Trends of testing for and diagnosis of α1-antitrypsin deficiency in the UK: more testing is needed.

α1-antitrypsin deficiency (AATD) significantly increases the risk of developing chronic obstructive pulmonary disease (COPD), and testing of all COPD patients for AATD is recommended by the World Health Organization, European Respiratory Society and Global Initiative for Chronic Obstructive Lung Disease (GOLD). We aimed to determine trends for testing and diagnosing AATD from 1990 to 2014.This study analysed all patients diagnosed with COPD from about 550 UK Optimum Patient Care Research Database general practices, including a subgroup of those diagnosed before the age of 60 years.We identified 107 024 COPD individuals, of whom 29 596 (27.6%) were diagnosed before 60 years of age. Of them, only 2.2% (95% CI 2.09-2.43%) had any record of being tested for AATD. Of those tested, 23.7% (95% CI 20.5-27.1%) were diagnosed with AATD. Between 1994 and 2013 the incidence of AATD diagnosis generally increased. A diagnosis of AATD was associated with being male, being an ex-smoker, more severe COPD with a lower forced expiratory volume in 1 s % pred and higher GOLD 2017 stages (all p<0.05).Despite an increase in the frequency of AATD testing since 1990, only 2.2% of patients diagnosed with COPD before the age of 60 years were tested. AATD prevalence was 23.7% in those tested. Thus, it appears that AATD remains markedly underdiagnosed in COPD patients.

Evaluation of inhaler technique and achievement and maintenance of mastery of budesonide/formoterol Spiromax® compared with budesonide/formoterol Turbuhaler® in adult patients with asthma: the Easy Low Instruction Over Time (ELIOT) study.

BACKGROUND: Incorrect inhaler technique is a common cause of poor asthma control. This two-phase pragmatic study evaluated inhaler technique mastery and maintenance of mastery with DuoResp® (budesonide-formoterol [BF]) Spiromax® compared with Symbicort® (BF) Turbuhaler® in patients with asthma who were receiving inhaled corticosteroids/long-acting ß2-agonists. METHODS: In the initial cross-sectional phase, patients were randomized to a 6-step training protocol with empty Spiromax and Turbuhaler devices. Patients initially demonstrating ≥1 error with their current device, and then achieving mastery with both Spiromax and Turbuhaler (absence of healthcare professional [HCP]-observed errors), were eligible for the longitudinal phase. In the longitudinal phase, patients were randomized to BF Spiromax or BF Turbuhaler. Co-primary endpoints were the proportions of patients achieving device mastery after three training steps and maintaining device mastery (defined as the absence of HCP-observed errors after 12 weeks of use). Secondary endpoints included device preference, handling error frequency, asthma control, and safety. Exploratory endpoints included assessment of device mastery by an independent external expert reviewing video recordings of a subset of patients. RESULTS: Four hundred ninety-three patients participated in the cross-sectional phase, and 395 patients in the longitudinal phase. In the cross-sectional phase, more patients achieved device mastery after three training steps with Spiromax (94%) versus Turbuhaler (87%) (odds ratio [OR] 3.77 [95% confidence interval (CI) 2.05-6.95], p < 0.001). Longitudinal phase data indicated that the odds of maintaining inhaler mastery at 12 weeks were not statistically significantly different (OR 1.26 [95% CI 0.80-1.98], p = 0.316). Asthma control improved in both groups with no significant difference between groups (OR 0.11 [95% CI -0.09-0.30]). An exploratory analysis indicated that the odds of maintaining independent expert-verified device mastery were significantly higher for patients using Spiromax versus Turbuhaler (OR 2.11 [95% CI 1.25-3.54]). CONCLUSIONS: In the cross-sectional phase, a significantly greater proportion of patients using Spiromax versus Turbuhaler achieved device mastery; in the longitudinal phase, the proportion of patients maintaining device mastery with Spiromax versus Turbuhaler was similar. An exploratory independent expert-verified analysis found Spiromax was associated with higher levels of device mastery after 12 weeks. Asthma control was improved by treatment with both BF Spiromax and BF Turbuhaler. TRIAL REGISTRATION: EudraCT 2013-004630-14 (registration date 23 January 2014); NCT02570425 .

