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Mastitis poses a considerable threat to productivity and to animal welfare on modern dairy farms. However, the common way of antibiotic treatment does not always lead to a cure. Unsuccessful cures can, among other reasons, occur due to biofilm formation of the causative agent. This has attracted interest from researchers to introduce promising alternative therapeutic approaches, such as the use of beneficial lactic acid bacteria (LAB). In fact, using LAB for treating mastitis probably requires the formation of a beneficial biofilm by the probiotic bacteria. The present study investigated the ability of five LAB strains, selected on the basis of results from previous studies, to remove and to replace pathogenic biofilms in vitro. For this purpose, Staphylococcus (S.) aureus ATCC 12,600 and two strains—S. xylosus (35/07) and S. epidermidis (575/08)—belonging to the group of coagulase negative staphylococci (CNS) were allowed to form biofilms in a 96-well plate. Subsequently, the LAB were added to the well. The biofilm challenge was evaluated by scraping off and suspending the biofilm cells, followed by a plate count of serial dilutions using selective media. All the LAB strains successfully removed the staphylococcal biofilms. However, only Lactobacillus (L.) rhamnosus ATCC 7469 and L. plantarum 2/37 formed biofilms of their own to replace the pathogenic ones.
Mastitis is one of the most important diseases threatening modern dairy herds. The idea of fighting the disease through colonising the udder with lactic acid bacteria (LAB), thereby building a beneficial biofilm, is the base for a probiotic approach towards mastitis control. The purpose of this study was to screen 13 LAB strains (eleven wild strains, two ATCC strains) inhibitory to the growth of mastitis-causing pathogens for their in vitro ability to form a biofilm and to adhere to bovine glandular mammary epithelium in order to assess their probiotic potential. Furthermore, we aimed to gain knowledge about the chemical nature of the adhesins involved by subjecting the bacteria to various chemical and enzymatical pre-treatments. The biofilms were grown on hydrophilic glass and on hydrophobic polypropylene in de Man, Rogosa and Sharpe (MRS) broth and afterwards quantified with a crystal violet assay. Biofilm formation was observed in all strains. However, the extent strongly depended on the strain, surface charge and medium. The adhesion assay also revealed a strong strain dependency, but this trait was also present in all of the investigated LAB isolates. Depending on the strain, chemical or enzymatical pre-treatment revealed carbohydrate molecules as well as proteins and lipids to be crucial for the adhesion of LAB to epithelial cells. The seven strains showing the strongest biofilm formation and/or adhesion represent promising candidates for further investigation in order to develop a probiotic remedy for the treatment of mastitis. Still, their safety for consumers and patients as well as their capability to colonise the udder remain to be investigated in in vivo studies.
During the intraoperative radiograph generation process with mobile image intensifier systems (C-arm) most of the radiation exposure for patient, surgeon and operation room personal is caused by scattered radiation. The intensity and propagation of scattered radiation depend on different parameters, e.g. the intensity of the primary radiation, and the positioning of the mobile image intensifier. Exposure through scattered radiation can be minimized when all these parameters are adjusted correctly. Because radiation is potentially dangerous and could not be perceived by any human sense the current education on correct adjustment of a C-arm is designed very theoretical. This paper presents an approach of scattered radiation calculation and visualization embedded in a computer based training system for mobile image intensifier systems called virtX. With the help of this extension the virtX training system should enrich the current radiation protection training with visual and practical training aspects.
Hintergrund und Fragestellung: Die durch röntgentechnische Diagnoseverfahren in der Medizin entstehende Strahlenbelastung für Patient und Personal soll laut Strahlenschutzverordnung so gering wie möglich gehalten werden. Um dieses zu erreichen ist ein professioneller und bedachter Umgang mit den Röntgengeräten unabdingbar. Dieses Verhalten kann derzeit jedoch nur theoretisch vermittelt werden, da sich ein Üben mit realer Strahlung von selbst verbietet. Daher stellt sich die Frage wie man die Strahlenschutzausbildung durch eine verbesserte Vermittlung der komplexen Thematik unterstützen kann. Methoden: Das CBT-System (Computer Based Training) virtX, welches das Erlernen der korrekten Handhabung mobiler Röntgengeräte unterstützt, wurde um Aspekte aus dem Bereich des Strahlenschutzes erweitert. Es wurde eine prototypische Visualisierung der entstehenden Streustrahlung sowie die Darstellung des Nutzstrahlenganges integriert. Des Weiteren wurde die Berechnung und Anzeige der virtuellen Einfallsdosis für das durchstrahlte Volumen sowie für den Bereich des Bildverstärkers hinzugefügt. Für die Berechnung und Visualisierung all dieser Komponenten werden die in virtX parametrisierbaren C-Bogen-Einstellungen, z.B. Stellung der Blenden, Positionierung des Röntgengerätes zum durchstrahlten Volumen und Strahlenintensität, herangezogen. Das so erweiterte System wurde auf einem dreitägigen Kurs für OP-Personal mit über 120 Teilnehmern eingesetzt und auf der Basis von Fragebögen evaluiert. Ergebnisse: Von den Teilnehmern gaben 55 einen ausgefüllten Evaluations-Fragebogen ab (Responserate 82%). Das Durchschnittsalter der 39 weiblichen und 15 männlichen Teilnehmer (einer o.A.) lag bei 33±8 Jahren, die Berufserfahrung bei 9,37±7 Jahren. Die Erfahrung mit dem C-Bogen wurde von einem Teilnehmer (2%) mit „Keine oder bisher nur Einführung erhalten“, von acht Teilnehmern (14%) mit „bediene einen C-Bogen gelegentlich“ und von 46 (84%) mit „bediene einen C-Bogen regelmäßig“ angegeben. 45 (92%) der Teilnehmer gaben an, durch die Visualisierung der Streustrahlung etwas Neues zur Vermeidung unnötiger Strahlenbelastung dazugelernt zu haben. Schlussfolgerung: Trotz einer bislang nur prototypischen Visualisierung der Streustrahlung können mit virtX zentrale Aspekte und Verhaltensweisen zur Vermeidung unnötiger Strahlenbelastung erfolgreich vermittelt werden und so Lücken der traditionellen Strahlenschutzausbildung geschlossen werden.
