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Implementing NICE Guidance and Quality Standards Outcomes Strategy
- 1. Primary Care management Chronic obstructive pulmonary disease Implementing NICE Guidance and Quality Standards Outcomes Strategy Additional information can be found at www.copdeducation.org.uk On behalf of the Southampton COPD Group
- 2. Outcomes strategy • July 2011 • Asthma as well as COPD • Improve Respiratory Health • Reduce number who develop COPD • Reduce premature death • Improve QOL • Safe and effective care • Asthmatics: free of Symptoms; Action Plans • QOF mMRC, SaO2 and PR • NICE quality standards
- 3. COPD Main Components • Smoking • Immunology • Microbiology – Bacteria and Virus • Individual – activity, co morbidities, BMI
- 4. NICE STANDARDS • Diagnostic Quality Standards • Therapy Quality Standard • Exacerbation Quality Standard • Assessment Quality Standard • Rehabilitation Quality Standard • End of life Quality Standard
- 5. NICE Quality outcome - spiro • 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.
- 6. Competencies • What level? • Education for health • Respiratory Education UK • Skills for Health • http://www.skillsforhealth.org.uk/service- area/copd/
- 7. Definition of COPD • Airflow obstruction is defined as reduced FEV1/FVC ratio (< 0.7) • It is no longer necessary to have an FEV1 < 80% predicted for definition of airflow obstruction • If FEV1 is ≥ 80% predicted, a diagnosis of COPD should only be made in the presence of respiratory symptoms, for example breathlessness or cough FEV1 = forced expiratory volume in 1 second FVC = forced vital capacity
- 8. Diagnose COPD: 1 • The presence of airflow obstruction should be confirmed by performing post- bronchodilator spirometry [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]
- 9. Diagnose COPD: 2 • Assess severity of airflow obstruction using reduction in FEV1 NICE clinical ATS/ERS 2004 GOLD 2008 NICE clinical guideline 12 guideline 101 (2004) (2010) Post- FEV1 % Post- Post- Post- bronchodilator predicted bronchodilator bronchodilator bronchodilator FEV1/FVC < 0.7 80% Mild Stage 1 (mild) Stage 1 (mild)* < 0.7 50–79% Mild Moderate Stage 2 Stage 2 (moderate) (moderate) < 0.7 30–49% Moderate Severe Stage 3 (severe) Stage 3 (severe) < 0.7 < 30% Severe Very severe Stage 4 (very Stage 4 (very severe)** severe)** * Symptoms should be present to diagnose COPD in people with mild airflow obstruction ** Or FEV1 < 50% with respiratory failure [new 2010]
- 10. Asthma or COPD • To help resolve cases where diagnostic doubt occurs, or both COPD and asthma are present, the following findings should be used to help identify asthma: • 1. a large (> 400 ml) response to bronchodilators • 2. a large (> 400 ml) response to 30 mg oral prednisolone daily for 2 weeks • 3. Serial peak flow measurements showing 20% or greater diurnal or day-to-day variability. (NICE 2010)
- 11. Other tests to confirm the diagnosis in the new patient CXR – excludes other conditions BMI – Big predictor in mortality terms but only in moderate and severe disease FBC - Polycythaemia Anaemia
- 12. “It has generally been assumed that individuals with the lowest FEV1 were also progressing the fastest as they had ‘‘clearly’’ lost more function than individuals with more normal lung function. However, evidence is accumulating that this assumption is in error, making it essential to distinguish between severity and activity” JØRGEN VESTBO 2010
- 13. What is the decline in mls/yr ? TORCH UPLIFT Gold II 60 49 Gold III 56 41 Gold IV 34 31
- 14. ECLIPSE Evaluation of copd longitudinally to identify predictive surrogate endpoints NEJM 2011
- 15. ECLIPSE • 2138 Patients • Followed up for 3 years • Baseline, 3,6,12,18, 24, 30, 36 months • Hypothesis was that there was a frequent exacerbation phenotype • Cost >£300m
- 16. Results • Best predictor of an exacerbation in the first year was • A treated exacerbation in the year before study entry OR 4.30 • MRC Score OR 1.83 • GOLD Stage OR 1.74 • Fibrinogen 1.35
- 17. FEV1 ECLIPSE
- 18. Assessment • 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. • CAT • BODE • mMRC • BMI • SaO2
