Economic Considerations of Cardiovascular Implantable Electronic Devices for The Treatment of Heart Failure.

PURPOSE OF REVIEW: Heart failure (HF) is a major public health problem worldwide, affecting more than 64 million people [1]. The complex and severe nature of HF presents challenges in providing cost-effective care as patients often require multiple hospitalizations and treatments. This review of relevant studies with focus on the last 10 years summarizes the health and economic implications of various HF treatment options in Europe and beyond. Although the main cost drivers in HF treatment are clinical (re)admission and decompensation of HF, an assessment of the economic impacts of various other device therapy options for HF care are included in this review. This includes: cardiovascular implantable electronic devices (CIEDs) such as cardiac-resynchronisation-therapy devices that include pacemaking (CRT-P), cardiac-resynchronisation-therapy devices that include defibrillation (CRT-D), implantable cardioverter/defibrillators (ICDs) and various types of pacemakers. The impact of (semi)automated (tele)monitoring as a relevant factor for increasing both the quality and economic impact of care is also taken into consideration. Quality of life adjusted life years (QALYs) are used in the overall context as a composite metric reflecting quantity and quality of life as a standardized measurement of incremental cost-effectiveness ratios (ICER) of different device-based HF interventions. RECENT FINDINGS: In terms of the total cost of different devices, CRT-Ds were found in several studies to be more expensive than all other devices in regards to runtime and maintenance costs including (re)implantation. In the case of CRT combined with an implantable cardioverter-defibrillator (CRT-D) versus ICD alone, CRT-D was found to be the most cost-effective treatment in research work over the past 10 years. Further comparison between CRT-D vs. CRT-P does not show an economic advantage of CRT-D as a minority of patients require shock therapy. Furthermore, a positive health economic effect and higher survival rate is seen in CRT-P full ventricular stimulation vs. right heart only stimulation. Telemedical care has been found to provide a positive health economic impact for selected patient groups-even reducing patient mortality. For heart failure both in ICD and CRT-D subgroups the given telemonitoring benefit seems to be greater in higher-risk populations with a worse HF prognosis. In patients with HF, all CIED therapies are in the range of commonly accepted cost-effectiveness. QALY and ICER calculations provide a more nuanced understanding of the economic impact these therapies create in the healthcare landscape. For severe cases of HF, CRT-D with telemedical care seems to be the better option from a health economic standpoint, as therapy is more expensive, but costs per QALY range below the commonly accepted threshold.

[Clinical courses and costs for hospitalizations of potentially immunocompromised COVID-19 patients in Germany]. / Klinische Verläufe und Kosten für Hospitalisierungen von COVID-19-Patienten mit potenziell eingeschränktem Immunsystem in Deutschland.

BACKGROUND: Patients at increased risk of inadequate immune response to COVID-19 vaccinations due to their underlying disease or therapy are potentially vulnerable to severe COVID-19 courses. The aim is to assess the population size, clinical courses and hospitalization costs of these patients in Germany. METHODS: This retrospective cohort study is based on extrapolations of a representative sample of statutory health insurance (SHI) claims data from 2020. Clinical COVID-19 courses, hospitalization costs and durations are compared between the insured group at increased risk for inadequate immune response to COVID-19 vaccinations (risk group) and the insured group without this risk. RESULTS: There are approximately 1.82 million SHI-insured individuals in the risk group, of whom an estimated 240 000 insured individuals do not develop a humoral immune response after 3 COVID-19 vaccinations. The risk group shows higher proportions with COVID-19 (relative risk [RR] 1.21; 95 % confidence interval [95 % CI] 1.20-1.23), hospitalizations for COVID-19 (RR 3.40; 95 % CI 3.33-3.48), hospitalizations for COVID-19 with intensive care treatment (RR 1.36; 95 % CI 1.30-1.42), and mortality (RR 5.14; 95 % CI 4.97-5.33) compared with the group without risk. In addition, hospitalizations in the risk group are on average 18 % longer (15.36 days vs. 13.00 days) and 19 % more expensive (12 371 € vs. 10 410 €). Expected hospitalization costs in the risk group are four times greater than in the group without risk (4115 € vs. 1017 €). CONCLUSIONS: The risk group is vulnerable to COVID-19 and requires additional resources in the German hospital sector. This results in a need for further protective measures. Further studies are needed to evaluate the impact of different viral variants, active and passive immunizations, and therapies on clinical COVID-19 courses and their costs.

Comparative effectiveness of factor Xa non-vitamin K antagonist oral anticoagulants versus phenprocoumon in patients with non-valvular atrial fibrillation.

