NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE 1 Guideline title SCOPE Chronic obstructive pulmonary disease: the management of adults with chronic obstructive pulmonary disease in primary and secondary care (partial update) 1.1 Short title COPD (partial update) 2 Background a) The National Institute for Health and Clinical Excellence ( NICE or the Institute ) has commissioned the National Collaborating Centre for Chronic Conditions to review recent evidence on chronic obstructive pulmonary disease (COPD) and to update some sections of the existing guideline Chronic obstructive pulmonary disease: management of chronic obstructive pulmonary disease in adults in primary and secondary care (NICE clinical guideline 12, 2004) for use in the NHS in England and Wales. The guideline will provide recommendations for good practice that are based on the best available evidence of clinical and cost effectiveness. b) NICE clinical guidelines support the implementation of National Service Frameworks (NSFs) in those aspects of care where a Framework has been published. The statements in each NSF reflect the evidence that was used at the time the Framework was prepared. The clinical guidelines and technology appraisals published by NICE after an NSF has been issued have the effect of updating the Framework. COPD (partial update) scope December 2008 Page 1 of 13
c) NICE clinical guidelines support the role of healthcare professionals in providing care in partnership with patients, taking account of their individual needs and preferences, and ensuring that patients (and their carers and families, if appropriate) can make informed decisions about their care and treatment. 3 Clinical need for the guideline a) Since the publication of NICE clinical guideline 12 (2004), there has been progress in the management of COPD, and the importance of systemic aspects of the disease also has been recognised. New initiatives such as the introduction of the Quality and Outcomes Framework for General Practice have helped the delivery of evidence-based care, but COPD is still a common cause of morbidity and mortality in England and Wales. b) People with COPD experience progressive breathlessness and reduction in exercise capacity. Exacerbations frequently result in hospital admission. COPD remains the fifth most common cause of death in England and Wales, accounting for more than 28,000 deaths in 2005. It is also one of the 10 most common causes of hospital admission. Many patients, including those with severe airflow obstruction, remain undiagnosed even though diagnostic testing using spirometry is increasingly available. c) The development of a Clinical Strategy for COPD (originally announced as a National Service Framework) was announced in 2006 and it is expected that this will be published in late 2008 or early 2009. This partial update will provide evidence-based recommendations that will support the implementation of the Clinical Strategy for COPD. 4 The guideline a) The guideline development process is described in detail in two publications that are available from the NICE website (see Further COPD (partial update) scope December 2008 Page 2 of 13
information ). The guideline development process: an overview for stakeholders, the public and the NHS describes how organisations can become involved in the development of a guideline. The guidelines manual provides advice on the technical aspects of guideline development. b) This scope defines what this guideline will (and will not) examine, and what the guideline developers will consider. This scope should be read along with the original scope for Chronic obstructive pulmonary disease: management of chronic obstructive pulmonary disease in adults in primary and secondary care (NICE clinical guideline 12, 2004), which is reproduced in the appendix. c) The areas that will be addressed by the guideline are described in the following sections. 4.1 Population 4.1.1 Groups that will be covered a) Adults (16 years and older) with stable COPD (including chronic bronchitis, emphysema and chronic airflow limitation/obstruction). 4.1.2 Groups that will not be covered a) People with asthma, bronchopulmonary dysplasia or bronchiectasis. b) Children younger than 16 years. c) People with an acute exacerbation of COPD. 4.2 Healthcare setting a) Care given by primary and secondary healthcare professionals who have responsibility for patients with COPD and who make decisions concerning their care. COPD (partial update) scope December 2008 Page 3 of 13
b) The guideline will also be relevant to the work, but will not cover the practice, of social services or patient support groups. 4.3 Clinical management 4.3.1 Topics that will be covered a) Diagnosis and severity classification: spirometry and post bronchodilator values multidimensional severity assessment indices, for example the BODE Index (which comprises body mass index, airflow obstruction, dyspnoea and exercise tolerance). b) Management of stable COPD and prevention of disease progression (updates section 7 of NICE clinical guideline 12): long-acting bronchodilators: beta2-agonists and anticholinergics (tiotropium, formoterol fumarate, salmeterol) as monotherapy and in combination, both with and without inhaled corticosteroids mucolytic therapy (carbocisteine and mecysteine hydrochloride). c) Note that guideline recommendations will normally fall within licensed indications; exceptionally, and only if clearly supported by evidence, use outside a licensed indication may be recommended. The guideline will assume that prescribers will use a drug s summary of product characteristics to inform their decisions for individual patients. d) The Guideline Development Group will take reasonable steps to identify ineffective interventions and approaches to care. If robust and credible recommendations for re-positioning the intervention for optimal use, or changing the approach to care to make more efficient use of resources, can be made, they will be clearly stated. If the resources released are substantial, consideration will be given to listing such recommendations in the Key priorities for implementation section of the guideline. COPD (partial update) scope December 2008 Page 4 of 13
