[Genetic tumour diagnostics and personalised medicine from a systems perspective]. / Genetische Tumordiagnostik und Personalisierte Medizin aus der System-Perspektive.

High-quality studies are necessary and feasible in personalised medicine in order to evaluate the benefits across the entire treatment chain of biomarker tests and resulting treatments in regard to patient-relevant endpoints. With the introduction of genome sequencing in oncology, a considerable number of new treatment concepts with mostly low-quality evidence can be expected. High quality requirements, interdisciplinary cooperation structures, knowledge-generating care and the connection of patient care at the expense of the statutory health insurance funds, with research at the expense of the manufacturers or public funding, are necessary.

Treated post-acute sequelae after COVID-19 in a German matched cohort study using routine data from 230,256 adults.

Background: Post-acute sequelae after COVID-19 are still associated with knowledge gaps and uncertainties at the end of 2022, e.g., prevalence, pathogenesis, treatment, and long-term outcomes, and pose challenges for health providers in medical management. The aim of this study was to contribute to the understanding of the multi-faceted condition of long-/ post-COVID. It was designed to evaluate whether a prior SARS-CoV-2 infection during the first COVID-19 wave in Germany increases the rate of disease, as measured via a record of insurance data on diagnoses, symptoms, and treatment, in the subsequent 12 months compared with matched control groups without recorded SARS-CoV-2 infection. Method: 50 outcome variables at disease, symptom and treatment levels (14 main categories and 36 sub-categories; new diagnoses) were defined from health insurance data. Logistic regression was carried out for two groups of patients tested positive in a PCR test in March/April 2020 for SARS-CoV-2, compared to the respective risk-adjusted (age, administrative region, 1:5 propensity-score matching), contemporaneous control group without prior documented SARS-CoV-2 infection (CG): First, individuals with outpatient treatment of acute COVID-19, indicating a not severe course (COV-OUT), and second, individuals with inpatient treatment of acute COVID-19, indicating a severe course (COV-IN) were compared with their respective control group. Results: The mortality rate in COV-OUT (n = 32,378) and COV-IN (n = 5,998) groups is higher compared to their control groups with odds ratio (OR) 1.5 [95%CI (1.3, 1.6)] and 1.7 [95%CI (1.5, 1.8)] respectively. Both groups were more likely to have experienced at least one outcome compared to their CG [OR = 1.4, 95%CI (1.4, 1.4)]; OR = 2.5, 95%CI [2.4, 2.6]). 42/37 (COV-IN/COV-OUT) outcome variables showed increased ORs. COV-OUT: Loss of taste and smell [OR = 5.8, 95%CI (5.1, 6.6)], interstitial respiratory diseases [OR = 2.8, 95%CI (2.0, 4.1)] and breathing disorders [OR = 3.2, 95%CI (2.2, 4.7)] showed the highest ORs. COV-IN: Interstitial respiratory diseases [OR = 12.2, 95%CI (8.5, 17.5)], oxygen therapy [OR = 8.1, 95%CI (6.4, 10.2)] and pulmonary embolism/anticoagulation [OR = 5.9, 95%CI (4.4, 7.9)] were the most pronounced. Conclusion: Following a SARS-CoV-2 infection during the first wave of the COVID-19 pandemic in Germany, 8.4 [COV-OUT, 95%CI (7.7, 9.1)] respectively 25.5 [COV-IN, 95%CI (23.6, 27.4)] percentage points more subjects showed at least one new diagnosis/symptom/treatment compared to their matched CG (COV-OUT: 44.9%, CG: 36.5%; COV-IN: 72.0%, CG: 46.5%). Because the symptoms and diagnoses are so varied, interdisciplinary and interprofessional cooperation among those providing management is necessary.

6-month mortality and readmissions of hospitalized COVID-19 patients: A nationwide cohort study of 8,679 patients in Germany.

BACKGROUND: COVID-19 frequently necessitates in-patient treatment and in-patient mortality is high. Less is known about the long-term outcomes in terms of mortality and readmissions following in-patient treatment. AIM: The aim of this paper is to provide a detailed account of hospitalized COVID-19 patients up to 180 days after their initial hospital admission. METHODS: An observational study with claims data from the German Local Health Care Funds of adult patients hospitalized in Germany between February 1 and April 30, 2020, with PCR-confirmed COVID-19 and a related principal diagnosis, for whom 6-month all-cause mortality and readmission rates for 180 days after admission or until death were available. A multivariable logistic regression model identified independent risk factors for 180-day all-cause mortality in this cohort. RESULTS: Of the 8,679 patients with a median age of 72 years, 2,161 (24.9%) died during the index hospitalization. The 30-day all-cause mortality rate was 23.9% (2,073/8,679), the 90-day rate was 27.9% (2,425/8,679), and the 180-day rate, 29.6% (2,566/8,679). The latter was 52.3% (1,472/2,817) for patients aged ≥80 years 23.6% (1,621/6,865) if not ventilated during index hospitalization, but 53.0% in case of those ventilated invasively (853/1,608). Risk factors for the 180-day all-cause mortality included coagulopathy, BMI ≥ 40, and age, while the female sex was a protective factor beyond a fewer prevalence of comorbidities. Of the 6,235 patients discharged alive, 1,668 were readmitted a total of 2,551 times within 180 days, resulting in an overall readmission rate of 26.8%. CONCLUSIONS: The 180-day follow-up data of hospitalized COVID-19 patients in a nationwide cohort representing almost one-third of the German population show significant long-term, all-cause mortality and readmission rates, especially among patients with coagulopathy, whereas women have a profoundly better and long-lasting clinical outcome compared to men.

