Refinement of the Clinical Scenario Evaluation Framework for Assessment of Competing Development Strategies with an Application to Multiple Sclerosis

When competing strategies for development programs, clinical trial designs, or data analysis methods exist, the alternatives need to be evaluated in a systematic way to facilitate informed decision making. Here we describe a refinement of the recently proposed clinical scenario evaluation framework for the assessment of competing strategies. The refinement is achieved by subdividing key elements previously proposed into new categories, distinguishing between quantities that can be estimated from preexisting data and those that cannot and between aspects under the control of the decision maker from those that are determined by external constraints. The refined framework is illustrated by an application to a design project for an adaptive seamless design for a clinical trial in progressive multiple sclerosis.

A vector approach to the assessment of undergraduate engineering courses

In any undergraduate engineering programme there is a need to assess the balance and flavour of the various educational strands. In order for a quality assurance of these programmes to be met there is a need to evaluate the course load, academic content and the assessment marks of each course in the undergraduate programme. The existing ranges of QA methods for these programmes are focused on one or two of these issues and do not provide a comprehensive assessment procedure. Following a review of the existing QA methods, this paper will define a three-dimensional approach to the assessment of the educational aspects of an undergraduate course. Various features of this method will be described and potential benefits explained.

Assessment of the consistency of H2O line intensities over the near-infrared using sun-pointing ground-based Fourier transform spectroscopy

We report on the consistency of water vapour line intensities in selected spectral regions between 800–12,000 cm−1 under atmospheric conditions using sun-pointing Fourier transform infrared spectroscopy. Measurements were made across a number of days at both a low and high altitude field site, sampling a relatively moist and relatively dry atmosphere. Our data suggests that across most of the 800–12,000 cm−1 spectral region water vapour line intensities in recent spectral line databases are generally consistent with what was observed. However, we find that HITRAN-2008 water vapour line intensities are systematically lower by up to 20% in the 8000–9200 cm−1 spectral interval relative to other spectral regions. This discrepancy is essentially removed when two new linelists (UCL08, a compilation of linelists and ab-initio calculations, and one based on recent laboratory measurements by Oudot et al. (2010) [10] in the 8000–9200 cm−1 spectral region) are used. This strongly suggests that the H2O line strengths in the HITRAN-2008 database are indeed underestimated in this spectral region and in need of revision. The calculated global-mean clear-sky absorption of solar radiation is increased by about 0.3 W m−2 when using either the UCL08 or Oudot line parameters in the 8000–9200 cm−1 region, instead of HITRAN-2008. We also found that the effect of isotopic fractionation of HDO is evident in the 2500–2900 cm−1 region in the observations.

Assessment of CloudSat reflectivity measurements and ice cloud properties using ground-based and airborne cloud radar observations

A quantitative assessment of Cloudsat reflectivities and basic ice cloud properties (cloud base, top, and thickness) is conducted in the present study from both airborne and ground-based observations. Airborne observations allow direct comparisons on a limited number of ocean backscatter and cloud samples, whereas the ground-based observations allow statistical comparisons on much longer time series but with some additional assumptions. Direct comparisons of the ocean backscatter and ice cloud reflectivities measured by an airborne cloud radar and Cloudsat during two field experiments indicate that, on average, Cloudsat measures ocean backscatter 0.4 dB higher and ice cloud reflectivities 1 dB higher than the airborne cloud radar. Five ground-based sites have also been used for a statistical evaluation of the Cloudsat reflectivities and basic cloud properties. From these comparisons, it is found that the weighted-mean difference ZCloudsat − ZGround ranges from −0.4 to +0.3 dB when a ±1-h time lag around the Cloudsat overpass is considered. Given the fact that the airborne and ground-based radar calibration accuracy is about 1 dB, it is concluded that the reflectivities of the spaceborne, airborne, and ground-based radars agree within the expected calibration uncertainties of the airborne and ground-based radars. This result shows that the Cloudsat radar does achieve the claimed sensitivity of around −29 dBZ. Finally, an evaluation of the tropical “convective ice” profiles measured by Cloudsat has been carried out over the tropical site in Darwin, Australia. It is shown that these profiles can be used statistically down to approximately 9-km height (or 4 km above the melting layer) without attenuation and multiple scattering corrections over Darwin. It is difficult to estimate if this result is applicable to all types of deep convective storms in the tropics. However, this first study suggests that the Cloudsat profiles in convective ice need to be corrected for attenuation by supercooled liquid water and ice aggregates/graupel particles and multiple scattering prior to their quantitative use.

