Growth development of children and adolescents with inflammatory bowel disease in the period 2000-2014 based on data of the Saxon pediatric IBD registry: a population-based study.

BACKGROUND: The incidence of inflammatory bowel disease (IBD) in children is on the increase worldwide. Growth disorders are common in pediatric patients with inflammatory bowel disease. The aim of this paper is to investigate anthropometric indicators, including height and weight in children with inflammatory bowel disease in Saxony, one of the German federal states, and to evaluate growth trends in patients by comparing their height and weight with that of healthy children in Germany. METHODS: In Saxony, all children and adolescents with IBD were registered in the Saxon Pediatric IBD Registry from 2000 to 2014. The data used are therefore based on a total area-wide survey over 15 years. For this study, 421 datasets of children and adolescents aged 0-14 years with Crohn's disease (CD) (n = 291) or ulcerative colitis (UC) (n = 130) were analyzed. Z-score and percentile calculations were used to compare differences between IBD patients and the general population. RESULTS: The children with CD or UC (both sexes) had a significant lower weight at diagnosis (the mean weight z-score had negative values) versus the general population. The weight values lay mostly below P50 (the 50th percentile, median), more precisely, mostly between P10 and P50 of the body weight child growth curve for corresponding sexes (KiGGS 2003-2006). The height values of both sexes at diagnosis lay also mostly below P50 (the 50th percentile, median) of the child body growth curve for corresponding sexes (KiGGS 2003-2006), i.e. the mean height z-score was negative. But only the children with CD had a significant lower height, more precisely, mostly between P25 and P50 versus the general population (KIGGS). For children with UC the difference was not significant. CONCLUSION: In pediatric patients with IBD the possibility of growth disturbance, mainly in the form of weight retardation, is very probable.

Treatment in certified cancer centers is related to better survival in patients with colon and rectal cancer: evidence from a large German cohort study.

BACKGROUND: Certified cancer centers aim to ensure high-quality care by establishing structural and procedural standards according to evidence-based guidelines. Despite the high clinical and health policy relevance, evidence from a nation-wide study for the effectiveness of care for colorectal cancer in certified centers vs. other hospitals in Germany is still missing. METHODS: In a retrospective cohort study covering the years 2009-2017, we analyzed patient data using demographic information, diagnoses, and treatments from a nationwide statutory health insurance enriched with information on certification. We investigated whether patients with incident colon or rectal cancer did benefit from primary therapy in a certified cancer center. We used relative survival analysis taking into account mortality data of the German population and adjustment for patient and hospital characteristics via Cox regression with shared frailty for patients in hospitals with and without certification. RESULTS: The cohorts for colon and rectal cancer consisted of 109,518 and 51,417 patients, respectively, treated in a total of 1052 hospitals. 37.2% of patients with colon and 42.9% of patients with rectal cancer were treated in a certified center. Patient age, sex, comorbidities, secondary malignoma, and distant metastases were similar across groups (certified/non-certified) for both colon and rectal cancer. Relative survival analysis showed significantly better survival of patients treated in a certified center, with 68.3% (non-certified hospitals 65.8%) 5-year survival for treatment of colon cancer in certified (p < 0.001) and 65.0% (58.8%) 5-year survival in case of rectal cancer (p < 0.001), respectively. Cox regression with adjustment for relevant covariates yielded a lower hazard of death for patients treated in certified centers for both colon (HR = 0.92, 95% CI = 0.89-0.95) and rectal cancer (HR = 0.92, 95% CI = 0.88-0.95). The results remained robust in a series of sensitivity analyses. CONCLUSIONS: This large cohort study yields new important evidence that patients with colorectal cancer have a better chance of survival if treated in a certified cancer center. Certification thus provides one powerful means to improve the quality of care for colorectal cancer. To decrease the burden of disease, more patients should thus receive cancer care in a certified center.

[Does the Innovation Fund Improve Healthcare Provision? A Critical Assessment of the Status of Implementing Successful Innovation Fund Projects into Healthcare Practice]. / Verbessert der Innovationsfonds die Versorgung? Eine kritische Bestandsaufnahme zum Stand der Implementierung erfolgreicher Innovationsfondsprojekte in die Versorgungspraxis.

