Understanding health care pathways of patients with sepsis: protocol of a mixed-methods analysis of health care utilization, experiences, and needs of patients with and after sepsis.

BACKGROUND: Sepsis is associated with about 20% of deaths worldwide. It often presents with non-specific initial symptoms, making its emergency treatment an interdisciplinary and cross-sectoral challenge. Three in four sepsis survivors suffers from new cognitive, psychological, or physical sequelae for which specific treatment concepts are scarce. The AVENIR project aims to improve the understanding of patient pathways, and subjective care experiences and needs along the entire healthcare pathway before, with and after sepsis. Based on this, concrete recommendations for the organization of care and patient information materials will be developed with close patient participation. METHODS: Mixed-methods study including (1) analysis of anonymized nationwide health claims data from Germany, (2) linkage of health claims data with patient care reports (PCR) of emergency medical services from study regions in two federal states within Germany, and (3) qualitative exploration of the patient, relative, and care provider perspective on sepsis care. In (1), we analyze inpatient and outpatient health care utilization until 30 days pre-sepsis; clinical sepsis care including intra- and inter-hospital transfers; and rehabilitation, inpatient and outpatient aftercare of sepsis survivors as well as costs for health care utilization until 24 months post-sepsis. We attempt to identify survivor classes with similar health care utilization by Latent Class Analyses. In (2), PCR are linked with health claims data to establish a comprehensive database outlining care pathways for sepsis patients from pre-hospital to follow-up. We investigate e.g., whether correct initial assessment is associated with acute (e.g., same-day lethality) and long-term (e.g., new need for care, long-term mortality) outcomes of patients. We compare the performance of sepsis-specific screening tools such as qSOFA, NEWS-2 or PRESEP in the pre-clinical setting. In (3), semi-structured interviews as well as synchronous and asynchronous online focus groups are conducted and analyzed using qualitative content analyses techniques. DISCUSSION: The results of the AVENIR study will contribute to a deeper understanding of sepsis care pathways in Germany. They may serve as a base for improvements and innovations in sepsis care, that in the long-term can contribute to reduce the personal, medical, and societal burden of sepsis and its sepsis sequelae. TRIAL REGISTRATION: Registered at German Clinical Trial Register (ID: DRKS00031302, date of registration: 5th May 2023).

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.

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.

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.

[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.

Pirfenidone vs. nintedanib in patients with idiopathic pulmonary fibrosis: a retrospective cohort study.

BACKGROUND: Two antifibrotic drugs, pirfenidone and nintedanib, are licensed for the treatment of patients with idiopathic pulmonary fibrosis (IPF). However, there is neither evidence from prospective data nor a guideline recommendation, which drug should be preferred over the other. This study aimed to compare pirfenidone and nintedanib-treated patients regarding all-cause mortality, all-cause and respiratory-related hospitalizations, and overall as well as respiratory-related health care costs borne by the Statutory Health Insurance (SHI). METHODS: A retrospective cohort study with SHI data was performed, including IPF patients treated either with pirfenidone or nintedanib. Stabilized inverse probability of treatment weighting (IPTW) based on propensity scores was applied to adjust for observed covariates. Weighted Cox models were estimated to analyze mortality and hospitalization. Weighted cost differences with bootstrapped 95% confidence intervals (CI) were applied for cost analysis. RESULTS: We compared 840 patients treated with pirfenidone and 713 patients treated with nintedanib. Both groups were similar regarding two-year all-cause mortality (HR: 0.90 95% CI: 0.76; 1.07), one-year all cause (HR: 1.09, 95% CI: 0.95; 1.25) and respiratory-related hospitalization (HR: 0.89, 95% CI: 0.72; 1.08). No significant differences were observed regarding total (€- 807, 95% CI: €- 2977; €1220) and respiratory-related (€- 1282, 95% CI: €- 3423; €534) costs. CONCLUSION: Our analyses suggest that the patient-related outcomes mortality, hospitalization, and costs do not differ between the two currently available antifibrotic drugs pirfenidone and nintedanib. Hence, the decision on treatment with pirfenidone versus treatment with nintedanib ought to be made case-by-case taking clinical characteristics, comorbidities, comedications, individual risk of side effects, and patients' preferences into account.

