Agencies In Germany Research Articles

Conducted energy weapons (CEW)

Conducted energy weapons (CEW, TASER) are increasingly used by law enforcement agencies in Germany. The CEWs are intended to reduce violence against police officers and to reduce moderate to severe injuries of police officers and aggressors. The delivery of repetitive electrical impulses causes neuromuscular paralysis and incapacitation; however, there are safety concerns due to deaths related to CEWs. The aim of this article is to provide an overview of the medical risks associated with the use of CEWs. Aliterature search was carried out using relevant databases. The CEWs offer agood overall safety profile but in rare cases can have serious or life-threatening health risks. These include injuries to vulnerable body regions and falls. Myocardial capture and malignant arrhythmia can be triggered in animal experiments. The cause of death following the use of aconducted energy device (CED) can often not be clearly attributed due to competing causes; however, in studies with volunteers arrhythmia has not been observed so far. Overall, the risk of life-threatening cardiac arrhythmia in humans appears to be low, although still present. Particularly vulnerable risk groups include children, people with ahistory of mental illness or with intoxication, pregnant women and cardiac device wearers. Even though in principle CEWs can trigger malignant arrhythmia, the risk is low and the causality of death after CEW deployment often remains unclear. In the medical care of patients after CEW use, comorbidities such as intoxication or mental illness must be considered.

PP97 How Health Technology Agencies Estimate Target Population Size For Medical Devices: The Example Of Spinal Cord Stimulation

IntroductionSpinal cord stimulation (SCS) is an effective and safe option for patients with refractory neuropathic pain, with positive health technology assessment (HTA) recommendations across Western Europe, yet SCS uptake remains low. Estimating target patient populations within HTAs may impact upon medical device uptake, pricing and access. However, there is a dearth of information on how this is typically conducted. This study aimed to compare the approaches of Western Europe HTA agencies for estimating the target population for SCS.MethodsA survey was conducted among members of the Health Economics and Reimbursement function from Western Europe to collect country-specific information on how HTA agencies assess the target population of medical devices (MD). The estimations of the target population for SCS were extracted from HTA publications and compared.ResultsEight Health Economics and Reimbursement (HER) Analysts from France, Germany, the United Kingdom (UK), Belgium, Spain, Italy, Sweden and Norway completed the survey. HTA Agencies in France, UK and Belgium routinely ask for epidemiological data in the manufacturer submission, whereas in Germany, Sweden and Norway the request is dependent on the type of HTA submission. All HTA agencies, except NICE (UK), perform an independent estimation of the target population. HTA agencies in Germany and UK typically use epidemiological data from industry. In all countries, the estimation of the target population may indirectly impact the price of the MD, especially when budget impact analysis indicates a potential high use of healthcare resources. Only France, Belgium and UK have published HTA recommendations about SCS, however the estimated target population, nor the number of patients with refractory neuropathic pain, is not always included. Only the French and UK HTA agencies publish an approximation of the target population for SCS using the number of patients implanted every year.ConclusionsThis study showed there is a lack of harmonization between Western European HTA agencies’ guidelines on the inclusion and estimation of target patient populations. The new EU HTA Regulation should help to address this situation.

Availability of New Medicines in the US and Germany From 2004 to 2018

Germany's unique approach to coverage determination and pricing has ensured that effective medicines remain on the market, often at prices reduced through negotiation. However, less is known about trade-offs of this approach with regard to initial availability of medicines. To examine differences in the timing and scope of new medicines available in Germany and the US. This retrospective cohort study analyzed initial availability of new medicines approved by regulatory agencies in Germany and the US between January 1, 2004, and December 31, 2018, and followed up through December 31, 2019. Data analysis was conducted from January 1, 2020, to July 1, 2022. A total of 599 novel approvals were reviewed. Generic, biosimilar, vaccine, and combination medicines were excluded. US Food and Drug Administration approvals were reviewed for therapies categorized as new molecular entities or new active ingredients. German approvals were reviewed from secondary administrative data of authorized medicines that determine availability in Germany, including data presented by the European Medicines Agency. Approvals were analyzed to determine the percentage of medicines approved and available in the US, Germany, or both countries and compare the times to reach the market. Analysis of 599 new medicines demonstrated that fewer were available in Germany compared with the US (80% vs 92% of all potential therapies) and that the median difference in time to market was 4 months (95% CI, -44.40 to 44.76 months). Forty-nine medicines were approved in Germany but not in the US, 75% of which were rejected by the US Food and Drug Administration, were withdrawn, or had US equivalent agents. In this cohort study, fewer new medicines were available in Germany compared with the US between 2004 and 2018. In addition, drugs entered the German market later than in the US.

