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Guideline Summary
Guideline Title
Chronic obstructive pulmonary disease.
Bibliographic Source(s)
University of Michigan Health System. Chronic obstructive pulmonary disease. Ann Arbor (MI): University of Michigan Health System; 2010 May. 17 p. [7 references]
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Chronic obstructive pulmonary disease

Guideline Category
Diagnosis
Evaluation
Management
Prevention
Rehabilitation
Risk Assessment
Treatment
Clinical Specialty
Critical Care
Family Practice
Geriatrics
Internal Medicine
Physical Medicine and Rehabilitation
Preventive Medicine
Pulmonary Medicine
Thoracic Surgery
Intended Users
Advanced Practice Nurses
Nurses
Occupational Therapists
Pharmacists
Physician Assistants
Physicians
Respiratory Care Practitioners
Guideline Objective(s)
  • To provide a framework for management of chronic obstructive pulmonary disease (COPD) and for the treatment of mild to moderate acute exacerbations
  • To improve symptoms, quality of life, and lung function while reducing morbidity and mortality for patients with COPD
Target Population

Adults with chronic obstructive pulmonary disease (COPD)

Interventions and Practices Considered

Diagnosis/Evaluation

  1. Considering a diagnosis of chronic obstructive pulmonary disease (COPD) based on risk factors, symptoms, physical examination, and clinical history
  2. Differential diagnosis
  3. Pulmonary function testing with post-bronchodilator assessment
  4. Imaging (chest x-ray, chest computed tomography [CT])
  5. Alpha-1 antitrypsin testing
  6. Oxygen saturation and arterial blood gas testing
  7. Assessment for and management of comorbid diseases

Management/Treatment

  1. Patient education
  2. Preventive care including smoking cessation, vaccination, and avoidance of second hand smoke, occupational fumes, and particulates/air pollution
  3. Medication for chronic care including bronchodilators (short and long-acting B2-agonists and anticholinergics), inhaled corticosteroids

    Note: Oral glucocorticosteroids were considered, but are not generally recommended for use; theophylline was considered, but not recommended as a preferred treatment; leukotriene modifiers were considered, but not recommended for use

  4. Medications for acute care: bronchodilators, systemic corticosteroids, and antibiotics
  5. Follow-up care
  6. Oxygen therapy
  7. Sputum culture

    Note: considered, but not recommended

  8. Pulmonary rehabilitation
  9. Surgical therapy including bullectomy, lung volume reduction surgery, and lung transplantation
  10. Complementary and alternative medicine
  11. Palliative care
  12. Referral to specialist
Major Outcomes Considered
  • Incidence and prevalence of chronic obstructive pulmonary disease
  • Predictive value and utility of diagnostic tests
  • Quality of life
  • Pulmonary function
  • Morbidity
  • Mortality

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

The team began the search of literature by accepting the results of the literature searches performed for fairly recent systematic reviews (see "Annotated References" in the original guideline document for full citation):

Screening for Chronic Obstructive Pulmonary Disease (COPD): Screening for chronic obstructive pulmonary disease using spirometry: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. Apr 1 2008;148(7):529-534. (Searched literature through Dec. 2006.)

Chronic COPD Management: Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline from the American College of Physicians. Annals of Internal Medicine, 2007;147(9):633-638. (Searched diagnosis and management [except below], through May 2005.)

Management of stable chronic obstructive pulmonary disease: a systematic review for a clinical practice guideline. Ann Intern Med. Nov 6 2007;147(9):639-653. (Searched inhaled therapies, pulmonary rehabilitation, disease management, and supplemental oxygen, through March 2007.)

COPD Acute Exacerbation Management: Contemporary management of acute exacerbations of COPD: a systematic review and meta-analysis. Chest. Mar 2008;133(3):756-766. (Searched literature through Nov. 2006)

To update those searches with more recent literature and to examine literature on other topics, a systematic search of literature on Medline was performed. The major search term was chronic obstructive pulmonary disease. The searches were for either guidelines or controlled trials for literature on human adults in the English language. Within these parameters individual searches were performed for the following topics starting with the indicated dates:

