Obesity is linked to disease severity in moderate to severe atopic dermatitis-Data from the prospective observational TREATgermany registry.

BACKGROUND: There are conflicting data on a potential association between obesity and atopic dermatitis (AD). The purpose of this study was to investigate the relationship between obesity and AD disease severity. METHODS: Patients from the TREATgermany registry cohort were divided into three groups according to their body mass index (BMI). Due to low numbers, underweight patients (BMI <18.5 kg/m2) were excluded from the analysis. Physician- and patient-reported disease severity scores as well as additional phenotypic characteristics were evaluated for association with BMI. Generalized linear mixed models and multinomial logit models, respectively, were applied to investigate the association of BMI, age, sex and current systemic AD treatment with disease severity. RESULTS: This study encompassed 1416 patients, of which 234 (16.5%) were obese (BMI ≥30 kg/m2). Obesity was associated with lower educational background and smoking. Otherwise, obese and non-obese AD patients had similar baseline characteristics. Increased BMI was associated with higher oSCORAD (adjusted ß: 1.24, 95% CI: 1.05-1.46, p = 0.013) and Patient-oriented eczema measure (POEM) (adjusted ß: 1.09, 95% CI: 1.01-1.17, p = 0.038). However, the absolute difference in the overall oSCORAD was small between obese and non-obese AD patients (Δ oSCORAD = 2.5). Allergic comorbidity was comparable between all three groups, with the exception of asthma which was more pronounced in obese patients (p < 0.001). DISCUSSION: In this large and well-characterized AD patient cohort, obesity is significantly associated with physician- and patient-assessed measures of AD disease severity. However, the corresponding effect sizes were low and of questionable clinical relevance. The overall prevalence of obesity among the German AD patients was lower than in studies on other AD cohorts from different countries, which confirms previous research on the German population and suggests regional differences in the interdependence of AD and obesity prevalence.

Association of Tumor Necrosis Factor-α Inhibitors with Incident Dementia: Analysis Based on Population-Based Cohort Studies.

BACKGROUND AND OBJECTIVE: Preliminary evidence suggests a possible preventive effect of tumor necrosis factor-α inhibitors (TNFi) on incident dementia. The objective of the analysis was to investigate the association between TNFi and the risk of incident dementia in a population undergoing treatment for rheumatological disorders. METHODS: We followed patients aged ≥ 65 years with dementia and rheumatological conditions in two cohort studies, DANBIO (N = 21,538), a Danish clinical database, and AOK PLUS (N = 7112), a German health insurance database. We defined incident dementia using diagnostic codes and/or medication use and used Cox regression to compare the associations of TNFi with other rheumatological therapies on the risk of dementia. To ensure that the patients were receiving long-term medication, we included patients with rheumatic diseases and systemic therapies. RESULTS: We observed similar trends towards a lower risk of dementia associated with TNFi versus other anti-inflammatory agents in both cohorts (hazard ratios were 0.92 [95% confidence interval 0.76, 1.10] in DANBIO and 0.89 [95% confidence interval 0.63, 1.24] in AOK PLUS, respectively). CONCLUSIONS: Tumor necrosis factor-α inhibitors may decrease the risk of incident dementia although the association did not reach statistical significance in this analysis. Further research, ideally with randomization, is needed to gauge the potential of repurposing TNFi for dementia prevention and/or treatment.

Prioritization and Resource Allocation in the Context of the COVID-19 Pandemic: Recommendations for Colorectal and Pancreatic Cancer in Germany.

In the context of the COVID-19 pandemic, there has been a scarcity of resources with various effects on the care of cancer patients. This paper provides an English summary of a German guideline on prioritization and resource allocation for colorectal and pancreatic cancer in the context of the pandemic. Based on a selective literature review as well as empirical and ethical analyses, the research team of the CancerCOVID Consortium drafted recommendations for prioritizing diagnostic and treatment measures for both entities. The final version of the guideline received consent from the executive boards of nine societies of the Association of Scientific Medical Societies in Germany (AWMF), 20 further professional organizations and 22 other experts from various disciplines as well as patient representatives. The guiding principle for the prioritization of decisions is the minimization of harm. Prioritization decisions to fulfill this overall goal should be guided by (1) the urgency relevant to avoid or reduce harm, (2) the likelihood of success of the diagnostic or therapeutic measure advised, and (3) the availability of alternative treatment options. In the event of a relevant risk of harm as a result of prioritization, these decisions should be made by means of a team approach. Gender, age, disability, ethnicity, origin, and other social characteristics, such as social or insurance status, as well as the vehemence of a patient's treatment request and SARS-CoV-2 vaccination status should not be used as prioritization criteria. The guideline provides concrete recommendations for (1) diagnostic procedures, (2) surgical procedures for cancer, and (3) systemic treatment and radiotherapy in patients with colorectal or pancreatic cancer within the context of the German healthcare system.

