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This article explores nursing, patient records, and ideology within the context of the National Socialist "euthanasia" program (Aktion T4) in Germany and Austria from 1939 to 1941, which targeted individuals with mental and physical disabilities for systematic killing. Using Hannah Arendt's concept of the "banality of evil," it examines how ordinary individuals, including nurses, became agents of atrocity by adhering to bureaucratic orders. Jacques Ellul's Ethics of Technology framework is employed to analyze how National Socialist ideology manipulated technological processes to enhance efficiency in genocidal goals. Propaganda was crucial in garnering public support, blurring the lines between technology, ethics, and ideology. Archival research at documentation centers and national archives reveals methods for deciding who was killed, the role of family in medical records, and nurses' involvement in the T4 operation. Three narratives of T4 victims illustrate the personal impacts of these bureaucratic and ideological practices. The article reflects on contemporary nursing, emphasizing the importance of ethical standards and vigilance against data and misuse of technology in health care. This historical examination serves as a reminder of the potential consequences of depersonalization and blind adherence to institutional priorities, underscoring the need for critical engagement with the ethical dimensions of nursing practice. [ABSTRACT FROM AUTHOR]

Exoskeletal devices are new technologies that have been developed in the medical field to provide assistance and rehabilitation for persons with motor impairments. Among these impairments, spinal cord injury and stroke are the most common. Drawing on materials collected during multi‐sited ethnography conducted in France, Germany and Switzerland from 2014 to 2019, I suggest that exoskeletons contribute to a more general process that I identify as 'aiming at the "proper" body'. As they materially craft motor impaired bodies but also are responsible for datafication and dataveillance, exoskeletons allow to categorise new aspects of 'risky' bodies. Simultaneously, they foster conflicts between experts' perspectives about rehabilitation practice and the users' phenomenological experiences that exoskeletons aim to transform. After describing how exoskeletons expand the realm of contemporary medical technologies in their purpose of 'aiming at "proper" bodies' while being 'miraculous', I identify two conceptions of 'risky' bodies: a first one related to materiality, a second one to processes of digitalisation to which exoskeletons actively participate. Finally, I investigate some conflicting levels between the regimes of expert knowledge and the phenomenological experiences of the users and reassess the latter's role in rehabilitation practice with exoskeletons. [ABSTRACT FROM AUTHOR]

Viele Labore haben aktuell Probleme, frei werdende Stellen von Medizinischen Technolog:innen neu zu besetzen. Glaubt man dem Gutachten des Deutschen Krankenhausinstituts, wird sich die Situation bis zum Jahr 2030 noch weiter verschärfen. Das Gesetz für Medizinische Technolog:innen in der Laboratoriumsanalytik stellt Labore vor große Herausforderungen, bietet aber auch Chancen, dem Fachkräftemangel entgegenzuwirken. Ein gemeinsames Handeln von Laboratorien als Ausbildungsbetrieben, der Berufsfachschulen für Medizinische Technolog:innen und der Politik wäre in diesem Kontext sehr wünschenswert. [ABSTRACT FROM AUTHOR]

Purpose: The investigation goal is the analysis of the relation between healthcare expenditures and other resources, and COVID-19 fatality rates among European countries to design effective health policies for crisis management. Design/methodology/approach: Research methodology is based on descriptive statistics and various parametric methods, also including a linear model of regression to analyze basic relationships of variables under study. Findings: Results show that a lower COVID-19 fatality rate is associated with higher levels of health expenditure (% GDP), of healthcare expenditure per capita, health expenditure in preventive care (% GDP), hospitals per million inhabitants, physicians, nurses, hospital beds and curative acute care beds per 1,000 inhabitants. Regression analysis shows that a 1% increase in healthcare expenditures per capita of countries, it reduces the level of COVID-19 fatality rate by 0.74%. In fact, many countries in Eastern Europe with low healthcare expenditures per capita in 2019 (e.g., Bulgaria, Romania, Hungary, Poland, Latvia, Slovakia, Lithuania, etc.), they have experienced high COVID-19 fatality rates. Instead, a lot of countries in Western Europe, with high healthcare expenditures per capita, such as Germany, Denmark, Austria, and the Netherlands, they had resilient health systems to face pandemic crisis and lower COVID-19 fatality rates. Practical implications: These findings suggest strategies of systematic and continuous investments in healthcare, medical technologies, and ICT infrastructures to support effective health policy of crisis management in countries to face future pandemic crisis and other emergencies in society. Originality/value: The explanation of critical role of high health expenditure (% GDP) and healthcare expenditure per capita to support robust health systems that bolster the resilience in nations to face health emergencies and worldwide crises. [ABSTRACT FROM AUTHOR]

In Bayesian random‐effects meta‐analysis, the use of weakly informative prior distributions is of particular benefit in cases where only a few studies are included, a situation often encountered in health technology assessment (HTA). Suggestions for empirical prior distributions are available in the literature but it is unknown whether these are adequate in the context of HTA. Therefore, a database of all relevant meta‐analyses conducted by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) was constructed to derive empirical prior distributions for the heterogeneity parameter suitable for HTA. Previously, an extension to the normal‐normal hierarchical model had been suggested for this purpose. For different effect measures, this extended model was applied on the database to conservatively derive a prior distribution for the heterogeneity parameter. Comparison of a Bayesian approach using the derived priors with IQWiG's current standard approach for evidence synthesis shows favorable properties. Therefore, these prior distributions are recommended for future meta‐analyses in HTA settings and could be embedded into the IQWiG evidence synthesis approach in the case of very few studies. [ABSTRACT FROM AUTHOR]