  1. Etiology: Smoking, particulate inhalation exposures, alpha-1-antitrypsin deficiency, life expectancy based on FEV1/BODE [1/07]
  2. Screening: Questionnaires, pulmonary function testing/spirometry, [1/03]
  3. Diagnosis: History (risk factors, symptoms), physical exam [6/05]
  4. Diagnostic studies: PFTs, alpha-1-antitrypsin level, chest x-ray, 6 minute walk test, chest CT [6/05]
  5. Diagnostic classification: GOLD classes, MRC or MMRC dyspnea scale, BODE index [6/05]
  6. Definition and diagnosis: Acute exacerbation [12/06]
  7. Other "diagnosis" not included in C–F above [6/05]
  8. Comorbid diseases (increased risk) [6/05]
  9. Prevention: Smoking cessation, vaccination (influenza, pneumococcus) [1/07]
  10. Prevention: Irritant avoidance [1/03]
  11. Pharmacologic treatment: Bronchodilators, inhaled corticosteroids [4/07]
  12. Treatment: Supplemental oxygen [4/07]
  13. Treatment: Pulmonary rehabilitation [4/07]
  14. Treatment: Complementary and alternative medicine [1/03]
  15. Treatment: Mental health, psychosocial support [1/03]
  16. Treatment: Acute exacerbation – outpatient management, hospitalization [12/06]
  17. Referral to pulmonary sub-specialist [4/07]
  18. Surgical treatment: Lung volume reduction surgery, lung transplantation [4/07]
  19. Treatment: Follow up care, monitoring, chronic disease management [1/03]
  20. Treatment: Palliative care [1/03]
  21. Other "treatment" not in I–T above [12/06]
  22. Other not in A–U above [12/06]

The search was conducted in components each keyed to a specific causal link in a formal problem structure (available upon request). The search was supplemented with very recent clinical trials known to expert members of the panel. Negative trials were specifically sought. The search was a single cycle.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Levels of Evidence

  1. Randomized controlled trials
  2. Controlled trials, no randomization
  3. Observational trials
  4. Opinion of expert panel
Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review
Description of the Methods Used to Analyze the Evidence

Conclusions were based on prospective randomized controlled trials (RCTs) if available, to the exclusion of other data; if RCTs were not available, observational studies were admitted to consideration. If no such data were available for a given link in the problem formulation, expert opinion was used to estimate effect size.

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

Not stated

Rating Scheme for the Strength of the Recommendations

Strength of Recommendation

  1. I = Generally should be performed
  2. II = May be reasonable to perform
  3. III = Generally should not be performed
Cost Analysis

Cost-effectiveness of lung volume reduction surgery is not demonstrated for even the most favorable National Emphysema Treatment Trial (NETT) subgroup (i.e., chronic obstructive pulmonary disease [COPD] patients with upper lobe emphysema and reduced exercise capacity) unless outcomes are expected to remain favorable for 10 years.

Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation

Drafts of this guideline were reviewed in clinical conferences and by distribution for comment within departments and divisions of the University of Michigan Medical School to which the content is most relevant: Emergency Medicine, Family Medicine, General Medicine, Geriatric Medicine, Obstetrics & Gynecology (Women's Health), and Pulmonary & Critical Care Medicine. The Executive Committee for Clinical Affairs of the University of Michigan Hospitals and Health Centers endorsed the final version.

Recommendations

Major Recommendations

Note from the University of Michigan Health System (UMHS) and the National Guideline Clearinghouse (NGC): The following guidance was current as of May 2010. Because UMHS occasionally releases minor revisions to its guidance based on new information, users may wish to consult the original guideline document External Web Site Policy for the most current version.

Note from NGC: The following key points summarize the content of the guideline. Refer to the full text for additional information, including detailed information on diagnosis and treatment of chronic obstructive pulmonary disease (COPD).

The levels of evidence (A, B, C, D) and grades of recommendations (I-III) are defined at the end of the "Major Recommendations" field.

