Challenges in the assessment of medical devices: the MedtecHTA project

Assessing medical devices (MDs) raises challenges which require us to reflect on whether current methods are adequate. Major features of devices are: (i) device–operator interaction can generate learning curve effects; (ii) incremental nature of innovation needs to be addressed by careful identification of the alternatives for comparative and incremental costeffectiveness analysis; and (iii) broader organizational impact in terms of training and infrastructure, coupled with dynamic pricing, requires a more flexible approach to costing. The objective of the MedtecHTA project was to investigate improvements in HTA methods to allow for more comprehensive evaluation of MDs. It consisted of several work packages concerning (i) the available evidence on the currently adopted approaches for regulation and HTA of medical devices; (ii) the geographical variation in access to MDs; (iii) the development of methodological frameworks for conducting comparative effectiveness research and economic evaluation of MDs; and (iv) the organizational impact of MDs. This introductory paper summarizes the main results of the project and draws out the main overarching themes. This supplement represents a comprehensive report of all the main findings of the MedtecHTA project, and it is intended to be the main source for researchers and policy makers wanting information on the project

Experimental and computational investigation of co production and dispersion in an automotive repair shop

Carbon monoxide (CO), a highly toxic gas, is produced during the incomplete combustion of carbon-based fuels. In indoor environments, high CO concentrations constitute a serious occupational health hazard; this is especially true in the case of automotive repair shop (ARS) employees who are exposed on a daily basis to vehicle exhaust streams. The present study focuses on the experimental investigation and numerical simulation of CO production and dispersion inside an ARS facility. Detailed measurements of CO concentration, vehicle traffic and ventilation system velocities are performed; the obtained data are appropriately formulated to provide quantitative information for modelling purposes. A detailed Computational Fluid Dynamics simulation of the developing transient flow-field is performed. The numerical results are validated using the experimental data; an overall good qualitative and quantitative agreement is achieved. Aiming to improve the energy efficiency of the mechanical ventilation system, three alternative scenarios are investigated; it is shown that the utilization of a dynamic ventilation system may result in significant energy consumption benefits, while, at the same time, CO concentrations remain below the values suggested by current occupational health legislation. The obtained results may be utilized to assist the design of mechanical ventilation systems for ARS facilities

Habitat specificity of a threatened and endemic cliff-dwelling halophyte

Research ArticleCoastal areas and other saline environments are major contributors to regional and global biodiversity patterns. In these environments, rapidly changing gradients require highly specialized plants like halophytes. In European coastal cliff-tops, rocky and sandy seashores, and saltmarshes, typical halophytes from the genus Limonium are commonly found. Among them, the aneuploid tetraploid (2n ¼ 4x ¼ 35, 36, 37) Limonium multiflorum, endemic to the west coast of Portugal, is an interesting case study for investigating the ecology and conservation of a halophyte agamospermic species. Although it is listed in the IUCN red list of threatened species, information on its population size or rarity, as well as its ecology, in some respects is still unknown. Field surveys in the largest known population were performed (Raso cape, Portugal) in order to determine habitat requirements and conservation status. A total of 88 quadrats were monitored, 43 of which contained at least one L. multiflorum individual. For each sampled quadrat, four abiotic and four biotic variables as well as two spatially derived variables were recorded. Principal component analysis and cluster analysis showed narrow habitat specificity for this species which appeared to be intolerant to competition with invasive alien plants. We conclude that in situ conservation in a local ‘hotspot’ of this rare and vulnerable species emerges as a priority in order to ensure that biodiversity is not los