Treatment in Certified Breast Cancer Centers Improves Chances of Survival of Patients with Breast Cancer: Evidence Based on Health Care Data from the WiZen Study.

Introduction: Certified breast cancer centers offer specific quality standards in terms of their structure, diagnostic and treatment approaches with regards to breast surgery, drug-based cancer therapy, radiotherapy, and psychosocial support. Such centers aim to improve treatment outcomes of breast cancer patients. The question investigated here was whether patients with primary breast cancer have a longer overall survival if they are treated in a certified breast cancer center compared to treatment outside these centers. Methods: We used patient-specific data (demographics, diagnoses, treatments) obtained from data held by mandatory health insurance companies ( gesetzliche Krankenversicherung , GKV) and clinical cancer registries (KKR) for the period 2009-2017 as well as hospital characteristics recorded in standardized quality reports. Using multivariable Cox regression analysis, we investigated differences in survival between patients treated in hospitals certified as breast cancers centers by the German Cancer Society (DKG) and patients treated in hospitals which had not been certified by the DKG. Results: The sample population consisted of 143720 (GKV data) and 59780 (KKR data) patients with breast cancer, who were treated in 1010 hospitals across Germany (280 DKG-certified, 730 not DKG-certified). 63.5% (GKV data) and 66.7% (KKR data) of patients, respectively, were treated in DKG-certified breast cancer centers. Cox regression analysis for overall survival which included patient and hospital characteristics found a significantly lower mortality risk for patients treated in DKG-certified breast cancer centers (GKV data: HR = 0.77, 95% CI = 0.74-0.81; KKR data: HR = 0.88, 95% CI = 0.85-0.92). This result remained stable even after several sensitivity analyses including stratified estimates for subgroups of patients and hospitals. The effect was even more pronounced for recurrence-free survival (KKR data: HR = 0.78, 95% CI = 0.74-0.82). Conclusions: Patients who are treated by an interdisciplinary team in a DKG-certified breast cancer had clear and statistically significantly better survival rates. Certification is therefore an effective means of improving the quality of care, and more patients should be treated in certified breast cancer centers.

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.

Health related Quality of Life over time in German sarcoma patients. An analysis of associated factors - results of the PROSa study.

Introduction: Sarcomas are rare cancers and very heterogeneous in their location, histological subtype, and treatment. Health-Related Quality of Life (HRQoL) of sarcoma patients has rarely been investigated in longitudinal studies. Methods: Here, we assessed adult sarcoma patients and survivors between September 2017 and February 2020, and followed-up for one year in 39 study centers in Germany. Follow-up time points were 6 (t1) and 12 months (t2) after inclusion. We used a standardized, validated questionnaire (the European Organisation for Research and Treatment of Cancer Quality of Life Core Instrument (EORTC QLQ-C30) and explored predictors of HRQoL in two populations (all patients (Analysis 1), patients in ongoing complete remission (Analysis 2)) using generalized linear mixed models. Results: In total we included up to 1111 patients at baseline (915 at t1, and 847 at t2), thereof 387 participants were in complete remission at baseline (334 at t1, and 200 at t2). When analyzing all patients, HRQoL differed with regard to tumor locations: patients with sarcoma in lower extremities reported lower HRQoL values than patients with sarcomas in the upper extremities. Treatment which included radiotherapy and/or systemic therapy was associated with lower HRQoL. For patients in complete remission, smoking was associated with worse HRQoL-outcomes. In both analyses, bone sarcomas were associated with the worst HRQoL values. Being female, in the age group 55-<65 years, having lower socioeconomic status, and comorbidities were all associated with a lower HRQoL, in both analyses. Discussion: HRQoL increased partially over time since treatment and with sporting activities. HRQoL improved with time since treatment, although not in all domains, and was associated with lifestyle and socioeconomic factors. Bone sarcomas were the most affected subgroup. Methods to preserve and improve HRQoL should be developed for sarcoma patients.