Background:
Promoting patient and occupational safety are two key challenges for hospitals. When aiming to improve these two outcomes synergistically, psychosocial working conditions, leadership by hospital management and supervisors, and perceptions of patient and occupational safety climate have to be considered. Recent studies have shown that these key topics are interrelated and form a critical foundation for promoting patient and occupational safety in hospitals. So far, these topics have mainly been studied independently from each other. The present study investigated hospital staffs’ perceptions of four different topics: (1) psychosocial working conditions, (2) leadership, (3) patient safety climate, and (4) occupational safety climate. We present results from a survey in two German university hospitals aiming to detect differences between nurses and physicians.
Methods:
We performed a cross-sectional study using a standardized paper-based questionnaire. The survey was conducted with nurses and physicians to assess the four topics. The instruments mainly consisted of scales of the German version of the COPSOQ (Copenhagen Psychosocial Questionnaire), one scale of the Copenhagen Burnout Inventory (CBI), scales to assess leadership and transformational leadership, scales to assess patient safety climate using the Hospital Survey on Patient Safety Culture (HSPSC), and analogous items to assess occupational safety climate.
Results:
A total of 995 completed questionnaires out of 2512 distributed questionnaires were returned anonymously. The overall response rate was 39.6%. The sample consisted of 381 physicians and 567 nurses. We found various differences with regard to the four topics. In most of the COPSOQ and the HSPSC-scales, physicians rated psychosocial working conditions and patient safety climate more positively than nurses. With regard to occupational safety, nurses
indicated higher occupational risks than physicians.
Conclusions:
The WorkSafeMed study combined the assessment of the four topics psychosocial working conditions, leadership, patient safety climate, and occupational safety climate in hospitals. Looking at the four topics provides an overview of where improvements in hospitals may be needed for nurses and physicians. Based on these results,
improvements in working conditions, patient safety climate, and occupational safety climate are required for health care professionals in German university hospitals – especially for nurses.
Correction to: https://doi.org/10.1186/s12913-018-3862-7
In the original publication of this article, the authors missed that reverse coding was necessary for the item “Do you work separate from your colleagues?” before calculating the scale ‘social relations’. So they corrected the analysis accordingly. The results with the revised scale show that there are no longer any significant differences between nurses and physicians with regard to this scale.
Der Artikel befasst sich mit der Zusammensetzung multiprofessioneller Teams in Beratungsstellen - bezogen auf die Grundprofessionen. Er zeigt auf, dass die Psychologie in der Geschichte der Beratungsstellen eine dominante Rolle im multiprofessionellen Gefüge übernommen hat, mit der Folge, dass bis heute um professionsspezifische Handlungsansätze der Sozialen Arbeit in der Beratung, sowie um ein gutes Verhältnis von Psychologie und Sozialer Arbeit gerungen werden muss. Es wird aufgedeckt, dass dieses Ringen auch im Umgang mit der empirisch nachgewiesenen, neuen quantitativen Dominanz der Sozialen Arbeit im multiprofessionellen Gefüge sichtbar wird und ein nur defizitorientierter, dominant psychologischer Blick darauf vermieden werden sollte.
Objectives: Injury to major white matter pathways during language-area associated glioma surgery often leads to permanent loss of neurological function. The aim was to establish standardized tractography of language pathways as a predictor of language outcome in clinical neurosurgery.
Methods: We prospectively analyzed 50 surgical cases of patients with left perisylvian, diffuse gliomas. Standardized preoperative Diffusion-Tensor-Imaging (DTI)-based tractography of the 5 main language tracts (Arcuate Fasciculus [AF], Frontal Aslant Tract [FAT], Inferior Fronto-Occipital Fasciculus [IFOF], Inferior Longitudinal Fasciculus [ILF], Uncinate Fasciculus [UF]) and spatial analysis of tumor and tracts was performed. Postoperative imaging and the resulting resection map were analyzed for potential surgical injury of tracts. The language status was assessed preoperatively, postoperatively and after 3 months using the Aachen Aphasia Test and Berlin Aphasia Score. Correlation analyses, two-step cluster analysis and binary logistic regression were used to analyze associations of tractography results with language outcome after surgery.
Results: In 14 out of 50 patients (28%), new aphasic symptoms were detected 3 months after surgery. The preoperative infiltration of the AF was associated with functional worsening (cc = 0.314; p = 0.019). Cluster analysis of tract injury profiles revealed two areas particularly related to aphasia: the temporo-parieto-occipital junction (TPO; temporo-parietal AF, middle IFOF, middle ILF) and the temporal stem/peri-insular white matter (middle IFOF, anterior ILF, temporal UF, temporal AF). Injury to these areas (TPO: OR: 23.04; CI: 4.11 – 129.06; temporal stem: OR: 21.96; CI: 2.93 – 164.41) was associated with a higher-risk of persisting aphasia.
Conclusions: Tractography of language pathways can help to determine the individual aphasia risk profile presurgically. The TPO and temporal stem/peri-insular white matter were confirmed as functional nodes particularly sensitive to surgical injuries.
