Trastuzumab treatment of patients with early, HER2-positive breast cancer in 17 certified German breast cancer centers.

PURPOSE: Since 2008, guidelines recommend that patients with HER2-positive early breast cancer (BC) should receive adjuvant chemotherapy in combination with trastuzumab in Germany. However, recent studies highlight that a substantial share of patients do not receive trastuzumab. We investigate which patient characteristics are associated with a tumor board recommendation for trastuzumab in Breast Cancer Centers (BCC) certified by the German Cancer Society (DKG) and the German Society for Senology, and if the recommendation differs between BCCs. MATERIALS AND METHODS: Multi-level modeling was performed using quality assurance data based on 3052 HER2-positive, operated patients with a first diagnosis of early BC treated between 2006 and 2019 in 17 BCCs in Germany to investigate whether trastuzumab recommendation varies with patient sex, age, and disease characteristics, as well as over time and across BCCs. RESULTS: Tumor board recommendations for trastuzumab differ substantially between BCCs (intraclass correlation coefficient [ICC] null model: 0.11). Our final model (ICC 0.17, Akaike Information Criterion [AIC], 1328.0, R2 0.69) shows that physicians in BCCs more often recommend trastuzumab to patients who are younger than 60 years and those with a recommendation for any additional therapy (chemotherapy, radiation or endocrine therapy) (all p < 0.05). Furthermore, there is a significant time-dependent increase of trastuzumab recommendations (odds ratio [OR] = 1.38, 95% confidence interval [CI] = 1.31-1.46, p < 0.05). CONCLUSION: In certified BCCs in Germany, guideline concordant trastuzumab recommendation is increasing since 2006 (positive cohort effect). Recommendation of trastuzumab for HER2-positive BC patients in BCCs is significantly associated with patients' age and the recommendations for other additional therapy strategies, apart from surgery. The quality assurance data analyzed do not include potentially relevant confounders, such as socioeconomic status or comorbidities.

PRO B: evaluating the effect of an alarm-based patient-reported outcome monitoring compared with usual care in metastatic breast cancer patients-study protocol for a randomised controlled trial.

BACKGROUND: Despite the progress of research and treatment for breast cancer, still up to 30% of the patients afflicted will develop distant disease. Elongation of survival and maintaining the quality of life (QoL) become pivotal issues guiding the treatment decisions. One possible approach to optimise survival and QoL is the use of patient-reported outcomes (PROs) to timely identify acute disease-related burden. We present the protocol of a trial that investigates the effect of real-time PRO data captured with electronic mobile devices on QoL in female breast cancer patients with metastatic disease. METHODS: This study is a randomised, controlled trial with 1:1 randomisation between two arms. A total of 1000 patients will be recruited in 40 selected breast cancer centres. Patients in the intervention arm receive a weekly request via an app to complete the PRO survey. Symptoms will be assessed by study-specific optimised short forms based on the EORTC QLQ-C30 domains using items from the EORTC CAT item banks. In case of deteriorating PRO scores, an alarm is sent to the treating study centre as well as to the PRO B study office. Following the alarm, the treating breast cancer centre is required to contact the patient to inquire about the reported symptoms and to intervene, if necessary. The intervention is not specified and depends on the clinical need determined by the treating physician. Patients in the control arm are prompted by the app every 3 months to participate in the PRO survey, but their response will not trigger an alarm. The primary outcome is the fatigue level 6 months after enrolment. Secondary endpoints include among others hospitalisations, use of rescue services and overall QoL. DISCUSSION: Within the PRO B intervention group, we expect lower fatigue levels 6 months after intervention start, higher levels of QoL, less unplanned hospitalisations and less emergency room visits compared to controls. In case of positive results, our approach would allow a fast and easy transfer into clinical practice due to the use of the already nationwide existing IT infrastructure of the German Cancer Society and the independent certification institute OnkoZert. TRIAL REGISTRATION: DRKS (German Clinical Trials Register) DRKS00024015 . Registered on 15 February 2021.

Use of social service counseling by cancer patients: an analysis of quality assurance data of 6339 breast cancer patients from 13 certified centers in Germany treated between 2015 and 2017.

