0 Chronic obstructive pulmonary disease Implementing NICE guidance 2 nd Edition July 2011 NICE clinical guideline 101

NICE Pathway The NICE COPD pathway covers the management of COPD in adults in primary care and secondary care and shows recommendations on: When to consider referral Diagnosis Managing stable COPD Managing exacerbations Palliative Care Click here to go to NICE Pathways website

What this presentation covers Background Scope Definition Recommendations Costs and savings Discussion NICE COPD quality standard Find out more

Epidemiology About 3 million people have chronic obstructive pulmonary disease (COPD) in the UK Nearly 900,000 people in England and Wales are diagnosed as having COPD and an estimated 2 million people have COPD which remains undiagnosed Symptoms usually develop insidiously making it difficult to determine the true prevalence of the disease Most patients are not diagnosed until they are in their fifties

Background COPD is predominantly caused by smoking and is characterised by airflow obstruction that: - is not fully reversible - does not change markedly over several months - is usually progressive in the long term Exacerbations often occur, where there is a rapid and sustained worsening of symptoms beyond normal day- to-day variations requiring a change in treatment

Scope The scope for the guideline update was to examine: a) Diagnosis and severity classification: spirometry and post-bronchodilator values multidimensional severity assessment indices (for example, the BODE index) b) Management of stable COPD and prevention of disease progression long-acting bronchodilators: beta 2 agonists and anticholinergics (tiotropium, formoterol fumarate, salmeterol) as monotherapy and in combination, both with and without inhaled corticosteroids mucolytic therapy (carbocisteine and mecysteine hydrochloride) BODE = body mass index, airflow obstruction, dyspnoea and exercise tolerance

Definition of COPD Airflow obstruction is defined as reduced FEV 1 /FVC ratio (< 0.7) It is no longer necessary to have an FEV 1 < 80% predicted for definition of airflow obstruction If FEV 1 is ≥ 80% predicted, a diagnosis of COPD should only be made in the presence of respiratory symptoms, for example breathlessness or cough COPD produces symptoms, disability and impaired quality of life which may respond to pharmacological and other therapies that have limited or no impact on the airflow obstruction. FEV 1 = forced expiratory volume in 1 second FVC = forced vital capacity

Natural History The Fletcher-Peto Diagram, illustrating the effects of smoking on rate of decline in FEV 1

Diagnose COPD Consider a diagnosis of COPD for people who are: over 35, and smokers or ex-smokers, and have any of these symptoms: - exertional breathlessness - chronic cough - regular sputum production, -frequent winter ‘bronchitis’ -Wheeze And no clinical features of asthma [2004]

Diagnose COPD: Spirometry Perform spirometry if COPD seems likely [2004] The presence of airflow obstruction should be confirmed by performing post-bronchodilator spirometry [new 2010] Consider alternative diagnoses or investigations in: - older people without typical symptoms of COPD where the FEV1/FVC ratio is < younger people with symptoms of COPD where the FEV1/FVC ratio is ≥ 0.7 [new 2010] All health professionals involved in the care of people with COPD should have access to spirometry and be competent in the interpretation of the results [2004]

Differentiating COPD from asthma Clinical featuresCOPDAsthma Smoker or ex-smokerNearly allPossibly Symptoms under age 35RareOften Chronic productive coughCommonUncommon BreathlessnessPersistent and progressive Variable Night time waking with breathlessness and or wheeze UncommonCommon Significant diurnal or day to day variability of symptoms uncommonCommon [2004]

Differentiating COPD from asthma: 2 If diagnostic uncertainty remains, the following findings should be used to help identify asthma: - FEV 1 and FEV 1 /FVC ratio return to normal with drug therapy - a very large (>400ml) FEV 1 response to bronchodilators or to 30mg prednisolone daily for 2 weeks - serial peak flow measuremenst showing significant (20% or greater) diurnal or day-to-day variability - remaining diagnostic uncertainty may be resolved by referral for more detailed investigations [2004]