The health-related quality of life of sarcoma patients treated with neoadjuvant versus adjuvant radiotherapy - Results of a multi-center observational study.

AIM: The sequence of radiotherapy and resection in patients with soft tissue sarcomas is usually discussed on an individual basis. Better understanding of potential differences of health-related quality of life (QoL) between patients undergoing adjuvant (ART) versus neoadjuvant radiotherapy (NART) is therefore helpful for clinical decision making. METHODS: Adult sarcoma patients from 39 hospitals completed the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30). Differences in global QoL, physical functioning, role functioning, fatigue, pain, and insomnia between ART versus NART were investigated with multivariate regression, adjusting for age, gender, chemotherapy, grading, stage, tumor location, recurrence/distant metastasis, sarcoma type, time since last treatment, and treatment status using validated thresholds. RESULTS: A total of 1110 patients participated. Of them, 340 had received radiotherapy (NART: n = 95, 28%; ART: n = 245, 72%). Global QoL was 59.3 on average after NART and 60.5 after ART (Badj = 1.0, p = 0.74). Physical functioning was 65.9 compared to 70.5 (Badj = 4.2; p = 0.16), role function 48.8 vs. 56.7 (Badj = 7.0, p = 0.08), fatigue 47.5 vs. 45.4 (Badj = -1.2; p = 0.71), pain 40.2 vs. 34.1 (Badj = -6.8; p = 0.08), and insomnia 33.7 vs. 41.6 (Badj = 5.5, p = 0.16). Among patients with NART, clinically relevant QoL impairments were less frequent 2 years after treatment compared to < 2 years thereafter (n = 6 vs. n = 4 on average). CONCLUSION: There is little evidence for QoL differences in most domains and overall QoL between the two irradiation groups. However, patients after NART might experience worse role functioning and pain but fewer problems with insomnia compared to patients after ART.

Treatment of Colorectal Cancer in Certified Centers: Results of a Large German Registry Study Focusing on Long-Term Survival.

(1) Background: The WiZen study is the largest study so far to analyze the effect of the certification of designated cancer centers on survival in Germany. This certification program is provided by the German Cancer Society (GCS) and represents one of the largest oncologic certification programs worldwide. Currently, about 50% of colorectal cancer patients in Germany are treated in certified centers. (2) Methods: All analyses are based on population-based clinical cancer registry data of 47.440 colorectal cancer (ICD-10-GM C18/C20) patients treated between 2009 and 2017. The primary outcome was 5-year overall survival (OAS) after treatment at certified cancer centers compared to treatment at other hospitals; the secondary endpoint was recurrence-free survival. Statistical methods included Kaplan-Meier analysis and multivariable Cox regression. (3) Results: Treatment at certified hospitals was associated with significant advantages concerning 5-year overall survival (HR 0.92, 95% CI 0.89, 0.96, adjusted for a broad range of confounders) for colon cancer patients. Concentrating on UICC stage I-III patients, for whom curative treatment is possible, the survival benefit was even larger (colon cancer: HR 0.89, 95% CI 0.84, 0.94; rectum cancer: HR 0.91, 95% CI 0.84, 0.97). (4) Conclusions: These results encourage future efforts for further implementation of the certification program. Patients with colorectal cancer should preferably be directed to certified centers.

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.

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.

Initial Cancer Treatment in Certified Versus Non-Certified Hospitals.

