Survival of patients undergoing cardiac resynchronization therapy with or without defibrillator: the RESET-CRT project.

AIMS: Cardiac resynchronization therapy (CRT) is an established treatment for heart failure. There is contradictory evidence whether defibrillator capability improves prognosis in patients receiving CRT. We compared the survival of patients undergoing de novo implantation of a CRT with defibrillator (CRT-D) option and CRT with pacemaker (CRT-P) in a large health claims database. METHODS AND RESULTS: Using health claims data of a major German statutory health insurance, we analysed patients with de novo CRT implantation from 2014 to 2019 without indication for defibrillator implantation for secondary prevention of sudden cardiac death. We performed age-adjusted Cox proportional hazard regression and entropy balancing to calculate weights to control for baseline imbalances. The analysis comprised 847 CRT-P and 2722 CRT-D patients. Overall, 714 deaths were recorded during a median follow-up of 2.35 years. A higher cumulative incidence of all-cause death was observed in the initial unadjusted Kaplan-Meier time-to-event analysis [hazard ratio (HR): 1.63, 95% confidence interval (CI): 1.38-1.92]. After adjustment for age, HR was 1.13 (95% CI: 0.95-1.35) and after entropy balancing 0.99 (95% CI: 0.81-1.20). No survival differences were found in different age groups. The results were robust in sensitivity analyses. CONCLUSION: In a large health claims database of CRT implantations performed in a contemporary setting, CRT-P treatment was not associated with inferior survival compared with CRT-D. Age differences accounted for the greatest part of the survival difference that was observed in the initial unadjusted analysis.

A long-term cost-effectiveness analysis of cardiac resynchronisation therapy with or without defibrillator based on health claims data.

BACKGROUND: In Germany, CRT devices with defibrillator capability (CRT-D) have become the predominant treatment strategy for patients with heart failure and cardiac dyssynchrony. However, according to current guidelines, most patients would also be eligible for the less expensive CRT pacemaker (CRT-P). We conducted a cost-effectiveness analysis for CRT-P devices compared to CRT-D devices from a German payer's perspective. METHODS: Longitudinal health claims data from 3569 patients with de novo CRT implantation from 2014 to 2019 were used to parametrise a cohort Markov model. Model outcomes were costs and effectiveness measured in terms of life years. Transition probabilities were derived from multivariable parametric survival regression that controlled for baseline differences of CRT-D and CRT-P patients. Deterministic and probabilistic sensitivity analyses were conducted. RESULTS: The Markov model predicted a median survival of 84 months for CRT-P patients and 92 months for CRT-D patients. In the base case, CRT-P devices incurred incremental costs of € - 13,093 per patient and 0.30 incremental life years were lost. The ICER was € 43,965 saved per life year lost. In the probabilistic sensitivity analysis, uncertainty regarding the effectiveness was observed but not regarding costs. CONCLUSION: This modelling study illustrates the uncertainty of the higher effectiveness of CRT-D devices compared to CRT-P devices. Given the difference in incremental costs between CRT-P and CRT-D treatment, there would be significant potential cost savings to the healthcare system if CRT-D devices were restricted to patients likely to benefit from the additional defibrillator.

Optimizing telemedical care in neurological outpatients by characterizing the patients' needs in the physician-patient relationship-content analysis of guideline-based interviews.

BACKGROUND: The use of new concepts in patient care, such as video-consultations, reminder systems, and online evaluation portals, is becoming increasingly important in the physician-patient relationship and outpatient care. This study examines the acceptance of these approaches in a neurological setting and determines the patients' preferences. METHODS: We analyzed 16 guideline-based qualitative interviews with neurological patients using qualitative content analysis (inductive category formation). RESULTS: The patients commented on the benefits and challenges of integrating new concepts of medical care. They identified advantages of telemedical care, including time savings (7 of 16; 43,8%) for both the patient and the physician, the prospect of more intensive (4 of 16; 25%) care, and the possibility for a quick response in case of urgent needs (3 of 16; 18.8%). Several challenges were reported, such as the limitations for patients with psychiatric (2 of 16; 12.5%) or complex diseases (4 of 16; 25%) and limited options for diagnostic procedures (such as physical examination (4 of 16; 25%)). For individual neurological patients' needs, telemedical and telecommunication structures could be discussed, which support the patients' specific requirements, such as answering questions while having a recall (2 of 16; 12.5%) and avoiding the journey (8 of 16; 50%). Also, patients are rejecting evaluation portals and are skeptical of telecare in the treatment of neurological diseases. DISCUSSION: The perception of telemedical care and the successful integration of new medical care concepts depend on fulfilling the individual patient's needs. Regardless of the preferred nature of physician-patient interactions, there are specific instruments that can intensify the relationship. These individual needs of the patients must be inquired about and accommodated for. CONCLUSIONS: For the first time, we could characterize the properties of optimal telemedical care for neurological patients. Interviews like the ones we conducted should be repeated during and after the pandemic, referring to our results and compare.

