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Massive Open Online Courses (MOOCs) have left their mark on the face of education during the recent years. At the Hasso Plattner Institute (HPI) in Potsdam, Germany, we are actively developing a MOOC platform, which provides our research with a plethora of e-learning topics, such as learning analytics, automated assessment, peer assessment, team-work, online proctoring, and gamification. We run several instances of this platform. On openHPI, we provide our own courses from within the HPI context. Further instances are openSAP, openWHO, and mooc.HOUSE, which is the smallest of these platforms, targeting customers with a less extensive course portfolio. In 2013, we started to work on the gamification of our platform. By now, we have implemented about two thirds of the features that we initially have evaluated as useful for our purposes. About a year ago we activated the implemented gamification features on mooc.HOUSE. Before activating the features on openHPI as well, we examined, and re-evaluated our initial considerations based on the data we collected so far and the changes in other contexts of our platforms.
Background and Aims: Ostarek et al. (2019) claimed a conclusive
demonstration that language comprehension relies profoundly on
visual simulations. They presented participants with visual noise during sentence-picture verification (SPV) and measured lateralized button response speed. The authors selectively eliminated the classical congruency effect (faster yes decisions when pictures match the objects implied by the sentences) with ‘‘high level’’ noise made from images of other objects. However, that visual noise included tool pictures, known to activate lateralized motor affordances. Moreover, some of their sentences described motor actions. This raises the question whether motor simulation may have contaminated their results.
Methods: Replicating Ostarek et al. (2019), 33 right-handed
participants performed SPV but either without visual noise or while viewing (a) only left-handled or (b) only right-handled or (c) alternatingly left- and right-handled tools. Accuracy and reaction times of manual yes responses were analyzed. Additionally, hand-relatedness of sentences was rated.
Results: Replicating Ostarek et al. (2019), the classical SPV congruency effect appeared without noise and vanished when alternatingly handled tools were presented. Crucially, it reappeared when noise objects were consistently either left- or righthandled. Higher hand-relatedness of sentence content reduced SPV performance and accuracy was lower with right-handled noise.
Conclusion: First, we demonstrated an interaction between motor-
related language, visual affordances and motor responses in SPV.
This result supports the embodied view of language processing.
Second, we identified a motor process not previously known in SPV. This extends our understanding of mental simulation and calls for methodological controls in future studies.
Eccentric exercises (ECC) induce reversible muscle damage, delayed-onset muscle soreness and an inflammatory reaction that is often followed by a systemic anti-inflammatory response. Thus, ECC might be beneficial for treatment of metabolic disorders which are frequently accompanied by a low-grade systemic inflammation. However, extent and time course of a systemic immune response after repeated ECC bouts are poorly characterized.
PURPOSE: To analyze the (anti-)inflammatory response after repeated ECC loading of the trunk.
METHODS: Ten healthy participants (33 ± 6 y; 173 ± 14 cm; 74 ± 16 kg) performed three isokinetic strength measurements of the trunk (concentric (CON), ECC1, ECC2, each 2 wks apart; flexion/extension, velocity 60°/s, 120s MVC). Pre- and 4, 24, 48, 72, 168h post-exercise, muscle soreness (numeric rating scale, NRS) was assessed and blood samples were taken and analyzed [Creatine kinase (CK), C-reactive protein (CRP), Interleukin-6 (IL-6), IL-10, Tumor necrosis factor-α (TNF-α)]. Statistics were done by Friedman‘s test with Dunn‘s post hoc test (α=.05).
RESULTS: Mean peak torque was higher during ECC1 (319 ± 142 Nm) than during CON (268 ± 108 Nm; p<.05) and not different between ECC1 and ECC2 (297 ± 126 Nm; p>.05). Markers of muscle damage (peaks post-ECC1: NRS 48h, 4.4±2.9; CK 72h, 14407 ± 19991 U/l) were higher after ECC1 than after CON and ECC2 (p<.05). The responses over 72h (stated as Area under the Curve, AUC) were abolished after ECC2 compared to ECC1 (p<.05) indicating the presence of the repeated bout effect. CRP levels were not changed. IL-6 levels increased 2-fold post-ECC1 (pre: 0.5 ± 0.4 vs. 72h: 1.0 ± 0.8 pg/ml). The IL-6 response was enhanced after ECC1 (AUC 61 ± 37 pg/ml*72h) compared to CON (AUC 33 ± 31 pg/ml*72h; p<.05). After ECC2, the IL-6 response (AUC 43 ± 25 pg/ml*72h) remained lower than post-ECC1, but the difference was not statistically significant. Serum levels of TNF-α and of the anti-inflammatory cytokine IL-10 were below detection limits. Overall, markers of muscle damage and immune response showed high inter-individual variability.
