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ICSI

I NSTITUTE FOR C LINICAL S YSTEMS I MPROVEMENT

Health Care Guideline

The information contained in this ICSI Health Care Guideline is intended primarily for health professionals and the following expert audiences: physicians, nurses, and other health care professional and provider organizations; health plans, health systems, health care organizations, hospitals and integrated health care delivery systems; medical specialty and professional societies; researchers; federal, state and local government health care policy makers and specialists; and employee benefit managers. This ICSI Health Care Guideline should not be construed as medical advice or medical opinion related to any specific facts or circumstances. If you are not one of the expert audiences listed above you are urged to consult a health care professional regarding your own situation and any specific medical questions you may have. In addition, you should seek assistance from a health care professional in interpreting this ICSI Health Care Guideline and applying it in your individual case. This ICSI Health Care Guideline is designed to assist clinicians by providing an analytical framework for the evaluation and treatment of patients, and is not intended either to replace a clinicians judgment or to establish a protocol for all patients with a particular condition. An ICSI Health Care Guideline rarely will establish the only approach to a problem. Copies of this ICSI Health Care Guideline may be distributed by any organization to the organizations employees but, except as provided below, may not be distributed outside of the organization without the prior written consent of the Institute for Clinical Systems Improvement, Inc. If the organization is a legally constituted medical group, the ICSI Health Care Guideline may be used by the medical group in any of the following ways: copies may be provided to anyone involved in the medical groups process for developing and implementing clinical guidelines; the ICSI Health Care Guideline may be adopted or adapted for use within the medical group only, provided that ICSI receives appropriate attribution on all written or electronic documents; and copies may be provided to patients and the clinicians who manage their care, if the ICSI Health Care Guideline is incorporated into the medical groups clinical guideline program. All other copyright rights in this ICSI Health Care Guideline are reserved by the Institute for Clinical Systems Improvement. The Institute for Clinical Systems Improvement assumes no liability for any adaptations or revisions or modifications made to this ICSI Health Care Guideline .

ICS I
I NSTITUTE FOR C LINICAL S Y S T E M S I M P ROV E M E N T

Health Care Guideline:

Chronic Obstructive Pulmonary Disease


1

Sixth Edition January 2007


Work Group Leader
James Mickman, MD Pulmonology & Critical Care Medicine, HealthPartners Medical Group

Symptoms of or risk factors for COPD


A
2

A = Annotation

Ask about tobacco use/exposure at every visit


A
3

Work Group Members


Family Medicine Allen Horn, MD CentraCare Clinic G. Paul Kerestes, MD Allina Medical Clinic Nursing and Health Education Catherine Youngman, RN HealthPartners Medical Group Pharmacy Stefanie Larson, RPH Park Nicollet Health Services Pulmonary & Critical Care Medicine Delmar Gillespie, MD Mayo Clinic Charlene McEvoy, MD HealthPartners Regions Hospital Respiratory Therapy Scott Copeman, RRT, RCP Mayo Clinic Jeff Norton, CRT, RCP Fairview Health Services Measurement and Implementation Advisor Teresa Hunteman, RRT, CPHQ ICSI Facilitator Linda Setterlund, MA ICSI

Establish diagnosis of COPD Medical history Physical examination Spirometry (pre- and post-bronchodilator) Chest radiograph
4

Acute exacerbation?
A no
10

yes

Evaluation
A

Treatment
A

Establish severity of stable COPD Mild Moderate Severe


11

Arrange for follow-up


A

yes

Positive response to treatment?


A no
9

Step-care pharmacologic approach for managing stable COPD


A
12

Admit to hospital out of guideline


A

Other pharmacologic treatment


A
13

Non-pharmacologic treatment applicable to all levels of severity Encourage exercise Education Pulmonary rehab program for moderate, severe disease
A
14

Assess for hypoxemia and hypercapnia and treat if indicated


A
15

These clinical guidelines are designed to assist clinicians by providing an analytical framework for the evaluation and treatment of patients, and are not intended either to replace a clinician's judgment or to establish a protocol for all patients with a particular condition. A guideline will rarely establish the only approach to a problem.

Long-term management Schedule regular follow-up visits Evaluation and monitoring of comorbidities Refer to pulmonary specialist Surgical options for severe disease Discuss health care directives (advance directives) and goals of care
A

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Table of Contents

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Algorithms and Annotations ................................................................................................................1-41


Algorithm ..............................................................................................................................................1 Foreword Scope and Target Population ..........................................................................................................3 Clinical Highlights and Recommendations ....................................................................................3 Priority Aims ..................................................................................................................................3 Related ICSI Scientific Documents ................................................................................................4 Brief Description of Evidence Grading ..........................................................................................4 Disclosure of Potential Conflict of Interest ....................................................................................4 Annotations ...........................................................................................................................................5-36 Appendices............................................................................................................................................37-41 Appendix A Estimated Comparative Daily Dosage for Inhaled Corticosteroids..............................................................................................................37 Appendix B Medicare Standard for Oxygen Coverage...............................................................38 Appendix C Summary of Structure and Services Pulmonary Rehabilitation Program ..............................................................................................39-41

Supporting Evidence ..............................................................................................................................42-59


Evidence Grading System .....................................................................................................................43-44 References .............................................................................................................................................45-51 Conclusion Grading Worksheets ...........................................................................................................52-59 Conclusion Grading Worksheet A Annotation #11 (Pharmacological Management) .................52-59

Support for Implementation ................................................................................................................60-65


Priority Aims and Suggested Measures ................................................................................................61-62 Measurement Specifications ...........................................................................................................63 Key Implementation Recommendations ...............................................................................................64 Knowledge Products and Resources .....................................................................................................64 Other Resources Available ....................................................................................................................65

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Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Foreword
Scope and Target Population
Although chronic obstructive pulmonary disease (COPD) can occur in adults of any age, especially smokers, it most commonly occurs in people 45 years and older. The target population for this guideline is people with symptoms of stable COPD as well as acute exacerbations of COPD.

Clinical Highlights and Recommendations


Assess patients for symptoms and risk factors for COPD, including asking about tobacco use/exposure at every visit. (Annotations #1, 2) Establish diagnosis and severity of COPD through spirometry, pre- and post-bronchodilator and chest radiograph, in addition to history and physical examination. (Annotation #3) After establishing severity, assess patient needs for pharmacologic and non-pharmacologic treatment and provide appropriate therapy as indicated. (Annotations #11, 12, 13) Management of COPD should include an education plan suited to the patient's specific needs, encouragement of exercise, tobacco use cessation and other behavioral changes, and monitoring of immunization status. (Annotations #2, 13) A trial of inhaled steroids is indicated for symptoms not controlled by scheduled bronchodilators. (Annotation #11) A course of systemic steroids is beneficial for COPD exacerbations. (Annotation #6) Tiotropium offers significant advantages compared to other bronchodilators to patients whose symptoms are not controlled by albuterol. (Annotation #11) For patients with severe symptoms, despite maximal medical therapy, lung volume reduction surgery and transplantation may be an option. (Annotation #15) Patients should be regularly assessed for hypoxemia; appropriate oxygen therapy should be prescribed accordingly. (Annotation #14) Physicians should discuss advance directives/health care directives and goals of care as early as possible. (Annotation #15)

Priority Aims
1. Increase the quality and use of spirometry testing in the diagnosis of patients with COPD. 2. Increase the number of patients with COPD who receive information on the options for tobacco cessation and information on the risks of continued smoking. 3. Reduce COPD exacerbation requiring emergency department (ED) evaluation or hospital admission. 4. Increase the appropriate use of pharmacotherapy prescribed for patients with COPD. 5. Increase patients' education and management skills with COPD. 6. Increase the number of patients with COPD presenting with an acute exacerbation who have an oxymetric evaluation.

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Foreword

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Related ICSI Scientific Documents


Related Guidelines Diagnosis and Management of Asthma Emergency and Inpatient Management of Asthma Respiratory Illness in Adults and Children Tobacco Use Cessation and Prevention in Adults Palliative Care Lung Volume Reduction Surgery for Emphysema (#23, 2003) Case Management for Chronic Illness, the Frail Elderly, and Acute MI (#44, 1998) Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease ( #32, 1997) Chronic Obstructive Pulmonary Disease for Patients and Families

Technology Assessment Reports

Patient and Family Guidelines

Evidence Grading
Individual research reports are assigned a letter indicating the class of report based on design type: A, B, C, D, M, R, X. Key conclusions are assigned a conclusion grade: I, II, III, or Grade Not Assignable. A full explanation of these designators is found in the Supporting Evidence section of the guideline.

Disclosure of Potential Conflict of Interest


In the interest of full disclosure, ICSI has adopted the policy of revealing relationships work group members have with companies that sell products or services that are relevant to this guideline topic. The reader should not assume that these financial interests will have an adverse impact on the content of the guideline, but they are noted here to fully inform readers. Readers of the guideline may assume that only work group members listed below have potential conflicts of interest to disclose. No work group members have potential conflicts of interest to disclose. ICSI's conflict of interest policy and procedures are available for review on ICSI's Web site at http://www.icsi.org.