The Primary Care Respiratory Society-UK Quality Award: development and piloting of quality standards for primary care respiratory medicine.

In an attempt to improve the standards of primary respiratory care in the UK, the Primary Care Respiratory Society-UK (PCRS-UK), in conjunction with other leading respiratory-interested health professional and patient groups, has devised a General Practice Quality Award for Respiratory Medicine. The Award is divided into three modules separated into a total of seven clinical standards (in parentheses): 'Clinical' (prevention, early and accurate diagnosis, acute care, chronic care); 'Organisational' (equipment); and 'The Practice Team' (practice learning needs, educational strategy). Assessment is by submission of a written portfolio of 37 pieces of evidence including audit, reflective learning, patient feedback, and significant event analyses. The Award was piloted in five respiratory-interested practices across the UK. The practices reported improvements in practice organisation, practice teamwork, improved process measures such as improvement in quality of spirometry, and improved patient access to patient services. All practices in the UK are being invited to apply for the Award in 2013. It is hoped that it will provide a framework and stimulus for provision of high-quality primary respiratory care, not only in the UK, but also some aspects of the Award may be applicable on a wider international scale.

Clinical and cost effectiveness of switching asthma patients from fluticasone-salmeterol to extra-fine particle beclometasone-formoterol: a retrospective matched observational study of real-world patients.

BACKGROUND: Efficacy trials suggest that extra-fine particle beclometasone dipropionate-formoterol (efBDP-FOR) is comparable to fluticasone propionate-salmeterol (FP-SAL) in preventing asthma exacerbations at a clinically equivalent dosage. However, switching from FP-SAL to efBDP-FOR has not been evaluated in real-world asthma patients. AIMS: The REACH (Real-world Effectiveness in Asthma therapy of Combination inHalers) study investigated the clinical and cost effectiveness of switching typical asthma patients from FP-SAL to efBDP-FOR. METHODS: A retrospective matched (1:3) observational study of 1,528 asthma patients aged 18-80 years from clinical practice databases was performed. Patients remaining on FP-SAL (n=1,146) were compared with those switched to efBDP-FOR at an equivalent or lower inhaled corticosteroid (ICS) dosage (n=382). Clinical and economic outcomes were compared between groups for the year before and after the switch. Non-inferiority (at least equivalence) of efBDP-FOR was tested against FP-SAL by comparing exacerbation rates during the outcome year. RESULTS: efBDP-FOR was non-inferior to FP-SAL (adjusted exacerbation rate ratio 1.01 (95% CI 0.74 to 1.37)). Switching to efBDP-FOR resulted in significantly better (p<0.05) odds of achieving overall asthma control (no asthma-related hospitalisations, bronchial infections, or acute oral steroids; salbutamol ≤200µg/day) and lower daily short-acting ß2-agonist usage at a lower daily ICS dosage (mean -130µg/day FP equivalents; p<0.001). It also reduced mean asthma-related healthcare costs by £93.63/patient/year (p<0.001). CONCLUSIONS: Asthma patients may be switched from FP-SAL to efBDP-FOR at an equivalent or lower ICS dosage with no reduction in clinical effectiveness but a significant reduction in cost.

Implementation of a primary care asthma management quality improvement programme across 68 general practice sites.

Despite national and international guidelines, asthma is frequently misdiagnosed, control is poor and unnecessary deaths are far too common. Large scale asthma management programme such as that undertaken in Finland, can improve asthma outcomes. A primary care asthma management quality improvement programme was developed with the support of the British Lung Foundation (now Asthma + Lung UK) and Optimum Patient Care (OPC) Limited. It was delivered and cascaded to all relevant staff at participating practices in three Clinical Commissioning Groups. The programme focussed on improving diagnostic accuracy, management of risk and control, patient self-management and overall asthma control. Patient data were extracted by OPC for the 12 months before (baseline) and after (outcome) the intervention. In the three CCGs, 68 GP practices participated in the programme. Uptake from practices was higher in the CCG that included asthma in its incentivised quality improvement programme. Asthma outcome data were successfully extracted from 64 practices caring for 673,593 patients. Primary outcome (Royal College of Physicians Three Questions [RCP3Q]) data were available in both the baseline and outcome periods for 10,328 patients in whom good asthma control (RCP3Q = 0) increased from 36.0% to 39.2% (p < 0.001) after the intervention. The odds ratio of reporting good asthma control following the intervention was 1.15 (95% CI 1.09-1.22), p < 0.0001. This asthma management programme produced modest but highly statistically significant improvements in asthma outcomes. Key lessons learnt from this small-scale implementation will enable the methodology to be improved to maximise benefit in a larger scale role out.