BACKGROUND: According to the National Cancer Plan in Germany, all cancer patients should receive high-quality care in accordance with evidence-based treatment guidelines. Certification programs were established for this purpose but have not yet been comprehensively evaluated. METHODS: In the WiZen project, which was supported by the Innovation Fund (supported project number 01VSF17020), controlled cohort studies were performed to investigate whether initial treatment in hospitals with or without a certificate from the German Cancer Society was associated with a difference in overall survival (primary endpoint) in patients with cancer of the colon, rectum, lung, pancreas, breast, cervix, prostate, endometrium, and ovary, head and neck cancer, and neuro-oncological tumors. The studies were based on nationwide data from adult insurees of the AOK statutory health insurance carrier for the years 2009-2017. RESULTS: The majority of patients with all entities except breast cancer received their initial treatment in non-certified hospitals. Initial treatment in a certified hospital was found to be beneficial in terms of overall survival for all cancer entities, even after extensive adjustment for patient- and hospital-related confounders. The hazard ratio (HR) ranged from 0.97 (95% CI: [0.94; 1.00]) for lung cancer to 0.77 [0.74; 0.81] for breast cancer, corresponding to an absolute risk reduction (ARR) for overall survival of 0.62 months for lung cancer to 4.61 months for cervical cancer. CONCLUSION: The WiZen study shows for the entities studied that initial cancer treatment in a certified center is associated with lower mortality. Despite the recommendations of the National Cancer Plan, however, more than 40% of all cancer patients still receive their initial treatment in a non-certified hospital. The preferential provision of initial care in certified hospitals would be likely to improve overall survival. Although the study design does not permit any conclusion with regard to causality, the findings seem robust considering that a control group was used, confounders were taken into account, and the study population was of large size.

Effects of the Pandemic on the Care of Patients With Colorectal Cancer.

BACKGROUND: During the COVID-19 pandemic, there was a decrease in the rates of diagnosis and treatment of cancer. However, only a few detailed analyses have been made to date regarding the effect of the pandemic on the care of cancer patients in Germany. Such studies are needed as the basis for well-founded recommendations on health-care delivery priorities during pandemics and other, comparable situations of crisis. METHODS: This review is based on publications that were retrieved by a selective search of the literature for controlled studies from Germany on the effects of the pandemic on colonoscopies, first diagnoses of colorectal cancer (CRC), surgical procedures for CRC, and CRC-related mortality. RESULTS: Compared to 2019, the rate of screening colonoscopies performed by physicians in private practice was 1.6% higher in 2020 and 4.3% higher in 2021. On the other hand, the rate of diagnostic colonoscopies in the inpatient setting was 15,7% lower in 2020, while that of therapeutic colonoscopies was 11.7% lower. According to the data evaluated here, first diagnoses of CRC were 2.1% less common in January to September in 2020 than they had been in 2019; according to routine data collected by the statutory health insurance provider GRK, surgery for CRC was 10% less common in 2020 than in 2019. With regard to mortality, sufficient data from Germany were lacking to draw definite conclusions. International modeling data suggest an increase in mortality due to decreased colorectal screening rates during the pandemic that may at least be partially compensated for by intensified screening strategies following the pandemic. CONCLUSION: Three years after the onset of the COVID-19 pandemic, there is still only a limited evidence base for an evaluation of the effects of the pandemic on medical care and on the outcomes of patients with CRC in Germany. The implementation of central data and research infrastructures will be necessary for further study of the long-term effects of this pandemic, as well as to enable optimal preparedness for future crisis situations.

Development of a risk score to identify patients at high risk for a severe course of COVID-19.

Aim: We aimed to develop a risk score to calculate a person's individual risk for a severe COVID-19 course (POINTED score) to support prioritization of especially vulnerable patients for a (booster) vaccination. Subject and methods: This cohort study was based on German claims data and included 623,363 individuals with a COVID-19 diagnosis in 2020. The outcome was COVID-19 related treatment in an intensive care unit, mechanical ventilation, or death after a COVID-19 infection. Data were split into a training and a test sample. Poisson regression models with robust standard errors including 35 predefined risk factors were calculated. Coefficients were rescaled with a min-max normalization to derive numeric score values between 0 and 20 for each risk factor. The scores' discriminatory ability was evaluated by calculating the area under the curve (AUC). Results: Besides age, down syndrome and hematologic cancer with therapy, immunosuppressive therapy, and other neurological conditions were the risk factors with the highest risk for a severe COVID-19 course. The AUC of the POINTED score was 0.889, indicating very good predictive validity. Conclusion: The POINTED score is a valid tool to calculate a person's risk for a severe COVID-19 course. Supplementary Information: The online version contains supplementary material available at 10.1007/s10389-023-01884-7.

[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.

Working situation and burden of work limitations in sarcoma patients: results from the multi-center prospective PROSa study.

