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A further step in the process of developing better service and standards of care for patients with COPD
The full version of the new NICE guidelines on the management of chronic obstructive pulmonary disease (COPD) is published as a supplement to this issue of Thorax.1 These guidelines have been developed for the National Institute for Clinical Excellence (NICE) by the National Collaborating Centre for Chronic Conditions (NCC-CC) based at the Royal College of Physicians, London with the involvement of many members of the British Thoracic Society (BTS). The Guideline Development Group and Consensus Reference Group involved in the production of the guidelines included members with diverse professional backgrounds and, crucially, also included patient representatives. The scope of the guidelines is wide. They address the diagnosis and assessment of people with COPD as well as the pharmacological and non-pharmacological management of stable disease and exacerbations.
With the recent update to the GOLD guidelines2 and the forthcoming publication of joint guidelines by the American Thoracic Society (ATS) and the European Respiratory Society (ERS), the need for new British guidelines could be questioned. I have no doubt that there is a role for these guidelines as they address issues such as pulmonary rehabilitation from a British perspective and, most importantly, are truly evidence-based. Moreover, in the absence of a National Service Framework for respiratory medicine, and the reality that such a framework is unlikely to be introduced in the near future, these NICE guidelines offer the best hope of raising the standards of care of this common disabling chronic disease.
The key issues for practising clinicians are:
What is new in these guidelines?
How do they relate to other international guidelines?
Significant changes in practice have evolved since the BTS guidelines on the management of COPD were published in 1997,3 and more evidence is available about the effects of treatments such as inhaled steroids and long acting bronchodilators. The guidelines also make updated recommendations on the diagnosis and assessment of COPD. This was one of the areas that received most comments during the two stage consultation process during guideline development.
DIAGNOSIS AND ASSESSMENT OF COPD
The guidelines make the bold statement that, in most cases, the diagnosis of COPD can be made on the basis of a good history with confirmation of the presence of airflow limitation using spirometry. They do not recommend assessment of the change in forced expiratory volume in 1 second (FEV1) in response to a single dose of an inhaled bronchodilator or a short course of oral or inhaled corticosteroids. A belief has emerged that the results of such an assessment made on a single occasion can categorically distinguish COPD from asthma. Moreover, it is believed that by making this measurement it is possible to identify a significant number of patients who have asthma, but who would otherwise be condemned to the diagnostic and therapeutic ignominy of being misdiagnosed as having COPD. It has also been thought that the results of such a measurement can be used to predict the long term response to treatment. There are undoubtedly a few patients in whom the history will not be clear cut and in whom a large change in FEV1 may help to identify a reversible component (an absolute change in FEV1 of 400 ml is suggested as the discriminator). The principal objection to our recommendation is that, unless the test is done in everyone, patients showing such a response will still be missed. There are a number of problems with such an approach. The distribution of changes in FEV1 following a single dose of a bronchodilator is normally distributed.4 It is not bimodal and any cut off used to distinguish two subgroups is therefore entirely arbitrary. Furthermore, we know that, if the measurement is repeated on different occasions, different results may be obtained.5 Finally, depending on the agent used to produce the change in FEV1—for example, salbutamol from a metered dose inhaler, nebulised salbutamol, or oral corticosteroids—different responses may be produced.6 The new ATS/ERS guidelines also recognise these limitations and do not advocate assessing the response to a single dose of a bronchodilator or a short course of corticosteroids as part of the diagnostic process, and the next revision of the GOLD guidelines will also dispense with this approach (personal communication, P M A Calverley). There is good evidence that the response to a single dose of a bronchodilator or short courses of corticosteroids has no bearing on the long term response to treatment.
The guidelines do recognise that there may be a very few patients who appear to have COPD on the basis of the history but who show significant clinical responses to inhaled therapy. In these patients it is important to review the diagnosis and this we believe constitutes a much more meaningful “reversibility test”. The results of this review of response to treatment forms part of the diagnostic process and we believe fulfils the quality marker in the new general practice contract in the UK.
MANAGEMENT OF COPD
The guidelines have moved away from the linear approach to COPD management embodied in the “escalator” presented in the 1997 BTS guidelines. We recognise that COPD is a heterogeneous condition that affects patients in different ways, and that a patient centred approach to their management is required rather than a unidirectional stepwise approach. This may appear more complicated on paper but is simple to apply in practice and is necessary to achieve optimal control of symptoms. There are still no validated severity assessment tools that encompass the multidimensional nature of the disease, and we therefore continue to recommend using FEV1 as a percentage of the predicted as a marker of the severity of airflow obstruction, but acknowledge that this may not reflect the impact of the disease in that individual. We have changed the FEV1 cut off points and these now match those in the updated GOLD and new ATS/ERS guidelines, although the terminology is slightly different: an FEV1 of 50–80% predicted constitutes mild airflow obstruction, 30–49% moderate airflow obstruction, and <30% severe airflow obstruction.
