This paper is mainly devoted to the comparison between the calculation and experimental results of primary and secondary streamer development in a point-to-plane positive corona discharge in dry air ...at atmospheric pressure. The qualitative agreement between experimental and calculation results based on the hydrodynamics approximation shows that the O radical is mainly produced in the secondary streamer which is in good agreement with the recent literature measurements using TALIF diagnostics. However, the O radical production yield (in terms of radicals produced per energy injected) is more efficient in the primary streamer than in the secondary one. The main positive corona discharge characteristics are revisited using fast electrical and optical ICCD and streak camera measurements. The calculation shows two streamer radii of, respectively, 10 mum (associated with the radial extension of a high electron density region) and 200 mum (corresponding to the extension of the radial space charge electric field).
Background The Patient Assessment of Constipation–Quality of Life (PAC‐QOL) is a self‐reported questionnaire measuring health‐related quality of life (HRQL) of constipated patients and was used as ...secondary endpoint in three identical double‐blind, randomized, placebo‐controlled Phase III clinical trials. These 12‐week trials in subjects with severe chronic constipation evaluated the effects of prucalopride, a selective 5‐HT4 agonist given orally once daily.
Methods To consolidate the main treatment effect results observed in the prucalopride trial populations, analyses were undertaken on the pooled data of the three trials to confirm the psychometric properties of the PAC‐QOL and to provide guidance for the interpretation of the clinical significance of its scores.
Key Results The evaluation of the psychometric properties confirmed the PAC‐QOL reliability, validity and responsiveness to measure the impact of chronic constipation symptoms on HRQL in the prucalopride trials. The 1‐point improvement in PAC‐QOL scores used as target response level for the main treatment effect analyses was validated as a relevant definition of response for treatment group comparisons. Cumulative distribution curves, drawn for each treatment group to provide more complete information on treatment effects than single minimal important difference point estimates, demonstrated consistent superior effects of prucalopride over placebo on all PAC‐QOL scores.
Conclusions & Inferences The PAC‐QOL questionnaire is a useful measurement tool to assess, from a patient perspective, the potential therapeutic value of chronic constipation treatments in clinical trials and, by directly reflecting the patient’s own perspective on constipation and its treatment, eventually also for informing daily medical practice.
Des douleurs abdominales et un purpura Meyering, D.; Pages, M.; Dubois, D. ...
La revue de medecine interne,
12/2009, Letnik:
30, Številka:
12
Journal Article
The extent to which patient-based outcomes can be used to evaluate and communicate the effect of new drugs and devices is a subject of much debate. Criteria for evaluating the scientific quality of ...data to support health-related quality of life (HRQL) and other patient-based labeling and promotional claims in the United States and Europe have been proposed by various scientists and organizations. Since March 2000, a working group composed of members of the International Society for Quality of Life Research (ISOQOL), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the Pharmaceutical Manufacturer's Association Health Outcomes Committee (PhRMA-HOC), and the European Regulatory Issues on Quality of Life Assessment (ERIQA) met to discuss and coordinate the various recommendations by their respective groups and address the need to harmonize outcomes review criteria within and across United States and European regulatory agencies. Over time, the discussion expanded from HRQL outcomes to include any outcome based on data provided by the patient or patient proxy, that is, patient-reported outcomes (PROs). The working group therefore became known as the PRO Harmonization Group.
Working with a member of the US Food and Drug Administration (FDA), four key issues requiring clarification were identified: how PROs are defined and put into operation for research purposes; the added value of PROs in the drug review and evaluation process; selected questions related to the PRO measurement and research methodology; and the interest and demand for PRO information by decision makers. On February 15, 2001, all members of the PRO Harmonization Group attended a meeting in Rockville, Maryland, to discuss these four issues further, and on February 16, 2001, a formal presentation was made to representatives from various departments and reviewing divisions of the FDA. These presentations are summarized in this report.
All participants agreed that PROs are important for understanding the impact of treatment on patient functioning and well-being. They also stressed the need to communicate PRO information to key decision makers, including regulatory agencies, clinicians, patients and their families, and payers. Finally, the meeting resulted in plans for continuing the dialogue on PRO measurement and interpretation.