Health technology assessment (HTA) in England, France and Germany: what do matched drug pairs tell us about recommendations by national HTA agencies?

Aims: To explore health technology assessment (HTA) outcomes of matched drug pairs by national agencies in Germany (Gemeinsamer Bundesausschuss, GBA), France (Haute Autorité de Santé, HAS) and England and Wales (NICE). Methods: We considered published GBA decisions, HAS reports and NICE guidance from January 2011 to June 2018. HTAs of matched pairs were compared overall, and for non-cancer and cancer drugs separately. We further analyzed the role of additional attributes related to cancer therapies. Results: Matched pairs show higher concordance for GBA/HAS than for GBA/NICE and HAS/NICE. Overall, NICE evaluated technologies more favorably than GBA and HAS. GBA appraisals ofcancer drugs, however, tended to be more positive than cancer-related recommendations by NICE and HAS. Conclusion: The findings indicate substantial variations in HTAs, although cancer-related outcomes seem to diverge less than non-cancer results.

COVID-19 Pandemic and Resilience of the Transnational Home-Based Elder Care System between Poland and Germany

ABSTRACT As COVID-19 puts older people in long-term institutional care at the highest risk of infection and death, the need for home-based care has increased. Germany relies largely on migrant caregivers from Poland. Yet the pandemic-related mobility restrictions reveal the deficiencies of this transnational elder care system. This article asks if this system is resilient. In order to answer this question, the research team conducted interviews with 10 experts and randomly selected representatives of brokering and sending agencies in Germany and Poland. We interviewed 13 agencies in Germany and 15 in Poland on the agencies’ characteristics, recruitment strategies, challenges of the pandemic, and impact of legal regulations in the sector. The analysis shows that the system could mobilize adaptive capacities and continue to deliver services, but its absorptive capacity is limited. To enhance resilience, policies working toward formalization and legalization of care services across national borders are required.

Technological Solutions and Contested Interpretations of Scientific Results: Risk Assessment of Diesel Emissions in the United States and in West Germany, 1977\u20131995

This article traces the different classifications of diesel emissions either as “safe” or as “hazardous” in the US and in West Germany between 1977 and 1995. It argues that the environmental regulation of diesel emissions was a political threshold. It contributes to our general understanding of how politicians, environmental lobbyists, scientists, and engineers constructed the standards and norms that defined the “safe” limit of environmental pollutants. After discussing how diesel emissions came under review as a potential carcinogen, I will show that the coding as “safe” or as “hazardous” resulted from negotiations that were entirely dependent on the temporal, geographical, and intellectual contexts in which diesel technology, scientific research on their emissions, and political regulation were embedded. In particular, I trace the differences in German and US regulatory policy. While US regulation relied more on epidemiology that provided only weak data on the carcinogenicity of diesel particulates in the early 1980s, German government agencies tended to base their policy around the mid-1980s more on the results of animal tests and shortly afterwards also on epidemiology. Furthermore, the article reveals how US and German automakers tried to foster doubt on the carcinogenicity of diesel emissions and how their approaches differed and shifted. Thereby, it sheds light on the triangular relationship between technology, science, and politics in regulatory processes by analyzing the different roles of the state, automakers, scientists, and environmental agencies in Germany and in the United States.