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Introduction: Randomized controlled trials (RCTs) are the gold standard when comparing treatment effectiveness, and Health Technology Assessment (HTA) agencies state a clear preference for such direct comparisons. When these are not available, an indirect treatment comparison (ITC) is an alternative option. The objective of this study was to assess the acceptance of ITC methods by HTA agencies across England, France, Germany, Italy, and Spain, using oncology cases for a homogeneous sample of HTA evaluations. Methods: The study was conducted on the PrismAccess database in May 2021 to retrieve HTA evaluation reports for oncology treatments for solid tumors, in which an ITC was presented. The analysis was restricted to HTA evaluation reports published between April 2018 and April 2021 in England, France, Germany, Italy, and Spain. Identified HTA evaluation reports were screened and reviewed by two independent reviewers. For each ITC presented, the methodology and its acceptance by the HTA agency were analyzed. Results: Five hundred and forty-three HTA evaluation reports were identified, of which 120 (22%) presented an ITC. This proportion was the highest in England (51%) and lowest in France (6%). The overall acceptance rate of ITC methods was 30%, with the highest in England (47%) and lowest in France (0%). Network meta-analysis (NMA; 23%) was the most commonly used ITC technique, with a 39% acceptance rate overall, followed by Bucher ITC (19%; 43% acceptance rate) and matching-adjusted indirect comparison (13%; 33% acceptance rate). The most common criticisms of the ITC methods from HTA agencies related to data limitations (heterogeneity and lack of data; 48% and 43%, respectively) and the statistical methods used (41%). Conclusions: The generally low acceptance rate of ITC methods by HTA agencies in oncology suggests that, whilst in the absence of a direct comparison ITCs may provide relevant evidence, this evidence is not widely considered sufficient for the purpose of HTA evaluations. The perception of ITC methods for the purpose of HTA evaluations varies substantially between countries. There is a need for further clarity on the properties of ITC techniques and the assessment of their results as ITC methods continue to evolve quickly and further techniques may become available in the future. [ABSTRACT FROM AUTHOR]

Aim: In this article, we aim to raise awareness of some of the clinical concerns surrounding the management of oncology wounds, particularly malignant fungating wounds. We will also provide practical wound management recommendations for healthcare professionals to consider when managing this wound type. We aim to assess the potential of a 100% chitosan with bioactive microfibre gelling (BMG™) dressing (MaxioCel®), to support wound management and work in partnership with industry to deliver clinical education on the management of oncology wounds, including malignant fungating wounds. Method: A case study series was undertaken over four weeks, using the chitosan BMG dressing. Results: We recruited 10 patients during the study. The chitosan BMG dressing facilitated a significant improvement in wound tissue type, exudate levels, and periwound skin, as well as reduced malodour. A reduction in patient-reported pain levels was also noted throughout the evaluation process. Conclusion: The introduction of BMG fibre technology demonstrated good outcomes in this patient group, in a short period of time. Importantly for this patient group, the BMG dressing was able to remain in situ during radiotherapy treatment, allowing uninterrupted management of the wounds. [ABSTRACT FROM AUTHOR]

Digital health technologies (DHTs) can optimise healthcare costs and improve quality and efficiency of care. However, the fast-paced rate of innovation and varying evidence standards can make it difficult for decision-makers to assess these technologies in an efficient and evidence-based manner. We sought to develop a comprehensive framework to assess the value of novel patient-facing DHTs used to manage chronic diseases by eliciting stakeholder value preferences. Literature review and primary data collection from a three-round web-Delphi exercise was utilized. 79 participants from 5 stakeholder groups (patients, physicians, industry, decision makers, and influencers) and 3 countries (United States of America, United Kingdom, and Germany) took part. Likert scale data were statistically analyzed to determine intergroup differences in both country and stakeholder groups, stability of results, and overall consensus. The resulting co-created framework comprised 33 stable indicators with consensus from quantitative value judgments across domains: health inequalities, data rights and governance, technical and security, economic characteristics, clinical characteristics, and user preferences. Lack of stakeholder consensus was observed on the importance of value-based care models, optimizing resources for sustainable systems, and stakeholder involvement in DHT design, development, and implementation; however, this was because of high rates of neutrality and not negative judgments. Supply-side actors and academic experts were the most unstable stakeholder groups. Stakeholder value judgments revealed a need for a coordinated regulatory and health technology assessment policy response that updates laws to meet technological innovations, offers a pragmatic approach to evidence standards to assess DHTs, and involves stakeholders to understand and meet their needs. • Digital health technologies (DHTs) differ from traditional medical technologies because they involve widespread, and sometimes continuous, collection, analysis, and transmission of patient data after market entry. There is currently no technology-agnostic wide-reaching value framework for evaluating DHTs, capturing multiple stakeholder value preferences in different health system archetypes. Through a Delphi exercise, we incorporated diverse stakeholder viewpoints from the United Kingdom, United States, and Germany to propose an evidence-based value framework for assessing patient-facing DHTs focused on chronic disease management. • Statistically significant stakeholder consensus relates to clinical and economic characteristics, which align with current regulations and health technology assessment methodologies and around value indicators that are not reflected in current regulations and health technology assessment policies, particularly regarding personal data rights. Lack of stakeholder consensus centers around the importance of value-based care models, optimizing resources for sustainable systems, and stakeholder involvement in DHT design, development, and implementation and results from high rates of neutrality rather than negative judgments. • We have created a value framework comprising 33 stable indicators with consensus across 6 value domains, notably health inequalities, data rights and governance, technical and security, economic characteristics, clinical characteristics and user preferences. Included indicators are split between ratings of "very important" and "important" resulting from consensus between key stakeholder groups consisting of patients, physicians, supply-side actors, decision makers, and influencers. Decision makers can utilize this framework when assessing potential technologies to include in their health system packages. [ABSTRACT FROM AUTHOR]

