Apixaban, edoxaban and rivaroxaban but not dabigatran are associated with higher mortality compared to vitamin-K antagonists: A retrospective German claims data analysis.

BACKGROUND: Vitamin-K antagonists (VKAs) have widely been replaced by non-VKA oral anticoagulants (NOACs). This includes Austria, Germany and Switzerland, where as VKA, instead of warfarin, the much longer-acting phenprocoumon is used, which was not compared to NOACs in clinical trials. METHODS: Using administrative data from a large German health insurance, we included all anticoagulation-naïve patients with a first prescription of a NOAC or VKA between 2012 and 2020. We analysed overall survival, major adverse cardiac and cerebrovascular events, major thromboembolic events and major bleeding. RESULTS: Overall, 570,137 patients were included (apixaban: 26.9%, dabigatran: 4.6%, edoxaban: 8.8%, rivaroxaban: 39.1% and VKA: 20.7% of these 99.4% phenprocoumon). In the primary analysis using a 1:1 propensity score matching-cohort (PSM-cohort), a significantly higher overall mortality was found for apixaban, edoxaban and rivaroxaban (all p < 0.001) but not for dabigatran (p = 0.13) compared to VKA. In this PSM-cohort, 5-year mortality was 22.7% for apixaban versus 12.7% for VKA, 19.5% for edoxaban versus 11.4% for VKA, 16.0% for rivaroxaban versus 12.3% for VKA (all p < 0.001) and 13.0% for dabigatran versus 12.8% for VKA (p = 0.06). The observed effect was confirmed in sensitivity analyses using un-weighted and three different weighted Fine-Gray regression models on the basis of the entire cohort. CONCLUSIONS: In this large real-world analysis, apixaban, edoxaban and rivaroxaban, but not dabigatran, were associated with worse survival compared to VKA. These findings, consistent with a few other studies including phenprocoumon, cast profound doubts on the unreflected, general use of NOACs. Randomized trials should assess whether phenprocoumon might actually be superior to NOACs.

A refined ICD-10 diagnoses-based approach for retrospective analysis of potential palliative care need and coverage in claims data of deceased.

Objectives: ICD-10-based approaches often provide the basis for retrospective estimation of potential palliative care need. Applying the ICD-10-based Murtagh et al. classification from 2014 (Murtagh classification), developed using mortality data, to administrative claims data leads to inconsistencies in estimating palliative care need. The aim of the study was to refine the classification for palliative care need estimation in deceased individuals with cancer and non-cancer diagnosis. Methods: A retrospective population-based study comparing Murtagh classification to a new ICD-10-based classification (revised by expert opinion) was conducted using outpatient and inpatient claims data, including billing codes for palliative care. Palliative care need was estimated for diagnoses groups and was contrasted with palliative care utilization rates in the last year of life. Our dataset included records of 417,405 individuals who deceased in 2016-2019. Results: Out of individuals deceased in 2019 (n = 117,436), 81.4% had at least one diagnosis from the new classification, while 97.0% had at least one diagnosis from the Murtagh classification. Classification revision thus identified fewer individuals as potentially in need of palliative care. Among individuals with cancer, 70.7% (vs. 55.7% via Murtagh classification) received palliative care. In non-cancer subgroups, the utilization rate was considerably lower, with a maximum of 36.7% (vs. 33.7% via Murtagh classification) in 2019. Similar results were observed for the other years. Conclusion: Compared to the ICD10-based Murtagh classification, the revised ICD-10-based classification enables more realistic estimations if the cause of death is unavailable and reveals higher rates of palliative care coverage and differences especially in cancer versus non-cancer diseases. German Clinical Trials Register (DRKS00024133).

[Antibiotic Prescription Rates For Respiratory Tract Infections Treated In The Outpatient Sector Based On Routine Data From A German Health Insurance Company]. / Antibiotikaverordnungsraten bei ambulant behandelten Infektionen der oberen Atemwege anhand von Routinedaten einer deutschen Krankenkasse.