Assessment of evaluations made to healthy eating policies in Europe: a review within the EATWELL Project

Objective: To identify and assess healthy eating policies at national level which have been evaluated in terms of their impact on awareness of healthy eating, food consumption, health outcome or cost/benefit. Design: Review of policy documents and their evaluations when available. Setting: European Member States. Subjects: One hundred and twenty-one policy documents revised, 107 retained. Results: Of the 107 selected interventions, twenty-two had been evaluated for their impact on awareness or knowledge and twenty-seven for their impact on consumption. Furthermore sixteen interventions provided an evaluation of health impact, while three actions specifically measured any cost/benefit ratio. The indicators used in these evaluations were in most cases not comparable. Evaluation was more often found for public information campaigns, regulation of meals at schools/canteens and nutrition education programmes. Conclusions: The study highlights the need not only to develop harmonized and verifiable procedures but also indicators for measuring effectiveness and success and for comparing between interventions and countries. EU policies are recommended to provide a set of indicators that may be measured consistently and regularly in all countries. Furthermore, public information campaigns should be accompanied by other interventions, as evaluations may show an impact on awareness and intention, but rarely on consumption patterns and health outcome.

Recommendations for the viability assessment of probiotics as concentrated cultures and in food matrices

Due to the fact that probiotic cells need to be alive when they are consumed, culture-based analysis (plate count) is critical in ascertaining the quality (numbers of viable cells) of probiotic products. Since probiotic cells are typically stressed, due to various factors related to their production, processing and formulation, the standard methodology for total plate counts tends to underestimate the cell numbers of these products. Furthermore, products such as microencapsulated cultures require modifications in the release and sampling procedure in order to correctly estimate viable counts. This review examines the enumeration of probiotic bacteria in the following commercial products: powders, microencapsulated cultures, frozen concentrates, capsules, foods and beverages. The parameters which are specifically examined include: sample preparation (rehydration, thawing), dilutions (homogenization, media) and plating (media, incubation) procedures. Recommendations are provided for each of these analytical steps to improve the accuracy of the analysis. Although the recommendations specifically target the analysis of probiotics, many will apply to the analysis of commercial lactic starter cultures used in food fermentations as well.

Measuring significant variability characteristics: An assessment of three UK renewables

The variability of renewable energy is widely recognised as a challenge for integrating high levels of renewable generation into electricity systems. However, to explore its implications effectively, variability itself should first be clearly understood. This is particularly true for national electricity systems with high planned penetration of renewables and limited interconnection such as the UK. Variability cannot be considered as a distinct resource property with a single measurable parameter, but is a multi-faceted concept best described by a range of distinct characteristics. This paper identifies relevant characteristics of variability, and considers their implications for energy research. This is done through analysis of wind, solar and tidal current resources, with a primary focus on the Bristol Channel region in the UK. The relationship with electricity demand is considered, alongside the potential benefits of resource diversity. Analysis is presented in terms of persistence, distribution, frequency and correlation between supply and demand. Marked differences are seen between the behaviours of the individual resources, and these give rise to a range of different implications for system integration. Wind shows strong persistence and a useful seasonal pattern, but also a high spread in energy levels at timescales beyond one or two days. The solar resource is most closely correlated with electricity demand, but is undermined by night-time zero values and an even greater spread of monthly energy delivered than wind. In contrast, the tidal resource exhibits very low persistence, but also much greater consistency in energy values assessed across monthly time scales. Whilst this paper focuses primarily on the behaviour of resources, it is noted that discrete variability characteristics can be related to different system impacts. Persistence and predictability are relevant for system balancing, whereas statistical distribution is more relevant when exploring issues of asset utilisation and energy curtailment. Areas of further research are also identified, including the need to assess the value of predictability in relation to other characteristics.

A multimodel assessment of the influence of regional anthropogenic emission reductions on aerosol direct radiative forcing and the role of intercontinental transport