- 21. Nice outcomes - therapy • People with COPD have a current individualised comprehensive management plan • People with COPD are offered inhaled and oral therapies, in accordance with NICE guidance, as part of an individualised comprehensive management plan
- 22. 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 FEV1 ≥ 50% predicted: either LABA or LAMA • if FEV1 < 50% predicted: either LABA+ICS in a combination inhaler, or LAMA • Offer LAMA & LABA+ICS to people with COPD who remain breathless or have exacerbations despite taking LABA+ICS, • Triple therapy not dependent on FEV1 • Inhaler technique and ability to activate the device ICS = inhaled corticosteroid LABA = long-acting beta2 agonist [new 2010] LAMA = long-acting muscarinic agonist
- 23. Therapy
- 24. New treatment
- 25. New documents
- 28. Bronchodilators are the cornerstone of COPD treatment • Target airflow limitation → bronchodilating by altering airway smooth muscle tone • Improve emptying of the lung • Ideally: reduce hyperinflation at rest and during exercise GOLD 2011. Available from: www.goldcopd.org Spencer et al. Cochrane Database Syst Rev 11;10:CD007033
- 29. GOLD 2011: Pharmacologic management of COPD*‡ (C) (D) GOLD 4 LABA+ICS or LAMA LABA+ICS or LAMA ≥2 LABA+ICS and LAMA or LABA and LAMA LABA+ICS and PDE4-inh or GOLD 3 LABA and LAMA or LAMA and ICS or LAMA and PDE4-inh Exacerbations per year SABA or SAMA prn LABA or LAMA First choice; GOLD 2 1 Second choice LABA or LAMA or SABA and SAMA LABA and LAMA GOLD 1 0 (A) (B) mMRC 0−1 mMRC ≥2 CAT <10 CAT ≥10 GOLD 2011
- 30. Bronchodilators Long acting bronchodilators are beneficial in not just in terms of improving FEV1 and reducing exacerbations but also by reducing resting and dynamic hyperinflation There is a potential benefit in combining long acting bronchodilators from different pharmacological classes in COPD patients (LABA and LAMA)
- 31. Dynamic Hyperinflation Exercise
- 32. Overview of bronchodilators approved in the last 5 years and in development for treatment of COPD Drug Class Route Company Development stage Indacaterol LABA Inhaled, QD Novartis Approved Olodaterol LABA Inhaled, QD BI Phase III Vilanterol LABA Inhaled, QD Theravance/GSK Phase II Aclidinium LAMA Inhaled, BID Almirall/Forest Approved Glycopyrronium LAMA Inhaled, QD Novartis Approved QD = once daily; BID = twice daily
- 33. The role of inhaled corticosteroids in COPD Where do they fit?
- 34. GOLD 2011: Pharmacologic management of COPD*‡ (C) (D) GOLD 4 LABA+ICS or LAMA LABA+ICS or LAMA ≥2 LABA+ICS and LAMA or LABA and LAMA LABA+ICS and PDE4-inh or GOLD 3 LABA and LAMA or LAMA and ICS or LAMA and PDE4-inh Exacerbations per year SABA or SAMA prn LABA or LAMA First choice; GOLD 2 1 Second choice LABA or LAMA or SABA and SAMA LABA and LAMA GOLD 1 0 (A) (B) mMRC 0−1 mMRC ≥2 CAT <10 CAT ≥10 GOLD 2011
- 35. Inhaled Corticosteroids • Recommended prescription in combination with LABA in patients with FEV1<50% and exacerbations • Reduce exacerbation frequency by approximately 25% in most studies in patients of this phenotype • They are however overprescribed in COPD (often as monotherapy where there is limited evidence of efficacy)
- 36. Clinical trial data show that many patients with moderate COPD are receiving ICS (1) GOLD I II III IV Long-acting bronchodilators 61.8 67.3 69.3 65.1 SAMA 41.7 50.7 59.9 47.6 SABA 68.8 76.3 78.9 73.2 ICS 63.7 67.2 72.5 66.2 Theophyllines 24.7 34.9 36.1 30.5 *Total includes six Stage I (mild) patients SAMA = short-acting muscarinic antagonist SABA = short- acting β2-agonist; ICS = inhaled corticosteroid Tashkin, et al. ATS 2006
- 37. Secondary endpoint: Change from baseline post-bronchodilator FEV1 (L) 0.1 0.09 Treatment TIO 0.08 Change in Post-dose FEV1 (L) SFC 0.07 0.06 0.05 0.04 0.03 0.02 0.01 P=0.218 -2 10 22 34 46 58 70 82 94 106 Wedzicha et al AJRCCM 2008
- 38. Time to First Pneumonia adverse event 12 11 10 Probability of Event (%) 9 8 7 6 5 4 Treatment 3 TIO 2 SFC 1 0 0 13 26 39 52 65 78 91 104 Time to Event (Weeks) Cox Hazard Ratio 95% CI p-value SFC vs TIO 1.94 (1.19, 3.17) 0.008 Wedzicha et al AJRCCM 2008
- 39. Nice outcome - smoking • People with COPD who smoke are regularly encouraged to stop and are offered the full range of evidence-based smoking cessation support.