BACKGROUND: Integrated social care may help to mitigate social risk factors in order to achieve more equitable health outcomes. In cancer centers certified according to the criteria set out by the German Cancer Society, every patient must be given low-threshold access to qualified social workers at the center for in-house social service counseling (SSC). Previous analyses have demonstrated large variation in the utilization of these services across individual centers. Therefore, this research aims at investigating whether SSC utilization varies regarding breast cancer patient characteristics and center characteristics presenting a unique approach of using routine data. METHODS: Multilevel modeling was performed using quality assurance data based on 6339 patients treated in 13 certified breast cancer centers in Germany in order to investigate whether SSC utilization varies with patient sex, age, and disease characteristics as well as over time and across centers. RESULTS: In the sample, 80.3% of the patients used SSC. SSC use varies substantially between centers for the unadjusted model (ICC = 0.24). Use was statistically significantly (P < .001) more likely in women, patients with invasive (in comparison to tumor in situ/ductal carcinoma in situ) diseases (P < .001), patients with both breasts affected (P = .03), patients who received a surgery (P < .001), patients who were diagnosed in 2015 or 2017 compared to 2016 (P < .001) and patients older than 84 years as compared to patients between 55 and 64 years old (P = .002). CONCLUSION: The analysis approach allows a unique insight into the reality of cancer care. Sociodemographic and disease-related patient characteristics were identified to explain SSC use to some extent.

Establishing a global quality of care benchmark report.

BACKGROUND: The Movember funded TrueNTH Global Registry (TNGR) aims to improve care by collecting and analysing a consistent dataset to identify variation in disease management, benchmark care delivery in accordance with best practice guidelines and provide this information to those in a position to enact change. We discuss considerations of designing and implementing a quality of care report for TNGR. METHODS: Eleven working group sessions were held prior to and as reports were being built with representation from clinicians, data managers and investigators contributing to TNGR. The aim of the meetings was to understand current data display approaches, share literature review findings and ideas for innovative approaches. Preferred displays were evaluated with two surveys (survey 1: 5 clinicians and 5 non-clinicians, 83% response rate; survey 2: 17 clinicians and 18 non-clinicians, 93% response rate). RESULTS: Consensus on dashboard design and three data-display preferences were achieved. The dashboard comprised two performance summary charts; one summarising site's relative quality indicator (QI) performance and another to summarise data quality. Binary outcome QIs were presented as funnel plots. Patient-reported outcome measures of function score and the extent to which men were bothered by their symptoms were presented in bubble plots. Time series graphs were seen as providing important information to supplement funnel and bubble plots. R Markdown was selected as the software program principally because of its excellent analytic and graph display capacity, open source licensing model and the large global community sharing program code enhancements. CONCLUSIONS: International collaboration in creating and maintaining clinical quality registries has allowed benchmarking of process and outcome measures on a large scale. A registry report system was developed with stakeholder engagement to produce dynamic reports that provide user-specific feedback to 132 participating sites across 13 countries.

Predictors of the regional variation of prostatectomy or radiotherapy: evidence from German cancer registries.

OBJECTIVE: To assess the association of public health parameters with the regional variation in the initial treatment for prostate cancer. METHODS: We used data from German epidemiologic cancer registries for the years 2009-2013. Presence of a certified cancer center, a radiotherapy and/or urology institution, the district-specific GDP, and population density were used as predictors. Patients with indication for adjuvant treatment were excluded (T3b). Only districts with defined quality criteria were eligible. We used general linear mixed models (equivalent to logistic regression) with a covariance matrix weighted by the Euclidean distances between districts. Models were adjusted for age, grading, and TNM stage. We performed sensitivity analyses by imputing missing data with multiple imputation and considering extreme case scenarios. We applied inverse probability weighting to account for missing values. RESULTS: When radiotherapy/surgery is compared to neither treatment, the probability for the latter was higher in East than in West Germany (OR 1.7, 95% CI 1.43-2.02). The same was true for districts with both, a radiotherapy and urologic treatment facility (OR 1.43, 1.19-1.72). Analyzing radiotherapy vs. surgery, the probability for prostatectomy was inversely associated with the presence of a radiotherapy unit when compared to districts with neither treatment facility (OR 0.52, 95% CI 0.38-0.73). Patients treated in East Germany were more likely to receive a surgical treatment (OR 1.34, 95% CI 1.08-1.66). Sensitivity analyses revealed no relevant change of effect estimates. CONCLUSION: Treatment differs between East and West Germany and is associated with the presence of a radiotherapy or urology clinic.

Barriers and Facilitating Factors for Research Involvement in Cancer Centers: A Survey of Colorectal Cancer Center Coordinators in Germany, Austria, and Switzerland.

