Print a4_clinical_guideline_template

Chronic obstructive pulmonary
disease
Management of chronic obstructive pulmonary
disease in adults in primary and secondary care
Clinical Guideline 12
February 2004
Developed by the National Collaborating Centre forChronic Conditions Clinical Guideline 12
Chronic obstructive pulmonary disease
Management of chronic obstructive pulmonary disease in adults in primary and secondary care
Issue date: February 2004
This document, which contains the Institute's full guidance on the management of chronicobstructive pulmonary disease in adults, is available from the NICE website(www.nice.org.uk/CG012NICEguideline).
An abridged version of this guidance (a 'quick reference guide') is also available from the NICEwebsite (www.nice.org.uk/CG012quickrefguide). Printed copies of the quick reference guide canbe obtained from the NHS Response Line: telephone 0870 1555 455 and quote reference numberN0462.
Information for the Public is available from the NICE website or from the NHS Response Line(quote reference number N0463 for a version in English and N0464 for a version in English andWelsh).
The quick reference guide for this guideline has been distributed to the following: • Respiratory nurse specialists in England and • NHS trust chief executives in England and Wales • Clinical governance leads in England and Wales • Senior pharmacists and pharmaceutical advisors • Medical and nursing directors in England and • Senior health visitors, practice nurses and • NHS trust, PCT and LHB libraries in England and • Strategic health authority chief executives in • Consultants in occupational health medicine in • Directors of directorates of health and social • Consultants in rehabilitation medicine in • Chief Executive of the NHS in England • Consultants in respiratory medicine in England • Consultants in elderly care in England and • Clinical directors for physiotherapy in England • Chief Medical, Nursing and Pharmaceutical • Directorate nurse managers for occupational • Medical Director & Head of NHS Quality - Welsh • Directorate nurse managers for rehabilitation in • Representative bodies for health services, professional organisations and statutory bodies • Directorate nurse managers for respiratory This guidance is written in the following context:
This guidance represents the view of the Institute, which was arrived at after careful consideration
of the evidence available. Health professionals are expected to take it fully into account when
exercising their clinical judgement. The guidance does not, however, override the individual
responsibility of health professionals to make decisions appropriate to the circumstances of the
individual patient, in consultation with the patient and/or guardian or carer.
National Institute for
Clinical Excellence
MidCity Place71 High HolbornLondon WC1V 6NA ISBN: 1-84257-542-2Published by the National Institute for Clinical ExcellenceFebruary 2004 Copyright National Institute for Clinical Excellence, February 2004. All rights reserved. This material may be freelyreproduced for educational and not-for-profit purposes within the NHS. No reproduction by or for commercialorganisations is allowed without the express written permission of the National Institute for Clinical Excellence.
Contents
Working definition of chronic obstructive pulmonary disease
Key priorities for implementation
Guidance
Diagnosing COPD
Symptoms
Spirometry
Further investigations
Reversibility testing
Assessment of severity
Identification of early disease
Referral for specialist advice
Managing stable COPD
Smoking cessation
Inhaled bronchodilator therapy
Theophylline
Corticosteroids
Combination therapy
Delivery systems used to treat patients with
stable COPD
Non-invasive ventilation
Management of pulmonary hypertension and cor
pulmonale
1.2.10 Pulmonary rehabilitation
1.2.11 Vaccination and anti-viral therapy
1.2.12 Lung surgery
1.2.13 Alpha-1 antitrypsin replacement therapy
1.2.14 Mucolytic therapy
1.2.15 Anti-oxidant therapy
1.2.16 Anti-tussive therapy
1.2.17 Prophylactic antibiotic therapy
1.2.18 Multidisciplinary management
1.2.19 Fitness for general surgery
1.2.20 Follow up of patients with COPD
Management of exacerbations of COPD
Definition of an exacerbation
Assessment of need for hospital treatment
Investigation of an exacerbation
Hospital-at-home and assisted-discharge schemes
Pharmacological management
Oxygen therapy during exacerbations of COPD
Non-invasive ventilation and COPD exacerbations
Invasive ventilation and intensive care
Respiratory physiotherapy and exacerbations
1.3.10 Monitoring recovery from an exacerbation
1.3.11 Discharge planning
Notes on the scope of the guidance
Implementation in the NHS
In general
Research recommendations
Full guideline
Related NICE guidance
Review date
Appendix A:
Appendix B:
Appendix C:
Appendix D:
Technical detail on the criteria for audit Appendix E:
NICE Guideline – Chronic obstructive pulmonary disease Working definition of chronic obstructive
pulmonary disease
Chronic obstructive pulmonary disease (COPD) is characterised byairflow obstruction. The airflow obstruction is usually progressive,not fully reversible and does not change markedly over severalmonths. The disease is predominantly caused by smoking.
• Airflow obstruction is defined as a reduced FEV1 (forced expiratory volume in 1 second) and a reduced FEV1/FVC ratio (where FVC isforced vital capacity), such that FEV1 is less than 80% predictedand FEV1/FVC is less than 0.7. • The airflow obstruction is due to a combination of airway and • The damage is the result of chronic inflammation that differs from that seen in asthma and which is usually the result of tobaccosmoke.
• Significant airflow obstruction may be present before the • COPD produces symptoms, disability and impaired quality of life which may respond to pharmacological and other therapies thathave limited or no impact on the airflow obstruction.
• COPD is now the preferred term for the conditions in patients with airflow obstruction who were previously diagnosed as havingchronic bronchitis or emphysema.
• Other factors, particularly occupational exposures, may also contribute to the development of COPD.
There is no single diagnostic test for COPD. Making a diagnosis relieson clinical judgement based on a combination of history, physicalexamination and confirmation of the presence of airflow obstructionusing spirometry.
NICE Guideline – Chronic obstructive pulmonary disease Key priorities for implementation
The following recommendations have been identified as prioritiesfor implementation.
Diagnose COPD
• A diagnosis of COPD should be considered in patients over the age of 35 who have a risk factor (generally smoking) and whopresent with exertional breathlessness, chronic cough, regularsputum production, frequent winter ‘bronchitis’ or wheeze. Thepresence of airflow obstruction should be confirmed byperforming spirometry. • All health professionals managing patients with COPD should have access to spirometry and be competent in the interpretationof the results. Stop smoking
• Encouraging patients with COPD to stop smoking is one of the most important components of their management. All COPDpatients still smoking, regardless of age, should be encouraged tostop, and offered help to do so, at every opportunity.
Effective inhaled therapy
• Long-acting inhaled bronchodilators (beta2-agonists and/or anticholinergics) should be used to control symptoms and improveexercise capacity in patients who continue to experience problemsdespite the use of short-acting drugs.
• Inhaled corticosteroids should be added to long-acting bronchodilators to decrease exacerbation frequency in patientswith an FEV1 less than or equal to 50% predicted who have hadtwo or more exacerbations requiring treatment with antibiotics ororal corticosteroids in a 12-month period.
Pulmonary rehabilitation for all who need it
• Pulmonary rehabilitation should be made available to all NICE Guideline – Chronic obstructive pulmonary disease Use non-invasive ventilation
• Non-invasive ventilation (NIV) should be used as the treatment of choice for persistent hypercapnic ventilatory failure duringexacerbations not responding to medical therapy. It should bedelivered by staff trained in its application, experienced in its useand aware of its limitations. • When patients are started on NIV, there should be a clear plan covering what to do in the event of deterioration and ceilings oftherapy should be agreed.
Manage exacerbations
• The frequency of exacerbations should be reduced by appropriate use of inhaled corticosteroids and bronchodilators, andvaccinations. • The impact of exacerbations should be minimised by: – giving self-management advice on responding promptly to the – starting appropriate treatment with oral corticosteroids and/or – use of non-invasive ventilation when indicated– use of hospital-at-home or assisted-discharge schemes.
Multidisciplinary working
• COPD care should be delivered by a multidisciplinary team.