- 40. 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]
- 42. FRESH • http://www.freshne.com/ • http://www.freshne.com/everybreath/
- 43. Nice Outcomes - oxygen •People with COPD potentially requiring long-term oxygen therapy are assessed in accordance with NICE guidance by a specialist oxygen service. •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
- 44. Long term oxygen therapy –who? •FEV1 < 30% predicted •Cyanosis •Polycythaemia. •Peripheral oedema. •Raised jugular venous pressure. •Oxygen saturations < 92% on air.
- 45. Ambulatory • For people with LTOT • Maximises the hours of oxygen • Some use in significant de- saturators • May have use in exercise classes
- 46. Nebulisers • Mainstay of therapy should be by a conventional inhaled route. • Majority of patients get little added benefit from nebulisers. • Consider nebulisers if: • Patient lacks dexterity to use inhalers. • Patient has cognitive impairment. • Patient has severe COPD and is still symptomatic despite high dose inhaled bronchodilator therapy.
- 47. Nice outcome - rehab • People with COPD meeting appropriate criteria are offered an effective, timely and accessible multidisciplinary pulmonary rehabilitation programme.
- 48. Provide pulmonary rehabilitation Make available to all Hold at times that appropriate people, including Pulmonary suit patients, and in those recently hospitalised rehabilitation buildings with good for an acute exacerbation An individually tailored access multidisciplinary programme of care to optimise patients’ Tailor multi-component, physical and social Offer to all patients who multidisciplinary performance and autonomy consider themselves interventions to individual functionally disabled by patient’s needs COPD [new 2010]
- 49. What does it achieve ? • Pulmonary rehabilitation • Reduces the number of hospital days • Reduces health-care utilization • Increases exercise tolerance • Reduces need for 02 • Reduces exacerbation frequency
- 50. NICE outcome - exacerbations • 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. • 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. • 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. • People admitted to hospital with an exacerbation of COPD are
- 51. 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 • The frequency of exacerbations should be reduced by appropriate use of inhaled corticosteroids and bronchodilators, and vaccinations [2004]
- 52. End of life outcome •People with advanced COPD, and their carers, are identified and offered palliative care that addresses physical, social and emotional needs.
Notas del editor
- ABOUT THIS PRESENTATION: This presentation has been written to help you raise awareness of the NICE clinical guideline on ‘Chronic obstructive pulmonary disease: management of chronic obstructive pulmonary disease in adults in primary and secondary care’ (partial update). This guideline has been written for all healthcare professionals, people with COPD and their carers, patient support groups, commissioning organisations and service providers. The development of this guideline has updated sections of NICE clinical guideline 12 (published February 2004). Other recommendations from 2004 remain appropriate and form part of the new comprehensive guideline. New or updated recommendations have been made for spirometry, assessment of prognostic factors, and to the section on inhaled therapy (which now incorporates the previously separate sections on inhaled bronchodilators, inhaled corticosteroids and inhaled combination therapy). In this presentation and in the NICE guideline, recommendations are marked as following: [2004] indicates the evidence has not been updated and reviewed since the original guideline. [2007] applies to two specific recommendations that were developed as part of a technology appraisal in 2007. [2010] indicates that the evidence has been reviewed but no change has been made to the recommendation. [new 2010] indicates that the evidence has been reviewed and the recommendation has been updated or added. The guideline is available in a number of formats, including a quick reference guide. You should have copies of the quick reference guide available at your presentation so that your audience can refer to it. See the end of the presentation for ordering details. You can add your own organisation ’s logo alongside the NICE logo. We have included notes for presenters, broken down into ‘key points to raise’, which you can highlight in your presentation, and ‘additional information’ that you may want to draw on, such as a rationale or an explanation of the evidence for a recommendation. Where necessary, the recommendation will be given in full. DISCLAIMER This slide set is an implementation tool and should be used alongside the published guidance. This information does not supersede or replace the guidance itself. PROMOTING EQUALITY Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties.
