PMCC PMCC

Search tips
Search criteria

Advanced
Results 1-11 (11)
 

Clipboard (0)
None

Select a Filter Below

Journals
Year of Publication
more »
1.  A summary of the new GINA strategy: a roadmap to asthma control 
The European Respiratory Journal  2015;46(3):622-639.
Over the past 20 years, the Global Initiative for Asthma (GINA) has regularly published and annually updated a global strategy for asthma management and prevention that has formed the basis for many national guidelines. However, uptake of existing guidelines is poor. A major revision of the GINA report was published in 2014, and updated in 2015, reflecting an evolving understanding of heterogeneous airways disease, a broader evidence base, increasing interest in targeted treatment, and evidence about effective implementation approaches. During development of the report, the clinical utility of recommendations and strategies for their practical implementation were considered in parallel with the scientific evidence.
This article provides a summary of key changes in the GINA report, and their rationale. The changes include a revised asthma definition; tools for assessing symptom control and risk factors for adverse outcomes; expanded indications for inhaled corticosteroid therapy; a framework for targeted treatment based on phenotype, modifiable risk factors, patient preference, and practical issues; optimisation of medication effectiveness by addressing inhaler technique and adherence; revised recommendations about written asthma action plans; diagnosis and initial treatment of the asthma−chronic obstructive pulmonary disease overlap syndrome; diagnosis in wheezing pre-school children; and updated strategies for adaptation and implementation of GINA recommendations.
This paper summarises key changes in the GINA global strategy report, a practical new resource for asthma care http://ow.ly/ObvYi
doi:10.1183/13993003.00853-2015
PMCID: PMC4554554  PMID: 26206872
2.  The GINA asthma strategy report: what’s new for primary care? 
The Global Initiative for Asthma (GINA) was established in 1993 by the World Health Organization and National Heart Lung and Blood Institute to develop a global strategy for managing and preventing asthma. GINA reports, now funded independently through the sale of GINA products, have provided the foundation for many national guidelines. They are prepared by international experts from primary, secondary and tertiary care, and are annually updated following a review of evidence. In 2014, a major revision of the GINA report was published, that took into account advances in evidence not only about asthma and its treatment, but also about how to improve implementation of evidence-based recommendations in clinical practice. This paper summarises key changes relevant to primary care in the new GINA report. A noticeable difference is the report’s radically different approach, now clinically-focussed, with multiple practical tools and flow charts to improve its utility for busy frontline clinicians. Key changes in recommendations include a new, diagnosis-centred definition of asthma; more detail about how to assess current symptom control and future risk; a comprehensive approach to tailoring treatment for individual patients; expanded indications for commencing inhaled corticosteroids; new recommendations for written asthma action plans; a new chapter on diagnosis and initial treatment of patients with asthma–COPD overlap syndrome; and a revised approach to diagnosing asthma in preschool children. The 2014 GINA report (further updated in 2015) moved away from a ‘textbook’ approach to provide clinicians with up-to-date evidence about strategies to control symptoms and minimise asthma risk, in a practical, practice-centred format.
doi:10.1038/npjpcrm.2015.50
PMCID: PMC4519996  PMID: 26224549
3.  Measuring peak flow enhances adherence to monitoring in asthma 
Thorax  2007;62(8):741-742.
doi:10.1136/thx.2006.073395
PMCID: PMC2117274  PMID: 17687102
4.  Barriers and facilitators to patient recruitment to a cluster randomized controlled trial in primary care: lessons for future trials 
Background
Primary-care based randomized controlled trials (RCTs) build an important evidence base for general practice but little evidence exists about barriers to recruitment which often hamper such trials.
We investigated the issues that impeded and facilitated recruitment to a clinical trial in general practice.
Methods
GPs participating in a cluster RCT that tested interventions for improving medication adherence and asthma control completed a survey comprising quantitative and free text questions about their recruitment experiences. We used backward regression to analyze quantitative data and coded free text responses into themes.