NICE Guideline – Chronic obstructive pulmonary disease The following guidance is evidence based. The grading scheme usedfor the recommendations (A, B, C, D, NICE or HSC) is described inAppendix A; a summary of the evidence on which the guidance isbased is provided in the full guideline (see Section 5). Guidance
Diagnosing COPD
The diagnosis of COPD depends on thinking of it as a cause ofbreathlessness or cough. The diagnosis is suspected on the basis ofsymptoms and signs and supported by spirometry. Symptoms
A diagnosis of COPD should be considered in patients over the age of 35 who have a risk factor (generally smoking)and who present with one or more of the followingsymptoms: • exertional breathlessness• chronic cough• regular sputum production• frequent winter ‘bronchitis’• wheeze.
Patients in whom a diagnosis of COPD is considered should also be asked about the presence of the following factors: • weight loss• effort intolerance• waking at night • ankle swelling• fatigue• occupational hazards• chest pain• haemoptysis.
NB These last two symptoms are uncommon in COPD andraise the possibility of an alternative diagnosis.
One of the primary symptoms of COPD is breathlessness.
The Medical Research Council (MRC) dyspnoea scale (seeTable 1) should be used to grade the breathlessnessaccording to the level of exertion required to elicit it.
NICE Guideline – Chronic obstructive pulmonary disease Grade Degree of breathlessness related to activities
Not troubled by breathlessness except on strenuous exercise Short of breath when hurrying or walking up a slight hill Walks slower than contemporaries on level ground because ofbreathlessness, or has to stop for breath when walking at own pace Stops for breath after walking about 100 m or after a few minutes onlevel ground Too breathless to leave the house, or breathless when dressing orundressing Adapted from Fletcher CM, Elmes PC, Fairbairn MB et al. (1959) The significance ofrespiratory symptoms and the diagnosis of chronic bronchitis in a workingpopulation. British Medical Journal 2:257–66.
Spirometry
• at the time of diagnosis• to reconsider the diagnosis, if patients show an exceptionally good response to treatment.
All health professionals managing patients with COPD should have access to spirometry and be competent in theinterpretation of the results.
Spirometry can be performed by any healthcare worker who has undergone appropriate training and who keepshis or her skills up to date.
Spirometry services should be supported by quality control It is recommended that ERS 1993 reference values* are used but it is recognised that these values may lead tounder-diagnosis in the elderly and are not applicable inblack and Asian populations.
* Quanjer PH, Tammeling GJ, Cotes JE et al. (1993) Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests,European Community for Steel and Coal. Official Statement of the EuropeanRespiratory Society. European Respiratory Journal (Suppl) 16:5–40.
NICE Guideline – Chronic obstructive pulmonary disease Further investigations
At the time of their initial diagnostic evaluation, in addition to spirometry all patients should have: • a chest radiograph to exclude other pathologies• a full blood count to identify anaemia or polycythaemia• body mass index (BMI) calculated. Additional investigations should be performed to aid management in some circumstances (see Table 2). Patients identified as having alpha-1 antitrypsin deficiency should be offered the opportunity to be referred to aspecialist centre to discuss the clinical management of thiscondition.
Investigation
To exclude asthma if diagnostic doubt remains If early onset, minimal smoking history or familyhistory To investigate symptoms that seem disproportionate to carbon monoxide (TLCO) the spirometric impairment To investigate symptoms that seem disproportionate tothe spirometric impairment To investigate abnormalities seen on a chestradiograph To assess cardiac status if features of cor pulmonale To assess cardiac status if features of cor pulmonale To assess need for oxygen therapyIf cyanosis, or cor pulmonale present, or if FEV1 < 50%predicted To identify organisms if sputum is persistently presentand purulent NICE Guideline – Chronic obstructive pulmonary disease Reversibility testing
In most patients, routine spirometric reversibility testing is not necessary as a part of the diagnostic process or to planinitial therapy with bronchodilators or corticosteroids. Itmay be unhelpful or misleading because: • repeated FEV1 measurements can show small • the results of a reversibility test performed on different occasions can be inconsistent and not reproducible • over-reliance on a single reversibility test may be misleading unless the change in FEV1 is greater than400 ml • the definition of the magnitude of a significant change • response to long-term therapy is not predicted by acute COPD and asthma are frequently distinguishable on the basis of history (and examination) in untreated patientspresenting for the first time. Features from the history andexamination (such as those listed in Table 3) should be usedto differentiate COPD from asthma whenever possible.
Longitudinal observation of patients (whether using spirometry, peak flow or symptoms) should also be used tohelp differentiate COPD from asthma.
Table 3 Clinical features differentiating COPD and asthma Night time waking with breathlessness and/or Significant diurnal or day to day variability of NICE Guideline – Chronic obstructive pulmonary disease To help resolve cases where diagnostic doubt remains, or both COPD and asthma are present, the following findingsshould be used to help identify asthma: • a large (greater than 400 ml) response to • a large (greater than 400 ml) response to 30 mg oral • serial peak flow measurements showing 20% or greater Clinically significant COPD is not present if the FEV1 andFEV1/FVC ratio return to normal with drug therapy.
If diagnostic uncertainty remains, referral for more detailed investigations, including imaging and measurement ofTLCO, should be considered.
If patients report a marked improvement in symptoms in response to inhaled therapy, the diagnosis of COPD shouldbe reconsidered.
Assessment of severity
COPD is heterogeneous, so no single measure can give an adequateassessment of the true severity of the disease in an individualpatient. Severity assessment is, nevertheless, important because it hasimplications for therapy and relates to prognosis.
Mild airflow obstruction can be associated with significant disability in patients with COPD. A true assessment ofseverity should include assessment of the degree of airflowobstruction and disability, the frequency of exacerbationsand the following known prognostic factors: • FEV1• TLCO • breathlessness (MRC scale)• health status• exercise capacity• BMI• partial pressure of oxygen in arterial blood (PaO2)• cor pulmonale.
The severity of airflow obstruction should be assessed according to the reduction in FEV1 as shown in Table 4.
NICE Guideline – Chronic obstructive pulmonary disease Table 4 Assessment of severity of airflow obstruction according to FEV1 as apercentage of the predicted value Severity
Identification of early disease
Spirometry should be performed in patients who are over 35, current or ex-smokers, and have a chronic cough.
Spirometry should be considered in patients with chronic bronchitis. A significant proportion of these will go on todevelop airflow limitation.
Referral for specialist advice
It is recommended that referrals for specialist advice are made when clinically indicated. Referral may beappropriate at all stages of the disease and not solely inthe most severely disabled patients (see Table 5).
Patients who are referred do not always have to be seen by a respiratory physician. In some cases they may be seen bymembers of the COPD team who have appropriate trainingand expertise.
Managing stable COPD
Smoking cessation
An up-to-date smoking history, including pack years smoked (number of cigarettes smoked per day, divided by20, multiplied by the number of years smoked), should bedocumented for everyone with COPD.
All COPD patents still smoking, regardless of age, should be encouraged to stop, and offered help to do so, at everyopportunity.
Unless contraindicated, bupropion or nicotine replacement therapy combined with an appropriate support programmeshould be used to optimise smoking quit rates for peoplewith COPD.
NICE Guideline – Chronic obstructive pulmonary disease Confirm diagnosis, optimisepharmacotherapy and access othertherapists NICE Guideline – Chronic obstructive pulmonary disease NICE Technology Appraisal Guidance No 39 (see Section 6) “If a smoker’s attempt to quit is unsuccessful withtreatment using either NRT or bupropion, the NHS shouldnormally fund no further attempts within 6 months.
However, if external factors interfere with a person’s initialattempt to stop smoking, it may be reasonable to try againsooner.” Inhaled bronchodilator therapy
Short-acting bronchodilators, as necessary, should be the initial empirical treatment for the relief of breathlessnessand exercise limitation.
The effectiveness of bronchodilator therapy should not be assessed by lung function alone but should include avariety of other measures such as improvement insymptoms, activities of daily living, exercise capacity, andrapidity of symptom relief.
Patients who remain symptomatic should have their inhaled treatment intensified to include long-actingbronchodilators or combined therapy with a short-actingbeta2-agonist and a short-acting anticholinergic.
Long-acting bronchodilators should be used in patients who remain symptomatic despite treatment with short-acting bronchodilators because these drugs appear to haveadditional benefits over combinations of short-actingdrugs.