BACKGROUND: Non-vitamin K antagonist oral anticoagulants (NOACs) have largely supplanted vitamin K antagonists (VKAs) for oral anticoagulation in non-valvular atrial fibrillation (NVAF). However, data on the real-world effectiveness of NOACs vs. phenprocoumon, a VKA widely used in Germany, are limited. The RELOADED study aimed to compare effectiveness of factor Xa NOACs and phenprocoumon in NVAF in clinical practice. METHODS: Patients who started on a factor Xa NOAC or phenprocoumon for NVAF during the study period were enrolled from the Institute for Applied Healthcare Research Berlin. Patients were followed from first prescription until the end of exposure or available data. Primary outcomes were analyzed by Cox proportional hazard regression models and included ischemic stroke and systemic embolism for effectiveness, and intracranial hemorrhage (ICH) for safety. Subgroups of interest were patients with diabetes and patients with renal impairment. RESULTS: The total study population was 64,920; 36.3% of patients initiated phenprocoumon, 34.4% initiated rivaroxaban, 25.0% apixaban, and 4.4% edoxaban. Treatment with phenprocoumon is associated with a similar risk of ischemic stroke/systemic embolism as treatment with rivaroxaban or apixaban; while rivaroxaban (adjusted hazard ratio [HR] 0.57, 95% confidence interval [CI] 0.43-0.75) and apixaban (adjusted HR 0.43, 95% CI 0.31-0.6) were associated with a lower risk of ICH compared to phenprocoumon in NVAF patients. The use of rivaroxaban and apixaban was associated with a lower risk of developing kidney failure in patients with diabetes or renal impairment in comparison to those treated with phenprocoumon. CONCLUSION: The factor Xa NOACs rivaroxaban and apixaban demonstrated similar effectiveness and lower rates of ICH compared with phenprocoumon in this study.

Epidemiology and treatment of pain associated with osteoarthritis of the knee in Germany: A retrospective health claims data analysis.

Objective: Osteoarthritis of the knee (knee OA) is a serious joint disease leading to pain and reduced quality of life. Pharmacological treatments include anti-inflammatories, analgesics, intraarticular hyaluronic acid, and intraarticular corticosteroids while for severe knee OA, knee replacement is an option. This study examined the incidence, prevalence, patient characteristics, and uptake of medical and surgical treatments in knee OA patients in Germany. Design: A non-interventional, retrospective health claims data analysis with anonymized data from the InGef database was performed. Patients ≥18 years were analyzed cross-sectionally for each year 2015-2020. Newly diagnosed patients in 2015 were also longitudinally analyzed until end of 2020. Results: Annual knee OA prevalence increased from 7.07 â€‹% in 2015 to 7.39 â€‹% in 2020. Annual incidence proportions ranged from 1.71 â€‹% in 2015 to 1.46 â€‹% in 2020. Knee replacement was the most common surgery, with rising patient numbers (e.g., 7918 patients in 2015 and 8975 patients in 2019). Approximately 62 â€‹% of patients newly diagnosed in 2015 received prescription pharmacological pain treatment during follow-up. Most (96.95 â€‹%) received non-opioid analgesics, followed by weak opioids (8.14 â€‹%) and strong opioids (3.00 â€‹%) as first-line treatment (combinations possible). Knee surgery was performed in 16.6 â€‹% of patients during follow-up. Median time from first diagnosis until surgery was 346 days for any knee surgery and 564 days for knee replacement. Conclusions: The number of patients with knee OA in Germany is steadily rising, along with an increasing number of surgical interventions, especially knee replacement. Time until first surgery and knee replacement is relatively short, even for newly diagnosed patients.

Changes in patient care through flexible and integrated treatment programs in German psychiatric hospitals: meta-analyses based on a series of controlled claims-based cohort studies.

BACKGROUND: Global treatment budgets, i.e. predefined budgets for patients treated in hospital independent of the setting within the hospital, together with flexible and integrated treatment (FIT) have been introduced in some German psychiatric hospitals since 2013. We investigated pooled changes in inpatient, day-care, outpatient treatment, and continuity of care for patients with mental disorders in 12 FIT-hospitals. METHODS: We conducted a series of 12 controlled cohort studies regarding FIT hospitals using anonymized patient claims data from more than 70 German statutory health insurance funds. Each study compared one FIT-hospital to matched patients from equivalent non-FIT-hospitals (routine care). We included only those patients without treatment in the respective hospital within two years prior to first hospital treatment (either FIT or routine care). We contrasted results between the year prior to with the first and second year after patient's first treatment (treatment continuity: only group comparison) using multivariate multi-level models. To approximate the difference-in-difference effect in the meta-analysis, we used the interaction terms group (FIT hospital vs. routine care) x time (year before vs. first or second patient year after study inclusion) in the Poisson models. RESULTS: The 12 studies included 36,069 patients with 2,358 patients from a Department of child and adolescent psychiatry. The pooled effect revealed a 5.1 days lower increase in inpatient treatment in FIT-hospitals during the first patient year compared to routine care. Results were statistically significant for adult care FIT-hospitals but not for child and adolescent FIT-hospitals. Utilization of day-care treatment increased more in most FIT-hospitals during the first year, while outpatient contacts increased in some and decreased in others. The odds of treatment continuity increased by 1.4 in FIT-hospitals compared to non-FIT-hospitals. CONCLUSIONS: Global treatment budgets lead to the intended changes in mental health care in the majority of FIT-hospitals compared to routine care in this large real-world evidence study from Germany. For child and adolescent psychiatry, more evidence is needed to draw firm conclusions. TRIAL REGISTRATION: This study was registered in the database "Health Services Research Germany" (trial number: VVfD_EVA64_15_003713).