CONCLUSION: Despite maximal ECC loading of a large muscle group, no anti-inflammatory and just weak inflammatory responses were detected in healthy adults. Whether ECC elicits a different reaction in inflammatory clinical conditions is unclear.
The ionospheric delay of global navigation satellite systems (GNSS) signals typically is compensated by adding a single correction value to the pseudorange measurement of a GNSS receiver. Yet, this neglects the dispersive nature of the ionosphere. In this context we analyze the ionospheric signal distortion beyond a constant delay. These effects become increasingly significant with the signal bandwidth and hence more important for new broadband navigation signals. Using measurements of the Galileo E5 signal, captured with a high gain antenna, we verify that the expected influence can indeed be observed and compensated. A new method to estimate the total electron content (TEC) from a single frequency high gain antenna measurement of a broadband GNSS signal is proposed and described in detail. The received signal is de facto unaffected by multi-path and interference because of the narrow aperture angle of the used antenna which should reduce the error source of the result in general. We would like to point out that such measurements are independent of code correlation, like in standard receiver applications. It is therefore also usable without knowledge of the signal coding. Results of the TEC estimation process are shown and discussed comparing to common TEC products like TEC maps and dual frequency receiver estimates.
Hulleman & Olivers' (H&O's) model introduces variation of the functional visual field (FVF) for explaining visual search behavior. Our research shows how the FVF can be studied using gaze-contingent displays and how FVF variation can be implemented in models of gaze control. Contrary to H&O, we believe that fixation duration is an important factor when modeling visual search behavior.
The Internet can be considered as the most important infrastructure for modern society and businesses. A loss of Internet connectivity has strong negative financial impacts for businesses and economies. Therefore, assessing Internet connectivity, in particular beyond their own premises and area of direct control, is of growing importance in the face of potential failures, accidents, and malicious attacks. This paper presents CORIA, a software framework for an easy analysis of connectivity risks based on large network graphs. It provides researchers, risk analysts, network managers and security consultants with a tool to assess an organization's connectivity and paths options through the Internet backbone, including a user-friendly and insightful visual representation of results. CORIA is flexibly extensible in terms of novel data sets, graph metrics, and risk scores that enable further use cases. The performance of CORIA is evaluated by several experiments on the Internet graph and further randomly generated networks.
Editorial
(2017)
Photonic sensing in highly concentrated biotechnical processes by photon density wave spectroscopy
(2017)
Photon Density Wave (PDW) spectroscopy is introduced as a new approach for photonic sensing in highly concentrated biotechnical processes. It independently quantifies the absorption and reduced scattering coefficient calibration-free and as a function of time, thus describing the optical properties in the vis/NIR range of the biomaterial during their processing. As examples of industrial relevance, enzymatic milk coagulation, beer mashing, and algae cultivation in photo bioreactors are discussed.
Conclusion
(2016)
This chapter revisits the role of the new modes of governance in areas of limited statehood. First, it states that there is no linear relationship between degrees of statehood and the overall effectiveness of new modes of sustainability governance. Second, the chapter states that, in most of the cases, national governments are hesitant or even actively hamper the development of new modes of governance. Third, it shows that the absence of the shadow of hierarchy can indeed lead to ineffective new modes of governance. However, the shadow of hierarchy does not necessarily need to be cast by states. Finally, the author reviews the complexities involved in participatory practices, stressing the importance of institutional structures and knowledgeable brokers. The chapter concludes by outlining fields for future research.