INTRODUCTION: Since 2015, the Federal Joint Committee (G-BA)'s Innovation Fund has been supporting projects in health services research and new health service models ("Neue Versorgungsformen", NVF). By the end of 2022, 211 projects in the NVF category had been funded. A key objective is the transfer of successful projects into standard care. This article analyzes previous projects regarding their incorporation into routine care based on transfer recommendations of the Innovation Fund Committee ("Innovationsausschuss" IA). METHOD: Descriptive analysis of all projects completed by August 1, 2023 with transfer recommendations in the "NVF" funding stream. Presentation by topic, project duration, time until IA transfer decision, categorization, and number of institutions and organizations (recipients) addressed per project, their feedback published on the G-BA website, response rates per recipient group, and a content classification and interpretation of exemplary feedback. Recommendations based on the results and their discussion in an expert workshop. RESULTS: Out of 57 NVF projects, 17 had a transfer recommendation. A total of 57 feedback responses were received from a total of 431 recipients addressed by the IA across these projects. Response rates varied significantly. One-third of inquiries to the G-BA and its member organizations received a response (31%), while only every fifth inquiry to federal states (18%) and professional societies (18%) got a response. Less than one in ten inquiries to the Federal Ministry of Health (8%), administrative bodies (6%), and the German Medical Association (0%) received a response. Project-specific feedback within a recipient group was often contradictory or limited to regional scope. DISCUSSION AND CONCLUSION: The transfer process reveals significant structural and procedural obstacles regarding the incorporation of projects evaluated as successful into routine health care. To ensure that funding from the innovation fund is most effectively used, there needs to be a realistic chance of successful transfer of positive project outcomes into routine care. The DNVF recommends stronger involvement of rule-competent institutions, mandatory publication of responses, structured moderation of the transfer process, expanding types of selective contracts, financing of implementation phases and of studies drawing on results across successful NVF projects.

Changes in the probability of hysterectomy in the city of Mainz and Mainz-Bingen region, Germany.

BACKGROUND: To assess the hysterectomy probability by calendar period and age, the overall and the age-specific prevalence of hysterectomy in women aged 30-65 years. METHODS: Baseline data (2005-2007) from the population-based MARZY study conducted in Mainz and Mainz-Bingen, Germany, were analysed. 6429 women aged 30-65 years were asked whether they had undergone a hysterectomy and the date and indication of the procedure. We calculated the 5-year age-specific prevalence of hysterectomy and estimated the probability of undergoing a hysterectomy combining two approaches: 1) Kaplan-Meier and 2) Inverse probability weighting (IPW). We assessed potential changes over calendar periods by simulating survival curves, having hysterectomy as the event, employing a Cox proportional hazard model. RESULTS: Data on hysterectomy were available for 4719 women. Of these, 961 (20.4%) had undergone a hysterectomy between 1960 and 2006. The hysterectomy prevalence was highest among the 60-64 year-olds (40.7%). The IPW-corrected probability of having a hysterectomy up to the age of 65 years was 36.4%. The age-specific probability of hysterectomy increased from 0.1% (20-24 years), peaking at 45-49 years (7.8%) and declining thereafter to less than 5% among women aged 50 and older. Over time, women were hysterectomised at an increasingly older age. Most hysterectomies (86.7%) were done due to benign disease. CONCLUSIONS: A shift to older age at hysterectomy with an advancing calendar period likely reflects changes in clinical practice in Germany. TRIAL REGISTRATION: Landesärztekammer Rheinland-Pfalz: 837.438.03 (4100).

Modelling the effect of demographic change and healthcare infrastructure on the patient structure in German hospitals - a longitudinal national study based on official hospital statistics.

BACKGROUND: Effects of demographic change, such as declining birth rates and increasing individual life expectancy, require health system adjustments offering age- and needs-based care. In addition, healthcare factors can also influence health services demand. METHODS: The official German hospital statistics database with odd-numbered years between 1995 and 2011 was analysed. This is a national comprehensive database of all general hospital inpatient services delivered. Official data from hospital statistics were linked at the district level with demographic and socio-economic data as well as population figures from the official regional statistics. Panel data regression, modelling case numbers per hospital, was performed for 13 diagnosis groups that characterised the patient structure. Socio-demographic variables included age, sex, household income, and healthcare factors included bed capacity, personnel and hospital characteristics. RESULTS: The median number of annual treatments per hospital increased from 6 015 (5th and 95th percentile [670; 24 812]) in 1995 to 7 817 in 2011 (5th and 95th percentile [301; 33 651]). We developed models characterising the patient structure of health care in Germany, considering both socio-demographic and hospital factors. Demographic factors influenced case numbers across all major diagnosis groups. For example, the age groups 65-74 and 75 + influenced cerebrovascular disease case numbers (p < 0.001). Other important factors included human and material resources of hospitals or the household income of patients. Distinct differences between the models for the individual diagnosis groups were observed. CONCLUSIONS: Hospital planning should not only consider demographic change but also hospital infrastructure and socio-economic factors.