Results
40/55 of enrolled GPs recruited patients, but only one-third reached the planned recruitment target (5 patients/GP). In univariate analyses, poor patient recruitment by GPs was significantly associated with longer time to first patient enrolment, GP-perceived poor access to eligible patients and GP working in a practice training medical students. In regression analysis, only the first was significant (p = 0.001); the explained variance of the model was 48%. Themes from free text responses described recruitment barriers at the level of GP (e.g. GPs excluding patients for whom research appeared too challenging), practice (e.g. practice cultures disempowered GPs), patient (e.g. reluctance to change treatment for research) and study (e.g. protocol requirements complicating recruitment). Facilitators included GPs perceiving good support from the research team.
Conclusion
Targeted recruitment support early in the recruitment phase may enhance recruitment rates. Over time, interventions to enhance a general practice research culture are also likely to enhance skills to recruit patients, even for complex interventions. We recommend systematic evaluation of recruitment approaches and outcomes in future RCTs to optimize feasibility and success of these important trials.
Trial registration
Australian and New Zealand Clinical Trials Registry ACTRN12610000854033 (date registered 14/10/2010).
doi:10.1186/s12874-015-0012-3
PMCID: PMC4369080  PMID: 25887970
Attitude of health personnel; Patient selection; General practitioners; Physician-patient relations; Randomized controlled trials as topic; Asthma/prevention & control
5.  The Effect of Inhaled IFN-β on Worsening of Asthma Symptoms Caused by Viral Infections. A Randomized Trial 
Rationale: Ex vivo, bronchial epithelial cells from people with asthma are more susceptible to rhinovirus infection caused by deficient induction of the antiviral protein, IFN-β. Exogenous IFN-β restores antiviral activity.
Objectives: To compare the efficacy and safety of inhaled IFN-β with placebo administered to people with asthma after onset of cold symptoms to prevent or attenuate asthma symptoms caused by respiratory viruses.
Methods: A total of 147 people with asthma on inhaled corticosteroids (British Thoracic Society Steps 2–5), with a history of virus-associated exacerbations, were randomized to 14-day treatment with inhaled IFN-β (n = 72) or placebo (n = 75) within 24 hours of developing cold symptoms and were assessed clinically, with relevant samples collected to assess virus infection and antiviral responses.
Measurements and Main Results: A total of 91% of randomized patients developed a defined cold. In this modified intention-to-treat population, asthma symptoms did not get clinically significantly worse (mean change in six-item Asthma Control Questionnaire <0.5) and IFN-β treatment had no significant effect on this primary endpoint, although it enhanced morning peak expiratory flow recovery (P = 0.033), reduced the need for additional treatment, and boosted innate immunity as assessed by blood and sputum biomarkers. In an exploratory analysis of the subset of more difficult-to-treat, Step 4-5 people with asthma (n = 27 IFN-β; n = 31 placebo), Asthma Control Questionnaire-6 increased significantly on placebo; this was prevented by IFN-β (P = 0.004).
Conclusions: Although the trial did not meet its primary endpoint, it suggests that inhaled IFN-β is a potential treatment for virus-induced deteriorations of asthma in difficult-to-treat people with asthma and supports the need for further, adequately powered, trials in this population.
Clinical trial registered with www.clinicaltrials.gov (NCT 01126177).
doi:10.1164/rccm.201312-2235OC
PMCID: PMC4226052  PMID: 24937476
innate immunity; treatment; respiratory virus
6.  A pragmatic cluster randomized controlled trial of early intervention for chronic obstructive pulmonary disease by practice nurse-general practitioner teams: Study Protocol 
Background
Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of disability, hospitalization, and premature mortality. General practice is well placed to diagnose and manage COPD, but there is a significant gap between evidence and current practice, with a low level of awareness and implementation of clinical practice guidelines. Under-diagnosis of COPD is a world-wide problem, limiting the benefit that could potentially be achieved through early intervention strategies such as smoking cessation, dietary advice, and exercise. General practice is moving towards more structured chronic disease management, and the increasing involvement of practice nurses in delivering chronic care.
Design
A pragmatic cluster randomised trial will test the hypothesis that intervention by a practice nurse-general practitioner (GP) team leads to improved health-related quality of life and greater adherence with clinical practice guidelines for patients with newly-diagnosed COPD, compared with usual care. Forty general practices in greater metropolitan Sydney Australia will be recruited to identify patients at risk of COPD and invite them to attend a case finding appointment. Practices will be randomised to deliver either practice nurse-GP partnership care, or usual care, to patients newly-diagnosed with COPD.