BACKGROUND: Acute uncomplicated upper respiratory tract infections (RTIs) are common reasons for antibiotic prescriptions in the outpatient sector, although>90% are of viral origins and mostly self-limiting. Germany has a low antibiotic prescription rate compared to other European countries, but there are regional differences. Disease-specific quality indicators (QI) developed by the European Surveillance of Antimicrobial Consumption Network (ESAC-Net) address the prescription rates (target <20%) and choice of antibiotic (target>80%) in a general practitioner population. The aim of this analysis was to operationalise the ESAC-Net-QI using secondary data from a health insurance company at the level of diseases and healthcare facilities, as well as to analyse areas for improvement. METHOD: The underlying database comprises the panel physician billing, hospital and prescription data in accordance with German law (§§ 295, 300 and 301 SGB V) of the Barmer health insurance company for the year 2022. Categorical features are presented as frequency and percentage. Maximum specificity was aimed, hence potentially risky disease courses were excluded. RESULTS: The overall RTI prescription rate of antibiotics was 25% in 2022 before applying inclusion and exclusion criteria (1,197,568/4,720,786). After applying the algorithm, the prescription rate for all RTI cases dropped to 6% (80,786/1,365,646). When specific RTI indications are considered, 35% (13,465/38,913) of acute bronchitis and acute sinusitis cases (4,971/14,051) received an antibiotic prescription each. At the facility level, 38% of practices (1,396/3,705) treating acute bronchitis and 41% of practices (539/1,300) treating acute sinusitis achieved the target of<20% antibiotic prescriptions. Only 29% of all RTI cases with antibiotic prescriptions (23,733/80,786) received a first-choice antibiotic. CONCLUSION: Our analysis indicates that the ESAC-Net-QI for RTIs can be calculated at case and facility levels using routine health insurance data. For specific RTIs, there were indications of improvement potential in the frequency and selection of prescribed antibiotics.

Conservative Versus Operative Treatment of Proximal Humerus Fractures in Older Individuals­an Analysis of Insurance Data.

BACKGROUND: Little is known about the frequency and results of conservative treatment of proximal humerus fractures in older individuals. METHODS: Billing data of the BARMER health insurance carrier for all patients of age 65 and above with proximal humerus fractures in the years 2005-2021 were retrospectively analyzed with multivariable Cox regression models, taking account of the patients' age, sex, and comorbidity profiles. The defined primary endpoints were overall survival (OS), major adverse events (MAE), thromboembolic events (TE), and complications of surgery or of trauma. Multivariable p values for the effect of treatment on all primary endpoints were jointly adjusted with the Bonferroni-Holm method. RESULTS: 54% of 81 909 patients were treated conservatively. Conservative treatment was more common in those who received their diagnosis as outpatients (79.5%, vs. 37.2% for inpatients). Operative treatment was associated with significantly longer overall survival (long-term HR 0.89, 95% confidence interval [0,86; 0,91]) and fewer MAE (0.90; [0.88; 0.92]) and TE (0.89; [0.87; 0.92]), but more complications due to surgery or trauma (1.66; [1,.4; 1.78]; all p < 0.001). 3.1% of the patients who had been initially treated conservatively underwent surgery within 6 months of their diagnosis. Risk factors for the failure of conservative treatment included alcohol abuse, obesity, cancer, diabetes mellitus, Parkinson disease, and osteoporosis. CONCLUSION: The conservative treatment of proximal humerus fracture is associated with a lower overall rate of complications due to surgery or trauma, but also with more MAE and TE and higher overall mortality. These findings underline the need for individualized and risk-adjusted treatment recommendations.

Impact of COVID-19 Infections among Unvaccinated Patients with Congenital Heart Disease: Results of a Nationwide Analysis in the First Phase of the Pandemic.