The shift towards RES introduces challenges related to power system stability due to the characteristics of inverter-based resources (IBRs) and the intermittent nature of renewable resources. This paper addresses these challenges by conducting comprehensive time and frequency simulations on the IEEE two-area benchmark power system with detailed type 4 wind turbine generators (WTGs), including turbines, generators, converters, filters, and controllers. The simulations analyse small-signal and transient stability, considering variations in active and reactive power, short-circuit events, and wind variations. Metrics such as rate of change of frequency (RoCoF), frequency nadir, percentage of frequency variation, and probability density function (PDF) are used to evaluate the system performance. The findings emphasise the importance of including detailed models of RES in stability analyses and demonstrate the impact of RES penetration on power system dynamics. This study contributes to a deeper understanding of RES integration challenges and provides insights for ensuring the reliable and secure operation of power systems in the presence of high levels of RES penetration.
This paper presents the implementation of a GMVC-based WAPSS to damp the interarea modes of power systems. The choise for the GMVC to tackle this problem lies on the fact that it can be used to compensate the time delay due to the latency of the transmission system in a more natural way than other controllers. The paper shows that it is possible to improve system’s closed-loop stability since its behavior is the same as if the time delay is not regarded. Simulation results with Kundur’s System prove that a latency of 1 second at a conventional WAPSS might lead system’s power to oscillate for 50 seconds for a short-circuit at the transmission line, whereas the oscillation decreases to only 5 seconds if the GMVC-based WAPSS is implemented.
Ever since the 1996 revision of the Declaration of Helsinki, the World Medical Association has attempted to address ethical and scientific concerns of its diverse stakeholders for Articles 33 (use of placebo) and 34 (posttrial provisions), most recently in 2013. Both are inextricably linked to standard of care, an essential element of any comparative, interventional clinical trial. But has this now 20-year-long ethical debate truly been put to rest? The choice of standard of care in clinical trials remains a complex issue, particularly for comparative trials conducted in emerging countries.
The lytic efficacy of bacteriophages against Staphylococcus aureus isolates from bovine milk was investigated in vitro, regarding possible applications in the therapy of udder inflammation caused by bacterial infections (mastitis). The host range of sequenced, lytic bacteriophages was determined against a collection of 92 Staphylococcus (S.) aureus isolates. The isolates originated from quarter foremilk samples of clinical and subclinical mastitis cases. A spot test and a subsequent plaque assay were used to determine the phage host range. According to their host range, propagation and storage properties, three phages, STA1.ST29, EB1.ST11, and EB1.ST27, were selected for preparing a bacteriophage mixture (1:1:1), which was examined for its lytic activity against S. aureus in pasteurized and raw milk. It was found that almost two thirds of the isolates could be lysed by at least one of the tested phages. The bacteriophage mixture was able to reduce the S. aureus germ density in pasteurized milk and its reduction ability was maintained in raw milk, with only a moderate decrease compared to the results in pasteurized milk. The significant reduction ability of the phage mixture in raw milk promotes further in vivo investigation.
The antimicrobial activity of a phagemixture and a lactic acid bacteriumagainst Staphylococcus aureus isolates from bovine origin was investigated in vitro with regard to possible applications in the therapy of udder inflammation (mastitis) caused by bacterial infections. The S. aureus isolates used for inoculation derived from quarter foremilk samples of mastitis cases. For the examination of the antimicrobial activity, the reduction of the S. aureus germ density was determined [log10 cfu/mL]. The phage mixture consisted of the three obligatory lytic and S. aureus-specific phages STA1.ST29, EB1.ST11 and EB1.ST27 (1:1:1). The selected Lactobacillus plantarum strain with proven antimicrobial properties and the phage mixture were tested against S. aureus in milk, both alone and in combination. The application of the lactic acid bacterium showed only a low reduction ability for a 24 h incubation period. The bacteriophage mixture as well as its combination with the lactic acid bacterium showed high antimicrobial activity against S. aureus for a 24 h incubation period at 37 C, with only the phage mixture showing significance.
A study to assess the knowledge and attitude towards HIV of pharmacy students from Mumbai university
(2020)
Background: India is the biggest HIV epidemic in the world. The role of a pharmacist is pivotal in educating the general masses. The aim of the study was to determine the knowledge and attitude of pharmacy students from University of Mumbai.
Methods: A cross-sectional study was conducted in University of Mumbai during February-March 2020. Therein, 307 students (214: females and 94: males) participated in the study. The questionnaire was distributed in the classroom and data was collected by means of Google-forms. Furthermore, the data was analysed using IBM SPSS version 23.
Results: The participants demonstrated good knowledge (84%) and attitude (76%) score. With respect to knowledge score, no significant difference was observed except for responses of two questions, aim of the antiretroviral therapy (ART) and Avoidance of sexual intercourse can decrease the risk of HIV. With respect to attitude score, Volunteering to work at an institute for the welfare of HIV patients showed a significant difference.
Conclusion: The current study showed that there were no misconceptions or negative attitude regarding HIV among the students. However, a study with greater sample size must be conducted across India for further investigation.
Der Beitrag stellt zunächst die Ergebnisse einer Auswertung von Stellenanzeigen aus der Mailingliste InetBib vor, die zeigt, dass die Nachfrage nach Absolventinnen und Absolventen bibliothekarischer Studiengänge mit einer Qualifikation für den Aufgabenbereich der Vermittlung von Informationskompetenz
seit dem Jahr 2000 signifikant gestiegen ist. Ergänzend hierzu präsentieren die Autorinnen die Ergebnisse einer Befragung unter Vertreterinnen und Vertretern der bibliothekarischen Berufspraxis zu im Bereich der Vermittlung von Informationskompetenz geforderten Kompetenzen und deren
Gewichtung innerhalb der verschiedenen Qualifikationsstufen.