This chapter investigates the trajectory of establishing the Forest Stewardship Council (FSC) in the early 1990s as the first private transnational certification organization with an antagonistic stakeholder body. Its main contribution is a micro-analysis of the founding assembly in 1993. By investigating the role of brokers within the negotiation as one institutional scope condition for ‘arguing’ having occurred, the chapter adopts a dramaturgical approach. It contends that the authority of brokers is not necessarily institutionally given, but needs to be gained: brokers have to prove situationally that their knowledge is relevant and that they are speaking impartially in the interest of progress rather than their own. The chapter stresses the importance of procedural knowledge which brokers provide in contrast to policy knowledge.
Introduction
(2016)
The Paris Agreement for Climate Change or the Sustainable Development Goals (SDGs) rely on new modes of governance for implementation. Indeed, new modes of governance such as market-based instruments, public-private partnerships or multi-stakeholder initiatives have been praised for playing a pivotal role in effective and legitimate sustainability governance. Yet, do they also deliver in areas of limited statehood? States such as Malaysia or the Dominican Republic partly lack the ability to implement and enforce rules; their statehood is limited. This introduction provides the analytical framework of this volume and critically examines the performance of new modes of governance in areas of limited statehood, drawing on the book’s in-depth case studies on issues of climate change, biodiversity, and health.
We investigated the possibility to identify motor units (MUs) with high-density surface electromyography (HDEMG) over experimental sessions in different days. 10 subjects performed submaximal knee extensions across three sessions in three days separated by one week, while EMG was recorded from the vastus medialis muscle with high-density electrode grids. The shapes of the MU action potentials (MUAPs) over multiple channels extracted from HDEMG decomposition were matched across sessions by cross-correlation. Forty and twenty percent of the MUs decomposed could be tracked across two and three sessions, respectively (average cross correlation 0.85 +/- 0.04). The estimated properties of the matched motor units were similar across the sessions. For example, mean discharge rate and recruitment thresholds were measured with an intra-class correlation coefficient (ICCs) > 0.80. These results strongly suggest that the same MUs were indeed identified across sessions. This possibility will allow monitoring changes in MU properties following interventions or during the progression of neuromuscular disorders.
Structural health monitoring activities are of primal importance for managing transport infrastructure, however most SHM methodologies are based on point-based sensors that have limitations in terms of their spatial positioning requirements, cost of development and measurement range. This paper describes the progress on the SENSKIN EC project whose objective is to develop a dielectric-elastomer and micro-electronics-based sensor, formed from a large highly extensible capacitance sensing membrane supported by advanced microelectronic circuitry, for monitoring transport infrastructure bridges. Such a sensor could provide spatial measurements of strain in excess of 10%. The actual sensor along with the data acquisition module, the communication module and power electronics are all integrated into a compact unit, the SENSKIN device, which is energy-efficient, requires simple signal processing and it is easy to install over various surface types. In terms of communication, SENSKIN devices interact with each other to form the SENSKIN system; a fully distributed and autonomous wireless sensor network that is able to self-monitor. SENSKIN system utilizes Delay-/Disruption-Tolerant Networking technologies to ensure that the strain measurements will be received by the base station even under extreme conditions where normal communications are disrupted. This paper describes the architecture of the SENSKIN system and the development and testing of the first SENSKIN prototype sensor, the data acquisition system, and the communication system.
Surface acoustic wave (SAW) devices are well-known for gravimetric sensor applications. In biosensing applications, chemical-and biochemically evoked adsorption processes at surfaces are detected in liquid environments using delay-line or resonator sensor configurations, preferably in combination with appropriate microfluidic devices. In this paper, a novel SAW-based impedance sensor type is introduced which uses only one interdigital electrode transducer (IDT) simultaneously as SAW generator and sensor element. It is shown that the amplitude of the reflected S-11 signal directly depends on the input impedance of the SAW device. The input impedance is strongly influenced by mass adsorption which causes a characteristic and measurable impedance mismatch.
