Regular treatment with salmeterol and inhaled steroids for chronic asthma: serious adverse events

Epidemiological evidence has suggested a link between beta(2)-agonists and increased asthma mortality. There has been much debate about possible causal links for this association, and whether regular (daily) long-acting beta(2)-agonists are safe.ObjectivesThe aim of this review is to assess the risk of fatal and non-fatal serious adverse events in trials that randomised patients with chronic asthma to regular salmeterol with inhaled corticosteroids versus the same dose of inhaled corticosteroids alone.Search strategyTrials were identified using the Cochrane Airways Group Specialised Register of trials. Web sites of clinical trial registers were checked for unpublished trial data and Food and Drug Administration (FDA) submissions in relation to salmeterol were also checked. The date of the most recent search was October 2008.Selection criteriaControlled parallel design clinical trials on patients of any age and severity of asthma were included if they randomised patients to treatment with regular salmeterol and inhaled corticosteroids (in separate or combined inhalers), and were of at least 12 weeks duration.Data collection and analysisTwo authors independently selected trials for inclusion in the review. Outcome data were independently extracted by two authors. Unpublished data on mortality and serious adverse events were obtained from the sponsors, and from FDA submissions.Main resultsThe review included 30 studies (10,873 participants) in adults and adolescents, and three studies (1,173 participants) in children. The overall risk of bias was low and data on serious adverse events were obtained from all studies.Six deaths occurred in 5,710 adults on regular salmeterol with inhaled corticosteroids, and five deaths in 5,163 adults on regular inhaled corticosteroids at the same dose. The difference was not statistically significant (Peto OR 1.05; 95% CI 0.32 to 3.47) and the absolute difference between groups in risk of death of any cause was 0.00005 (95% CI -0.002 to 0.002). No deaths were reported in 1,173 children, and no deaths were reported to be asthma-related.Non-fatal serious adverse events of any cause were reported in 134 adults on regular salmeterol with inhaled corticosteroids, compared to 103 adults on regular inhaled corticosteroids; again this was not a significant increase (Peto OR 1.17; 95% CI 0.90 to 1.52). The absolute difference in the risk of non-fatal serious adverse events was 0.003 (95% CI -0.002 to 0.009).There were three of 586 children with serious adverse events on regular salmeterol with inhaled corticosteroids, compared to four out of 587 on regular inhaled corticosteroids: there was no significant difference between treatments (Peto OR 0.75; 95% CI 0.17 to 3.31).Asthma-related serious adverse events were reported in 23 and 21 adults in each group respectively, a non-significant difference (Peto OR 0.95; 95% CI 0.52 to 1.73), and only one event was reported in children.Authors' conclusionsNo significant differences have been found in fatal or non-fatal serious adverse events in trials in which regular salmeterol has been randomly allocated with inhaled corticosteroids, in comparison to inhaled corticosteroids at the same dose. Although 10,873 adults and 1,173 children have been included in trials, the number of patients suffering adverse events is too small, and the results are too imprecise to confidently rule out a relative increase in all-cause mortality or non-fatal adverse events. It is therefore not possible to determine whether the increase in all-cause non-fatal serious adverse events reported in the previous meta-analysis on regular salmeterol alone is abolished by the additional use of regular inhaled corticosteroids. The absolute difference between groups in the risk of serious adverse events was small. There were no asthma-related deaths and few asthma-related serious adverse events. Clinical decisions and information for patients regarding regular use of salmeterol have to take into account the balance between known symptomatic benefits of salmeterol and the degree of uncertainty and concern associated with its potential harmful effects

Improving progression to sustainable unsupported employment: a review of strategies developed by Workstep providers

This report evaluates the strategies and practices of Workstep providers aimed at moving adults (i.e. age 16+) with significant physical, mental and personal barriers into sustainable jobs and identifies barriers to progress. Case studies illustrate effective practice

Validation of Ultrahigh Dependability for Software-Based Systems

Modern society depends on computers for a number of critical tasks in which failure can have very high costs. As a consequence, high levels of dependability (reliability, safety, etc.) are required from such computers, including their software. Whenever a quantitative approach to risk is adopted, these requirements must be stated in quantitative terms, and a rigorous demonstration of their being attained is necessary. For software used in the most critical roles, such demonstrations are not usually supplied. The fact is that the dependability requirements often lie near the limit of the current state of the art, or beyond, in terms not only of the ability to satisfy them, but also, and more often, of the ability to demonstrate that they are satisfied in the individual operational products (validation). We discuss reasons why such demonstrations cannot usually be provided with the means available: reliability growth models, testing with stable reliability, structural dependability modelling, as well as more informal arguments based on good engineering practice. We state some rigorous arguments about the limits of what can be validated with each of such means. Combining evidence from these different sources would seem to raise the levels that can be validated; yet this improvement is not such as to solve the problem. It appears that engineering practice must take into account the fact that no solution exists, at present, for the validation of ultra-high dependability in systems relying on complex software