Der Beitrag stellt Ergebnisse der Fachgruppe Informationskompetenz der KIBA vor, in der alle Lehrenden im Bereich der Vermittlung von Medien- und Informationskompetenz an bibliotheks- und informationswissenschaftlichen Studiengängen in Deutschland zusammenarbeiten. Ausgangspunkt ist das „Framework Informationskompetenz“, ein Anforderungsrahmen, der gemeinsame Standards in der Qualifikation von Studierenden der Bibliotheks- und Informationswissenschaft für das Aufgabenfeld der Förderung von Informationskompetenz sichern soll. Es wird aufgezeigt, wie die in diesem Rahmenmodell formulierten Qualifikationsstandards in den verschiedenen Studiengängen umgesetzt werden und wo es bedarfsbezogene Ausprägung und Gewichtung in den Qualifikationszielen gibt.
Catholic Ownership, Physician Leadership and Operational Strategies: Evidence from German Hospitals
(2022)
Previous research has revealed that Catholic hospitals are more likely follow a strategy of horizontal diversification and maximization of the number of patients treated, whereas Protestant hospitals follow a strategy of horizontal specialization and focus on vertical differentiation. However, there is no empirical evidence pertaining to this mechanism. We conduct an empirical study in a German setting and argue that physician leadership mediates the relationship between ownership and operational strategies. The study includes the construction of a model combining data from a survey and publicly available information derived from the annual quality reports of German hospitals. Our results show that Catholic hospitals opt for leadership structures that ensure operational strategies in line with their general values, i.e., operational strategies of maximizing volume throughout the overall hospital. They prefer part-time positions for chief medical officers, as chief medical officers are identified to foster strategies of maximizing the overall number of patients treated. Hospital owners should be aware that the implementation of part-time and full-time leadership roles can help to support their strategies. Thus, our results provide insights into the relationship between leadership structures at the top of an organization, on the one hand, and strategic choices, on the other.
Wohnungslose Menschen wurden systematisch diskreditiert und werden immer noch systematisch ausgegrenzt. Die Angebote für wohnungslose Menschen sind unzureichend und lückenhaft. Die besonderen Erfahrungen und Bedürfnisse der Betroffenen müssen besser als bisher berücksichtigt werden um bedarfsgerechtere Hilfen und Angebote zu gestalten. Hierfür ist die Einbeziehungen der Betroffenen in Planung und Ausgestaltung der Angebote systematisch und unbefristet zu fördern. Um den Interessen der Betroffenen Gehör zu verschaffen sind entsprechende Ressourcen bereitzustellen und Kommunikationswege zu eröffnen.
Mein Beitrag versucht, die philosophischen und geschichtlichen Hintergründe eines zentralen Begriffs bei Saul D. Alinsky neu auszuleuchten, dem Begriff des Ressentiments. Alinsky, der Begründer des Community Organizing, hat bei der Organisation von Bürgergruppen versucht, vorhandene Ressentiments aufzulösen, indem er die zugrundeliegende Diskriminierungen artikulierbar macht, sie in politische Forderungen verwandelt, die schließlich in Verhandlungen umgesetzt werden. Er sah darin auch ein Verfahren, die Menschen vor falschen Agitatoren zu schützen.
The objective of this study was to investigate the association between teat skin colonization and intramammary infection (IMI) with Staphylococcus aureus or Streptococcus agalactiae at the quarter level in herds with automatic milking systems. Milk and teat skin samples from 1,142 quarters were collected from 300 cows with somatic cell count >200,000 cells/mL from 8 herds positive for Strep. agalactiae. All milk and teat skin samples were cultured on calf blood agar and selective media. A subset of samples from 287 quarters was further analyzed using a PCR assay (Mastit4 PCR; DNA Diagnostic A/S, Risskov, Denmark). Bacterial culture detected Staph. aureus in 93 (8.1%) of the milk samples and 75 (6.6%) of the teat skin samples. Of these, 15 (1.3%) quarters were positive in both the teat skin and milk samples. Streptococcus agalactiae was cultured in 84 (7.4%) of the milk samples and 4 (0.35%) of the teat skin samples. Of these, 3 (0.26%) quarters were positive in both the teat skin and milk samples. The PCR detected Staph. aureus in 29 (10%) of the milk samples and 45 (16%) of the teat skin samples. Of these, 2 (0.7%) quarters were positive in both the teat skin and milk samples. Streptococcus agalactiae was detected in 40 (14%) of the milk samples and 51 (18%) of the teat skin samples. Of these, 16 (5.6%) quarters were positive in both the teat skin and milk samples. Logistic regression was used to investigate the association between teat skin colonization and IMI at the quarter level. Based on bacterial culture results, teat skin colonization with Staph. aureus resulted in 7.8 (95% confidence interval: 2.9; 20.6) times higher odds of Staph. aureus IMI, whereas herd was observed as a major confounder. However, results from the PCR analyses did not support this association. Streptococcus agalactiae was isolated from the teat skin with both PCR and bacterial culture, but the number of positive teat skin samples detected by culture was too low to proceed with further analysis. Based on the PCR results, Strep. agalactiae on teat skin resulted in 3.8 (1.4; 10.1) times higher odds of Strep. agalactiae IMI. Our results suggest that Staph. aureus and Strep. agalactiae on teat skin may be a risk factor for IMI with the same pathogens. Focus on proper teat skin hygiene is therefore recommended also in AMS.
Background
The business of clinical research has changed in the past two decades, shifting from industrialised Western countries to so-called emerging markets such as Eastern Europe, Latin America and Africa. An appraisal of the trends could identify associated factors that may have implications for the local populations and their endemic diseases.
