Management of stable chronic obstructive pulmonary disease in primary and secondary care: summary of updated NICE guidanceBMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c3134 (Published 25 June 2010) Cite this as: BMJ 2010;340:c3134
- John O’Reilly, consultant physician 1,
- Melvyn M Jones, senior lecturer2, general practitioner3,
- Jill Parnham, operations director4,
- Kate Lovibond, senior health economist4,
- Michael Rudolf, consultant physician5
- on behalf of the Guideline Development Group
- 1Aintree University Hospital, Liverpool L9 7AL
- 2University College London Medical School Department of Primary Care and Population Health, London N19 5LW
- 3Warden Lodge Surgery, Cheshunt EN8 8NW
- 4National Clinical Guideline Centre, Royal College of Physicians of London, London NW1 4LE
- 5Ealing Hospital NHS Trust, Ealing UB1 3HW
- Correspondence to:
Over three million people in the United Kingdom are estimated to have chronic obstructive pulmonary disease (COPD), of whom more than two million remain undiagnosed, representing the so called “missing millions” alluded to in the draft national strategy for COPD.1 2 3 This article summarises the most recent recommendations from the National Institute for Health and Clinical Excellence (NICE) on the management of stable chronic obstructive pulmonary disease in primary and secondary care,4 which update the COPD guidelines first published by NICE in 2004.5 The summary contains the most important recommendations relating to new diagnostic criteria for COPD, changes to the classification of severity of airflow obstruction, the need for multidimensional severity assessment, a new algorithm for inhaled drug treatments (figure⇓), and the value of early pulmonary rehabilitation.
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 updated recommendations are given in italic in square brackets.
Consider a diagnosis of COPD in patients aged over 35 years who have a risk factor (generally smoking) and present with exertional breathlessness, chronic cough, regular sputum production, frequent winter “bronchitis” or wheeze.
Measure post-bronchodilator spirometry to confirm the diagnosis of COPD. (Updated recommendation.) [Based on observational studies and the experience and opinion of the Guideline Development Group (GDG)]
Consider alternative diagnoses or investigations in:
-Older people without typical symptoms of COPD where the ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) is <0.7
-Younger people with symptoms of COPD where the FEV1/FVC ratio is ≥0.7.
(Updated recommendation.) [Based on observational studies and the experience and opinion of the GDG]
Assess the severity of airflow obstruction according to the reduction in FEV1 as shown in table 1⇓. (Updated recommendation.) [Based on the experience and opinion of the GDG] This classification of severity of airflow obstruction is now aligned with other international guidelines6 7; it refers only to the severity of airflow obstruction and not the clinical severity of COPD, for which a more comprehensive assessment is necessary.
Disability related to COPD can be poorly reflected in the FEV1. A more comprehensive assessment of severity includes the degree of airflow obstruction and disability, the frequency of exacerbations, and the following known prognostic factors: breathlessness (Medical Research Council dyspnoea scale (table 2⇓), health status, body mass index, cor pulmonale, FEV1, exercise capacity (for example, six minute walking test—usually only available in secondary care), transfer factor for carbon monoxide (usually only available in secondary care), and partial pressure of oxygen in arterial blood (usually only available in secondary care). Calculate the BODE index (body mass index, airflow obstruction (FEV1 % predicted), dyspnoea, and exercise capacity (six minute walking distance, usually not available in primary care)9) to assess prognosis where its component information is currently available. (Updated recommendation.) [Based on observational studies and the experience and opinion of the GDG]
Refer for specialist advice when clinically indicated. This may be appropriate at all stages of the disease and not only in the most severely disabled patients. Indications include diagnostic uncertainty, rapidly changing disease (both on spirometry and in symptoms), and onset of complications such as cor pulmonale (see full guidance for detailed table).
