Asthma is one of the commonest chronic diseases in the UK. Acute exacerbations of asthma are unpredictable, disruptive and frightening. They cause considerable morbidity and account for a large component of the health service costs of asthma. The widespread use of an asthma self-management plan, designed to encourage disease monitoring and timely intervention, can reduce exacerbations and is, therefore, recommended for all patients with asthma. Unfortunately, the majority of patients are not provided with such a plan. There are a variety of reasons for this but uncertainty about what to include in the plan when asthma control is deteriorating, but before the need for orally administered corticosteroids, is a contributing factor. The aim of this trial is to determine whether an asthma self-management plan, which includes a temporary quadrupling of the dose of inhaled corticosteroid when asthma control starts to deteriorate, reduces asthma exacerbations requiring orally administered corticosteroids or unscheduled health care consultation for asthma. A multicentre, pragmatic, randomised trial in adults aged over 16 years with a clinical diagnosis of asthma, treated with a licensed dose of inhaled corticosteroid and at least one exacerbation in the previous 12 months requiring treatment with systemic corticosteroids. Participants will be randomised to either a self-management plan, which includes a temporary (maximum of 14 days) fourfold increase in inhaled corticosteroid or the same plan without an increase in inhaled corticosteroid. Participants will be followed up at 6 and 12 months and will attend the clinic for an additional visit if their asthma control deteriorates. The primary outcome is time to first asthma exacerbation, defined as the need for systemic corticosteroids and/or unscheduled health care consultation for asthma. The estimated sample size is 1800 participants. The FAST trial is an independent study that has been prioritised and commissioned by the National Institute for Health Research (NIHR) in the United Kingdom. It will provide high-quality evidence to inform clinical decision-making on the role of an asthma self-management plan, which includes a temporary fourfold increase of inhaled corticosteroid, when asthma control starts to deteriorate. The first participant was randomised on 17th May 2013 and recruitment will close on 31 January 2016 with the last patient last visit taking place in January 2017. ISRCTN: 15441965 , registered on 25 April 2013.
Acute upper gastrointestinal bleeding is the commonest medical emergency managed by gastroenterologists in the United Kingdom. The most frequently identified source of bleeding is peptic ulcer disease, but other important causes exist, particularly oesophageal or gastric varices, which are classically associated with more severe bleeding. A large audit in the UK in 20071 indicated that the rate of mortality from acute upper gastrointestinal bleeding (about 7%) has not changed much over the past 50 years, and that service provision varies considerably across the UK. This article summarises the most recent recommendations from the National Institute for Health and Clinical Excellence (NICE) on the management of acute upper gastrointestinal bleeding.2
NICE recommendations are based on systematic reviews of the best available evidence and explicit consideration of cost effectiveness. When minimal evidence is available, recommendations are based on the Guideline Development Group’s experience and opinion of what constitutes good practice. Evidence levels for the recommendations are given in italic in square brackets.
### Risk assessment
At presentation with acute upper gastrointestinal bleeding, assess for risk of serious adverse events or need for intervention. To do this use the following formal risk assessment scoring systems for all patients with acute gastrointestinal bleeding: the Blatchford scoring system3 at first assessment and the full Rockall scoring system4 after endoscopy (tables 1⇓ and 2⇓). [ Based on low to very low quality evidence from prospective and retrospective case reviews ]
View this table:
Table 1
The Blatchford scoring system.3 For a patient with acute upper gastrointestinal bleeding, add up scores in the right hand column for each risk marker (if no value applies for a particular marker, score 0) to derive a total score*
View this table:
Table 2
The full (post-endoscopy) Rockall scoring system.4 For a patient with acute upper gastrointestinal bleeding, add up scores at the top of the …
Guidelines recommend against antibiotic use to treat asthma attacks. A study with telithromycin reported benefit, but adverse reactions limit its use.
Objective
To determine whether azithromycin added to standard care for asthma attacks in adults results in clinical benefit.
Design, Setting, and Participants
The Azithromycin Against Placebo in Exacerbations of Asthma (AZALEA) randomized, double-blind, placebo-controlled clinical trial, a United Kingdom–based multicenter study in adults requesting emergency care for acute asthma exacerbations, ran from September 2011 to April 2014. Adults with a history of asthma for more than 6 months were recruited within 48 hours of presentation to medical care with an acute deterioration in asthma control requiring a course of oral and/or systemic corticosteroids.