Assessment of the Potential of Concentrating Cancer Care in Hospitals With Certification Through Survival Analysis. / Potenzialabschätzung für die Konzentration der Versorgung von Krebspatient:innen in Kliniken mit DKG-Zertifizierung mittels Überlebenszeitanalyse.

BACKGROUND: Certification programs seek to improve the quality of complex interdisciplinary models of care such as cancer treatment through structuring the process of care in accordance with evidence-based guidelines. In Germany, the German Cancer Society (Deutsche Krebsgesellschaft, DKG) provides a certification programme for cancer care that covers more than one thousand centers. In a recent retrospective cohort study, it has been shown on a large, nationwide data set based on data from a statutory health insurance and selected clinical cancer registries, that there is a benefit in survival for cancer patients who have received initial treatment in hospitals certified by the DKG. Here, we deduce two absolute measures from the relative benefit in survival with the aim to quantify this benefit if all patients had been treated in a certified center. METHODS: The WiZen study analysed survival of adult patients insured by the AOK with a cancer diagnosis between 2009 and 2017 in certified hospitals vs. non-certified hospitals. Besides Kaplan-Meier-estimators, Cox regression with shared frailty was used for 11 types of cancer in total, adjusting for patient-specific information such as demographic characteristics and comorbidities as well as hospital characteristics and temporal trend. Based on this regression, we predict adjusted survival curves that directly address the certification effect. From the adjusted survivals, we calculated years of life lost (YLL) and number needed to treat (NNT), along with a difference in deaths 5 years after diagnosis. RESULTS: Based on our estimate for the 537,396 patients that were treated in a non-certified hospital included in the WiZen study, corresponding to 68,7% of the study population, we find a potential of 33,243 YLL per year in Germany based on the size of the German population as of 2017. The potential to avoid death cases 5 years from diagnosis totals 4,729 per year in Germany. CONCLUSION: While Cox regression is an important tool to evaluate the benefit that arises from variables with a potential impact on survival such as certification, its direct results are not well suited to quantify this benefit for decision makers in health care. The estimated years of life lost and the number of deaths that could have been avoided 5 years from diagnosis avoid mis-interpretation of the hazard ratios commonly used in survival analysis and should help to inform key stakeholders in health care without specialist background knowledge in statistics. Our measures, directly adressing the effect of certification, can furthermore be used as a starting point for health-economic calculations. Steering the care of cancer patients primarily to certified hospitals would have a high potential to improve outcomes.

[Methodology and Attribution Success of a Data Linkage of Clinical Registry Data with Health Insurance Data]. / Methodik und Zuordnungserfolg eines Linkage von Daten klinischer Krebsregister mit Abrechnungsdaten gesetzlicher Krankenkassen.

BACKGROUND: The aim of the project "Effectiveness of care in oncological centres" (WiZen), funded by the innovation fund of the federal joint committee, is to investigate the effectiveness of certification in oncology. The project uses nationwide data from the statuory health insurance AOK and data from clinical cancer registries from three different federal states from 2006-2017. To combine the strengths of both data sources, these will be linked for eight different cancer entities in compliance with data protection regulations. METHODS: Data linkage was performed using indirect identifiers and validated using the health insurance's patient ID ("Krankenversichertennummer") as a direct identifier and gold standard. This enables quantification of the quality of different linkage variants. Sensitivity and specificity as well as hit accuracy and a score addressing the quality of the linkage were used as evaluation criteria. The distributions of relevant variables resulting from the linkage were validated against the original distributions in the individual datasets. RESULTS: Depending on the combination of indirect identifiers, we found a range of 22,125 to 3,092,401 linkage hits. An almost perfect linkage could be achieved by combining information on cancer type, date of birth, gender and postal code. A total of 74,586 one-to-one linkages were achieved with these characteristics. The median hit quality for the different entities was more than 98%. In addition, both the age and sex distributions and the dates of death, if any, showed a high degree of agreement. DISCUSSION AND CONCLUSION: SHI and cancer registry data can be linked with high internal and external validity at the individual level. This robust linkage enables completely new possibilities for analysis through simultaneous access to variables from both data sets ("the best of both worlds"): Information on the UICC stage that stems from the registries can now be combined, for instance, with comorbidities from the SHI data at the individual level. Due to the use of readily available variables and the high success of the linkage, our procedure constitutes a promising method for future linkage processes in health care research.