Improvements in health care depend on research involving health-care providers (HCPs) and health-care organizations (HCOs). Existing research suggests that involvement in research studies is still much lower than it could be. This study investigates factors that may impede or facilitate research involvement. A standardized online questionnaire was used to carry out a survey, in 3 countries, of key informants in colorectal cancer centers that hold certification in accordance with the requirements of the German Cancer Society. A total of 184 individuals responded (response rate 65%). The respondents found it difficult to identify studies suitable for their patients (40% agreement), criticized the small overall number of studies available (48%), and found that many studies are not worthwhile financially (56%). Among respondents who were not involved in studies as the principal investigators (PIs), 66% agreed they lacked the research infrastructure needed and 81% that they did not have enough staff. Among respondents who were involved as PIs, only 22% indicated that their hospital management encouraged them to initiate and conduct clinical trials. Eighty-five percent of the respondents agreed that the general population lacks information about the importance of studies. Five recommendations for health policy makers are derived from these findings for ways of increasing the involvement of HCPs and HCOs in research, and in cancer research in particular.

Shifting cancer care towards Multidisciplinarity: the cancer center certification program of the German cancer society.

BACKGROUND: Over the last decades numerous initiatives have been set up that aim at translating the best available medical knowledge and treatment into clinical practice. The inherent complexity of the programs and discrepancies in the terminology used make it difficult to appreciate each of them distinctly and compare their specific strengths and weaknesses. To allow comparison and stimulate dialogue between different programs, we in this paper provide an overview of the German Cancer Society certification program for multidisciplinary cancer centers that was established in 2003. MAIN BODY: In the early 2000s the German Cancer Society assessed the available information on quality of cancer care in Germany and concluded that there was a definite need for a comprehensive, transparent and evidence-based system of quality assessment and control. This prompted the development and implementation of a voluntary cancer center certification program that was promoted by scientific societies, health-care providers, and patient advocacy groups and based on guidelines of the highest quality level (S3). The certification system structures the entire process of care from prevention to screening and multidisciplinary treatment of cancer and places multidisciplinary teams at the heart of this program. Within each network of providers, the quality of care is documented using tumor-specific quality indicators. The system started with breast cancer centers in 2003 and colorectal cancer centers in 2006. In 2017, certification systems are established for the majority of cancers. Here we describe the rationale behind the certification program, its history, the development of the certification requirements, the process of data collection, and the certification process as an example for the successful implementation of a voluntary but powerful system to ensure and improve quality of cancer care. CONCLUSION: Since 2003, over 1 million patients had their primary tumors treated in a certified center. There are now over 1200 sites for different tumor entities in four countries that have been certified in accordance with the program and transparently report their results from multidisciplinary treatment for a substantial proportion of cancers. This led to a fundamental change in the structure of cancer care in Germany and neighboring countries within one decade.

Effect of an evidence-based guideline on the treatment of maxillofacial cancer: A prospective analysis.

BACKGROUND: In 2012, a guideline for the diagnosis and treatment of oral cavity cancer based on the best available evidence was implemented at certified German cancer centres for head and neck carcinomas. The present analysis was performed to determine whether the implementation of the guideline via certification improved the level of care, leading to a benefit for the patients. METHODS: A prospective observational study was performed based on the annual operating figures at 31 certified head and neck cancer centres. From 76 statements and recommendations, 9 indicators were derived defining important steps during treatment. The annual shift of the figures was documented for each indicator and was used to measure the impact of the guideline. This was achieved by determining the number of patients having received the recommended treatment related to the total number in each centre over a period of 3 years. RESULTS: In 2014, 1570 primary cases with an oral cavity carcinoma were treated at our centres, 31.2% representing stage IVA. Except for two, all indicators showed increasing numbers of achievement from 2012 to 2014, reaching median values between 91% and 100% in 2014. In particular, median values for imaging and interdisciplinary treatment to evaluate the presence of second primaries and metastases increased by 20% and 30%, respectively. Median values decreased by 14% for recommended adjuvant radiation, because of non-acceptance by the patients. Moreover, elective neck dissection was performed less frequently in cN0 categories. CONCLUSIONS: Implementation of the national cancer guideline by means of certification evidently had a positive impact on patients suffering from oral squamous cell carcinoma and led to the improved achievement of most evidence-based treatment recommendations over time. Further research involving high-level clinical studies is needed to cover all aspects of this specific tumour entity.