COPD is underdiagnosed and misdiagnosed. Routine population screening is not recommended [IIID] but early case finding is encouraged. [ID] Appropriate comprehensive treatment can improve symptoms and quality of life. [IA]

Diagnosis

  • Consider COPD in any patient with dyspnea, chronic cough or sputum production, and/or a history of inhalational exposures known to be risk factors. [ID]
  • Pulmonary function testing with post-bronchodilator assessment demonstrating a reduced forced expiratory volume in one second/forced vital capacity (FEV1/FVC) ratio is required for diagnosis; severity of FEV1 decline (measured as % of predicted FEV1) establishes severity. [ID]

Treatment

  • Smoking cessation is the single most important intervention to slow the rate of lung function decline regardless of disease severity. [IA]
  • Chronic medication management includes:
    • Bronchodilators (B2-agonists and anticholinergics) in stepwise progression based on disease severity (see Tables 9 & 10 in the original guideline document) with the goal of improving symptoms. [IA]
    • Inhaled corticosteroids should be considered only for patients with severe disease (FEV1 <50% predicted) and frequent (at least annual) exacerbations. [IA]
    • Supplemental oxygen if resting oxygen saturation ≤88% or partial pressure of oxygen in arterial blood (PaO2) ≤55. [IA]
  • Acute exacerbation medication management includes bronchodilators (B2-agonists and anticholinergics), antibiotics, and corticosteroid therapy based on clinical indications (see Table 12 in the original guideline document). Empiric antibiotics are recommended for patients with increased sputum purulence plus either increased dyspnea or increased sputum volume. [IA] Sputum culture is not routinely recommended. [IIIC]
  • Pulmonary rehabilitation should be considered for all patients with functional impairment. [IA]
  • Surgical therapy options include bullectomy, lung volume reduction surgery, and lung transplantation. [IIA] Total life expectancy should be incorporated into shared decision making regarding the potential benefits of surgery. [IID] Pulmonary consultation is advised for consideration of surgical options. [ID]
  • Palliative care should be discussed with patients desiring less aggressive therapy, avoidance of endotracheal intubation, or symptomatic care at the end of life. [ID]

Table 1. Overview of Diagnosis and Management of Patients with COPD

Diagnosis

Clinical suspicion. Risk factors of exposure to smoking (≥10 pack-years) or inhalation irritants. Chronic cough, sputum production, or dyspnea. (See symptoms and signs in Table 2 in the original guideline document.)

Pulmonary function test. Required for diagnosis. Post-bronchodilator FEV1/FVC <0.70 is required to demonstrate airflow obstruction that is not fully reversible.

Alternative diagnoses. If pulmonary function testing is negative or equivocal, consider alternative diagnoses (see Tables 3 & 4 in the original guideline document) or consider referral to pulmonary specialist.

Alpha-1 antitrypsin level. Assess for deficiency in settings of clinical suspicion: age 45 or less, absence of other risk factors or severity of disease out of proportion to risk factors, prominent basilar lucency, family history, or bronchiectasis.

Initial Assessment, Patient Education, Prevention, and Treatment

COPD severity staging. Post-bronchodilator FEV1 determines stage (see Table 5 in the original guideline document).

  • For patients with severe disease (FEV1 <50%), obtain oximetry on room air. Respiratory failure (O2 saturation ≤88%) indicates very severe disease (see Table 11 in the original guideline document).
  • For marginal resting room air oxygen saturation (89–93%), perform 6 minute walk test to assess for ambulatory desaturation (see Table 11 in the original guideline document).
  • BODE index assessment (see Table 6 in the original guideline document) may be used to determine prognosis for severe disease, but is usually deferred to referral specialists. (BODE = Body-mass index, Airflow obstruction [% of predicted FEV1], Dyspnea using the modified Medical Research Council dyspnea scale [see Table 7 in the original guideline document], and Exercise capacity [distance walked in 6 minutes].)

Patient education. Provide educational overview of COPD pathology, causes, diagnosis, staging, exacerbation triggers, and treatment options (see Table 8 in the original guideline document).

Smoking cessation. Encourage all smokers to quit, and assist them in quitting. (See the University of Michigan Health System [UMHS] guideline, Smoking Cessation.)

Inhaled irritant control. Identify and review how to avoid triggers and exposures known to cause/aggravate COPD: smoking, second hand smoke, occupational fumes and chemicals, indoor air pollution (e.g., cooking with biomass fuels), outdoor air pollution, infection.

Medical therapy. Select bronchodilator and consider inhaled corticosteroid therapy based on COPD severity by stage and by current frequency of exacerbations (see Table 9 in the original guideline document). Table 10 in the original guideline document provides dose and cost information for medications.

Oxygen therapy. Initiate long term oxygen for patients with oxygen saturation ≤88% (see Table 11 in the original guideline document).