Long-acting bronchodilators should also be used in patients who have two or more exacerbations per year.
The choice of drug(s) should take into account the patient’s response to a trial of the drug, the drug’s side effects,patient preference and cost.
Theophylline
In this section of the guideline, the term theophylline is used tomean slow-release formulations of this drug. Theophylline should only be used after a trial of short- acting bronchodilators and long-acting bronchodilators, orin patients who are unable to use inhaled therapy, as thereis a need to monitor plasma levels and interactions.
NICE Guideline – Chronic obstructive pulmonary disease Particular caution needs to be taken with the use of theophylline in elderly patients because of differences inpharmacokinetics, the increased likelihood of comorbiditiesand the use of other medications.
The effectiveness of the treatment with theophylline should be assessed by improvements in symptoms, activitiesof daily living, exercise capacity and lung function.
The dose of theophylline prescribed should be reduced at the time of an exacerbation if macrolide or fluroquinoloneantibiotics (or other drugs known to interact) areprescribed.
Corticosteroids
None of the inhaled corticosteroids currently available are licensedfor use alone in the treatment of COPD. The followingrecommendations therefore include usage outside licensedindications, and prescribers need to remember that responsibility forsuch prescribing lies with them.
Oral corticosteroid reversibility tests do not predict response to inhaled corticosteroid therapy and should notbe used to identify which patients should be prescribedinhaled corticosteroids.
Inhaled corticosteroids should be prescribed for patients with an FEV1 less than or equal to 50% predicted, who arehaving two or more exacerbations requiring treatmentwith antibiotics or oral corticosteroids in a 12-monthperiod. The aim of treatment is to reduce exacerbationrates and slow the decline in health status and not toimprove lung function per se.
Clinicians should be aware of the potential risk of developing osteoporosis and other side effects in patientstreated with high-dose inhaled corticosteroids (especially inthe presence of other risk factors), and should discuss therisk with patients.
Maintenance use of oral corticosteroid therapy in COPD is not normally recommended. Some patients with advancedCOPD may require maintenance oral corticosteroids whenthese cannot be withdrawn following an exacerbation. In NICE Guideline – Chronic obstructive pulmonary disease these cases, the dose of oral corticosteroids should be keptas low as possible.
Patients treated with long-term oral corticosteroid therapy should be monitored for the development of osteoporosisand given appropriate prophylaxis. Patients over the age of65 should be started on prophylactic treatment, withoutmonitoring.
Combination therapy
If patients remain symptomatic on monotherapy, their treatment should be intensified by combining therapiesfrom different drug classes. Effective combinations include: • beta2-agonist and anticholinergic• beta2-agonist and theophylline• anticholinergic and theophylline• long-acting beta2-agonist and inhaled corticosteroid.
The clinical effectiveness of combined treatments can be assessed by improvements in symptoms, activities of dailyliving, exercise capacity and lung function. Combinationtreatment should be discontinued if there is no benefitafter 4 weeks.
Delivery systems used to treat patients with stable COPD
Most patients – whatever their age – are able to acquire andmaintain adequate inhaler technique given adequate instruction.
The exception to this is that those with significant cognitiveimpairment (as a guideline, those with a Hodkinson AbbreviatedMental Test Score of 4 or less) are unable to use any form of inhalerdevice. In most patients, however, a pragmatic approach guided byindividual patient assessment is needed in choosing a device.
In most cases bronchodilator therapy is best administered using a hand-held inhaler device (including a spacer deviceif appropriate).
If the patient is unable to use a particular device satisfactorily, it is not suitable for him or her and analternative should be found.
Inhalers should be prescribed only after patients have received training in the use of the device and havedemonstrated satisfactory technique.
NICE Guideline – Chronic obstructive pulmonary disease Patients should have their ability to use an inhaler device regularly assessed by a competent healthcare professionaland, if necessary, should be re-taught the correcttechnique.
To ensure optimum efficacy for each patient with COPD, the dose of medication should be titrated according toindividual clinical response.
The spacer should be compatible with the patient’s It is recommended that spacers are used in the following • The drug is administered by repeated single actuations of the metered dose inhaler into the spacer, with eachfollowed by inhalation.
• There should be minimal delay between inhaler • Tidal breathing can be used as it is as effective as single Spacers should be cleaned no more than monthly as more frequent cleaning affects their performance (due to buildup of static). They should be cleaned with water andwashing-up liquid and allowed to air dry. The mouthpieceshould be wiped clean of detergent before use.
Patients with distressing or disabling breathlessness despite maximal therapy using inhalers should be considered fornebuliser therapy.
1.2.6.10 Nebulised therapy should not continue to be prescribed without assessing and confirming that one or more of thefollowing occurs: • a reduction in symptoms• an increase in the ability to undertake activities of daily • an increase in exercise capacity• an improvement in lung function.
1.2.6.11 Nebulised therapy should not be prescribed without an assessment of the patient’s and/or carer’s ability to use it.
NICE Guideline – Chronic obstructive pulmonary disease 1.2.6.12 A nebuliser system that is known to be efficient should be used. Once available, Comité Europeen de Normalisation(European Committee for Standardisation, CEN) datashould be used to assess efficiency.
1.2.6.13 Patients should be offered a choice between a facemask and a mouthpiece to administer their nebulised therapy,unless the drug specifically requires a mouthpiece (forexample, anticholinergic drugs).
1.2.6.14 If nebuliser therapy is prescribed, the patient should be provided with equipment, servicing, advice and support.
Clinicians should be aware that inappropriate oxygen therapy in people with COPD may cause respiratorydepression.
LTOT is indicated in patients with COPD who have a PaO2 less than 7.3 kPa when stable or a PaO2 greater than 7.3and less than 8 kPa when stable and one of: secondarypolycythaemia, nocturnal hypoxaemia (oxygen saturationof arterial blood [SaO2] less than 90% for more than 30%of time), peripheral oedema or pulmonary hypertension.
To get the benefits of LTOT patients should breathe supplemental oxygen for at least 15 hours per day. Greaterbenefits are seen in patients receiving oxygen for 20 hoursper day.
The need for oxygen therapy should be assessed in: • all patients with severe airflow obstruction (FEV1 less • patients with cyanosis • patients with polycythaemia• patients with peripheral oedema • patients with a raised jugular venous pressure • patients with oxygen saturations less than or equal to Assessment should also be considered in patients withmoderate airflow obstruction (FEV1 30–49% predicted).
NICE Guideline – Chronic obstructive pulmonary disease To ensure all patients eligible for long-term oxygen therapy (LTOT) are identified, pulse oximetry should be available inall healthcare settings.
The assessment of patients for LTOT should comprise the measurement of arterial blood gasses on two occasions atleast 3 weeks apart in patients who have a confidentdiagnosis of COPD, who are receiving optimum medicalmanagement and whose COPD is stable.
Patients receiving LTOT should be reviewed at least once per year by practitioners familiar with LTOT and this reviewshould include pulse oximetry.
Oxygen concentrators should be used to provide the fixed supply at home for long-term oxygen therapy.
Patients should be warned about the risks of fire and explosion if they continue to smoke when prescribedoxygen.
1.2.7.10 People who are already on LTOT who wish to continue with oxygen therapy outside the home, and who areprepared to use it, should have ambulatory oxygenprescribed.
1.2.7.11 Ambulatory oxygen therapy should be considered in patients who have exercise desaturation, are shown tohave an improvement in exercise capacity and/or dyspnoeawith oxygen, and have the motivation to use oxygen.
1.2.7.12 Ambulatory oxygen therapy is not recommended in COPD if PaO2 is greater than 7.3 kPa and there is no exercisedesaturation.
1.2.7.13 Ambulatory oxygen therapy should only be prescribed after an appropriate assessment has been performed by aspecialist. The purpose of the assessment is to assess theextent of desaturation, and the improvement in exercisecapacity with supplemental oxygen, and the oxygen flowrate required to correct desaturation, aiming to keep theSaO2 above 90%.
1.2.7.14 Small light-weight cylinders, oxygen-conserving devices and portable liquid oxygen systems should be available for thetreatment of patients with COPD.