Background: The reimbursement of new technologies in inpatient care is not always linked to a requirement for evidence-based evaluation of patient benefit. In Germany, every new technology approved for market was until recently eligible for reimbursement in inpatient care unless explicitly excluded. The aim of this work was (1) to investigate the type of evidence that was available at the time of introduction of 25 innovative technologies and how this evidence evolved over time, and (2) to explore the relationship between clinical evidence and utilization for these technologies in German inpatient care. Methods: This study combined different methods. A systematic search for evidence published between 2003 and 2017 was conducted in four bibliographic databases, clinical trial registries, resources for clinical guidelines, and health technology assessment—databases. Information was also collected on funding mechanisms and safety notices. Utilization was measured by hospital procedures captured in claims data. The body of evidence, funding and safety notices per technology were analyzed descriptively. The relationship between utilization and evidence was explored empirically using a multilevel regression analysis. Results: The number of included publications per technology ranges from two to 498. For all technologies, non-comparative studies form the bulk of the evidence. The number of randomized controlled clinical trials per technology ranges from zero to 19. Some technologies were utilized for several years without an adequate evidence base. A relationship between evidence and utilization could be shown for several but not all technologies. Conclusions: This study reveals a mixed picture regarding the evidence available for new technologies, and the relationship between the development of evidence and the use of technologies over time. Although the influence of funding and safety notices requires further investigation, these results re-emphasize the need for strengthening market approval standards and HTA pathways as well as approaches such as coverage with evidence development. [ABSTRACT FROM AUTHOR]

In response to rapidly rising pharmaceutical costs, many countries have introduced health technology assessment (HTA) as a 'fourth hurdle'. We evaluated the causal effect of HTA based regulation on access to pharmaceuticals by using the introduction of Germany's HTA system (AMNOG) in 2011. We obtained launch data on pharmaceuticals for 30 European countries from the IQVIA (formerly IMS) database. Using difference-in-difference models, we estimated the effect of AMNOG on launch delay, the ranking order of launch delays and the availability of pharmaceuticals. We then compared the results for Germany to Austria, Czechia, Italy, Portugal and the UK. Across all six countries, launch delay decreased from the pre-AMNOG period (25.01 months) to the post-AMNOG period (14.34 months). However, the introduction of AMNOG consistently reduced the magnitude of the decrease in launch delay in Germany compared to the comparator countries (staggered DiD: + 4.31 months, p = 0.05). Our logit results indicate that the availability of pharmaceuticals in Germany increased as a result of AMNOG (staggered logit: + 5.78%, p = 0.009). We provide evidence on the trade-off between regulation and access. This can help policymakers make better informed decisions to strike the right balance between cost savings achieved through HTA based regulation and access to pharmaceuticals. [ABSTRACT FROM AUTHOR]

Precision medicine is increasingly important in cancer treatment. Tumor-agnostic therapies are used regardless of tumor entity because they target specific biomarkers in tumors. In Germany, the benefit assessment of oncological pharmaceuticals has traditionally been entity specific. Thus, the assessment of tumor-agnostic therapies leaves stakeholders with various challenges. Our aim was to systematically identify challenges and possible solutions for the benefit assessment of therapies in tumor-agnostic indications using a 2-step sequential qualitative approach. To identify relevant challenges, we conducted qualitative interviews with different stakeholders who were involved in previous benefit assessments of tumor-agnostic therapies in Germany. To identify possible solutions for these challenges, we systematically searched MEDLINE, Embase, and the websites of European health technology assessment bodies for relevant literature. We identified 9 categories of challenges of which the following were deemed particularly relevant: the absence of direct comparative studies, challenges regarding the use of basket studies and indirect comparisons, challenges in determining the appropriate comparative therapy in a tumor-agnostic indication, and challenges on the system side. Seven categories of solutions were identified, including an increased use of real-world evidence, making conditional decisions in the context of systematic reassessments, splitting the field of application, and finding (new) ways to design and analyze basket studies. A range of possible solutions, which can help to meet the identified challenges in Germany, have been found. Future research should investigate the acceptance and feasibility of these solutions. • The benefit assessment of tumor-agnostic therapies leaves stakeholders with various challenges. • The article systemized these challenges and identified possible solutions for the benefit assessment of tumor-agnostic therapies in Germany. Categories of challenges included the determination of the appropriate comparator, no comparative studies, and basket studies. Solutions proposed in the literature are manifold and include, for example, the increased use of real-world evidence. • We identified a range of possible solutions, which could guide future reforms, in Germany and beyond, toward more value in health. Future research should investigate the acceptance and feasibility of these solutions. [ABSTRACT FROM AUTHOR]

A stable and nationwide mobile network coverage is increasingly regarded as essential. This requires an expansion of mobile networks throughout the country. However, the installation of masts and antennas has often been the subject of con- flict in Germany, especially due to fears about potential health effects of electromagnetic fields. Transmitters become both a trigger and a target of social protests. From a discourse-theoretical perspective, we identify central lines of argumentation in the German cellular network conflicts. A triangulation of quantitatively oriented and qualitative analysis components forms the methodological basis. Regional case studies provide an opportunity to identify local differences. A comparison of past and recent conflicts reveals discursive shifts over time. Debates about the possible health effects of mobile radio were particularly contentious in the context of UMTSmobile phone expansion at the turn of the millennium. The (planned) installation of transmitters at the local level often sparked this discussion. During the expansion of the 5G network, in addition to the debate about the health risks of the technology, questions are now being raised about whether and to whom the expansion is necessary. Compared to the previous period of investigation, local conflicts about transmitters now appear to be less virulent and can be found primarily in southern and southwestern Germany. [ABSTRACT FROM AUTHOR]