Chronic Disease Management

Vaccinate against influenza and pneumococcus. Provide annual flu shots for all COPD patients. Provide pneumococcal vaccination. Provide a booster pneumococcal vaccine for patients age 65 and older if they received their first dose before age 65 and if more than five years have passed.

Pulmonary rehabilitation. Refer patients with functional limitations to pulmonary rehabilitation.

Medical therapy. Monitor patient adherence and correct usage. Prescribe long-acting bronchodilators for patients with frequent symptoms. For patients with exacerbations requiring systemic steroids or antibiotics within the past year and FEV1 ≤50% predicted, consider adding inhaled corticosteroid therapy (see Table 9 in the original guideline document). Table 10 in the original guideline document provides dose and cost information.

Oxygen therapy. Titrate long-term oxygen for patients with oxygen saturation ≤88% to achieve resting and exercise oxygen saturation ≥90% (see Table 11 in the original guideline document).

Inhaled irritant control. Provide ongoing smoking cessation counseling and irritant control counseling. (See the UMHS guideline Smoking Cessation.)

Monitor comorbidities. Consider increased risk for cardiovascular disease, depression, anxiety, and other smoking related diseases such as osteoporosis and cancer. Monitor blood sugar control for diabetic patients on inhaled corticosteroids. Monitor for glaucoma and cataracts for patients on inhaled corticosteroids.

Refer to COPD specialist. For patients with alpha-1-antitrypsin deficiency, severe disease (FEV1 ≤50%), supplemental oxygen dependence, severe exacerbation and/or frequent exacerbations, consider referral for co-management and consideration of surgical options.

Advanced care planning. Engage patients in shared decision making regarding goals of therapy and advanced directives.

Acute Exacerbation Management

Assess exacerbation severity. Determine severity based on history, physical, and pulse oximetry.

Consider etiology. Assess clinically for risk of pneumonia, congestive heart failure, pulmonary embolism, or other causes of respiratory decline. Consider chest radiograph if clinically indicated.

Determine care setting. Consider hospitalization for patients with marked symptoms, severe underlying disease, significant complicating comorbidities, respiratory failure, uncertain diagnosis, or insufficient outpatient supports.

Medical therapy. Select bronchodilators, antibiotics, and corticosteroid therapy based on clinical indications with the goal of reducing the frequency of future exacerbations (see Table 12 in the original guideline document).

Oxygen therapy. Titrate oxygen for patients with oxygen saturation ≤88% to achieve resting and exercise oxygen saturation ≥90% (see Table 11 in the original guideline document).

Follow-up. Consider repeat spirometry 4-6 weeks following exacerbation if symptoms have not returned to baseline. Re-evaluate necessity of oxygen therapy.

Definitions:

Level of Evidence

  1. Randomized controlled trials
  2. Controlled trials, no randomization
  3. Observational trials
  4. Opinion of expert panel

Grade of Recommendation

  1. Generally should be performed
  2. May be reasonable to perform
  3. Generally should not be performed
Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

Conclusions were based on prospective randomized controlled trials (RCTs) if available, to the exclusion of other data; if RCTs were not available, observational studies were admitted to consideration. If no such data were available for a given link in the problem formulation, expert opinion was used to estimate effect size.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate management of chronic obstructive pulmonary disease (COPD) can improve symptoms, quality of life, and lung function while reducing morbidity and mortality for patients with COPD.

Potential Harms

Long-Acting B2-Agonists (LABAs) and Anticholinergics

  • Long-acting B2-agonists (LABAs). A U.S. Food and Drug Administration (FDA) advisory panel recently reviewed long-acting beta-agonists and recommended that long-acting beta-agonists not be used as single-agent therapy in asthma (see University of Michigan Health System [UMHS] Asthma guideline). While long-acting beta agonists may increase blood pressure and heart rate, data for chronic obstructive pulmonary disease (COPD) patients from the Towards a Revolution in COPD Health (TORCH) study (a three-year, placebo controlled trial in COPD of fluticasone propionate and salmeterol combination versus fluticasone alone, salmeterol alone, or placebo) found no increased risk of all-cause death or cardiovascular death in the salmeterol group. Thus, for patients with COPD, long-acting beta-agonists may still be used without an inhaled corticosteroid. These data further underscore the importance of distinguishing asthma from COPD.
  • Anticholinergics. A recent meta-analysis suggested that inhaled anticholinergics (ipratropium and tiotropium) are associated with significantly increased risk of cardiovascular death, myocardial infarction (MI), or stroke among patients with COPD. However, since then, data from the Understanding Potential Long-term Impacts on Function with Tiotropium (UPLIFT) study (a four-year, placebo controlled trial of tiotropium) found no significant increase in myocardial infarction or stroke in the tiotropium treated group. The clinician should be aware that anticholinergic drugs may also worsen symptoms and signs associated with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction and should be used with caution in patients with any of these conditions.