NICE Guideline – Chronic obstructive pulmonary disease Table 6 Appropriate equipment for ambulatory oxygen therapy Equipment
For a duration of use of less than 90 minutes For a duration of use less than 4 hours but 1.2.7.15 A choice about the nature of equipment prescribed should take account of the hours of ambulatory oxygen userequired by the patient and the oxygen flow rate required(see Table 6).
1.2.7.16 Short-burst oxygen therapy should only be considered for episodes of severe breathlessness in patients with COPDnot relieved by other treatments.
1.2.7.17 Short-burst oxygen therapy should only continue to be prescribed if an improvement in breathlessness followingtherapy has been documented.
1.2.7.18 When indicated, short-burst oxygen should be provided Non-invasive ventilation
Adequately treated patients with chronic hypercapnic ventilatory failure who have required assisted ventilation(whether invasive or non-invasive) during an exacerbationor who are hypercapnic or acidotic on LTOT should bereferred to a specialist centre for consideration of long-term NIV.
Management of pulmonary hypertension and cor pulmonale
Diagnosis of pulmonary hypertension and cor pulmonale In the context of this guideline, the term ‘cor pulmonale’ has beenadopted to define a clinical condition that is identified and managedon the basis of clinical features. This clinical syndrome of cor NICE Guideline – Chronic obstructive pulmonary disease pulmonale includes patients who have right heart failure secondaryto lung disease and those in whom the primary pathology isretention of salt and water, leading to the development ofperipheral oedema.
A diagnosis of cor pulmonale should be considered if • peripheral oedema• a raised venous pressure• a systolic parasternal heave• a loud pulmonary second heart sound.
It is recommended that the diagnosis of cor pulmonale is made clinically and that this process should involveexcluding other causes of peripheral oedema.
Patients presenting with cor pulmonale should be assessed for the need for long-term oxygen therapy.
Oedema associated with cor pulmonale can usually be controlled symptomatically with diuretic therapy.
The following are not recommended for the treatment of • angiotensin-converting enzyme inhibitors• calcium channel blockers• alpha-blockers• digoxin (unless there is atrial fibrillation).
1.2.10 Pulmonary rehabilitation
Pulmonary rehabilitation is defined as a multidisciplinary programmeof care for patients with chronic respiratory impairment that isindividually tailored and designed to optimise the individual’sphysical and social performance and autonomy. 1.2.10.1 Pulmonary rehabilitation should be made available to all 1.2.10.2 Pulmonary rehabilitation should be offered to all patients who consider themselves functionally disabled by COPD(usually MRC grade 3 and above). Pulmonary rehabilitationis not suitable for patients who are unable to walk, haveunstable angina or who have had a recent myocardialinfarction.
NICE Guideline – Chronic obstructive pulmonary disease 1.2.10.3 For pulmonary rehabilitation programmes to be effective, and to improve concordance, they should be held at timesthat suit patients, and in buildings that are easy forpatients to get to and have good access for people withdisabilities. Places should be available within a reasonabletime of referral.
1.2.10.4 Pulmonary rehabilitation programmes should include multi- component, multidisciplinary interventions, which aretailored to the individual patient’s needs. The rehabilitationprocess should incorporate a programme of physicaltraining, disease education, nutritional, psychological andbehavioural intervention.
1.2.10.5 Patients should be made aware of the benefits of pulmonary rehabilitation and the commitment required togain these.
1.2.11 Vaccination and anti-viral therapy
1.2.11.1 Pneumococcal vaccination and an annual influenza vaccination should be offered to all patients with COPD asrecommended by the Chief Medical Officer.
1.2.11.2 NICE Technology Appraisal Guidance No. 58 (see Section 6) “Within their licensed indications, zanamivir andoseltamivir are recommended for the treatment of at-riskadults who present with influenza-like illness and who canstart therapy within 48 hours of the onset of symptoms.” The technology appraisal also notes that zanamivir shouldbe used with caution in people with COPD because of riskof bronchospasm. If people with COPD are prescribedzanamivir they should be made aware of the risks and havea fast-acting bronchodilator available.
1.2.12 Lung surgery
1.2.12.1 Patients who are breathless, and have a single large bulla on a CT scan and an FEV1 less than 50% predicted shouldbe referred for consideration of bullectomy.
1.2.12.2 Patients with severe COPD who remain breathless with marked restrictions of their activities of daily living, despitemaximal medical therapy (including rehabilitation), should NICE Guideline – Chronic obstructive pulmonary disease be referred for consideration of lung volume reductionsurgery if they meet all of the following criteria: • FEV1 more than 20% predicted • PaCO2 less than 7.3 kPa • upper lobe predominant emphysema • TLCO more than 20% predicted.
1.2.12.3 Patients with severe COPD who remain breathless with marked restrictions of their activities of daily living despitemaximal medical therapy should be considered for referralfor assessment for lung transplantation, bearing in mindcomorbidities and local surgical protocols. Considerationsinclude: • age• FEV1• PaCO2• homogeneously distributed emphysema on CT scan • elevated pulmonary artery pressures with progressive 1.2.13 Alpha-1 antitrypsin replacement therapy
1.2.13.1 Alpha-1 antitrypsin replacement therapy is not recommended in the management of patients with alpha-1antitrypsin deficiency (see also recommendation 1.1.3.3).
1.2.14 Mucolytic therapy
1.2.14.1 Mucolytic drug therapy should be considered in patients with a chronic cough productive of sputum.
1.2.14.2 Mucolytic therapy should be continued if there is symptomatic improvement (for example, reduction infrequency of cough and sputum production).
1.2.15 Anti-oxidant therapy
1.2.15.1 Treatment with alpha-tocopherol and beta-carotene supplements, alone or in combination, is notrecommended.
1.2.16 Anti-tussive therapy
1.2.16.1 Anti-tussive therapy should not be used in the NICE Guideline – Chronic obstructive pulmonary disease 1.2.17 Prophylactic antibiotic therapy
1.2.17.1 There is insufficient evidence to recommend prophylactic antibiotic therapy in the management of stable COPD.
1.2.18 Multidisciplinary management
Multidisciplinary working is breaking down historic demarcation ofroles and many of the activities in managing COPD can beundertaken by individuals from different professional backgrounds.
Many of these activities may be undertaken in the clinic or in thepractice as part of routine care by the practitioner seeing the patientbut in certain circumstances it may be necessary for the patient to bereferred to a specialist department, such as physiotherapy. 1.2.18.1 COPD care should be delivered by a multidisciplinary team.
1.2.18.2 The following functions should be considered when defining the activity of the multidisciplinary team: • assessing patients (including performing spirometry, assessing the need for oxygen, the need for aids for dailyliving and the appropriateness of delivery systems forinhaled therapy) • managing patients (including non-invasive ventilation, pulmonary rehabilitation, hospital-at-home/early-discharge schemes, providing palliative care, identifyingand managing anxiety and depression, advising patientson relaxation techniques, dietary issues, exercise, socialsecurity benefits and travel) • advising patients on self-management strategies• identifying and monitoring patients at high risk of exacerbations and undertaking activities which aim toavoid emergency admissions • advising patients on exercise• education of patients and other health professionals. 1.2.18.3 It is recommended that respiratory nurse specialists form part of the multidisciplinary COPD team.
1.2.18.4 If patients have excessive sputum, they should be taught: • the use of positive expiratory pressure masks • active cycle of breathing techniques.
NICE Guideline – Chronic obstructive pulmonary disease Identifying and managing anxiety and depression 1.2.18.5 Healthcare professionals should be alert to the presence of depression in patients with COPD. The presence of anxietyand depression should be considered in patients: • who are hypoxic (SaO2 less than 92%)• who have severe dyspnoea• who have been seen at or admitted to a hospital with an 1.2.18.6 The presence of anxiety and depression in patients with COPD can be identified using validated assessment tools.
1.2.18.7 Patients found to be depressed or anxious should be treated with conventional pharmacotherapy.
1.2.18.8 For antidepressant treatment to be successful, it needs to be supplemented by spending time with the patientexplaining why depression needs to be treated alongsidethe physical disorder.