Long-Term Observation of Patients With Cancer - an Entity-Independent Registry for Healthcare and Translational Research at the University Medicine Dresden (Cancer-Reg-VT). / Langzeitbeobachtung von Patienten mit Krebserkrankungen ­ ein entitätsunabhängiges Register für Versorgungsforschung und translationale Forschung an der Universitätsmedizin Dresden (Cancer-Reg-VT).

INTRODUCTION: Translational research is important, especially in medicine where decisions affect people's lives. Clinical registries and the studies embedded in them allow the depiction of actual care practice under routine conditions. Translating the findings of health services research back into clinical research through prospective cohort studies has the potential to drive medical innovations faster, more effectively and, above all, in a more targeted manner. These must therefore be a central component of cutting-edge oncological research. OBJECTIVE: The aim of the registry is the establishment of clinical cohorts and the provision of a comprehensive, high-quality data set for oncological diseases. METHODS/DESIGN: The registry will prospectively record all patients treated for cancer at Dresden University Hospital (UKD). In addition to the data from the hospital information systems (ORBIS, TDS, GEPADO, etc.), monitoring of health-related quality of life (HRQOL) is to be carried out at regular intervals at the beginning and during the course of treatment. In addition, individual linkage with data from clinical cancer registries and health insurance companies (including AOK PLUS) is planned for a period of five years before and after inclusion. All these data will be merged in a registry database. The selection of variables and measurement time points is closely based on the guidelines for colorectal carcinoma of the international initiative ICHOM (International Consortium for Health Outcomes Measurement). The study management software (STeVe) separates personal identification characteristics (IDAT) and medical data (MDAT) at an early stage. The independent trust centre of the TU Dresden (Treuhandstelle) ensures that no personal data enter the registry database. It is thereby also ensured that the data owners involved (UKD, biobank, health insurance company, cancer registry, patient) only receive the personal data they need for allocation. The MOSAIC software tools recommended by the TMF (Technologie- und Methodenplattform für die vernetzte medizinische Forschung e.V.) are used to manage the pseudonyms. DISCUSSION/CONCLUSION: With the registry, previously missing evidence on the effectiveness, safety and costs of diagnostic and therapeutic measures can be made, taking into account long-term and patient-reported outcomes of routine care. The data potentially allow for the identification of barriers to and facilitators of innovative promising cancer diagnostics and therapies. They also enable generation of scientifically relevant hypotheses in the field of translational and outcomes research.

Is treatment in certified cancer centers related to better survival in patients with pancreatic cancer? Evidence from a large German cohort study.

BACKGROUND: Treatment of cancer patients in certified cancer centers, that meet specific quality standards in term of structures and procedures of medical care, is a national treatment goal in Germany. However, convincing evidence that treatment in certified cancer centers is associated with better outcomes in patients with pancreatic cancer is still missing. METHODS: We used patient-specific information (demographic characteristics, diagnoses, treatments) from German statutory health insurance data covering the period 2009-2017 and hospital characteristics from the German Standardized Quality Reports. We investigated differences in survival between patients treated in hospitals with and without pancreatic cancer center certification by the German Cancer Society (GCS) using the Kaplan-Meier estimator and Cox regression with shared frailty. RESULTS: The final sample included 45,318 patients with pancreatic cancer treated in 1,051 hospitals (96 GCS-certified, 955 not GCS-certified). 5,426 (12.0%) of the patients were treated in GCS-certified pancreatic cancer centers. Patients treated in certified and non-certified hospitals had similar distributions of age, sex, and comorbidities. Median survival was 8.0 months in GCS-certified pancreatic cancer centers and 4.4 months in non-certified hospitals. Cox regression adjusting for multiple patient and hospital characteristics yielded a significantly lower hazard of long-term, all-cause mortality in patients treated in GCS-certified pancreatic centers (Hazard ratio = 0.89; 95%-CI = 0.85-0.93). This result remained robust in multiple sensitivity analyses, including stratified estimations for subgroups of patients and hospitals. CONCLUSION: This robust observational evidence suggests that patients with pancreatic cancer benefit from treatment in a certified cancer center in terms of survival. Therefore, the certification of hospitals appears to be a powerful strategy to improve patient outcomes in pancreatic cancer care. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT04334239 ).

Exploring relationships between in-hospital mortality and hospital case volume using random forest: results of a cohort study based on a nationwide sample of German hospitals, 2016-2018.