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Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Algorithm Annotations
1. Symptoms of or Risk Factors for COPD
COPD may be indicated by the presence of one of the following symptoms: Chronic cough (duration greater than three months) with or without sputum production Dyspnea with or without wheezing History of tobacco use or prolonged exposure to secondhand or environmental smoke Asthma Environmental exposure to occupational dust and chemicals (e.g., cadmium) Alpha1- antitrypsin deficiency Chronic respiratory infections

COPD should also be considered if the patient has one or more of the following risk factors:

2. Ask About Tobacco Use/Exposure at Every Visit Key Points:


Tobacco cessation and oxygen therapy are the only interventions proven to prolong survival of patients with COPD.
Ten to fifteen percent of long-term smokers develop COPD with accelerated rates of decline in FEV1. Advice and support from physicians and other health professionals are potentially powerful influences on tobacco cessation. According to the U.S. Surgeon General, tobacco use is one of the most important public health issues of our time. The National Cancer Institute, which is the primary federal agency for tobacco control, states that the keys to patient awareness and education about tobacco cessation in a clinical setting are: ASK ADVISE ASSESS ASSIST ARRANGE about tobacco use at every visit all users to stop users' willingness to make a quit attempt users' efforts to quit follow-up

Reinforcement of tobacco cessation and follow-up for patients with COPD are extremely important. Pharmacotherapy, social support and skills training/problem solving are the key treatments for tobacco cessation. Nicotine patches, nasal sprays, inhalers and oral medication are all available to help patients achieve cessation (Dale, 2001; Institute for Clinical Systems Improvement, 2000; U.S. Department of Health and Human Services, 2000). For more information about tobacco cessation, please refer to the ICSI Tobacco Use Prevention and Cessation for Adults and Mature Adolescents guideline and the U.S. Department of Health and Human Services Clinical Practice Guideline, Treating Tobacco Use and Dependence. Supporting evidence is of classes: A, R

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Algorithm Annotations

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

3. Establish Diagnosis of COPD Key Points:


The American Thoracic Society (ATS) defines COPD as follows: COPD is a disease characterized by the presence of airflow obstruction due to chronic bronchitis or emphysema; the airflow obstruction is generally progressive, may be accompanied by airway hyperreactivity and may be partially reversible. Chronic bronchitis is defined as the presence of chronic productive cough for three months in each of two successive years in a patient in whom other causes of chronic cough have been excluded. Emphysema is defined as an abnormal permanent enlargement of the air spaces distal to the terminal bronchioles, accompanied by destruction of their walls and without obvious fibrosis.
The diagnosis of COPD should be suspected based on the patient's medical history and physical examination, but requires spirometry to determine the degree of airflow limitation. Signs/symptoms for which COPD may be suspected: Wheezing, prolonged expiratory phase of respiration, rhonchi and cough Dyspnea (exertional or at rest) Chronic sputum production Hyperinflation of the chest with increased anterior-posterior (A-P) diameter Use of accessory muscles of respiration Pursed-lip breathing Signs of cor pulmonale: Increased pulmonic component of the second heart sound Neck vein distention Lower extremity edema Hepatomegaly NOTE: finger clubbing is not characteristic of COPD and should alert the clinician to another condition such as idiopathic pulmonary fibrosis (IPF), cystic fibrosis, lung cancer or asbestosis. Airflow obstruction is measured by spirometry and shows a reduced forced expiratory volume in one second (FEV1) and FEV1/FVC (forced vital capacity) ratio. Measuring pre- and post-bronchodilator spirometry is important to identify those patients with partial reversibility of airflow obstruction. Partial reversibility is defined as improvement in airflow by 12% of baseline and 200 mL after administration of a bronchodilator.

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Algorithm Annotations Spirometry

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Spirometry is an established and important method of measuring lung function for the diagnosis and management of patients with COPD. It is recommended for symptomatic patients at risk of COPD, particularly smokers greater than 45 years of age, and for regular follow-up of patients with documented COPD (Wilt, 2005). Pre- and Post-bronchodilator FEV1 It is important to distinguish COPD from asthma, because treatment and prognosis differ. Measurement of pre- and post-bronchodilator FEV1 can assist with this differentation. In asthma, the spirometric abnormality tends to return to normal with bronchodilators, although this distinction between COPD and asthma is not strictly rigid. Factors commonly used to distinguish COPD from asthma include age of onset, smoking history, triggering factors and occupational history. If the quality of available spirometry is questionable, formal spirometry in a PFT lab should be considered. Full PFTs with lung volumes and Diffusion Capacity (DLCO) are not recommended nor necessary to establish diagnosis or severity of COPD. Spirometry, interpretation strategies, selection of reference values and quality control should be performed in compliance with the Standards on Spirometry published by the American Thoracic Society (ATS) (ATS, 1991) and with the ATS' Statement on Standardization of Spirometry 1994 update (ATS, 1994). The spirometer must meet or exceed requirements proposed by the ATS. Automated maneuver acceptability and reproducibility messages must be displayed and reported. Spirometers should produce a paper record. The use of a nose clip for all spirometric maneuvers is strongly recommended. Subjects may be studied in either the sitting or standing position. Universal precautions should be applied in all instances in which there is potential for blood and body fluid exposure. Appropriate use of gloves and hand washing are highly recommended. Patients suspected of having M. tuberculosis or other airborne organisms should be tested in areas complying with the U.S. Public Health Service recommendations for air exchange and ventilation. Daily calibration prior to testing using a calibrated known volume syringe with a volume of at least 3 liters performed to manufacturer's recommendations is recommended. A log documenting instrument calibrations should be maintained. Discussion of spirometry results with current smokers should be accompanied by strong advice to quit smoking and referral to smoking cessation resources.

(AARC Clinical Practice Guideline, 1996; American Thoracic Society, 1991; American Thoracic Society, 1995; Ferguson, 2000; American Thoracic Society, 1994) Although peak flow meters should not be used to diagnose or monitor COPD, monitoring of peak expiratory flow (PEF) at home and at work can be used in certain situations to determine reversibility of and variability in airway obstruction. Supporting evidence is of class: R Chest Radiograph A chest radiograph is recommended at the time of diagnosis to exclude other causes. The chest radiograph in COPD is often normal but may show signs of hyperinflation, a flattened diaphragm, or bullae.

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Algorithm Annotations Bronchitis and Emphysema

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

The airflow obstruction in COPD may be due to chronic bronchitis or emphysema. Chronic bronchitis is defined as the presence of a chronic productive cough for three months in each of two successive years in a patient in whom other causes of chronic cough have been excluded. Emphysema is defined as an abnormal permanent enlargement of the air spaces distal to the terminal bronchioles, accompanied by destruction of their walls and without obvious fibrosis. Radiographically, bullae may be visible on a chest computerized tomography scan or occasionally on a chest radiograph. Clinically, emphysema typically presents with a non-productive or minimally productive cough and progressive dyspnea. Since both chronic bronchitis and emphysema result in airflow limitation, management goals are similar. Differential Diagnosis In addition to asthma, possible differential diagnoses for COPD include bronchiectasis, cystic fibrosis, obliterative bronchiolitis, congestive heart failure and upper airway lesions. For more information on diagnosis and treatment of asthma, please refer to the ICSI Diagnosis and Treatment of Asthma guideline.

Definition of COPD from Other Guidelines:


The Global Initiative for Chronic Obstructive Lung Disease (Global Initiative for Chronic Obstructive Lung Disease) defines COPD as follows: A preventable and treatable disease characterized by chronic airflow limitation that is not fully reversible. Airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lungs.

(Global Initiative for Chronic Obstructive Lung Disease, 2006) The British Thoracic Society (BTS) defines COPD as follows: A chronic, slowly progressive disorder characterized by airflow obstruction that does not change markedly over several months. Most of the lung function impairment is fixed, although some reversibility can be produced by bronchodilator. The diagnosis requires a history of chronic progressive symptoms (cough and/or wheeze and/or breathlessness), objective evidence of airway obstruction ideally by spirometric testing that does not return to normal with treatment. The presence of chronic cough and sputum production for at least three months of two consecutive years in the absence of other diseases is used as a definition of chronic bronchitis, but does not necessarily signify the presence of airway obstruction or a diagnosis of COPD.

(British Thoracic Society, 1997) The European Respiratory Society (ERS) defines COPD as follows: A disorder characterized by reduced maximum expiratory flows and slow, forced emptying of the lungs; features do not change markedly over several months Airflow limitation due to varying combinations of airway disease and emphysema Patients exhibit minimal reversibility of airflow limitation with bronchodilators

(European Respiratory Society, 1995)

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Algorithm Annotations

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Recommended Tools for the Diagnosis of COPD from Other Guidelines


Spirometry is recommended by ATS, BTS, ERS and GOLD Pre- and post-bronchodilator recommended by ATS, BTS, ERS and GOLD Chest radiograph recommended by ATS, ERS and GOLD. BTS recommends chest radiograph if disease is severe Resting oxygen saturation measurement suggested by ERS in moderate or severe disease, and BTS in severe disease ABG recommended by ERS in moderate or severe disease or if oxygen saturation is less than 92%, by ATS in moderate or severe disease, and by BTS and GOLD in severe disease Screening for alpha1-antitrypsin concentration recommended by ERS, GOLD and ATS in patients who develop COPD at a young age

Reversibility Testing (measurement of pre- and post-bronchial dilator)


NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (Global Initiative for Chronic Obstructive Lung Disease): Generally performed only once at time of diagnosis, this test is useful to help rule out asthma, to establish a patient's best attainable lung function, to gauge a patient's prognosis, and to guide treatment decisions. Even patients who do not show a significant FEV1 response to a short-acting bronchodilator test can benefit symptomatically from long-term bronchodilator treatment. A positive bronchodilator response (FEV1 greater than 200 mL and 15% over baseline value) suggests asthma. More than 20% variability in absolute measurement of serial PEF may suggest asthma. Atopy and marked improvement of spirometry with administration of bronchodilators or glucocorticosteroids favor the diagnosis of asthma. Testing of bronchoconstrictor response is of doubtful clinical value in patients with established airflow limitation. Significant reversibility is indicated by an increase of over 12% and 200 mL after inhaling a shortacting bronchodilator.