In this paper, the applicability of deep downhole geoelectrical monitoring for detecting CO2 related signatures is evaluated after a nearly ten year period of CO2 storage at the Ketzin pilot site. Deep downhole electrode arrays have been studied as part of a multi-physical monitoring concept at four CO2 pilot test sites worldwide so far. For these sites, it was considered important to implement the geoelectrical method into the measurement program of tracking the CO2 plume. Analyzing the example of the Ketzin site, it can be seen that during all phases of the CO2 storage reservoir development the resistivity measurements and their corresponding tomographic interpretation contribute in a beneficial manner to the measurement, monitoring and verification (MMV) protocol. The most important impact of a permanent electrode array is its potential as tool for estimating reservoir saturations.
Water management tools are necessary to guarantee the preservation of natural resources while ensuring optimum utilization. Linear regression models are a simple and quick solution for creating prognostic capabilities. Multivariate models show higher precision than univariate models. In the case of Waiwera, implementation of individual production rates is more accurate than applying just the total production rate. A maximum of approximately 1,075 m3/day can be pumped to ensure a water level of at least 0.5 m a.s.l. in the monitoring well. The model should be renewed annually to implement new data and current water level trends to keep the quality.
Predicting macroscopic elastic rock properties requires detailed information on microstructure
(2017)
Predicting variations in macroscopic mechanical rock behaviour due to microstructural changes, driven by mineral precipitation and dissolution is necessary to couple chemo-mechanical processes in geological subsurface simulations. We apply 3D numerical homogenization models to estimate Young’s moduli for five synthetic microstructures, and successfully validate our results for comparable geometries with the analytical Mori-Tanaka approach. Further, we demonstrate that considering specific rock microstructures is of paramount importance, since calculated elastic properties may deviate by up to 230 % for the same mineral composition. Moreover, agreement between simulated and experimentally determined Young’s moduli is significantly improved, when detailed spatial information are employed.
Integration and development of the energy supply in China and worldwide is a challenge for the years to come. The innovative idea presented here is based on an extension of the “power-to-gas-to-power” technology by establishing a closed carbon cycle. It is an implementation of a low-carbon energy system based on carbon dioxide capture and storage (CCS) to store and reuse wind and solar energy. The Chenjiacun storage project in China compares well with the German case study for the towns Potsdam and Brandenburg/Havel in the Federal State of Brandenburg based on the Ketzin pilot site for CCS.
Dissolved CO2 storage in geological formations with low pressure, low risk and large capacities
(2017)
Geological CO2 storage is a mitigation technology to reduce CO2 emissions from fossil fuel combustion. However, major concerns are the pressure increase and saltwater displacement in the mainly targeted deep groundwater aquifers due to injection of supercritical CO2. The suggested solution is storage of CO2 exclusively in the dissolved state. In our exemplary regional case study of the North East German Basin based on a highly resolved temperature and pressure distribution model and a newly developed reactive transport coupling, we have quantified that 4.7 Gt of CO2 can be stored in solution compared to 1.5 Gt in the supercritical state.
Cost models play an important role for the efficient implementation of software systems. These models can be embedded in operating systems and execution environments to optimize execution at run time. Even though non-uniform memory access (NUMA) architectures are dominating today's server landscape, there is still a lack of parallel cost models that represent NUMA system sufficiently. Therefore, the existing NUMA models are analyzed, and a two-step performance assessment strategy is proposed that incorporates low-level hardware counters as performance indicators. To support the two-step strategy, multiple tools are developed, all accumulating and enriching specific hardware event counter information, to explore, measure, and visualize these low-overhead performance indicators. The tools are showcased and discussed alongside specific experiments in the realm of performance assessment.
This paper discusses a new approach for designing and deploying Security-as-a-Service (SecaaS) applications using cloud native design patterns. Current SecaaS approaches do not efficiently handle the increasing threats to computer systems and applications. For example, requests for security assessments drastically increase after a high-risk security vulnerability is disclosed. In such scenarios, SecaaS applications are unable to dynamically scale to serve requests. A root cause of this challenge is employment of architectures not specifically fitted to cloud environments. Cloud native design patterns resolve this challenge by enabling certain properties e.g. massive scalability and resiliency via the combination of microservice patterns and cloud-focused design patterns. However adopting these patterns is a complex process, during which several security issues are introduced. In this work, we investigate these security issues, we redesign and deploy a monolithic SecaaS application using cloud native design patterns while considering appropriate, layered security counter-measures i.e. at the application and cloud networking layer. Our prototype implementation out-performs traditional, monolithic applications with an average Scanner Time of 6 minutes, without compromising security. Our approach can be employed for designing secure, scalable and performant SecaaS applications that effectively handle unexpected increase in security assessment requests.