PURPOSE: We investigated predictors of limitations in work performance, odds of drop out of work, and odds of receiving disability pension in sarcoma patients. METHODS: We measured clinical and sociodemographic data in adult sarcoma patients and recorded if the patients received a (1) disability pension at baseline or (2) had dropped out of work 1 year after initial assessment. (3) Work limitations were assessed using the Work-limitations questionnaire (WLQ©). We analyzed exploratively. RESULTS: (1) Amongst 364 analyzed patients, odds to receive a disability pension were higher in patients with abdominal tumors, older patients, high grade patients and with increasing time since diagnosis. (2) Of 356 patients employed at baseline, 21% (n = 76) had dropped out of work after 1 year. The odds of dropping out of work were higher in bone sarcoma patients and in patients who received additive radiotherapy ± systemic therapy compared with patients who received surgery alone. Odds of dropping out of work were less amongst self-employed patients and dropped with increasing time since diagnosis. (3) Work limitations were higher in woman and increased with age. Patients with bone and fibrous sarcomas were more affected than liposarcoma patients. Patients with abdominal tumors reported highest restrictions. Sarcoma treatment in the last 6 months increased work limitations. CONCLUSION: Work limitations, drop out of work and dependence on a disability pension occurs frequently in patients with sarcoma adding to the burden of this condition. We were able to identify vulnerable groups in both the socioeconomic and disease categories.

Mental burden and moral distress among oncologists and oncology nurses in Germany during the third wave of the COVID-19 pandemic: a cross-sectional survey.

PURPOSE: There is evidence for mental burden and moral distress among healthcare workers during the pandemic. However, there is scarcity of analyses regarding possible correlations of mental burden and moral distress in this context. This study provides data to quantify mental burden and possible associations with moral distress among physicians and nurses working in oncology in Germany. METHODS: We conducted a cross-sectional online survey with physicians and nurses working in oncology in Germany between March and July 2021. Next to sociodemographic characteristics and working conditions, mental burden and moral distress were assessed using standardized instruments. Binary multivariate logistic regression using the enter method was performed in order to explore the relationship between mental burden and moral distress. RESULTS: 121 physicians and 125 nurses were included in the study. Prevalence of clinically relevant depressive symptoms, anxiety, somatic symptoms, burnout symptoms and moral distress was 19.2, 14.5, 12.7, 46.0 and 34.7% in physicians and 41.4, 24.0, 46.8, 46.6 and 60.0% in nurses respectively. Mental burden was significantly associated with moral distress, being female/diverse, younger age < 40 and increase in workload. Nurses who felt sufficiently protected from COVID-19 reported significantly less moral distress. CONCLUSION: To improve pandemic resilience, there is a need to ensure safe working environment including psychosocial support. Further evidence on risk and protective factors for moral distress is needed to be able to develop and implement strategies to protect healthcare workers within and beyond the pandemic.

[Further Development and Interoperability in Oncological Care Structures, Quality Control and Research]. / Weiterentwicklung und Vernetzung der onkologischen Versorgungsstrukturen, der Qualitätssicherung und der Forschung.

How can we improve the interoperability of medical guidelines and the implementation and measurement of outcomes in medical health care for cancer patients as well as for care providers? This is the aim of the working group "Quality and Cross-linking". The following publication gives an overview of the targets reached in the development of guidelines together with quality indicators and documentation in cancer registries.

Indication for spinal surgery: associated factors and regional differences in Germany.

BACKGROUND: Rising surgery rates have raised questions about the indications for spinal surgery. The study investigated patient-level and regional factors associated with spinal surgery for patients with spinal diseases. METHODS: We undertook a cohort study based on routine healthcare data from Germany of 18.4 million patients within 60.9 million episodes of two patient-years before a possible spinal surgery in the time period 2008 to 2016. Using a Poisson model, the effects of a broad range of patient-related (sociodemographic, morbidity, social status), disease- and healthcare-related (physicians' specialty, conservative treatments) and regional variables were analyzed. RESULTS: There was substantial regional heterogeneity in the occurrence of spinal surgery which decreased by only one quarter when controlling for the various determinants assessed. Previous musculoskeletal and mental health disorders as well as physical therapy were associated with a lower probability of surgery in the fully-adjusted model. Prescriptions for pain medication and consultations of specialists were associated with a higher probability of surgery. However, the specific severity of the vertebral diseases could not be taken into account in the analysis. Furthermore, a substantial proportion of patients with surgery did not receive a consultation with an outpatient specialist (29.5%), preoperative diagnostics (37.0%) or physical therapy (48.3%) before hospital admission. CONCLUSION: This large study on spinal diseases in Germany highlights important patterns in medical care of spinal diseases and their association with the probability of spinal surgery. However, only a relatively small proportion of the regional heterogeneity in spinal surgery could be explained by the extensive consideration of confounders, which suggests the relevance of other unmeasured factors like physicians' preferences.