British Thoracic Society, COPD Guidelines Group of the Standards of Care Committee: -

European Respiratory Society (ERS): -

American Thoracic Society (ATS): -

4. Acute Exacerbation?
Signs and symptoms of an acute exacerbation of COPD may include any of the following: Increased dyspnea Increased heart rate Increased cough

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Algorithm Annotations Increased sputum production Change in sputum color or character Use of accessory muscles of respiration Peripheral edema Development or increase in wheeze Change in mental status Fatigue Fever Increased respiratory rate Decrease in FEV1 or peak expiratory flow Hypoxemia Chest tightness

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Change in mental status or a combination of two or more of the following new symptoms indicates a severe acute exacerbation: Dyspnea at rest Respiratory rate of greater than 25 breaths per minute Heart rate of greater than 110 beats per minute Use of accessory muscles of respiration

5. Evaluation
When a patient with known COPD presents with a moderate to severe acute exacerbation, the following key elements of the history, physical examination and laboratory/radiology evaluation should be considered: History Baseline respiratory status Present treatment regimen and recent medication use Signs of airway infection, e.g., fever and/or change in volume and/or color of sputum Duration of worsening symptoms Limitation of activities History of previous exacerbations Increased cough Decrease in exercise tolerance Chest tightness Change in alertness Other non-specific symptoms including malaise, difficulty sleeping, and fatigue

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Algorithm Annotations

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Symptoms associated with comorbid acute and chronic conditions Although rarely used, non-selective beta-blockers may contribute to bronchospasms Measurement of heart rate and blood pressure Measurement of respiratory rate Measurement of pulse oximetry Measurement of temperature Respiratory distress Accessory respiratory muscle use Increased pulmonary findings (e.g., wheezing, decreased air entry, prolonged expiratory phase etc.) Peripheral edema Somnolence and/or hyperactivity Acute comorbid conditions Chest x-ray (in patients with suspected pneumonia) ABG (if O2 saturation less than 88%, positive history of hypercapnia, questionable accuracy of oximetry, somnolence, or other evidence of impending respiratory failure [e.g., respiratory rate greater than 40 breaths per minute]) Theophylline level (if theophylline is being utilized) WBC (in patients with suspected severe respiratory infection) A sputum culture and an antibiogram, if available, should be performed when an infectious exacerbation does not respond to initial antibiotic treatment (Global Initiative for Chronic Obstructive Lung Disease, 2006). It is important that the sputum specimen is of good quality. Brain Natriuretic Peptide (BNP), a simple blood lab test, can be of some use in evaluating a patient presenting with dyspnea, although its interpretation needs to be carefully applied along with clinical and other lab data such as chest x-ray and echocardiogram. Its sensitivity and specificity in this setting increase at levels above 400 but do not differentiate between acute left ventricular (LV) failure, cor pulmonale or pulmonary embolism (McCullough, 2002). It is of particular value if the level is very low. The probability of LV failure as a cause of dyspnea is less than 10% if the BNP is less than 100 (Maisel, 2002).

Physical Examination

Laboratory/Radiology

In patients with an acute COPD exacerbation, spirometry is of little value. For that reason, oximetry and/or arterial blood gases should be monitored. There is little evidence regarding the contribution of additional laboratory testing or the usefulness of electrocardiography or echocardiography in an acute exacerbation of COPD. They may be a useful consideration if the diagnosis is unclear, in order to evaluate other comorbid conditions. (McCrory, 2001) Supporting evidence is of classes: B, M, R

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Algorithm Annotations

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

6. Treatment Key Points:


Albuterol is the preferred bronchodilator in the setting of an acute exacerbation of COPD because of its rapid onset of action. Ipratropium may be added to produce additive bronchodilation and allow the use of lower doses of albuterol. Steroids should be used in acute exacerbations. It is mandatory to check oxygen saturation or ABG measurement.
Bronchodilators
Albuterol is the preferred bronchodilator in the setting of an acute exacerbation of COPD because of its rapid onset of action. Serial administration is indicated until either relief of symptoms and improvement in signs of respiratory failure is achieved, or side effects of tachycardia and/or tremor develop. If clinical improvement does not occur before side effects develop, ipratropium may be added to produce additive bronchodilation and allow the use of lower doses of albuterol, thus diminishing dose-dependent toxicity. However, no study has examined the benefit of using both agents concurrently. Administration of either agent by MDI with a spacer or by nebulization is acceptable, though the patient may be too dyspneic to retain a MDI puff effectively or severe coughing may prevent effective employment. In such cases, nebulization is necessary and arrangement for home use should be made (Moayyedi, 1995; O'Driscoll, 1989; Patrick, 1990; Turner, 1997). Supporting evidence is of classes: A, M

Role of Levalbuterol (Xopenex) in COPD


There are many theoretical advantages of levalbuterol over albuterol in the treatment of bronchospasm. Albuterol is a racemic combination of two isomers: the "R" isomer (levalbuterol) that is a potent bronchodilator, and the "S" isomer that has been shown in animal studies to counteract bronchodilation and can promote inflammation. Unfortunately, clinical studies in human subjects with bronchospasm have not consistently shown greater bronchodilation, or fewer side effects of levalbuterol over equivalent doses of a racemic agent such as albuterol. In individual patients with COPD and acute bronchospasm, who demonstrate excessive tachycardia and/or tremor, ipratropium is the next bronchodilator of choice. Levalbuterol may be an acceptable alternative as a trial agent, especially in patients whose bronchospasm worsens or shows no improvement on ipratropium (Costello, 1999; Nelson, 1999; Scott, 2003). Supporting evidence is of classes: C, R

Steroids
Studies have shown benefits of systemic steroids in the outpatient management of COPD exacerbation. Doses of oral prednisone 30-60 mg per day should be used for 10 to 14 days. If longer durations are needed, consider a tapering schedule. There is no need to discontinue inhaled steroids while the patient is taking oral prednisone. In fact, the inhaled steroid may serve as a "systemic-steroid-sparing-agent" and the concomitant use may minimize the dose of systemic steroids needed to diminish airway inflammation (Davies, 1999; McEvoy, 2000; Niewoehner, 1999). Supporting evidence is of classes: A, R

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Algorithm Annotations

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Antibiotics
If the acute exacerbation of COPD is clearly post-viral, antibiotics may not be necessary. In the presence of a more prolonged illness, especially with purulent sputum, an antibiotic is warranted. The choice of antibiotic is controversial and needs to be tailored to the individual situation. "First-line agents," such as amoxicillin, TMP/SMX and doxycycline are often effective. If the incidence of resistant organisms is 25% or higher in the community, the use of a "second-line agent" may be preferable. These second-line agents include second-generation cephalosporins, azithromycin, clarithromycin and amoxicillin/clavulanate (Anthonisen, 1987; Amsden, 2003; Chodosh, 1998).

Oxygen saturation/ABG measurement


Oxymetric evaluation of patients with COPD exacerbations is mandatory. Patients with O 2 saturations of 80%-90% on room air can be titrated with supplemental O2 to a saturation level of 90% with little concern of significant hypercarbia, unless such intervention results in somnolence. In such cases, or if the O2 saturation is less than 80% upon presentation, an ABG should be obtained. If the pH is less than 7.32, admission to the hospital should be arranged because of the risk of acute respiratory failure. If outpatient management has been decided upon, the patient should be ambulated to determine what O2 flow is needed to maintain O2 saturations at 90% while walking. Home O2 then needs to be arranged (Bone, 1978). Supporting evidence is of class: D

7. Positive Response to Treatment?


The following criteria may be used as evidence of improvement in COPD exacerbation: Decrease in cough, sputum production, fever or dyspnea Decrease in respiratory rate Decrease in heart rate Decrease in accessory muscle use Increase in function and endurance

8. Arrange for Follow-Up


A follow-up appointment between the primary care clinician and the patient should occur within one to four weeks to reassess management strategies and supplemental oxygen needs.

9. Admit to Hospital Out of Guideline


The following may be indications to consider hospital admission for an acute exacerbation of COPD: Marked increase in intensity of symptoms, such as sudden development of resting dyspnea History of severe COPD, especially if mechanical ventilation was required Onset of new physical signs (e.g., cyanosis, peripheral edema) Failure of exacerbation to respond to initial outpatient medical management High risk comorbidities, pulmonary (e.g., pneumonia requiring hospitalization) or cardiac symptoms Increasing hypoxemia despite supplemental oxygen

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Algorithm Annotations New or worsening CO2 retention or Ph less than 7.32

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Marked decrease in ability to ambulate, eat or sleep due to dyspnea History of prolonged, progressive symptoms Newly occurring arrhythmias Diagnostic uncertainty Older age Insufficient home support Decrease in alertness

(McCrory, 2001) Supporting evidence is of class: M

10. Establish Severity of Stable COPD Key Points:


Both spirometry and/or signs and symptoms are used to establish severity.
The signs, symptoms and airflow limitation in COPD vary with the severity of the disease. The severity of COPD may be categorized according to the following table. Table I
Category of COPD
Mild

FEV1 (% predicted)
80 or greater

Typical Symptoms and Signs


No abnormal signs Cough ( sputum) Little or no dyspnea

Moderate

Between 80 and 50

Breathlessness ( wheeze on moderate exertion) Cough ( sputum) Variable abnormal signs (general reduction in breath sounds, presence of wheezes) Hypoxemia may be present

Severe Very severe

30 to 50 Less than 30

Dyspnea with any exertion or at rest Wheeze and cough often prominent Lung hyperinflation usual; cyanosis, peripheral edema and polycythemia in advanced disease Hypoxemia and hypercapnia are common

Adapted from NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) workshop summary.