Outcomes of monthly video consultations as an add-on to regular care for children with type 1 diabetes: A 6-month quasi-randomized clinical trial followed by an extension phase.

OBJECTIVE: To explore the outcomes of monthly video consultations for children with diabetes. METHODS: The Virtual Outpatient Diabetes Clinic for Children and Youth (VIDIKI) was a 6-month multicenter controlled clinical trial followed by an extension phase. The 240 participants (1-16 years), all using a CGM, were quasi-randomized by residence location to the intervention group (IG) or the waitlist-control group (WG). The IG started immediately after enrollment with monthly video consultations as an add-on to regular care, while the WG received regular care for 6 months before starting the intervention. The extension phase lasted between 12 months and 2 years, depending on the enrollment date. Linear regression was applied to model the primary outcome of HbA1c after 6 months and other metabolic and psychosocial outcomes. RESULTS: After covariate adjustments, the HbA1c at 6 months-corresponding to the controlled treatment phase-was 0.11% lower in the IG than that in the WG (95% CI -0.31 to 0.09, P = .277). For the total study sample, a significant HbA1c improvement was found after 12 months of video consultations, which increased further until month 15. The diabetes burden of the main caregivers was lower, and parental treatment satisfaction was significantly higher in the IG than that in the WG. CONCLUSIONS: The VIDIKI study found no significant HbA1c difference between IG and WG after 6 months in the controlled phase, but there was a decreased diabetes burden and increased treatment satisfaction for the parents. In the longitudinal perspective, a significant HbA1c improvement was found after 12 and 15 months.

[The creation of a data protection policy: a guide to telemedicine healthcare projects]. / Die Erstellung eines Datenschutzkonzeptes: eine Anleitung für telemedizinische Versorgungsprojekte.

In Germany, an increasing number of telemedical pilot projects are in the implementation phase. All these projects have in common that they continuously produce, store, and exchange highly sensitive digital data. A basic prerequisite for projects implemented in conformity with the law is a comprehensive data protection concept, especially after the introduction of the European Data Protection Regulation (DSGVO) in May 2018.The preparation of a data protection concept for a telemedical project is illustrated in this article using the example of the care project "Virtual Diabetes Outpatient Clinic for Children and Adolescents" (ViDiKi), which started on 1 April 2017 and is funded by the Innovation Fund of the Joint Federal Committee (G-BA). Firstly, the legal basis for data protection and the related challenges in the application of new communication technologies are explained. Subsequently, the creation and structure of the data protection concept are described.The data protection concept for a project is constantly changing. It must be audited and regularly evaluated to ensure the security of patient data and to regulate data flows, data storage, and data processing. In practice, a secure and legally compliant exchange of data between study participants and physicians can thus be achieved.

Expanded nursing competencies to improve person-centred care for nursing home residents with complex health needs (Expand-Care): study protocol for an exploratory cluster-randomised trial.

INTRODUCTION: Older age is associated with multimorbidity, chronic diseases and acute deteriorations and leads to complex care needs. Nursing home residents are more often unnecessarily transferred to emergency departments or hospitals than community dwellers-largely due to a lack of qualified staff and diffusion of responsibility in the institutions. In Germany, only few academically trained nurses work in nursing homes, and their potential roles are unclear. Therefore, we aim to explore feasibility and potential effects of a newly defined role profile for nurses with bachelors' degree or equivalent qualification in nursing homes. METHODS AND ANALYSIS: A pilot study (Expand-Care) with a cluster-randomised controlled design will be conducted in 11 nursing homes (cluster) in Germany, with an allocation ratio of 5:6 to the intervention or control group, aiming to include 15 residents per cluster (165 participants in total). Nurses in the intervention group will receive training to perform role-related tasks such as case reviews and complex geriatric assessments. We will collect data at three time points (t0 baseline, t1 3 months and t2 6 months after randomisation). We will measure on residents' level: hospital admissions, further health services use and quality of life; clinical outcomes (eg, symptom burden), physical functioning and delivery of care; mortality, adverse clinical incidents and changes in care level. On nurses' level, we will measure perception of the new role profile, competencies and implementation of role-related tasks as part of the process evaluation (mixed methods). An economic evaluation will explore resource use on residents' (healthcare utilisation) and on nurses' level (costs and time expenditure). ETHICS AND DISSEMINATION: The ethics committees of the University of Lübeck (Nr. 22-162) and the University Clinic Hamburg-Eppendorf (Nr. 2022-200452-BO-bet) approved the Expand-Care study. Informed consent is a prerequisite for participation. Study results will be published in open-access, peer-reviewed journals and reported at conferences and in local healthcare providers' networks. TRIAL REGISTRATION NUMBER: DRKS00028708.