Inhaled Glucocorticosteroids (ICS)

  • Withdrawal from treatment with inhaled glucocorticosteroids can lead to short term increase in exacerbations in some patients.
  • An increase in the frequency of pneumonia, particularly in patients ≥65, has also been reported. The frequency of reported pneumonia appears to be approximately double in several studies comparing inhaled corticosteroid/LABA combinations versus placebo in COPD. However, in the largest published mortality study in COPD, no increase in pulmonary related deaths was noted in the ICS/LABA combination therapy group as compared to placebo. In patients with COPD being treated with ICS, particularly those over 65, the clinician should be aware of the possible increased risk of pneumonia and maintain a lower threshold for considering a diagnosis of pneumonia when patients present with increased symptoms.
  • Inhaled corticosteroids may also increase a patient's risk for cataracts or glaucoma. Regular eye exams should be considered for patients using these medications. Patients should also be warned about the possibility of ICS related thrush and vocal changes. Rinsing the mouth after use of ICS should be encouraged. Decrease in bone density is a theoretic risk of this class of medication although there is little long-term data in this patient population.

Qualifying Statements

Qualifying Statements

These guidelines should not be construed as including all proper methods of care or excluding other acceptable methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding any specific clinical procedure or treatment must be made by the physician in light of the circumstances presented by the patient.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Patient Resources
Staff Training/Competency Material
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
End of Life Care
Getting Better
Living with Illness
IOM Domain
Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)
University of Michigan Health System. Chronic obstructive pulmonary disease. Ann Arbor (MI): University of Michigan Health System; 2010 May. 17 p. [7 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2010 May
Guideline Developer(s)
University of Michigan Health System - Academic Institution
Source(s) of Funding

University of Michigan Health System

Guideline Committee

Chronic Obstructive Pulmonary Disease (COPD) Guideline Team

Composition of Group That Authored the Guideline

Team Leader: Davoren A Chick, MD, General Medicine

Team Members: Paul J Grant, MD, General Medicine; Meilan K Han, MD, MS, Pulmonary Medicine; R Van Harrison, PhD, Medical Education; Elisa B Picken, MD, Family Medicine

University of Michigan Medical Center (UMMC) Guidelines Oversight Team: Connie J Standiford, MD; William E Chavey, MD; R Van Harrison, PhD

Financial Disclosures/Conflicts of Interest

The University of Michigan Health System endorses the Guidelines of the Association of American Medical Colleges and the Standards of the Accreditation Council for Continuing Medical Education that the individuals who present educational activities disclose significant relationships with commercial companies whose products or services are discussed. Disclosure of a relationship is not intended to suggest bias in the information presented, but is made to provide readers with information that might be of potential importance to their evaluation of the information.

Team Member Relationship Company
Davoren A. Chick, MD None  
Paul J. Grant, MD None  
Meilan K. Han, MD Consultant Novartis, Nycomed
Speaker's bureau Boehringer Ingelheim, GlaxoSmithKline, CLS Boehring
Advisory board CLS Boehring
R. Van Harrison, PhD None  
Elisa B. Picken, MD None  
Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available from the University of Michigan Health System Web site External Web Site Policy.

Availability of Companion Documents

Continuing Medical Education (CME) information is available from the University of Michigan Health System Web site External Web Site Policy.

Patient Resources

The following is available:

  • Learn about COPD (chronic obstructive pulmonary disease). Health topics. Ann Arbor (MI): University of Michigan Health System; 2008 May. Various p. Electronic copies: Available from the University of Michigan Health System Web site External Web Site Policy.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI Institute on October 13, 2010.

Copyright Statement

This NGC summary is based on the original guideline, which is copyrighted by the University of Michigan Health System (UMHS).

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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