Interventions
Azithromycin 500 mg daily or matched placebo for 3 days.
Main Outcomes and Measures
The primary outcome was diary card symptom score 10 days after randomization, with a hypothesized treatment effect size of −0.3. Secondary outcomes were diary card symptom score, quality-of-life questionnaires, and lung function changes, all between exacerbation and day 10, and time to a 50% reduction in symptom score.
Results
Of 4582 patients screened at 31 centers, 199 of a planned 380 were randomized within 48 hours of presentation. The major reason for nonrecruitment was receipt of antibiotics (2044 [44.6%] screened patients). Median time from presentation to drug administration was 22 hours (interquartile range, 14-28 hours). Exacerbation characteristics were well balanced across treatment arms and centers. The primary outcome asthma symptom scores were mean (SD), 4.14 (1.38) at exacerbation and 2.09 (1.71) at 10 days for the azithromycin group and 4.18 (1.48) and 2.20 (1.51) for the placebo group, respectively. Using multilevel modeling, there was no significant difference in symptom scores between azithromycin and placebo at day 10 (difference, −0.166; 95% CI, −0.670 to 0.337), nor on any day between exacerbation and day 10. No significant between-group differences were observed in quality-of-life questionnaires or lung function between exacerbation and day 10, or in time to 50% reduction in symptom score.
Conclusions and Relevance
In this randomized population, azithromycin treatment resulted in no statistically or clinically significant benefit. For each patient randomized, more than 10 were excluded because they had already received antibiotics.
This paper explores the complex landscape of evaluating the impact of digital cultural heritage initiatives within the European Union. While present body of research has so far addressed various facets of digital culture and heritage, including digital humanities, a comprehensive understanding of the impact of digital heritage projects on broader cultural, social, and economic contexts remains a critical gap. This is particularly important given the increasing emphasis on demonstrating value of and securing support for these initiatives. The EU recognizes this strategic importance, promoting digital transformation within the cultural heritage sector and setting ambitious digitization goals. However, the shift from digitization to digital transformation, alongside the more traditional concerns of access and preservation, requires a focus on sustainability, encompassing social and environmental impact, long-term preservation, and economic viability. By employing critical desk research, this paper examines the EU policies concerning digital cultural heritage and the challenges of measuring impact, discussing key concepts like sustainability and digital maturity. It provides an overview of prominent impact assessment frameworks, analysing their strengths and limitations and considering their appropriateness for today policy context. We conclude by arguing the importance of developing and applying holistic IA frameworks that consider the diverse values and long-term sustainability of digital cultural heritage initiatives, facilitating a shift from simply collecting data to demonstrating meaningful change.
Asthma exacerbations are frightening for patients and are occasionally fatal. We tested the concept that a plan for patients to manage their asthma (self-management plan), which included a temporary quadrupling of the dose of inhaled glucocorticoids when asthma control started to deteriorate, would reduce the incidence of severe asthma exacerbations among adults and adolescents with asthma.We conducted a pragmatic, unblinded, randomized trial involving adults and adolescents with asthma who were receiving inhaled glucocorticoids, with or without add-on therapy, and who had had at least one exacerbation in the previous 12 months. We compared a self-management plan that included an increase in the dose of inhaled glucocorticoids by a factor of 4 (quadrupling group) with the same plan without such an increase (non-quadrupling group), over a period of 12 months. The primary outcome was the time to a first severe asthma exacerbation, defined as treatment with systemic glucocorticoids or an unscheduled health care consultation for asthma.A total of 1922 participants underwent randomization, of whom 1871 were included in the primary analysis. The number of participants who had a severe asthma exacerbation in the year after randomization was 420 (45%) in the quadrupling group as compared with 484 (52%) in the non-quadrupling group, with an adjusted hazard ratio for the time to a first severe exacerbation of 0.81 (95% confidence interval, 0.71 to 0.92; P=0.002). The rate of adverse effects, which were related primarily to local effects of inhaled glucocorticoids, was higher in the quadrupling group than in the non-quadrupling group.In this trial involving adults and adolescents with asthma, a personalized self-management plan that included a temporary quadrupling of the dose of inhaled glucocorticoids when asthma control started to deteriorate resulted in fewer severe asthma exacerbations than a plan in which the dose was not increased. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN15441965 .).
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