1.2.18.9 BMI should be calculated in patients with COPD (see • The normal range for BMI is 20 to less than 25. • If the BMI is abnormal (high or low), or changing over time, the patient should be referred for dietetic advice. • If the BMI is low, patients should also be given nutritional supplements to increase their total calorificintake, and be encouraged to take exercise to augmentthe effects of nutritional supplementation. The NICE guideline Nutritional support in adults: oralsupplements, enteral and parenteral feeding, can bereferred to when it is available (scheduled for publicationin December 2005).
1.2.18.10 In older patients, attention should also be paid to changes in weight, particularly if the change is more than 3 kg.
1.2.18.11 Opioids should be used when appropriate to palliate breathlessness in patients with end-stage COPD which isunresponsive to other medical therapy.
NICE Guideline – Chronic obstructive pulmonary disease 1.2.18.12 Benzodiazepines, tricyclic antidepressants, major tranquillisers and oxygen should also be used whenappropriate for breathlessness in patients with end-stageCOPD unresponsive to other medical therapy.
1.2.18.13 Patients with end-stage COPD and their family and carers should have access to the full range of services offered bymultidisciplinary palliative care teams, including admissionto hospices.
1.2.18.14 Patients should be regularly asked about their ability to undertake activities of daily living and how breathless theybecome when doing these.
1.2.18.15 Clinicians managing patients with COPD should assess their need for occupational therapy using validated tools.
1.2.18.16 Patients disabled by COPD should be considered for referral for assessment by a social services department.
1.2.18.17 All patients on LTOT planning air travel should be assessed in line with the BTS recommendations*.
1.2.18.18 All patients with an FEV1 less than 50% predicted who are planning air travel should be assessed in line with the BTSrecommendations.
1.2.18.19 All patients known to have bullous disease should be warned that they are at a theoretically increased risk ofdeveloping a pneumothorax during air travel.
1.2.18.20 Scuba diving is not recommended for patients with COPD.
1.2.18.21 There are significant differences in the response of patients with COPD and asthma to education programmes.
Programmes designed for asthma should not be used inCOPD.
* Managing passengers with respiratory disease planning air travel: British Thoracic Society recommendations (2002) Thorax 57(4):289–304.
NICE Guideline – Chronic obstructive pulmonary disease 1.2.18.22 Specific educational packages should be developed for • Suggested topics for inclusion are listed in Appendix C of the full guideline (see Section 5 for details of the fullguideline).
• The packages should take account of the different needs of patients at different stages of their disease.
1.2.18.23 Patients with moderate and severe COPD should be made aware of the technique of NIV. Its benefits and limitationsshould be explained so that, if it is ever necessary in thefuture, they will be aware of these issues (see Section1.3.7).
1.2.18.24 Patients at risk of having an exacerbation of COPD should be given self-management advice that encourages them torespond promptly to the symptoms of an exacerbation.
1.2.18.25 Patients should be encouraged to respond promptly to the • starting oral corticosteroid therapy if their increased breathlessness interferes with activities of daily living(unless contraindicated) • starting antibiotic therapy if their sputum is purulent• adjusting their bronchodilator therapy to control their 1.2.18.26 Patients at risk of having an exacerbation of COPD should be given a course of antibiotic and corticosteroid tablets tokeep at home for use as part of a self-managementstrategy (see recommendation 1.3.5.9). 1.2.18.27 The appropriate use of these tablets should be monitored.
1.2.18.28 Patients given self-management plans should be advised to contact a healthcare professional if they do not improve.
1.2.19 Fitness for general surgery
1.2.19.1 The ultimate clinical decision about whether or not to proceed with surgery should rest with a consultantanaesthetist and consultant surgeon taking account of thepresence of comorbidities, the functional status of thepatient and the necessity of the surgery.
NICE Guideline – Chronic obstructive pulmonary disease 1.2.19.2 It is recommended that lung function should not be the only criterion used to assess patients with COPD beforesurgery. Composite assessment tools such as the ASAscoring system are the best predictors of risk.
1.2.19.3 If time permits, the medical management of the patient should be optimised prior to surgery and this might includeundertaking a course of pulmonary rehabilitation.
1.2.20 Follow up of patients with COPD
1.2.20.1 Follow up of all patients with COPD should include: • highlighting the diagnosis of COPD in the case record and recording this using Read codes on a computerdatabase • recording the values of spirometric tests performed at diagnosis (both absolute and percent predicted) • offering smoking cessation advice• recording the opportunistic measurement of spirometric parameters (a loss of 500 ml or more over 5 years willselect out those patients with rapidly progressing diseasewho may need specialist referral and investigation).
1.2.20.2 Patients with mild or moderate COPD should be reviewed at least once per year, or more frequently if indicated, andthe review should cover the issues listed in Table 7.
1.2.20.3 For most patients with stable severe disease regular hospital review is not necessary, but there should be locallyagreed mechanisms to allow rapid access to hospitalassessment when necessary.
1.2.20.4 When patients with severe COPD are reviewed in primary care, they should be seen at least twice a year, and specificattention should be paid to the issues listed in Table 7.
1.2.20.5 Patients with severe disease requiring interventions such as long-term non-invasive ventilation should be reviewedregularly by specialists.
NICE Guideline – Chronic obstructive pulmonary disease Table 7 Summary of follow up of patients with COPD in primary care Mild/Moderate
Frequency
At least annual
At least twice per year
• Need for referral to specialist • Presence of depression • Inhaler technique• Need for social services and Management of exacerbations of COPD
Definition of an exacerbation
An exacerbation is a sustained worsening of the patient’s symptomsfrom their usual stable state which is beyond normal day-to-dayvariations, and is acute in onset. Commonly reported symptoms areworsening breathlessness, cough, increased sputum production andchange in sputum colour. The change in these symptoms oftennecessitates a change in medication.
1.3.2 Assessment of need for hospital treatment
Factors that should be used to assess the need to treat patients in hospital are listed in Table 8.
NICE Guideline – Chronic obstructive pulmonary disease Table 8 Factors to consider when deciding where to treat the patient Treat at home
Treat in hospital
cardiac disease and insulin-dependentdiabetes) Investigation of an exacerbation
The diagnosis of an exacerbation is made clinically and does notdepend on the results of investigations; however, in certainsituations, investigations may assist in ensuring appropriatetreatment is given. Different investigation strategies are required forpatients managed in hospital (who will tend to have more severeexacerbations) and those managed in the community. NICE Guideline – Chronic obstructive pulmonary disease In patients with an exacerbation managed in primary care: • sending sputum samples for culture is not recommended • pulse oximetry is of value if there are clinical features of In all patients with an exacerbation referred to hospital: • a chest radiograph should be obtained• arterial blood gas tensions should be measured and the • an ECG should be recorded (to exclude comorbidities)• a full blood count should be performed and urea and electrolyte concentrations should be measured • a theophylline level should be measured in patients on • if sputum is purulent, a sample should be sent for • blood cultures should be taken if the patient is pyrexial Hospital-at-home and assisted-discharge schemes
Hospital-at-home and assisted-discharge schemes are safe and effective and should be used as an alternative way ofmanaging patients with exacerbations of COPD who wouldotherwise need to be admitted or stay in hospital.
The multi-professional team required to operate these schemes should include allied heath professionals withexperience in managing patients with COPD, and mayinclude nurses, physiotherapists, occupational therapistsand generic health workers.
There are currently insufficient data to make firm recommendations about which patients with anexacerbation are most suitable for hospital at home orearly discharge. Patient selection should depend on theresources available and absence of factors associated with aworse prognosis, such as acidosis.
Patient’s preferences about treatment at home or in NICE Guideline – Chronic obstructive pulmonary disease Pharmacological management
Increased breathlessness is a common feature of an exacerbation ofCOPD. This is usually managed by taking increased doses of short-acting bronchodilators and these drugs may be given using differentdelivery systems. Delivery systems for inhaled therapy during exacerbations Both nebulisers and hand-held inhalers can be used to administer inhaled therapy during exacerbations of COPD.
