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 and climate change-what is the potential of real-world data?] / Gesundheit und Klimawandel ­ welche Potenziale haben versorgungsnahe Daten?

This article addresses the question of how climate change may affect health and to what extent real-world data can contribute to research in this topic area. Climate change is altering the environmental and living conditions of humankind, and has thus also become a relevant health problem. The increase in extreme weather events, changes in exposure to UV and air pollution, and the climate-associated spread of allergens or novel pathogens are significantly changing the spectrum of diseases and the need for medical care in the population. However, in Germany, only few findings on the consequences for the healthcare system and on particularly affected population groups exist so far. Real-world data (primary data, register data, and administrative data) in combination with environmental exposure data and other relevant data (e.g., socio-economic data) have the potential to significantly advance research on the health consequences of climate change. This paper identifies changes in environmental and living conditions and associated health risks. It describes the databases that are generally available for analysing health effects of climate change. A concrete example is used to show how individual health data (in this case claims data of the statutory health insurance), environmental exposure data and other data can be successfully combined. Finally, the article offers a comprehensive overview of open research questions that can be answered with real-world data.

Association between hospital onset of infection and outcomes in sepsis patients - A propensity score matched cohort study based on health claims data in Germany.

BACKGROUND: Hospital-acquired infections are a common source of sepsis. Hospital onset of sepsis was found to be associated with higher acute mortality and hospital costs, yet its impact on long-term patient-relevant outcomes and costs is unknown. OBJECTIVE: We aimed to assess the association between sepsis origin and acute and long-term outcomes based on a nationwide population-based cohort of sepsis patients in Germany. METHODS: This retrospective cohort study used nationwide health claims data from 23 million health insurance beneficiaries. Sepsis patients with hospital-acquired infections (HAI) were identified by ICD-10-codes in a cohort of adult patients with hospital-treated sepsis between 2013 and 2014. Cases without these ICD-10-codes were considered as sepsis cases with community-acquired infection (CAI) and were matched with HAI sepsis patients by propensity score matching. Outcomes included in-hospital/12-month mortality and costs, as well as readmissions and nursing care dependency until 12 months postsepsis. RESULTS: We matched 33,110 HAI sepsis patients with 28,614 CAI sepsis patients and 22,234 HAI sepsis hospital survivors with 19,364 CAI sepsis hospital survivors. HAI sepsis patients had a higher hospital mortality than CAI sepsis patients (32.8% vs. 25.4%, RR 1.3, p < .001). Similarly, 12-months postacute mortality was higher (37.2% vs. 30.1%, RR=1.2, p < .001). Hospital and 12-month health care costs were 178% and 22% higher in HAI patients than in CAI patients, respectively. Twelve months postsepsis, HAI sepsis survivors were more often newly dependent on nursing care (33.4% vs. 24.0%, RR=1.4, p < .001) and experienced 5% more hospital readmissions (mean number of readmissions: 2.1 vs. 2.0, p < .001). CONCLUSIONS: HAI sepsis patients face an increased risk of adverse outcomes both during the acute sepsis episode and in the long-term. Measures to prevent HAI and its progression into sepsis may be an opportunity to mitigate the burden of long-term impairments and costs of sepsis, e.g., by early detection of HAI progressing into sepsis, particularly in normal wards; adequate sepsis management and adherence to sepsis bundles in hospital-acquired sepsis; and an improved infection prevention and control.

Association of age with 1-year outcome in patients with acute ischaemic stroke treated with thrombectomy: real-world analysis in 18 506 patients.