BACKGROUND: Relationships between in-hospital mortality and case volume were investigated for various patient groups in many empirical studies with mixed results. Typically, those studies relied on (semi-)parametric statistical models like logistic regression. Those models impose strong assumptions on the functional form of the relationship between outcome and case volume. The aim of this study was to determine associations between in-hospital mortality and hospital case volume using random forest as a flexible, nonparametric machine learning method. METHODS: We analyzed a sample of 753,895 hospital cases with stroke, myocardial infarction, ventilation > 24 h, COPD, pneumonia, and colorectal cancer undergoing colorectal resection treated in 233 German hospitals over the period 2016-2018. We derived partial dependence functions from random forest estimates capturing the relationship between the patient-specific probability of in-hospital death and hospital case volume for each of the six considered patient groups. RESULTS: Across all patient groups, the smallest hospital volumes were consistently related to the highest predicted probabilities of in-hospital death. We found strong relationships between in-hospital mortality and hospital case volume for hospitals treating a (very) small number of cases. Slightly higher case volumes were associated with substantially lower mortality. The estimated relationships between in-hospital mortality and case volume were nonlinear and nonmonotonic. CONCLUSION: Our analysis revealed strong relationships between in-hospital mortality and hospital case volume in hospitals treating a small number of cases. The nonlinearity and nonmonotonicity of the estimated relationships indicate that studies applying conventional statistical approaches like logistic regression should consider these relationships adequately.

The Clinical Complexity of Penile Cancer: Current Clinical-Epidemiological Data from the Database of the Free State of Saxony/Germany.

OBJECTIVES: The aim of this study was to assess penile cancer incidence, clinical characteristics, treatment options, transparency of clinical quality, and relative survival based on data from the clinical cancer registry. SUBJECTS AND METHODS: A total of 898 patients with tumours of the penis were diagnosed and analysed in the period from 2000 to 2018; they were documented in the 4 regional clinical cancer registries and summarized in the Command Office of these 4 registries. RESULTS: The standardized incidence rate increased from 0.86 in 2000 to 2.67 in 2018. Most tumours were located at the glans (42.9%) followed by the prepuce (19.5%) and corpus penis (6.9%); they were classified into pT1a/pT1b (20.0%/7.0%), pT2 (23.5%), pT3 (12.4%), and pT4 (0.8%). In only 32.0% of all documented cases, a stage-related lymphadenectomy (LND) was carried out. Negative surgical margins were found in only 70% and the Rx status in 15.1%. Primary metastasis was detected in pN1 (5.1%), pN2 (3.9%), pN3 (3.1%), and M1 status in 3.0%, respectively. The predominant therapy was surgery in 78.3%. The proportion of penile partial resections was significantly (p = 0.0045) regredient over the control period. Adjuvant chemotherapy was performed in 4.7%, adjuvant external-beam radiotherapy in 3.0%. The 5-year relative overall survival rate was 74.7% and ranged from 108.0% (stage 0) to 17.1% (stage IV). A total of 29 hospitals performed tumour operations. CONCLUSIONS: The multitude of clinical and epidemiological variables available in clinical cancer registries allows a safe assessment of tumour dynamics themselves, as well as good quality of transparency and broadly acceptable guideline adherence. Deviations from the accepted level of evidence were found in the grading definition, in the high quota of positive surgical margins, in the defensive indication position to the glans resurfacing/reconstruction and diagnostical LND. Based on these relevant findings in the database combined with the low frequency of the tumour in area/clinics/year, we recommended establishing SCCP reference clinics. This work is the first time that European standardized rate-based cancer registry data on penile cancer from Germany has been communicated.

Patient-Level and Hospital-Level Risk Factors for In-Hospital Mortality in Patients Ventilated for More Than 24 Hours: Results of a Nationwide Cohort Study.