[Pneumococcal Vaccination Coverage Rates (VCRs) Among Persons with Vaccine-Relevant Underlying Conditions and Persons Aged 60 Years and Older - An Analysis of Secondary Data from the Statutory Health Insurance (SHI) System]. / Impfquoten der Pneumokokken-Impfung bei Personen mit impfrelevanten Grunderkrankungen und Personen ab 60 Jahren ­ Eine Analyse von Sekundärdaten der Gesetzlichen Krankenversicherung (GKV).

BACKGROUND: In addition to standard vaccination for patients aged 60 and older, the Standing Committee on Vaccination (STIKO) recommends immunization against pneumococci for anyone at increased risk, including patients with chronic vaccine-relevant underlying conditions. In Germany, the Robert Koch Institute (RKI) regularly publishes vaccination coverage rates (VCRs) for these patient groups, without stratifying by other parameters. This study examines VCRs of patients with underlying chronic diseases, stratified by disease groups and entities, the re-vaccination rate, and VCRs in patients aged 60 years and older. METHODS: This descriptive retrospective cohort study is based on a sample of about 4 million SHI-insured patients aged 16 years and older for the years 2014 to 2019, from the Institute for Applied Health Research (InGef) database. The sample is representative of age and sex distribution in the German population. RESULTS: Extrapolated to the total SHI-population, the overall pneumococcal VCR in patients aged 60 years and older was 45.9 % (of n= InGef standard vaccination cohort: 1 009 763). Among all at-risk patients aged 16 years and older with chronic underlying diseases, only 17.1 % had received an indicated vaccination (InGef indicated vaccination cohort: 1 379 680). Stratified by disease entity, those with underlying pulmonary emphysema had the highest VCR, at 39.0 % (of n= 28 121). Of those who received a vaccination due to an underlying chronic disease, only 23.9 % were re-vaccinated after 6 years (InGef re-vaccination cohort: 12 328). Across all vaccination cohorts, VCRs increased with age. DISCUSSION: The recommendations made by STIKO for pneumococcal vaccination based on age or an underlying chronic condition are not being implemented adequately in Germany. Although STIKO explicitly recommends vaccination from 60 years of age, the 60 to 64-year-old age group had a strikingly low VCR (13.0 % of n=268 862). Fewer than one in five patients aged 16 years and older with an underlying chronic condition had received the recommended indicated vaccination. To adequately prevent potential disease, higher vaccination rates should be targeted. This could probably be achieved through more stringent vaccination management, appropriate software solutions with vaccination reminders, monetary incentives for achieving higher vaccination rates and documentation of vaccination status in disease management programs.

Agreement between self-reports and statutory health insurance claims data on healthcare utilization in patients with mental disorders.

BACKGROUND: Data on resource use are frequently required for healthcare assessments. Studies on healthcare utilization (HCU) in individuals with mental disorders have analyzed both self-reports and administrative data. Source of data may affect the quality of analysis and compromise the accuracy of results. We sought to ascertain the degree of agreement between self-reports and statutory health insurance (SHI) fund claims data from patients with mental disorders. METHODS: Claims data from six German SHI and self-reports were obtained along with a cost-effectiveness analysis performed as a part of a controlled prospective multicenter cohort study conducted in 18 psychiatric hospitals in Germany (PsychCare), including patients with pre-defined psychiatric disorders. Self-reports were collected using the German adaption of the Client Sociodemographic and Service Receipt Inventory (CSSRI) questionnaire with a 6-month recall period. Data linkage was performed using a unique pseudonymized identifier. Missing responses were coded as non-use for all analyses. HCU was calculated for inpatient and outpatient care, day-care services, home treatment, and pharmaceuticals. Concordance was measured using Cohen's Kappa (κ) and intraclass correlation coefficient (ICC). Regression approaches were used to investigate the effect of independent variables on the agreements. RESULTS: In total 274 participants (mean age 47.8 [SD = 14.2] years; 47.08% women) were included in the analysis. No significant differences were observed between the linked and unlinked patients in terms of baseline characteristics. Total agreements values were 63.9% (κ = 0.03; PABAK = 0.28) for outpatient contacts, 69.3% (κ = 0.25; PABAK = 0.39) for medication use, 81.0% (κ = 0.56; PABAK = 0.62) for inpatient days and 86.1% (κ = 0.67; PABAK = 0.72) for day-care services. There was varied quantitative agreement between data sources, with the poorest agreement for outpatient care (ICC [95% CI] = 0.22 [0.10-0.33]) and the best for psychiatric day-care services (ICC [95% CI] = 0.72 [0.66-0.78]). Marital status and time since first treatment positively affected the chance of agreement on utilization of outpatient services. CONCLUSIONS: Although there were high levels of absolute agreement, the measures of concordance between administrative records and self-reports were generally minimal to moderate. Healthcare investigations should consider using linked or at least different data sources to estimate HCU for specific utilization areas, where unbiased information can be expected. TRIAL REGISTRATION: This study was part of the multi-center controlled PsychCare trial (German Clinical Trials Register No. DRKS00022535; Date of registration: 2020-10-02).

Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis.

BACKGROUND: With its digital health application (DiGA)-system, Germany is considered one of Europe's pioneers in the field of evidence-based digital health. Incorporating DiGA into standard medical care must be based on evidence-based success factors; however, a comprehensive overview of the evidence required of scientific studies for their approval is lacking. OBJECTIVE: The study aims to, (1) identify specific requirements defined by the Federal Institute for Drugs and Medical Devices (German: Bundesinstitut für Arzneimittel- und Medizinprodukte; BfArM) to design adequate studies, proving a positive healthcare effect, and (2) to assess the evidence given for applications permanently listed in the DiGA directory. METHODS: A multi-step approach was used: (1) identification of the evidence requirements for applications permanently listed in the DiGA directory, (2) identification of the evidence available supporting them. RESULTS: All DiGA permanently listed in the DiGA directory (13 applications) are included in the formal analysis. Most DiGA addressed mental health (n = 7), and can be prescribed for one or two indications (n = 10). All permanently listed DiGA have demonstrated their positive healthcare effect through a medical benefit, and most of them provide evidence for one defined primary endpoint. All DiGA manufacturers conducted a randomized controlled trial. DISCUSSION: It is striking that- although patient-relevant structural and procedural improvements show high potential for improving care, especially in terms of processes - all DiGA have provided a positive care effect via a medical benefit. Although BfArM accepts study designs with a lower level of evidence for the proof of a positive healthcare effect, all manufacturers conducted a study with a high level of evidence. CONCLUSION: The results of this analysis indicate that permanently listed DiGA meet higher standards than required by the guideline.

Epidemiology and Risk Factors of Clostridioides difficile Infections in Germany: A Health Claims Data Analysis.

INTRODUCTION: Clostridioides difficile infection (CDI) is increasingly recognized as a public health threat at the community level in addition to being one of the most common causes of healthcare-associated infections. In Germany, the epidemiology of CDI is primarily informed by national hospital-based CDI surveillance. We used health claims data from Germany to obtain valuable insights on population-level disease burden and risk factors for CDI. METHODS: This was a retrospective cohort study using a representative sample from the InGef research database. Overall and age- and sex-stratified CDI incidence rates were estimated for German adults from 2013 to 2017 using different case definitions (i.e., main, broad, strict), and further stratified by setting (inpatient versus outpatient). Risk factors for CDI were assessed for the 2013-2016 period. RESULTS: The CDI incidence rate was high but declined by 15.3% from 2013 [141 (95% confidence interval, CI 137-145) cases/100,000 person-years] to 2017 [120 (95% CI 116-123)]. Annual CDI incidence rates were higher in female patients and the elderly. The most important risk factors for CDI were chronic inflammatory bowel disease [odds ratio (OR) 4.7, 95% CI 4.0-5.5], chemotherapy (OR 4.7, 95% CI 4.1-5.2), chronic kidney disease (OR 2.9, 95% CI 2.6-3.3), and ciprofloxacin receipt (OR 2.6, 95% CI 2.4-2.8). CONCLUSIONS: Despite prevention strategies leading to declining incidence, CDI remains an important public health threat in Germany, with a high burden in the hospital setting and an outpatient epidemiology that is poorly understood. These findings, which are relevant both regionally and globally, can be used as a basis for further research on the full burden of CDI in Germany.

Health Care for Inpatients with a Proximal Humeral Fracture - an Analysis of Health Insurance Data. / Versorgungsrealität stationär behandelter Patienten mit proximaler Humerusfraktur ­ Eine Analyse auf Basis von GKV-Daten.