BACKGROUND: To evaluate the association of age with long-term outcome after thrombectomy. METHODS: In a retrospective cohort study based on routine healthcare data from Germany between 2010 and 2018, we included 18 506 patients with acute ischaemic stroke treated with mechanical thrombectomy. Association between age and mortality, disability, and level of care at 1 year was assessed. RESULTS: The median age was 76 years, 36.3% were aged ≥80 years and 55.8% were women. Patients aged ≥80 compared with those <80 years had a higher mortality (55.4% vs 28.5%; adjusted HR 1.13; 95% CI 1.05 to 1.31), more often had moderate/severe disability (35.5% vs 33.2%, adjusted HR 1.14; 95% CI 1.06 to 1.23) and less frequently had no/slight disability (17.4% vs 41.0%) at 1 year. Older age was associated with a higher likelihood of living in a nursing home (13.4% vs 9.2%, adjusted HR 1.09; 95% CI 0.97 to 1.22) and a lower likelihood of living at home (33.8% vs 62.8%) at 1 year. These associations were also robust when analysed in patients with no disability prior to stroke. Factors most strongly associated with worse 1-year outcomes in elderly patients were chronic limb-threatening ischaemia (67.9% vs 56.4%; HR 1.59, 95% CI 1.38 to 1.82), dementia at baseline (65.2% vs 47.3%; HR 1.29, 95% CI 1.17 to 1.44) and ventilation >48 hours (79.3% vs 52.2%; HR 2.91, 95% CI 2.66 to 3.18). CONCLUSIONS: In this large 'real-world' cohort, outcomes after mechanical thrombectomy were strongly associated with age. Of patients aged ≥80 years more than half were dead and less than one-fifth were functionally independent at 1 year. Certain comorbidities and ventilation >48 hours were associated with even worse outcomes.

Contemporary Treatment and Outcome of Patients with Ischaemic Lower Limb Amputation: A Focus on Sex Differences.

OBJECTIVE: Chronic limb threatening ischaemia (CLTI) has a devastating prognosis with high rates of lower limb amputation (LLA) and deaths. This is an illustration of contemporary management and the long term fate of patients after ischaemic LLA, particularly with respect to sex, using real world data. METHODS: This was a multisectoral cross sectional and longitudinal analysis of health claims data from the largest German health insurance database (AOK). Data of 39 796 propensity score matched patients hospitalised for ischaemic LLA between 2010 and 2018 were analysed for cardiovascular comorbidities, treatment, and for subsequent cardiovascular and limb events, with a distinct focus on sex. Matching was performed, to ensure that the rate of major amputations and the age distribution were equal in both groups (in both sexes). An observation period of two years before index and a follow up (FU) period until 2019 were included. RESULTS: Before index amputation, 68% of patients had received any kind of peripheral revascularisation. The use of statins (37.0% vs. 42.6%) and antithrombotic substances (54.9% vs. 61.8%) was lower in women than in men (p < .001). During two year FU, cardiovascular and limb events occurred among women and men as follows: limb re-amputation (26.7% vs. 31.2%), myocardial infarction (10.9% vs. 14.5%), stroke (20.8% vs. 20.7%), and death from any cause (51.0% vs. 53.3%, p < .001 except for stroke). After adjustment for cardiovascular comorbidities and vascular procedures, female sex was associated with a higher probability of death (HR 1.04, 95% CI 1.04 - 1.04). CONCLUSION: Patients undergoing ischaemic LLA still have a poor prognosis marked by high rates of recurrent cardiovascular and limb events resulting in a > 50% mortality rate within two years. The continuous lack of guideline recommended therapies, particularly in women, may be associated with the persisting poor outcome, necessitating urgent further investigation.

Contemporary in-hospital and long-term prognosis of patients with acute ST-elevation myocardial infarction depending on renal function: a retrospective analysis.

BACKGROUND: Cardiovascular disease is often associated with chronic kidney disease (CKD), resulting in an increased risk for poor outcome. We sought to determine short-term mortality and overall survival in ST-elevation myocardial infarction (STEMI) patients with different stages of CKD. METHODS: In our retrospective cohort study with health insurance claims data of the Allgemeine Ortskrankenkasse (AOK), anonymized data of all STEMI patients hospitalized between 2010 and 2017 were analyzed regarding presence and severity of concomitant CKD. RESULTS: A total of 175,187 patients had an index-hospitalisation for STEMI (without CKD: 78.6% patients, CKD stage 1: 0.8%, CKD stage 2: 4.8%, CKD stage 3: 11.7%, CKD stage 4: 2.8%, CKD stage 5: 0.7%, CKD stage 5d: 0.6%). Patients with CKD were older and had more co-morbidities than patients without CKD. With increasing CKD severity, patients received less revascularization therapies (91.2%, 85.9%, 87.0%, 81.8%, 71.7%, 76.9% and 78.6% respectively, p < 0.001). After 1 year, guideline-recommended medications were prescribed less frequently in advanced CKD (83.4%, 79.3%, 81.5%, 74.7%, 65.0%, 59.4% and 53.7%, respectively, p < 0.001). CKD stages 4, 5 and 5d as well as chronic limb threatening ischemia (CLTI) were associated with decreased overall survival [CKD stage 4: hazard ratio (HR) 1.72; 95% CI 1.66-1.78; CKD stage 5: HR 2.55; 95% CI 2.37-2.73; CKD stage 5d: 5.64; 95% CI 5.42-5.86; CLTI: 2.06; 95% CI 1.98-2.13; all p < 0.001]. CONCLUSIONS: CKD is a frequent co-morbidity in patients with STEMI and is associated with a worse prognosis especially in advanced stages. Guideline-recommended therapies in patients with STEMI and CKD are still underused.