Case characteristics, resource use, and outcomes of 10 021 patients with COVID-19 admitted to 920 German hospitals: an observational study.

Background Nationwide, unbiased, and unselected data of hospitalised patients with COVID-19 are scarce. Our aim was to provide a detailed account of case characteristics, resource use, and outcomes of hospitalised patients with COVID-19 in Germany, where the health-care system has not been overwhelmed by the pandemic. METHODS: In this observational study, adult patients with a confirmed COVID-19 diagnosis, who were admitted to hospital in Germany between Feb 26 and April 19, 2020, and for whom a complete hospital course was available (ie, the patient was discharged or died in hospital) were included in the study cohort. Claims data from the German Local Health Care Funds were analysed. The data set included detailed information on patient characteristics, duration of hospital stay, type and duration of ventilation, and survival status. Patients with adjacent completed hospital stays were grouped into one case. Patients were grouped according to whether or not they had received any form of mechanical ventilation. To account for comorbidities, we used the Charlson comorbidity index. FINDINGS: Of 10 021 hospitalised patients being treated in 920 different hospitals, 1727 (17%) received mechanical ventilation (of whom 422 [24%] were aged 18-59 years, 382 [22%] were aged 60-69 years, 535 [31%] were aged 70-79 years, and 388 [23%] were aged ≥80 years). The median age was 72 years (IQR 57-82). Men and women were equally represented in the non-ventilated group, whereas twice as many men than women were in the ventilated group. The likelihood of being ventilated was 12% for women (580 of 4822) and 22% for men (1147 of 5199). The most common comorbidities were hypertension (5575 [56%] of 10 021), diabetes (2791 [28%]), cardiac arrhythmia (2699 [27%]), renal failure (2287 [23%]), heart failure (1963 [20%]), and chronic pulmonary disease (1358 [14%]). Dialysis was required in 599 (6%) of all patients and in 469 (27%) of 1727 ventilated patients. The Charlson comorbidity index was 0 for 3237 (39%) of 8294 patients without ventilation, but only 374 (22%) of 1727 ventilated patients. The mean duration of ventilation was 13·5 days (SD 12·1). In-hospital mortality was 22% overall (2229 of 10 021), with wide variation between patients without ventilation (1323 [16%] of 8294) and with ventilation (906 [53%] of 1727; 65 [45%] of 145 for non-invasive ventilation only, 70 [50%] of 141 for non-invasive ventilation failure, and 696 [53%] of 1318 for invasive mechanical ventilation). In-hospital mortality in ventilated patients requiring dialysis was 73% (342 of 469). In-hospital mortality for patients with ventilation by age ranged from 28% (117 of 422) in patients aged 18-59 years to 72% (280 of 388) in patients aged 80 years or older. INTERPRETATION: In the German health-care system, in which hospital capacities have not been overwhelmed by the COVID-19 pandemic, mortality has been high for patients receiving mechanical ventilation, particularly for patients aged 80 years or older and those requiring dialysis, and has been considerably lower for patients younger than 60 years. FUNDING: None.

[Measuring, assessing, acting: A practice test of quality indicators for coronary heart disease]. / Messen, Bewerten, Handeln: Qualitätsindikatoren zur Koronaren Herzkrankheit im Praxistest.

