357 research outputs found
Prototyping for Requirements Elicitation and Validation: A Participative Prototype Evaluation Methodology
Prototyping is widely recommended as an excellent mechanism for requirements elicitation and validation. However, few details are available on how prototypes should be used for this purpose, especially in a group environment. The goal of this research is to develop and evaluate a methodology for using prototyping to elicit and validate requirements from large user groups. An initial prototype evaluation methodology was developed, assessed during a pilot case study, and revised to support different evaluation phases and types. The revised participative prototype evaluation methodology provides a specific structure for each prototype evaluation phase with detailed methods and GroupSystems tools defined for each evaluation type. An overview of the face-to-face procedures by evaluation type is included in this paper
Participative Analysis of Systems Integration Opportunities
In an effort to increase information sharing while simultaneously decreasing costs, many organizations are moving to integrated data and systems. However, researchers caution thatthe costs and benefits of integration must be carefully evaluated. This paper presents a participative integration analysis methodology for determining not only what can be integrated, but also what should be integrated. Results of the initial case study show that a small group can effectively decide what should be integrated and develop a proposed integration strategy. The results also highlighted that participants intuitively used business scenarios to identify integration opportunities and analyzethe business impacts of integration. Therefore, the participative integration analysis methodology was updated to incorporate scenarios as the central evaluative construct. This methodology will result in recommendations for integrated systems and business processe
QualiBuild Train the Trainer Lessons Learned from the Development of a Program for Training Trainers of Construction
In response to recent directives to promote quality energy efficient buildings throughout Europe, the EU funded Build UP Skills Ireland (BUSI) project launched a national skills gap analysis of the construction sector in 2011. Generally, the gap that was identified was one of knowledge rather than skills. However, this knowledge is fundamental for the successful implementation of low energy buildings. The BUSI analysis also found that the majority of trainers of construction related crafts lacked the experience and knowledge on the implementation of energy efficient buildings. Consequently, the follow on Build UP Skills QualiBuild project focussed on the development and delivery of a Train the Trainer programme which would address this. The QualiBuild Train the Trainer pilot was designed with a focus on active learning, incorporating a flipped learning model for the delivery of a blended learning programme. This was facilitated by the development of learner manuals for each of the programme modules which presented the course content to the learners ahead of face-to-face workshop events. Group learning activities were then employed as a means for achieving one of the key learning outcomes identified in the programme development, a need for attitudinal change. This paper will offer a rationale for the design, structure and delivery methods adopted for the programme. It will also present and discuss the successes and failures of the pilot along with recommendations for future offerings of similar type programmes
Effect of fixed-dose subcutaneous reslizumab on asthma exacerbations in patients with severe uncontrolled asthma and corticosteroid sparing in patients with oral corticosteroid-dependent asthma : results from two phase 3, randomised, double-blind, placebo-controlled trials
BACKGROUND:
Reslizumab 3 mg/kg administered intravenously is approved for the treatment of severe eosinophilic asthma. We assessed the safety and efficacy of subcutaneous reslizumab 110 mg in two trials in patients with uncontrolled severe asthma and increased blood eosinophils. The aim was to establish whether subcutaneous reslizumab 110 mg can reduce exacerbation rates in these patients (study 1) or reduce maintenance oral corticosteroid dose in patients with corticosteroid-dependent asthma (study 2).
METHODS:
Both studies were randomised, double-blind, placebo-controlled, phase 3 studies. Entry criteria for study 1 were uncontrolled severe asthma, two or more asthma exacerbations in the previous year, a blood eosinophil count of 300 cells per μL or more (including no more than 30% patients with an eosinophil count <400 cells/μL), and at least a medium dose of inhaled corticosteroids with one or more additional asthma controllers. Patients in study 2 had severe asthma, a blood eosinophil count of 300 cells per μL or more, daily maintenance oral corticosteroid (prednisone 5-40 mg, or equivalent), and high-dose inhaled corticosteroids plus another controller. Patients were randomly assigned (1:1) to subcutaneous reslizumab (110 mg) or placebo once every 4 weeks for 52 weeks in study 1 and 24 weeks in study 2. Patients and investigators were masked to treatment assignment. Primary efficacy outcomes were frequency of exacerbations during 52 weeks in study 1 and categorised percentage reduction in daily oral corticosteroid dose from baseline to weeks 20-24 in study 2. Primary efficacy analyses were by intention to treat, and safety analyses included all patients who received at least one dose of study treatment. These studies are registered with ClinicalTrials.gov, NCT02452190 (study 1) and NCT02501629 (study 2).