A cross-sectoral approach to utilizing health claims data for quality assurance in medical rehabilitation: study protocol of a combined prospective longitudinal and retrospective cohort study.

BACKGROUND: Measuring the quality of provided healthcare presents many challenges, especially in the context of medical rehabilitation. Rehabilitation is based on a holistic biopsychosocial model of health that includes a person's long-term functioning; hence, outcome domains are very diverse. In Germany, rehabilitation outcomes are currently assessed via patient and physician surveys. Health insurance claims data has the potential to simplify current quality assurance procedures in Germany, since its comprehensive collection is federally mandated from every healthcare provider. By using a cross-sectoral approach, quality assessments in rehabilitation can be adjusted for the quality provided in previous sectors and individual patient risk factors. METHODS: SEQUAR combines two studies: In a prospective longitudinal study, 600 orthopedic rehabilitation patients and their physicians are surveyed at 4 and 2 time points, respectively, throughout rehabilitation and a follow-up period of 6 months. The questionnaires include validated instruments used in the current best-practice quality assurance procedures. In a retrospective cohort study, a nationwide claims database with more than 312,000 orthopedic rehabilitation patients will be used to perform exploratory analysis for the identification of quality indicators. The identified SEQUAR claims data quality indicators will be calculated for our prospective study participants and tested for their ability to approximate or replace the currently used, best-practice quality indicators based on primary data. DISCUSSION: The identified SEQUAR quality indicators will be used to draft a novel, state-of-the-art quality assurance procedure that reduces the administrative burden of current procedures. Further research into the applicability to other indications of rehabilitation is required. TRIAL REGISTRATION: WHO UTN: U1111-1276-7141; DRKS-ID: DRKS00028747 (Date of Registration in DRKS: 2022/08/10).

Socioeconomic differences in the utilization of diagnostic imaging and non-pharmaceutical conservative therapies for spinal diseases.

BACKGROUND: A different utilization of health care services due to socioeconomic status on the same health plan contradicts the principle of equal treatment. We investigated the presence and magnitude of socioeconomic differences in utilization of diagnostic imaging and non-pharmaceutical conservative therapies for patients with spinal diseases. METHODS: The cohort study based on routine healthcare data from Germany with 11.7 million patient-years between 2012 and 2016 for patients with physician-confirmed spinal diseases (ICD-10: M40-M54), occupation and age 20 to 64 years. A Poisson model estimated the effects of the socioeconomic status (school education, professional education and occupational position) for the risk ratio of receiving diagnostic imaging (radiography, computed tomography, magnetic resonance imaging) and non-pharmaceutical conservative therapies (physical therapy including exercise therapy, manual therapy and massage, spinal manipulative therapy, acupuncture). RESULTS: Patients received diagnostic imaging in 26%, physical therapy in 32%, spinal manipulative therapy in 25%, and acupuncture in 4% of all patient-years. Similar to previous survey-based studies higher rates of utilization were associated with higher socioeconomic status. These differences were most pronounced for manual therapy, exercise therapy, and magnetic resonance imaging. CONCLUSIONS: The observed differences in health care utilization were highly related to socioeconomic status. Socioeconomic differences were higher for more expensive health services. Further research is necessary to identify barriers to equitable access to health services and to take appropriate action to decrease existing social disparities.

Sex-related differences in treatment and outcome of chronic limb-threatening ischaemia: a real-world cohort.