A qualitative study of stakeholder views of a community-based anticipatory care service for patients with COPD.

BACKGROUND: The need to consider anticipatory preventive care for people with chronic obstructive pulmonary disease (COPD) has been highlighted in UK guidelines and policy. AIMS: To explore stakeholder views of the utility and design of a community-based anticipatory care service (CBACS) for COPD. METHODS: This was a qualitative study using focus groups and in-depth interviews in North-East Scotland. Key stakeholders were purposively sampled: GPs (n=7), practice nurses (n=6), community nurses (n=4), district nurses (n=6), physiotherapists (n=6), pharmacists (n=8), COPD Managed Clinical Network members (n=8), NHS managers (n=4), the COPD Early Supported Discharge (ESD) Team (n=7), patients and carers (n=7). Data were analysed using framework analysis. RESULTS: A CBACS for COPD was broadly acceptable to most participants although not all wished direct involvement. Patient education and empowerment, clear roles, effective communication across traditional service boundaries, generic and clinical skills training, ongoing support and a holistic service were seen as crucial. Potential issues included: resources; anticipatory care being in conflict with the 'reactive' ethos of NHS care; and the breadth of clinical knowledge required. CONCLUSION: A CBACS for COPD requires additional resources and professionals will need to adapt to a new model of service delivery for which they may not be ready.

Knowledge of asthma guidelines: results of a UK General Practice Airways Group (GPIAG) web-based 'Test your Knowledge' quiz.

A web-based questionnaire, comprising 11 multiple choice questions, tested the knowledge of visitors to the General Practice Airways Group (GPIAG) online summary of the British Asthma guideline. On average, the 413 respondents answered less than half the questions correctly. GP scores were significantly lower than practice nurses. Improving clinicians' knowledge of asthma is a prerequisite for improving management.

A Comparison of the Real-Life Clinical Effectiveness of the Leading Licensed ICS/LABA Combination Inhalers in the Treatment for COPD.

Introduction: The Fostair® 100/6 (BDP/FF) pressurized metered-dose inhaler, delivering an extrafine formulation, is licensed for asthma and COPD in the UK. However, its real-life effectiveness for COPD has not been evaluated. This study compared the clinical effectiveness of BDP/FF against other licensed ICS/LABA combination inhalers: the Seretide® Accuhaler® (FP/SAL) and the Symbicort® Turbohaler® (BUD/FF). Methods: A matched historical cohort study was conducted using records of patients with diagnostic codes for COPD from the Optimum Patient Care Research Database (OPCRD). Patients who had received BDP/FF as their first ICS/LABA were matched 1:1 with patients who had received FP/SAL or BUD/FF, resulting in two matched comparisons. Additional analysis was conducted on patients who had never had diagnostic codes for asthma. Noninferiority in terms of the proportion of patients with moderate/severe COPD exacerbations on the different inhalers in the following year was assessed. Noninferiority was achieved if the upper CI limit were ≤1.2. Results: This study included 537 and 540 patient pairs in the BDP/FF vs FP/SAL cohort and the BDP/FF vs BUD/FF cohort, respectively. The proportion of patients with COPD exacerbations in the BDP/FF group was not significantly different from either the FP/SAL (68.7% vs 70.2%, AOR 0.89, 95% CI 0.67-1.19) or BUD/FF group (68.5% vs 69.4%, AOR 0.79, 95% CI 0.58-1.08). Noninferiority of BDP/FF in preventing COPD exacerbations was fulfilled in both comparisons. In patients without asthma, BDP/FF was also noninferior to BUD/FF (proportion with COPD exacerbations, 67.8% vs 64.7%, AOR 0.79, 95% CI 0.51-1.1997). Additionally, a significantly lower proportion of patients prescribed BDP/FF had COPD exacerbations than FP/SAL (64.8% vs 73.7%, AOR 0.64 95% CI 0.43-0.96). Conclusion: Initiating ICS/LABA treatment of COPD with extrafine-formulation BDP/FF was noninferior in preventing moderate/severe exacerbations compared to FP/SAL and BUD/FF.