Mixed-projection treemaps
(2017)
This paper presents a novel technique for combining 2D and 2.5D treemaps using multi-perspective views to leverage the advantages of both treemap types. It enables a new form of overview+detail visualization for tree-structured data and contributes new concepts for real-time rendering of and interaction with treemaps. The technique operates by tilting the graphical elements representing inner nodes using affine transformations and animated state transitions. We explain how to mix orthogonal and perspective projections within a single treemap. Finally, we show application examples that benefit from the reduced interaction overhead.
The maximum entropy method is used to predict flows on water distribution networks. This analysis extends the water distribution network formulation of Waldrip et al. (2016) Journal of Hydraulic Engineering (ASCE), by the use of a continuous relative entropy defined on a reduced parameter set. This reduction in the parameters that the entropy is defined over ensures consistency between different representations of the same network. The performance of the proposed reduced parameter method is demonstrated with a one-loop network case study.
The maximum entropy method is used to derive an alternative gravity model for a transport network. The proposed method builds on previous methods which assign the discrete value of a maximum entropy distribution to equal the traffic flow rate. The proposed method however, uses a distribution to represent each flow rate. The proposed method is shown to be able to handle uncertainty in a more elegant way and give similar results to traditional methods. It is able to incorporate more of the observed data through the entropy function, prior distribution and integration limits potentially allowing better inferences to be made.
Lately, first implementation approaches of Internet of Things (IoT) technologies penetrate industrial value-adding processes. Within this, the competence requirements for employees are changing. Employees’ organization, process, and interaction competences are of crucial importance in this new IoT environment, however, in students and vocational training not sufficiently considered yet. On the other hand, conventional learning factories evolve and transform to digital learning factories. Nevertheless, the integration of IoT technology and its usage for training in digital learning factories has been largely neglected thus far. Existing learning factories do not explicitly and properly consider IoT technology, which leads to deficiencies regarding an appropriate development of employees’ Industrial IoT competences. The goal of this contribution is to point out a didactic concept that enables development and training of these new demanded competences by using an IoT laboratory. For this purpose, a design science approach is applied. The result of this contribution is a didactic concept for the development of Industrial IoT competences in an IoT laboratory.
In this extended abstract, we will analyze the current challenges for the envisioned Self-Adaptive CPS. In addition, we will outline our results to approach these challenges with SMARTSOS [10] a generic approach based on extensions of graph transformation systems employing open and adaptive collaborations and models at runtime for trustworthy self-adaptation, self-organization, and evolution of the individual systems and the system-of-systems level taking the independent development, operation, management, and evolution of these systems into account.
E-commerce marketplaces are highly dynamic with constant competition. While this competition is challenging for many merchants, it also provides plenty of opportunities, e.g., by allowing them to automatically adjust prices in order to react to changing market situations. For practitioners however, testing automated pricing strategies is time-consuming and potentially hazardously when done in production. Researchers, on the other side, struggle to study how pricing strategies interact under heavy competition. As a consequence, we built an open continuous time framework to simulate dynamic pricing competition called Price Wars. The microservice-based architecture provides a scalable platform for large competitions with dozens of merchants and a large random stream of consumers. Our platform stores each event in a distributed log. This allows to provide different performance measures enabling users to compare profit and revenue of various repricing strategies in real-time. For researchers, price trajectories are shown which ease evaluating mutual price reactions of competing strategies. Furthermore, merchants can access historical marketplace data and apply machine learning. By providing a set of customizable, artificial merchants, users can easily simulate both simple rule-based strategies as well as sophisticated data-driven strategies using demand learning to optimize their pricing strategies.