This study aimed to describe the role of real-world data (RWD) and real-world evidence (RWE) in health technology assessment (HTA) in 5 European countries and to identify the hurdles to the acceptance of RWE and suggest directions toward its more effective use. Authors from France, Germany, Italy, and Sweden used a common template to extract evidence. For England, the Cancer Drugs Fund was described and analyzed as a particular model for the use of RWD to provide evidence for coverage decisions and managed entry agreements. In all countries except Germany, HTA bodies acknowledged the relevance of RWD/RWE to address postlaunch uncertainties. In Germany, evidence from randomized controlled trials remains the gold standard, and evidence based on RWD is generally rejected. Multiple sources of RWD exist, but the quality, the immediate relevance of existing sources, and their interoperability limit their adaptation to the specifics of a given drug. This leads to skepticism about the validity of the evidence. Timing is also a key issue: the production of evidence may not be synchronized with the HTA and pricing bodies' agendas. The Cancer Drugs Fund case emphasizes that a strong partnership among all stakeholders and a pragmatic use of existing data, alongside clinical evidence provided by companies, are key success factors. A continuous investment in national health information systems is a key issue for providing valid RWE. Processes and aids to guide the acceptability and usage of RWE derived from pairing between sources and questions are essential. • Using a combination of desk research and expert opinion collated by country experts in England, France, Germany, Italy, and Sweden, this article aimed to provide the reader with an understanding of the use of real-world evidence for health technology assessment and reimbursement decisions in each geography. • The article also helps identify key issues shared across the countries and identify areas of improvement that might reduce skepticism and promote more efficient use of real-world evidence. [ABSTRACT FROM AUTHOR]

The article presents the discussion on inaugural guideline on diabetes technology being published. Topics include created a means to utilize technology without requiring on body devices though studies in the pediatric population; and clinical trials and real‐world data demonstrated improvements in glycemia with use of automated insulin delivery (AID).

The article focuses on the challenges and complexities of recruiting foreign medical technology professionals to address labor shortages in Germany. It highlights the lengthy and intricate process of recognition for foreign qualifications, the role of recruitment agencies, and the importance of fostering a welcoming environment for newcomers to ensure successful integration.

This article discusses a recent methodological change to assess the additional benefit of drug intervention by the German Federal Joint Committee (Gemeinsamer Bundesausschuss), a key stakeholder in EUnetHTA21 (European Network for Health Technology Assessment joint consortium for future EU HTA regulation), methodological workstream. The German Federal Joint Committee (Gemeinsamer Bundesausschuss) set a universal individual response threshold at ≥ 15% of the scale range of the measurement instrument, for all patient-reported outcomes, to achieve an additional benefit rating for a given pharmaceutical intervention. This approach is originally based on a corresponding recommendation from the Institute for Quality and Efficiency in Health Care. The merits of this approach are reviewed from various perspectives, including the evidence basis, statistical and psychometric considerations, and regulatory perspectives by the ISPOR Clinical Outcomes Assessment Special Interest Group's multistakeholder group of authors (academia, contract research organizations, and industry). Particular focus is placed on the patient perspective within the Institute for Quality and Efficiency in Health Care approach. The article development incorporated feedback from ISPOR members during well-attended ISPOR US and European conference presentations and 2 formal rounds of written review. The authors concluded that the ≥ 15% response threshold is incongruent with previously defined and scientifically established thresholds and is not well-suited for universal implementation. Further scientific evidence and discussion among all stakeholders are needed, especially should this universal rule be considered in the context of future joint clinical assessments of health technologies in the European Union scheduled from 2025 onward. [ABSTRACT FROM AUTHOR]

The article focuses on percutaneous transluminal coronary angioplasty (PTCA) as an innovative treatment for coronary artery disease. Topics include the development of stents and image guidance systems for PTCA, the role played by radiologic technologists in cardiac interventional medical procedures, and the opportunities for improving the quality of cardiac catheterization laboratory (CCL).

Digital technologies in health care, including artificial intelligence (AI) and robotics, constantly increase. The aim of this study was to explore attitudes of 2020 medical students' generation towards various aspects of eHealth technologies with the focus on AI using an exploratory sequential mixed-method analysis. Data from semi-structured interviews with 28 students from five medical faculties were used to construct an online survey send to about 80,000 medical students in Germany. Most students expressed positive attitudes towards digital applications in medicine. Students with a problem-based curriculum (PBC) in contrast to those with a science-based curriculum (SBC) and male undergraduate students think that AI solutions result in better diagnosis than those from physicians (p < 0.001). Male undergraduate students had the most positive view of AI (p < 0.002). Around 38% of the students felt ill-prepared and could not answer AI-related questions because digitization in medicine and AI are not a formal part of the medical curriculum. AI rating regarding the usefulness in diagnostics differed significantly between groups. Higher emphasis in medical curriculum of digital solutions in patient care is postulated. [ABSTRACT FROM AUTHOR]

Aim: The goal is to design and, in a next step, establish a scalable, multi-center telemonitoring platform based on existing systems for monitoring COVID-19 patients in home quarantine. In particular, the focus will be on raw data acquisition, integration of sensor data into the hospital system, structured data storage, and interoperability. Subject and methods: Data necessary for monitoring, otherwise provided in various portals, will be continuously queried and integrated into the hospital system via a new interface in this proof-of-concept work. Results: Based on extensive preliminary work at Klinikum rechts der Isar with a structured clinical database, we extend our system's integration of raw data and visualization in dashboards, as well as scientific provision of data from mobile sensors for monitoring patients in home quarantine. Conclusion: Based on existing integrated telemonitoring systems supporting semantic and syntactic interoperability, short-term provision of scientific databases is possible. The integration of different mobile sensors into a clinical system for remote monitoring of patients around the clock is still new and to our knowledge unique. [ABSTRACT FROM AUTHOR]