BMI-Stratified Exploration of the 'Obesity Paradox': Heart Failure Perspectives from a Large German Insurance Database.

Background: The global rise of obesity and its association with cardiovascular risk factors (CVRF) have highlighted its connection to chronic heart failure (CHF). Paradoxically, obese CHF patients often experience better outcomes, a phenomenon known as the 'obesity paradox'. This study evaluated the 'obesity paradox' within a large cohort in Germany and explored how varying degrees of obesity affect HF outcome. Methods: Anonymized health claims data from the largest German insurer (AOK) for the years 2014-2015 were utilized to analyze 88,247 patients hospitalized for myocardial infarction. This analysis encompassed baseline characteristics, comorbidities, interventions, complications, and long-term outcomes, including overall survival, freedom from CHF, and CHF-related rehospitalization. Patients were categorized based on body mass index. Results: Obese patients encompassed 21.3% of our cohort (median age 68.69 years); they exhibited a higher prevalence of CVRF (p < 0.001) and comorbidities than non-obese patients (median age 70.69 years). Short-term outcomes revealed lower complication rates and mortality (p < 0.001) in obese compared to non-obese patients. Kaplan-Meier estimations for long-term analysis illustrated increased incidences of CHF and rehospitalization rates among the obese, yet with lower overall mortality. Multivariable Cox regression analysis indicated that obese individuals faced a higher risk of developing CHF and being rehospitalized due to CHF but demonstrated better overall survival for those classified as having low-level obesity (p < 0.001). Conclusions: This study underscores favorable short-term outcomes among obese individuals. The 'obesity paradox' was confirmed, with more frequent CHF cases and rehospitalizations in the long term, alongside better overall survival for certain degrees of obesity.

Complications and Outcomes in 39,864 Patients Receiving Standard Care Plus Mechanical Circulatory Support or Standard Care Alone for Infarct-Associated Cardiogenic Shock.

BACKGROUND: Temporary mechanical circulatory support devices (tMCS) are increasingly being used in patients with infarct-associated cardiogenic shock (AMICS). Evidence on patient selection, complications and long-term outcomes is lacking. We aim to investigate differences in clinical characteristics, complications and outcomes between patients receiving no tMCS or either intra-aortic balloon pump (IABP), veno-arterial extracorporeal membrane oxygenation (V-A ECMO) or Impella® for AMICS, with a particular focus on long-term outcomes. METHODS: Using health claim data from AOK-Die Gesundheitskasse (local health care funds), we retrospectively analysed complications and outcomes of all insured patients with AMICS between 1 January 2010 and 31 December 2017. RESULTS: A total of 39,864 patients were included (IABP 5451; Impella 776; V-A ECMO 833; no tMCS 32,804). In-hospital complications, including renal failure requiring dialysis (50.3% V-A ECMO vs. 30.5% Impella vs. 29.2 IABP vs. 12.1% no tMCS), major bleeding (38.1% vs. 20.9% vs. 18.0% vs. 9.3%) and sepsis (22.5% vs. 15.9% vs. 13.9% vs. 9.3%) were more common in V-A ECMO patients. In a multivariate analysis, the use of both V-A ECMO (HR 1.57, p < 0.001) and Impella (HR 1.25, p < 0.001) were independently associated with long-term mortality, whereas use of IABP was not (HR 0.89, p < 0.001). Kaplan-Meier estimates showed better survival for patients on IABP compared with Impella, V-A ECMO and no-tMCS. Short- and long-term mortality was high across all groups. CONCLUSIONS: Our data show noticeably more in-hospital complications in patients on tMCS and higher mortality with V-A ECMO and Impella. The use of both devices is an independent risk factor for mortality, whereas the use of IABP is associated with a survival benefit.

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.

Epidemiology of cardiac amyloidosis in Germany: a retrospective analysis from 2009 to 2018.