AIMS: The prevalence of chronic limb-threatening ischaemia (CLTI) is increasing and available data often derive from cohorts with various selection criteria. In the present study, we included CLTI patients and studied sex-related differences in their risk profile, vascular procedures, and long-term outcome. METHODS AND RESULTS: We analysed 199 953 unselected patients of the largest public health insurance in Germany (AOK: Local healthcare funds), hospitalized between 2010 and 2017 for a main diagnosis of CLTI. A baseline period of 2 years before index hospitalization to assess comorbidities and previous procedures, and a follow-up period until 2018 were included. Female CLTI patients were older (median 81.4 vs. 73.8 years in males; P < 0.001) and more often diagnosed with hypertension, atrial fibrillation, chronic heart failure, and chronic kidney disease. Male patients suffered more frequently from diabetes mellitus, dyslipidaemia, smoking, cerebrovascular disease, and chronic coronary syndrome (all P < 0.001). Within hospitalized CLTI patients, females represent the minority (43% vs. 57%; P < 0.001) and during index hospitalization, women underwent less frequently diagnostic angiographies (67 vs. 70%) and revascularization procedures (61 vs. 65%; both P < 0.001). Moreover, women received less frequently guideline-recommended drugs like statins (35 vs. 43%) and antithrombotic therapy (48 vs. 53%; both P < 0.001) at baseline. Interestingly, after including age and comorbidities in a Cox regression analysis, female sex was associated with increased overall-survival (OS) [hazard ratio (HR) 0.95; 95% confidence interval (CI) 0.94-0.96] and amputation-free survival (AFS) (HR 0.84; 95% CI 0.83-0.85; both P < 0.001). CONCLUSION: Female patients with CLTI were older, underwent less often vascular procedures, and received less frequently guideline-recommended medication. Nevertheless, female sex was independently associated with better OS and AFS during follow-up.

[Specialization of Acute Stroke Care in Germany: Structural Changes During 2006-2017]. / Spezialisierung der Schlaganfallversorgung in Deutschland: Strukturveränderungen im Zeitraum von 2006­2017.

HINTERGRUND: Um die Schlaganfallversorgung zu optimieren, wurden in Deutschland in den letzten Jahren verschiedene qualitätsfördernde Maßnahmen (qfM) in regional unterschiedlichem Maß eingeführt. Ob sich diese Maßnahmen über die Jahre flächendeckend etabliert haben, ist unklar. METHODE: Für die strukturbezogenen Analysen der Schlaganfallversorgung in Deutschland wurden alle relevanten dokumentierten Schlaganfälle (ICD-10) aus den Qualitätsberichten (QB) deutscher Krankenhäuser und eine repräsentative Stichprobe von Krankenversicherungsdaten (AOK) im Zeitraum von 2006 (QB)/2007 (AOK) bis 2017 verwendet. Diese Informationen wurden u. a. durch Angaben zu zertifizierten Stroke Units der Deutschen Schlaganfall-Gesellschaft (DSG) und Daten zur Führung von regionalen Schlaganfall-Registern der Arbeitsgemeinschaft Deutschsprachiger Schlaganfall-Register (ADSR) ergänzt. Zur Verfolgung der Veränderungen des Versor-gungsgeschehens im deutschen Bundesgebiet wurden die Daten mit geografischen Daten (Bundesamt für Kartographie und Geodäsie) verknüpft. Es erfolgten univariate Analysen der Daten und eine Trend-Analyse der verschiedenen qfM im Jahresverlauf (Konkordanzkoeffizient nach Kendall). ERGEBNISSE: Die QB Analysen zeigten einen Anstieg kodierter Schlaganfälle in Krankenhäusern mit qfM um 14-20%. In 2006 wurden 80% der Schlaganfälle (QB) in einem Krankenhaus mit min. einer qfM kodiert, in 2017 95%. Diese Entwicklungen spiegelten sich auch in den AOK-Routinedaten wider, wobei in 2007 89% und in 2017 97% der Patient:innen unter mindestens einer qfM behandelt wurden. Dabei waren in 2007 bei 55% der behandelnden Krankenhäuser qfM vorhanden, in 2017 bei 72%. SCHLUSSFOLGERUNG: Patient:innen werden inzwischen signifikant häufiger in Krankenhäusern mit Spezialisierung auf die Schlaganfallversorgung behandelt. Auch die verschiedenen qfM haben sich im Laufe der Jahre im gesamten Bundesgebet verbreitet, jedoch existieren noch Versorgungslücken, die geschlossen werden sollten, damit in Zukunft alle Patient:innen qualitativ hochwertig behandelt werden können. BACKGROUND: In order to optimize stroke care, various quality-enhancing measures (qfM) have been introduced in Germany in recent years to varying degrees across regions, with the aim of achieving the best possible quality of care. It is unclear whether these measures have become established nationwide over the years. METHOD: For the structural analyses of stroke care in Germany, all relevant documented strokes (ICD-10) from the quality reports (QB) of German hospitals and a representative sample of health insurance data (AOK) for the period from 2006 (QB)/2007 (AOK) to 2017 were used. This information was supplemented by data on certified stroke units from the German Stroke Society (DSG) and data on the maintenance of regional stroke registries from the Working Group of German-Speaking Stroke Registers (ADSR), among others. To track changes in patterns of care in Germany, the data were linked with geographic data (Federal Agency for Cartography and Geodesy). Univariate analyses of the data and a trend analysis of the different qfM over the year (Kendall concordance coefficient) were performed. RESULTS: The analyses (QB) showed an increase in coded strokes in hospitals with qfM between 14-20%. In 2006, 80% of strokes (QB) were coded in hospitals with at least one qfM and 95% in 2017. Comparing years, AOK data showed similar trends: in 2007, 89% of patients were treated in hospitals with at least one qfM and 97% in 2017. In 2007, 55% of treating hospitals had qfM and 72% in 2017. CONCLUSION: Meanwhile, patients are more often treated in hospitals that specialise in stroke care. In addition, the various qfM have spread across the nation over the years, but there are still gaps in care that should be addressed to ensure quality care for all patients in the future.

