Iain Small

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.

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.

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 β2-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.

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.

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.

Practical approach to managing exercise-induced asthma in children and adults.

with asthma made worse by exercise, which is a common phenomenon. However, true exercise-induced asthma, where symptoms only occur in response to physical activity, is relatively uncommon. The mistake to make in this consultation would be to concentrate exclusively on the exercise-induced symptoms whereas, in reality, the situation encompasses many of the important general themes that are current in asthma care across most societies. Firstly, this is a call to return to the basics of asthma management. If her asthma hasn’t been reviewed for 18 months, then she had a diagnosis made when she was no older than 81/2 years of age. Although there is published evidence that spirometry can be accurately assessed from age 5 years onward, in real-life practice objective measurement of lung function using spirometry or peak expiratory flow (PEF) monitoring is difficult in young children. It is worth reviewing how the diagnosis was made – whether she had a positive response to treatment that was sustained over time, and whether withdrawal of her inhaled corticosteroid (ICS) led to a return of symptoms. In addition, family and personal history of atopy, and the presence of characteristic diurnal symptoms, any deterioration in response to viral, irritant or allergic triggers, and the presence of high pitched rhonchi (or wheeze) on auscultation whilst symptomatic would be useful pointers to a diagnosis of asthma. In addition to reviewing the diagnosis, this consultation is an opportunity to check both her concordance with therapy (cross referencing her statements with her prescription records) and her inhaler technique. The clinical difficulty now is that our patient is established on regular ICS therapy, making it much more difficult to demonstrate obstructive lung function or diurnal variation, or indeed a fall in PEF in response to triggers. Nonetheless, she should be taught how to use a PEF meter, checking her technique and her understanding of how to document the result, and she should be asked to keep a record for a minimum of two weeks, including not only morning and evening pre-bronchodilator recordings, but also any recordings when symptomatic, particularly relating to exercise. Ideally we should obtain a post-bronchodilator (20-30 minutes) reading following on from an exercise-induced fall in value. A change of 12% would be significant, although it is worth noting that a failure to bronchodilate does not exclude asthma. Another way of establishing exercise-induced symptoms and bronchoconstriction would be to arrange a supervised exercise session (for example in the surgery or pulmonary function laboratory), using either a simple step, or the more complex incremental shuttle walk/run. Ideally, this should take place in a safe environment, where a deterioration in the girl’s condition can be monitored and treated. Breathing cold air (never difficult to arrange in the North East of Scotland!) is likely to result in even more effective bronchoconstriction. Ninety percent of people with asthma are affected by exercise, and exercise induces asthma symptoms in 35-45% of people with allergic rhinitis. Even when these two patient groups are excluded, however, there is still a 3-10% incidence of exercise-induced asthma in the general population. This distinction is important when it comes to treatment. In a true case of isolated exercise-induced asthma, it is reasonable to prescribe only a short acting β2-agonist, taken (where possible) in anticipation of the event, or to relieve symptoms. Where more conventional asthma is being triggered by exercise, a formal assessment of asthma control using a validated tool such as the Children’s Asthma Control Test will help guide treatment choices. Exercise bronchodilation can then be superimposed onto this regime. In our patient, there may be a role for giving her a long-acting

Standards for diagnostic spirometry within-session repeatability in primary care

Dear Sirs, We were very interested to read the correspondence from GruffyddJones et al. in the most recent issue of the PCRJ. We thank them for their request that we should provide further clarification regarding within-session repeatability when performing diagnostic spirometry. The 2009 Spirometry Standards document to which they refer recommended 150 ml as the limit for within-session repeatability for FEV1 and FVC, in accordance with American Thoracic Society (ATS) and European Respiratory Society (ERS) standards. Gruffydd-Jones et al. favour a target of 100 ml. However, apart from reference to previous correspondence from Fletcher and Loveridge (citing a sample of 10 subjects), and Cooper, they provide no published evidence to support their opinion. The ATS/ERS guidelines have not been updated (the 150 ml limit remains current), nor has there been an update to the British Thoracic Society (BTS)/Association for Respiratory Technology and Physiology (ARTP) guideline published in 1994 which suggested 100 ml. Nevertheless, we note that Gruffydd-Jones et al. point out that the GOLD guideline recommendation in 2011 moved to 100 ml. We have followed-up this point. In fact, this is apparently a typing error (personal communication from Jorgen Vestbo, Chair GOLD Science Committee); on page 12, the guidance suggests “5% or 100 mL whichever is the greater”. In effect, if the patient has an FEV1 or FVC of more than 2 litres the 5% guidance takes precedence and makes the 100 ml reading redundant. In primary care we aim to achieve comparable standards to our specialist colleagues. Ferguson et al., in their consensus statement from the National Lung Health Education Program (NLHEP), suggested a rating system (A-F) for assessing quality of spirometry. Grades A and B required a minimum difference of 100 and 101-150 ml respectively, with Grade C requiring 151-200 ml difference between the best two FEV1 and FVC readings. Grade D required only one acceptable manoeuvre but with FEV1 values within 200 ml, and Grade F signified no acceptable manoeuvres. Three recent publications have utilised a similar quality control grading system, involving over 55,000 spirometry tests by specialists and in primary care, and demonstrate quite clearly that the 100 ml limit suggested by Gruffydd-Jones and colleagues is unrealistic. Enright et al. studied 13,599 good quality spirometry tests by specialists at the World Trade Center, 80% of which achieved grade A and B standards (within 200 ml). Leuppi et al. considered 29,817 consecutive spirometry tests that had taken place in primary care and found that 41% achieved grade A and B (within 200 ml) and 11.8% had the lowest grade F. Finally, recently published data from the European Spirometry Tent performed at ERS meetings, which reported on 12,448 tests of which 10,395 (83.5%) were termed acceptable (only grade F rejected), showed that the overall standard for grade A and B in this specialist environment was 30.8% (with the best results being undertaken in 2004 in Glasgow, but still only achieving 51.4%). As the available evidence suggests that our specialist colleagues find it difficult to achieve repeatability within 200 ml in 50% of tests, it is inappropriate to suggest setting a 100 ml standard for within-session repeatability in general practice. We therefore maintain our recommendation – i.e. that spirometry within-session repeatability should be within 150 ml in keeping with ATS/ERS guidance, until justified by evidence from specialists to the contrary. However, we strongly support efforts like the European Spirometry Driving License project aimed at improving standards of measurements, which will in the future enable the adoption of stricter quality criteria in general as well as in specialist practice, and we look forward to the publication of high quality evidence demonstrating that this level of measurement is achievable.

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.

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. AATD remains markedly underdiagnosed in COPD patients and case-finding strategies for both conditions should be implemented http://ow.ly/wXK830k3RNf

AB041. Effectiveness and cost impact evaluation of fluticasone propionate/formoterol compared to fluticasone propionate/salmeterol

Background Treatment of asthmatics with an inhaled corticosteroid (ICS) and long-acting beta agonist (LABA) is recommended for maintenance treatment according to Step 3 in the GINA guidelines. Fixed-dose combination (FDC) inhalers simplify the dosing regimen and may improve adherence over their separate components. However, the effectiveness and cost impact of FDC devices containing fluticasone propionate/formoterol (FP/FOR) compared to fluticasone/salmeterol (FP/SAL) in asthma patients who initiate or switch to FDC ICS/LABA inhalers have not been studied in real-life patients in the United Kingdom. To determine whether FP/FOR is non-inferior to FP/SAL in patients who initiate or switch to a FDC ICS/LABA therapy with respect to decreasing the occurrence of asthma exacerbations and overall cost impact.