Objectives
To identify potential reasons why emerging countries have become attractive places for international sponsors to conduct their clinical trials.
Methods
Using ClinicalTrials.gov, the Pan African Clinical Trials Registry, the National Health Research Database and the Nigeria Clinical Trials Registry, trend data on clinical research development were determined for two emerging African markets, Nigeria and South Africa (SA), from 2010 to 2018. Also, health data on the two countries from the fact sheets of health statistics of the World Health Organization were compared, as well as regulatory and ethical conditions. Available data were analysed using descriptive statistics and trend analysis.
Results
The impact of globalisation is evident from the upward trend in clinical trials in SA before 2010, and the clear downward trend thereafter. One reason for this change could be the alignment of SA’s regulatory and ethical frameworks with the Western world. In contrast,
the upward trend is only just beginning in Nigeria, with the introduction of ethical/regulatory frameworks, and supportive institutions making the business of clinical research more attractive on an international level. Although the number of international and local sponsors increased in Nigeria from 2010 to 2018, only the latter increased in SA, with the former decreasing over the same period. Overall, there is a mismatch between country-specific diseases and the drugs being tested, to the extent that leprosy, which is endemic in Nigeria, and tuberculosis in SA were not in the list of top 10 study areas in either country.
Conclusions
The globalisation trend is evident in the clinical trials business, but cannot be generalised to all emerging countries. Timing and intensity vary from country to country relative to factors that advance the existing profit-orientated business models of the sponsors. Furthermore, various diseases have been localised, which entails a diversely increasing need for research.
Economic and political/governmental infrastructural factors are major contributors to the economic development/growth of all sectors of a country, such as in the area of healthcare systems and clinical research, including the pharmaceutical industry. But what is the interaction between economic, and political/governmental infrastructural factors and the development of healthcare systems, especially, the performance of the pharmaceutical industry? Information from selected articles of a literature search of PubMed and by using Google Advanced Search led to the generation of five categories of infrastructural factors, and were filled with data from 41 African Countries using the World Health Organization data repository. Median changes over time were given and tested by Wilcoxon signed-rank test and Friedman test, respectively. Analysis of factors related to availability of healthcare facilities showed that physicians and pharmacies were significant increased, with insignificantly decreased number of hospital beds. Healthcare Financing by the Government showed notable differences. Private health spending decreased significantly unlike Gross National Income. Analysis of infrastructural factors showed that stable supply of electricity and the associated use of the Internet improved significantly. The low level of data on the expansion of paved road networks suggests less developed medical services in remote rural areas. Healthcare systems in African countries improved over the last two decades, but differences between the individual countries still prevail and some of the countries cannot yet offer an attractive sales market for the products of pharmaceutical companies.
Background: The globalization of clinical research should also benefit the population in developing markets. In this context, the approval of tested medicines and the associated expansion of medical care beyond clinical studies would be desirable as a possible long-term benefit.
Objectives: This study was designed to compare the development of the number of clinical trials with the number of marketing authorizations of medicines on the African continent. To contrast these 2 parameters, the data were analyzed using the model of an ecological study.
Methods: To reflect the broad spectrum of African developing countries with diverse levels of development, the data collection was based on 2 geographically selected sample countries each from Central, North, East, West, and Southern Africa. Based on the ClinicalTrials.gov registry, the first step was to collect trends data on the development of the clinical trials in the 10 selected countries of the country list of the African Region published by the World Health Organization for the period 2015 to 2018. Subsequently, data on the current number of marketing authorizations of medicines in the selected sample countries were identified using the online registries of the national authorities. The data were utilized in comparative analyses.
Results: Eight out of 10 model countries showed an increase in the number of clinical trials, with the exceptions of Cameroon and Libya, which showed an overall decline in research activity over the entire time. In direct comparison with drug registrations, the numbers indicate a similar development. The only exception here is Nigeria, a country with a solid performance in clinical research and yet a decrease in medicine registrations since 2015.
Conclusions: The expected increase in the development of clinical research as result of the globalization trend can basically be observed in most of the model countries. However, this increase does not guarantee an improvement in the number of medicine registrations. Although this is evident in some of the selected model countries, it cannot be projected to the entire African region. This may be linked to the diverse development of the individual countries due to the different political situations and the varying degrees of clinical research infrastructure.
Objectives:
The aim was to identify theoretically expected as well as actually reported benefits from drug development and the importance of individual patient benefits compared to the collective benefits to society in general.
Background:
Ethical guidelines require that clinical research involving humans offer the potential for benefit. A number of characteristics can be applied to define research benefit. Often benefit is categorized as being either direct or indirect. Indirect benefits can involve collective benefits for society rather than any benefits to the trial patient or subject. The purpose of this review was to examine which potential individual and societal benefits were mentioned as being expected in publications from government experts and which were mentioned in publications describing completed drug development trial results.
Methods:
Literature on research benefit was first identified by searching the PubMed database using several combinations of the key words benefit and clinical research. The search was limited to articles published in English. A Google search with the same combinations of key words but without any language limitation was then performed. Additionally, the reference lists of promising articles were screened for further thematically related articles. Finally, a narrative review was performed of relevant English- and German-language articles published between 1996 and 2016 to identify which of several potential benefits were either theoretically expected or which were mentioned in publications on clinical drug development trial results.