Background: The outcome data and predictors for mortality among patients with congenital heart disease (CHD) affected by COVID-19 are limited. A more detailed understanding may aid in implementing targeted prevention measures in potential future pandemic events. Methods: Based on nationwide administrative health insurance data, all the recorded in-hospital cases of patients with CHD with COVID-19 in 2020 were analyzed. The demographics, treatment details, as well as 30-day mortality rate were assessed. The associations of the patients' characteristics with death were assessed using multivariable logistic regression analysis. Results: Overall, 403 patients with CHD were treated in- hospital for COVID-19 in 2020. Of these, 338 patients presented with virus detection but no pneumonia whilst, 65 patients suffered from associated pneumonia. The cohort of patients with pneumonia was older (p = 0.04) and presented with more cardiovascular comorbidities such as diabetes mellitus (p = 0.08), although this parameter did not reach a statistically significant difference. The 30-day mortality rate was associated with highly complex CHD (odds ratio (OR) 7.81, p = 0.04) and advanced age (OR 2.99 per 10 years, p = 0.03). No child died of COVID-related pneumonia in our dataset. Conclusions: COVID-19 infection with associated pneumonia chiefly affected the older patients with CHD. Age and the complexity of CHD were identified as additional predictors of mortality. These aspects might be helpful to retrospectively audit the recommendations and guide health politics during future pandemic events.

Utilization and quality of palliative care in patients with hematological and solid cancers: a population-based study.

BACKGROUND: Palliative care (PC) contributes to improved end-of-life care for patients with hematologic malignancies (HM) and solid tumors (ST) by addressing physical and psychological symptoms and spiritual needs. Research on PC in HM vs. ST patients is fragmented and suggests less use. METHODS: We analyzed claims data of all deceased members of a large German health insurance provider for the year before death. First, we analyzed the frequency and the beginning of different types of PC and compared patients with HM vs. ST. Second, we analyzed the adjusted impact of PC use on several end-of-life quality outcomes in patients with HM vs. ST. We performed simple and multiple (logistic) regression analysis, adjusted for relevant covariates, and standardized for age and sex. RESULTS: Of the 222,493 deceased cancer patients from 2016 to 2020, we included 209,321 in the first analysis and 165,020 in the second analysis. Patients with HM vs. ST received PC less often (40.4 vs. 55.6%) and later (34 vs. 50 days before death). PC use significantly improved all six quality indicators for good end-of-life care. HM patients had worse rates in five of the six indicators compared with ST patients. Interaction terms revealed that patients with ST derived greater benefit from PC in five of six quality indicators than those with HM. CONCLUSION: The data highlight the need to integrate PC more often, earlier, and more effectively into the care of patients with HM.

Short Term Outcomes and Treatment Intensity of Major Cardiovascular Emergencies During the COVID-19 Pandemic in Germany.

OBJECTIVE: There has been a decline in hospital admission rates in many countries since the beginning of the COVID-19 pandemic. Patient selection differed from episodes before the pandemic. This study investigated changes in baseline characteristics as well as the short term mortality rate and probability of receiving an invasive procedure while considering sex disparities. METHODS: Claims data provided by Germany's second largest insurance fund, BARMER, were used. Patients without COVID-19 who were treated for ST segment elevation myocardial infarction (STEMI), non-ST segment elevation myocardial infarction (NSTEMI), acute limb ischaemia (ALI), and stroke between 1 January 2018 and 31 December 2021 were included. Outcomes were compared separately for both sexes between the years before the pandemic (2018/2019) and during the pandemic (2020/2021). Propensity scores with exact matching were used to balance confounders including age, drug prescriptions in the previous year, federal state, month of admission, domiciliary care, and the Elixhauser comorbidities. Short term death and probability of invasive procedures were determined using cumulative incidence functions and Cox regressions. RESULTS: The cohort consisted of 140 989 hospitalisations of 122 340 individual patients (48.3% female) with 102 960 matched cases. Baseline characteristics were similar between episodes in the unmatched cohort. Earlier discharge was observed for all strata except for males with ALI or STEMI, where the probability of early discharge was unchanged. The probability of receiving an invasive procedure was increased for both sexes with ALI, NSTEMI, and STEMI but not for stroke. The analyses suggested neither a statistically significant increase of the in hospital mortality rate nor the 30 day mortality rate after the pandemic started. CONCLUSION: There was no evidence for a direct or indirect impact of the pandemic on major short term hospital outcomes. While the probability of receiving an invasive procedure increased for STEMI, NSTEMI, and ALI, the overall short term mortality rate was unaffected for both sexes.

Outpatient Psychotherapy in Germany.