Diagnose COPD: assessment of severity Assess severity of airflow obstruction using reduction in FEV 1 NICE clinical guideline 12 (2004) ATS/ERS 2004GOLD 2008NICE clinical guideline 101 (2010) Post- bronchodilator FEV 1 /FVC FEV 1 % predicted Post- bronchodilator < 0.780%MildStage 1 (mild)Stage 1 (mild)* < 0.750–79%MildModerateStage 2 (moderate) < 0.730–49%ModerateSevereStage 3 (severe) < 0.7< 30%SevereVery severeStage 4 (very severe)** * Symptoms should be present to diagnose COPD in people with mild airflow obstruction ** Or FEV 1 < 50% with respiratory failure [new 2010]

Patient with COPD Palliative care SmokingBreathlessness & exercise limitation Frequent exacerbations Respiratory failure Cor pulmonale Abnormal BMI Chronic productive cough Anxiety & depression Managing stable COPD Assess symptoms/problems Manage those that are present as below Patients with COPD should have access to the wide range of skills available from a multidisciplinary team

Managing stable COPD: Stop smoking Encouraging patients with COPD to stop smoking is one of the most important components of their management All COPD patients still smoking, regardless of age, should be encouraged to stop, and offered help to do so, at every opportunity Record a smoking history, including pack years smoked Offer nicotine replacement therapy, varenicline or bupropion (unless contraindicated) combined with a support programme to optimise quit rates [2010] [2004]

Managing stable COPD: Promote effective inhaled therapy In people with stable COPD who remain breathless or have exacerbations despite using short-acting bronchodilators as required, offer the following as maintenance therapy: if FEV 1 ≥ 50% predicted: either LABA or LAMA if FEV 1 < 50% predicted: either LABA+ICS in a combination inhaler, or LAMA Offer LAMA in addition to LABA+ICS to people with COPD who remain breathless or have exacerbations despite taking LABA+ICS, irrespective of their FEV 1 ICS = inhaled corticosteroid LABA = long-acting beta 2 agonist LAMA = long-acting muscarinic agonist [new 2010]

Managing stable COPD: inhaled therapies SABA or SAMA as required* Breathlessness and exercise limitation Exacerbations or persistent breathlessness Persistent exacerbations or breathlessness LABALAMA Discontinue SAMA ________ Offer LAMA in preference to regular SAMA four times a day LABA + ICS in a combination inhaler ________ Consider LABA + LAMA if ICS declined or not tolerated LAMA Discontinue SAMA ________ Offer LAMA in preference to regular SAMA four times a day FEV 1 ≥ 50% FEV 1 < 50% LABA + ICS in a combination inhaler ________ Consider LABA + LAMA if ICS declined or not tolerated LAMA + LABA + ICS in a combination inhaler OfferConsider * SABAs (as required) may continue at all stages

Managing stable COPD: Oral corticosteroids Maintenance use of oral corticosteroid therapy in COPD is not recommended Some patients with advanced COPD may require maintenance oral corticosteroids when these cannot be withdrawn following an exacerbation The does of oral corticosteroids should be kept as low as possible Any patient treated with long term corticosteroid therapy should be monitored for the development of osteoporosis and given appropriate prophylaxis. Patients over the age of 65 should be started on prophylactic treatment without the need for monitoring

Managing stable COPD: Oxygen Clinicians should be aware that inappropriate oxygen therapy in people with COPD may cause respiratory depression Use appropriate oxygen therapy: Long-term oxygen therapy Ambulatory Short burst

Managing stable COPD: Cor pulmonale A diagnosis of cor pulmonale should be considered if patients have: - Peripheral odema, raised venous pressure, systolic parasternal heave, a loud pulmonary second heart sound. Assess need for oxygen Use diuretics [2004]

Managing stable COPD: provide pulmonary rehabilitation Pulmonary rehabilitation An individually tailored multidisciplinary programme of care to optimise patients’ physical and social performance and autonomy Tailor multi-component, multidisciplinary interventions to individual patient’s needs Hold at times that suit patients, and in buildings with good access Offer to all patients who consider themselves functionally disabled by COPD Make available to all appropriate people, including those recently hospitalised for an acute exacerbation [new 2010]