In this study, we assess changes of aerosol optical depth (AOD) and direct radiative forcing (DRF) in response to the reduction of anthropogenic emissions in four major pollution regions in the Northern Hemisphere by using results from nine global models in the framework of the Hemispheric Transport of Air Pollution (HTAP). DRF at top of atmosphere (TOA) and surface is estimated based on AOD results from the HTAP models and AOD-normalized DRF (NDRF) from a chemical transport model. The multimodel results show that, on average, a 20% reduction of anthropogenic emissions in North America, Europe, East Asia, and South Asia lowers the global mean AOD (all-sky TOA DRF) by 9.2% (9.0%), 3.5% (3.0%), and 9.4% (10.0%) for sulfate, particulate organic matter (POM), and black carbon (BC), respectively. Global annual average TOA all-sky forcing efficiency relative to particle or gaseous precursor emissions from the four regions (expressed as multimodel mean ± one standard deviation) is  ±3.5 ±0.8,  ±4.0 ±1.7, and 29.5 ±18.1mWm ±2 per Tg for sulfate (relative to SO2), POM, and BC, respectively. The impacts of the regional emission reductions on AOD and DRF extend well beyond the source regions because of intercontinental transport (ICT). On an annual basis, ICT accounts for 11 ±5% to 31 ±9% of AOD and DRF in a receptor region at continental or subcontinental scale, with domestic emissions accounting for the remainder, depending on regions and species. For sulfate AOD, the largest ICT contribution of 31 ±9% occurs in South Asia, which is dominated by the emissions from Europe. For BC AOD, the largest ICT contribution of 28 ±18% occurs in North America, which is dominated by the emissions from East Asia. The large spreads among models highlight the need to improve aerosol processes in models, and evaluate and constrain models with observations.

Self-assessment of the outcome of early medical abortion versus clinic follow-up in India : a randomised, controlled, non-inferiority trial

Background: The need for multiple clinical visits remains a barrier to women accessing safe legal medical abortion services. Alternatives to routine clinic follow-up visits have not been assessed in rural low-resource settings. We compared the effectiveness of standard clinic follow-up versus home assessment of outcome of medical abortion in a low-resource setting. Methods: This randomised, controlled, non-inferiority trial was done in six health centres (three rural, three urban) in Rajasthan, India. Women seeking early medical abortion up to 9 weeks of gestation were randomly assigned (1:1) to either routine clinic follow-up or self-assessment at home. Randomisation was done with a computer-generated randomisation sequence, with a block size of six. The study was not blinded. Women in the home-assessment group were advised to use a pictorial instruction sheet and take a low-sensitivity urine pregnancy test at home, 10-14 days after intake of mifepristone, and were contacted by a home visit or telephone call to record the outcome of the abortion. The primary (non-inferiority) outcome was complete abortion without continuing pregnancy or need for surgical evacuation or additional mifepristone and misoprostol. The non-inferiority margin for the risk difference was 5%. All participants with a reported primary outcome and who followed the clinical protocol were included in the analysis. This study is registered with ClinicalTrials.gov, number NCT01827995. Findings: Between April 23, 2013, and May 15, 2014, 731 women were recruited and assigned to clinic follow-up (n=366) or home assessment (n=365), of whom 700 were analysed for the main outcomes (n=336 and n=364, respectively). Complete abortion without continuing pregnancy, surgical intervention, or additional mifepristone and misoprostol was reported in 313 (93%) of 336 women in the clinic follow-up group and 347 (95%) of 364 women in the home-assessment group (difference -2.2%, 95% CI -5.9 to 1.6). One case of haemorrhage occurred in each group (rate of adverse events 0.3% in each group); no other adverse events were noted. Interpretation Home assessment of medical abortion outcome with a low-sensitivity urine pregnancy test is non-inferior to clinic follow-up, and could be introduced instead of a clinic follow-up visit in a low-resource setting.

Entry strategies into biosimilars: assessment of entry modes into the field of biosimilars from the perspective of pharmaceuticals, generics and biologics companies

Indústria farmacêutica de hoje está em transição. Como grandes blockbuster drogas estão perdendo ou estão prestes a perder a proteção de patente, e as grandes empresas farmacêuticas não estão substituindo os produtos com novas drogas químicas inovadoras, a indústria busca novas áreas de crescimento. Uma dessas áreas é o mercado de biossimilares, que está sendo inseridos por produtos farmacêuticos, genéricos e empresas de produtos biológicos. Mesmo que o grande potencial de mercado será acordado por volta de 2020, quando importantes blockbusters biológicos perder a proteção de patente, as empresas precisam decidir logo se querem participar ou não devido a elevadas barreiras à entrada técnicos, bem como de desenvolvimento de longo prazos. Como todas as empresas vêm de diferentes origens, compreendem capacidades diferentes e têm diferentes incentivos de entrada, a questão que surge é se esses fatos estão relacionados com as suas estratégias de entrada correspondentes. A tese utiliza estudos de caso de cada segmento da indústria farmacêutica - produtos farmacêuticos, biológicos e genéricos - e examina através de entrevistas semi-estruturadas, por isso que os participantes do estudo de caso entrevistados explicitamente escolhido sua estratégia de entrada. Os dados de entrevistas será então ligada a quadros estratégicos da revisão da literatura e irá ser utilizado para uma comparação global e análise. O estudo revelou que o fundo do participante do mercado que influenciam a sua estratégia de entrada. Os principais pontos de influência derivam tanto as barreiras à entrada, bem como os incentivos de entrada. A tese não é possível determinar o sucesso futuro do modo de entrada analisados no novo mercado.