BACKGROUND: There are only limited possibilities for doctors in outpatient services to establish quality management that is based on data-driven feedback regarding the quality of health care. However, transparency about one's own activities is a prerequisite for refining this quality. The aim of this project was to make the quality of care for patients with coronary heart disease (CHD) more transparent, use this as a basis to initiate improvement processes, and explore the framework conditions and factors promoting or inhibiting the intended improvement of health care quality. METHOD: 48 general practitioners (GPs) in 32 GP practices from a Bavarian doctors' network (Qualität und Effizienz, QuE) participated in the project. On the basis of claims data from the AOK-Bayern (a statutory health insurance in Bavaria), data from disease management programs (DMP) and medically documented data, 11 quality indicators for patients with CHD were calculated. The indicator scores were individually presented in feedback reports for each doctor's practice. These were the basis for two quality circles. The indicators were measured again after 12 months, and changes against the baseline measurement were registered. GPs from Bavaria formed the control group. Focus groups with the quality circle moderators and two participant surveys were used to identify promoting and inhibiting factors. RESULTS: The baseline values showed a good level of care. Potential for improvement became apparent for pharmacotherapy with beta blockers and statins. After conducting the quality circles four of the eleven indicators showed an increase as intended ("beta blockers for CHD and cardiac insufficiency", "beta blockers after myocardial infarction", "statins", "successful blood pressure control"). For three of these indicators the increase rates were higher than those in the Bavarian control group. One indicator ("statins") was striking because of the wide variation of practice values suggesting differences in care within the network. The majority of participating doctors regarded the database as valid. Quality circles were highly appreciated as an opportunity for professional exchange among colleagues. The data-based feedback reports helped to make deficits in health care transparent and to identify actions that need to be taken. Barriers to implementing quality improvement measures in clinical practice became apparent. DISCUSSION: Reflecting quality indicators in quality circles can effectively trigger quality improvement processes. Barriers would appear to exist, in particular, to the implementation of measures into daily practice routine. Additional organizational support offered by higher-level quality management structures, IT solutions for patient-related data processing as well as a system of financial compensation, which rewards professional concern for quality, may help to overcome the existing barriers.

Comparative risks of bleeding, ischemic stroke and mortality with direct oral anticoagulants versus phenprocoumon in patients with atrial fibrillation.

PURPOSE: The pivotal trials for stroke prevention in non-valvular atrial fibrillation (NVAF) compared rivaroxaban, dabigatran, and apixaban with warfarin, as did most claims-based studies. Comparisons with phenprocoumon, the most frequently used vitamin K antagonist (VKA) in Germany, are scarce. METHODS: Risk of bleeding, ischemic stroke, and all-cause mortality in patients with NVAF were analyzed using data for 2010 to 2014 from a large German claims database. New users of oral anticoagulants from January 2012 to December 2013 were included and observed over 1 year. Baseline characteristics were adjusted using propensity score matching and logistic regression. Several sensitivity analyses were carried out. RESULTS: Fifty-nine thousand four hundred forty-nine rivaroxaban, 23,654 dabigatran, 4894 apixaban, and 87,997 matched phenprocoumon users were included. Adjusted hazard ratios (95% confidence intervals) compared with phenprocoumon were as follows: hospitalized bleedings: rivaroxaban 1.04 (0.97; 1.11), dabigatran 0.87 (0.77; 0.98), and apixaban 0.65 (0.50; 0.86); ischemic stroke: rivaroxaban 1.05 (0.94; 1.17), dabigatran 1.14 (0.96; 1.35), and apixaban 1.84 (1.20; 2.84); all-cause mortality: rivaroxaban 1.17 (1.11; 1.22), dabigatran 1.04 (0.95; 1.13), and apixaban 1.14 (0.97; 1.34). CONCLUSIONS: With rivaroxaban, no significant differences were observed compared to phenprocoumon with regard to hospitalized bleedings or ischemic strokes. Dabigatran was associated with fewer bleedings and a similar risk of ischemic strokes compared to phenprocoumon. Apixaban was also associated with fewer bleedings but was unexpectedly associated with more ischemic strokes, possibly reflecting selective prescribing. The association of rivaroxaban with higher all-cause mortality unrelated to bleedings or strokes has been described previously but remains to be explained.

DO STUDY RESULTS TRANSLATE INTO PRACTICE? INTRACRANIAL STENTING IN GERMANY.

OBJECTIVES: Enrolment into the SAMMPRIS trial published in September 2011 had to be stopped due to a 2.5 higher 30-day stroke and death rate in patients with percutaneous transluminal angioplasty and stenting (PTAS) compared with the control group with only medical therapy. After these results were published, one would have expected a change toward a clearer definition of indications for intracranial stent implantation in patients with intracranial artery stenosis, using this treatment only in patients suffering from recurrent strokes despite aggressive medical management. METHODS: The frequency of intracranial stenting and indication parameters in patients with intracranial artery stenosis were assessed from 2010 to 2013 using claims data for all inpatient episodes from Germany's largest provider of statutory health insurance. RESULTS: The number of intracranial stenting procedures decreased slowly from 580 in 2010 to 375 in 2013. With a rate of 29 percent there was no change between 2010 and 2013 of patients who were admitted to hospital for stent implantation, without documentation of an acute stroke or transient ischemic attack (TIA). Before PTAS, one-third of patients were admitted twice because of a stroke or TIA over a period of 5 years, 17 percent of patients had been prescribed platelet aggregation inhibitors and at least two admissions to hospital were for an ischemic cerebrovascular event before PTAS. CONCLUSIONS: Our analysis of German claims data provides little evidence of changed indications for stenting in cases of intracranial atherosclerotic disease which one might expect to be caused by the emergence of high-level evidence.