[Sex Disparities in Treatment and Outcome of Patients with Lower Extremity Arterial Disease: A Secondary Data Analysis]. / Geschlechtsspezifische Unterschiede in der Versorgung und dem Outcome von pAVK Patienten ­ Eine Sekundärdatenanalyse.

AIM OF THE STUDY: The aim of our study was to analyse sex-specific differences in diagnosis and treatment of patients with lower extremity artery disease (LEAD) at Rutherford stage (RF) 1-3, based on secondary data. Furthermore, we focussed on the influence of the biological sex on short- and long-term outcome. METHODS: The GenderVasc project is carried out in cooperation with the AOK Research Institute (WIdO). As data basis, anonymized routine data from all insured patients of the AOK were used. All patients hospitalized due to a main diagnosis of LEAD at RF 1-3 were included and in addition to the multisectoral cross-sectional analysis, longitudinal analysis (follow-up of up to 10 years) of the health claims data was performed and evaluated. RESULTS: Our secondary data analysis of 42,197 patients with intermittent claudication (IC, LEAD at RF 1-3) showed that male patients were more often hospitalized due to LEAD, while women were older at time-point of index hospitalisation (female: 72.6 vs. male: 66.4 years). Fewer vascular procedures (diagnostic angiography and revascularisation) were carried out in females. Moreover, the prescription of guideline-recommended medications (statins and antithrombotic therapy) was lower in women compared to men. Multivariable Cox regression showed, after adjusting for age, cardiovascular risk profile and performed vascular procedure, that female sex was protective with respect to overall survival and progression of LEAD (progress to chronic limb-threatening ischemia or ischemic amputation). CONCLUSION: In Germany, female LEAD patients were older and less likely to receive guideline-recommended therapy, while female sex is protective in terms of overall survival and progression of LEAD. The extent to which increased age or the presence of other comorbidities influence the decision for or against a vascular procedure can only be assumed from a secondary data analysis. Furthermore, the prescription of drugs in multimorbid patients is challenging and the compliance of the patients with prescribed medication intake is not part of our analysis. Nevertheless, targeted analysis, as in the GenderVasc project, are urgently needed to identify and describe differences in the medical care between the sexes.

[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.

Associations between structure- and process-orientated measures and stroke long term mortality - an observational study based on routine data.