The proximal humeral fracture is one of the most common fractures in the elderly. While epidemiological factors have been well studied, the influence of a proximal humeral fracture on morbidity, mortality and associated costs has not yet been adequately analysed.On a basis of 4.1 million insurance holders of the German public health insurance (GKV), patients with (study population, SP) and without (comparison group, VG) a proximal humeral fracture (pHF) were compared with regard to comorbidity, rehospitalisation, mortality, drug and aid needs as well as number of physician contacts. Study period was between 2012 and 2016.6068 patients of the SP met the inclusion and exclusion criteria (age 69.4 ± 14.3 years; male : female = 28.2% : 71.8%). 4781 patients (78.8%) received surgical, 1287 patients (21.2%) conservative treatment of the pHF. Rehospitalisations and visits to the general practitioner occurred more frequently in the SP vs. VG (p < 0.01). Contacts with specialists after pHF varied according to specialty, as did newly occurring diseases. Typical specialities for preventive examinations were significantly less common (gynaecology p < 0.01, pathology p < 0.01, dermatology p < 0.01). According to pHF, the costs of SP for drugs (2490.76 ± 1395.51 € vs. 2167.86 ± 1314.43 €; p = 0.04), medical therapies (867.01 ± 238.67 € vs. 393.26 ± 217.55 €; p < 0.01) and aids (821.02 ± 415.73 € vs. 513.52 ± 368.76 €; p < 0.01) were significantly above the VG. The two-year survival after pHF is lower in the SP than in the VG (p < 0.01).The results show increased morbidity and mortality as well as medical costs after a proximal humeral fracture. Preventive examinations and treatments are rarer. In the future, care concepts for patients with proximal humeral fractures should not only be optimised with regard to functional scores and reduced complication rates, but also with regard to quality of life and preservation of general health.

Lengths of inpatient stay and sick leave of patients with mental diseases: disorder-specific effects of flexible and integrated treatment programs in Germany.

Mental disorders pose a worldwide growing public health burden. One of the major challenges for healthcare systems remains to respond to the need of patients with mental disorders for continuous and flexible treatment. The EVA64 study evaluates novel programs of flexible and integrative treatment (FIT) in hospitals. This manuscript presents results from the evaluation of FIT hospitals in comparison to hospitals from regular routine care. In addition to data from adult patients, we also present data from affiliated child and adolescent psychiatric wards employing FIT programs. Using comprehensive claims data, primary outcomes are the utilization of inpatient care and sick leave for a priori defined clusters of mental disorders. We stratify between patients already under treatment (ongoing treatment) and patients with incident treatment cases (initial treatment) at the point of inclusion in the study. In the initial treatment group, we found a significant reduction in the length of inpatient stay of 4.1 days in FIT hospitals compared to routine care. While patients with mood affective disorders (-1.8 days) and patients with neurotic, stress-related, and somatoform disorders (-3.6 days) showed an even stronger effect of the reduction of inpatient lengths of stay, the effect was significantly weaker in patients with mental and behavioral disorders due to use of alcohol (+3.3 days). Regarding the duration of sick leave, we found no significant treatment effect of FIT programs compared to routine care. In the ongoing treatment group of adult patients, we found a significantly lower utilization of inpatient treatment by 1.3 days as well as a shorter duration of sick leave by 4.3 days in FIT hospitals compared to routine care. In the cohort of children and adolescent patients, we also did not observe a significant treatment effect in either the initial treatment group or the ongoing treatment group. Registration: this study was registered in the database "Health Services Research Germany" (trial number: VVfD_EVA64_15_003713).

Lichen planus in Deutschland - Epidemiologie, Behandlung und Komorbidität. Eine retrospektive Krankenkassendatenanalyse.

HINTERGRUND UND ZIELE: Lichen planus (LP) ist eine chronisch entzündliche Hauterkrankung, die eine große Belastung für die betroffenen Patienten darstellt. Es liegen jedoch nur wenige Daten zu dieser Erkrankung vor. Ziel dieser Studie ist es, das Wissen über die Epidemiologie und die Behandlungsmuster des LP anhand von Abrechnungsdaten deutscher Krankenkassen zu erweitern. PATIENTEN UND METHODEN: Diese retrospektive Beobachtungsstudie nutzte die InGef-Forschungsdatenbank. Es wurden prävalente und inzidente LP-Patienten aus den Jahren 2015 und 2018 identifiziert. Für demografische Charakteristika, Behandlungsmuster und Komorbidität wurden deskriptive Statistiken berechnet. ERGEBNISSE: Die Prävalenz des LP lag bei 95,9 und die Inzidenz bei 20,1 pro 100 000 Personen im Jahr 2018, was 79 605 prävalenten LP-Fällen in Deutschland entspricht. Die erste LP-Diagnose wurde in der Regel von einem Dermatologen oder Hausarzt gestellt. Drei Viertel der inzidenten und die Hälfte der prävalenten Patienten erhielten eine topische Therapie, meist ohne zusätzliche systemische Therapie. Die Komorbidität des LP stand im Einklang mit bereits bekannten Assoziationen. SCHLUSSFOLGERUNGEN: Die verfügbaren Therapieoptionen sind nach wie vor begrenzt, was den ungedeckten Bedarf an sicheren und wirksamen systemischen Behandlungsmodalitäten unterstreicht. Der LP ist häufig mit klinisch relevanter systemischer Komorbidität verbunden. Zusammengenommen könnten diese Beobachtungen zu einem verbesserten Verständnis der Krankheitslast führen und das diagnostische Bewusstsein für diese Erkrankung unter Klinikern schärfen.