Frequency of psycho-oncologic and social service counseling in cancer centers relative to center site and hospital characteristics: Findings from 879 center sites in Germany, Austria, Switzerland, and Italy.

BACKGROUND: There is extensive evidence that patients with cancer and cancer survivors have a strong need for expert support in relation to the psychological and social consequences of the disease. The requirements set out in the German Cancer Society's cancer center certification system include the routine provision of psycho-oncologic care (POC) and social service counseling for every patient. The current study investigated which organizational and structural characteristics in hospitals account for variations in psychosocial care provision in these centers. METHODS: Data routinely collected during the certification process regarding the percentages of psychosocial care provision and characteristics of center sites and hospitals were matched with data with regard to size of the municipality, teaching hospital status, and institutional ownership. Linear multilevel regression analyses were performed to identify the characteristics of hospitals and center sites that were related to psychosocial care provision. RESULTS: Substantial differences were found for different types of cancer (eg, a greater provision of psychosocial care in centers specializing in breast rather than prostate cancer). There was more POC provision in longer-certified centers and less in rural areas and university hospitals. Much of the variation between hospitals remains unexplained. CONCLUSIONS: Although the implementation of mandatory psychosocial services generally provides patients with access to POC and social service counseling, the wide differences in the provision of counseling indicate that additional measures are needed to avoid inequalities resulting from the center at which a patient receives cancer treatment. Cancer 2016;122:3538-3545. © 2016 American Cancer Society.

Quality assessment in prostate cancer centers certified by the German Cancer Society.

PURPOSE: In 2008, the German Cancer Society certification program for prostate cancer centers (PCCs) was introduced, fostering multidisciplinary and interprofessional cooperation. Since then, 97 PCCs have been certified. This paper describes the PCC certification program, quality indicators (QI) that are reported during certification, as well as changes over time and correlates of QI fulfillment. METHODS: Observational data from 70,683 primary prostate cancer (PCa) cases treated between 2010 and 2013 in certified PCC sites are analyzed using descriptive and correlation analyses. RESULTS: Fulfillment of the requirements is high with over 80 % of the sites fulfilling the requirements for most of the presented QIs with defined target values. Fulfillment increased slightly over time, with significant improvements in conducting multidisciplinary tumor conferences (increasing proportion of cases presented pre- and post-treatment, increasing participation of specialists), psycho-oncologic care, social service counseling and research participation. Bivariate associations between hospital characteristics and QIs observed were most distinct for time since first certification. CONCLUSIONS: Results suggest that the PCC certification program presented contributes to establishing multidisciplinary teams over time and assures the provision of high-quality PCa care. However, differences in fulfillment of the requirements exist with regard to hospital characteristics beyond the scope of the certification system.

Social service counseling in cancer centers certified by the German Cancer Society.

Social workers are an integral part of care provided in cancer centers that are certified according to the requirements of the German Cancer Society. This article reports on the tasks of social workers in German cancer care and on the proportion of patients that receives social service counseling (SSC) in breast, lung, colorectal, skin, gynecological, prostate, pancreas, neurological, and head and neck cancer centers based on data from 367,297 patients treated between 2009 and 2012. The highest proportions of patients (median >75%) are provided with SSC in breast and colorectal cancer centers, whereas the median is below 30% in skin cancer centers. Variation between centers and center types is high.

Quality of care in breast cancer centers: results of benchmarking by the German Cancer Society and German Society for Breast Diseases.

A total of 218 breast cancer centers, with 274 operating sites, have been certified since 2003 in accordance with the criteria set out by the German Cancer Society (Deutsche Krebsgesellschaft) and the German Society for Breast Diseases (Deutsche Gesellschaft für Senologie). Most of these centers are located in Germany, but centers in Austria, Switzerland, and Italy have also been certified. This paper presents the results for quality indicators (QIs) from 2009 to 2012, based on data from 195,342 primary breast cancer patients, in order to illustrate the development and progress of these centers. Descriptive results on interdisciplinary collaboration (6 QIs), guideline adherence (15 QIs), and specialist expertise (7 QIs) are reported over time. Fulfillment of the certification requirements was high and remained relatively stable over time, with the extent of variation between sites declining. Sites that do not reach the target values are asked to comment on the discrepancies, and their comments, as well as the QI results, are used by centers and auditors during an on-site auditing process and to constantly revise the QIs set out by the guideline and the certification commission.