Diagnostic spirometry in primary care: Proposed standards for general practice compliant with American Thoracic Society and European Respiratory Society recommendations: a General Practice Airways Group (GPIAG)1 document, in association with the Association for Respiratory Technology & Physiology (ARTP)2 and Education for Health3 1 www.gpiag.org 2 www.artp.org 3 www.educationforhealth.org.uk.

Primary care spirometry services can be provided by trained primary care staff, peripatetic specialist services, or through referral to hospital-based or laboratory spirometry. The first of these options is the focus of this Standards Document. It aims to provide detailed information for clinicians, managers and healthcare commissioners on the key areas of quality required for diagnostic spirometry in primary care--including training requirements and quality assurance. These proposals and recommendations are designed to raise the standard of spirometry and respiratory diagnosis in primary care and to provide the impetus for debate, improvement and maintenance of quality for diagnostic (rather than screening) spirometry performed in primary care. This document should therefore challenge current performance and should constitute an aspirational guide for delivery of this service.

An algorithm recommendation for the pharmacological management of allergic rhinitis in the UK: a consensus statement from an expert panel.

Allergic rhinitis is a frequent presenting problem in primary care in the UK, and has increased in prevalence over the last 30 years. When symptomatic, patients report significant reduction in their quality of life and impairment in school and work performance. Achieving adequate symptom control is pivotal to successful allergic rhinitis management, and relies mostly on pharmacotherapy. While it is recognised that most mild-moderate allergic rhinitis symptoms can be managed successfully in primary care, important gaps in general practitioner training in relation to allergic rhinitis have been identified. With the availability of new effective combination therapies, such as the novel intranasal formulation of azelastine hydrochloride and fluticasone propionate in a single device (Dymista®; Meda), the majority of allergic rhinitis symptoms can be treated in the primary care setting. The primary objective of this consensus statement is to improve diagnosis and treatment of allergic rhinitis in primary care, and offer guidance on appropriate referral of difficult-to-treat patients into secondary care. The guidance provided herein outlines a sequential treatment pathway for allergic rhinitis in primary care that incorporates a considered approach to improve the management of allergic rhinitis symptoms and improve compliance and patient satisfaction with therapy. Adherence with this care pathway has the potential to limit the cost of providing effective allergic rhinitis management in the UK by avoiding unnecessary treatments and investigations, and avoiding the need for costly referrals to secondary care in the majority of allergic rhinitis cases. The fundamentals presented in this consensus article should apply in most health-care settings.

Initiating or changing to a fixed-dose combination of Fluticasone propionate/Formoterol over Fluticasone propionate/Salmeterol: A real-life effectiveness and cost impact evaluation.

OBJECTIVE: Asthma has a substantial impact on quality of life and health care resources. The identification of a more cost-effective, yet equally efficacious, treatment could positively influence the economic burden of this disease. Fluticasone propionate/Formoterol (FP/FOR) may be as effective as Fluticasone Salmeterol (FP/SAL). We evaluated non-inferiority of asthma control in terms of the proportion of patients free from exacerbations, and conducted a cost impact analysis. METHODS: This historical, matched cohort database study evaluated two treatment groups in the Optimum Patient Care Research Database in the UK: 1) an FP/FOR cohort of patients initiating treatment with FP/FOR or changing from FP/SAL to FP/FOR and; 2) an FP/SAL cohort comprising patients initiating, or remaining on FP/SAL pMDI combination therapy. The main outcome evaluated non-inferiority of effectiveness (defined as prevention of severe exacerbations, lower limit of the 95% confidence interval (CI) of the mean difference between groups in patient proportions with no exacerbations is -3.5% or higher) in patients treated with FP/FOR versus FP/SAL. RESULTS: After matching 1:3, we studied a total of 2472 patients: 618 in the FP/FOR cohort (174 patients initiated on FP/FOR and 444 patients changed to FP/FOR) and 1854 in the FP/SAL cohort (522 patients initiated FP/SAL and 1332 continued FP/SAL). The percentage of patients prescribed FP/FOR met non-inferiority as the adjusted mean difference in proportion of no severe exacerbations (95%CI) was 0.008 (-0.032, 0.047) between the two cohorts. No other significant differences were observed except acute respiratory event rates, which were lower for patients prescribed FP/FOR (rate ratio [RR] 0.82, 95% CI 0.71, 0.94). CONCLUSIONS: Changing to, or initiating FP/FOR combination therapy, is associated with a non-inferior proportion of patients who are severe exacerbation-free at a lower average annual cost compared with continuing or initiating treatment with FP/SAL.

