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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 for CRT-D devices and 8.16 years for CRT-P devices (log-rank test p

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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 § 20 (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., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Background: The introduction of continuous glucose monitoring (CGM) implies new challenges for diabetes care. As CGM systems are often directly linked to a web-based software solution, structured telemedicine care using a video-consultation may be a new option for families who care for children with type 1 diabetes mellitus (T1DM)., Methods: "ViDiKi" (Virtual Diabetes Outpatient Clinic for Children and Youth) is a multicenter controlled trial carried out in Northern Germany. ViDiKi will examine if monthly telemedical consultations, in addition to regular care, will improve glycemic control and psychosocial outcomes. The primary outcome is glycemic control as measured by a change in glycated hemoglobin (HbA1c). A total of 240 participants aged between one year and 16 years using a CGM with multiple daily injections (MDI) or insulin pump therapy were recruited and assigned to a starter group or a six-month waiting control group. The sample size is designed to detect a between-group difference of 0.5% in HbA1c change at six months. Secondary outcomes are variability of blood glucose, health-related quality of life, self-efficacy, and satisfaction with telemedicine. To gain deeper insight into the experience of using telemedicine, qualitative interviews will be conducted. In a health-economic analysis, the costs of telemedicine and a cost-of-care analysis will be calculated., Conclusions: The results from the ViDiKi study shall give important information on the feasibility and putative benefits of telemedicine in children with T1DM and their caregivers., German Clinical Trails Register (drks): DRKS00012645.

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.