BACKGROUND: Prolonged ventilation is associated with a high risk of death. This study investigated both patient-level and hospital-level risk factors for in-hospital mortality in patients ventilated for more than 24 hours. METHODS: The analyses were conducted in the framework of a German national multicenter retrospective cohort study. Patient and hospital characteristics were examined using descriptive statistics. Risk factors of in-hospital mortality were analyzed using multilevel robust Poisson regressions for binary outcomes. Potential effect modifications were examined by stratified analyses. RESULTS: The sample includes 95 672 cases of patients ventilated >24 hours in 163 hospitals covering the period 2016 to 2017. According to the results of multilevel Poisson regressions, main patient-level risk factors for in-hospital mortality were age (per year relative risk [RR] = 1.021, 95% CI = 1.020-1.023), stroke (RR = 1.459; 95% CI = 1.361-1.563), emergency case admission (RR = 1.273, 95% CI = 1.156-1.403), and transfer from another hospital (RR = 1.169, 95% CI = 1.084-1.261). The individual risk of in-hospital death was positively associated with hospital size (RR of hospitals with 600-799 beds vs <100 beds = 1.412, 95% CI = 1.095-1.820) and negatively related to cumulated ventilation patient time (per 1000 days RR = 0.995, 95% CI = 0.993-0.996). University hospital status was identified as an effect modifier, particularly with regard to the patients' admission reasons. The RR of in-hospital death in patients admitted after transfer from another hospital was higher in university hospitals (RR = 1.456, 95% CI = 1.298-1.634) compared to nonuniversity hospitals (RR = 1.077, 95% CI = 1.019-1.139). Likewise, patients admitted as emergency case had a higher relative risk in university hospitals (RR = 1.619, 95% CI = 1.359-1.929) than in nonuniversity hospitals (RR = 1.141, 95% CI = 1.080-1.205). CONCLUSION: By providing evidence on multiple patient-level and hospital-level risk factors for in-hospital mortality in patients ventilated for more than 24 hours, this large multicenter study has main implications for quality assessment of clinical care and the adequate specification of risk adjustment models. The revealed effect modifications indicate the relevance of stratified analyses.

[Methodological Challenges when Using Claims Data of more than 70 Statutory Health Insurances - A Progress Report from the EVA64 Study]. / Methodische Herausforderungen bei der Nutzung von Daten von mehr als 70 gesetzlichen Krankenkassen ­ Ein Werkstattbericht aus der EVA64-Studie.

AIM OF THE STUDY: The adequate and need-based medical care of mentally ill patients places special demands on psychiatric care. The §64b Social Code Book (SGB) V enables mentoring mentally ill people through multiprofessional, cross-sectoral model projects across the treatment phase and implementing new forms of financing. These model projects have been evaluated in a prospective and retrospective claims data-based controlled cohort study (EVA64) since 2015. METHODS: In September 2016 and since then annually, the data transfer of all statutory health insurance funds (SHI) involved in this evaluation took place for the first time on the basis of a consented data set description. For later analysis, the clear identification of the index hospital admission and the assignment to the model or control group are important. The methodological challenges of data provision by the data owner, the formal and content-related data preparation as well as the subsequent establishing of an evaluation data set are discussed in detail. RESULTS: So far, data from 71 SHI has been taken into account. In each case 20 tables with claims data from outpatient and inpatient care (including psychiatric institute outpatient departments [PIA]), drug and medical supplies as well as data from incapacity to work and personal data of the insurees. Not all tables could be filled completely by the SHIs. In addition, updates of the study designs require the adaptation of the data selection process. Even though data sets have been delievered regularly the data preparation process is still not routine. CONCLUSION: The scientific use of claims data of numerous SHIs in the context of an evaluation study represents a great challenge. In the absence of reference values for abnormalities and implausibilities, an a priori determination of test algorithms was limited; instead they had to be updated every year. The individual examination of the data of all health insurance companies remains very complex. The detailed documentation of these algorithms provides support for future comparable studies.

Trastuzumab and survival of patients with metastatic breast cancer.

INTRODUCTION: Prognosis of Her2-positive breast cancer has changed since the introduction of trastuzumab for treatment in metastatic and early breast cancer. It was described to be even better compared to prognosis of Her2-negative metastatic breast cancer. The purpose of this study was to evaluate the effect of trastuzumab in our cohort. Besides the effect of adjuvant pretreatment with trastuzumab on survival of patients with metastatic Her2-positive breast cancer was analyzed. METHODS: All patients with primary breast cancer of the Regional Breast Cancer Center Dresden diagnosed during the years 2001-2013 were analyzed for treatment with or without trastuzumab in the adjuvant and in the metastatic treatment setting using Kaplan-Meier survival estimation and Cox regression. Age and tumor stage at time of first diagnosis of breast cancer as well as hormone receptor status, grading, time, and site of metastasis at first diagnosis of distant metastatic disease were analyzed. RESULTS: Of 4.481 female patients with primary breast cancer, 643 presented with metastatic disease. Her2-positive status was documented in 465 patients, including 116 patients with primary or secondary metastases. Median survival of patients with Her2-positive primary metastatic disease was 3.0 years (95% CI 2.3-4.0). After adjustment for other factors, survival was better in patients with Her2-positive breast cancer with trastuzumab therapy compared to Her2-negative metastatic disease (HR 2.10; 95% CI 1.58-2.79). Analysis of influence of adjuvant therapy with and without trastuzumab by Kaplan-Meier showed a trend for better survival in not pretreated patients. Median survival was highest in hormone receptor-positive Her2-positive (triple-positive) primary metastatic breast cancer patients with 3.3 years (95% CI 2.3-4.6). CONCLUSION: Prognosis of patients with Her2-positive metastatic breast cancer after trastuzumab treatment is more favorable than for Her2-negative breast cancer. The role of adjuvant chemotherapy with or without trastuzumab warrants further research. Survival is best in triple-positive metastatic breast cancer. This will effect counseling at the time of first diagnosis of metastatic breast cancer.