Cost assessment of efficiency losses in hydroelectric plants

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Laboratory Assessment of two Active Ingredients for Control of Coptotermes gestroi (Isoptera: Rhinotermitidae)

The subterranean termite Coptotermes gestroi Wasmann (Isoptera: Rhinotermitidae) is a pest of major economic importance in urban environments of southeastern Brazil. Compared to using pesticides for termite control, termite bait products target termites more specifically and also address environmental contamination issues. In this point of view, we performed two different bioassays ill order to evaluate the efficacy of boric acid and fipronil against different populations of C. gestroi. The results showed that concentration between 2000 and 3000 ppm of boric acid caused approximately 100 percent mortality ill termites. Concentrations between 0.01 and 0.0001 ppm of fipronil resulted in 100% termite mortality after 2 wk exposure. The data displayed a fast mortality of termites contaminated with fipronil, even with small concentrations, and therefore it is riot a Suitable product to be used ill baits against C gestroi. The present Study showed a delayed toxicity of boric acid against the subterranean termite C gestroi which suggests a need for further field tests.

Assessment of tropical forest degradation by selective logging and fire using Landsat imagery

Many studies have assessed the process of forest degradation in the Brazilian Amazon using remote sensing approaches to estimate the extent and impact by selective logging and forest fires on tropical rain forest. However, only a few have estimated the combined impacts of those anthropogenic activities. We conducted a detailed analysis of selective logging and forest fire impacts on natural forests in the southern Brazilian Amazon state of Mato Grosso, one of the key logging centers in the country. To achieve this goal a 13-year series of annual Landsat images (1992-2004) was used to test different remote sensing techniques for measuring the extent of selective logging and forest fires, and to estimate their impact and interaction with other land use types occurring in the study region. Forest canopy regeneration following these disturbances was also assessed. Field measurements and visual observations were conducted to validate remote sensing techniques. Our results indicated that the Modified Soil Adjusted Vegetation Index aerosol free (MSAVI(af)) is a reliable estimator of fractional coverage under both clear sky and under smoky conditions in this study region. During the period of analysis, selective logging was responsible for disturbing the largest proportion (31%) of natural forest in the study area, immediately followed by deforestation (29%). Altogether, forest disturbances by selective logging and forest fires affected approximately 40% of the study site area. Once disturbed by selective logging activities, forests became more susceptible to fire in the study site. However, our results showed that fires may also occur in undisturbed forests. This indicates that there are further factors that may increase forest fire susceptibility in the study area. Those factors need to be better understood. Although selective logging affected the largest amount of natural forest in the study period, 35% and 28% of the observed losses of forest canopy cover were due to forest fire and selective logging combined and to forest fire only, respectively. Moreover, forest areas degraded by selective logging and forest fire is an addition to outright deforestation estimates and has yet to be accounted for by land use and land cover change assessments in tropical regions. Assuming that this observed trend of land use and land cover conversion continues, we predict that there will be no undisturbed forests remaining by 2011 in this study site. Finally, we estimated that 70% of the total forest area disturbed by logging and fire had sufficiently recovered to become undetectable using satellite data in 2004. (C) 2010 Elsevier B.V. All rights reserved.

Laboratory assessment of two active ingredients for control of coptotemes gestroi (Isoptera: Rhinotermitidae)

The subterranean termite Coptotermes gestroi Wasmann (Isoptera: Rhinotermitidae) is a pest of major economic importance in urban environments of southeastern Brazil. Compared to using pesticides for termite control, termite bait products target termites more specifically and also address environmental contamination issues. In this point of view, we performed two different bioassays in order to evaluate the efficacy of boric acid and fipronil against different populations of C. gestroi. The results showed that concentrations between 2000 and 3000 ppm of boric acid caused approximately 100 percent mortality in termites. Concentrations between 0.01 and 0.0001 ppm of fipronil resulted in 100% termite mortality after 2 wk exposure. The data displayed a fast mortality of termites contaminated with fipronil, even with small concentrations, and therefore it is not a suitable product to be used in baits against C. gestroi. The present study showed a delayed toxicity of boric acid against the subterranean termite C. gestroi which suggests a need for further field tests.

A preliminary assessment of the policies implemented by the governments of Latin America and the Caribbean in response to the crisis - May 2010 Meeting

Includes bibliography