Lichen planus in Germany - epidemiology, treatment, and comorbidity. A retrospective claims data analysis.

BACKGROUND AND OBJECTIVES: Lichen planus (LP) is a chronic inflammatory skin disease and is a major burden for affected patients. However, data on this condition are scarce. This study aims to expand the knowledge on the epidemiology and treatment patterns of LP using German health claims data. PATIENTS AND METHODS: This retrospective observational study was based on the InGef research database. Prevalent and incident LP patients were identified in the years 2015 and 2018. Descriptive statistics were calculated for demographic characteristics, treatment patterns, and comorbidity. RESULTS: The prevalence of LP was 95.9 and the incidence was 20.1 per 100,000 individuals in 2018, corresponding to 79,605 prevalent LP cases in Germany. The first LP diagnosis was generally documented by a dermatologist or a primary care physician. Three-quarters of the incident and half of the prevalent patients received topical therapy, mostly without further systemic therapy. Comorbidity in LP patients was consistent with previously known associations. CONCLUSIONS: Available treatment options remain limited, underscoring the unmet need for safe and efficacious systemic treatment modalities. Lichen planus is frequently accompanied by clinically relevant systemic comorbidity. Taken together, these observations may improve our understanding of the burden of this disease and increase diagnostic awareness among clinicians.

Glycaemic variability is associated with all-cause mortality in COVID-19 patients with ARDS, a retrospective subcohort study.

There is high mortality among intensive care unit (ICU) patients with acute respiratory distress syndrome (ARDS) caused by coronavirus disease (COVID-19). Important factors for COVID-19 mortality are diabetes status and elevated fasting plasma glucose (FPG). However, the effect of glycaemic variability on survival has not been explored in patients with COVID-19 and ARDS. This single-centre cohort study compared several metrics of glycaemic variability for goodness-of-fit in patients requiring mechanical ventilation due to COVID-19 ARDS in the ICU at University Hospital Aachen, Germany. 106 patients had moderate to severe ARDS (P/F ratio median [IQR]: 112 [87-148] mmHg). Continuous HRs showed a proportional increase in mortality risk with daily glycaemic variability (DGV). Multivariable unadjusted and adjusted Cox-models showed a statistically significant difference in mortality for DGV (HR: 1.02, (P) < 0.001, LR(P) < 0.001; HR: 1.016, (P) = 0.001, LR(P) < 0.001, respectively). Kaplan-Meier estimators yielded a shorter median survival (25 vs. 87 days) and a higher likelihood of death (75% vs. 31%) in patients with DGV ≥ 25.5 mg/dl (P < 0.0001). High glycaemic variability during ICU admission is associated with significant increase in all-cause mortality for patients admitted with COVID-19 ARDS to the ICU. This effect persisted even after adjustment for clinically predetermined confounders, including diabetes, median procalcitonin and FPG.

Pneumococcal vaccination rates in immunocompromised patients in Germany: A retrospective cohort study to assess sequential vaccination rates and changes over time.

BACKGROUND: Pneumococcal vaccination is recommended by the German Standing Committee on Vaccination (STIKO) for infants, elderly 60+ years and patients at risk. In 2016, a sequential pneumococcal vaccination schedule (conjugate vaccine followed by polysaccharide vaccine 6-12 months later) supplemented this recommendation for immunocompromised patients ≥2 years of age. Previous research showed low pneumococcal vaccination rates (pnc-VR) in this vulnerable group. Moreover, no evidence is available on adherence to the newer sequential schedule. This study aimed to analyze the development of pnc-VRs in immunocompromised patients and rates of sequential vaccinations according to the STIKO recommendations. METHODS: Using a representative health claims database, we assigned incident immunocompromised patients ≥2 years of age to one of two successive cohorts to observe trends over time: cohort A (first diagnosis of immunocompromised condition between 01/2013 and 12/2014), and cohort B (first diagnosis between 01/ 2015 and 12/2017). Pnc-VR within two years after first diagnosis and cumulative pnc-VR was compared among both cohorts. In cohort B, we assessed sequential pnc-VR within 15 months of the first vaccination. For additional analyses, patients were stratified by age, gender and immunocompromising condition. RESULTS: Cohort A and B comprised 193,521 and 289,279 patients, respectively. Overall pnc-VR increased over time from 4.3% (cohort A; 95%-confidence interval: 4.3%-4.4%) to 6.0% (cohort B; 5.9%-6.1%), with highest pnc-VRs in men ≥60 years (11.3%: 11.1%-11.6%) and HIV patients (15.2%: 13.1%-17.4%). Cumulative pnc-VRs in cohort B were higher in any quarter following diagnosis when compared with cohort A. Overall sequential pnc-VR in cohort B was 4.0% (3.7%-4.3%), with a higher rate observed in patients aged 16-59 (6.8%: 6.0%-7.7%) vs. patients aged ≥60 years (3.1%: 2.8%-3.4%). CONCLUSION: While some improvements were seen over time, pnc-VRs remain very low in immunocompromised patients, as did sequential vaccination rates. Current recommendations to protect immunocompromised patients from pneumococcal infections are not being sufficiently implemented.