Direct Costs of Healthcare for Children with Type 1 Diabetes Using a CGM System: A Health Economic Analysis of the VIDIKI Telemedicine Study in a German Setting.

AIMS: The Virtual Diabetes Outpatient Clinic for Children and Adolescents (VIDIKI) study was a 6-month quasi-randomized, multicentre study followed by an extension phase to evaluate the effects of monthly video consultations in addition to regular care. A health economic analysis was conducted to assess the direct costs. METHODS: The cost data of 240 study participants (1-16 years of age) with type 1 diabetes who were already using a continuous glucose monitoring system were collected in the first 6 months of the study. The intervention group (IG) received monthly video consultations plus regular care, and the waiting control group (WG) received only regular care. Cost data were collected for a comparable anonymized group of children from the participating health insurance companies during the 6-month period before the study started (aggregated data group [AG]). RESULTS: Cost data were analysed for the AG (N=840) 6 months before study initiation and those for the study participants (N=225/240). Hospital treatment was the highest cost category in the AG. There was a cost shift and cost increase in the IG and WG, whereby diabetes supplies were the highest cost category. The mean direct diabetes-associated 6-month costs were € 4,702 (IG) and € 4,936 (WG). CONCLUSION: The cost development within the cost collection period over two years possibly reflects the switch to higher-priced medical supplies. Video consultation as an add-on service resulted in a small but nonsignificant reduction in the overall costs.

Device runtime and costs of cardiac resynchronization therapy pacemakers - a health claims data analysis.

Introduction: This study investigates the runtime and costs of biventricular defibrillators (CRT-D) and biventricular pacemakers (CRT-P). Accurate estimates of cardiac resynchronization therapy (CRT) device runtime across all manufactures are rare, especially for CRT-P. Methods: Health claims data of a large nationwide German health insurance was used to analyze CRT device runtime. We defined device runtime as the time between the date of implantation and the date of generator change or removal. The median costs for implantation, change, and removal of a CRT device were calculated accordingly. Results: In total, the data set comprises 17,826 patients. A total of 4,296 complete runtimes for CRT-D devices and 429 complete runtimes for CRT-P devices were observed. Median device runtime was 6.04 years for CRT-D devices and 8.16 years for CRT-P devices (log-rank test p<0.0001). The median cost of implantation for a CRT-D device was 14,270 EUR, and for a CRT-P device 9,349 EUR. Conclusions: Compared to CRT-P devices, CRT-D devices had a significantly shorter device runtime of about two years. Moreover, CRT-D devices were associated with higher cost. The study provides important findings that can be utilized by cost-effectiveness analyses.

Monthly video consultation for children and adolescents with type 1 diabetes mellitus during the COVID-19 pandemic.

AIMS: To explore the impact of primarily telemedical care for children and adolescents with type 1 diabetes by monthly video consultations on metabolic control and parents' treatment satisfaction and disease-specific burden during the COVID-19 pandemic. METHODS: In this 12-month multicenter observational follow-up VIDIKI 2.0 study, 100 participants (3-18 years) received monthly video consultations, which partially replaced quarterly outpatient clinic appointments during the pandemic. The children's metabolic parameters as well as the parents' treatment satisfaction and diabetes specific burden were assessed at study entry and 12 months later. RESULTS: During the study, 912 video consultations took place (mean 0.84 ±â€¯0.23 / patient/month). The children's HbA1c remained stable, while mean sensor glucose level and glucose management indicator decreased. Simultaneously, parents' treatment satisfaction significantly increased, and their diabetes-specific burden and distress decreased. CONCLUSIONS: Primarily telemedical care of children and adolescents with type 1 diabetes during the COVID-19 pandemic via monthly video consultations resulted in a significant improvement in parents' treatment satisfaction and their diabetes-specific burden and distress. It was associated with a slight improvement in mean sensor glucose and glucose management indicator, while HbA1c remained stable. Thus, video consultations offer great potential to enhance standard care for children and adolescents with diabetes.