OBJECTIVES: Various measures are used to improve the quality of stroke care. In Germany, these include concentrating treatment in specialized facilities (stroke units), mandatory quality comparisons of hospitals in some German states, and treatment according to prespecified structure and process specifications (neurological complex treatment 8-981 or 8-98b). These measures have previously only been analyzed individually and regarding short-term patient outcomes. This study analyzes these measures in combination, considering patients' comorbidities as well as stroke severity in a longitudinal perspective. MATERIALS/METHODS: Analyses were based on data from 243,415 insurees of Germany's biggest health insurance (AOK) admitted to hospitals between 2007 and 2017 with cerebral infarction. Mortality risk was calculated using Cox regressions adjusted for various covariates. Kaplan-Meier analyses were differentiated by treatment site (stroke unit/external quality assurance/ Federal State Consortium of Quality Assurance Hesse - LAGQH) were performed, followed by log-rank tests and p-value adjustment. Trend analyses were performed for treatment types in combination with treatment sites. RESULTS: All analyses showed significant advantages for patients who received Neurological Complex Treatment, especially when the treatment was performed under external quality assurance conditions and/or in stroke units. There was an increasing frequency of specialized stroke treatment. CONCLUSIONS: Quality-enhancing structures and processes are associated with a lower mortality risk after stroke. There appears to be evidence of a cascading benefit from the implementation of neurological complex treatment, external quality assurance, and ultimately, stroke units. Consecutively, care should be concentrated in hospitals that meet these specifications. However, since measures are often applied in combination, it remains unclear which specific measures are crucial for patient outcome.

Identifying and Investigating Ambulatory Care Sequences Before Invasive Coronary Angiography.

BACKGROUND: The concept of care pathways is widely used to provide efficient, timely, and evidence-based medical care. Recently, the investigation of actual empirical patient pathways has gained attention. We demonstrate the usability of State Sequence Analysis (SSA), a data mining approach based on sequence clustering techniques, on comprehensive insurance claims data from Germany to identify empirical ambulatory care sequences. We investigate patients with coronary artery disease before invasive coronary angiography (CA) and compare identified patterns with guideline recommendations. This patient group is of particular interest due to high and regionally varying CA rates. METHODS: Events relevant for the care of coronary artery disease patients, namely physician consultations and medication prescriptions, are identified based on medical guidelines and combined to define states. State sequences are determined for 1.5 years before CA. Sequence similarity is defined for clustering, using optimal matching with theory-informed substitution costs. We visualize clusters, present descriptive statistics, and apply logistic regression to investigate the association of cluster membership with subsequent undesired care events. RESULTS: Five clusters are identified, the included patients differing with respect to morbidity, urbanity of residential area, and health care utilization. Clusters exhibit significant differences in the timing, structure, and extent of care before CA. When compared with guideline recommendations, 3 clusters show signs of care deficits. CONCLUSIONS: Our analyses demonstrate the potential of SSA for exploratory health care research. We show how SSA can be used on insurance claims data to identify, visualize, and investigate care patterns and their deviations from guideline recommendations.

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 ).

Regional variation in coronary angiography rates: the association with supply factors and the role of indication: a spatial analysis.

BACKGROUND: Coronary angiographies (CAs) are among the most common diagnostic procedures carried out in German hospitals, and substantial regional differences in their frequency of use have been documented. Given the heterogeneity with regard to the expected benefits and the varying scope for discretion depending on the indication for the procedure, we hypothesized that the observed variation and the association of need and supply factors differs by indication for CA. METHODS: We investigated the correlation between supply factors and the regional rates of CAs in Germany while controlling for need using spatial-autoregressive error models (SARE) and spatial cross-regressive models with autoregressive errors (SCRARE). The overall rates of CAs and the rates in specific patient subgroups, namely, patients with and without myocardial infarction (MI), were calculated based on a comprehensive set of nationwide routine data from three statutory health insurances at the district level. RESULTS: Although little variation was found in cases with MI, considerable variation was seen in the overall cases and cases without MI. The SARE models revealed a positive association between the number of hospitals with a cardiac catheterization laboratory per 10,000 population and the rates of overall cases and cases without MI, whereas no such relationship existed in cases with MI. Additionally, an association between regional deprivation and the rates of CAs was found in cases with MI, but no such association was seen in cases without MI. CONCLUSIONS: The results supported the hypothesis that the relative association of need and supply factors differed by the indication for CA. Although the regional differences in the frequency of use of CAs can only be explained in part by the factors examined in our study, it offers insight into patient access to and the provision of CA services and can provide a platform for further local research.

Long-term outcomes of stroke unit care in older stroke patients: a retrospective cohort study.