The best correlation with morbidity and mortality is decrease in FEV1. With FEV1 greater than 1.0 L, there is a slight increase in mortality at 10 years. With FEV1 less than 0.75 L, the approximate mortality rate at one year is 30%, and at 10 years is 95%. Because of the relationship of prognosis and FEV1, the severity

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Algorithm Annotations

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

of COPD is staged on the basis of this spirometry measurement. Patients are categorized as mild, moderate or severe. The COPD work group selected the COPD severity categories recommended by GOLD because they are straightforward and correlate with clinical experience. However, it is clear that there are widespread differences relative to disease severity classification among published guidelines (Hodgkin, 1990; Pauwels, 2001). Supporting evidence is of class: R

11. Step-Care Pharmacologic Approach for Managing Stable COPD Key Points:
Drug therapy is determined by severity of symptoms.
Each step in Table II represents an intervention that should be considered only if the previous course of action fails to improve symptoms of COPD. Step 1 is an intervention that is generally associated with mild COPD. Step 2 is associated with moderate COPD. Steps 3 and 4 are associated with severe and very severe COPD. A table of estimated comparative daily dosages for inhaled corticosteroids is attached in Appendix A, "Estimated Comparative Daily Dosage for Inhaled Corticosteroids."

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Algorithm Annotations Table II


STEP
1 Consider Step 2 if symptoms persist 2 Continue PRN inhaled short-acting bronchodilator PLUS scheduled dosing of one of the following: Tiotropium (Spiriva) Salmeterol* (Serevent Discus) Formoterol* (Foradil) Albuterol (Proventil, Ventolin) Ipratropium (Atrovent) Albuterol + Ipratropium (Combivent) Levalbuterol (Xopenex) Consider Step 3 if symptoms persist 3 Continue therapy specified in Step 2 and perform corticosteroid trial. Assess symptoms before and after trial period, especially cough and sputum production. Also measure postbronchodilator FEV1, 6-minute walk before and after trial. Consider Step 4 if symptoms persist * Tiotropium is the preferred scheduled bronchodilator.

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

PHARMACEUTICAL INTERVENTION
Inhaled short-acting bronchodilator

DOSING INFORMATION AND COMMENTS


Short-acting beta agonist (albuterol is preferred) 2-4 puffs as needed (every 4-6 hours) See Annotation #11

one capsule (inhaled) daily 1 puff twice daily 1 puff (12 mcg) twice daily 2-4 puffs 4 times a day 2-4 puffs 4 times a day 2-4 puffs 4 times a day 0.63-1.25 mg every 6-8 hours via nebulizer 2 puffs every 4-6 hours Prednisone oral 30-40 mg/day for 2-4 weeks or inhaled corticosteroid (see Appendix A) at less than 2000 mcg for 68 weeks/day or dose equivalent of another inhaled steroid for 6-8 weeks (Approximately 15% of patients who undergo a corticosteroid trial will have improved symptoms and postbronchodilator FEV1)

positive

Step 4: Response After Step 3

negative

POSITIVE RESPONSE: greater than or equal to 15% improvement in post-bronchodilator FEV1, symptoms, improvement in 6-minute walk PHARMACEUTICAL INTERVENTION Taper off or discontinue oral corticosteroids and prescribe or continue inhaled corticosteroids.

NEGATIVE RESPONSE: less than 15% improvement in post-bronchodilator FEV1 or no improvement in symptoms PHARMACEUTICAL INTERVENTION Discontinue corticosteroids and consider theophylline as adjunctive therapy with inhaled bronchodilators (2 agonists and/or anticholinergic)

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Algorithm Annotations

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Bronchodilator Medications Albuterol or Ipratropium


Albuterol and ipratropium are equipotent as bronchodilators, improving dyspnea and exercise tolerance equally well. No dramatic evidence showing an advantage of either albuterol or ipratropium as a scheduled first-step therapy for COPD symptoms or improved quality of life has been shown in the medical literature. Albuterol is recommended as the first-line treatment for patients with symptoms of mild COPD because the onset of bronchodilator effect (15 minutes) is more rapid than ipratropium (30-90 minutes). The dose-response curve of albuterol for improvement in FEV1 continues to increase to at least eight puffs. Ipratropium is to be used on a regularly scheduled basis rather than as needed (PRN) because its' dose-response time is too long to titrate its use to control symptoms. Ipratropium bronchodilator duration (two puffs for four hours) is greater than albuterol (two puffs for two or three hours). The dose-response curve for ipratroprium levels off above six puffs, whereas therapeutic efficacy for albuterol continues to increase at higher doses, although side effects such as tremor can develop. Studies were small and may not have been of a statistical power to detect differences between bronchodilators. (Blosser, 1995; Easton, 1986; Rennard, 1996) Clinicians should consider replacing ipratropuim with tiotropium as a scheduled bronchodilator because it provides improved benefits and only requires once-a-day dosing (Oostenbrink, 2004). Supporting evidence is of classes: A, M

Combination Albuterol and Ipratropium


Many studies show that the combination of ipratropium 0.5 mg and albuterol 2.5 mg provides greater bronchodilator effect compared to each alone; however, the same effect could probably be achieved by doubling the dose of either agent. This is reflective of the additive bronchodilator effect of both, as expected. No study compares the combination of ipratropium and albuterol to an equivalent dose of albuterol or ipratropium (e.g., four puffs of combination to four puffs of albuterol or ipratropium). One study also showed that patients randomized to albuterol two puffs four times/day had 18% more COPD exacerbations than those randomized to ipratropium two puffs four times/day (therefore "more expensive" p<0.05). Baseline FEV1 and FVC with ipratropium was greater than with albuterol after 90 days (p<0.05 and <0.01). No significant difference in quality of life was demonstrated, however. After 90 days, the albuterol group was less responsive to albuterol than the ipratropium group was responsive to albuterol (p>0.0001). (Dorinsky, 1999; Moayyedi, 1995) Supporting evidence is of class: A

Tiotropium
Tiotropium, a new dry powder, once-daily long-acting anticholinergic, was compared to salmeterol in a sixmonth study. Significant improvements in bronchodilation, symptoms and quality of life were demonstrated by tiotropium over salmeterol. Improved morning pre-dose bronchodilation was also seen at six months (Donahue, 2004). Due to these benefits and the once-daily dosing, tiotropium offers significant advantages as a scheduled bronchodilator to patients whose symptoms are not controlled by albuterol. Tiotropium replaces the use of ipratropium in the setting of stable COPD. Tiotropium has additive effects to long-acting beta-agonists (Cazzola, 2004; van Noord, 2006). In patients with moderate to severe COPD, tiotropium has also been demonstrated to significantly reduce both exacerbations and hospitalizations when added to the COPD treatment regimen (Niewoehner, 2005).

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Algorithm Annotations

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

If a patient with COPD has unacceptable symptoms while on tiotropium, a long-acting beta-agonist can be added (van Noord, 2006). No studies have compared the additive effects of tiotropium with steroids as a single agent in effectiveness of COPD management. Supporting evidence is of class: A

Long-Acting Beta-Agonists (LABAs) Formoterol


Twice-daily dosing of formoterol offers advantages similar to those of salmeterol. Data also show that formoterol has quicker onset of action than salmeterol (Dahl, 2001; Kottakis, 2002).

Salmeterol
Glaxo-Wellcome, Inc., maker of salmeterol, funded a study that showed salmeterol gave greater increase in FEV1 and FVC than albuterol or ipratropium, much longer duration of BD and, therefore, greater "area under the curve." Improvements in dyspnea and exercise tolerance were similar to those using ipratropium. Sixteen weeks of salmeterol therapy provided an increased baseline FEV1 of 7%. Salmeterol at doses of eight puffs produced no significant cardiovascular effects in patients with COPD (heart rate or PVCs). However, tremor developed after four puffs. Quality of life indicators increased with salmeterol compared to PRN use of albuterol. Significant evidence exists for salmeterol to be used as a scheduled treatment for COPD. When compared to other beta-agonists, its benefits include a higher and more prolonged BD effect. In addition, salmeterol's twice-daily dosing compared to four times/day dosing required by albuterol and ipratropium may improve compliance (Matera, 1995; Matera, 1996; Patakas, 1998). Supporting evidence is of class: A

Summary
Albuterol is the preferred agent for as-needed control of symptoms in patients with mild COPD and as an additive as needed agent to a scheduled bronchodilator in patients with more severe COPD because the onset of bronchodilator effect (15 minutes) is more rapid than ipratropium (30-90 minutes). Tiotropium has been shown to be a superior scheduled bronchodilator to salmeterol and ipratropium. As a scheduled bronchodilator, salmeterol has the main advantage of requiring only twice-daily dosing, and therefore may improve compliance. Albuterol and ipratropium are equipotent as bronchodilators, improving dyspnea and exercise tolerance equally well. Salmeterol is a long-acting bronchodilator that is a suitable agent for scheduled administration. [Conclusion Grade II: See Conclusion Grading Worksheet A Annotation #11 (Pharmacological Management)] (Brusasco, 2003; Donohue, 2002; Hvizdos, 2002) Supporting evidence is of classes: A, R

Systemic Corticosteroid Trials


Prednisone up to 40 mg/day for 10-14 days (ATS, 1995) Prednisone 30 mg/day for two weeks or inhaled corticosteroid for six weeks (BTS, 1997) A trial of prednisone (0.4-0.6 mg/kg for two to four weeks or inhaled corticosteroids at less than 2,000 mcg/day for six to eight weeks) may be used to test reversibility of airflow (ERS, 1995).