- NOTES FOR PRESENTER There is no single diagnostic test for COPD. Making a diagnosis relies on clinical judgement based on a combination of history, physical examination and confirmation of the presence of airflow obstruction using spirometry.
- NOTES FOR PRESENTERS: Recommendations in full: Measure post-bronchodilator spirometry to confirm the diagnosis of COPD. [1.1.2.2] 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. [1.1.2.4] Related recommendations: 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. [1.1.3.1] Additional investigations should be performed to aid management in some circumstances (see page 6 of the QRG) [1.1.3.2] Spirometry should be performed at the time of the diagnosis and to reconsider the diagnosis. Consider alternative diagnoses in: older people without typical symptoms of COPD where the FEV 1 /FVC ratio is < 0.7 younger people with symptoms of COPD where the FEV 1 /FVC ratio is >0.7 Spirometry services should be supported by quality control processes. Use ERS 1993 reference values but be aware these may lead to under diagnosis in older people and are not applicable in black and Asian populations.
- NOTES FOR PRESENTERS: Key points to raise: Disability in COPD can be poorly reflected in the FEV 1 . A more comprehensive assessment also includes: - degree of airflow obstruction and disability - frequency of exacerbations - prognostic factors such as breathlessness (assessed using the Medical Research Council [MRC] scale), carbon monoxide lung transfer factor [T L CO], health status, exercise capacity, BMI, partial pressure of oxygen in arterial blood [PaO 2 ] and cor pulmonale. Investigate symptoms that seem disproportionate to the spirometric impairment using a CT scan or T L CO testing. Calculate the BODE index (BMI, airflow obstruction, dyspnoea and exercise capacity) to assess prognosis (where the component information is currently available). Assess severity of airflow using the table on the slide. Recommendation in full: The severity of airflow obstruction should be assessed according to the reduction in FEV 1 as shown in table on the slide [1.1.6.1] Abbreviations: ATS, American Thoracic Society; ERS, European Respiratory Society; FVC, forced vital capacity; GOLD, Global Initiative for Chronic Obstructive Lung Disease References : Quanjer PH, Tammeling GJ, Cotes 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 European Respiratory Society. European Respiratory Journal (Suppl) 16:5-40. Celli BR, MacNee W (2004) Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position Paper. European Respiratory Journal 23(6): 932-46. Global Initiative for Chronic Obstructive Lung Disease (GOLD) Global Strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease.
- NOTES FOR PRESENTERS: Please refer your audience to page 10 of the QRG which focuses on delivery systems (inhalers, spacers and nebulisers). Key points to raise: In people with stable COPD and an FEV 1 ≥ 50% who remain breathless or have exacerbations despite maintenance therapy with a LABA: [1.2.2.7] - consider LABA + ICS in a combination inhaler consider LAMA in addition to LABA where ICS is declined or not tolerated. Consider LABA+ ICS in a combination inhaler in addition to LAMA for people with stable COPD who remain breathless or have exacerbations despite maintenance therapy with LAMA irrespective of their FEV 1 . [ 1.2.2.9] The choice of drug(s) should take into account the person ’s symptomatic response and preference, and the drug’s potential to reduce exacerbations, its side effects and cost. [1.2.2.10] Be aware of the potential risk of developing side effects (including non-fatal pneumonia) in people with COPD treated with inhaled corticosteroids and be prepared to discuss with patients [1.2.2.3]
- Reference GOLD. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease, Updated 2009. Available at http://www.goldcopd.com/
- GOLD 2011. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011. Available from: http://www.goldcopd.org/.
- GOLD 2011. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011. Available from: http://www.goldcopd.org/.
- GOLD guidelines recommend maintenance treatment with long-acting inhaled bronchodilators for patients with stage II COPD and to reserve inhaled corticosteroids for patients with stage III and IV (severe and very severe COPD) and frequent exacerbations. However this analysis of baseline data from 5583 patients with available data recruited into a large prospective clinical trial (COPD patients > 40 years of age with post-bronchodilator FEV 1 < 70% and FEV 1 /FVC < 70%) indicates that treatment guidelines are not being adhered to for all patients. Only 62% patients at stage II (moderate) COPD were receiving long-acting bronchodilators and this reached only 70% even in very severe patients. Further, the majority of patients with stage II COPD were already receiving inhaled corticosteroids, despite the fact that this is not currently recommended in the guidelines. Reasons for this could include initial misdiagnosis of asthma and a reluctance to withdraw ICS treatment from patients already receiving them. Reference Tashkin D et al. Prescribing patterns according to COPD treatment guidelines in patients enrolled in a global clinical trial. PATS 2006;3(Abstracts issue): A111.