Multidisciplinary working COPD care should be delivered by a multidisciplinary team that includes respiratory nurse specialists Consider referral to specialist departments (not just respiratory physicians) [2004] Specialist departmentWho might benefit? PhysiotherapyAdvice about excessive sputum Dietetic advicePeople with BMI that is high, low or changing over time Occupational therapyPeople needing help with daily living activities Social servicesPeople disabled by COPD Multidisciplinary palliative care teams People with end-stage COPD (and their families and carers)

Follow-up of patients with COPD Follow-up of patients should include: -Highlighting the diagnosis in the case record -Recording the values of spirometric tests -Offering stop smoking advice -Recording the opportunistic measurement of spirometric parameters Patients should be reviewed at least once per year For most patients with stable severe disease regular hospital review is not necessary [2004]

Managing exacerbations Minimise impact of exacerbations by: - giving self-management advice on responding promptly to symptoms of exacerbation - starting appropriate treatment with oral steroids and/or antibiotics - use of non-invasive ventilation when indicated - use of hospital-at-home or assisted-discharge schemes The frequency of exacerbations should be reduced by appropriate use of inhaled corticosteroids and bronchodilators, and vaccinations [2004]

Use non-invasive ventilation (NIV) Use NIV as the treatment of choice for persistent hypercapnic ventilatory failure during exacerbations not responding to medical therapy NIV should be delivered by staff trained in its application, experienced in its use and aware of its limitations When starting NIV, make a clear plan covering what to do in the event of deterioration and agree ceilings of therapy [2004]

Palliative care Palliative care depends on good understanding of patients’: - Perception of their quality of life - Satisfaction with current functioning - Expectations Opioids, benzodiazepines, tricyclic antidepressants, major tranquilisers and oxygen can be used for the palliation of breathlessness in patients with end stage COPD unresponsive to other medical therapy Providers of care should adopt an effective and equitable standardised approach to palliative care such as that provided by the Liverpool care pathway or equivalent [2004]

Costs per 100,000 population Costs are based on recommendations which have the most significant resource impact: Costs per annum £ Current cost of prescribing524,291 Future cost of prescribing624,812 Incremental cost of prescribing100,521 Estimated 5% reductions in hospital admissions30,302 Estimated cost of implementation70,219

Discussion How can we improve identification and diagnosis of people over 35 who have a risk factor? How does our use of spirometry compare with the recommendations? How will our prescribing practice need to change? What pulmonary rehabilitation services are available? How do we minimise the risk of exacerbations for our patients?

NHS Lung Improvement Visit the NHS Lung Improvement Programme webpages ( for further practical support consistent with implementing the recommendations in this guidelinewww.improvement.nhs.uk/lung

NHS Evidence Visit NHS Evidence for the best available evidence on all aspects of respiratory diseases, including COPD Click here to go to the NHS Evidence website

Find out more Visit for: the guideline the quick reference guide ‘Understanding NICE guidance’ costing report audit support baseline assessment tool

NICE quality standard COPD July 2011

Quality standards A quality standard is a set of specific, concise statements that: act as markers of high-quality, cost-effective patient care across a pathway or clinical area, covering treatment and prevention are derived from the best available evidence such as NICE guidance or other NHS evidence accredited sources are produced collaboratively with the NHS and social care, along with their partners and service users

COPD quality standard This quality standard covers Assessment, diagnosis and clinical management of chronic obstructive pulmonary disease (COPD) in adults. It does not include prevention, screening or case finding. The quality standard consists of 13 quality statements.

Quality statement 1 People with COPD have one or more indicative symptoms recorded, and have the diagnosis confirmed by post ‑ bronchodilator spirometry carried out on calibrated equipment by healthcare professionals competent in its performance and interpretation. Quality measure Process: a)Proportion of people with COPD who have one or more indicative symptoms recorded. b) Proportion of people with COPD who have the diagnosis confirmed by post ‑ bronchodilator spirometry

Quality statement 2 People with COPD have a current individualised comprehensive management plan, which includes high- quality information and educational material about the condition and its management, relevant to the stage of disease. Quality measure Process: Proportion of people with COPD who have a current individualised comprehensive management plan, which includes high-quality information and educational material about the condition and its management, relevant to the stage of disease.