The choice of delivery system should reflect the dose of drug required, the ability of the patient to use the deviceand the resources available to supervise the administrationof the therapy.
Patients should be changed to hand-held inhalers as soon as their condition has stabilised because this may permitearlier discharge from hospital.
If a patient is hypercapnic or acidotic the nebuliser should be driven by compressed air, not oxygen (to avoidworsening hypercapnia). If oxygen therapy is needed itshould be administered simultaneously by nasal cannulae.
The driving gas for nebulised therapy should always be In the absence of significant contraindications, oral corticosteroids should be used, in conjunction with othertherapies, in all patients admitted to hospital with anexacerbation of COPD.
In the absence of significant contraindications, oral corticosteroids should be considered in patients managedin the community who have an exacerbation with asignificant increase in breathlessness which interferes withdaily activities.
Patients requiring corticosteroid therapy should be encouraged to present early to get maximum benefits (seerecommendations 1.2.17.24–27).
Prednisolone 30 mg orally should be prescribed for 7 to 14 NICE Guideline – Chronic obstructive pulmonary disease 1.3.5.10 It is recommended that a course of corticosteroid treatment should not be longer than 14 days as there is no advantagein prolonged therapy.
1.3.5.11 For guidance on stopping oral corticosteroid therapy it is recommended that clinicians refer to the British NationalFormulary section 6.3.2.
1.3.5.12 Osteoporosis prophylaxis should be considered in patients requiring frequent courses of oral corticosteroids.
1.3.5.13 Patients should be made aware of the optimum duration of treatment and the adverse effects of prolonged therapy.
1.3.5.14 Patients, particularly those discharged from hospital, should be given clear instructions about why, when and how tostop their corticosteroid treatment.
1.3.5.15 Antibiotics should be used to treat exacerbations of COPD associated with a history of more purulent sputum.
1.3.5.16 Patients with exacerbations without more purulent sputum do not need antibiotic therapy unless there is consolidationon a chest radiograph or clinical signs of pneumonia.
1.3.5.17 Initial empirical treatment should be an aminopenicillin, a macrolide, or a tetracycline. When initiating empiricalantibiotic treatment, prescribers should always takeaccount of any guidance issued by their localmicrobiologists.
1.3.5.18 When sputum has been sent for culture, the appropriateness of antibiotic treatment should be checkedagainst laboratory culture and sensitivities when theybecome available.
1.3.5.19 Intravenous theophylline should only be used as an adjunct to the management of exacerbations of COPD if there is aninadequate response to nebulised bronchodilators.
1.3.5.20 Care should be taken when using intravenous theophylline because of interactions with other drugs and potentialtoxicity if the patient has been on oral theophylline.
NICE Guideline – Chronic obstructive pulmonary disease 1.3.5.21 Theophylline levels should be monitored within 24 hours of starting treatment and subsequently as frequently asindicated by the clinical circumstances.
1.3.5.22 It is recommended that doxapram is used only when non-invasive ventilation is either unavailable or consideredinappropriate.
Oxygen therapy during exacerbations of COPD
The oxygen saturation should be measured in patients with an exacerbation of COPD, if there are no facilities tomeasure arterial blood gases.
If necessary, oxygen should be given to keep the SaO2 Pulse oximeters should be available to all healthcare professionals managing patients with exacerbations ofCOPD and they should be trained in their use. Cliniciansshould be aware that pulse oximetry gives no informationabout the PCO2 or pH.
In the interim period while the recommendation on the availability of oximeters is implemented, oxygen should begiven to all patients with an exacerbation of COPD who arebreathless, if the oxygen saturations are not known.
During the transfer to hospital the following points should • It is not desirable to exceed an oxygen saturation of 93%. Oxygen therapy should be commenced atapproximately 40% and titrated upwards if saturationfalls below 90% and downwards if the patient becomesdrowsy or if the saturation exceeds 93–94%.
• Patients with known type II respiratory failure need special care, especially if they require a long ambulancejourney or if they are given oxygen at home for aprolonged period before the ambulance arrives.
When the patient arrives at hospital, arterial blood gases should be measured and the inspired oxygen concentrationnoted in all patients with an exacerbation of COPD.
Arterial blood gas measurements should be repeatedregularly, according to the response to treatment.
NICE Guideline – Chronic obstructive pulmonary disease The aim of supplemental oxygen therapy in exacerbations of COPD is to maintain adequate levels of oxygenation(SaO2 greater than 90%), without precipitatingrespiratory acidosis or worsening hypercapnia. Patientswith pH less than 7.35 should be considered for ventilatorysupport.
Non-invasive ventilation and COPD exacerbations
NIV should be used as the treatment of choice for persistent hypercapnic ventilatory failure duringexacerbations despite optimal medical therapy.
It is recommended that NIV should be delivered in a dedicated setting with staff who have been trained in itsapplication, who are experienced in its use and who areaware of its limitations.
When patients are started on NIV there should be a clear plan covering what to do in the event of deterioration andceilings of therapy should be agreed.
Invasive ventilation and intensive care
Patients with exacerbations of COPD should receive treatment on intensive care units, including invasiveventilation when this is thought to be necessary.
During exacerbations of COPD, functional status, BMI, requirement for oxygen when stable, comorbidities andprevious admissions to intensive care units should beconsidered, in addition to age and FEV1, when assessingsuitability for intubation and ventilation. Neither age norFEV1 should be used in isolation when assessing suitability.
NIV should be considered for patients who are slow to Respiratory physiotherapy and exacerbations
Physiotherapy using positive expiratory pressure masks should be considered for selected patients withexacerbations of COPD, to help with clearing sputum.
NICE Guideline – Chronic obstructive pulmonary disease 1.3.10 Monitoring recovery from an exacerbation
1.3.10.1 Patients’ recovery should be monitored by regular clinical assessment of their symptoms and observation of theirfunctional capacity.
1.3.10.2 Pulse oximetry should be used to monitor the recovery of patients with non-hypercapnic, non-acidotic respiratoryfailure.
1.3.10.3 Intermittent arterial blood gas measurements should be used to monitor the recovery of patients with respiratoryfailure who are hypercapnic or acidotic, until they arestable.
1.3.10.4 Daily monitoring of PEF or FEV1 should not be performed routinely to monitor recovery from an exacerbationbecause the magnitude of changes is small compared withthe variability of the measurement.
1.3.11 Discharge planning
1.3.11.1 Spirometry should be measured in all patients before 1.3.11.2 Patients should be re-established on their optimal maintenance bronchodilator therapy before discharge.
1.3.11.3 Patients who have had an episode of respiratory failure should have satisfactory oximetry or arterial blood gasresults before discharge.
1.3.11.4 All aspects of the routine care that patients receive (including appropriateness and risk of side effects) shouldbe assessed before discharge.
1.3.11.5 Patients (or home carers) should be given appropriate information to enable them to fully understand the correctuse of medications, including oxygen, before discharge.
1.3.11.6 Arrangements for follow-up and home care (such as visiting nurse, oxygen delivery, referral for other support) shouldbe made before discharge.
1.3.11.7 Before the patient is discharged, the patient, family and physician should be confident that he or she can managesuccessfully. When there is remaining doubt a formalactivities of daily living assessment may be helpful.
NICE Guideline – Chronic obstructive pulmonary disease Notes on the scope of the guidance
All NICE guidelines are developed in accordance with a scopedocument that defines what the guideline will and will not cover.
The scope of this guideline was established at the start of thedevelopment of this guideline, following a period of consultation; itis available from www.nice.org.uk/article.asp?a=32649 The guideline offers best practice advice on the care of adults whohave a clinical working diagnosis of COPD including chronicbronchitis, emphysema, and chronic airflow limitation/obstruction.
The guideline is relevant to primary and secondary healthcareprofessionals who have direct contact with patients with COPD, andmake decisions about their care.
The guideline covers diagnostic criteria and identification of earlydisease. The guideline also makes recommendations on themanagement of stable patients, exacerbations and preventingprogression of the disease. The guideline does not cover the management of people withasthma, bronchopulmonary dysplasia and bronchiectasis, nor does itcover children.