BACKGROUND: A structural reform of the German psychotherapy guideline in 2017 was intended to facilitate access to outpatient guideline psychotherapy. In the present study, we evaluate the effects of this reform in particular for patients with a comorbidity of mental disorders and chronic physical conditions (cMP). METHODS: Pre-post analyses of the two primary endpoints "percentage of mentally ill persons who have made an initial contact with a psychotherapist" and "waiting time for guideline psychotherapy" were carried out employing population-based and weighted routine statutory health insurance data from the German BARMER. The secondary endpoints included evaluations from the patients' perspective, based on a representative survey of patients in psychotherapy, and an overview of the health care situation based on data from the National Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung, KBV) (study registration number: DRKS00020344). RESULTS: From 2015 to 2018, the percentage of mentally ill persons who had made an initial contact with a psychotherapist rose moderately, from 3.7% (95% confidence interval, [3.6; 3.7]) to 3.9% [3.8; 3.9] among persons with cMP and from 7.3% [7.2; 7.4] to 7.6% [7.5; 7.7] among those with mental disorders but without any chronic physical condition (MnoP). The new structural elements were integrated into patient care. The interval of time between the initial contact and the beginning of guideline psychotherapy became longer in both groups, from a mean of 80.6 [79.4; 81.8] to 114.8 [113.4; 116.2] days among persons with complex disease and from 80.2 [79.2; 81.3] to 109.6 [108.4; 111.0] days among persons with non-complex disease; most patients considered the waiting time. Approximately 8% of the patients who sought psychotherapy reported that they had not obtained access to a psychotherapist. CONCLUSION: Neither in general nor for patients with cMP did the introduction of the structural reform appreciably lower the access barriers to psychotherapy. Further steps are needed so that outpatient care can meet the needs of all patients and particularly those with cMP.

PAIN2.0: study protocol for a multicentre randomised controlled trial to evaluate the efficacy of a 10-week outpatient interdisciplinary multimodal pain therapy to manage recurrent pain for patients with risk factors of developing chronic pain in Germany.

BACKGROUND: Up to 27% of the German population suffers from recurrent or persistent pain (lasting more than three months). Therefore, prevention of chronic pain is one major object of pain management interventions. The aim of this nationwide, multicentre, randomised controlled trial is to evaluate the efficacy of a 10-week ambulatory (outpatient) interdisciplinary multimodal pain therapy (A-IMPT) for patients with recurrent pain and at risk of developing chronic pain. This project was initiated by the German Pain Society (Deutsche Schmerzgesellschaft e.V.) and the public health insurance provider BARMER. It is currently funded by the German Innovation Fund (01NVF20023). The study PAIN2.0 focuses on reducing pain intensity and pain-related disability and investigates whether this intervention can improve physical activity, psychological well-being, and health literacy. METHODS: PAIN2.0 is designed as a multicentre 1:1 randomised controlled trial with two parallel groups (randomisation at the patient level, planned N = 1094, duration of study participation 12 months, implemented by 22 health care facilities nationwide). After 6 months, patients within the control group also receive the intervention. The primary outcomes are pain intensity and pain-related impairment, measured as Characteristic Pain Intensity (PI) and Disability Score (DS) (Von Korff), as well as patient-related satisfaction with the intervention. Secondary outcomes are the number of sick leave days, sickness allowance, treatment costs, psychological distress, health-related quality of life, and catastrophizing. The effects of the intervention will be analysed by a parallel-group comparison between the intervention and control groups. In addition, the long-term effects within the intervention group will be observed and a pre-post comparison of the control group before and after the intervention will be performed. DISCUSSION: Recurrent or persistent pain is common in the German population and causes high costs for patients and society. The A-IMPT aims to improve pain and pain-related impairments in pain patients at risk of chronification, thereby reducing the risk of developing chronic pain with its high socioeconomic burden. This new therapy could easily be integrated into existing therapy programs if positively evaluated. TRIAL REGISTRATION: The trial PAIN2.0 has been registered in the German Clinical Trials Register (DRKS) since 21/11/2022 with the ID DRKS00030773 .