Video Consultation for Parents with a Child Newly Diagnosed with Type 1 Diabetes: A Qualitative Study.

AIMS: With the exception of the coronavirus pandemic, video consultations have not been a part of the standard care for children with diabetes in Germany. The "Virtual Diabetes Outpatient Clinic for Children and Adolescents 2.0" (VIDIKI 2.0) study investigated the effect of monthly and supplementary video consultations on standard care over one year. The qualitative substudy investigated the experiences of families with a child newly diagnosed with type 1 diabetes mellitus (T1DM) who received at least four weekly supplementary video consultations. METHODS: Guideline-based qualitative interviews were conducted with seven families with children under the age of eight and T1DM onset shortly before study entry. The answers were analyzed using a qualitative content analysis approach, particularly inductive category formation. RESULTS: Families of patients with T1DM onset have questions, almost daily, concerning various aspects of insulin therapy. The offer of high-frequency video consultations can reduce the number of trips to the diabetes team, facilitate the organization of daily life and increase the sense of security. CONCLUSION: Video consultations as a supplementary offer of health care, especially after diabetes onset, were considered very helpful by the affected families. High-frequency video consultations may provide a tool to overcome existing deficiencies in specialized diabetes care.

Venetoclax enhances the efficacy of therapeutic antibodies in B-cell malignancies by augmenting tumor cell phagocytosis.

Immunotherapy has evolved as a powerful tool for the treatment of B-cell malignancies, and patient outcomes have improved by combining therapeutic antibodies with conventional chemotherapy. Overexpression of antiapoptotic B-cell lymphoma 2 (Bcl-2) is associated with a poor prognosis, and increased levels have been described in patients with "double-hit" diffuse large B-cell lymphoma, a subgroup of Burkitt's lymphoma, and patients with pediatric acute lymphoblastic leukemia harboring a t(17;19) translocation. Here, we show that the addition of venetoclax (VEN), a specific Bcl-2 inhibitor, potently enhanced the efficacy of the therapeutic anti-CD20 antibody rituximab, anti-CD38 daratumumab, and anti-CD19-DE, a proprietary version of tafasitamab. This was because of an increase in antibody-dependent cellular phagocytosis by macrophages as shown in vitro and in vivo in cell lines and patient-derived xenograft models. Mechanistically, double-hit lymphoma cells subjected to VEN triggered phagocytosis in an apoptosis-independent manner. Our study identifies the combination of VEN and therapeutic antibodies as a promising novel strategy for the treatment of B-cell malignancies.

[COVID-19: Would compulsory vaccination be legally possible?] / COVID-19: Wäre eine Impfpflicht rechtlich möglich?

As the pandemic continues, there is increasing hope vaccinations are becoming available. As a solution for a nationwide immunization against the virus, a compulsory vaccination is repeatedly discussed. However, some opponents of vaccination are threatened by the idea of a possible mandatory vaccination. It is therefore necessary to discuss whether such a compulsory vaccination is theoretically legally enforceable. This article discusses the current legal situation in Germany. The introduction of a potential compulsory vaccination against the SARS-CoV-2 virus represents an encroachment on the fundamental right of physical integrity. According to §â€Š20 (6) IfSG, a protective vaccination for threatened parts of the population is permissible by statutory order, if a transmissible disease with clinically severe courses occurs and its epidemic spread can be expected.

Cardiac Resynchronisation Therapy in Patients with Moderate to Severe Heart Failure in Germany: A Cost-Utility Analysis of the Additional Defibrillator.

