groups, defined according to the number of procedures performed per year. The total number of anatomical lung resections for the diagnosis of lung cancer increased by 24 % from 9376 resections in 2005 to 11,614 resections in 2015. In 2015, 57 % of anatomical lung resections in patients with lung cancer were performed in 47 high volume centres (hospitals with ≥ 75 resections/year); the remaining 43 % of the resections were distributed among 271 hospitals performing fewer than 75 resections per year. In hospitals performing fewer than 25 procedures/year, hospital mortality was almost twice as high as in large centres with ≥ 75 resections per year (5.7 vs. 3.0 %, mean value 2005 to 2015). In summary, our data indicate that a small number of high-volume hospitals perform the major part of lung resections of lung cancer in Germany with better survival as compared to low-volume hospitals. Based on current nationwide data a clear association between hospital volume and surgical mortality could be demonstrated.

Recommendation of adjuvant trastuzumab treatment in HER-2-positive breast cancer patients: insights from quality indicator data collected in certified breast cancer centers in Germany, Italy, Austria, and Switzerland.

PURPOSE: 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. METHODS: Patient data from 274 BCCs treating 53,777 primary cases in 2015 were analyzed using descriptive statistics. RESULTS: 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%). CONCLUSIONS: 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.

Considerations on the Improved Integration of Medical Guidelines into Routine Clinical Practice - a Review and Concept Proposal.

Medical guidelines have become established as the standard for the comprehensive synopsis of all available information (scientific trials, expert opinion) on diagnosis and treatment recommendations. The transfer of guidelines to clinical practice and subsequent monitoring has however proven difficult. In particular the potential interaction between guideline developers and guideline users has not been fully utilised. This review article analyses the status quo and existing methodological and technical information solutions supporting the guideline life cycle. It is shown that there are numerous innovative developments that in isolation do not provide comprehensive support. The vision of the "Living Guidelines 2.0" is therefore presented. This outlines the merging of guideline development and implementation on the basis of clinical pathways and guideline-based quality control, and building on this, the generation of information for guideline development and research.

[Obstacles and facilitators of conducting studies - the perspective of colorectal cancer centers' coordinators]. / Hemmende und fördernde Faktoren bei der Durchführung von Studien - Die Sicht von Darmkrebszentrumskoordinatorinnen und -koordinatoren.

INTRODUCTION: Clinical trials and health services research are crucial pillars for improving patient care. This paper examines factors inhibiting and promoting the study activity and the knowledge and use of trial registries (e. g. DRKS, StudyBox) as an opportunity to learn about existing studies. MATERIAL AND METHODS: The coordinators of 274 cancer center sites certified according to the requirements of the German Cancer Society were surveyed using a standardized online questionnaire. Data were analyzed using descriptive and bivariate statistics to identify associations with characteristics of the sites (e. g. patient volume, ownership, teaching status). RESULTS: 176 sites participated in the survey (64.2 %). The central obstacle to study participa-tion from the centers' view is the low number of existing studies. General knowledge of the population about studies was considered low. Trial registries are known to almost all respondents, but are rarely used. DISCUSSION: The results of the survey suggest that comprehensive measures are needed to sustainably increase the study activity. These include, for example, better information about studies, for example through appropriate databases, and (industry-independent) research funding. One possible way to sensitize patients for studies could be the comprehensive education of the population about the purpose of studies.

[Indicator analysis of prostate cancer centers certified by the German Cancer Society 2015]. / Kennzahlenanalyse der DKG-zertifizierten Prostatakrebszentren des Jahres 2015.

BACKGROUND: Since the first prostate cancer center was certified by the German Cancer Society (DKG) in 2008, there are currently 94 centers at 95 sites. During certification, data on the implementation of the requirements are collected. These data can be used for benchmarking purposes. OBJECTIVES: This paper describes the development and monitoring of indicators and presents a selection of recent results. MATERIALS AND METHODS: The descriptive results on 18,288 primary cases from 91 sites with complete data are presented. RESULTS: The prostate cancer center certification system has reached a plateau both in regard to the absolute number of centers and the total proportion of all primary cases treated in Germany. The implementation of the requirements is at a high level overall, although some centers have difficulties fulfilling selected key figures, e.g., the study quota requirement. CONCLUSION: The evaluation of current indicators documented good structural and process quality, which correspond for the most part to the target values for the total cohort. In the future, assessing medium and long-term outcome quality will be of greater importance, particularly with regard to patient-reported outcomes.

[Requirements for organ-specific oncology centers]. / Anforderungen an Organkrebszentren.