e) If there is evidence, the guideline will consider any subgroups (for example, ethnicity) in whom the recognition and diagnosis of COPD may differ from recognition and diagnosis in the general population. 4.3.2 Topics that will not be covered The following topics, originally covered in NICE clinical guideline 12, will not be covered in this partial update a) Short-acting bronchodilator therapy (except as a comparator for long-acting bronchodilator therapy). b) Theophylline. c) Phosphodiesterase type 4 inhibitors. d) Drug delivery systems. e) Oxygen therapy. f) Management of pulmonary hypertension and cor pulmonale. g) Pulmonary rehabilitation interventions. h) Vaccination and antiviral therapy. i) Lung surgery. j) Alpha-1 antitrypsin replacement therapy. k) Antioxidant therapy. l) Antitussive therapy. m) Prophylactic antibiotic therapy. n) Multidisciplinary management (respiratory nurse specialists, physiotherapy, identifying and managing anxiety and depression, nutritional factors, palliative care, assessment for occupational therapy, social services, education, self-management, advice on travel). COPD (partial update) scope December 2008 Page 5 of 13
o) Fitness for general surgery. p) Follow-up of patients with COPD. q) Management of exacerbations. r) Audit criteria. 4.4 Status 4.4.1 Scope This is the final scope. 4.4.2 Guideline The development of the guideline recommendations will begin in September 2008. 5 Related NICE guidance The guideline will partially update the following NICE guidance: Chronic obstructive pulmonary disease: management of chronic obstructive pulmonary disease in adults in primary and secondary care. NICE clinical guideline 12 (2004). Available from www.nice.org.uk/cg12 The guideline will incorporate the following NICE guidance: Varenicline for smoking cessation. NICE technology appraisal guidance 123 (2007). Available from www.nice.org.uk/ta123 6 Further information The guideline development process is described in: The guideline development process: an overview for stakeholders, the public and the NHS The guidelines manual. COPD (partial update) scope December 2008 Page 6 of 13
These are available from the NICE website (www.nice.org.uk/guidelinesmanual). Information on the progress of the guideline will also be available from the website. COPD (partial update) scope December 2008 Page 7 of 13
Appendix: Scope for NICE clinical guideline 12 NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE 1 Guideline title SCOPE Chronic obstructive pulmonary disease: the management of adults with chronic obstructive pulmonary disease in primary and secondary care 1.1 Short title COPD 2 Background a) The National Institute for Clinical Excellence ( NICE or the Institute ) has commissioned the National Collaborating Centre for Chronic Conditions to develop a clinical guideline on the management of chronic obstructive pulmonary disease for use in the NHS in England and Wales. This follows referral of the topic by the Department of Health and National Assembly for Wales (see appendix). The guideline will provide recommendations for good practice that are based on the best available evidence of clinical and cost effectiveness. b) The Institute s clinical guidelines will support the implementation of National Service Frameworks (NSFs) in those aspects of care where a Framework has been published. The statements in each NSF reflect the evidence that was used at the time the Framework was prepared. The clinical guidelines and technology appraisals published by the Institute after an NSF has been issued will have the effect of updating the Framework. Scope for NICE clinical guideline 12 (2004) Page 8 of 13
3 Clinical need for the guideline a) COPD is the fifth commonest cause of death in England and Wales, accounting for nearly 28,000 deaths each year and Britain has one of the highest death rates from COPD in the European Union. It is estimated that there are about 600,000 patients in the UK with diagnosed COPD and there may be as many again who remain undiagnosed. COPD patients are frequent users of primary and secondary care services with an estimate of one in eight hospital admissions being due to COPD. Consultation rates in general practice rise with age from 417 in those aged 45 64 per 10,000 population per year to 1032 in those aged 75 84 per year per 10,000 population (BTS, 1997). COPD results in an estimated 27 million lost working days per year. b) Recent national guidelines in the area include the guideline developed by the British Thoracic Society (Thorax 1997; 52 [suppl 5]; S1), the GOLD International guidelines (2001), Use of Nebulisers (Thorax 1997; 52 [suppl 2]) and the NIV guidelines (in press: Thorax). c) Technology appraisals on the Institute s programme that will inform this guideline include guidance on zanamivir (Relenza) for influenza, smoking cessation treatments and nicotine replacement therapy (expected March 2002) and comparison of the effectiveness of inhaler devices in asthma and chronic obstructive airways disease: a systematic review of the literature (Health Technology Assessment 2001; Vol. 5: No. 26). 4 The guideline a) The guideline development process is described in detail in three booklets that are available from the NICE website (see Further information ). The Guideline Development Process Information for Stakeholders describes how organisations can become involved in the development of a guideline. Scope for NICE clinical guideline 12 (2004) Page 9 of 13