BACKGROUND: Cardiac resynchronisation therapy (CRT) is a well-established form of treatment for patients with heart failure and cardiac dyssynchrony. There are two different types of CRT devices: the biventricular pacemaker (CRT-P) and the biventricular defibrillator (CRT-D). The latter is more complex but also more expensive. For the majority of patients who are eligible for CRT, both devices are appropriate according to current guidelines. The purpose of this study was to conduct a cost-utility analysis for CRT-D compared to CRT-P from a German payer's perspective. METHODS: A cohort Markov-model was developed to assess average costs and quality-adjusted life-years (QALY) for CRT-D and CRT-P. The model consisted of six stages: one for the device implementation, one for the absorbing state death, and two stages ("Stable" and "Hospital") for either a CRT device or medical therapy. The time horizon was 20 years. Deterministic and probabilistic sensitivity analyses and scenario analyses were conducted. RESULTS: The incremental cost-effectiveness ratio (ICER) of CRT-D compared with CRT-P was €24,659 per additional QALY gained. In deterministic sensitivity analysis, the survival advantage of CRT-D to CRT-P was the most influential input parameter. In the probabilistic sensitivity analysis 96% of the simulated cases were more effective but also more costly. CONCLUSIONS: Therapy with CRT-D compared to CRT-P resulted in an additional gain of QALYs, but was more expensive. In addition, the ICER was subject to uncertainty, especially due to the uncertainty in the survival benefit. A randomised controlled trial and subgroup analyses would be desirable to further inform decision making.

Assessing the health-related management of people with differences of sex development.

PURPOSE: Health care requirements and perception of people with differences of sex development (DSD) have changed enormously since the "Chicago Consensus Conference" in 2005. Therefore, new standards of care and evaluation of care have to be developed. METHODS: We summarize the social and legal approach to care for DSD during the last two decades and report the main results of European research activities. RESULTS: The last two decades were accompanied by legal and societal discussion regarding how to deal with a nonbinary concept of sex. This leads to the necessity to assess health care requirements for individuals with DSD in an objective manner. We briefly review the results of the recently funded European research projects dealing with health-related issues in DSD like EU COST Action DSD, I-DSD, and dsd-LIFE, and address the compilation of quality indicators that will be needed to benchmark health care provision and health care-related outcomes. CONCLUSIONS: The benchmarking process has to be implemented among health care providers for individuals with DSD within the European Reference Networks for Rare Conditions.

Assessing the benefits and challenges of video consultations for the treatment of children with type 1 diabetes - A qualitative study among diabetes professionals.

BACKGROUND: Video consultations are promoted as a tool to effectively supplement paediatric diabetes outpatient care. However, knowledge about attitudes of diabetes professionals towards this new technology is lagging behind. Diabetologists and diabetes nurses participating in a controlled study (the VIDIKI study) with monthly video consultations for children with type 1 diabetes were interviewed about their experience with this type of communication. RESEARCH DESIGN AND METHODS: Guideline-based qualitative interviews with 9 telemedicine experts (7 paediatric diabetologists and 2 diabetes nurses) and 7 paediatric diabetologists who agreed to the telemedical co-treatment of their patients were analysed using qualitative content analysis, in particular inductive category formation. RESULTS: Diabetes experts reported generally positive attitudes towards video consultations. They identified a number of unique benefits of telemedical interventions, including higher frequency of contacts, greater sense of patient´s safety, ability to interact with patients in their own homes, more timely and accurate medical monitoring, and improved data management. Additionally, it was important to the experts to maintain regular face-to-face consultations and to ensure close communication between telemedicine and outpatient clinical experts. CONCLUSIONS: Prerequisites for successful video consultations include a comprehensive initial technical training and an agreement on treatment responsibilities of all health care professionals involved in the patient's care. Under these conditions, the experts reported significant advantages of video consultation in the treatment of children with type 1 diabetes.

Engineering of CD19 Antibodies: A CD19-TRAIL Fusion Construct Specifically Induces Apoptosis in B-Cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL) Cells In Vivo.

B-cell precursor acute lymphoblastic leukemia (BCP-ALL) is the most frequent malignancy in children and also occurs in adulthood. Despite high cure rates, BCP-ALL chemotherapy can be highly toxic. This type of toxicity can most likely be reduced by antibody-based immunotherapy targeting the CD19 antigen which is commonly expressed on BCP-ALL cells. In this study, we generated a novel Fc-engineered CD19-targeting IgG1 antibody fused to a single chain tumor necrosis factor (TNF)-related apoptosis-inducing ligand (TRAIL) domain (CD19-TRAIL). As TRAIL induces apoptosis in tumor cells but not in healthy cells, we hypothesized that CD19-TRAIL would show efficient killing of BCP-ALL cells. CD19-TRAIL showed selective binding capacity and pronounced apoptosis induction in CD19-positive (CD19+) BCP-ALL cell lines in vitro and in vivo. Additionally, CD19-TRAIL significantly prolonged survival of mice transplanted with BCP-ALL patient-derived xenograft (PDX) cells of different cytogenetic backgrounds. Moreover, simultaneous treatment with CD19-TRAIL and Venetoclax (VTX), an inhibitor of the anti-apoptotic protein BCL-2, promoted synergistic apoptosis induction in CD19+ BCP-ALL cells in vitro and prolonged survival of NSG-mice bearing the BCP-ALL cell line REH. Therefore, IgG1-based CD19-TRAIL fusion proteins represent a new potential immunotherapeutic agent against BCP-ALL.