BACKGROUND: Improved imaging modalities contributed to increasing awareness of cardiac amyloidosis. Contemporary data on frequency trends in Germany are lacking. METHODS: In a retrospective study using health claims data of a German statutory health insurance, patients with diagnostic codes of amyloidosis and concomitant heart failure between 2009 and 2018 were identified. RESULTS: Prevalence increased from 15.5 to 47.6 per 100,000 person-years, and incidence increased from 4.8 to 11.6 per 100,000 person-years, with a continuous steepening in the slope of incidence trend. In patients with amyloidosis and heart failure age and proportion of men significantly increased, whereas the frequency of myeloma and nephrotic syndrome significantly decreased over time. Median (IQR) survival time after first diagnosis was 2.5 years (0.5-6 years), with a 9% (95% CI 2-15%, p = 0.008) reduced risk of death in the second compared to the first 5 years of observation. In the 2 years prior and 1 year after diagnosis, mean total health care costs were 6568 €, 11,872 € and 21,955 € per person and year. CONCLUSION: The rise in cardiac amyloidosis has continuously accelerated in the last decade. Considering the adverse outcome and high health care burden, further effort should be put on early detection of the disease to implement available treatment.

German Claims Data for Real-World Research: Content Coverage Evaluation in OMOP CDM.

Research on real-world data is becoming increasingly important. The current restriction to clinical data in Germany limits the view of the patient. To gain comprehensive insights, claims data can be added to the existing knowledge. However, standardized transfer of German claims data into OMOP CDM is currently not possible. In this paper, we conducted an evaluation regarding the coverage of source vocabularies and data elements of German claims data in OMOP CDM. We point out the need to extend vocabularies and mappings to support research on German claims data.

Depression and Anxiety in Heart Transplant Recipients: Prevalence and Impact on Post-Transplant Outcomes.

BACKGROUND: Depression and anxiety (DA) are common mental disorders in patients with chronic diseases, but the research regarding their prevalence in heart transplantation (HTx) is still limited. METHODS: We performed an analysis of the prevalence and prognostic relevance of DA in patients who underwent HTx between 2010 and 2018 in Germany. Data were obtained from Allgemeine Ortskrankenkasse (AOK), which is the largest public health insurance provider. RESULTS: Overall, 694 patients were identified. More than a third of them were diagnosed with DA before undergoing HTx (n = 260, 37.5%). Patients with DA more often had an ischaemic cardiomyopathy (p < 0.001) and a history of previous myocardial infarction (p = 0.001) or stroke (p = 0.002). The prevalence of hypertension (p < 0.001), diabetes (p = 0.004), dyslipidaemia (p < 0.001) and chronic kidney disease (p = 0.003) was higher amongst transplant recipients with DA. Patients with DA were more likely to suffer an ischaemic stroke (p < 0.001) or haemorrhagic stroke (p = 0.032), or develop septicaemia (p = 0.050) during hospitalisation for HTx. Our analysis found no significant differences between the groups with respect to in-hospital mortality. The female sex and mechanical circulatory support were associated with an inferior prognosis. Pretransplant non-ischaemic cardiomyopathy was related to a favourable outcome. CONCLUSIONS: DA affect up to a third of the population undergoing HTx, with a greater prevalence in patients with comorbidities. DA are associated with a higher incidence of stroke and septicaemia after HTx.

Assessing the Use of German Claims Data Vocabularies for Research in the Observational Medical Outcomes Partnership Common Data Model: Development and Evaluation Study.