Extensive literature searching and professional systematic reviewing was used to assess the evidence base for treatment. The biggest areas of change from the previous BTS guidelines concern the use of long acting bronchodilators, inhaled corticosteroids, and mucolytic therapy. There is now persuasive evidence of benefit from the use of long acting bronchodilators, both β2 agonists and anticholinergic agents, and their use is recommended in patients who remain symptomatic despite the use of short acting bronchodilators. We recommend that the criteria for their use and the assessment of their benefits should not depend solely on lung function changes but should include simple questions about changes in symptoms, exercise tolerance, and quality of life.
We believe that the role of inhaled corticosteroids has also become clearer and recommend that they should be used in patients with an FEV1 <50% predicted and a history of two or more exacerbations in the previous year in an attempt to reduce the future exacerbation rate. In these circumstances they will generally be used in combination with a long acting bronchodilator. This remains a highly complex and somewhat controversial area where approaches to data analysis are still evolving. Hopefully, by the time of the next guideline revision, these issues will have been resolved. Mortality data from prospective randomised trials of these treatments that are currently in progress should help us to interpret these findings clinically and, if necessary, to revise our recommendations.
Despite widespread use in Europe, mucolytic therapy has not been used in the UK and, until early last year, mucolytic drugs were “black listed” in the NHS. There is good evidence for their efficacy in reducing exacerbations and improving symptoms in patients with chronic bronchitis and some direct evidence of benefit in patients with COPD. We believe that they should be tried in patients with a chronic cough productive of sputum and, if clinical benefit is observed, they should be continued.
The guidelines recognise the importance of multidisciplinary approaches to the management of COPD. Pulmonary rehabilitation is rightly recommended for all patients who are disabled by COPD, and we hope that this may facilitate the universal provision of pulmonary rehabilitation programmes. Hospital at home and assisted discharge schemes are also new approaches to the management of exacerbations of COPD. These schemes appear to work and relieve pressure on hospital beds, and are recommended where local circumstances require. NICE guidelines do not make recommendations about how services should be provided and organised: these are matters for local clinicians and commissioners, but the needs for the services are clearly delineated.
The recommendations on oxygen therapy in COPD are largely in line with those contained in the Royal College of Physicians report commissioned by the Department of Health.7 The Department has recently signalled its intention to review the provision of oxygen services. The final conclusions of this review were not known at the time that the recommendations were finalised, but we have no reason to believe that the conclusions will conflict with the recommendations contained in these guidelines. We understand that they are likely to focus on the process of assessing and prescribing oxygen rather than the criteria for deciding who needs oxygen therapy.
Exacerbations are now recognised as key events in the natural history of COPD and appropriate emphasis is given to their prevention and management. Non-invasive ventilation has been shown to be the treatment of choice for episodes of respiratory failure associated with exacerbations and its use is recommended. Again, it is hoped that this will facilitate the universal provision of such services.
We hope that these guidelines will help encourage clinicians to manage COPD better. Unlike the recent BTS/SIGN asthma guidelines8 which provide evidence to support management strategies already in widespread use, there is a lot that is new in these COPD guidelines that is not happening in practice at present but which will hopefully become universal over the next few years. The Guideline Development Group has identified seven key priorities for implementation—areas where it was felt that recommendations were likely to have the biggest impact on the management of COPD. These key priorities cover:
diagnosis of COPD;
effective inhaled treatment;
use of non-invasive ventilation for exacerbations;
effective prevention and management of exacerbations; and
importance of multidisciplinary working.
The BTS COPD Consortium will be working to ensure that the key messages contained in the guideline reach all relevant health professionals. As NICE guidelines, the recommendations also reach health commissioners who will be expected to respond and implement the guidance. Let us hope that this is a further significant step in the process of developing better service and standards of care for patients with respiratory diseases.
A further step in the process of developing better service and standards of care for patients with COPD
Declaration of competing interests
David Halpin has received sponsorship from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Pfizer & Schering Plough to attend national and international meetings, and has received fees from them for speaking at educational meetings.
Declarations of competing interests for members of the Guideline Development Group may be obtained from the National Collaborating Centre for Chronic Conditions (NCC-CC) by writing to the following address:
Ms Jane Ingham
Manager Clinical Effectiveness and Evaluation Unit and National Collaborating Centre for Chronic Conditions
Royal College of Physicians
11 St Andrew's Place
London W1A 4LE
Tel: +44 (0)20 7935 1174
Fax: +44 (0)20 7487 3988
Declarations of interest for members of the Guideline Development Group are available from the NCC-CC.