Fundamental spray and combustion measurements of soy methyl-ester biodiesel

Although biodiesel has begun to penetrate the fuel market, its effect on injection processes, combustion and emission formation under diesel engine conditions remains somewhat unclear. Typical exhaust measurements from engines running biodiesel indicate that particulate matter, carbon monoxide and unburnt hydrocarbons are decreased, whereas nitrogen oxide emissions tend to be increased. However, these observations are the result of complex interactions between physical and chemical processes occurring in the combustion chamber, for which understanding is still needed. To characterize and decouple the physical and chemical influences of biodiesel on spray mixing, ignition, combustion and soot formation, a soy methyl-ester (SME) biodiesel is injected into a constant-volume combustion facility under diesel-like operating conditions. A range of optical diagnostics is performed, comparing biodiesel to a conventional #2 diesel at the same injection and ambient conditions. Schlieren high-speed imaging shows virtually the same vapour-phase penetration for the two fuels, while simultaneous Mie-scatter imaging shows that the maximum liquid-phase penetration of biodiesel is higher than diesel. Differences in the liquid-phase penetration are expected because of the different boiling-point temperatures of the two fuels. However, the different liquid-phase penetration does not affect overall mixing rate and downstream vapour-phase penetration because each fuel spray has similar momentum and spreading angle. For the biodiesel and diesel samples used in this study, the ignition delay and lift-off length are only slightly less for biodiesel compared to diesel, consistent with the fuel cetane number (51 for biodiesel, 46 for diesel). Because of the similarity in lift-off length, the differences in equivalence ratio distribution at the lift-off length are mainly affected by the oxygen content of the fuels. For biodiesel, the equivalence ratio is reduced, which, along with the fuel molecular structure and oxygen content, significantly affects soot formation downstream. Spatially resolved soot volume fraction measurements obtained by combining line-of-sight laser extinction measurements with planar laser-induced incandescence imaging show that the soot concentration can be reduced by an order of magnitude for biodiesel. These integrated measurements of spray mixing, combustion and quantitative soot concentration provide new validation data for the development of computational fluid dynamics spray, combustion and soot formation models suitable for the latest biofuels.This work was supported by the Spanish Ministry of Science and Innovation for Jean-Guillaume Nerva's visiting research, through the OPTICOMB project [TRA2007-67961-C03-01].Nerva, J.; Genzale, CL.; Kook, S.; García Oliver, JM.; Pickett, LM. (2013). Fundamental spray and combustion measurements of soy methyl-ester biodiesel. International Journal of Engine Research. 14(4):373-390. https://doi.org/10.1177/1468087412456688S373390144(2009). World Energy Outlook 2009. World Energy Outlook. doi:10.1787/weo-2009-enMonyem, A., & H. Van Gerpen, J. (2001). The effect of biodiesel oxidation on engine performance and emissions. Biomass and Bioenergy, 20(4), 317-325. doi:10.1016/s0961-9534(00)00095-7LAPUERTA, M., ARMAS, O., & RODRIGUEZFERNANDEZ, J. (2008). Effect of biodiesel fuels on diesel engine emissions. Progress in Energy and Combustion Science, 34(2), 198-223. doi:10.1016/j.pecs.2007.07.001Fisher, B. T., Knothe, G., & Mueller, C. J. (2010). Liquid-Phase Penetration under Unsteady In-Cylinder Conditions: Soy- and Cuphea-Derived Biodiesel Fuels Versus Conventional Diesel. Energy & Fuels, 24(9), 5163-5180. doi:10.1021/ef100594pFang, T., Lin, Y.