We compare Visual Berrypicking, an interactive approach allowing users to explore large and highly faceted information spaces using similarity-based two-dimensional maps, with traditional browsing techniques. For large datasets, current projection methods used to generate maplike overviews suffer from increased computational costs and a loss of accuracy resulting in inconsistent visualizations. We propose to interactively align inexpensive small maps, showing local neighborhoods only, which ideally creates the impression of panning a large map. For evaluation, we designed a web-based prototype for movie exploration and compared it to the web interface of The Movie Database (TMDb) in an online user study. Results suggest that users are able to effectively explore large movie collections by hopping from one neighborhood to the next. Additionally, due to the projection of movie similarities, interesting links between movies can be found more easily, and thus, compared to browsing serendipitous discoveries are more likely.
We develop a simple two-zone interpretation of the broadband baseline Crab nebula spectrum between 10(-5) eV and similar to 100 TeV by using two distinct log-parabola energetic electrons distributions. We determine analytically the very-high energy photon spectrum as originated by inverse-Compton scattering of the far-infrared soft ambient photons within the nebula off a first population of electrons energized at the nebula termination shock. The broad and flat 200 GeV peak jointly observed by Fermi/LAT and MAGIC is naturally reproduced. The synchrotron radiation from a second energetic electron population explains the spectrum from the radio range up to similar to 10 keV. We infer from observations the energy dependence of the microscopic probability of remaining in proximity of the shock of the accelerating electrons.
Web-based E-Learning uses Internet technologies and digital media to deliver education content to learners. Many universities in recent years apply their capacity in producing Massive Open Online Courses (MOOCs). They have been offering MOOCs with an expectation of rendering a comprehensive online apprenticeship. Typically, an online content delivery process requires an Internet connection. However, access to the broadband has never been a readily available resource in many regions. In Africa, poor and no networks are yet predominantly experienced by Internet users, frequently causing offline each moment a digital device disconnect from a network. As a result, a learning process is always disrupted, delayed and terminated in such regions. This paper raises the concern of E-Learning in poor and low bandwidths, in fact, it highlights the needs for an Offline-Enabled mode. The paper also explores technical approaches beamed to enhance the user experience inWeb-based E-Learning, particular in Africa.
Recently, Kocyan & Wiland-Szymańska (2016) have published a thorough research article on one of the outstanding members of the family Hypoxidaceae on the Seychelles, which resulted in the raise of a new genus (Friedmannia Kocyan & Wiland-Szymańska 2016: 60) to accommodate the former Curculigo seychellensis Bojer ex Baker (1877: 368). However, it has turned out that the name Friedmannia Chantanachat & Bold (1962: 45) already exists in literature for a green alga, which renders the new hypoxid genus illegitimate (Melbourne Code; McNeill et al. 2012). Therefore, we assign a new generic epithet to Curculigo seychellensis.
Editorial
(2017)
Background: Infliximab (IFX), an anti-TNF monoclonal antibody approved for the treatment of inflammatory bowel disease, is dosed per kg body weight (BW). However, the rationale for body size adjustment has not been unequivocally demonstrated [1], and first attempts to improve IFX therapy have been undertaken [2]. The aim of our study was to assess the impact of different dosing strategies (i.e. body size-adjusted and fixed dosing) on drug exposure and pharmacokinetic (PK) target attainment. For this purpose, a comprehensive simulation study was performed, using patient characteristics (n=116) from an in-house clinical database.
Methods: IFX concentration-time profiles of 1000 virtual, clinically representative patients were generated using a previously published PK model for IFX in patients with Crohn's disease [3]. For each patient 1000 profiles accounting for PK variability were considered. The IFX exposure during maintenance treatment after the following dosing strategies was compared: i) fixed dose, and per ii) BW, iii) lean BW (LBW), iv) body surface area (BSA), v) height (HT), vi) body mass index (BMI) and vii) fat-free mass (FFM)). For each dosing strategy the variability in maximum concentration Cmax, minimum concentration Cmin (= C8weeks) and area under the concentration-time curve (AUC), as well as percent of patients achieving the PK target, Cmin=3 μg/mL [4] were assessed.
Results: For all dosing strategies the variability of Cmin (CV ≈110%) was highest, compared to Cmax and AUC, and was of similar extent regardless of dosing strategy. The proportion of patients reaching the PK target (≈⅓ was approximately equal for all dosing strategies.