The active intervention will involve the practice nurse and GP working in partnership with the patient in developing and implementing a care plan involving (as appropriate), smoking cessation, immunisation, pulmonary rehabilitation, medication review, assessment and correction of inhaler technique, nutritional advice, management of psycho-social issues, patient education, and management of co-morbidities.
The primary outcome measure is health-related quality of life, assessed with the St George’s Respiratory Questionnaire 12 months after diagnosis. Secondary outcome measures include validated disease-specific and general health related quality of life measures, smoking and immunisation status, medications, inhaler technique, and lung function. Outcomes will be assessed by project officers blinded to patients’ randomization groups.
Discussion
This study will use proven case-finding methods to identify patients with undiagnosed COPD in general practice, where improved care has the potential for substantial benefit in health and healthcare utilization. The study provides the capacity to trial a new model of team-based assessment and management of newly diagnosed COPD in Australian primary care.
Trial registration
ACTRN12610000592044\
doi:10.1186/1748-5908-7-83
PMCID: PMC3457839  PMID: 22958678
7.  Experiences of community pharmacists involved in the delivery of a specialist asthma service in Australia 
Background
The role of community pharmacists in disease state management has been mooted for some years. Despite a number of trials of disease state management services, there is scant literature into the engagement of, and with, pharmacists in such trials. This paper reports pharmacists’ feedback as providers of a Pharmacy Asthma Management Service (PAMS), a trial coordinated across four academic research centres in Australia in 2009. We also propose recommendations for optimal involvement of pharmacists in academic research.
Methods
Feedback about the pharmacists’ experiences was sought via their participation in either a focus group or telephone interview (for those unable to attend their scheduled focus group) at one of three time points. A semi-structured interview guide focused discussion on the pharmacists’ training to provide the asthma service, their interactions with health professionals and patients as per the service protocol, and the future for this type of service. Focus groups were facilitated by two researchers, and the individual interviews were shared between three researchers, with data transcribed verbatim and analysed manually.
Results
Of 93 pharmacists who provided the PAMS, 25 were involved in a focus group and seven via telephone interview. All pharmacists approached agreed to provide feedback. In general, the pharmacists engaged with both the service and research components, and embraced their roles as innovators in the trial of a new service. Some experienced challenges in the recruitment of patients into the service and the amount of research-related documentation, and collaborative patient-centred relationships with GPs require further attention. Specific service components, such as the spirometry, were well received by the pharmacists and their patients. Professional rewards included satisfaction from their enhanced practice, and pharmacists largely envisaged a future for the service.
Conclusions
The PAMS provided pharmacists an opportunity to become involved in an innovative service delivery model, supported by the researchers, yet trained and empowered to implement the clinical service throughout the trial period and beyond. The balance between support and independence appeared crucial in the pharmacists’ engagement with the trial. Their feedback was overwhelmingly positive, while useful suggestions were identified for future academic trials.
doi:10.1186/1472-6963-12-164
PMCID: PMC3439711  PMID: 22709371
Pharmacy; Asthma; Disease management service; Experiences; Feedback
8.  Overall asthma control achieved with budesonide/formoterol maintenance and reliever therapy for patients on different treatment steps 
Respiratory Research  2011;12(1):38.
Background
Adjusting medication for uncontrolled asthma involves selecting one of several options from the same or a higher treatment step outlined in asthma guidelines. We examined the relative benefit of introducing budesonide/formoterol (BUD/FORM) maintenance and reliever therapy (Symbicort SMART® Turbuhaler®) in patients previously prescribed treatments from Global Initiative for Asthma (GINA) Steps 2, 3 or 4.
Methods
This is a post hoc analysis of the results of five large clinical trials (>12000 patients) comparing BUD/FORM maintenance and reliever therapy with other treatments categorised by treatment step at study entry. Both current clinical asthma control during the last week of treatment and exacerbations during the study were examined.