Results:
The principal benefits from drug development discussed included 2 main types of benefit, namely individual benefits for the patients and collective benefits for society. Twenty-one of an overall total of 26 articles discussing theoretically expected benefits focused on individual patient benefits, whereas 17 out of 26 articles mentioned collective benefits to society. In these publications, the most commonly mentioned theoretically expected individual patient benefit was the chance to receive up-to-date care (38.1%). A general increase in knowledge about health care, treatments, or drugs (70.6%) was the most commonly mentioned theoretically expected benefit for society. In contrast, all 13 publications reporting actual benefits of clinical drug development trials focused on personal benefits and only 1 of these publications also mentioned a societal benefit. The most commonly mentioned individual benefit was an increased quality of life (53.9%), whereas the only mentioned collective benefit to society was a general gain of knowledge (100.0%).
Conclusions:
Both theoretically expected and actually reported benefits in the majority of the included publications emphasized the importance of individual patient benefits from drug development rather than the collective benefits to society in general. The authors of these publications emphasized the right of each individual patient or subject to look for and expect some personal benefit from participating in a clinical trial rather than considering societal benefit as a top priority. From an ethical point of view, the benefits each individual patient receives from his or her participation in a clinical trial might also be seen as a societal benefit, especially when the drug or device tested, if approved for marketing, would eventually be made available for other similar patients from the country in which the clinical trial was conducted.
From an ethical perspective, clinical research involving humans is only acceptable if it involves the potential for benefit. Various characteristics can be applied to differentiate research benefit. Often benefit is categorized in direct or indirect benefit, whereby indirect benefit might be further differentiated in collective or benefit for the society, excluding or including the trial patient in the long term. Ethical guidelines, such as the Declaration of Helsinki in its latest version, do not precisely favor a particular type of benefit.
Publication Bias
(2016)
According to the Declaration of Helsinki, as well as the Statement on Public Disclosure of Clinical Trial Results of the World Health Organization, every researcher has the ethical obligation to publish research results on all trials with human participants in a complete and accurate way within 12 months after the end of the trial.1,2 Nevertheless, for several reasons, not all research results are published in an accurate way in case they are released at all. This phenomenon of publication bias may not only create a false impression on the reliability of clinical research business, but it may also affect the evidence of clinical conclusions about the best treatments, which are mostly based on published data and results.
Delphi is a frequently used research method in the information systems (IS) field. The last fifteen years have seen many variants of the Delphi Method proposed and used in IS research. However, these variants do not seem to be properly derived; while all variants share certain characteristics, their reasoning for differentiation inconsistently varies. It seems that researchers tend to create “new” Delphi Method variants, although the underlying modification of the Delphi Method is, in fact, minor. This leads to a heterogeneity of Delphi Method variants and undermines scientific rigor when using Delphi. The study addresses this deficit and (1) identifies different variants of Delphi and determines their characteristics, (2) critically reflects to what extent a clear distinction between these variants exists, (3) shows the clearly distinguishable Delphi Method variants and their characteristics, (4) develops a proposed taxonomy of Delphi Method variants, and (5) evaluates and applies this taxonomy. The proposed taxonomy helps clearly differentiate Delphi Method variants and enhances methodological rigor when using the Delphi Method.
The growing importance of renewable generation connected to distribution grids requires an increased coordination between transmission system operators (TSOs) and distribution system operators (DSOs) for reactive power management. This work proposes a practical and effective interaction method based on sequential optimizations to evaluate the reactive flexibility potential of distribution networks and to dispatch them along with traditional synchronous generators, keeping to a minimum the information exchange. A modular optimal power flow (OPF) tool featuring multi-objective optimization is developed for this purpose. The proposed method is evaluated for a model of a real German 110 kV grid with 1.6 GW of installed wind power capacity and a reduced order model of the surrounding transmission system. Simulations show the benefit of involving wind farms in reactive power support reducing losses both at distribution and transmission level. Different types of setpoints are investigated, showing the feasibility for the DSO to fulfill also individual voltage and reactive power targets over multiple connection points. Finally, some suggestions are presented to achieve a fair coordination, combining both TSO and DSO requirements.
Background: To improve interprofessional collaboration between registered nurses (RNs) and general practitioners (GPs) for nursing home residents (NHRs), the interprof ACT intervention package was developed. This complex intervention includes six components (e.g., shared goal setting, standardized procedures for GPs’ nursing home visits) that can be locally adapted. The cluster‑randomized interprof ACT trial evaluates the effects of this intervention on the cumulative incidence of hospital admissions (primary outcome) and secondary outcomes (e.g., length of hospital stays, utilization of emergency care services, and quality of life) within 12 months. It also includes a process evaluation which is subject of this protocol. The objectives of this evaluation are to assess the implementation of the interprof ACT intervention package and downstream effects on nurse–physician collaboration as well as preconditions and prospects for successive implementation into routine care.
Methods: This study uses a mixed methods triangulation design involving all 34 participating nursing homes (clusters). The quantitative part comprises paper‑based surveys among RNs, GPs, NHRs, and nursing home directors at baseline and 12 months. In the intervention group (17 clusters), data on the implementation of preplanned implementation strategies (training and supervision of nominated IPAVs, interprofessional kick‑off meetings) and local implementation activities will be recorded. Major outcome domains are the dose, reach and fidelity of the implementation of the intervention package, changes in interprofessional collaboration, and contextual factors. The qualitative part will be conducted in a subsample of 8 nursing homes (4 per study group) and includes repeated non‑participating observations and semistructured interviews on the interaction between involved health professionals and their work processes. Quantitative and qualitative data will be descriptively analyzed and then triangulated by means of joint displays and mixed methods informed regression models.
Discussion: By integrating a variety of qualitative and quantitative data sources, this process evaluation will allow comprehensive assessment of the implementation of the interprof ACT intervention package, the changes induced in interprofessional collaboration, and the influence of contextual factors. These data will reveal expected and unexpected changes in the procedures of interprofessional care delivery and thus facilitate accurate conclusions for the further design of routine care services for NHRs.