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Algorithm Annotations

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Every-other-day dosing of oral corticosteroids may minimize side effects yet still provide anti-inflammatory benefits. The value of oral corticosteroids in treating stable COPD is controversial. While oral corticosteroids are useful in treating acute exacerbations, their long-term use in stable COPD is beneficial in only 10%-15% of cases. Supporting evidence is of class: R

Inhaled Corticosteroids
Airway inflammation is a prominent feature in some patients with COPD. Although the benefits of inhaled corticosteroids are well established in asthma, their utility for the chronic management of COPD is controversial. Previous studies have shown that inhaled corticosteroids do not decelerate the rate of decline in expiratory flow volumes over time in patients with COPD. A recent meta-analysis showed that high doses (but not medium or low doses) of inhaled corticosteroids did slow the rate of decline in forced expiratory volume in one second (FEV1) in patients with COPD. Another study suggested that inhaled corticosteroids may reduce airway hyperreactivity and decrease clinical symptoms of COPD, including dyspnea and cough. The effects of inhaled corticosteroids on clinical outcomes such as COPD exacerbation rates, hospital readmission rates, and mortality have been evaluated. A systematic review of all placebo-controlled, randomized trials of inhaled corticosteroids given for at least six months for stable COPD demonstrated a beneficial effect in reducing rates of COPD exacerbation. In this review, the use of inhaled corticosteroid therapy reduced the rate of exacerbations with similar benefits in those who were and were not pretreated with systemic steroids. Inhaled corticosteroid therapy was also associated with increased rates of oropharyngeal candidiasis and skin bruising over placebo. The effects on bone mineral density and mean cortisol concentrations were variable. No effects on mortality were seen. In contrast, in a population-based cohort study, patients who received inhaled corticosteroid therapy after hospitalization discharge for COPD had a relative risk reduction for all-cause mortality of 29% and for repeat hospitalization of 24%. (Alsaeedi, 2002; Burge, 2000; Lung Health Study Research Group, 2000; Paggiaro, 1998; Sin, 2001; van Grunsven, 1999; Vestbo, 1999; Weir, 1993) Two recent large studies compared the effects of combined fluticasone and salmeterol to placebo in patients with severe but stable COPD. Those randomized to combination therapy had significant improvement in symptoms, spirometry, quality of life, and exacerbations. However, 50% of patients were current smokers. Subgroup analysis was not published in these papers, leaving questions regarding whether these beneficial effects are expected in non-smoking patients without evidence of airway inflammation (Hannania, 2003; Calverley, 2003). There is evidence that a trial of oral prednisone may not accurately predict which patients will respond to inhaled steroids (Senderovitz, 1999; Boothman-Burrell, 1997; Shim, 1985). Supporting evidence is of classes: A, B, M

Methods of Drug Delivery


Metered Dose Inhaler (MDI) with Spacer Some studies support the use of spacers to obtain effective MDI drug delivery. The increased distance slows the velocity of the fine particles, increasing their chances of reaching the bronchial tree. It is of utmost importance to train and retrain patients, nurses, physicians and pharmacists in proper inhaler technique for optimal drug delivery. Evidence of the effectiveness of one type of spacer over another is variable and controversial.

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Algorithm Annotations

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Chlorofluorocarbons (CFCs) are freon compounds commonly used as propellants in commercial aerosols including MDIs. Concerns have been raised about the toxicity of freon and its role in depleting the ozone layer. The production of ozone-depleting substances is being phased out worldwide under terms of an international agreement. Since most MDIs in the U.S. contain CFCs as propellants, they will eventually need to be reformulated (UN Environment Programme, 2000). MDIs that use CFCs as a propellant will not be removed until sufficient alternatives exist to serve patient needs. The FDA is developing strategies to ensure that patients in the U.S. who rely on MDIs to maintain their health will have continued access to an array of safe and effective treatment options. Non-freon alternatives include hydrofluorocarbons (HFAs). These non-freon formations are well-tolerated and equally efficacious when compared with compounds containing freon. Dry Powder Inhaler (DPI) DPIs are an alternative to MDIs that are strongly supported by study data. DPIs deliver drugs in dry-powder form without the use of propellants. In addition, DPIs are breath-activated, eliminating the need to synchronize inhalation with actuation. DPIs have been developed as a response to concerns about freon toxicity. Newer DPI products deliver pure drug from self-enclosed, multiple-dose devices that help avoid the potential adverse effects of additives used in MDIs. Table II contrasts features of conventional pressurized MDIs and DPIs.

Table III: Contrasting Features of Conventional Pressurized Metered-Dose Inhaler and Dry Powder Inhaler
MDI
1. Aerosol generation dependent on propellants. 2. Requires coordination of actuation with inhalation. 3. With correct technique, the lung deposition of the drug is 10%-15%. 4. With add-on spacer device, may be improved drug deposition into the lungs and oropharyngeal side effects may be reduced. 5. Because of propellants and other additives, patients feel the drug delivered. 6. No dose indicators. Risk of continued use of empty inhaler.

DPI
1. Aerosol generation does not require any propellants. 2. Relatively easy to administer, since it is breath-activated. 3. Lung deposition of the drug is similar to properly used MDI (in some studies deposition is greater in DPI than MDI). 4. No add-on spacer device needed.

5. Patient may not feel the drug delivered and may be uncertain of the drug dosing. 6. Newer multidose DPIs have a window with dose indicator.

Adapted from Vaswani, 1998. Nebulizers Aerosol particle diameters range from 1-5 mcg in SVN (small volume nebulizer), which are comparable with MDI or DPI. Studies have shown no difference in the efficacy of the delivery methods. Reports suggest that between 47% and 89% of adults may have unacceptable inhaler technique. Clinical situations in which nebulized therapy is preferable to either MDI or DPI include:

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Algorithm Annotations Patients incapable of performing MDI or DPI maneuver

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Adults who have a vital capacity less than 1.5 times their predicted tidal volume (7mL/kg)

Aerosol therapy via nebulizer is generally considered expensive, inconvenient and inefficient. Nebulizer therapy should be considered a second choice when compared with other modes of aerosol delivery, e.g., MDIs and DPIs. The following is a comparison of the advantages and disadvantages of aerosol delivery via nebulizer.

Table IV: Comparison of Nebulizers and MDIs


Nebulizers Advantages Pneumatic small volume nebulizers (SVN)
Limited patient coordination High dose levels possible Continuous therapy available No chlorofluorocarbon (CFC) release Covered by Medicare Expensive compressed gas source required Greater time required (expense) Some medications not readily available

Disadvantages

Ultrasonic small volume nebulizers (USN)


Less patient coordination Fast delivery No CFC release or compressed gas source required Expensive initial purchase Contamination possible Electrical or mechanical malfunction Not portable Some medications not available

Adapted from Ward, 1997.

Theophylline
Theophylline has a narrow therapeutic index with potentially significant adverse effects and drug interactions that must be carefully considered and closely monitored during therapy. The use of theophylline for COPD has decreased over the past decade for various reasons. Newer inhalational therapies have potentially equal or greater efficacy. There is concern about adverse reaction and drug-interaction profiles of theophylline. Based upon a retrospective valuation of 3,720 patients with COPD enrolled in 10 bronchodilator clinical trials from 1987 to 1995, the percentage of patients receiving oral theophylline decreased significantly from 63% to 29% related to changing prescribing and COPD management practices (Van Andel, 1999). The mechanisms of action of theophylline in COPD remain unclear. The assumption that theophylline relaxes bronchial smooth muscle by inhibiting phosphodiesterase, subsequently leading to an increase of cAMP, is no longer generally accepted as the predominant mode producing efficacy. Newer proposed mechanisms of action include antagonism of the effects of prostaglandins and adenosine; alternation of calcium metabolism by cells; inhibition of mediator release, membrane phospholipid methylation, and calcium ion influx in mast cells; and the inhibition of specific phosphodiesterase enzymes, leading to smooth muscle relaxation and inhibition of inflammatory cell function (Vaz Fragoso, 1993). www.icsi.org
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Algorithm Annotations

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

A table of drug interactions with theophylline has been published (Michalets, 1998). There is general agreement among previously published consensus guidelines for the management of COPD that theophylline has a role after inhaled bronchodilators prove inadequate; however, there is disagreement as to whether theophylline should be considered before or after corticosteroid use. There is considerable evidence that theophylline provides significant improvement in spirometry and/or symptoms such as dyspnea of patients with COPD and particularly chronic stable disease and in combination with other bronchodilator therapies. Theophylline may also improve mucociliary clearance, diaphragmatic strength, cardiovascular function, central respiratory drive and exercise capacity. The degree of efficacy of theophylline in patients with COPD, however, may be influenced by the chronicity and severity of obstruction, duration of therapy, and extent of follow-up evaluation, and the use must be individualized to the patient and clinical situation. Potential adverse effects with theophylline are gastrointestinal irritation (nausea, dyspepsia and GERD) due to increased gastric acid secretion, irritability, tremor and sleep disturbance. Theophylline has a narrow therapeutic index: seizures and tachyarrhythmias correlate positively with higher serum concentrations. Theophylline is extensively hepatically metabolized primarily by cytochrome P4501A2. As a result, several drugs, cigarette smoking and hepatic insufficiency, in addition to cardiac decompensation and age, may alter theophylline's clearance. Supporting evidence is of classes: D, R

12. Other Pharmacologic Treatment


Antibiotics
The routine use of antibiotics is not recommended except for treatment of bacterial exacerbations of COPD.