Quality statement 3 People with COPD are offered inhaled and oral therapies, in accordance with NICE guidance, as part of an individualised comprehensive management plan. Quality measure Process: a) Proportion of people with COPD who are offered inhaled and oral therapies in accordance with NICE guidance. b) Proportion of people with COPD who receive their inhaled and oral therapies as part of an individualised comprehensive management plan.

Quality statement 4 People with COPD have a comprehensive clinical and psychosocial assessment, at least once a year or more frequently if indicated, which includes degree of breathlessness, frequency of exacerbations, validated measures of health status and prognosis, presence of hypoxaemia and comorbidities. Quality measure Process: Proportion of people with COPD who had a comprehensive clinical and psychosocial assessment in the previous 12 months which includes degree of breathlessness, frequency of exacerbations, validated measures of health status and prognosis, presence of hypoxaemia and comorbidities.

Quality statement 5 People with COPD who smoke are regularly encouraged to stop and are offered the full range of evidence-based smoking cessation support. Quality measure Process: Proportion of people with COPD who smoke who are offered the full range of evidence-based smoking cessation support.

Quality statement 6 People with COPD meeting appropriate criteria are offered an effective, timely and accessible multidisciplinary pulmonary rehabilitation programme. Quality measure Process: Proportion of people with COPD meeting appropriate criteria who receive an effective, timely and accessible multidisciplinary pulmonary rehabilitation programme.

Quality statement 7 People who have had an exacerbation of COPD are provided with individualised written advice on early recognition of future exacerbations, management strategies (including appropriate provision of antibiotics and corticosteroids for self-treatment at home) and a named contact. Quality measure Process: Proportion of people who have had an exacerbation of COPD who are given individualised written advice on early recognition of future exacerbations, management strategies (including appropriate provision of antibiotics and corticosteroids for self-treatment at home) and a named contact.

Quality statement 8 People with COPD potentially requiring long-term oxygen therapy are assessed in accordance with NICE guidance by a specialist oxygen service. Quality measure Process: Proportion of people with COPD with oxygen saturation less than or equal to 92% when stable, who are assessed for LTOT in accordance with NICE guidance by a specialist oxygen service.

Quality statement 9 People with COPD receiving long-term oxygen therapy are reviewed in accordance with NICE guidance, at least annually, by a specialist oxygen service as part of the integrated clinical management of their COPD. Quality measure Process: Proportion of people with COPD receiving LTOT, who have had a review in the previous 12 months by a specialist oxygen service in accordance with NICE guidance, as part of the integrated clinical management of their COPD.

Quality statement 10 People admitted to hospital with an exacerbation of COPD are cared for by a respiratory team, and have access to a specialist early supported-discharge scheme with appropriate community support.

Quality statement 10 continued Quality measure Process: a) Proportion of people with COPD admitted to hospital with an exacerbation who are cared for by a respiratory team b) Proportion of people with COPD admitted to hospital with an exacerbation, and who meet the criteria for early supported discharge, who are placed on a specialist early supported discharge scheme with appropriate community support.

Quality statement 11 People admitted to hospital with an exacerbation of COPD and with persistent acidotic ventilatory failure are promptly assessed for, and receive, non ‑ invasive ventilation delivered by appropriately trained staff in a dedicated setting.

Quality statement 11 continued Quality measure Process: a)Proportion of people admitted to hospital with an exacerbation of COPD and with persistent acidotic ventilatory failure, who are promptly assessed for NIV, and for whom any subsequent delivery is promptly undertaken. b) Proportion of people admitted to hospital and receiving NIV for an exacerbation of COPD and persistent acidotic ventilatory failure, who have it delivered by appropriately trained staff in a dedicated setting.

Quality statement 12 People admitted to hospital with an exacerbation of COPD are reviewed within 2 weeks of discharge. Quality measure Process: Proportion of people discharged from hospital following an admission with an exacerbation of COPD, who are reviewed within 2 weeks of discharge.

Quality statement 13 People with advanced COPD, and their carers, are identified and offered palliative care that addresses physical, social and emotional needs. Quality measure Process: Proportion of people with advanced COPD, and their carers, who receive palliative care that addresses physical, social and emotional needs.

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