BACKGROUND: older patients are less frequently treated in stroke units (SUs). Clinicians do not seem convinced that older patients benefit from specialised treatment in SU similarly to younger patients. OBJECTIVE: our study aimed to compare older patients' long-term outcomes with and without SU treatment. METHODS: this study used routinely collected health data of 232,447 patients admitted to hospitals in Germany between 2007 and 2017 who were diagnosed with ischaemic stroke (ICD 10 I63). The sample included 29,885 patients aged ≥90 years. The outcomes analysed were 10-, 30- and 90-day, and 1-, 3- and 5-year mortality and the combinations of death or recurrence, inpatient treatment and increase in long-term care needs. Bivariate chi-square tests and multivariable logistic regression analyses were used, adjusting for the covariates age, sex, co-morbidity, long-term care needs before stroke and socioeconomic status of the patients' region of origin. RESULTS: between 2007 and 2017, 57.1% of patients aged <90 years and 49.6% of those aged ≥90 years were treated in a SU. The 1-year mortality rate of ≥90-year-olds was 56.9 and 61.9% with and without SU treatment, respectively. The multivariable-adjusted risk of death in ≥90-year-olds with SU treatment was odds ratio (OR) = 0.67 (95% confidence interval [CI] = 0.62-0.73) 10 days after the initial event and OR = 0.76 (95% CI = 0.71-0.82) 3 years after stroke. CONCLUSIONS: even very old patients with stroke benefit from SU treatment in the short and long term. Therefore, SU treatment should be the norm even in older patients.

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.

Assessing the effect of a regional integrated care model over ten years using quality indicators based on claims data - the basic statistical methodology of the INTEGRAL project.

BACKGROUND: The regional integrated health care model "Healthy Kinzigtal" started in 2006 with the goal of optimizing health care and economic efficiency. The INTEGRAL project aimed at evaluating the effect of this model on the quality of care over the first 10 years. METHODS: This methodological protocol supplements the study protocol and the main publication of the project. Comparing quality indicators based on claims data between the intervention region and 13 structurally similar control regions constitutes the basic scientific approach. Methodological key issues in performing such a comparison are identified and solutions are presented. RESULTS: A key step in the analysis is the assessment of a potential trend in prevalence for a single quality indicator over time in the intervention region compared to the corresponding trends in the control regions. This step has to take into account that there may be a common - not necessarily linear - trend in the indicator over time and that trends can also appear by chance. Conceptual and statistical approaches were developed to handle this key step and to assess in addition the overall evidence for an intervention effect across all indicators. The methodology can be extended in several directions of interest. CONCLUSIONS: We believe that our approach can handle the major statistical challenges: population differences are addressed by standardization; we offer transparency with respect to the derivation of the key figures; global time trends and structural changes do not invalidate the analyses; the regional variation in time trends is taken into account. Overall, the project demanded substantial efforts to ensure adequateness, validity and transparency.

Impact of the COVID-pandemic on the incidence of tonsil surgery and sore throat in Germany.

PURPOSE: To longitudinally evaluate the impact of the COVID-19-pandemic on the incidence of inpatient tonsil surgery and outpatient primary care of sore throat in Germany. METHODS: A retrospective interrupted time-series analysis was conducted. The national database of the Hospital Remuneration System was used to retrieve the number of operations performed between January 2019 and September 2021 including elective and non-elective cases with the exception of malign diseases. Three episodes were compared on a weekly basis: before, during, and after the first national lockdown (March 16-May 3, 2020). We also analysed the number of outpatient doctor contacts of sore throat patients in 2019 and 2020. RESULTS: Overall, 144,069 surgical cases were included in the analysis. The first lockdown resulted in an abrupt and significant decrease of all types of tonsil surgery (p < 0.01). The incidence of tonsillectomy decreased from 556 (before) to 111 (during) and 326 (after) cases per week (relative risk 0.24; 95% CI 0.19-0.30, and 0.82; 95% CI 0.73-0.92). After the lockdown, the incidence persisted on a lower level compared to 2019. The number of doctor contacts decreased from 2,967,322 in 2019 to 1,976,617 in 2020 (- 33.4%). CONCLUSIONS: The first lockdown was associated with a significant decrease of all types of tonsil surgery. A return to pre-pandemic surgical activity was not identified. The findings were accompanied by a significant decrease of outpatient doctor contacts of sore throat patients in primary care, particularly in the subgroup of children and adolescents. The impact of the second lockdown, starting in December 2020, was by far not comparable.