Background: Innovative medical technologies are commonly associated with positive expectations. At the time of their introduction into care, there is often little evidence available regarding their benefits and harms. Accordingly, some innovative medical technologies with a lack of evidence are used widely until or even though findings of adverse events emerge, while others with study results supporting their safety and effectiveness remain underused. This study aims at examining the diffusion patterns of innovative medical technologies in German inpatient care between 2005 and 2017 while simultaneously considering evidence development.Methods: Based on a qualitatively derived typology and a quantitative clustering of the adoption curves, a representative sample of 21 technologies was selected for further evaluation. Published scientific evidence on efficacy/effectiveness and safety of the technologies was identified and extracted in a systematic approach. Derived from a two-dimensional classification according to the degree of utilization and availability of supportive evidence, the diffusion patterns were then assigned to the categories "Success" (widespread/positive), "Hazard" (widespread/negative), "Overadoption" (widespread/limited or none), "Underadoption" (cautious/positive), "Vigilance" (cautious/negative), and "Prudence" (cautious/limited or none).Results: Overall, we found limited evidence on the examined technologies regarding both the quantity and quality of published randomized controlled trials. Thus, the categories "Prudence" and "Overadoption" together account for nearly three-quarters of the years evaluated, followed by "Success" with 17%. Even when evidence is available, the transfer of knowledge into practice appears to be inhibited.Conclusions: The successful implementation of safe and effective innovative medical technologies into practice requires substantial further efforts by policymakers to strengthen systematic knowledge generation and translation. Creating an environment that encourages the conduct of rigorous studies, promotes knowledge translation, and rewards innovative medical technologies according to their added value is a prerequisite for the diffusion of valuable health care. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has seen one of the first large-scale uses of digital contact tracing to track a chain of infection and contain the spread of a virus. The new technology has posed challenges both for governments aiming at high and effective uptake and for citizens weighing its benefits (e.g., protecting others' health) against the potential risks (e.g., loss of data privacy). Our cross-sectional survey with repeated measures across four samples in Germany ( N = 4357 ) focused on psychological factors contributing to the public adoption of digital contact tracing. We found that public acceptance of privacy-encroaching measures (e.g., granting the government emergency access to people's medical records or location tracking data) decreased over the course of the pandemic. Intentions to use contact tracing apps—hypothetical ones or the Corona-Warn-App launched in Germany in June 2020—were high. Users and non-users of the Corona-Warn-App differed in their assessment of its risks and benefits, in their knowledge of the underlying technology, and in their reasons to download or not to download the app. Trust in the app's perceived security and belief in its effectiveness emerged as psychological factors playing a key role in its adoption. We incorporate our findings into a behavioral framework for digital contact tracing and provide policy recommendations. [ABSTRACT FROM AUTHOR]

There are no effective treatments in progressive supranuclear palsy (PSP). The aim of this study was to test the efficacy of theta burst repetitive transcranial magnetic stimulation (rTMS) on postural instability in PSP. Twenty PSP patients underwent a session of sham or real cerebellar rTMS in a crossover design. Before and after stimulation, static balance was evaluated with instrumented (lower back accelerometer, Rehagait®, Hasomed, Germany) 30-s trials in semitandem and tandem positions. In tandem and semitandem tasks, active stimulation was associated with increase in time without falls (both p=0.04). In the same tasks, device-extracted parameters revealed significant improvement in area (p=0.007), velocity (p=0.005), acceleration and jerkiness of sway (p=0.008) in real versus sham stimulation. Cerebellar rTMS showed a significant effect on stability in PSP patients, when assessed with mobile digital technology, in a double-blind design. These results should motivate larger and longer trials using non-invasive brain stimulation for PSP patients. [ABSTRACT FROM AUTHOR]

The article focuses on the use of Next Generation Sequencing (NGS) for rapid infection diagnostics, highlighting its ability to identify multiple pathogens from a single sample, which offers significant advantages over traditional blood culture methods. It discusses the collaboration between the Dr. Wisplinghoff laboratory and Noscendo to enhance patient care through NGS technology in Germany.

After-sales services form an important consideration for customers when buying a product, and play a major role for companies in the field of customer retention. With regard to the capital goods segment of the medical technology industry (medtech), however, the status of research on after-sales services is limited. Methods: A largely standardized questionnaire was developed, focussing on the forms and significance of various after-sales services. The questionnaire was sent to small and medium-sized medtech companies in Germany which include durable capital goods in their portfolio. During the 2016/17 assessment period, n = 327 questionnaires were returned. The data was subjected to descriptive and multivariate analyses. Results: The medtech companies regard after-sales services as being of high importance. A multivariate factor analysis underscored a content-related structure after providing active after-sales services rather than a tendency towards interactive after-sales services. Conclusions: The empirical results confirmed that the large majority of medtech companies attach a high level of importance to after-sales services, and indicate that the level of importance and the content-related structure for each service may differ. The results can possibly be generalized to cover medtech companies outside of Germany, as well as other businesses working in the field of healthcare. [ABSTRACT FROM AUTHOR]

Objectives: Determining the price and reimbursement of a new medicine is a national competence within the Member States of the European Union that is carried out by health technology authorities and is based mainly on the added therapeutic value (ATV). The primary objective of this study was to compare the ATVs granted by the French (Haute Autorité de Santé, HAS) and the German (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWIG) authorities. The secondary objective was to analyze the reasons for the discrepancies observed.Methods: Retrospective cohort of all ATVs assigned by HAS and IQWIG for the period 2011 to 2017. ATV assessments were classified as major, considerable, minor, no benefit, or not quantifiable. The concordance between the authorities was evaluated, and a qualitative analysis of highly discordant assessments was performed.Results: One hundred and ninety-one drugs were evaluated by both agencies. The overall percentage of agreement was 50.3%. It was 73.1% for no benefit of ATVs, 37.5% for minor ATVs, 31.2% for considerable ATVs, and 5% for major ATVs. Highly conflicting assessments (n = 35) mainly concerned antineoplastic drugs (n = 14) and anti-infectives (n = 14). The main reasons for inconsistency concerned the following: a different appreciation of the subgroup analysis of efficacy data (n = 15), the appropriateness of comparators (n = 15), the surrogate endpoints (n = 10), methodological differences (n = 8), and the benefit/risk criteria that were used (n = 6).Conclusion: In the context of the common assessment of ATVs promoted by the European Commission, the harmonization between member states regarding the way evaluation criteria are assessed deserves to be addressed. [ABSTRACT FROM AUTHOR]