The bio-based plastic market is forecast to grow in the next years. With a growing market share and product range, the implementation of circular thinking is becoming more and more important also for bio-based plastics to enable a sound circular economy for these group of plastics. Therefore, it is important to assess the environmental performance for different end-of-life options of bio-based plastics from an early stage on. This review presents a comprehensive overview on the current status quo of different end-of-life options for bio-based plastics from an environmental perspective. Based on the status quo and the corresponding impact assessment results, the global plastic demand as well as the technical substitution potential of bio-based plastics, the environmental saving potential in case of the different end-of-life options was calculated. The review shows that there is a focus on polylactic acid (PLA) regarding end-of-life assessment, with studies covering all end-of-life options. The focus of the impact assessment has been set on global warming potential (GWP). With respect to GWP, the analysis of a future global potential of PLA showed, for mechanical recycling, the highest saving potential with 94.1 Mio. t CO2-eq. per year in comparison to virgin material.
A novel method has been implemented to prepare metal oxide nanopowders covered with known quantities of adsorbed water; we subsequently studied the γ-radiolysis of ZrO2 nanopowders covered with H2O layers. H2 yields from the adsorbed water radiolysis are of importance in multiple industrial contexts – the nuclear industry being a prime example. Measured H2 yields at water coverages of just below and above one monolayer are around 350 times greater than for neat water, but these yields decrease rapidly with increasing water loading of the ZrO2 nanoparticles, approaching the yield of bulk water at coverages of tens of water layers. The observed plateau of the yields at 0.5 to 2.0 monolayers coverage can be explained by the ease with which electronic excitations in the ZrO2 can be transferred across the interface to the first one or two adsorbed water layers. However, with increasing water loading, energy transfer to water layers further away from the interface becomes less efficient, and above ~30 water layers, most of the water is not affected by any exciton formation in the ZrO2.
The ability to functionalize graphene with several methods, such as radical reactions, cycloadditions, hydrogenation, and oxidations, allows this material to be used in a large range of applications. In this framework, it is essential to be able to control the efficiency and stability of the functionalization process—this requires understanding how the graphene reactivity is affected by the environment, including the substrate. In this work we provide an insight on the substrate dependence of graphene reactivity towards hydrogenation by comparing three different substrates: silicon, hexagonal boron nitride (h-BN), and molybdenum disulfide (MoS2). Although MoS2 and h-BN have flatter surfaces than silicon, we found that the H coverage of graphene on h-BN is about half of the H coverage on graphene on both silicon and MoS2. Therefore, graphene shows strongly reduced reactivity towards hydrogenation when placed on h-BN. The difference in hydrogenation reactivity between h-BN and MoS2 may indicate a stronger van der Waals force between graphene and h-BN, compared to MoS2, or may be related to the chemical properties of MoS2, which is a well-known catalyst for hydrogen evolution reactions.
Background
Maternal postpartum depression has an impact on mother-infant interaction. Mothers with depression display less positive affect and sensitivity in interaction with their infants compared to non-depressed mothers. Depressed women also show more signs of distress and difficulties adjusting to their role as mothers than non-depressed women. In addition, depressive mothers are reported to be affectively more negative with their sons than with daughters.
Methods
A non-clinical sample of 106 mother-infant dyads at psychosocial risk (poverty, alcohol or drug abuse, lack of social support, teenage mothers and maternal psychic disorder) was investigated with EPDS (maternal postpartum depressive symptoms), the CARE-Index (maternal sensitivity in a dyadic context) and PSI-SF (maternal distress). The baseline data were collected when the babies had reached 19 weeks of age.
Results
A hierarchical regression analysis yielded a highly significant relation between the PSI-SF subscale "parental distress" and the EPDS total score, accounting for 55% of the variance in the EPDS. The other variables did not significantly predict the severity of depressive symptoms. A two-way ANOVA with "infant gender" and "maternal postpartum depressive symptoms" showed no interaction effect on maternal sensitivity.
Conclusions
Depressive symptoms and maternal sensitivity were not linked. It is likely that we could not find any relation between both variables due to different measuring methods (self-reporting and observation). Maternal distress was strongly related to maternal depressive symptoms, probably due to the generally increased burden in the sample, and contributed to 55% of the variance of postpartum depressive symptoms.
Background:
This study examined the extent to which regulatory problems in infants at 4 and 6 months influence childhood development at 12 months. The second aim of the study was to examine the influence maternal distress has on 4-month-old children’s subsequent development as well as gender differences with regard to regulatory problems and development.
Methods:
153 mother-child dyads enrolled in the family support research project “Nobody slips through the net” constituted the comparison group. These families faced psychosocial risks (e.g. poverty, excessive demands on the mother, and mental health disorders of the mother, measured with the risk screening instrument Heidelberger Belastungsskala - HBS) and maternal stress, determined with the Parental Stress Index (PSI-SF). The children’s developmental levels and possible early regulatory problems were evaluated by means of the Ages and Stages Questionnaires (ASQ) and a German questionnaire assessing problems of excessive crying along with sleeping and feeding difficulties (SFS).
Results:
A statistically significant but only low, inverse association between excessive crying, whining and sleep problems at 4 and 6 months and the social development of one-year-olds (accounting for 5% and 8% of the variance respectively) was found. Feeding problems had no effect on development. Although regulatory problems in infants were accompanied by increased maternal stress level, these did not serve as a predictor of the child’s social development at 12 months. One-year-old girls reached a higher level of development in social and fine motor skills. No gender differences were found with regard to regulatory problems, nor any moderating effect of gender on the relation between regulatory problems and level of development.