Tumour stage distribution and survival of malignant melanoma in Germany 2002-2011.

BACKGROUND: Over the past two decades, there has been a rising trend in malignant melanoma incidence worldwide. In 2008, Germany introduced a nationwide skin cancer screening program starting at age 35. The aims of this study were to analyse the distribution of malignant melanoma tumour stages over time, as well as demographic and regional differences in stage distribution and survival of melanoma patients. METHODS: Pooled data from 61 895 malignant melanoma patients diagnosed between 2002 and 2011 and documented in 28 German population-based and hospital-based clinical cancer registries were analysed using descriptive methods, joinpoint regression, logistic regression and relative survival. RESULTS: The number of annually documented cases increased by 53.2% between 2002 (N = 4 779) and 2011 (N = 7 320). There was a statistically significant continuous positive trend in the proportion of stage UICC I cases diagnosed between 2002 and 2011, compared to a negative trend for stage UICC II. No trends were found for stages UICC III and IV respectively. Age (OR 0.97, 95% CI 0.97-0.97), sex (OR 1.18, 95% CI 1.11-1.25), date of diagnosis (OR 1.05, 95% CI 1.04-1.06), 'diagnosis during screening' (OR 3.24, 95% CI 2.50-4.19) and place of residence (OR 1.23, 95% CI 1.16-1.30) had a statistically significant influence on the tumour stage at diagnosis. The overall 5-year relative survival for invasive cases was 83.4% (95% CI 82.8-83.9%). CONCLUSIONS: No distinct changes in the distribution of malignant melanoma tumour stages among those aged 35 and older were seen that could be directly attributed to the introduction of skin cancer screening in 2008.

Impact of breast cancer subtypes and patterns of metastasis on outcome.

Clinical outcome of patients with stage IV breast cancer is dependent on tumor biology, extent, and localization of metastases. Routine imaging diagnostics for distant metastasis is not recommended by the national guidelines for breast cancer follow-up. In this study, we evaluated different patterns of metastases of cancer subtypes in order to generate hypotheses on individualization of follow-up after breast cancer in the adjuvant setting. Patients of the Regional Breast Cancer Center Dresden diagnosed within the years 2006-2011 were classified into the five intrinsic subtypes luminal A (ER+, Her2-, G1/2), luminal B/Her2 negative (ER+, Her2-, G3), triple positive (ER+, PR+, Her2+), Her2-enriched (ER-, Her2+), and triple negative (ER-, PR-, Her2-) and with a median follow-up of 45 months. Tumor stage at time of first diagnosis of breast cancer as well as time and site of metastasis at first diagnosis of distant metastatic disease was analyzed. Tumor specimen of 2284 female patients with primary breast cancer was classified into five subtypes. Distant recurrence-free survival at 3 years was most unfavorable in Her2-enriched (66.8 %), triple negative (75.9 %), and triple-positive breast cancer (81.7 %). The same subtypes most frequently presented with visceral metastases only at first presentation: Her2-enriched 46.9 %, triple negative 45.5 %, and triple-positive breast cancer 37.5 %. Longest median survival of 2.3 years was seen in luminal A and in Her2-enriched metastatic disease, respectively. Median survival was significantly better in the luminal A, Her2-enriched, and triple-positive subtype compared to triple-negative breast cancer (p < 0.005). Differences in time to metastatic disease, first localization of metastases, and overall survival after diagnosis of metastatic disease were shown. Considering new targeted therapies and the option of surgery of oligometastases, screening for visceral metastases might be reasonable after diagnosis of Her2-positive subtypes.

Health-related quality of life for pre-diabetic states and type 2 diabetes mellitus: a cross-sectional study in Västerbotten Sweden.