-C., Foong, T. M., & Lee, C. (2009). Biodiesel combustion in an optical HSDI diesel engine under low load premixed combustion conditions. Fuel, 88(11), 2154-2162. doi:10.1016/j.fuel.2009.02.033Pastor, J. V., García-Oliver, J. M., Nerva, J.-G., & Giménez, B. (2011). Fuel effect on the liquid-phase penetration of an evaporating spray under transient diesel-like conditions. Fuel, 90(11), 3369-3381. doi:10.1016/j.fuel.2011.05.006Fisher, B. T., & Mueller, C. J. (2010). Liquid penetration length of heptamethylnonane and trimethylpentane under unsteady in-cylinder conditions. Fuel, 89(10), 2673-2696. doi:10.1016/j.fuel.2010.04.024Kim, H. J., Park, S. H., Suh, H. K., & Lee, C. S. (2009). Atomization and Evaporation Characteristics of Biodiesel and Dimethyl Ether Compared to Diesel Fuel in a High-Pressure Injection System. Energy & Fuels, 23(3), 1734-1742. doi:10.1021/ef800811gSuh, H. K., Roh, H. G., & Lee, C. S. (2008). Spray and Combustion Characteristics of Biodiesel∕Diesel Blended Fuel in a Direct Injection Common-Rail Diesel Engine. Journal of Engineering for Gas Turbines and Power, 130(3). doi:10.1115/1.2835354Pickett, L. M., & Siebers, D. L. (2006). Soot Formation in Diesel Fuel Jets Near the Lift-Off Length. International Journal of Engine Research, 7(2), 103-130. doi:10.1243/146808705x57793Pickett, L. M., Kook, S., Persson, H., & Andersson, Ö. (2009). Diesel fuel jet lift-off stabilization in the presence of laser-induced plasma ignition. Proceedings of the Combustion Institute, 32(2), 2793-2800. doi:10.1016/j.proci.2008.06.082Yoo, C. S., Richardson, E. S., Sankaran, R., & Chen, J. H. (2011). A DNS study on the stabilization mechanism of a turbulent lifted ethylene jet flame in highly-heated coflow. Proceedings of the Combustion Institute, 33(1), 1619-1627. doi:10.1016/j.proci.2010.06.147Pastor, J. V., Payri, R., Gimeno, J., & Nerva, J. G. (2009). Experimental Study on RME Blends: Liquid-Phase Fuel Penetration, Chemiluminescence, and Soot Luminosity in Diesel-Like Conditions. Energy & Fuels, 23(12), 5899-5915. doi:10.1021/ef9007328Benajes, J., Molina, S., Novella, R., & Amorim, R. (2010). Study on Low Temperature Combustion for Light-Duty Diesel Engines. Energy & Fuels, 24(1), 355-364. doi:10.1021/ef900832cPickett, L. M., & Siebers, D. L. (2002). An investigation of diesel soot formation processes using micro-orifices. Proceedings of the Combustion Institute, 29(1), 655-662. doi:10.1016/s1540-7489(02)80084-0Siebers, D. L., & Pickett, L. M. (2004). Injection Pressure and Orifice Diameter Effects on Soot in DI Diesel Fuel Jets. Thermo- and Fluid Dynamic Processes in Diesel Engines 2, 109-132. doi:10.1007/978-3-662-10502-3_7Pickett, L. M., & Siebers, D. L. (2004). Soot in diesel fuel jets: effects of ambient temperature, ambient density, and injection pressure. Combustion and Flame, 138(1-2), 114-135. doi:10.1016/j.combustflame.2004.04.006Cheng, A. S., Upatnieks, A., & Mueller, C. J. (2006). Investigation of the impact of biodiesel fuelling on NOx emissions using an optical direct injection diesel engine. International Journal of Engine Research, 7(4), 297-318. doi:10.1243/14680874jer05005Cheng, A. S. (Ed), Upatnieks, A., & Mueller, C. J. (2007). Investigation of Fuel Effects on Dilute, Mixing-Controlled Combustion in an Optical Direct-Injection Diesel Engine. Energy & Fuels, 21(4), 1989-2002. doi:10.1021/ef0606456Klein-Douwel, R. J. H., Donkerbroek, A. J., van