Mental comorbidities in adolescents and young adults with juvenile idiopathic arthritis: an analysis of German nationwide health insurance data.

BACKGROUND: Studies on prevalence rates of mental comorbidities in patients with juvenile idiopathic arthritis (JIA) have reported varying results and provided limited information on related drugs. The purpose of this study was to determine the prevalence of selected mental health diagnoses and the range of associated drug prescriptions among adolescents and young adults (AYA) with JIA compared with general population controls. FINDINGS: Nationwide statutory health insurance data of the years 2020 and 2021 were used. Individuals aged 12 to 20 years with an ICD-10-GM diagnosis of JIA in ≥ 2quarters, treated with disease-modifying antirheumatic drugs and/or glucocorticoids were included. The frequency of selected mental health diagnoses (depression, anxiety, emotional and adjustment disorders) was determined and compared with age- and sex-matched controls. Antirheumatic, psychopharmacologic, psychiatric, and psychotherapeutic therapies were identified by Anatomical Therapeutic Chemical (ATC) codes and specialty numbers. Based on data from 628 AYA with JIA and 6270 controls, 15.3% vs. 8.2% had a diagnosed mental health condition, with 68% vs. 65% receiving related drugs and/or psychotherapy. In both groups, depression diagnosis became more common in older teenagers, whereas emotional disorders declined. Females with and without JIA were more likely to have a mental health diagnosis than males. Among AYA with any psychiatric diagnosis, 5.2% (JIA) vs. 7.0% (controls) received psycholeptics, and 25% vs. 27.3% psychoanaleptics. CONCLUSIONS: Selected mental health conditions among 12-20-year-old JIA patients are diagnosed more frequently compared to general population. They tend to occur more frequently among females and later in childhood. They are treated similarly among AYA regardless of the presence of JIA.

[Quality Contract for the Prevention of Postoperative Delirium]. / Qualitätsvertrag zur Prävention des postoperativen Delirs.

Delirium is one of the most common postoperative complications. Delayed initiation of treatment leads to an increased mortality rate within the first 90 days and to an increased need for post-hospital care. Similarly, neurocognitive disorders (NCDs) occur in a quarter of affected patients over the long-term. The use of evidence-based guideline recommendations can reduce incidence rates of delirium, shorten delirium duration, and prevent complications. Implementing delirium management according to evidence-based guideline recommendations requires a transformation process that integrates all stakeholders. In May 2017, the Federal Joint Committee (G-BA), the highest decision-making body in the German healthcare system, approved the quality contract (QC) as a new instrument for improving healthcare in Germany. With QC, hospitals have the opportunity to set up better conditions for the transformation process of delirium management, because with QC funding, initial hurdles can be more easily overcome, such as establishing and sustaining new structures or mobilizing resources. The cooperation of all stakeholders - but above all their shared understanding - of the need for transformation is crucial for the successful implementation of delirium management. The digitization of cross-departmental processes in particular is an elementary component in a modern transformation process. This creates new opportunities and processes that offer added value for patients and caregivers. Patients thus experience delirium management as a coherent interdisciplinary and multiprofessional concept that is implemented transparently, comprehensibly, and evidence-based.

[A regional comparison of outcomes quality and costs of general and specialized palliative care in Germany: a claims data analysis]. / Ergebnisqualität und Kosten der allgemeinen und spezialisierten Palliativversorgung in Deutschland im regionalen Vergleich: eine GKV-Routinedatenstudie.

BACKGROUND: The main framework conditions for palliative care are set at the regional level. The scope of the forms of care used (outpatient, inpatient, general, specialized) varies widely. What is the quality of outcomes achieved by the palliative care provided on a federal states level? What are the associated costs of care? METHOD: Retrospective observational study using BARMER claims data from 145,372 individuals who died between 2016 and 2019 and had palliative care in the last year of life. Regional comparison with regard to the following outcomes: proportion of palliative care patients who died in the hospital, potentially burdensome care in the last 30 days of life (ambulance calls, [intensive care] hospitalizations, chemotherapy, feeding tubes, parenteral nutrition), total cost of care (last three months), cost of palliative care (last year), and cost-effectiveness ratios. Calculation of patient/resident characteristic adjusted rates, costs, and ratios. RESULTS: Federal states vary significantly with respect to the outcomes (also adjusted) of palliative care. Palliative care costs vary widely, most strongly for specialized outpatient palliative care (SAPV). Across all indicators and the cost-effectiveness ratio of total cost of care to at-home deaths, Westphalia-Lippe shows favorable results. CONCLUSION: Regions with better quality and more favorable cost (ratios) can provide guidance for other regions. The extent to which the new federal SAPV agreement can incorporate the empirical findings should be reviewed. Patient-relevant outcome parameters should be given greater weight than parameters aiming at structures of care.