- Key point There is no significant difference between SFC and TIO for the change from baseline in lung function, at the end of the study (2years) 1 Post-bronchodilator FEV 1 was compared between treatments at each treatment visit using a mixed model repeated measures analysis with covariates of baseline value, baseline smoking status, disease severity, age gender and country. 2 Both treatments achieved an improvement in their lung function from baseline, however this improvement was not statistically significant and there were no significant differences between the two treatments and after 2 years, both treatments had returned to the optimised mean FEV 1 value. The adjusted mean change in post-bronchodilator FEV 1 at 2 years was -0.01L for SFC and 0.01L for TIO (treatment difference -0.02L, 95% CI -0.06, 0.01: p=0.218) Periods of early withdrawal of severe patients will also drive improvement in mean FEV 1 in the TIO arm. In summary You cannot use INSPIRE to compare FEV 1 . 1. Wedzicha et al 2008. AJRCCM. The prevention of COPD exacerbations by salmeterol/fluticasone propionate and tiotropium bromide. Published ahead of print on 4 th October 2007 2. Seemungal TA, Stockley R Calverley PM, Hagan G, Wedzicha JA. Investigating New Standards for Prophylaxis in Reduction of Exacerbations – The INSPIRE study methodology. J. COPD 2007; 4 (3): 173 – 184
- Key points There was a significant increase in pneumonia reporting in patients taking SFC compared with those taking TIO Pneumonia was reported by 8% patients taking Seretide and 4% of patients taking tiotropium. The hazard ratio for time to pneumonia was 1.94 (95% CI 1.19, 3.17 p=0.008) for Seretide compared with tiotropium over the 2 years. It does not appear that the pneumonias translated into an increase in fatal AE ’s Diary card data is being studied to investigate the signal further Data on file DFC/DOF/07/34174/1 2. Wedzicha et al 2008. AJRCCM. The prevention of COPD exacerbations by salmeterol/fluticasone propionate and tiotropium bromide. Published ahead of print on 4 th October 2007
- NOTES FOR PRESENTERS: Recommendations in full: An up-to-date smoking history, including pack years smoked (number of cigarettes smoked per day, divided by 20, multiplied by the number of years smoked), should be documented for everyone with COPD. [1.2.1.1] Unless contraindicated, offer NRT, varenicline or bupropion, as appropriate, to people who are planning to stop smoking combined with an appropriate support programme to optimise smoking quit rates for people with COPD. [1.2.2.3] Additional information: See ‘Varenicline for smoking cessation’ (NICE technology appraisal guidance 123) See ‘Smoking cessation services in primary care, pharmacies, local authorities and workplaces, particularly for manual working groups, pregnant women and hard to reach communities’ (NICE public health guidance 10) A NICE/BMJ Learning on-line educational module (free to all users) is available through the NICE website http://www.nice.org.uk/usingguidance/education/educational_tools.jsp
- NOTES FOR PRESENTERS: Recommendation in full: Pulmonary rehabilitation should be made available to all appropriate people with COPD including those who have had a recent hospitalisation for an acute exacerbation. [1.2.8.1] Pulmonary rehabilitation should be offered to all patients who consider themselves functionally disabled by COPD (usually MRC grade 3 and above). Pulmonary rehabilitation is not suitable for patients who are unable to walk, have unstable angina or who have had a recent myocardial infarction. [1.2.8.2] For pulmonary rehabilitation programmes to be effective, and to improve concordance, they should be held at times that suit patients, and in buildings that are easy for patients to get to and have good access for people with disabilities. Places should be available within a reasonable time of referral. [1.2.8.3] Pulmonary rehabilitation programmes should include multicomponent, multidisciplinary interventions, which are tailored to the individual patient’s needs. The rehabilitation process should incorporate a programme of physical training, disease education, nutritional, psychological and behavioural intervention . [1.2.8.4] Patients should be made aware of the benefits of pulmonary rehabilitation and the commitment required to gain these. [1.2.8.5]
- NOTES FOR PRESENTERS: Key points to raise Please refer your audience to page 17 of the QRG for factors to consider when deciding where to manage exacerbations. Pages 18 and 19 also show an algorithm for investigating and managing exacerbations of COPD. An exacerbation is a sustained worsening of the patient’s symptoms from their usual stable state which is beyond normal day-to-day variations, and is acute in onset. Commonly reported symptoms are worsening breathlessness, cough, increased sputum production and change in sputum colour. The change in these symptoms often necessitates a change in medication.