Vliet, A. P., Boot, M. D., Somers, L. M. T., Baert, R. S. G., … ter Meulen, J. J. (2009). Soot and chemiluminescence in diesel combustion of bio-derived, oxygenated and reference fuels. Proceedings of the Combustion Institute, 32(2), 2817-2825. doi:10.1016/j.proci.2008.06.140Fang, T., & Lee, C. F. (2009). Bio-diesel effects on combustion processes in an HSDI diesel engine using advanced injection strategies. Proceedings of the Combustion Institute, 32(2), 2785-2792. doi:10.1016/j.proci.2008.07.031Payri, F., Pastor, J. V., Nerva, J.-G., & Garcia-Oliver, J. M. (2011). Lift-Off Length and KL Extinction Measurements of Biodiesel and Fischer-Tropsch Fuels under Quasi-Steady Diesel Engine Conditions. SAE International Journal of Engines, 4(2), 2278-2297. doi:10.4271/2011-24-0037Kook, S., & Pickett, L. M. (2012). Liquid length and vapor penetration of conventional, Fischer–Tropsch, coal-derived, and surrogate fuel sprays at high-temperature and high-pressure ambient conditions. Fuel, 93, 539-548. doi:10.1016/j.fuel.2011.10.004Settles, G. S. (2001). Schlieren and Shadowgraph Techniques. doi:10.1007/978-3-642-56640-0Pickett, L. M., Manin, J., Genzale, C. L., Siebers, D. L., Musculus, M. P. B., & Idicheria, C. A. (2011). Relationship Between Diesel Fuel Spray Vapor Penetration/Dispersion and Local Fuel Mixture Fraction. SAE International Journal of Engines, 4(1), 764-799. doi:10.4271/2011-01-0686MUSCULUS, M., & PICKETT, L. (2005). Diagnostic considerations for optical laser-extinction measurements of soot in high-pressure transient combustion environments. Combustion and Flame, 141(4), 371-391. doi:10.1016/j.combustflame.2005.01.013Williams, T. C., Shaddix, C. R., Jensen, K. A., & Suo-Anttila, J. M. (2007). Measurement of the dimensionless extinction coefficient of soot within laminar diffusion flames. International Journal of Heat and Mass Transfer, 50(7-8), 1616-1630. doi:10.1016/j.ijheatmasstransfer.2006.08.024Kook, S., & Pickett, L. M. (2011). Soot volume fraction and morphology of conventional and surrogate jet fuel sprays at 1000-K and 6.7-MPa ambient conditions. Proceedings of the Combustion Institute, 33(2), 2911-2918. doi:10.1016/j.proci.2010.05.073De Francqueville, L., Bruneaux, G., & Thirouard, B. (2010). Soot Volume Fraction Measurements in a Gasoline Direct Injection Engine by Combined Laser Induced Incandescence and Laser Extinction Method. SAE International Journal of Engines, 3(1), 163-182. doi:10.4271/2010-01-0346Musculus, M. P. B., & Kattke, K. (2009). Entrainment Waves in Diesel Jets. SAE International Journal of Engines, 2(1), 1170-1193. doi:10.4271/2009-01-1355Desantes, J. M., Pastor, J. V., García-Oliver, J. M., & Pastor, J. M. (2009). A 1D model for the description of mixing-controlled reacting diesel sprays. Combustion and Flame, 156(1), 234-249. doi:10.1016/j.combustflame.2008.10.008Idicheria, C. A., & Pickett, L. M. (2011). Ignition, soot formation, and end-of-combustion transients in diesel combustion under high-EGR conditions. International Journal of Engine Research, 12(4), 376-392. doi:10.1177/1468087411399505Aizawa, T., & Kosaka, H. (2008). Investigation of early soot formation process in a diesel spray flame via excitation—emission matrix using a multi-wavelength laser source. International Journal of Engine Research, 9(1), 79-97. doi:10.1243/14680874jer01407Bruneaux, G. (2008). Combustion structure of free and wall-impinging diesel jets by simultaneous laser-induced fluorescence of formaldehyde, poly-aromatic hydrocarbons, and hydroxides. International Journal of Engine Research, 9(3), 249-265. doi:10.1243/14680874jer0010