Lessons learnt from a primary care asthma improvement project.

Asthma is a very common disease that can occur at any age. In the UK and in many other countries it is mainly managed in primary care. The published evidence suggests that the key to improving diagnosis and management lies in better training and education rather than in the discovery of new medications. An asthma improvement project managed through the British Lung Foundation is attempting to do this. The project has three pilot sites: two in England supported by the Department of Health and one in Scotland supported by the Scottish Government. If the project is successful it will be rolled out to other health areas within the UK. The results of this project are not yet available. This article highlights the challenges encountered in setting up the project and may well be applicable to other areas in the UK and to other countries where similar healthcare systems exist. The encountered challenges reflect the complex nature of healthcare systems and electronic data capture in primary care. We discuss the differences between general practices in their ability and willingness to support the project, the training and education of their staff on asthma management, governance issues in relation to information technology systems, and the quality of data capture. Virtually all the challenges have now been overcome, but discussing them should ensure that others become aware of them at an early stage should they wish to undertake similar projects in the future.

Patient insight into the impact of chronic obstructive pulmonary disease in the morning: an internet survey.

OBJECTIVE: To determine diurnal variability of symptoms in chronic obstructive pulmonary disease (COPD) and to assess the impact of COPD upon patients' morning activities and routines. RESEARCH DESIGN AND METHODS: Quantitative internet interviews with 803 COPD patients from Europe and the USA, including 289 patients with severe COPD. Severe COPD was defined according to regular use of COPD medication, third level of breathlessness or above using the modified Medical Research Council (MRC) dyspnoea scale (MRC dyspnoea score > or =3) and one or more COPD exacerbations in the preceding 12 months. RESULTS: Morning was the worst time of day for COPD symptoms, particularly in patients with severe COPD (reported by 46% of severe patients). In these patients, shortness of breath was the most frequently reported symptom, correlating strongly with problems experienced with morning activities. Morning activities most affected by COPD were walking up and down stairs, putting on shoes and socks, making the bed, dressing, showering or bathing and drying. The majority of patients were not taking their medication in time for it to exert its optimal effect. CONCLUSIONS: Many patients consider the impact of COPD on morning activities to be substantial. Physicians should question patients about morning activities to assess disease impact and to advise regarding the optimal time to use therapy. This was an internet-based questionnaire survey and possible bias in patient selection and self-reported diagnosis of COPD and its severity should be taken into account.

Summary of the 2008 BTS/SIGN British Guideline on the management of asthma.

The 2008 BTS/SIGN British Guideline on the management of asthma provides comprehensive updated evidence-based guidance on asthma management for healthcare professionals. This primary care-focussed summary has been produced to aid dissemination and implementation of the key guideline messages into primary care. The section on diagnosis emphasises the new integrated symptom-based approach with clinicians using their deductive skills to determine the probability that the patient has asthma. The various tools used for monitoring asthma are discussed. There are sections on both non-pharmacological and pharmacological management of chronic asthma in adults and children. Treatment options for children are subdivided into the under-5s and children aged 5-12 years. Poor asthma control is manifested by exacerbations and acute asthma. Personalised asthma action plans for guided self management should be provided and used when levels of asthma control change. There are sections on difficult asthma and the treatment of exacerbations and acute severe asthma. Various outcome measures for auditing the quality of asthma care are discussed.