War against “Internal Enemies”: Dr. Franz Lucas's Sterilization of Sinti and Roma in Ravensbrück Men's Camp in January 1945

AbstractFollowing the passing of the “Law for the Prevention of Offspring with Genetic Diseases” in July 1933, sterilization became a means to tighten the borders of the German ethnic community against outsiders, including Sinti and Roma. For a while, Sinti soldiers were spared sterilization. After Himmler's Auschwitz decree of December 1942, they were deported to Auschwitz-Birkenau. They escaped the extermination of other Sinti and Roma in the Zigeunerlager on the night of August 2, 1944, only because they represented a human shield deployable against advancing Russian troops. Still, the Reich insisted on sterilizing them and their families before placing them in front of enemy guns because they were still considered “internal enemies.” As a result, some forty Sinti men and boys were sterilized by Dr. Franz Lucas in the men's camp in Ravensbrück in January 1945. Focusing on their story challenges Lucas's portrayal as the victim of SS practices, a narrative that long benefitted from the testimony of non-Sinti prisoners. In addition, compensation agencies in Germany underestimated the ongoing effects of psychological trauma resulting from sterilization. Sinti victims who were subjected to an “expert assessment” of their blood purity before war's end underwent a renewed assessment of their productivity for German society after the war.

How Standardized is Occupational Coding? A Comparison of Results from Different Coding Agencies in Germany

Abstract As occupational data play a crucial part in many social and economic analyses, information on the reliability of these data and, in particular on the role of coding agencies, is important. Based on our review of previous research, we develop four hypotheses, which we test using occupation-coded data from the German General Social Survey and the field test data from the German Programme for the International Assessment of Adult Competencies. Because the same data were coded by several agencies, their coding results could be directly compared. As the surveys used different instruments, and interviewer training differed, the effects of these factors could also be evaluated. Our main findings are: the percentage of uncodeable responses is low (1.8–4.9%) but what is classified as “uncodeable” varies between coding agencies. Inter-agency coding reliability is relatively low κ ca. 0.5 at four-digit level, and codings sometimes differ systematically between agencies. The reliability of derived status scores is satisfactory (0.82–0.90). The previously reported negative relationship between answer length and coding reliability could be replicated and effects of interviewer training demonstrated. Finally, we discuss the importance of establishing common coding rules and present recommendations to overcome some of the problems in occupation coding.

PHP31 - IMPACT OF EUROPEAN MEDICINES AGENCY (EMA) CLINICAL TRIAL TRANSPARENCY POLICIES ON HEALTH TECHNOLOGY ASSESSMENT (HTA) DECISIONS IN GERMANY

Two European Medicines Agency (EMA) policies allow the public to access clinical trial data for medicines approved in the EU (e.g., clinical study reports, statistical analysis plans, summaries of clinical efficacy and safety, and clinical overviews) while protecting patients’ and commercial interests: Policy 0043 (effective December 2010) allows written requests for data, and Policy 0070 (effective January/July 2015) requires data to be published on the EMA’s clinical trial data site. We analyzed the use of these data in health technology assessments (HTAs) in Germany. The EMA clinical data publication website was searched for medicines with published clinical data (cut-off 31 May 2018) and for the date of approval in the EU. The websites of the HTA agencies in Germany were searched for assessments of these drugs; the reference lists were then checked to determine whether data published under these policies had been used in the decision-making process. We identified 90 medicines with clinical data published up to the cut-off date: Excluding generics, 28 had been assessed by IQWiG. HTA decisions occurred between 1.5 and 23.5 months after publication of the European Public Assessment Report. Fourteen of these assessments used clinical study reports as part of their evidence base; however, these were all for the product under review, rather than for comparators. We found no evidence that IQWiG had considered data published under the two policies. The EMA clinical trial data publication site is a key resource that is being underutilized in HTAs; this is likely to be due to delays in the publication of clinical data submitted in 2015 and 2016. A potential limitation of the study is that we would not have detected the use of clinical data in systematic reviews submitted by manufacturers. Similar schemes are in pilot phases in North America.