Antitussives
Regular use of antitussives is not recommended in COPD since cough can have a significant protective effect.

Antiviral Agents
Treatments other than vaccination are available to treat influenza but are not a substitute for vaccination unless it is contraindicated. Amantadine (Symmetrel) and rimantadine (Flumadine) are indicated for symptomatic treatment and prophylaxis of influenza A, which is more prevalent and more severe than influenza B. If started within the first 48 hours of symptom onset, amantadine and rimantadine may reduce the duration and symptoms by 50%. Zanamivir (Relenza) and oseltamivir (Tamiflu) are also available. Zanamivir must be inhaled whereas oseltamivir is available orally. Zanamivir and oseltamivir may be considered for treatment if there is an outbreak of influenza B. These medications are, however, very costly relative to their benefits. A consumer information report from the FDA regarding Relenza and chronic lung disease issued in October 2000 included a caution that "some patients have had bronchospasm (wheezing) or serious breathing problems when they used Relenza. Many, but not all, of these patients had previous asthma or chronic obstructive pulmonary disease. Relenza has not been shown to shorten the duration of influenza in people with these diseases. Because of the risk of side effects, and because it has not been shown to help them, Relenza is not generally recommended for people with chronic respiratory disease such as asthma or chronic obstructive pulmonary disease" (U.S. Food and Drug Administration, 2000).

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Algorithm Annotations Dosage and Cost a. c. Amantadine: Zanamivir

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

100 mg twice daily x 7 days $ 100 mg twice daily x 7 days $$ 10 mg (2 inhalations) every 12 hr for 5 days $$$ 75 mg by mouth twice daily for 5 days $$$$

b. Rimantadine: d. Oseltamivir

Leukotriene Modifiers
This drug class has not been adequately tested in COPD patients and its use cannot be recommended until additional evidence relative to its efficacy is available.

Mucolytics
In theory, reducing mucus viscosity and enhancing cough clearance or mucociliary clearance of mucus could improve pulmonary function and reduce the incidence of respiratory infections in individuals with COPD. Ideally, treatment would result in both objective (increase in FEV1) and subjective (better sense of well-being) improvement for those individuals. To date, there has been no conclusive evidence for significant improvement in pulmonary function with any of the agents studied so far. Guaifenesin is widely used as an over-the-counter expectorant but documented objective or even subjective improvement has not been consistently demonstrated. Iodinated glycerol was once thought to promote a decrease in symptoms and overall improvement in subjects with COPD, but this result could not be confirmed in subsequent investigations. Some evidence for improvement in subjects with chronic bronchitis is present using other agents, including inhaled surfactant, amiloride, hypertonic saline, N-acetylcysteine and acetylcysteine, but for now is not substantial enough to be conclusive. Albuterol may have some effect in improving mucociliary clearance, which may add to its utility as a bronchodilator. (Houtmeyers, 1999; Parvez, 1996; Petty, 1990; Rubin, 1999; Rubin, 1996) Supporting evidence is of classes: A, C, R

Oral Beta-Agonists
Inhaled bronchodilator therapy is preferred.

Vaccines
Influenza and pneumococcal pneumonia together are the sixth leading cause of death in the U.S. among persons 65 years of age or older. Immunization with pneumococcal and influenza vaccines are recommended by the U.S. Public Health Service's Advisory Committee on Immunization Practices to reduce infectious complications involving the respiratory tract (Centers for Disease Control,1999; Centers for Disease Control, 1997; Murphy, 1992). Pneumococcal The American Thoracic Society and the U.S. Public Health Service's Advisory Committee on Immunization Practices (ACIP) recommends pneumococcal vaccine for all COPD patients. Pneumococcal vaccination is generally good for life, but revaccination may provide additional protection in certain groups. The risks of revaccination are minimal, and the ACIP recommends revaccination once for COPD patients if at least five years have passed since receipt of the previous dose. Immunize at age 65 if not done previously. See the ICSI Immunizations guideline for Adults.

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Algorithm Annotations Influenza

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Influenza vaccine should be provided on an annual basis because of new antigens and waning immunity from the previous year. The optimal time for influenza vaccination is usually from early October through mid-November. To avoid a missed opportunity, vaccination can be done as soon as vaccine is available, but not prior to September. Vaccine may be given even after flu activity is known to be occurring in the community (Couch, 2000). Supporting evidence is of class: R

13. Non-Pharmacologic Treatment Applicable to All Levels of Severity Key Points:


Treatment of COPD should also include an education plan suited to the patient's specific needs, along with encouragement of exercise. Pulmonary rehabilitation programs are effective in improving exercise capacity, quality of life and perception of symptoms.
Encourage Exercise Regular exercise has been shown to reduce symptoms of COPD and improve the quality of life in patients with COPD. See "Pulmonary Rehabilitation Program for Moderate to Severe Disease" later in this annotation. For patients who do not have access to a pulmonary rehab program, it is reasonable to prescribe a regular exercise schedule. Education Considerations Patient education for those with COPD may be complex. Education methods aimed at continuous improvement should be incorporated into educational strategies that take the long-term relationships between patients and health care professionals into account. Patient Education Model The following model presents core learning-needs and objectives, along with some examples of tools to assist individual clinicians in designing a patient education plan. This model is based on the Transtheoretical Change Model (Prochaska Model), which emphasizes recognition of patients' stages of readiness to incorporate educational messages into long-term behavior change. Patient education should be tailored based on learning-needs assessments. It is important to develop a plan that includes the educator, patient and family. Learning assessment and feedback tools should: incorporate COPD needs and interventions within a conceptual behavior change model, be flexible enough to fit the various office practice models (step-care model with stages of change), and be flexible enough to match the cultural and learning styles of the intended target population.

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Algorithm Annotations Core Learning Needs/Objectives Knowledge of Basic Facts about COPD What is COPD? What symptoms are related to COPD?

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

What causes COPD? (emphasis on tobacco use) What diagnostic testing is usually necessary? Role of medications and modes of delivery Importance of appropriate immunizations

Skills (with or without a return visit by the patient to demonstrate skill improvement) Recognize symptoms of infections and exacerbations Breathing and physical exercise (at least lower extremity) Medication use and proper technique for inhalers (MDI/DPI), spacers, nebulizers, oxygen Environmental modification energy conservation, irritants Smoking cessation and dangers of continued use (from ICSI Tobacco Cessation guideline) Nutrition and exercise Quality of life factors dyspnea, fatigue, fear and depression Coping skills relaxation techniques, stress management and understanding of need to have COPD under control Written plan (with and without symptoms), exercise and medication diary When to call the clinic or seek emergency help Other educational support resources (e.g., pulmonary rehabilitation, tobacco cessation)

Attitude -

Partnership in Care -

Comprehensive programs, e.g., formal pulmonary rehabilitation, may expand on the above learning needs, as well as phase in additional health-related behavioral advice based on severity, resources and learning capacity of individual patients. How Does the Practitioner Know That Patient Education Is Making a Difference? In developing this patient education model, the ICSI COPD guideline work group identified a number of individual outcomes to be achieved through guided self-management that incorporate a process of education with objective monitoring and an explicit action plan. Individual outcomes to help practitioners know if education is making a difference include the following: Initiation of treatment for acute exacerbation is quicker

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Algorithm Annotations Decreased missed work days Improved self-efficacy and ability to perform ADLs

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Increased adherence to and use of medications (psychomotor skills) Variable impact on general quality of life measures

Barriers to Patient Education Barriers to successful implementation of patient education and subsequent long-term behavior change include individual educator and organizational factors such as: lack of education due to insufficient time, resources or finances of patient; inconsistent messages from health care team/sites; ineffective communication of goals/planning change; patient's fear of change and/or of not meeting expectations/lack of confidence in ability to understand and manage illness (self-efficacy); non-adherence; and insufficient time or resources for response or feedback on illness from practitioner.

Educational Framework/Themes for COPD Definitions In general, health education is concerned with a person's learning to live life in the healthiest way possible. Patient (health) education can be defined as: (Bartlett, 1985; Stewart, 1966) A process that is intended to improve the patient's level of knowledge, skill and attitude to effectively adopt or reinforce healthy behaviors. The process involving a planned learning experience using a combination of methods such as teaching, counseling and behavior modification techniques that influence an individual's knowledge and health behavior. The intent would be to prevent, promote, maintain or modify a jointly developed set of health-related behaviors for a given patient with COPD.

Self-efficacy is defined as a person's belief in his/her own capacity to perform a specific task. These expectations about personal success determine a patient's motivation to participate in behavior changes. For providers of care interacting with patients, outcome expectancy (conviction that certain behaviors will lead to certain outcomes) are influenced by efficacy expectancy (conviction that one can successfully execute the behavior required to produce the outcome). Personal experience is the most dependable source of self-efficacy, which in turn may influence health belief and need for further self-change (Celli, 1996; Scherer, 1996). Conceptual Models There are many theoretical frameworks for patient education that may be useful for various aspects of COPD care. Two frameworks that have been extensively studied and may be applicable to the COPD population include the Transtheoretical Change Model and the Precede-Proceed Model. Two areas where these have been applied include smoking cessation and physical activity.