Encourage all patients with COPD who are still smoking to stop, regardless of age; offer help to do so, at every opportunity
Unless contraindicated, offer nicotine replacement therapy (varenicline or bupropion, as appropriate) to patients with COPD who are planning to stop smoking, together with an appropriate support programme to optimise smoking quit rates. (Updated recommendation.) [Based on NICE guidelines PH10 and TA12310 11 ]
Promoting effective inhaled therapy
A new clinical algorithm provides an evidence based rationale for the sequencing of inhaled drugs used singly and in combination according to persistence of symptoms, exacerbations, and severity of airflow obstruction (figure⇑) and clarifies options for escalating inhaled treatment according to whether FEV1 is above or below 50%. (Updated recommendation.) [Based on very low to moderate quality evidence from randomised controlled trials, cost effectiveness evidence, and the experience and opinion of the GDG]
Be aware of the potential risk of developing side effects (including non-fatal pneumonia) in people with COPD treated with inhaled corticosteroids and be prepared to discuss with patients. (Updated recommendation.) [Based on very low to moderate quality evidence from randomised controlled trials]
Providing pulmonary rehabilitation
Make pulmonary rehabilitation available to all appropriate people with COPD (see below), including those who have had a recent hospital admission for an acute exacerbation. (Updated recommendation.) [Based on very low to low quality evidence from randomised controlled trials]
Offer pulmonary rehabilitation to all patients who consider themselves functionally disabled by COPD (usually Medical Research Council grade 3 and above (table 2⇑)). Pulmonary rehabilitation is not suitable for patients who are unable to walk, have unstable angina, or had a recent myocardial infarction.
Management of exacerbations and use of non-invasive ventilation
Recommendations on management of exacerbations and use of non-invasive ventilation were not included in the scope of the update and so remain unchanged from the 2004 guideline, except where considered necessary for consistency with other recent specific guidelines (for example, the British Thoracic Society’s guideline for emergency oxygen use in adult patients12).
Age related interpretation of spirometry and its relation to clinical severity assessment may be a challenge for some non-specialists; this will require education and training. Measurement of post-bronchodilator spirometry is likely to result in minimal increase in resource use as reversibility testing (which is not recommended in the guideline) is currently undertaken to fulfil Quality Outcome Framework criteria. Realigning severity of airflow obstruction to agree with other international guidelines will lead to some patients having their severity stage reclassified; patients will need reassurance that their clinical condition, need for appropriate treatment, and prognosis all remain unchanged.6 7 There is a potential economic impact of stronger new recommendations on inhaled therapies. In people with mild COPD the primary course of action is to encourage smoking cessation. Other treatments, recommended only when symptoms persist and/or when needed to prevent exacerbations, become more cost effective as the severity of disease progresses.
Further information on the guidance
This guidance update was prompted by concerns that practice might vary in use of diagnostic criteria for chronic obstructive pulmonary disease (COPD), use of pre-bronchodilator and post-bronchodilator spirometry, different severity classifications for airflow obstruction, use of inhaled drug treatments, and prescription of oral mucolytic drugs to prevent exacerbations.
Evidence statements in this summary relate to the guideline update. Quality ratings were based on GRADE methodology (www.gradeworkinggroup.org). These relate to the quality of the available evidence for assessed outcomes rather than the quality of the clinical study. Outcomes assessed included exacerbations, mortality, admissions to hospital, decline in forced expiratory volume in one second (FEV1), health related quality of life, adverse events, and breathlessness.
The guideline was developed according to NICE guideline development methods (www.nice.org.uk/aboutnice/howwework/developingniceclinicalguidelines/developing_nice_clinical_guidelines.jsp). This involved systematic searching, critically appraising, and summarising the clinical and cost effectiveness evidence. New cost effectiveness analysis was also undertaken, comparing a long acting muscarinic antagonist (LAMA), a long acting beta agonist (LABA) plus inhaled corticosteroid (ICS), and triple therapy (LAMA+LABA+ICS) as initial treatment options in people with COPD and an FEV1 <50%. A multidisciplinary guideline development group (GDG) comprising healthcare professionals from primary and secondary care and patient representatives discussed the evidence and formulated clinical recommendations. The guideline went through an external consultation with stakeholders. The GDG assessed the comments, reanalysed the data where necessary, and modified the guideline. Key priorities were identified for implementation and will form the basis of NICE national quality standards for COPD.
NICE has produced four different versions of the guideline: a full version; a quick reference guide; a version known as the “NICE guideline” that summarises the recommendations; and a version for patients and the public. All these versions are available from the NICE website (http://guidance.nice.org.uk/CG101).