Aim: To determine factors influencing the success of treatment for type 1 diabetes, defined as HbA1c < 58 mmol/mol (<7.5%), in a large paediatric cohort under real‐life conditions. Methods: This is a monocentric observational study analysing the determinants of glycaemic outcome (sex, age, comorbidities, sociodemographic factors, diabetes technology) in an entire cohort of people with diabetes aged up to 21 years. Glycaemic outcome was defined as an individual's median HbA1c and the prevalence of acute complications over this period. Results: Of 700 young people with type 1 diabetes [age 13.6 years (range: 1.4–20.9 years); diabetes duration 5.8 years (range: 0.1–18.3 years)], 63% were using an insulin pump and 32% any type of continuous glucose monitoring. Mean HbA1c was 61 mmol/mol [95% confidence interval (CI) 60–62; 7.7%, 95% CI 7.5–7.8]. Some 63% of children aged < 12 years reached HbA1c (58 mmol/mol (<7.5%) compared with 43% of older participants. The prevalence of severe hypoglycaemia was 2.41 events and that of diabetic ketoacidosis 1.4 events per 100 person‐years. Neither type of insulin therapy nor use of continuous glucose monitoring, sex or comorbidity with coeliac disease or thyroiditis was significantly associated with glycaemic outcome. However, age, diabetes duration, having a father not born in Germany, psychiatric comorbidities and family structure were associated with HbA1c. Conclusions: Current technologies and a multidisciplinary team approach allow high numbers of children and adolescents to realize tight glycaemic control with a low prevalence of acute complications. However, age‐related challenges, sociodemographic factors and psychological comorbidities are barriers to achieving best possible glycaemic outcome. What's new?: Several non‐medical factors such as overburdened parents and adolescents, cultural and sociodemographic characteristics, and psychosocial risks influence self‐management behaviour and thus treatment success in paediatric diabetes.Use of modern technology alone is not sufficient to optimize glycaemic outcomes.The implementation and use of technology needs to be discussed critically and tailored to the family's situation and coping capacity.Even with new technologies, diabetes management plans need to be individualized and focused on the family's strengths, barriers and psychosocial limitations. [ABSTRACT FROM AUTHOR]

The article offers information on The point-of-care testing (POCT) working group POCT of the German Society for Clinical Chemistry and Laboratory Medicine (DGKL) organized the 4th Munich POCT Symposium on the subject of "POCT at the Interface of Emerging Technologies and New Clinical Applications".

Background: Just under 3% of children in Germany, and approximately 6% of children in some other countries, such as Denmark, are now being conceived with the aid of in vitro fertilization (IVF) technology. Alongside the increased risk of organ malformation, there is now evidence for functional abnormalities due to epigenetic modifications. Methods: This review is based on pertinent publications retrieved by a literature search on currently known associations of IVF therapy with malformations and functional abnormalities. The potential implications for the treatment of infertility are discussed. Results: The risk of congenital malformations is approximately one-third higher in children conceived with the aid of IVF technology than in other children; specifically, there is an odds ratio (OR) of 1.29 (95% confidence interval, [1.03; 1.60]) for cardiac malformations, and there is a relative risk (RR) of 1.35 ([1.12; 1.64]) for musculo - skeletal malformations and 1.58 ([1.28; 1.94]) for genitourinary malformations. The risks of preterm birth and low birth weight are, respectively, 1.7 and 1.5 times higher in IVF singleton pregnancies than in non-IVF pregnancies. Cardiovascular changes are the main type of functional disturbance. Some of the risks associated with IVF have decreased in recent years. An association has been revealed between cardio vascular abnormalities and epigenetic modifications; the causes are thought to include not only maternal and paternal factors, but also the IVF techniques that are used. A modification of IVF therapies might lower the risks, but might also lower the success rate. Conclusion: For the well-being of the children to be conceived, IVF therapy should only be carried out in cases of infertility that cannot be treated by any other means, as the precise causes of the risks of IVF to child health are unclear. [ABSTRACT FROM AUTHOR]

This paper investigates Critical Success Factors that affect the performance of organizations involved in Medical Technology supply chains (MTSCs) in Germany. The Medical Technology sector in Germany is considered an innovative, fast-growing and promising industry, being third behind the USA and China as the biggest market in the world, worth 29.9 billion euros in 2017. MTSCs in this country are under pressure from health service funding and cheaper imports, primarily from China. Consequently, supply chain success is of high importance and OEM operational improvements are critical. This exploratory study involved a multiple case study approach where 15 OEMs within German MTSCs were investigated. Following within-case and cross-case analysis, empirical results led to the development of testable propositions, which constitute a foundation for further research investigation. The findings show that there are six, prioritized Critical Success Factors for MTSCs that include sales and operations planning, product development process and quality and compliance. These findings challenge existing assumptions about Critical Success Factors within MTSCs, providing practitioners with strategies showing that re-prioritized CSFs should improve the operational performance of OEMs. [ABSTRACT FROM AUTHOR]