Multiperspective and Multimethod Evaluation of Flexible and Integrative Psychiatric Care Models in Germany: Study Protocol of a Prospective, Controlled Multicenter Observational Study (PsychCare).

Background: New cross-sectoral mental health care models have been initiated in Germany to overcome the fragmentation of the German health care system. Starting in 2013, flexible and integrative psychiatric care model projects according to §64b SGB V German Social Law (FIT64b) have been implemented. The study "PsychCare" combines quantitative and qualitative primary data with routine health insurance data for the evaluation of these models. Effects, costs and cost-effectiveness from the perspectives of patients, relatives and care providers are compared with standard care. Additionally, quality indicators for a modern, flexible and integrated care are developed. This article describes the rationale, design and methods of the project. Methods: "PsychCare" is built on a multiperspective and multimethod design. A controlled prospective multicenter cohort study is conducted with three data collection points (baseline assessment, follow-up after 9 and 15 months). A total of 18 hospitals (10 FIT64b model and 8 matched control hospitals) have consecutively recruited in- and outpatients with pre-specified common and/or severe psychiatric disorders. Primary endpoints are differences in change of health-related quality of life and treatment satisfaction. Sociodemographic and service receipt data of the primary data collection are linked with routine health insurance data. A cost-effectiveness analysis, a mixed method, participatory process evaluation by means of qualitative surveys and the development of quality indicators are further elements of "PsychCare." Discussion and Practical Implications: The results based on data from different methodological approaches will provide essential conclusions for the improvement of hospital based mental health care in Germany. This should result in the identification of key FIT64b elements that can be efficiently implemented into standard care in Germany and re-structure the care strongly aligned to patient needs. Clinical Trial Registration: German Clinical Trial Register, identifier DRKS 00022535.

Population-based incidence and mortality of community-acquired pneumonia in Germany.

BACKGROUND: Little information on the current burden of community-acquired pneumonia (CAP) in adults in Germany is available. METHODS: We conducted a retrospective cohort study using a representative healthcare claims database of approx. 4 million adults to estimate the incidence rates (IR) and associated mortality of CAP in 2015. IR and mortality were stratified by treatment setting, age group, and risk group status. A pneumonia coded in the primary diagnosis position or in the second diagnosis position with another pneumonia-related condition coded in the primary position was used as the base cases definition for the study. Sensitivity analyses using broader and more restrictive case definitions were also performed. RESULTS: The overall IR of CAP in adults ≥18 years was 1,054 cases per 100,000 person-years of observation. In adults aged 16 to 59 years, IR for overall CAP, hospitalized CAP and outpatient CAP was 551, 96 and 466 (with a hospitalization rate of 17%). In adults aged ≥60 years, the respective IR were 2,032, 1,061 and 1,053 (with a hospitalization rate of 52%). If any pneumonia coded in the primary or secondary diagnosis position was considered for hospitalized patients, the IR increased 1.5-fold to 1,560 in the elderly ≥60 years. The incidence of CAP hospitalizations was substantially higher in adults ≥18 years with at-risk conditions and high-risk conditions (IR of 608 and 1,552, respectively), compared to adults without underlying risk conditions (IR 108). High mortality of hospitalized CAP in adults ≥18 was observed in-hospital (18.5%), at 30 days (22.9%) and at one-year (44.5%) after CAP onset. Mortality was more than double in older adults in comparison to younger patients. CONCLUSION: CAP burden in older adults and individuals with underlying risk conditions was high. Maximizing uptake of existing vaccines for respiratory diseases may help to mitigate the disease burden, especially in times of strained healthcare resources.

Vaccination rate and adherence of tick-borne encephalitis vaccination in Germany.