FINDINGS:
Between Aug 12, 2015, and Jan 31, 2018, 468 patients in study 1 were randomly assigned to placebo (n=232) or subcutaneous reslizumab (n=236), and 177 in study 2 to placebo (n=89) or subcutaneous reslizumab (n=88). In study 1, we found no significant difference in the exacerbation rate between reslizumab and placebo in the intention-to-treat population (rate ratio 0·79, 95% CI 0·56-1·12; p=0·19). Subcutaneous reslizumab reduced exacerbation frequency compared with placebo in the subgroup of patients with blood eosinophil counts of 400 cells per μL or more (0·64, 95% CI 0·43-0·95). Greater reductions in annual exacerbation risk (p=0·0035) and longer time to first exacerbation were observed for patients with higher trough serum reslizumab concentrations. In study 2, we found no difference between placebo and fixed-dose subcutaneous reslizumab in categorised percentage reduction in daily oral corticosteroid dose (odds ratio for a lower category of oral corticosteroid use in the reslizumab group vs the placebo group, 1·23, 95% CI 0·70-2·16; p=0·47). The frequency of adverse events and serious adverse events with reslizumab were similar to those with placebo in both studies.
INTERPRETATION:
Fixed-dose (110 mg) subcutaneous reslizumab was not effective in reducing exacerbation frequency in patients with uncontrolled asthma and increased blood eosinophils (≥300 cells/μL), or in reducing the daily maintenance oral corticosteroid dose in patients with oral corticosteroid-dependent severe eosinophilic asthma. Higher exposures than those observed with 110 mg subcutaneous reslizumab are required to achieve maximal efficacy.
FUNDING:
Teva Branded Pharmaceutical Products R&D
Nimbus-7 Earth radiation budget calibration history. Part 1: The solar channels
The Earth Radiation Budget (ERB) experiment on the Nimbus-7 satellite measured the total solar irradiance plus broadband spectral components on a nearly daily basis from 16 Nov. 1978, until 16 June 1992. Months of additional observations were taken in late 1992 and in 1993. The emphasis is on the electrically self calibrating cavity radiometer, channel 10c, which recorded accurate total solar irradiance measurements over the whole period. The spectral channels did not have inflight calibration adjustment capabilities. These channels can, with some additional corrections, be used for short-term studies (one or two solar rotations - 27 to 60 days), but not for long-term trend analysis. For channel 10c, changing radiometer pointing, the zero offsets, the stability of the gain, the temperature sensitivity, and the influences of other platform instruments are all examined and their effects on the measurements considered. Only the question of relative accuracy (not absolute) is examined. The final channel 10c product is also compared with solar measurements made by independent experiments on other satellites. The Nimbus experiment showed that the mean solar energy was about 0.1 percent (1.4 W/sqm) higher in the excited Sun years of 1979 and 1991 than in the quiet Sun years of 1985 and 1986. The error analysis indicated that the measured long-term trends may be as accurate as +/- 0.005 percent. The worse-case error estimate is +/- 0.03 percent
Building a better Mungbean: Breeding for reproductive resilience in a changing climate
Mungbean (Vigna radiata (L.) R. Wilczek var. radiata) is a significant food and cash crop grown in tropical and subtropical regions. Mungbean production and consumer demand have increased substantially over the last two decades, owing to its agronomic, nutritional and economic benefits. Despite increased breeding efforts and the expansion of mungbean production in various agro-climatic regions, further production is hindered by low yield and variability, which is partly attributed to the impacts of abiotic stress. Abiotic stress impacts on the physiology, morphology and reproductive ability of mungbean which influences yield. Exposure to abiotic stresses at the reproductive stage is considered the most critical for yield production. In this review, we evaluate how abiotic stress impacts mungbean growth and productivity when occurring during the reproductive stage and traits that may confer adaptation. We present the limitations of current research including limited number of genotypes, lack of field experiments and detailed experimental information. We highlight the opportunities to exploit new tools and technologies, such as high-throughput phenotyping platforms, gene editing, and genomic selection, to accelerate breeding efforts to develop more resilient mungbean cultivars for today and tomorrow
Development of analytical characterization tools for process monitoring of adenovirus-based vaccines (ChAdOx and Ad5)
Product quality understanding is a critical part of viral vector vaccine manufacturing and regulation. Mass spectrometry is a technique that has widely been applied to protein-based therapeutics and could be used as a characterisation tool to monitor viral vector vaccine product quality. The ultimate objective of this Bill and Melinda Gates Foundation funded project is to enable vaccine manufacturing in Low and Middle-income countries (LMIC) through increased scientific understanding of viral vector vaccine manufacturing bottlenecks and therefore de-risking of vaccine development and manufacturing.
Please click Download on the upper right corner to see the full abstract
- …