BACKGROUND: The interdisciplinary, interprofessional, and transsectoral cooperation of partners in a network is prerequisite for the certification of a prostate cancer center. The network reflects all phases and aspects of the disease from the patient's point of view. On the basis of quality indicators that are audited annually, the qualified partners of the network ensure quality of care. Quality indicators reflect the quality of the cooperation in the network, the treatment according to the evidence-based guideline, and the specific expertise of the partners. METHODS: The results of the quality indicators are evaluated annually and summarized in individual and general reports. The system of the quality indicators is an important tool for quality management and to improve daily oncological care. In the future, this system will be extended to include patient-reported outcomes in combination with the OncoBox. CONCLUSIONS: The ongoing quantitative and qualitative improvement makes the certification system a relevant instrument for health policy institutions and is useful in political discussions regarding quality assurance and improvement.

[Quality of Care in Certified Lung Cancer Centers]. / Versorgungsqualität in zertifizierten Lungenkrebszentren.

BACKGROUND: Since 2008, lung cancer centers can be certified in accordance with the criteria set out by the German Cancer Society (Deutsche Krebsgesellschaft). This paper reports on the certification program for lung cancer centers and presents data on 18 quality indicators collected during certification. METHODS: After checks for plausibility and completeness, data on quality indicators for the 2011 and 2012 patient cohorts as well as data of the treating centers were analyzed descriptively (relative/absolute frequencies, means, site medians). PATIENTS: 23,222 patients with ICD-10 diagnoses C33 und C34 from 35 (2012) and 24 operating sites (2011), respectively. RESULTS: From 2011 to 2012, both the number of certified sites and the number of patients treated increased. Fulfillment of the certification requirements is already high and improved slightly from 2011 to 2012. The implementation of indicators without target values is less advanced. CONCLUSION: Thanks to the medical and professional associations as well as the oncologic medical experts, the lung cancer certification program is evolving continuously. There has been a steady increase both in the number of patients treated and the number of lung cancer centers; certification requirements are also being increasingly fulfilled.

Establishment of the Certification System "Gynaecological Dysplasia" in Germany.

Gynaecological cancer centres have been established nationwide in Germany since 2008 according to the certification system of the German Cancer Society (Deutsche Krebsgesellschaft e. V. [DKG]) and the German Society for Gynaecology and Obstetrics (Deutsche Gesellschaft für Gynäkologie und Geburtshilfe e. V. [DGGG]). However, patient access to the certified gynaecological cancer centres is currently only possible through direct referrals. A longitudinal structure with the corresponding long-term documentation of both the high-grade precursors as well as the cancers does not exist as yet. According to the aims of the National Cancer Plan, a corresponding structure for the cancer entity "cervix carcinoma" should be established. The foundations for such a structure are appropriate diagnostic units that are responsible, after nationwide screening, for clarification according to guideline-conform principles. On the basis of the vote of the certification commission for gynaecological cancer centres under the chairmanship of the DKG, the Working Group for Gynaecological Oncology (Arbeitsgemeinschaft Gynäkologische Onkologie e. V. [AGO]), the Committee on Cervical Pathology and Colposcopy (Arbeitsgemeinschaft Zervixpathologie & Kolposkopie [AG-CPC]) and the DGGG the certification system for gynaecological dysplasia has been established. As a general principle, a distinction is made between the certification of a consulting practice for gynaecological dysplasia and a gynaecological dysplasia facility in order to integrate both outpatient and inpatient health-care facilities into the certification system. In analogy to the further catalogue of requirements from the DKG, quantitative and qualitative minimum numbers are demanded. Furthermore, the requirements of the certification process include a summary of patient information, the applied guidelines, continuing and further training, interdisciplinary cooperation in tumour boards, contents or, respectively, procedure descriptions for consulting practices and the trial participations. Central components of the questionnaire are quality indicators that can be used as specific and measurable elements to evaluate the quality of treatment. After successful pilot certification, finalisation of the updated version of the questionnaire and a completed specialist auditor training course for the certification of gynaecological dysplasia, it will be possible to establish a nationwide treatment system for dysplasia within certified structures.

Documented quality of care in certified colorectal cancer centers in Germany: German Cancer Society benchmarking report for 2013.