Bridging the gap between police and citizens: what we know, what we've done, and what can be done

Master's Project (M.A.) University of Alaska Fairbanks, 2017There is a long history of distrust between police and citizens and there have been no meaningful and sustained steps to correct this situation. Death and injuries are sustained by citizens and police, but still there has not been a real attempt to prevent this occurring because there is no trust between police and citizens and this lack of trust has created a rift or gap between police and citizens and this projects aim is to address the gap. Research into what causing damage and finding a way to repair the damaged relationship between police and citizens by way of finding approaches that tend to lead to trust between groups of people. Communication, a better ethics base for police, training and education, restorative justice, media, and the studying of social theories will help find a way to repair the damage. A collaboration of all of the aforementioned categories will tend to help bridge the gap between police and citizens. It is believed that by addressing the issues and the roots of the problems between police and citizens, a new relationship built on trust will emerge. By having a more trusting relationship there will be less harm caused to police and citizens

Towards Identifying and closing Gaps in Assurance of autonomous Road vehicleS - a collection of Technical Notes Part 1

This report provides an introduction and overview of the Technical Topic Notes (TTNs) produced in the Towards Identifying and closing Gaps in Assurance of autonomous Road vehicleS (Tigars) project. These notes aim to support the development and evaluation of autonomous vehicles. Part 1 addresses: Assurance-overview and issues, Resilience and Safety Requirements, Open Systems Perspective and Formal Verification and Static Analysis of ML Systems. Part 2: Simulation and Dynamic Testing, Defence in Depth and Diversity, Security-Informed Safety Analysis, Standards and Guidelines

Organizing and Representing Clerical Workers: The Harvard Model

[Excerpt] The private sector clerical work force is largely nonunion, simultaneously offering the labor movement a major source of potential membership growth and an extremely difficult challenge. Based on December 1990 data, there are eighteen million workers employed in office clerical, administrative support, and related occupations. Eighty percent of these employees are women, accounting for 30 percent of all women in the labor force. Among private sector office workers, 57 percent work in the low-union-density industry groups of services (only 5.7 percent union) and finance, insurance, and real estate (only 2.5 percent union). With barely over ten million total private sector union members, the labor movement can ill afford to overlook the thirteen million nonunion women who work in private sector clerical occupations. Concerned trade unionists are now searching for appropriate models for organizing and representing these workers. Two schools of thought have emerged. Some believe that clericals are like other workers and can be organized when job-related concerns predispose them to action. According to this view, private sector clerical organizing can proceed if and when unions devote sufficient attention and resources to the endeavor using conventional organizing techniques. Other unionists argue that clericals are different. Not only are they primarily women, but they also tend to be traditionally feminine and turned off by macho blue-collar unionism. According to this interpretation, a special approach is required regarding style, tactics, and/or issues to be addressed. I will focus on one highly visible private sector clerical organizing victory: the 1988 union win among Harvard University clerical and technical employees. The Harvard case is, in many ways, representative of the success unions have experienced among university-based clerical workers in recent years using rank-and-file grassroots oriented campaigns. And, as a private sector campaign that confronted intense management opposition, it also offers tactical lessons that are relevant beyond the confines of academia. Perhaps most important, the Harvard case presents us with a distinct organizing and bargaining model whose relevance to other organizing efforts deserves careful evaluation: the Harvard Union of Clerical and Technical Workers (HUCTW) not only employed a grassroots organizingapproach, but also devised a unique bargaining strategy that succeeded in institutionalizing and preserving rank-and-file involvement

New futures health trainers: an impact assessment

Although the health of the UK population has improved significantly over the last century, inequalities in health still exist, with some of Britain’s biggest killers being ‘preventable’ illnesses. The 2004 white paper ‘Choosing Health: Making Healthy Choices Easier’ aimed to introduce initiatives to reduce inequalities in health. One such initiative was ‘Health Trainers’ – a new role staffed by individuals drawn from and based in deprived areas. This role aimed to offer people in deprived communities practical advice about health improvement, and to facilitate access to health services This report aims to examine the impact of introducing the ‘New Futures Health Trainer’ role into criminal justice settings in terms of: a) Training for the Health Trainer Tutors/the development of the Health Trainer training course b) The impact of the training on the New Futures Health Trainers c) The organisational consequences of the role d) The impact of New Futures Health Trainers on clinical outcomes for prisoners/offenders on probation, and e) A brief examination of the relationship between ‘early adopter’ sites for Health Trainers in the community, and the prison/probation equivalen