Results
At each GINA treatment step, the proportion of patients achieving target levels of current clinical control were similar or higher with BUD/FORM maintenance and reliever therapy compared with the same or a higher fixed maintenance dose of inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) (plus short-acting β2-agonist [SABA] as reliever), and rates of exacerbations were lower at all treatment steps in BUD/FORM maintenance and reliever therapy versus same maintenance dose ICS/LABA (P < 0.01) and at treatment Step 4 versus higher maintenance dose ICS/LABA (P < 0.001). BUD/FORM maintenance and reliever therapy also achieved significantly higher rates of current clinical control and significantly lower exacerbation rates at most treatment steps compared with a higher maintenance dose ICS + SABA (Steps 2-4 for control and Steps 3 and 4 for exacerbations). With all treatments, the proportion of patients achieving current clinical control was lower with increasing treatment steps.
Conclusions
BUD/FORM maintenance and reliever therapy may be a preferable option for patients on Steps 2 to 4 of asthma guidelines requiring a more effective treatment and, compared with other fixed dose alternatives, is most effective in the higher treatment steps.
doi:10.1186/1465-9921-12-38
PMCID: PMC3082240  PMID: 21463522
9.  Long-Term Maintenance of Pharmacists' Inhaler Technique Demonstration Skills 
Objective
To assess the effectiveness of a single educational intervention, followed by patient education training, in pharmacists retaining their inhaler technique skills.
Methods
A convenience sample of 31 pharmacists attended an educational workshop and their inhaler techniques were assessed. Those randomly assigned to the active group were trained to assess and teach correct Turbuhaler and Diskus inhaler techniques to patients and provided with patient education tools to use in their pharmacies during a 6-month study. Control pharmacists delivered standard care. All pharmacists were reassessed 2 years after initial training.
Results
Thirty-one pharmacists participated in the study. At the initial assessment, few pharmacists demonstrated correct technique (Turbuhaler:13%, Diskus:6%). All pharmacists in the active group demonstrated correct technique following training. Two years later, pharmacists in the active group demonstrated significantly better inhaler technique than pharmacists in the control group (p < 0.05) for Turbuhaler and Diskus (83% vs.11%; 75% vs.11%, respectively).
Conclusion
Providing community pharmacists with effective patient education tools and encouraging their involvement in educating patients may contribute to pharmacists maintaining their competence in correct inhaler technique long-term.
PMCID: PMC2690903  PMID: 19513170
community pharmacists; dry powder inhalers; asthma; education
11.  Comparative effectiveness of long term drug treatment strategies to prevent asthma exacerbations: network meta-analysis 
Objective To determine the comparative effectiveness and safety of current maintenance strategies in preventing exacerbations of asthma.
Design Systematic review and network meta-analysis using Bayesian statistics.
Data sources Cochrane systematic reviews on chronic asthma, complemented by an updated search when appropriate.
Eligibility criteria Trials of adults with asthma randomised to maintenance treatments of at least 24 weeks duration and that reported on asthma exacerbations in full text. Low dose inhaled corticosteroid treatment was the comparator strategy. The primary effectiveness outcome was the rate of severe exacerbations. The secondary outcome was the composite of moderate or severe exacerbations. The rate of withdrawal was analysed as a safety outcome.
Results 64 trials with 59 622 patient years of follow-up comparing 15 strategies and placebo were included. For prevention of severe exacerbations, combined inhaled corticosteroids and long acting β agonists as maintenance and reliever treatment and combined inhaled corticosteroids and long acting β agonists in a fixed daily dose performed equally well and were ranked first for effectiveness. The rate ratios compared with low dose inhaled corticosteroids were 0.44 (95% credible interval 0.29 to 0.66) and 0.51 (0.35 to 0.77), respectively. Other combined strategies were not superior to inhaled corticosteroids and all single drug treatments were inferior to single low dose inhaled corticosteroids. Safety was best for conventional best (guideline based) practice and combined maintenance and reliever therapy.
Conclusions Strategies with combined inhaled corticosteroids and long acting β agonists are most effective and safe in preventing severe exacerbations of asthma, although some heterogeneity was observed in this network meta-analysis of full text reports.
doi:10.1136/bmj.g3009
PMCID: PMC4019015  PMID: 24919052

Results 1-11 (11)