BACKGROUND: Type 2 diabetes (T2D) decreases health-related quality of life, but there is a lack of information about the health status of people in pre-diabetic states. However, information on health utility weights (HUWs) for pre-diabetic states and T2D are essential to estimate the effect of prevention initiatives. We estimated and compared HUWs for healthy individuals, those with pre-diabetes and those with T2D in a Swedish population and evaluated the influence of age, sex, education and body mass index on HUWs. METHODS: Participants of the Västerbotten Intervention Program, Sweden, between 2002 and 2012, who underwent an oral glucose tolerance test or indicated they had T2D and who filled in the Short Form-36 questionnaire (SF-36) were included. Individuals were categorized as healthy, being in any of three different pre-diabetic states, or as T2D. The pre-diabetic states are impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or a combination of both (IFG&IGT). The SF-6D index was used to convert SF-36 responses to HUWs. HUWs were stratified by age, sex, education and body mass index. Beta regression analyses were conducted to estimate the effect of multiple risk factors on the HUWs. RESULTS: In total, 55 882 individuals were included in the analysis. The overall mean HUW was 0.764. The mean HUW of healthy individuals was 0.768, 0.759 for those with IFG, 0.746 for those with IGT, 0.745 for those with IFG&IGT, and 0.738 for those with T2D. In the overall model, all variables except underweight vs. normal weight were significantly associated with HUW. Younger age, male sex, and higher education were associated with increased HUW. Normal weight, or being overweight was associated with elevated HUW, while obesity was associated with lower HUW. CONCLUSIONS: Healthy individuals had higher HUWs than participants with T2D, while individuals with IFG, IGT or IFG&IGT had HUWs that ranged between those for NGT and T2D. Therefore, preventing the development of pre-diabetic states would improve health-related quality of life in addition to lowering the risk of developing T2D.

An audit of 1632 routinely collected cervical cancer screening smears from 398 women in Germany: Results from the TeQaZ Study.

OBJECTIVE: There is evidence in Germany that half of the cervical cancer (CC) cases had undergone screening frequently in the decade preceding their diagnosis, signaling cytology quality issues. This study investigates routine smear assessment accuracy in Germany. METHODS: Within a population-based case-control study in 9 German states, we recruited cases (women with a histologically confirmed diagnosis of CC) and population controls (women with no history of CC or hysterectomy). Two independent expert cytologists audited Pap smears taken within the 10 years preceding CC diagnosis (cases)/study entry (controls). We report the prevalence of positive results, as well as routine assessment's accuracy, as sensitivity, specificity, false-positive and false-negative rates along with 95% confidence intervals (95% CI). We also examined cases' smear history, to investigate possible false-positive recurrence. RESULTS: We audited 1632 smears of 392 women (18.9% cases, 81.1% controls). In the routine assessment, the overall prevalence of positive results was 4.5% (29.0% among cases). According to the expert audit, the overall prevalence of positive results was 7.7% (40.8% among cases). When restricting analyses to the 3 years preceding diagnosis/study entry, this prevalence increased to 11.9% overall (61.4% among cases). The overall sensitivity of the routine assessment was 54.9% (66.8% for cases). CONCLUSION: As cytology remains an important part of CC screening, quality issues must be urgently addressed in Germany. Shifting to objective methods such as primary high-risk HPV screening followed by triaging may help CC elimination in Germany.

What does "urgency" mean when prioritizing cancer treatment? Results from a qualitative study with German oncologists and other experts during the COVID-19 pandemic.

PURPOSE: Cancer care in Germany during the COVID-19 pandemic was affected by resource scarcity and the necessity to prioritize medical measures. This study explores ethical criteria for prioritization and their application in cancer practices from the perspective of German oncologists and other experts. METHODS: We conducted fourteen semi-structured interviews with German oncologists between February and July 2021 and fed findings of interviews and additional data on prioritizing cancer care into four structured group discussions, in January and February 2022, with 22 experts from medicine, nursing, law, ethics, health services research and health insurance. Interviews and group discussions were digitally recorded, transcribed verbatim and analyzed using qualitative content analysis. RESULTS: Narratives of the participants focus on "urgency" as most acceptable criterion for prioritization in cancer care. Patients who are considered curable and those with a high level of suffering, were given a high degree of "urgency." However, further analysis indicates that the "urgency" criterion needs to be further distinguished according to at least three different dimensions: "urgency" to (1) prevent imminent harm to life, (2) prevent future harm to life and (3) alleviate suffering. In addition, "urgency" is modulated by the "success," which can be reached by means of an intervention, and the "likelihood" of reaching that success. CONCLUSION: Our analysis indicates that while "urgency" is a well-established criterion, its operationalization in the context of oncology is challenging. We argue that combined conceptual and clinical analyses are necessary for a sound application of the "urgency" criterion to prioritization in cancer care.