The Therapeutic Role of Plastic and Reconstructive Surgery in the Interdisciplinary Treatment of Soft-Tissue Sarcomas in Germany-Cross-Sectional Results of a Prospective Nationwide Observational Study (PROSa).

Although the involvement of plastic surgery has been deemed important in the treatment of sarcoma patients to avoid oncological compromises and ameliorate patient outcomes, it is not ubiquitously available. The accessibility of defect reconstruction and its therapeutic impact on sarcoma care is the subject of this analysis. Cross-sectional data from 1309 sarcoma patients were collected electronically at 39 German study centers from 2017 to 2019. A total of 621 patients with surgical treatment for non-visceral soft-tissue sarcomas were included. The associated factors were analyzed exploratively using multifactorial logistic regression to identify independent predictors of successful defect reconstruction, as well Chi-squared and Cochran-Mantel-Haenszel tests to evaluate subgroups, including limb-salvage rates in extremity cases. A total of 76 patients received reconstructive surgery, including 52 local/pedicled versus 24 free flaps. Sarcomas with positive margins upon first resection (OR = 2.3, 95%CI = 1.2-4.4) that were excised at centers with lower degrees of specialization (OR = 2.2, 95%CI = 1.2-4.2) were independently associated with the need for post-oncological defect coverage. In this context, the inhouse availability of plastic surgery (OR = 3.0, 95%CI = 1.6-5.5) was the strongest independent predictor for successful flap-based reconstruction, which in turn was associated with significantly higher limb-salvage rates (OR = 1.4, 95%CI = 1.0-2.1) in cases of extremity sarcomas (n = 366, 59%). In conclusion, consistent referral to specialized interdisciplinary sarcoma centers significantly ameliorates patient outcomes by achieving higher rates of complete resections and offering unrestricted access to plastic surgery. The latter in particular proved indispensable for limb salvage through flap-based defect reconstruction after sarcoma resection. In fact, although there remains a scarcity of readily available reconstructive surgery services within the current sarcoma treatment system in Germany, plastic and reconstructive flap transfer was associated with significantly increased limb-salvage rates in our cohort.

Distress in soft-tissue sarcoma and gastrointestinal stromal tumours patients-Results of a German multicentre observational study (PROSa).

OBJECTIVE: Soft tissue sarcomas (STS) and gastrointestinal stromal tumours (GIST) are a group of rare malignant tumours with a high and heterogenous disease burden. As evidence is scarce, we analysed the prevalence of increased emotional distress and identified distress-associated factors in these patients. METHODS: The PROSa-study (Burden and medical care of sarcoma) was conducted between 2017 and 2020 in 39 study centres. Cross-sectional data from adult STS and GIST patients were analysed. Distress was measured with the Patient Health Questionnaire (PHQ-4). The relation of socioeconomic and clinical factors with distress was explored in adjusted logistic regression models. RESULTS: Among 897 patients, 17% reported elevated anxiety and 19% reported depression. Unemployed patients (odds ratio [OR] 6.6; 95% CI 2.9-15.0), and those with a disability pension (OR 3.1; 95% CI 1.9-5.0) were more likely to experience distress compared to employed patients. Also, patients with a disability pass had higher odds of increased distress than those without (OR 1.8; 95% CI 1.2-2.7). Lowest distress was observed in patients 2 to <5 years and ≥5 years after diagnosis (comparison: <6 months) (OR 0.4; 95% CI 0.2-0.6) and (0.3; 95% CI 0.2-0.6). Patients with thoracic STS (vs. lower limbs) had twice the odds to experience distress (OR 2.0; 95% CI 1.1-3.6). Distress was seen almost twice as often in patients with progressive disease (vs. complete remission) (OR 1.7; 95% CI 1.1-2.8). CONCLUSION: The prevalence of elevated distress in STS and GIST patients is high. In unemployed patients, in those with a disability pension and in newly diagnosed patients a noticeable increase was observed. Clinicians should be aware of these factors and consider the social aspects of the disease.