PHP42 - EARLY ACCESS PROGRAMS: A COMPARISON BETWEEN FRANCE, GERMANY AND THE UNITED KINGDOM

To provide an overview of the practical requirements for patient access to new therapies before marketing approval (early access programs: EAP) and to compare recent implementation of these programs in three countries. Targeted narrative literature review was performed. Publications were identified on NCBI, PubMed, Google Scholar, grey literature and websites of regulatory agencies from France (ANSM), Germany (BfArM and PEI) and the UK (MHRA). Early access is possible in all three countries through compassionate use programs (CUP: ATU de cohorte, Härtefall-Programme, EAMS) or individual-basis prescriptions (IBP: ATU nominative, individuelle Heilversuche and supply of unlicensed medicinal products or “specials”), but their implementation differ. All countries require authorizations for CUP. IBP do not require a submission to regulatory agencies in Germany, while authorizations are required for “specials” in the UK. In Germany and in the UK, the manufacturer has to provide the drug free of charge for CUP without further national regulation about drug costs and reimbursement for IBP. In France, authorizations are needed for CUP and IBP and the healthcare system supports all related costs. In 2017 France's ANSM authorized 265 ATU, which were mainly targeting neurological diseases, severe infectious diseases, cancers, blood disorders and metabolic diseases. In Germany ongoing CUP in June 2018 are mostly targeting cancers and genetic diseases. Between April 2014 and November 2015, over 500 patients benefited from UK’s EAMS, which targeted cancers and heart failure. Reports regarding safety and efficacy of the drugs during CUP must be provided to regulatory agencies in all 3 countries. Early access programs in the 3 countries are similar in the types of access granted (for specific populations) and the diseases they target corresponding to high unmet medical needs. The main differences between countries are seen in the financing of these programs.

Practices of activation in frontline interactions: Coercion, persuasion, and the role of trust in activation policies in Germany

AbstractFollowing Michael Lipsky's well‐known argument that policy is made in the daily encounters between street‐level bureaucracy and citizens, a growing body of research emphasizes that actors and organizations delivering social and labor‐market policy play a crucial role in welfare‐state politics. Using qualitative data collected at three local employment agencies in Germany, this article explores worker‐client relations as a crucial mechanism through which activation policies are translated into practice. The analysis investigates how caseworkers define their role and their relationships with clients. The findings show that it is essential for caseworkers to achieve client compliance. In such a context, building relationships of trust is a strategic instrument in overcoming possible barriers to co‐operation in the caseworker‐client interaction. Caseworkers develop strategies to create the impression of trustworthiness and to motivate both unemployed clients and employers to become trust‐givers in the caseworker‐client relation. While research has often stressed the dichotomy between disciplining and enabling elements of activation policies, our explorative study shows that persuasion and trust‐building are a further important dimension of the frontline delivery of activation policies. These strategies reflect the importance of emotional aspects of frontline work.

An Exploratory Study on the Quality Assurance Regulations of Long-term Care Agencies in Germany

An Exploratory Study on the Quality Assurance Regulations of Long-term Care Agencies in Germany

German temporary agency workers’ SWB: the impact of POS provided by agencies

PurposeThe purpose of this paper is to focus on the specific relationship between temporary agency workers (TAWs) and their employing temporary work agencies in Germany that is characterized – in contrast to other European countries – by agencies’ central role in employment and the prevalence of permanent contracts. The study addresses a research gap in understanding the mediating role of perceived organizational support (POS) provided by temporary work agencies in the relationship between employment-specific antecedents and TAWs’ subjective well-being (SWB).Design/methodology/approachBased on a sample of 350 TAWs in Germany, the mediating role of POS provided by agencies is analyzed using structural equation modeling.FindingsThe authors show that procedural justice, performance feedback and social network availability positively relate to POS while perceived job insecurity shows the expected negative influence and distributive justice has no impact on POS. POS, in turn, positively relates to SWB. The partially mediating effect of POS between employment-specific antecedents and SWB is also confirmed.Research limitations/implicationsThe study is based on cross-sectional data and self-reported measures; this may limit causal inferences.Practical implicationsThe results highlight the importance of agencies creating POS and reducing perceived job insecurity for improving TAWs’ SWB.Originality/valueThe study contributes to previous POS research by focusing on the agencies’ role and by showing the mediating effect of POS on TAWs’ SWB in Germany.

Do brief alcohol interventions among unemployed at-risk drinkers increase re-employment after 15 month?