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Algorithm Annotations General Goals

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

In order to be effective, patient education needs to be developed as an integral part of a disease management strategy with the goals of: increasing awareness and understanding of basic disease pathophysiology, facilitating long-term change toward health-preserving or enhancing attitudes and behaviors (improved self-efficacy and quality of life), and minimizing adverse effects from inappropriate use of therapeutic alternatives or interactions with recommended treatments by the care team.

A key theme in overall health education is consistency of educational messages between access points and along a time continuum tailored to meet the patient's learning needs and readiness to change. Critical Components The critical components of educator training and integration of the educator's role into the care process are: 1) communication skills, 2) interpersonal interactions and 3) ability to empathize with patient's needs and prioritize/evaluate desired reality-based behavior change(s). The interactive process between educator and patient occurs in the context of a created environment or learning space arising from each individual's internal state and his/her local external environment, and involves five interrelated domains: physiologic, psychologic, sociocultural, developmental and spiritual (Clark, 1994; Narsavage, 1997). The literature review related to impact and cost effectiveness of educational interventions in COPD is minimal and of variable quality for definitive recommendation. Educational programs should be of graded intensity and should be consistent with emphasis on tailoring to three levels: 1. Core messages to all patients as one-on-one office sessions 2. Add facilitator or peer-led support groups and other community resources 3. Add comprehensive rehab components (with or without specialty referral) Three chronic conditions that may be useful to benchmark for program design and implementation process include asthma, diabetes and osteoarthritis. How Does the Practitioner Know That Education Is Making a Difference? There are several conclusions reached in the research reviewed. There is no evidence to indicate that education alone can improve pulmonary function. Education is most effective when coupled with exercise programs and timely access to supportive care teams. There may be improvement in quality of life for patients receiving education about COPD, but the data is subjective and not consistently demonstrated. The meta-analysis conducted on 65 studies concluded that education alone had significant beneficial effect only on psychomotor skills (inhaler technique). There were only three relevant studies to review the effects of education alone, making conclusions on other outcomes unreliable. Education alone may reduce patients' use of short-acting 2-agonists by as much as one-half. Self-management studies did demonstrate statistical differences in response to changes in symptoms; one study showed patient initiation of prednisone 27% greater than control and antibiotic

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Algorithm Annotations

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

therapy 37% greater than control. Other studies showed improvement in self-efficacy but no changes in overall quality of life. Progressive muscle relaxation has been shown to reduce psychological distress and dyspnea. (Bauldoff, 1997; Devine, 1996; Folgering, 1994; Gibson, 1999; Ketelaars, 1994; Scherer, 1998; Watson, 1997) Supporting evidence is of classes: A, C, D, M, R, X

Pulmonary Rehabilitation Program for Moderate to Severe Disease


The primary goal of pulmonary rehabilitation is to decrease respiratory symptoms and improve quality of life. Pulmonary rehabilitation, with a multidisciplinary approach including education and exercise training, should be considered for COPD patients who have functional limitations that affect their quality of life, have maximized on standard medical therapy, and are not limited by other serious or unstable medical conditions. For willing patients who are able to learn about their disease and are motivated to participate in a comprehensive rehabilitation program, selecting a program that emphasizes regular in-home exercise verified by an exercise log is strongly recommended. Long-term benefits from programs after completion have not been demonstrated except for home-based exercise programs. A summary of structures and services in pulmonary rehabilitation is attached in Appendix C, "Summary of Structure and Services - Pulmonary Rehabilitation Program." Studies of pulmonary rehabilitation programs for patients with COPD, including an ICSI Technology Assessment, found the following: Pulmonary rehabilitation programs standardly available in the United States are effective in improving exercise capacity, quality of life and perception of symptoms but only for the duration of the program, typically 8-12 weeks. Deterioration toward baseline after completion of the program can be routinely expected, unless the patient continues to participate in an exercise program. Pulmonary function measurements are not beneficially affected. Pulmonary rehabilitation programs are generally safe for COPD patients. There is evidence that a long-term, structured exercise program can provide benefit for up to 18 months (Berry, 2003). Supervised follow-up may be helpful in maintaining improvements, although more studies are needed. A multidisciplinary approach, including exercise, maximizes the benefits of a pulmonary rehabilitation program when compared to a limited program focusing on education alone. There is a need for additional research to clarify questions related to patient selection, program components (including contents, duration, intensity and site) and long-term effects. In addition, there is a need to validate and standardize the outcome variables used to assess change. Please refer to the ICSI Technology Assessment Report, "Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease, #32" for full discussion. (American Thoracic Society [ATS], 1995; American Thoracic Society, 1999; Cambach, 1999; Donado, 1998; GOLD, 2006; Grosbois, 1999; Institute for Clinical Systems Improvement, 1997; Lacasse, 1997; Man, 2004; Resnikoff, 1998) Supporting evidence is of classes: A, C, M, R

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Algorithm Annotations

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

14. Assess for Hypoxemia and Hypercapnia and Treat If Indicated Key Points:
Assess for hypoxemia and consider assessment for hypercapnia.
Hypoxemia
Progressive hypoxemia is commonly associated with COPD patients. Hypoxemia can rapidly lead to clinical deterioration. By preventing or correcting cellular hypoxia, the treatment of hypoxemia can be life-preserving. Long-term oxygen supplementation has been demonstrated to improve survival in hypoxemic patients with COPD. However, tissue hypoxia may not always be adequately prevented or treated by simply addressing the hypoxemia. Rather, the physician must carefully evaluate the full scope of the oxygen transport and delivery (Medical Research Council Working Party, The, 1981; Weitzenblum, 1985). The evaluation of gas exchange status by arterial blood gas (ABG) measurement is recommended for initiation of oxygen therapy, as well as to determine PCO2 and acid-base status. Assessment for long-term oxygen needs by arterial blood gas analysis should be considered for stable outpatients with: 1. severe airflow obstruction; 2. symptomatic dyspnea with polycythemia, pulmonary hypertension (by ECG or echo), or altered mental status; 3. problematic heart failure; and 4. severe symptoms out of proportion to the degree of airway obstruction. Pulse oximetry cannot determine acid-base status and is not considered sufficiently accurate to replace ABG (available) measurement in an initial assessment. ABG measurement can be used to confirm the accuracy of pulse oximetry at rest and with exercise when oximetry is less reliable. Supporting evidence is of classes: A, C

Nocturnal Hypoxia
During sleep, even in individuals without COPD, minute ventilation decreases. In patients with COPD whose O2 saturation is already low or borderline, this hypoventilation results in hypoxia, which can exacerbate or precipitate pulmonary hypertension. Sleep disruption from hypoxia or sleep apnea can induce daytime hypersomnolence and may worsen symptoms of COPD. Risk factors for hypoxia during sleep: Severe COPD, especially with resting oxygen saturation less than 88% or exercise-induced hypoxia Evidence of cor pulmonale Daytime hypersomnolence in the absence of sleep deprivation Polycythemia

(Carskadon, 1981; Gimeno, 1986; Little, 1999; Nocturnal Oxygen Therapy Trial Group, 1980) Supporting evidence is of classes: A, C, D

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Screening for Nocturnal Hypoxia


Screening for nocturnal hypoxia can be done easily and inexpensively with overnight pulse oximetry in the home. The oximeter is returned to the clinic, where the overnight oximetry and heart rate data are downloaded. If a significant portion of the night's data indicates oxygen saturations below 88%, supplemental oxygen should be provided empirically at 1-2 L/min. Home oximetry can be repeated at that level to verify correction of hypoxia (Hoch, 1990; Knight, 1987). The patient should be referred to a sleep specialist to rule out sleep-related disordered breathing if additional abnormalities are present. Support evidence is of class: C

Hypercapnia
In an ambulatory, stable patient with COPD, assessment for hypercapnia by arterial blood gases (ABGs) should be considered in the following circumstances: Clinical suspicion of hypercapnia (asterixis, headache, hypersomnolence, altered mental status) FEV1 less than 1.0 Upon initiation of oxygen Morbid obesity Excessive daytime somnolence Problematic right heart failure/cor pulmonale Severe airflow obstruction

Carbon dioxide (CO2) retention may pose a threat in patients with impaired CO2 ventilatory drive. Careful titration of supplemental oxygen should be performed in these patients. A pH drop along with a rise in PaCO2 with initiation of oxygen therapy or an increase in inspired oxygen concentration is usually well tolerated in the ambulatory stable patient with COPD. If hypercapnia results in a decrease in mental status, the patient may need admission to a hospital for more intensive respiratory care and monitoring. In the unstable patient with resting hypercapnia, initiation of supplemental oxygen should be titrated upward, as there is a small risk of worsening CO2 retention. Reassessment by ABG and clinical status looking for signs/symptoms of hypercapnia is suggested 30 minutes after initiation of oxygen. Hypercapnia does not require specific therapy, but instead, therapeutic intervention should be directed at correcting the hypoxemia. Nonetheless, a pH drop along with a rise in PaCO2 with initiation of oxygen therapy, or an increase in inspired oxygen concentration is usually well tolerated in the ambulatory stable COPD patient. If hypercapnia results in a decrease in mental status, the patient may need admission to a hospital for more intensive respiratory care. These recommendations are further clarified in the ICSI Diagnosis and Treatment of Obstructive Sleep Apnea Hypopnea Syndrome guideline. (American Thoracic Society [ATS], 1995; Dunn, 1991; Lopez-Majano, 1973) Supporting evidence is of classes: C, R

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Oxygen Therapy
Important Points: Long-term oxygen therapy (more than 15 hours per day) improves survival and quality of life in hypoxemic patients. ABG measurement is recommended for initiation of oxygen therapy, as well as to determine PCO2 and acid-base status. Pulse oximetry is a good method for monitoring oxygen saturation and can be used in adjusting the oxygen flow setting. Indications for long-term oxygen therapy have been adopted by Medicare as reimbursement criteria.* Patients considered for long-term therapy may benefit from assessment by a pulmonologist. Supplemental long-term oxygen therapy should be provided at a flow rate sufficient to produce a resting PaO2 of greater than 55 mm Hg, or SaO2 greater than 89%. Titrate liter-flow to goal at rest: add 1 L/min during exercise or sleep or titrate during exercise to goal of SaO2 greater than 89%. Titrate sleep liter-flow to eight-hour sleep of SaO2 greater than 89%. Consider referral for sleep evaluation if patient experiences cyclic desaturation during sleep but is normoxemic at rest. Recheck Sa O2 or PaO2 in one-three months if hypoxia developed during an acute exacerbation. Rechecks should be performed annually if hypoxia is discovered in an outpatient with stable COPD.