[Evaluating the reform of the psychotherapy guideline using a mixed-methods approach: a study protocol]. / Mixed-Methods-Ansatz zur Evaluation der Reform der Psychotherapie-Richtlinie: ein Studienprotokoll.

INTRODUCTION: In Germany, psychotherapy in outpatient statutory health care is regulated by the Psychotherapy Guideline (PT-GL). A discussion on waiting times and inadequate care for patients resulted in a structural reform of the PT-GL in 2017. The reform aims to improve access to psychotherapy and the entire course of care and treatment. The purpose of the present study was the evaluation of the new elements and identification of obstacles and barriers in their implementation. METHODS: Quantitative and qualitative methods were used to evaluate the reform of the PT-GL. In a retrospective cohort-based analysis of anonymized administrative claim data from the statutory health insurances BARMER and AOK, the health care situation before and after the reform were compared. In addition, a cross-sectional questionnaire survey evaluated the implementation of the new care elements from the perspective of psychotherapists, general practitioners and patients. The questionnaires were developed based on focus groups with stakeholders and a literature search. The survey results provided the data basis for the cross-sectional analysis together with the routine data on the care situation after the reform of the PT-GL as well as aggregated, anonymized data from the National Association of Statutory Health Insurance Physicians on statutory health insurance care and on the use of the appointment service centers. CONCLUSION: By combining quantitative and qualitative data, the effects of the structural reform of the PT-GL of 2016 can be analyzed at the individual and structural level as well as in relation to the entire care and treatment process. Based on this, proposals for a needs-oriented further development of the PT-GL will be prepared, considering the perspectives of various interest groups.

Weekday-dependent long-term outcomes in gastrointestinal cancer surgery: a German population-based retrospective cohort study.

BACKGROUND: For most solid cancers, surgery represents the mainstay of curative treatment. Several studies investigating the effects of the weekday of surgery (WOS) on patient outcomes have yielded conflicting results. Barmer, the second-largest health insurance company in Germany, serves roughly 10% of the German population. The authors have used the Barmer database to evaluate how the weekday on which the surgery is performed influences long-term oncologic outcomes. METHODS: For this retrospective cohort study, the Barmer database was used to investigate the effect of the WOS (Monday-Friday) on outcomes following oncological resections of the colorectum ( n =49 003), liver ( n =1302), stomach ( n =5027), esophagus ( n =1126), and pancreas ( n =6097). In total, 62 555 cases from 2008 to 2018 were included in the analysis. The endpoints were overall survival (OS), postoperative complications, and the necessity for therapeutic interventions or reoperations. The authors further examined whether the annual caseload or certification as a cancer center influenced the weekday effect. RESULTS: The authors observed a significantly impaired OS for patients receiving gastric or colorectal resections on a Monday. Colorectal surgery performed on Mondays was associated with more postoperative complications and a higher probability of reoperations. The annual caseload or a certification as a colorectal cancer center had no bearing on the observed weekday effect. There is evidence that hospitals schedule older patients with more comorbidities earlier in the week, possibly explaining these findings. CONCLUSION: This is the first study investigating the influence of the WOS on long-term survival in Germany. Our findings indicate that, in the German healthcare system, patients undergoing colorectal cancer surgery on Mondays have more postoperative complications and, therefore, require significantly more reoperations, ultimately lowering the OS. This surprising finding appears to reflect an attempt to schedule patients with higher postoperative risk earlier in the week as well as semi-elective patients admitted on weekends scheduled for surgery on the next Monday.