BACKGROUND: Tick-borne encephalitis (TBE) is an arboviral infection of the central nervous system. As there is no causal treatment of TBE, disease prevention by vaccination is especially important. Immunization consists of a three-dose primary vaccination schedule, followed by regular booster doses. In Germany, the Standing Committee on Vaccination (STIKO) at the Robert Koch-Institute recommends TBE vaccination for all those at high risk of contracting TBE. This includes individuals living in, traveling to and/or working in risk areas, and being exposed to ticks. To our knowledge, there are currently no reliable data on TBE vaccination rates in Germany available. METHODS: This retrospective cohort study based on anonymized German health claims data was conducted to determine vaccination rates of TBE primary immunization in 2012 to 2015 by federal state, compliance with the vaccination schedule, and TBE vaccination uptake for the 2011 birth cohort. Vaccination protection rates for each federal state were simulated based on a compartmental model. RESULTS: Vaccination rates of an initiated primary immunization ranged from about 3% in the southern federal states to <1% in the northern federal states. Across all federal states, compliance with the vaccination schedule decreased with each subsequent vaccination. Slightly higher TBE vaccination uptake was determined in the 2011 birth cohort, as compared to the German school entry health examination statistics in 2017. Simulated vaccination protection rates for each federal state ranged from 10% in Hamburg to 51% in Baden-Wuerttemberg. CONCLUSIONS: While there was an overall low vaccination uptake and a discrepancy between areas of high vs. low TBE risk, this study also indicates a concerning decline in vaccination compliance. Vaccinating physicians should address the importance of adherence upon initiation of TBE vaccination.

Early risk markers for severe clinical course and fatal outcome in German patients with COVID-19.

BACKGROUND: Some patients with Corona Virus Disease 2019 (COVID-19) develop a severe clinical course with acute respiratory distress syndrome (ARDS) and fatal outcome. Clinical manifestations and biomarkers in early stages of disease with relevant predictive impact for outcomes remain largely unexplored. We aimed to identify parameters which are significantly different between subgroups. DESIGN: 125 patients with COVID-19 were analysed. Patients with ARDS (N = 59) or non-ARDS (N = 66) were compared, as well as fatal outcome versus survival in the two groups. KEY RESULTS: ARDS and non-ARDS patients did not differ with respect to comorbidities or medication on developing a fatal outcome versus survival. Body mass index was higher in patients with ARDS versus non-ARDS (p = 0.01), but not different within the groups in survivors versus non-survivors. Interleukin-6 levels on admission were higher in patients with ARDS compared to non-ARDS as well as in patients with fatal outcome versus survivors, whereas lymphocyte levels were lower in the different subgroups (all p<0.05). There was a highly significant 3.5-fold difference in fever load in non-survivors compared to survivors (p<0.0001). Extrapulmonary viral spread was detected more often in patients with fatal outcome compared to survivors (P = 0.01). Further the detection of SARS-CoV-2 in serum showed a significantly more severe course and an increased risk of death (both p<0.05). CONCLUSIONS: We have identified early risk markers for a severe clinical course, like ARDS or fatal outcome. This data might help develop a strategy to address new therapeutic options early in patients with COVID-19 and at high risk for fatal outcome.

[Prevalence, Costs of Medical Treatment and Modalities of Dialysis-dependent Chronic Renal Failure in Germany: Comparison of Dialysis Care of Nursing Home Residents and in Outpatient Units]. / Prävalenz, Kosten der Versorgung und Formen des dialysepflichtigen chronischen Nierenversagens in Deutschland: Vergleich der Dialyseversorgung innerhalb und außerhalb stationärer Pflegeeinrichtungen.

STUDY OBJECTIVES: Current estimates on the prevalence of chronic renal failure and the costs of dialysis in Germany's population are not available. The aim of this study was to assess the prevalence of dialysis-dependent chronic renal failure and treatment costs of dialysis-dependent patients in Germany as well as differences between those residing in nursing homes and those treated in outpatient units. METHODS: Health insurance claims from 4.5 million anonymized patients in the WIG2 research database were analyzed. Patients of all ages who had received outpatient dialysis treatment for chronic renal failure in 2017 (using uniform value scale code 13602) were included. These insurance claims were extrapolated to the German statutory health insurance population and, using official statistics, further to the entire population of Germany. Data on comorbidities, use of health resources, and costs were compared among patients residing in nursing homes and those treated in outpatient units. RESULTS: In 2017, there were 87,255 dialysis-dependent statutory health insurance patients (≙1,054 person/1 million population, pmp), and 100,202 in Germany's whole population (≙1,210 pmp). About 8% of dialysis-dependent patients (n=7,676) were living in nursing homes. Our analyses predict an increase in dialysis-dependent patients of about 20-23% (up to 120,000-123,000), with an increase of dialysis-dependent nursing home residents of 37-44% (up to 10,500-11,000) by 2040. Almost all dialysis-dependent patients were treated with hemodialysis; peritoneal dialysis was rarely observed. The average annual treatment costs for dialysis-dependent patients residing in nursing homes amounted to 57,205 Euro and 53,996 Euro per patient respectively, with total annual statutory health insurance treatment costs amounting to about 4.73 billion Euro in 2017. CONCLUSION: This study presents current estimates for dialysis-dependent chronic renal failure in Germany. Our findings on prevalence are comparable to data from other European countries and suggest a considerable increase in dialysis dependency by 2040, particularly for nursing home residents, resulting in a further increase in dialysis care costs. Hemodialysis was the most commonly used dialysis modality in patients living both in and out of nursing care facilities, with peritoneal dialysis rarely being used.