a) This document is the scope. It defines exactly what this guideline will (and will not) examine, and what the guideline developers will consider. The scope is based on the referral from the Department of Health and National Assembly for Wales (see Box). b) The areas that will be addressed by the guideline are described in the following sections. 4.1 Population 4.1.1 Groups that will be covered a) The guideline will offer best practice advice on the care of adults who have a clinical working diagnosis of COPD including chronic bronchitis, emphysema, and chronic airflow limitation/obstruction. 4.1.2 Groups that will not be covered a) The guideline will not cover the management of people with asthma, bronchopulmonary dysplasia or bronchiectasis. b) The guideline will not cover children (aged < 16 years). 4.2 Healthcare setting a) The guideline will cover the care received from primary and secondary healthcare professionals who have direct contact with and make decisions concerning the care of patients with COPD. b) The guideline will also be relevant to the work, but will not cover the practice, of social services, patient support groups or palliative care services. 4.3 Clinical management The guideline will include recommendations in the following areas. a) Diagnostic criteria, including the role of spirometry in primary and secondary care. Scope for NICE clinical guideline 12 (2004) Page 10 of 13
b) Identification of early disease to facilitate preventative approaches. The guideline will not cover general population screening, but will include opportunistic case find. c) Management of stable patients, management of acute exacerbations and prevention of progression of the disease, to include: smoking cessation, including pharmacological and nonpharmacological approaches as they relate specifically to COPD bronchodilator management including methods of delivery and methods of assessing efficacy inhaled and oral corticosteroid therapy non-pharmacological interventions, including pulmonary rehabilitation and respiratory physiotherapy, lifestyle advice including nutritional/metabolic assessment and management and self-management techniques the management of right heart failure as it pertains to COPD oxygen therapy including when It should be used and what type is appropriate in different circumstances non-invasive ventilation indications for surgery d) Criteria for admission and/or management at home of exacerbations. e) Management of depression and/or anxiety as it pertains directly to patients with COPD and is outside the scope of the Management of Depression guideline which is under development. f) Advice on treatment options will be based on the best evidence available to the development group. When referring to pharmacological treatments, the guideline will normally recommend use within licensed indications. Exceptionally, and only where the evidence clearly supports it, recommendations for the guideline Scope for NICE clinical guideline 12 (2004) Page 11 of 13
may recommend use outside the licence indications. The guideline assumes that prescribers will use the Summary of Product Characteristics to inform their prescribing decisions for individual patients. 4.4 Audit support within guideline The guideline will include review criteria for audit. 4.5 Status 4.5.1 Scope This is the final version of the scope. 4.5.2 Guideline The development of the guideline recommendations will begin in the second quarter of 2002. 5 Further information Information on the guideline development process is provided in: The Guideline Development Process Information for the Public and the NHS The Guideline Development Process Information for Stakeholders The Guideline Development Process Information for National Collaborating Centres and Guideline Development Groups. These booklets are available as PDF files from the NICE website (www.nice.org.uk). Information of the progress of the guideline will also be available from the website. 6 References BTS guidelines for the management of chronic obstructive pulmonary disease. The COPD Guidelines Group of the Standards of Care Committee of the BTS. Thorax 1997; 52 Suppl 5:S1-28. Scope for NICE clinical guideline 12 (2004) Page 12 of 13
Current best practice for nebuliser treatment. British Thoracic Society Nebulizer Project Group [published erratum appears in Thorax 1997 Sep; 52(9): 838] Thorax 1997; 52 (Suppl 2): S1-S3. Pocket Guide to COPD Diagnosis, Management, and Prevention. Global Initiative for Chronic Obstructive Lung Disease; U.S. Department of Health and Human Services; Public Health Service; National Institutes of Health; National Heart, Lung, and Blood Institute; NIH Publication No. 2701B Referral from the Department of Health and National Assembly for Wales 'To prepare clinical guidelines for the NHS in England and Wales for the prevention, diagnosis, management and treatment of COPD.' Scope for NICE clinical guideline 12 (2004) Page 13 of 13