Long-Term Effects of an Intensive Prevention Program After Acute Myocardial Infarction.

Effective long-term prevention after myocardial infarction (MI) is crucial to reduce recurrent events. In this study the effects of a 12-months intensive prevention program (IPP), based on repetitive contacts between non-physician "prevention assistants" and patients, were evaluated. Patients after MI were randomly assigned to the IPP versus usual care (UC). Effects of IPP on risk factor control, clinical events and costs were investigated after 24 months. In a substudy efficacy of short reinterventions after more than 24 months ("Prevention Boosts") was analyzed. IPP was associated with a significantly better risk factor control compared to UC after 24 months and a trend towards less serious clinical events (12.5% vs 20.9%, log-rank p = 0.06). Economic analyses revealed that already after 24 months cost savings due to event reduction outweighted the costs of the prevention program (costs per patient 1,070 € in IPP vs 1,170 € in UC). Short reinterventions ("Prevention Boosts") more than 24 months after MI further improved risk factor control, such as LDL cholesterol and blood pressure lowering. In conclusion, IPP was associated with numerous beneficial effects on risk factor control, clinical events and costs. The study thereby demonstrates the efficacy of preventive long-term concepts after MI, based on repetitive contacts between non-physician coworkers and patients.

The role of family confidants and caregivers in the care of older cancer patients: Extending the concept of "shared decision-making".

BACKGROUND AND AIMS: Family caregivers play an important role in assisting their family members with cancer, but their influence on the treatment decision-making process has not yet been adequately investigated. This exploratory study approached this topic via reconstructive methodology, focusing on assessing patient-caregiver relationships. METHODS: We conducted semi-structured interviews with 37 mostly elderly cancer patients (median age: 74 years) about the context of their diagnosis, treatment decision, and family support. Additionally, we interviewed 34 caregivers of cancer patients. Of these, 25 were related to patients interviewed. We analyzed the interviews via a multi-step coding method informed by Grounded Theory methodology toward characterizing patient-caregiver relationships, the treatment decision-making process, and the caregivers' role therein. RESULTS: In the majority of cases (86%), patients were being supported by caregivers. We categorized patient-caregiver relationships in regards to the caregivers' involvement in the therapy decision-making process. We found patient-caregiver interaction patterns that indicate the potential of caregivers to decidedly influence the therapy decision-making process. Yet, only in 38% of cases, a caregiver attended relevant patient-physician-consultations. CONCLUSION: Depending on the nature of the patient-caregiver relationship, the traditional concept of shared decision-making, which assumes a dyadic relationship, needs to be extended toward a more dynamic concept in which caregivers should be involved more frequently. This could enable physicians to better understand a patient's reasons for or against a therapy proposal and ensure that the patient's wishes are communicated and considered. On the other hand, strong caregiver-involvement bears risks of over-stepping elderly patients' wishes, thus violating patient autonomy.

[Legal Issues of Resource Allocation in the COVID-19 Pandemic - Between Utilitarianism and Life Value Indifference]. / Rechtsfragen der Ressourcenzuteilung in der COVID-19-Pandemie ­ Zwischen Utilitarismus und Lebenswertindifferenz.

The COVID-19 pandemic poses unprecedented challenges for the German health care system. What is already the case in some other countries, may occur in Germany in the near future also: Faced with limited ICU resources, doctors will be forced to decide which patients to treat and which to let die. This paper examines the legal implications of such decisions. It takes up arguments from the general discussion on prioritization in medicine. A constitutional hurdle for the application of utilitarian criteria (in particular patients' age or social role) comes from the principle that every human life is of equal value and must not be traded off against others ("life value indifference"). However, the limits that the Grundgesetz (German Basic Law) sets for state actions do not apply directly to doctors. According to the Musterberufsordnung (professional code of conduct), doctors act based on their conscience and the requirements of medical ethics and humanity. The implications of this normative standard for the prioritizing in an exceptional situation as the COVID 19 pandemic have not been sufficiently clarified. This uncertainty leads to emotional and moral burdens for doctors. The authors conclude that the German law grants a limited freedom of choice that allows physicians to apply utilitarian criteria in addition to purely medical decision algorithms.