Gaussianity Fair
(2017)
Eighteen scientists met at Jurata, Poland, to discuss various aspects of the transition from adolescence to adulthood. This transition is a delicate period facing complex interactions between the adolescents and the social group they belong to. Social identity, group identification and identity signalling, but also stress affecting basal salivary cortisol rhythms, hypertension, inappropriate nutrition causing latent and manifest obesity, moreover, in developing and under-developed countries, parasitosis causing anaemia thereby impairing growth and development, are issues to be dealt with during this period of the human development. In addition, some new aspects of the association between weight, height and head circumference in the newborns were discussed, as well as intrauterine head growth and head circumference as health risk indicators.
Root infinitives on Twitter
(2017)
Background: Evidence that home telemonitoring (HTM) for patients with chronic heart failure (CHF) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage. Therefore the CardioBBEAT trial was designed to prospectively assess the health economic impact of a dedicated home monitoring system for patients with CHF based on actual costs directly obtained from patients’ health care providers.
Methods: Between January 2010 and June 2013, 621 patients (mean age 63,0 ± 11,5 years, 88 % male) with a confirmed diagnosis of CHF (LVEF ≤ 40 %) were enrolled and randomly assigned to two study groups comprising usual care with and without an interactive bi-directional HTM (Motiva®). The primary endpoint was the Incremental Cost-Effectiveness Ratio (ICER) established by the groups’ difference in total cost and in the combined clinical endpoint “days alive and not in hospital nor inpatient care per potential days in study” within the follow up of 12 months. Secondary outcome measures were total mortality and health related quality of life (SF-36, WHO-5 and KCCQ).
Results: In the intention-to-treat analysis, total mortality (HR 0.81; 95% CI 0.45 – 1.45) and days alive and not in hospital (343.3 ± 55.4 vs. 347.2 ± 43.9; p = 0.909) were not significantly different between HTM and usual care. While the resulting primary endpoint ICER was not positive (-181.9; 95% CI −1626.2 ± 1628.9), quality of life assessed by SF-36, WHO-5 and KCCQ as a secondary endpoint was significantly higher in the HTW group at 6 and 12 months of follow-up.
Conclusions: The first simultaneous assessment of clinical and economic outcome of HTM in patients with CHF did not demonstrate superior incremental cost effectiveness compared to usual care. On the other hand, quality of life was improved. It remains open whether the tested HTM solution represents a useful innovative approach in the recent health care setting.
Preclinical assessment of penetration not only in intact, but also in barrier‐disrupted skin is important to explore the surplus value of novel drug delivery systems, which can be specifically designed for diseased skin. Here, we characterized physical and chemical barrier disruption protocols for short‐term ex vivo skin cultures with regard to structural integrity, physiological and biological parameters. Further, we compared the penetration of dexamethasone (Dex) in different nanoparticle‐based formulations in stratum corneum, epidermis and dermis extracts of intact vs. barrier‐disrupted skin as well as by dermal microdialysis at 6, 12 and 24 hours after topical application. Dex was quantified by liquid‐chromatography ‐ tandem‐mass spectrometry (LC‐MS/MS). Simultaneously, we investigated the Dex efficacy by interleukin (IL) analysis. Tape‐stripping (TS) and 4 hours sodium lauryl sulfate 5 % (SLS) exposure were identified as highly effective barrier disruption methods assessed by reproducible transepidermal water loss (TEWL) changes and IL‐6/8 increase which was more pronounced in SLS‐treated skin. The barrier state has also a significant impact on the Dex penetration kinetics: for all formulations, TS highly increased dermal Dex concentration despite the fact that nanocrystals quickly and effectively penetrated both, intact and barrier‐disrupted skin reaching significantly higher dermal Dex concentration after 6 hours compared to Dex cream. The surplus value of encapsulation in ethyl cellulose nanocarriers could mostly be observed when applied on intact skin, in general showing a delayed Dex penetration. Estimation of cytokines was limited due to the trauma caused by probe insertion. In summary, ex vivo human skin is a highly interesting short‐term preclinical model for the analysis of penetration and efficacy of novel drug delivery systems.