Conclusions:
Our results reinforce existing knowledge pertaining to the transactional association between regulatory problems in infants, maternal distress and dysfunctionality of mother-child interactions. They also provide evidence of a slight but distinct negative influence of crying and sleeping problems on children’s subsequent social development. Easily accessible support services provided by family health visitors (particularly to the so-called “at-risk families”) are strongly recommended to help prevent the broadening of children’s early regulatory problems into other areas of behavior.
This feasibility study investigates the flexural properties of biocomposites containing woven flax textiles (plain, twill, satin) and woven twill patterned hybrid textiles containing flax-/glass or flax-/carbon mixture for lightweight applications. Synthetic fibers are integrated as weft and flax fibers are integrated as warp yarns using a double-rapier weaving machine with a Jacquard attachment. The corresponding biocomposites are manufactured via vacuum infusion process using a biobased epoxy resin as a matrix. The manufactured biocomposites are analyzed with regard to their density and flexural properties. The results show that the use of hybrid textiles offers a promising solution for the manufacture of biocomposites with a higher biobased content and significantly improved flexural properties. Furthermore, the introduction of high-performance synthetic fibers in textiles enables the manufacture of biocomposites with an isotropic mechanical performance.
Food protein hydrolysates are often produced in unspecific industrial batch processes. The hydrolysates composition underlies process-related fluctuations and therefore the obtained peptide fingerprint and bioactive properties may vary. To overcome this obstacle and enable the production of specific hydrolysates with selected peptides, a ceramic capillary system was developed and characterized for the continuous production of a consistent peptide composition. Therefore, the protease Alcalase was immobilized on the surface of aminosilane modified yttria stabilized zirconia capillaries with a pore size of 1.5 μm. The loading capacity was 0.3 μg enzyme per mg of capillary with a residual enzyme activity of 43%. The enzyme specific peptide fingerprint produced with this proteolytic capillary reactor system correlated with the degree of hydrolysis, which can be controlled over the residence time by adjusting the flow rate. Common food proteins like casein, sunflower and lupin protein isolates were tested for continuous hydrolysis in the developed reactor system. The peptide formation was investigated by high-performance liquid chromatography. Various trends were found for the occurrence of specific peptides. Some are just intermediately occurring, while others cumulate by time. Thus, the developed continuous reactor system enables the production of specific peptides with desired bioactive properties.
Introduction: Piper crocatum Ruiz & Pav (P. crocatum) has been reported to accelerate the diabetic wound healing process empirically. Some studies showed the benefits of P. crocatum in treating various diseases but its mechanisms in diabetic wound healing have never been reported. In the present study we investigated the diabetic wound healing activity of the active fraction of P. crocatum on wounded hyperglycemia fibroblasts (wHFs).
Methods: Bioassay-guided fractionation was performed to get the most active fraction. The selected active fraction was applied to wHFs within 72 h incubation. Mimicking a diabetic condition was done using basal glucose media containing an additional 17 mMol/L D-glucose. A wound was simulated via the scratch assay. The collagen deposition was measured using Picro-Sirius Red and wound closure was measured using scratch wound assay. Underlying mechanisms through p53, aSMA, SOD1 and Ecadherin were measured using western blotting.
Results: We reported that FIV is the most active fraction of P. crocatum. We confirmed that FIV\(7.81 mg/ml, 15.62 mg/ml, 31.25 mg/ml, 62.5 mg/ml, and 125 mg/ml) induced the collagen deposition and wound closure of wHFs. Furthermore, FIV treatment (7.81 mg/ml, 15.62 mg/ml, 31.25 mg/ml) down-regulated the protein expression level of p53 and up-regulated the protein expression levels of aSMA, E-cadherin, and SOD1.
Discussion/conclusions: Our findings suggest that ameliorating collagen deposition and wound closure through protein regulation of p53, aSMA, E-cadherin, and SOD1 are some of the mechanisms by which FIV of P. crocatum is involved in diabetic wound healing therapy.
Prüfungsangst
(2003)
Context: Higher education is changing at an accelerating pace due to the widespread use of digital teaching and emerging technologies. In particular, AI assistants such as ChatGPT pose significant challenges for higher education institutions because they bring change to several areas, such as learning assessments or learning experiences.
Objective: Our objective is to discuss the impact of AI assistants in the context of higher education, outline possible changes to the context, and present recommendations for adapting to change.
Method: We review related work and develop a conceptual structure that visualizes the role of AI assistants in higher education.
Results: The conceptual structure distinguishes between humans, learning, organization, and disruptor, which guides our discussion regarding the implications of AI assistant usage in higher education. The discussion is based on evidence from related literature.
Conclusion: AI assistants will change the context of higher education in a disruptive manner, and the tipping point for this transformation has already been reached. It is in our hands to shape this transformation.
Coaxial Laser wire Direct Energy Deposition (L-DED) promises a direction-independent buildup due to a centric supply of the welding material. To fabricate Functionally Graded Materials (FGMs), a processing head was designed that is capable of supplying two wire materials into the processing zone. This study investigates the direction dependency of welding seams produced by two 1.4718 metal wires with a diameter of 0.8 mm in a coaxial laser setup using three separately controllable single laser beams with a maximum combined laser power of 660 W. The welding wires are supplied simultaneously to the laser spot under an incidence angle of 3.5° to the middle axis of the processing head. The seam geometry is investigated using a confocal laserscanning-microscope. A comparison of the height, width and macroscopic seam geometry reveals the influence of the welding direction on the seam geometry and quality in Laser Double wire Direct Energy Deposition (LD-DED).
Niemals bis zum Mond
(1994)