The February 16, 2001, meeting represented an important step in harmonizing efforts across various organizations and in opening a dialogue with the FDA around major issues related to methodologic standards for measuring and interpreting PROs in the drug evaluation process.
For risk assessment to be a relevant tool in the study of any type of system or activity, it needs to be based on a framework that allows for jointly analyzing both unique and repetitive events. ...Separately, unique events may be handled by predictive probability assignments on the events, and repetitive events with unknown/uncertain frequencies are typically handled by the probability of frequency (or Bayesian) approach. Regardless of the nature of the events involved, there may be a problem with imprecision in the probability assignments. Several uncertainty representations with the interpretation of lower and upper probability have been developed for reflecting such imprecision. In particular, several methods exist for jointly propagating precise and imprecise probabilistic input in the probability of frequency setting. In the present position paper we outline a framework for the combined analysis of unique and repetitive events in quantitative risk assessment using both precise and imprecise probability. In particular, we extend an existing method for jointly propagating probabilistic and possibilistic input by relaxing the assumption that all events involved have frequentist probabilities; instead we assume that frequentist probabilities may be introduced for some but not all events involved, i.e. some events are assumed to be unique and require predictive – possibly imprecise – probabilistic assignments, i.e. subjective probability assignments on the unique events without introducing underlying frequentist probabilities for these. A numerical example related to environmental risk assessment of the drilling of an oil well is included to illustrate the application of the resulting method.
•We formulate a set-up for combined analysis of unique and repetitive events in QRA•We extend an existing method joint probabilistic–possibilistic input propagation•A numerical example related to environmental risk assessment is included
The hourly concentrations of atmospheric ozone (O3) were measured at seven locations throughout the Treasure Valley during the summer of 2007, indicating a concentration gradient up to 30 percent, ...with the lowest levels measured on the northeast and the highest on the southwest parts of the Treasure Valley. A weak “weekend” effect was observed on Saturday despite morning NOx levels that were lower than those measured during the weekdays. The lowest ozone levels were measured on Sundays because of the absence of NOx emissions. The contribution of wildfire smoke was qualitatively assessed through the geospatial analysis of air mass backward trajectories along with the locations and durations of wildfires. For at least three sites, there was evidence of the direct contribution of wildfire smoke in four of the nine multi-day O3 events in which the measured ozone levels were higher than the 80th percentile value. For the rest five high O3 events, four of them had weaker indications of the influence of smoke, while one event (on July 4, 2007) was associated with the extended use of fireworks. During the high O3 events influenced by wildfires, max hourly and mean daily O3 concentrations were up to 15ppbv and 12ppbv, respectively, higher than those regularly measured in the Treasure Valley.
► We analyzed the spatial variation of ozone levels using quantitative statistical tools. ► We measured weekend elevated ozone levels despite reduced NOx emissions. ► We integrated of backward trajectories and wildfire data in a geospatial tool. ► We identified the contribution of wildfires smoke on ozone levels.
Summary Pseudomonas aeruginosa has been recovered in hospitals from many different sources including sinks and taps. Because P. aeruginosa is one of the main agents of nosocomial infections and ...increasingly resistant to antibiotics, environmental reservoirs in hospital settings are of great concern. We report here on a cluster of five cases of infection by P. aeruginosa expressing VIM carbapenemases (VIM-PA) in a nephrology intensive care unit. Our investigation pointed to transmission of VIM-PA via hands related to a contaminated tap. VIM-PA may be cross-transmitted to other patients if an environmental reservoir exists. Sinks and taps should be well designed and thoroughly cleaned and disinfected, and use of alcohol hand rub should be promoted.
Simulations are reported of the Thomson scatter spectrum of electrostatic waves (ESWs) excited in single laser hot spots by backward stimulated Raman scattering (BSRS). Under conditions similar those ...in the recent experiments of Kline et al. Phys. Rev. Lett. 94, 175003 (2005), a spectral streak, resulting from the trapping-induced frequency shift of the ESW, is found for high wave-number ESWs, similar to the observations. This shift and parametric frequency matching lead to isolated BSRS pulses. Modes with acoustic dispersion, resulting from the trapping-modified electron velocity distribution, can enhance the frequency range of the streak.
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