Background: National classifications and terminologies already routinely used for documentation within patient care settings enable the unambiguous representation of clinical information. However, the diversity of different vocabularies across health care institutions and countries is a barrier to achieving semantic interoperability and exchanging data across sites. The Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) enables the standardization of structure and medical terminology. It allows the mapping of national vocabularies into so-called standard concepts, representing normative expressions for international analyses and research. Within our project "Hybrid Quality Indicators Using Machine Learning Methods" (Hybrid-QI), we aim to harmonize source codes used in German claims data vocabularies that are currently unavailable in the OMOP CDM. Objective: This study aims to increase the coverage of German vocabularies in the OMOP CDM. We aim to completely transform the source codes used in German claims data into the OMOP CDM without data loss and make German claims data usable for OMOP CDM-based research. Methods: To prepare the missing German vocabularies for the OMOP CDM, we defined a vocabulary preparation approach consisting of the identification of all codes of the corresponding vocabularies, their assembly into machine-readable tables, and the translation of German designations into English. Furthermore, we used 2 proposed approaches for OMOP-compliant vocabulary preparation: the mapping to standard concepts using the Observational Health Data Sciences and Informatics (OHDSI) tool Usagi and the preparation of new 2-billion concepts (ie, concept_id >2 billion). Finally, we evaluated the prepared vocabularies regarding completeness and correctness using synthetic German claims data and calculated the coverage of German claims data vocabularies in the OMOP CDM. Results: Our vocabulary preparation approach was able to map 3 missing German vocabularies to standard concepts and prepare 8 vocabularies as new 2-billion concepts. The completeness evaluation showed that the prepared vocabularies cover 44.3% (3288/7417) of the source codes contained in German claims data. The correctness evaluation revealed that the specified validity periods in the OMOP CDM are compliant for the majority (705,531/706,032, 99.9%) of source codes and associated dates in German claims data. The calculation of the vocabulary coverage showed a noticeable decrease of missing vocabularies from 55% (11/20) to 10% (2/20) due to our preparation approach. Conclusions: By preparing 10 vocabularies, we showed that our approach is applicable to any type of vocabulary used in a source data set. The prepared vocabularies are currently limited to German vocabularies, which can only be used in national OMOP CDM research projects, because the mapping of new 2-billion concepts to standard concepts is missing. To participate in international OHDSI network studies with German claims data, future work is required to map the prepared 2-billion concepts to standard concepts.

Contemporary secondary prevention in survivors of ST-elevation myocardial infarction with and without chronic kidney disease: a retrospective analysis.

Background: Survivors of myocardial infarction have an elevated risk of long-term mortality. We sought to evaluate guideline-directed medical treatment and its impact on long-term mortality in survivors of ST-elevation myocardial infarction (STEMI) according to their chronic kidney disease (CKD) stage. Methods: Using German health insurance claims data, 157 663 hospitalized survivors of STEMI were identified. Regarding different CKD stages, we retrospectively analysed the filled prescriptions of platelet inhibitors (PAI)/oral anticoagulation, statins, beta-blocker and angiotensin-converting enzyme inhibitors/angiotensin II type 1 receptor antagonists (ACE-I/AT1-A) and their association with long-term mortality. Results: Prescription rates for all four guideline-directed drugs were highest in patients without or with mild CKD and lowest in patients on dialysis. They dropped from 73.4% to 39.2% in patients without CKD and from 47.1% to 29% in patients on dialysis within the 5-year follow-up period. Mortality rates were dramatically increased in patients with CKD compared with patients without CKD (5-year mortality: no CKD, 16.7%; CKD stage 3, 47.1%; CKD stage 5d, 69.7%). Filled prescriptions of at least one drug class [one drug: hazard ratio (HR) 0.70, 95% confidence interval (95% CI) 0.66-0.74; four drugs: HR 0.28, 95% CI 0.27-0.30; P < .001 for both] as well as the distinct drug classes (statins: HR 0.55, 95% CI 0.54-0.56; ACE-I/AT1-A: HR 0.68, 95% CI 0.67-0.70; beta-blocker: HR 0.87, 95% CI 0.85-0.90; PAI/oral anticoagulation: HR 0.97, 95% CI 0.95-1.00; all P < .05) improved long-term mortality. Conclusions: An improved long-term guideline-recommended drug therapy after STEMI regardless of renal impairment might lead to beneficial effects on long-term mortality.

Patients pathways before and after treatments in emergency departments: A retrospective analysis of secondary data in Germany.

Increasing emergency department (ED) utilization induces considerable pressure on ED staff and organization in Germany. Reasons for certain ED attendances are seen partly in insufficient continuity of care outside of hospitals. To explore the health care patterns before and after an ED attendance in Germany, we used claims data from nine statutory health insurance funds, covering around 25 % of statutory health insurees (1). We descriptively analyzed ED attendances for adult patients in 2016 according to their sociodemographic characteristics and diagnoses (2). Based on the ED attendance as initial event, we investigated health care provider utilization 180 days before and after the respective ED treatment and are presented by means of Sankey diagrams. In total, 4,757,536 ED cases of 3,164,343 insured individuals were analyzed. Back pain was the most frequent diagnosis in outpatient ED cases (5.0 %), and 80.2 % of the patients visited primary care physicians or specialists 180 days before and 78.8 % 180 days after ED treatment. Among inpatient cases, heart failure (4.6 %) was the leading diagnosis and 74.6 % used primary care physicians or specialists 180 days before and 65.1 % 180 days after ED treatment. The ED re-attendance slightly increased for back pain (4.9 % to 7.9 %) and decreased for heart failure (13.4 % to 12.6 %).