Implementation in the NHS
Local health communities should review their existing practice forthe management of COPD against this guideline as they developtheir Local Delivery Plans. The review should consider the resourcesrequired to implement the recommendations set out in Section 1,the people and processes involved and the timeline over which fullimplementation is envisaged. It is in the interests of patients that theimplementation timeline is as rapid as possible.
Relevant local clinical guidelines, care pathways and protocols shouldbe reviewed in the light of this guidance and revised accordingly. This guideline should be used in conjunction with the NICEtechnology appraisals listed in Section 6, and with the NationalService Framework for Older People, which is available fromwww.doh.gov.uk/nsf/olderpeople/index.htm NICE Guideline – Chronic obstructive pulmonary disease Suggested audit criteria are listed in Appendix D. These can be usedas the basis for local clinical audit, at the discretion of those inpractice.
Research recommendations
The following research recommendations have been identified forthis NICE guideline. The Guideline Development Group’s full set ofresearch recommendations is detailed in the full guideline producedby the National Collaborating Centre for Chronic Conditions (seeSection 5).
There is a need for long-term studies on the absolute andcomparative efficacy of: – long-acting bronchodilators– theophylline– mucolytics (including the development of outcome measures)– combination therapies– ambulatory oxygen– alpha-1 antitrypsin replacement therapy.
There is a need for further studies on the efficacy of:– nebulised therapy– non-invasive ventilation– oxygen delivery systems– physiotherapy– pulmonary rehabilitation (in particular its efficacy compared with pharmacological therapies and its efficacy in patients withmild and severe COPD).
There is a need for further studies on:– the content and efficacy of educational packages for patients – the content and efficacy of self-management strategies for Full guideline
The National Institute for Clinical Excellence commissioned thedevelopment of this guidance from the National CollaboratingCentre for Chronic Conditions. The Centre established a Guideline NICE Guideline – Chronic obstructive pulmonary disease Development Group, which reviewed the evidence and developedthe recommendations. The full guideline, Chronic ObstructivePulmonary Disease: Management of Chronic Obstructive PulmonaryDisease in Adults in Primary and Secondary Care, is published by theNational Collaborating Centre for Chronic Conditions; it is availableon its website www.rcplondon.ac.uk/college/ceeu/ncccc_index.htmthe NICE website (www.nice.org.uk/CG012fullguideline) and on thewebsite of the National Electronic Library for Health(www.nelh.nhs.uk). The members of the Guideline Development Group are listed inAppendix B. Information about the independent Guideline ReviewPanel is given in Appendix C.
The booklet The Guideline Development Process – Information forthe Public and the NHS has more information about the Institute’sguideline development process. It is available from the Institute’swebsite and copies can also be ordered by telephoning0870 1555 455 (quote reference N0038).
Related NICE guidance
National Institute for Clinical Excellence (2002). Guidance on the useof nicotine replacement therapy (NRT) and bupropion for smokingcessation. NICE Technology Appraisal Guidance No. 39. London:National Institute for Clinical Excellence. Available from:www.nice.org.uk/Docref.asp?d=30617 National Institute for Clinical Excellence (2003). Guidance on the useof zanamivir, oseltamivir and amantadine for the treatment ofinfluenza. NICE Technology Appraisal Guidance No. 58. London:National Institute for Clinical Excellence. Available from:www.nice.org.uk/Docref.asp?d=58060 NICE is in the process of developing the following guidance.
• Depression: the management of depression in primary and secondary care. Clinical guideline. (Publication expected June2004.) • Anxiety: management of generalised anxiety disorder and panic disorder (with or without agoraphobia) in adults in primary,secondary and community care. Clinical guideline. (Publicationexpected June 2004.) • Nutritional support in adults: oral supplements, enteral and parenteral feeding. Clinical guideline. (Publication expectedDecember 2005.) NICE Guideline – Chronic obstructive pulmonary disease Review date
The process of reviewing the evidence is expected to begin 4 yearsafter the date of issue of this guideline. Reviewing may begin earlierthan 4 years if significant evidence that affects the guidelinerecommendations is identified sooner. The updated guideline will beavailable within 2 years of the start of the review process.
A version of this guideline for patients with COPD and theircarers, and for the public, is available from the NICE website(www.nice.org.uk) or from the NHS response line (0870 1555 455:quote reference number N0463 for an English version and N0464for an English and Welsh version).
A quick reference guide for health professionals is also availablefrom the NICE website (www.nice.org/CG012quickrefguide) orfrom the NHS Response Line (telephone 0870 1555 455; quotereference number N0462) NICE Guideline – Chronic obstructive pulmonary disease The grading scheme and hierarchy of evidence used in this guidelineare shown in the table below.
Hierarchy of evidence
Grading of recommendations
Type of evidence
Evidence
or meta-analysis of randomisedcontrolled trials Evidence from at least onerandomised controlled trial Evidence from at least one othertype of quasi-experimental study Adapted from Eccles M, Mason J (2001) How to develop cost-conscious guidelines.
Health Technology Assessment 5 (16): 1–69.
NICE Guideline – Chronic obstructive pulmonary disease Appendix B: The Guideline Development Group Dr David MG Halpin* (Lead and Clinical Advisor)
Consultant Physician and Senior Lecturer, Royal Devon & Exeter
Hospital
Ms Jill Parnham*
Senior Health Services Research Fellow in Guideline Development,
National Collaborating Centre for Chronic Conditions
Dr David Bellamy*
General Practitioner, Bournemouth
Ms Julie Booker*
Respiratory Nurse Specialist, Rotherham General Hospital
Professor Peter Calverley* (seconded from the Consensus Reference
Group for three meetings)
Professor of Respiratory Medicine, University of Liverpool and
Aintree Hospital NHS Trust
Dr Martin Connolly*
Consultant Geriatrician, University of Manchester
Dr Rachel Garrod*
Senior Lecturer, Kingston University
Mr Ashley Green* (deputy for Esther Threlfall)
Breathe Easy Assistant Manager, British Lung Foundation
Ms Gwen Haylett*
Patient Representative
Dr Michael ML Morgan* (seconded from the Consensus Reference
Group for one meeting)
Consultant Physician, University Hospitals of Leicester NHS Trust
Ms Karen Reid*
Information Scientist, National Collaborating Centre for Chronic
Conditions
Dr Michael Rudolf*
Consultant Physician, Ealing Hospital NHS Trust
Ms Katherine Stevens*
Research Associate in Health Economics, School of Health and
Related Research, University of Sheffield
* Denotes member of both the Guideline Development Group and the Consensus NICE Guideline – Chronic obstructive pulmonary disease Ms Esther Threlfall*
UK Breathe Easy Manager, British Lung Foundation
Ms Jane Scullion* (attended two meetings as deputy for Julie
Booker),
Respiratory Consultant Nurse, University Hospital of Leicester
Ms Teresa Smith (attended five meetings as deputy for Julie Booker),
Senior Respiratory Nurse/Chest Clinic Manager, Heatherwood and
Wexham Park NHS Trust
Ms Elaine Stevenson (attended one meeting as deputy for Julie
Booker),
Clinical Practitioner Respiratory Care, Southern Derbyshire Acute
Hospitals Trust
Professor Jadwiga Wedzicha*
Professor of Respiratory Medicine, St Bartholomew's and the Royal
London School of Medicine
To support the development of this guideline, a Consensus ReferenceGroup was formed. This group used formal consensus techniques inits consideration of clinically important areas where there wasinsufficient evidence or disagreement over the interpretation of theevidence. Professor Duncan Geddes (Chair)
Professor of Respiratory Medicine, Royal Brompton Hospital NHS
Trust
Ms Alison Bent (attended one meeting as deputy for Mary Hickson)
Dietitian, Hammersmith Hospitals NHS Trust
Professor Peter Calverley
Professor of Respiratory Medicine, University of Liverpool and
Aintree Hospital NHS Trust
Dr Stephen Connellan
Consultant Physician, The Royal Wolverhampton Hospitals NHS Trust
Dr Sujal Desai (attended one meeting)
Radiologist, King’s College Hospital
Dr Gillian Hawksworth
Community Pharmacist
* Denotes member of both the Guideline Development Group and the Consensus NICE Guideline – Chronic obstructive pulmonary disease Dr Mary Hickson
Senior Research Dietician, Hammersmith Hospitals NHS Trust
Professor Walter W Holland
Emeritus Professor of Public Health Medicine, Visiting Professor,
London School of Economics
Dr Bill Homes (attended one meeting)
Group Medical Director, Nestor Healthcare Group Plc
Professor Paul Little
Professor of Primary Care Research, University of Southampton
Dr Michael ML Morgan
Consultant Physician, University Hospitals of Leicester NHS Trust
Ms Louise Sewell
Pulmonary Rehabilitation Specialist, University Hospitals of Leicester
NHS Trust
Dr Mangalam Sridhar
Consultant Physician, Hammersmith Hospitals NHS Trust
Dr Mike Thomas (attended one meeting as deputy for David
Bellamy)
General Practitioner, Minchinhampton, Gloucestershire
Ms Patrician Turner-Lawlor (attended one meeting as deputy for
Louise Sewell)
Senior Research Occupational Therapist, Cardiff and Vale NHS Trust
NICE Guideline – Chronic obstructive pulmonary disease The Guideline Review Panel is an independent panel that overseesthe development of the guideline and takes responsibility formonitoring its quality. The Panel includes experts on guidelinemethodology, health professionals and people with experience ofthe issues affecting patients and carers. The members of theGuideline Review Panel were as follows.