Assessing severity of COPD
Continuing advice to use a “fixed ratio” FEV1/FVC in spirometry rather than a lower limit of normal may overestimate COPD in older individuals and underestimate it in young adults, but remains more practical and easy to apply and avoids the need to use reference equations, which are not validated for some ethnic populations.13 14 15 16 17 Clinical skills are paramount in interpreting spirometry, particularly in assessing patients with symptoms suggesting COPD and asymptomatic people identified by screening spirometry.18 19 20
The updated guidance recommends long acting muscarinic antagonists rather than regular short acting muscarinic antagonists (SAMAs) in maintenance therapy on the basis of clinical and cost effectiveness evidence—a change from the previous guideline, in which both were options.
The use of an inhaled corticosteroid is recommended only in a combination inhaler with a long acting muscarinic antagonist. The clinical and cost effectiveness evidence for the use of LABA+ICS over LABA was strong in people with severe or very severe airflow obstruction (FEV1 <50%). Evidence was weaker in those with mild or moderate airflow obstruction (FEV1 ≥50), leading to a weaker recommendation only to consider LABA+ICS treatment if symptoms persisted with LABA alone. This must, however, clearly be prescribed within the drug licence.
Limited evidence for addition of LABA+ICS in those who are still symptomatic despite taking LAMA alone led to a recommendation only to consider triple therapy in this situation. The recommendation to offer LAMA in addition to LABA+ICS (triple therapy) to people with COPD who remain breathless or have exacerbations despite taking LABA+ICS, irrespective of their FEV1, was based on stronger clinical evidence.
Do not routinely use mucolytic drugs to prevent exacerbations in people with stable COPD. The guidelines give clear guidance on avoiding possible inappropriate use of mucolytics in the absence of a robust evidence base, as the different study outcomes reflect differences in patient populations and background treatments.
On the basis of its review of evidence, the GDG has made the following research recommendations to improve NICE guidance and patient care in the future. More information about why these were considered important is available in the full guideline.
In people with COPD does pulmonary rehabilitation during hospital admission for exacerbation and/or in the early recovery period (within one month of an exacerbation) improve quality of life and reduce admissions to hospital and exacerbations compared with a later (defined as after one month) pulmonary rehabilitation programme?
Could a simple multidimensional assessment be used to give a better indication of COPD outcomes than either FEV1 or other components measured alone in a wide range of patients with COPD, and would it be applicable in a primary care setting?
In people with COPD, does triple therapy (LABA, LAMA, and ICS) lead to better outcomes than single therapy (LAMA or LABA) or double therapy (LABA and ICS)?
In people with COPD, does mucolytic drug therapy prevent exacerbations in comparison with placebo and other therapies?
Cite this as: BMJ 2010;340:c3134
This is one of a series of BMJ summaries of new guidelines based on the best available evidence; they highlight important recommendations for clinical practice, especially where uncertainty or controversy exists.
The members of the Guideline Development Group are Christine Loveridge, Jadwiga Wedzicha, Karen Heslop, Katherine Leach, Kevin Gruffydd-Jones, Margaret Barnard, Melvyn M Jones, Peter Calverley, Phyo Myint, Sally Singh, Michael Rudolf, Bernard Higgins, John O’Reilly, Emily Crowe, Kate Lovibond, Jill Parnham, Lina Gulhane, Katrina Sparrow, and Celia Pincus; an invited expert, David Halpin, advised the group.
Contributors: JO’R drafted the article and is the guarantor. All authors revised the draft article critically for important intellectual content and approved the final version to be published.
Funding: The National Clinical Guideline Centre was commissioned and funded by the National Institute for Health and Clinical Excellence to write this summary.
Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: (1) all authors have no financial support for the submitted work from anyone other than their employer; (2) in the previous three years JO’R has received honorariums for lectures at educational meetings and support for travel and accommodation to attend educational conferences from Boehringer Ingelheim, TEVA, GSK, AstraZeneca, Cephalon, UCB, and Respironics. MR has received honorariums for lectures at educational meetings and support for travel and accommodation to attend educational conferences from Astra Zeneca, GSK, Pfizer, Novartis, MSD, Boehringer Ingelheim, and TEVA. KL worked for Medaxial before April 2008; JP received NICE funding for the guideline; (3) MMJ’s spouse has reported computed tomography scans for a GSK trial in chronic obstructive pulmonary disease but received no direct financial benefit and she has also received payment from Pfizer for presenting at an educational meeting on fungal infection; and (4) All authors were members of the Guideline Development Group for the NICE guideline (JO’R the clinical adviser, MMJ a GDG member, KL the senior health economist, JP the operations director, and MR the chair).
Provenance and peer review: Commissioned; not externally peer reviewed.