At-risk alcohol use is associated bi-directionally to unemployment, and decreases chances of re-employment. Brief alcohol interventions (BAI) can reduce at-risk alcohol use. This study aimed to investigate 15-month effects of BAI on unemployment among persons with at-risk alcohol use. As part of the randomized controlled 'Trial on proactive alcohol interventions among job-seekers, TOPAS', 1243 18- to 64-year-old job-seekers with at-risk alcohol use were systematically recruited at three job agencies in Germany (2008/09), and randomized to (i) a stage tailored intervention based on the trans-theoretical model of intentional behavior change (ST), (ii) a non-stage tailored intervention based on the theory of planned behavior (NST) and (iii) assessment only (AO). To test the effects of ST and NST on employment status 15 months after baseline, latent growth models were calculated among those initially unemployed (n = 586). In all three groups, unemployment significantly decreased over 15 months (ST: odds ratio, OR = 0.06; 95% confidence interval, CI: 0.01-0.27; NST: OR = 0.04; 95% CI: 0.01-0.18; AO: OR = 0.05; 95% CI: 0.01-0.21). No intervention effects were found on unemployment. Age (P = 0.002), school education (P = 0.001), self-rated health (P = 0.04), the Alcohol Use Disorder Identification Test-Consumption score (P = 0.02) and motivation to change (P = 0.04) significantly affected the development of unemployment over time. After 15 months, no BAI effect on unemployment was found. The mediated effect of BAIs on unemployment could be a longsome process needing longer follow-ups to be detected.

Stress-coping styles of 459 emergency care physicians in Germany

In addition to assessing stress-coping strategies in patients, equal attention should be paid to health-care professionals. The literature on the stress-coping strategies of emergency physicians - health-care professionals who are frequently subject to stress in afast-paced clinical setting - is scant. Therefore, we aimed to investigate the stress-coping strategies of emergency-care physicians (ECPs) in Germany. We conducted across-sectional study by approaching German Associations of Emergency Medicine Physicians and the two largest ECP recruitment agencies in Germany to invite their members to participate. We used the German Stress Coping Strategies Inventory ("Stressverarbeitungsfragebogen" SVF-78) to generate stress-coping scores that would cover both positive and negative strategies. Differences according to sex were also examined. Analyses including chi-square test, t test, and multinomial logistic regression modeling were performed. Atotal of 459German ECPs were included in the study. Compared with men, women tended to have negative coping strategies (beta= 1.77, p< 0.001). Specifically, women tended to use social support (beta= 1.55, p= 0.002), avoidance (beta= 2.59, p< 0.001), escape (beta= 1.39, p= 0.004), rumination (beta= 1.58, p< 0.001), and resignation (beta = 2.09, p< 0.001), while being less likely than men to rely on minimization and denial of guilt. ECPs experience stress in the same manner as patients and other professionals, and they must address and cope with stress appropriately. For future research, studies with alongitudinal approach to monitor the underlying mechanisms are suggested. For clinical practice and policy-making, structural changes in work patterns and psychological support should be considered, which may be of particular benefit for female ECPs.

Mass media and bureaucracy-bashing: Does the media influence public attitudes towards public administration?

At least part of the academic literature on public administration asserts that the mass media is responsible for the somewhat negative popular image of administrative agencies. Through negative reporting about the (mis-)behaviour of civil servants or about public administration as a whole, the media shape stereotypes in the collective mind of the citizens. However, while the ascribed role of mass media reporting is plausible, these effects have not yet been empirically verified. This article summarises the scientific discussion about the relationship between public administration and the mass media. Furthermore, it adds to this discussion by simultaneously examining both media usage and attitudes towards administrative agencies in Germany through a secondary analysis of data spanning nearly 30 years.

Unpacking social divisions of labor in markets: Generalized blockmodeling and the network boom in stock photography

During the advent of digital technology, the market for stock photography has undergone radical transformations that have disrupted incumbent businesses and produced new divisions of labor. Picture agencies have responded to this challenge with a veritable proliferation of inter-firm alliances. In the attempt to understand this network boom, this paper develops a theoretical link between the concept of regular equivalence and its capacity to detect intra-industry divisions of labor. Based on a network survey of picture agencies in Germany, a prespecified generalized blockmodel yields a valid representation of an increasing functional specialization of new value stages that translates into an extended social and spatial division of labor in ways that challenge a dualist theory of the division of creative labor.