Dr Bernard Higgins (Chair)
Consultant Chest Physician, Freeman Hospital, Newcastle upon Tyne
Dr Robert Higgins
Consultant in Renal and General Medicine, University Hospitals
Coventry and Warwickshire
Dr Marcia Kelson
Director, Patient Involvement Unit for NICE, London
Dr Peter Rutherford
Senior Lecturer in Nephrology, Medical Director, University College of
Wales College of Medicine
Dame Helena Shovelton
Chief Executive, British Lung Foundation
Fiona Wise
Acting Director of Modernisation, Bedfordshire and Hertfordshire
Strategic Health Authority
Dr John Young
Medical Director, Merck Sharp and Dohme
NICE Guideline – Chronic obstructive pulmonary disease Appendix D: Technical detail on the criteria foraudit Key priority
Criterion: data item
Exceptions:
interpreting
the evidence
1. Diagnose COPD
considered in patients over the age of 35 exertional breathlessness, chronic cough, presence of airflow obstruction should be Percentage of patientsconfirmed by performing spirometry. All spirometry and be competent in theinterpretation of the results. 2. Stop smoking
COPD patients still smoking, regardless of general practiceage should be encouraged to stop, and 3. Effective inhaled therapy
improve exercise capacity in patients who had two or more acting bronchodilators in patients with an corticosteroid therapyFEV1 ≤ 50% predicted who have had twoor more exacerbations requiringtreatment with antibiotics or oralcorticosteroids in a 12-month period inorder to decrease exacerbation frequency. 4. Pulmonary rehabilitation for all who
available to all appropriate patients with NICE Guideline – Chronic obstructive pulmonary disease Key priority
Criterion: data item
Exceptions:
interpreting
the evidence
5. Use non-invasive ventilation
persistent hypercapnic ventilatory failure medical therapy. It should be delivered bystaff trained in its application,experienced in its use and aware of itslimitations. When patients are started onNIV there should be a clear managementplan in the event of deterioration andceilings of therapy should be agreed.
6. Manage exacerbations
The frequency of exacerbations should be with exacerbations vaccinations. The impact of exacerbations should be minimised by:• giving self-management advice on responding promptly to the symptomsof an exacerbation NICE Guideline – Chronic obstructive pulmonary disease Definition of COPD
COPD is characterised by airflow obstruction. The airflow obstruction
is usually progressive, not fully reversible and does not change
markedly over several months. The disease is predominantly caused by
smoking.
Think of the diagnosis of COPD for patients who are:
• over 35
• smokers or ex-smokers
• have any of these symptoms:
– exertional breathlessness– chronic cough– regular sputum production– frequent winter ‘bronchitis’– wheeze • and have no clinical features of asthma (see table below) Perform spirometry if COPD seems likely.
Abbreviations
• FEV1 < 80% predicted
• And FEV1/FVC < 0.7
Spirometric reversibility testing is not usually necessary as part of the diagnostic process or to plan initial therapy If still doubt about diagnosis consider the following pointers:
• Asthma may be present if:
– there is a > 400 ml response to bronchodilators– serial peak flow measurements show significant diurnal or – there is a > 400 ml response to 30 mg prednisolone daily for 2 weeks • Clinically significant COPD is not present if FEV1 and FEV1/FVC ratio return to normal with drug therapy.
• Refer for more detailed investigations if needed (see page 10) If still in doubt, make a provisional diagnosis and
If no doubt, diagnose COPD and start treatment
Reassess diagnosis in view of response to treatment
Clinical features differentiating COPD and asthma
Night-time waking with breathlessness and/or wheeze Significant diurnal or day-to-day variability of symptoms Uncommon NICE Guideline – Chronic obstructive pulmonary disease Patient w
Assess symptoms/problems and manage t
Patients with COPD should have access to the wide ra Breathlessness and exercise limitation
Frequent exacerbations
Respirato
Use short-acting bronchodilator as needed If still symptomatic try combined therapy with a short-acting beta2-agonist and a short-acting If still symptomatic use a long-acting bronchodilator In moderate or severe COPD:
if still symptomatic consider a trial of a combination of a Stop therapy if inef
long-acting beta2-agonist and inhaled corticosteroid;
discontinue if no benefit after 4 weeks
If still symptomatic consider adding theophylline ≤ 50% and two or moreexacerbations in a 12-month period (NB Offer pulmonary rehabilitation to all patients who consider themselves functionally disabled (usually MRC Consider referral for surgery: bullectomy, lung volumereduction, transplantation Palliative care
• Opiates can be used for the palliation of breathlessness in patients with end-stage COPD unresponsive to other medical therapy
• Use benzodiazepines, tricyclic antidepressants, major tranquillisers and oxygen when appropriate
• Involve multidisciplinary palliative care teams
Abbreviations
BMI body mass index
FEV1 forced expiratory volume in 1 second
MRC Medical Research Council
LVRS lung volume reduction surgery
NICE Guideline – Chronic obstructive pulmonary disease with COPD
those that are present as described below
ange of skills available from a multidisciplinary team ory failure
Cor pulmonale
Abnormal BMI
Chronic productive cough
Anxiety and depression
NICE Guideline – Chronic obstructive pulmonary disease Algorithm 3: Managing exacerbations of COPD Exacerbations of COPD can be associated with increased:
• dyspnoea
• sputum purulence
• sputum volume
• cough
Initial management
• Increase frequency of bronchodilator use – consider giving via a nebuliser
• Oral antibiotics if purulent sputum
• Prednisolone 30 mg daily for 7–14 days – for all patients with significant increase
in breathlessness, and all patients admitted to hospital, unless contraindicated Decide where to manage
Investigations
Investigations
• Sputum culture not normally recommended • Arterial blood gases (record inspired oxygen • Pulse oximetry if severe exacerbation • ECG• Full blood count and urea and electrolytes• Theophylline level if patient on theophylline at Further management
• Sputum microscopy and culture if purulent • Establish on optimal therapy• Arrange multidisciplinary assessment if necessary Further management
Factors to consider when deciding where to manage patient
• Give oxygen to keep SaO2 above 90% • Assess need for non-invasive ventilation: – consider respiratory stimulant if NIV not available treatment
treatment in
hospital
• Consider intravenous theophyllines if poor response to Consider hospital-at-home or assisted-discharge scheme Before discharge
• Arrange multidisciplinary assessment if necessary Significant comorbidity(particularly cardiac disease and Abbreviations
LTOT
partial pressure of oxygen in arterial blood NICE Guideline – Chronic obstructive pulmonary disease NICE Guideline – Chronic obstructive pulmonary disease National Institute for
Clinical Excellence

Source: http://www.spiropharma.dk/uploads/CG12_Chronic_obstructive_pulmonary_disease_NICE_guideline.pdf