PURPOSE: In order to improve the quality of treatment for cancer patients the German Cancer Society (Deutsche Krebsgesellschaft) implemented a certification system for oncological care institutions. The certified colorectal cancer centers present the structures, processes and results of their network in the framework of an auditing procedure. METHODS: The current benchmarking report by the certified centers reflects the centers' reference results over a period of 3 years. The figures included in the benchmarking report reflect the areas of interdisciplinary collaboration, guideline-compliant treatment, and expertise of the main treatment partners. RESULTS: High percentages were shown for indicators reflecting pretreatment and postoperative case presentations in multidisciplinary team meetings (91.8 % or 98.1 %), psycho-oncologic care (54.8 %) as well as social service counseling (77.1 %). Good quality of the TME rectal specimen and adequate lymph-node retrieval (12 lymph nodes at least) was achieved by 93 % or 96.6 % of the centers. Adjuvant chemotherapy (colon, Union for International Cancer Control [UICC] stage III) or neoadjuvant radiotherapy or chemoradiotherapy (rectum, UICC stages II and III) received 73.7 % or 80 % of relevant patients. Quotas of anastomotic leakage in the colon or rectum were 4.4 % or 7.6 %, whereas postoperative mortality amounted to 2.6 %. CONCLUSIONS: The present analysis of the results, together with the centers' statements and the auditors' reports, shows that most of the targets for indicator figures are being better met over the course of time. In addition, however, there is a clear potential for improvement and the centers are verifiably addressing this. A transparent presentation of the quality of care and reflection on and discussion of the results among the treatment partners in the certified network and with the auditors during the certification process may contribute to constant quality improvement in oncological care.

[What can colorectal cancer centers achieve in the diagnostics and therapy of colorectal liver metastases?]. / Was leisten Darmkrebszentren bei der Diagnostik und Therapie kolorektaler Lebermetastasen?

Successful resection of liver metastases increases overall survival and can even be a curative approach in patients with colorectal cancer (CRC) and isolated liver metastases. Resection of liver metastases has clearly changed the therapy of this group of patients and has become a standard procedure that is being used increasingly more. Accordingly, liver metastasis resection has been included in the German evidence-based guidelines and also in international guidelines on the treatment of CRC. The treatment of colorectal liver metastases requires a multidisciplinary team of experts in the disease, including experienced radiologists, medical oncologists, radiotherapists, pathologists and surgeons. The interdisciplinary approach to the treatment in specialized tumor boards staffed by qualified experts is a prerequisite for successful certification as a colorectal cancer center by the German Cancer Society. Regular audits ensure that these requirements and that defined quality indicators regarding the tumor board and primary and secondary liver metastasis resection, are fulfilled. The certification system of the colorectal cancer centers requires and promotes conditions that allow an optimal and guideline-oriented treatment of colorectal liver metastases both at the level of personnel and infrastructure of a given center. The high primary and secondary resection rates in these centers testify that the multidisciplinary teams are effective. A detailed analysis of the audit reports reveals the close collaboration of all partners within the certified networks. These networks also comprise external cooperation with highly specialized hospitals if and when necessary. However, the annual report of the certificated colorectal cancer centers also demonstrates areas for further improvements in multidisciplinary cooperation.

Influence of Patient and Hospital Characteristics on the Performance of Direct Reconstruction after Mastectomy.

Aim: International studies have shown that the performance of a direct (or immediate) reconstruction (DR) after mastectomy is associated with patient (e.g., socio-economic status, insurance status, age) and hospital (number of cases, teaching status) characteristics. The present article addresses the question if such relationships also exist in Germany. Material and Methods: The results of a nationwide questionnaire to the patients of certified breast cancer centres were coupled with the clinical features of the patients and the characteristics of the hospital. Predictors for receiving a DR (vs. delayed or no reconstruction) were estimated by means of a logistic multilevel model for a sample of 1165 patients from 105 certified locations. Results: Substantial differences between the treating hospitals were found (intraclass correlation coefficient null model: 0.195) which can in part be explained by the total model (total model: 0.169). Patients with the following features are more likely to receive a DR: younger age, private health insurance, secondary school leaving certificate (vs. primary school leaving certificate), lower stage and acquisition of more information about reconstruction. ASA and partnership status are not statistically significantly related with DR. DR is more likely to be performed in hospitals with higher caseload of patients with primary breast cancer. Teaching status, operations per surgeon and urbanity of the location are not related to receiving a DR. Conclusions: Non-clinical features of the patients and the primary case number are associated with the performance of a DR, this poses questions concerning reasons and the equality of health care.

[Certification of head and neck tumor centers by the German Cancer Society : an overview]. / Zertifizierung von Kopf-Hals-Tumor-Zentren durch die Deutsche Krebsgesellschaft : Ein Überblick.