Background: The highest incidence and prevalence of mental health problems across the lifespan as well as the first onset of most long-term mental health conditions are reported for youths between 14 and 25 years of age. At the same time, only 25% of adolescents with mental health problems receive professional treatment. One explanation for poor treatment access in youths is their low help-seeking behavior. Barriers that can keep children and adolescents (C&A) from seeking professional help include a lack of perceived need, structural barriers, or stigma. Interventions based on e-technology might present an effective approach, overcoming these barriers by reducing stigma and providing low-threshold access with enhanced reach, ultimately facilitating help-seeking for mental health problems among youths.Methods: The study is designed as a multi-center, randomized controlled trial. In total, an estimated number of n = 1,500 C&A with mental health problems, drawn from a school-based sample of n = 15,000 pupils attending school grades 6 to 13 (≥ 12 years of age), recruited in five regions of Germany, will be randomized either to an intervention (ProHEAD online) or a control condition. C&A in the intervention group will receive online access to tailored information and individual advice on where to seek professional help for their specific needs close to their place of living, case reports of and interaction with peers, as well as the opportunity for online and telephone counseling. C&A in the control intervention will receive a recommendation to seek help and online information on where to find professional help. All participants will be asked to complete questionnaires concerning their help-seeking behavior at baseline, during the intervention (monitoring), and also at a 1 and 2 year follow-up. The primary endpoint is the number of C&A seeking conventional face-to-face professional help in the real-world setting within 1 year after their initial screening.Discussion: The trial will investigate if an Internet-based intervention can increase professional help-seeking in C&A with mental health problems. With its randomized controlled design and large-scale school-based sampling, the study aims to overcome the shortages of previous research. The intervention has the potential to narrow the treatment gap in C&A and to ultimately improve the mental health care system.Trial Registration: German Clinical Trials Register, DRKS00014685 . Registered on 7 July, 2018. [ABSTRACT FROM AUTHOR]

Health Technology Assessment is one of the standard instruments in support of the decision-making to define the public health services both internationally and in the German health care system. Besides system- atic reviews, benefit-harm-analyses, health economic evaluations, and, decision-analytic modelling, especially epidemiological and biometrical questions and methods play a key role. From this perspective discus- sions on increased European cooperation including calls for wider harmonization are attracting greater interests. The overall aim is, to present at the GMDS workshop relevant information on this emerging field of harmonization in Europe across similarities and differences in the HTA process. Current developments around the composition of the EU-HTA Network are provided. This network accepts the challenge to define and establish a "Joint Work" across Europe. Special emphasis was placed on the discussion on "Harmonization of HTA: is it a threat or does it mean support?". Furthermore, methodolo- gical discussions and questions are being addressed: "Are Real World Data and Surrogates possible parameters for decision-making or HTA?" [ABSTRACT FROM AUTHOR]

Background: Many health technology assessment (HTA) agencies express a preference for randomized controlled trial evidence when appraising health technologies; nevertheless, it is not always feasible or ethical to conduct such comparative trials.Objectives: To assess the role of noncomparative evidence in HTA decision making.Methods: The Web sites of the National Institute for Health and Care Excellence (NICE) in the United Kingdom, the Canadian Agency for Drugs and Technologies in Health (CADTH) in Canada, and the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen [IQWiG]) in Germany were searched for single HTA reports (published between January 2010 and December 2015). The product, indication, outcome, and clinical evidence presented (comparative/noncomparative) were double-extracted, with any discrepancies reconciled. A noncomparative study was defined as any study not presenting results against another treatment (including placebo or best supportive care), regardless of phase or setting, including dose-ranging studies.Results: A total of 549 appraisals were extracted. Noncomparative evidence was considered in 38% (45 of 118) of NICE submissions, 13% (34 of 262) of CADTH submissions, and 12% (20 of 169) of IQWiG submissions. Evidence submissions based exclusively on noncomparative evidence were presented in only 4% (5 of 118) of NICE appraisals, 6% (16 of 262) of CADTH appraisals, and 4% (6 of 169) of IQWiG appraisals. Most drugs appraised solely on the basis of noncomparative evidence were indicated for cancer or hepatitis C. Positive outcome rates (encompassing recommended/restricted/added-benefit decisions) for submissions presenting only noncomparative evidence were similar to overall recommendation rates for CADTH (69% vs. 68%, respectively), but were numerically lower for NICE (60% vs. 84%, respectively) and IQWiG (17% vs. 38%, respectively) (P > 0.05 for all).Conclusions: Noncomparative studies can be viewed as acceptable clinical evidence by HTA agencies when these study designs are justifiable and when treatment effect can be convincingly demonstrated, but their use is currently limited. [ABSTRACT FROM AUTHOR]

This article examines the current status and most important changes over time to the legislative framework on the health technology assessment-informed decision-making process on diagnostic and therapeutic 'methods' in Germany. The relevant information was obtained through documentary analysis covering the period 1990 to 2017. The findings show that, even if the outpatient care sector appears to be much more regulated than the inpatient sector (based on a strict separation of the two care settings), developments in Germany have led to a more tightened assessment framework, making the use of evidence a firm component in the decision-making process. Nevertheless, a comprehensive approach for a systematic assessment of diagnostic and therapeutic 'methods' still does not exist. Readjustments of current regulations in Germany, such as the existing 'Verbotsvorbehalt' (i.e. provision of a diagnostic and therapeutic 'method' possible unless actively delisted) in the inpatient care setting, as well as further developments at the European level are needed in order to create a system that ensures early access to innovation under controlled study conditions. [ABSTRACT FROM AUTHOR]

Countries adopt different methods and processes to evaluate the benefits and costs of health technologies. It is important to identify and analyse the factors that influence the uptake and use of these methods and processes across countries. In this article, we introduce a regulatory governance approach to the analysis of convergence, divergence and hybridity in Health Technology Assessment ( HTA) methods, discussing and critically analysing national processes for HTA in two major EU member states: England and Germany. We argue that any reasonably sophisticated account of national approaches to HTA must recognise that globalisation and the emergence of advanced industrial society involves the potential for widely varying processes, methods and evidential requirements. We suggest that this potential also confronts health policy analysts with the challenge of constructing analytical frameworks capable of identifying the diverse institutional, domestic and other factors that shape national approaches to HTA. [ABSTRACT FROM AUTHOR]