Survival of Patients with Acute Coronary Syndrome and Hematologic Malignancies-A Real-World Analysis.

BACKGROUND: The impact of the encounter between coronary heart disease (CHD) and cancer, and in particular hematologic malignancies (HM), remains poorly understood. OBJECTIVE: The aim of this analysis was to clarify how HM affects the prognosis of acute coronary syndrome (ACS). We analyzed German health insurance data from 11 regional Ortskrankenkassen (AOK) of patients hospitalized for ACS between January 2010 and December 2018, matched by age, sex and all comorbidities for short- and long-term survival and major adverse cardiac events (MACE). RESULTS: Of 439,716 patients with ACS, 2104 (0.5%) also had an HM. Myelodysplastic/myeloproliferative disorders (27.7%), lymphocytic leukemias (24.8%), and multiple myeloma (22.4%) predominated. These patients were about 6 years older (78 vs. 72 years *). They had an ST-segment elevation myocardial infarction (STEMI, 18.2 vs. 34.9% *) less often and more often had a non-STEMI (NSTEMI, 81.8 vs. 65.1% *). With the exception of dyslipidemia, these patients had more concomitant and previous cardiovascular disease and a worse NYHA stage. They were less likely to undergo coronary angiography (65.3 vs. 71.6% *) and percutaneous coronary intervention (PCI, 44.3 vs. 52.0% *), although the number of bleeding events was not relevantly increased (p = 0.22). After adjustment for the patients' risk profile, the HM was associated with reduced long-term survival. However, this was not true for short-term survival. Here, there was no difference in the STEMI patients, * p < 0.001. CONCLUSION: Survival in ACS and HM is significantly lower, possibly due to the avoidance of PCI because of a perceived increased risk of bleeding.

Optimization of HIV testing services in Germany using HIV indicator diseases: study protocol of the HeLP study.

BACKGROUND: Despite the potentially accompanying negative clinical, epidemiologic, and health economic effects, a large proportion of persons living with the human immunodeficiency virus (HIV) are diagnosed late. Internationally, numerous diseases are known to be HIV indicator diseases. Adequate HIV testing in the presence of HIV indicator diseases could help to diagnose unknown HIV infections earlier. The objective of the HeLP study is to validate published HIV indicator diseases for the German setting and to identify guidelines in terms of these indicator diseases in order to reduce knowledge gaps and increase HIV testing when HIV indicator diseases are diagnosed. METHODS: A mixed methods approach is used. In a first step, published HIV indicator diseases will be identified in a systematic literature review and subsequently discussed with clinical experts regarding their relevance for the German setting. For the validation of selected indicator diseases different data sets (two cohort studies, namely HIV-1 seroconverter study & ClinSurv-HIV, and statutory health insurance routine data) will be analyzed. Sensitivity analyses using different time periods will be performed. Guidelines of HIV indicator diseases validated in the HeLP study will be reviewed for mentioning HIV and for HIV testing recommendations. In addition, semi-standardized interviews (followed by a free discussion) with guideline creators will identify reasons why HIV testing recommendations were (not) included. Subsequently, a random sample of physicians in medical practices will be surveyed to identify how familiar physicians are with HIV testing recommendations in guidelines and, if so, which barriers are seen to perform the recommended tests in everyday care. DISCUSSION: The HeLP-study adopts the challenge to validate published HIV indicator diseases for the German setting and has the potential to close a knowledge gap regarding this objective. This has the potential to improve targeted HIV testing for patients with HIV indicator diseases and consequently lead to earlier HIV diagnosis. TRIAL REGISTRATION: DRKS00028743.