Employment trajectories of German baby boomers and their effect on statutory pension entitlements

Abstract Increasing disruptions and heterogeneity in employment biographies, a growing number of unemployment experiences, later labour market entries, and an increase in atypical forms of employment lead to declines of statutory pension entitlement accumulation over the life course. Moreover, in accordance with Easterlin (1987) , significant economic disadvantages can be expected for large generations. In fact, the German baby boomers born in the 1950s and 1960s, the next generation of pensioners, will have to accept several additional pension cuts due to pension reforms. Against this background, we ask how different employment patterns are related to disproportional statutory pension entitlements for German baby boomers in the middle of their working life. We examine work trajectories and their implications for accrued statutory pension entitlements by the age of 42 for two baby boomer cohorts in comparison to two older cohorts. For our analyses, we employ the Biographical Data of Selected Insurance Agencies in Germany (BASiD) for those born in 1947, 1953, 1959 and 1965 (N = 25,863). In the first step, we summarise the most important employment patterns of the cohorts under study. In the second step, we test the influence of these employment patterns on the accumulation of individual statutory pension entitlements until the age of 42 and compare the baby boomer cohorts to previous cohorts. We find that late entries to employment as well as diversified and unstable employment are related to lower levels of statutory pension entitlements for particular groups of German baby boomers.

Describing Changes in Road Condition by Numerically Described Multi-dimensional Probability Distributions

With regard to a systematic pavement maintenance, it is necessary to hold information about the current state of roads and to forecast its changes precisely. Therefore, a Pavement Management System (PMS) for highways was developed in the past few decades, which is shared meanwhile by mostly all road agencies in Germany. Most PMS consist of deterministic performance predicition models, which were developed based on historical empirical data. These deterministic prognoses are roundly approved and accepted, due to their simple practicability and comprehensibleness even though they contain any information concerning the quality of prediction. This lack of information includes the necessity to improve probabilistic prediction models to handle different kinds of maintenance strategies. Therefore, the aim of this thesis was to verify, if describing changes in road condition by numerically described multi-dimensional probability distributions is feasible and beneficial to improve the systematic management of maintenance. First, the following possible explanatory variables like age, traffic loads, design and width of lane were analyzed concerning their power of influence on rut depth and cracks. The results of these analyses of variance (ANOVA) confirmed that the age of roads is the most effective variable to predict the prospective condition of roads. Furthermore, the wide distributions of road condition represent that its development over time is influenced by a large number of predictors. As a consequence, a probabilistic forecast model was drafted in dependence of road age. Based on pavement condition survey data of more than 500km of Bavarian roads, a set of age-related transition probability matrices was developed for the use of recurrent Markov Chains. The practicability of this section based forecast model was tested with an example of use to forecast the prospective condition of an exemplary road section and pointed out its importance and profit in PMS. In this research a probabilistic age-related forecast model was developed which is able to indicate the variance of predicted road conditions. The developed forecast model gives a fundament to discuss several alternatives for maintenance strategies, which can be implemented in modern PMS. Furthermore, the consideration of variance of service life gives an expansive potential to be integrated in construction and maintenance contracts.

“It's optional, not mandatory”: Environmental justice in local environmental agencies in Germany

ABSTRACTEnvironmental justice is increasingly becoming a subject of academic debate in Germany. However, the realisation that environmental goods and hazards as well as the impacts of environmental policies are unequally distributed among social groups has not had many practical consequences yet. There are scattered initiatives and pilot projects aiming to address issues of environmental justice. Nevertheless, in the design and implementation of environmental policies there is no systematic consideration of their social dimension. In this paper, we outline the perspective of employees in German local environmental agencies on environmental justice. For this purpose, we conducted six qualitative interviews, which focused on the example of low emission zones. We identified three crucial aspects in these interviews: problem perception, motivation to act and perceived scope of action. Our main finding is that environmental justice is hardly an issue for environmental agencies and that this is the case because there is no necessity for them to consider social aspects in their work as this is neither legally required nor demanded in the public debate.