Background: Currently available Interferon-gamma release assays (IGRAs) show a considerable variability in serial testing for latent tuberculosis infection (LTBI). This study offers first results for the new generation IGRA QuantiFERON-TB Gold Plus (QFT-Plus) introduced in 2015 in comparison with its predecessor QuantiFERON-TB Gold In-Tube (QFT-GIT) from serial testing of students with a migration background at German universities. Methods: Forty-one students were selected from a previous study. All students with a positive IGRA were asked and 11 agreed to participate in this cohort study. Additionally 30 students with negative IGRA results were selected by chance. Weekly testing with QFT-Plus and QFT-GIT was performed in all individuals over a 4-week period. IGRA variability was evaluated by calculating conversion and reversion rates. Results: From 41 participants a total number of 163 serial measurements were analyzed for each IGRA, leading to 122 possible IGRA changes each. QFT-Plus had four conversions and two reversions leading to a conversion rate of 4.3% (4 of 93 possible conversions, 95% CI 1.4-11.3%) and reversion rate of 6.9% (2 of 29 possible reversions, 95% CI 1.2-24.2%). QFT-GIT had 2 conversions and 1 reversion causing slightly lower rates with 2.2% conversions (2 of 91, 95% CI 0.4-8.5%) and 3.2% reversions (1 of 31, 95% CI 0.2-18.5%). Inconsistent IGRA results occurred in 4 subjects for QFT-Plus (8 stable positives, 29 stable negatives) and in 2 subjects for QFT-GIT (9 stable positives, 30 stable negatives). Agreement between the two IGRAs was 95.1% (κ = 0.89). Variance attributed to the individuals was low (QFT-Plus: ICC = 0.88). Conclusion: This study confirms occurrence of conversions and reversions for the new QFT-Plus in serial testing of a high-risk cohort in a low-incidence setting with improbable new TB contact during the study. QFT-Plus conversion and reversion rates were slightly higher than for the QFT-GIT but overall they were lower for both IGRAs than in other studies that investigated IGRA variability. [ABSTRACT FROM AUTHOR]

The article reports that LK Mechanik + Blechverarbeitung GmbH, has inaugurated its newly built factory in Hüttenberg-Rechtenbach, Germany. It reports that it develops and manufactures steel and aluminum components and assemblies, emphasizing a modern and sustainable approach with open production lines, advanced machinery, and renewable energy sources, catering to various industries such as packaging, optics, automation, electronics, and medical technology.

Background: Previous evaluations of oncological medicines in the German early benefit assessment (EBA) procedure have demonstrated inconsistent acceptance of endpoints by regulatory authorities and the Federal Joint Committee (G-BA). Accepted standard endpoints for regulatory purposes are frequently not considered as patient-relevant in the German EBA system. In this study the acceptance of clinically acknowledged primary endpoints (PEPs) from regulatory trials in EBAs conducted by the G-BA was evaluated across three therapeutic areas. Methods: Medicines for oncological, metabolic and infectious diseases with EBAs finalised before 25 January 2016 were evaluated. Respective manufacturer's dossiers, regulatory assessments, G-BA appraisals and oral hearing minutes were reviewed, and PEPs were examined to determine whether they were considered relevant to patients by the G-BA. Furthermore, the acceptance of symptomatic vs asymptomatic PEPs was also analysed. Results: A total of 65 EBAs were evaluated. Mortality PEPs were widely accepted as patient-relevant but were only used in a minority of EBAs and exclusively in oncological diseases. Morbidity PEPs constituted around 72 % of assessed PEPs, but were excluded from the EBA in over half of the corresponding assessments as they were not considered patient-relevant. Symptomatic endpoints were largely deemed patient-relevant, whereas acceptance of asymptomatic endpoints varied between therapeutic areas. Conclusions: This evaluation identified inconsistencies in patient relevance of morbidity-related PEPs as well as in acceptance of asymptomatic endpoints by the G-BA in all three disease areas examined. Better harmonisation between the regulatory authorities and the G-BA is still required after 5 years of AMNOG health technology assessment in Germany. [ABSTRACT FROM AUTHOR]

Background: We know little about how procurement of a high-risk medical device (HRMD) affects clinical practice and outcomes. In health systems in high-income countries, and specifically those that maintain a national arthroplasty registry, procurement decisions are frequently guided by long-term clinical results, with the goal of ensuring at least standard quality of HRMDs. But in countries like Mexico, decision-making is often dominated by lowest acquisition price. We set out to study the impact of procurement for orthopaedic HRMDs on clinical procedures and outcomes.Methods: We based our qualitative study on 59 in-depth interviews with stakeholders from Mexico, Switzerland, Germany, and UK: orthopaedic specialists, government officials, other experts, and social security system managers or administrators. We took a healthcare delivery approach to capturing and comparing factors that affected the regulations of HRMDs and procurement processes, and to understanding connections between procurement and clinical practice.Results: Our findings demonstrate for procurement processes that the three European countries compared to Mexico don't have similar concerns with regards to their procurement processes. Deficiencies of procurement regulations and practices identified from representatives in Mexico were almost absent in European countries. We identified three areas of deficiency: 1) HRMD regulations based on insufficiently robust clinical evidence (mainly noted by European countries); 2) Follow-up on Health Technology Assessments is inadequate (noted by Mexico) and methodology not always good enough (noted by European countries); and, 3) Lowest-acquisition price often guides procurement decisions and thus may not align with needs of clinical procedures (noted by Mexico and some European countries).Conclusions: Procurement processes for orthopaedic HRMDs may have an impact on clinical procedures and outcomes. A favourable approach is one where orthopaedic specialists are parties to the procurement process, and post-market surveillance data informs decision-making. Actors in the procurement process can improve their impact on clinical procedures and outcomes by developing specific strategies that better align the needs of both, procurement and clinical procedures. [ABSTRACT FROM AUTHOR]