The German Cancer Society has certified centers of oncological care since 2003. This is realized by clearly specified criteria that are implemented in the centers' clinical practice and thus enable holistic care of oncology patients. The most important instrument here is the interdisciplinary and multiprofessional teamwork of all relevant disciplines. This transsectoral cooperation leads to continuous cooperation between out- and inpatient partners and contributes significantly to the high-quality care of oncology patients in all stages of disease. Validation of the fulfillment and implementation of the required criteria proceeds in the form of audits, the feedback from which enables the centers to continually improve their quality of care. The integration of these sustainable approaches into clinical practice not only increases patient satisfaction, but also improves the motivation of the center staff.

[The development process of colon cancer centres]. / Der Prozess der Entwicklung von Zentren am Beispiel des Darmkrebszentrums.

Colon carcinomas are the most common malignant tumours in the Western world. Important findings about the overall quality of medical care have been reported in multi-centre observational studies. A quality enhancement of therapeutic care can be achieved by an additional increase in diagnostic and therapeutic measures in the interdisciplinary setting. The development of colon cancer centres improves the chance to objectively observe the results of medical care induced by the development of an interdisciplinary and cross-sectoral unit that includes a comprehensive medical care for patients. The implementation of the current medical findings based on evidence in clinical routine, the inspection of the usage of guidelines by external specialists as part of an audit and the continuous correction of analysed deficits in the course of treatment guarantee a continuous improvement of service.

[Certified stomach cancer centres as seen by their directors: results of a questionaire to key personnel]. / Zertifizierte Darmkrebszentren aus Sicht der Zentrumsleitungen: Ergebnisse einer Schlüsselpersonenbefragung.

Since 2003 the German Cancer Society (Deutsche Krebsgesellschaft, DKG) has been certifying specific organ cancer centers in Germany. After 8 years activity, there are now more than 600 certified cancer centres that, as required by the national cancer plan, enable "oncological management at an assured quality level" in Germany. Anmong them are more than 200 certified centres for stomach cancer, that treat about 25 % of all newly diagnosed cases of stomach cancer. In this article we have examined the question as to what changes the certification concept has caused in the centres.

The Patients' View On Accredited Breast Cancer Centers: Strengths and Potential for Improvement.

Breast Care Centers that were accredited according to the German Cancer Society criteria were offered to participate in a standardized patient survey in 2010, which was conducted by the Institute for Medical Sociology, Health Services Research and Rehabilitation Science, Faculty of Human Science and Faculty of Medicine, University of Cologne. Patients were included consecutively between March and November 2010. The Cologne Patient Questionnaire-Breast Cancer (CPQ-BC) was used, which assesses a number of aspects of hospital care as perceived by the patients, among them provider-patient interaction, the disease-specific information provided, the quality of organization, and room amenities. 128 of 195 Breast Care Centers and 160 of 251 hospitals participated in the study. 8226 patients consented to the survey. The questionnaires of 7301 patients could be included in the analyses (89 %). Overall, the results showed that patients are satisfied with their hospital stay and that the accreditation criteria are implemented in a way that serves the patients. However, there is room for improvement for a number of issues, for example with regard to the provision of information and patient involvement in decision making. In addition, for a number of indicators substantial differences were found between the hospitals. The results of the survey provide information on the breast centers' development and can be used by the centers' surgery locations for benchmarking purposes, to identify strengths and weaknesses, and to take actions.

Key Informants' Perspectives on Accredited Breast Cancer Centres: Results of a Survey.

This paper presents the results of a survey among key informants that was conducted between June and September 2011 in Breast Cancer Centers that were accredited according to the criteria of the German Cancer Society (DKG). The survey intended to assess the degree to which the breast cancer center concept was accepted among the key informants as well as to gain an overview over structures and processes in the centers. The Questionnaire for Breast Cancer Centres Key Informants 2011 (FRIZ 2011) was used with two reminders having been sent out. Questionnaires were sent back from 149 of the 243 initially contacted hospitals (response rate: 61.3 %). The vast majority of respondents indicated to be part of the Breast Cancer Center management. 110 of the 149 hospitals did also participate in the patient survey conducted in 2010. Among the key informants surveyed, the concept is highly accepted with regard to improvements in patient care. Overall, the concept is regarded as "good" or "very good" by almost all respondents. Both contact to resident doctors and the hospitals' reputations improved since the implementation of the concept. Quality and patient safety were more often on the agenda than financial performance in the quality circles with the main co-operation partners of the Breast Cancer Centers.