Air Pollution, Aeroallergens, and Emergency Room Visits for Acute Respiratory Diseases and Gastroenteric Disorders among Young Children in Six Italian Cities

Past studies reported evidence of associations between air pollution and respiratory symptoms and morbility for children. Few studies examined associations between air pollution and emergency room (ER) visits for wheezing, and even fewer for gastroenteric illness. We conducted a multicity analysis of the relationship between air pollution and ER visits for wheezing and gastroenteric disorders in children 0-2 years of age.BACKGROUND: Past studies reported evidence of associations between air pollution and respiratory symptoms and morbidity for children. Few studies examined associations between air pollution and emergency room (ER) visits for wheezing, and even fewer for gastroenteric illness. We conducted a multicity analysis of the relationship between air pollution and ER visits for wheezing and gastroenteric disorder in children 0-2 years of age. METHODS: We obtained ER visit records for wheezing and gastroenteric disorder from six Italian cities. A cityspecific case-crossover analysis was applied to estimate effects of particulate matter (PM), nitrogen dioxide, sulfur dioxide, ozone, and carbon monoxide, adjusting for immediate and delayed effects of temperature. Lagged effects of air pollutants up to 6 prior days were examined. The cityspecific results were combined using a random-effect meta-analysis. RESULTS: CO and SO2 were most strongly associated with wheezing, with a 2.7% increase [95% confidence interval (CI), 0.5-4.9] for a 1.04 \u3bcg/m3 increase in 7day average CO and a 3.4% (95% CI, 1.5-5.3) increase for an 8.0 \u3bcg/m3 increase in SO2. Positive associations were also found for PM with aerodynamic diameter 64 10 \u3bcg and NO2. We found a significant association between the 3day moving average CO and gastroenteric disorders [3.8% increase (95% CI, 1.0-6.8)]. When data were stratified by season, the associations were stronger in summer for wheezing and in winter for gastroenteric disorders. CONCLUSION: Air pollution is associated with triggering of wheezing and gastroenteric disorders in children 0-2 years of age; more work is needed to understand the mechanisms to help prevent wheezing in children

Detectability of testosterone esters and estradiol benzoate in bovine hair and plasma following pour-on treatment

The abuse of synthetic esters of natural steroids such as testosterone and estradiol in cattle fattening and sports is hard to detect via routine urine testing. The esters are rapidly hydrolysed in vivo into substances which are also endogenously present in urine. An interesting alternative can be provided by the analysis of the administered synthetic steroids themselves, i.e., the analysis of intact steroid esters in hair by liquid chromatography tandem mass spectrometry (LC/MS/MS). However, retrospective estimation of the application date following a non-compliant finding is hindered by the complexity of the kinetics of the incorporation of steroid esters in hair. In this study, the incorporation of intact steroid esters in hair following pour-on treatment has been studied and critically compared with results from intramuscular treatment. To this end animals were pour-on treated with a hormone cocktail containing testosterone cypionate, testosterone decanoate and estradiol benzoate in different carriers. The animals were either treated using injection and pour-on application once or three times having 1 week between treatments using injection and pour-on application. Animals were slaughtered from 10–12 weeks after the last treatment. Both hair and blood plasma samples were collected and analysed by LC/MS/MS. From the results, it is concluded that after single treatment the levels of steroid esters in hair drop to CCβ levels (5–20 µg/kg) after 5–7 weeks. When treatment is repeated two times, the CCβ levels are reached after 9–11 weeks. Furthermore, in plasma, no steroid esters were detected; not even at the low microgramme per litre level but—in contrast with the pour-on application—after i.m. injection, significant increase of 17β-testosterone and 17β-estradiol were observed. These observations suggest that transport of steroid esters after pour-on application is not only performed by blood but also by alternative fluids in the animal so probably the steroid esters are already hydrolysed and epimerized before entering the blood

Broadening Exposure to Socio-Political Opinions via a Pushy Smart Home Device

Motivated by the effects of the filter bubble and echo chamber phenomena on social media, we developed a smart home device, Spkr, that unpredictably “pushes” socio-political discussion topics into the home. The device utilised trending Twitter discussions, categorised by their socio-political alignment, to present people with a purposefully assorted range of viewpoints. We deployed Spkr in 10 homes for 28 days with a diverse range of participants and interviewed them about their experiences. Our results show that Spkr presents a novel means of combating selective exposure to socio-political issues, providing participants with identifiably diverse viewpoints. Moreover, Spkr acted as a conversational prompt for discussion within the home, initiating collective processes and engaging those who would not often be involved in political discussions. We demonstrate how smart home assistants can be used as a catalyst for provocation by altering and pluralising political discussions within households