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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.
Objectives
Quality of care largely depends on successful teamwork, which in turn needs effective communication between health professionals. To communicate successfully in a team, health professionals need to strive for the same goals. However, it has been left largely unaddressed which goals professionals consider to be important. In this study, we aim to identify these goals and analyse whether differences between (1) personal and organisational goals, (2) different professions and (3) hierarchical levels exist in neonatal intensive care units (NICUs).
Design
Goals were identified based on a literature review and a workshop with health professionals and tested in a pilot study. Subsequently, in the main study, a cross-sectional employee survey was undertaken.
Setting and participants
1489 nurses and 537 physicians from 66 German NICUs completed the
questionnaire regarding personal and organisational goal importance between May and July 2013. Answers were given based on a 7-point Likert scale varying between none and exceptionally high importance.
Results
Results show that the goals can be subdivided into three main goal dimensions: patients, parents and staff. Furthermore, our results reveal significant differences between different professions and different hierarchical level: physicians rated patient goals with a
mean (95% CI) importance of 6.37 (3.32 to 6.43), which is significantly higher than nurses with a mean (95% CI) importance of 6.15 (6.12 to 6.19) (p<0.01). Otherwise, nurses classified parental goals as more important (p<0.01). Furthermore, professionals in leading positions rate patient goals significantly higher than professionals that are not in leading positions (6.36 (3.28 to 6.44) vs 6.19 (6.15 to 6.22), p<0.01).
Conclusions
Different employee goals need to be considered in decision-making
processes to enhance employee motivation and the effectiveness of teamwork.
For anomaly-based intrusion detection in computer networks, data cubes can be used for building a model of the normal behavior of each cell. During inference an anomaly score is calculated based on the deviation of cell metrics from the corresponding normality model. A visualization approach is shown that combines different types of diagrams and charts with linked user interaction for filtering of data.
This study investigates the influence of traumatic events on the mental health of North Korean refugee women by examining the prevalence and severity of posttraumatic stress disorder (PTSD), depression, and anxiety in comparison with their male counterparts (women = 496; men = 131). Our results suggest that women are at greater risk of developing mental health problems than men. In particular, symptoms of PTSD and anxiety were higher among women who experienced forced repatriation to North Korea, which is operationalized as a constellation of gendered traumatic incidents such as sexual abuse, rape, witnessing infanticides, and forced abortion. The policy implications of our results and suggestions for future studies are discussed.
Worldwide, seagrass meadows are under threat. Consequently, there is a strong need for seagrass restoration to guarantee the provision of related ecosystem services such as nutrient cycling, carbon sequestration and habitat provision. Seagrass often grows in vast meadows in which the presence of seagrass itself leads to a reduction of hydrodynamic energy. By modifying the environment, seagrass thus serves as foundation species and ecosystem engineer improving habitat quality for itself and other species as well as positively affecting its own fitness. On the downside, this positive feedback mechanism can render natural recovery of vanished and destroyed seagrass meadows impossible. An innovative approach to promote positive feedback mechanisms in seagrass restoration is to create an artificial seagrass (ASG) that mimics the facilitation function of natural seagrass. ASG could provide a window of opportunity with respect to suitable hydrodynamic and light conditions as well as sediment stabilization to allow natural seagrass to re-establish. Here, we give an overview of challenges and open questions for the application of ASG to promote seagrass restoration based on experimental studies and restoration trials and we propose a general approach for the design of an ASG produced from biodegradable materials. Considering positive feedback mechanisms is crucial to support restoration attempts. ASG provides promising benefits when habitat conditions are too harsh for seagrass meadows to re-establish themselves.
In the area of manufacturing and process automation in industrial applications, technical energy management systems are mainly used to measure, collect, store, analyze and display energy data. In addition, PLC programs on the control level are required to obtain the energy data from the field level. If the measured data is available in a PLC as a raw value, it still has to be processed by the PLC, so that it can be passed on to the higher layers in a suitable format, e.g. via OPC UA. In plants with heterogeneous field device installations, a high engineering effort is required for the creation of corresponding PLC programs. This paper describes a concept for a code generator that can be used to reduce this engineering effort.
Nowadays, most recommender systems are based on a centralized architecture, which can cause crucial issues in terms of trust, privacy, dependability, and costs. In this paper, we propose a decentralized and distributed MANET-based (Mobile Ad-hoc NETwork) recommender system for open facilities. The system is based on mobile devices that collect sensor data about users locations to derive implicit ratings that are used for collaborative filtering recommendations. The mechanisms of deriving ratings and propagating them in a MANET network are discussed in detail. Finally, extensive experiments demonstrate the suitability of the approach in terms of different performance metrics.
In this paper the workflow of the project 'Untersuchungs-, Simulations- und Evaluationstool für Urbane Logistik` (USEfUL) is presented. Aiming to create a web-based decision support tool for urban logistics, the project needed to integrate multiple steps into a single workflow, which in turn needed to be executed multiple times. While a service-oriented system could not be created, the principles of service orientation was utilized to increase workflow efficiency and flexibility, allowing the workflow to be easily adapted to new concepts or research areas.
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.