* Appendix B contains a summary of Medicare Oxygen Coverage Guidelines.

Oxygen Delivery Methods


The dual-prong nasal cannula is the standard means of continuous flow oxygen delivery for the stable COPD patient with hypoxemia. It is not only well tolerated, but is also simple and reliable. Care must be taken when assigning an estimated FiO2 to patients as this low-flow system can have great fluctuations (AARC, 1996). Reservoir cannulas, demand pulse delivery devices, and transtracheal oxygen delivery are oxygen-conserving devices that can improve the portability of oxygen therapy, reduce the overall costs of home oxygen therapy, especially in patients requiring higher flow rates, and can more effectively treat refractory hypoxemia. These devices function by delivering all of the oxygen during early inhalation. They reduce oxygen requirements by 25%-75% compared to continuous flow oxygen. Disadvantages of these devices are that they are bulky on the face, mechanically more complicated, and require additional care as well as additional training of the user. (Bower, 1988; Gibson, 1976; Kory, 1962; Soffer, 1985) Supporting evidence is of classes: C, D, M

COPD and Air Travel


Airline travel is safe for most patients with COPD. Hypoxemic patients should be evaluated clinically, and a decision should be made regarding oxygen requirements. Patients with COPD receiving continuous oxygen at home will require supplementation during flight. A doctor's order is required for patients who

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need supplemental oxygen during air travel. Special arrangements with oxygen or equipment suppliers and the airline must be made at least 48 hours prior to departure. Patients should check with airlines for restrictions and special arrangements that apply (Berg, 1992; Dilliard, 1991). Supporting evicence is of class: D

Use of supplemental O2 for patients with COPD and not currently on supplemental O2
Regression equations have been validated that predict pO2 at usual atmospheric pressures in aircraft. These predict that patients with FEV1 less than 80% and pO2 less than 80 will have in-flight pO2 less than 55% and therefore should be prescribed supplemental O2 at 2 L/M (liters/minute). Patients with underlying cardiovascular or cerebrovascular disease should be prescribed O2 if their FEV1 and pO2 are even higher (Cummins, 1989; Dilliard, 1989; Lien, 1998). Supporting evidence is of classes: D, R

15. Long-Term Management Key Points:


Obtaining the opinion of a pulmonary specialist may be beneficial at any stage of the disease. For patients with severe symptoms, despite maximal medical therapy, lung volume reduction surgery and transplantation may be an option. Referral to a pulmonologist should be made to evaluate candidacy. Physicians are encouraged to initiate and facilitate conversations about living wills and durable power of attorney for health care.
Schedule Regular Follow-Up Visits
Follow-up visits should be jointly established between primary care physicians and pulmonary specialists, and should be tailored to the learning stage and comorbidities of individual patients. The exact frequency of clinician visits is a matter of clinical judgment; however, the following may serve as a general guide for patients with stable COPD. Severity Mild Moderate Severe Regular Follow-Up Visit Yearly Three to six months Two to four months or more frequently as needed

Evaluation and Monitoring of Comorbidities


In treating patients with COPD, it is important to consider the presence of concomitant conditions such as bronchial carcinoma, tuberculosis, sleep apnea, depression, osteoporosis and heart failure. The appropriate diagnostic tools (chest radiograph, ECG, etc.) and referral to clinical specialists should be used whenever symptoms (e.g., hemoptysis) suggest one of these conditions (Global Initiative for Chronic Obstructive Lung Disease, 2006).

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Refer to Pulmonary Specialist


Obtaining the opinion of a pulmonary specialist may be beneficial at any stage of the disease. Referral may be indicated to confirm the diagnosis, facilitate tobacco cessation and optimize appropriate treatment. Referral may be indicated: for patients under age 40 years or with a family history of emphysema or A1-antitrypsin deficiency in order to identify the deficiency and treat and screen family members; to confirm diagnosis, rule out other etiologies, symptoms and complexities and to optimize treatment; if symptoms are not consistent with the lung function deficit as measured by pulmonary function tests; for patients with frequent infections and/or possible bronchiectasis; for assessment of long-term treatment with oral corticosteroids if results of steroid trial are unclear; to identify and assess patients for possible lung volume reduction surgery or lung transplantation; for patients with rapid decline in FEV1 to optimize early intervention; for patients with smoking history of less than 10 pack-years to exclude/confirm diagnosis; for patients with frequent exacerbations; and for patients who have been hospitalized for COPD.

Surgical Options for Severe Disease


Lung Volume Reduction Surgery for Emphysema The goal of lung volume reduction surgery (LVRS) is to relieve disabling dyspnea in patients in whom emphysema has limited activities of daily living and has proved refractory to optimal medical management. Following surgery, improvement has been noted in lung elastic recoil, respiratory function, ventilation/perfusion matching, and cardiovascular function. A variety of surgical approaches and reduction techniques have been used. Results of the National Emphysema Treatment Trial (NETT) have been published. 1. Overall, LVRS did not demonstrate a survival advantage over medical therapy. LVRS only yielded a survival advantage for patients with upper lobe emphysema and low baseline exercise capacity. LVRS demonstrated increased mortality and no functional improvement for patients with non-upper lobe emphysema. 2. LVRS only showed improvement in exercise capacity among a small subgroup of patients: those with upper lobe emphysema. Most patients' improvements returned to baseline after two years. 3. Significantly more patients with upper lobe emphysema randomized to LVRS had improved quality of life after two years as compared to non-surgical patients. 4. Due to the strictness of the exclusion criteria, conclusions from the NETT trial cannot be extended to the general population of patients with emphysema. 5. Pre-operative evaluation includes: ability to complete a six-minute walk of over 140 meters, completion of a pulmonary rehabilitation program, full pulmonary function tests, chest CT, echocardiogram, and possibly a right heart catheterization and a radionuclide stress test.

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6. LVRS should only be performed in medical centers with appropriately trained surgeons and availability of necessary equipment. (American Thoracic Society, 1995; Institute for Clinical Systems Improvement, 2003; National Emphysema Treatment Trial Research Group, 2003) Supporting evidence is of classes: A, R Bullectomy Giant bullous emphysema is a rare subset of patients in whom single or multiple large bullae encompass 30% or more of a hemithorax, often displacing potentially functional lung tissue as these large airspaces increase in volume. In appropriate cases, surgical resection of these bullae can restore significant pulmonary funcion and improve symptoms. CT scan is essential in evaluating these patients and referral to a pulmonary specialist is indicated (Boushy, 1968; Laros, 1986). Supporting evidence is of class: D Lung Transplantation Unilateral or bilateral lung transplantation is a treatment option in highly selected patients with severe COPD (Arcosoy, 1999). A few studies show improvement in quality of life parameters but no increase of survivability (Hosenpud, 1998). General selection guidelines for candidate selection for lung transplantation in COPD patients
Relative contraindications Age limits Heart-lung transplants ~55 yrs Double lung transplant ~60 yrs Single lung transplant ~65 yrs Symptomatic osteoporosis Oral corticosteroids greater than 20 mg day-1 prednisone Psychosocial problems Requirement for invasive mechanical ventilation Severe musculoskeletal disease affecting the thorax Substance addiction within previous six months Dysfunction of extrathoracic organ, particularly renal dysfunction HIV infection Active malignancy within two years except basal or squamous cell carcinoma of skin Hepatitis B antigen positively Hepatitus C with biopsy-proven evidence of liver disease

Absolute contraindications

Following the position of the American Thoracic Society and the European Respiratory Society (ATS/ERS COPD Standards, 2004), appropriate candidate selection is as follows: FEV1 less than or equal to 25% predicted (without reversibility), and/or Resting room air PaCO2 greater than 55 mm Hg, and/or Elevated PaCO2 with progressive deterioration requiring long-term oxygen therapy Elevated pulmonary arterial pressure with progressive deterioration

(Celli, 2004) A number of studies show that single lung transplant is safer and gives equal or improved spirometric parameters as compared to bilateral lung transplant (Bando, 1995; Arcosoy, 1999). Survival after transplant

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is 81.7%, 61.9% and 43.4% at one, three and five years. Perioperative mortality, rejection, bronchiolitis obliterans, cytomegalovirus, fungal and bacterial infections, and lymphoproliferative disease are associated with transplant surgery. Donor lung availability, high initial and ongoing immunosuppressive regimen costs are also considerations that must be considered. For further information, we recommend review of the American Thoracic Society COPD management recommendations at www.thoracic.org/COPD/10/surgery_for_copd.asp. Supporting evidence is of classes: C, R

Discuss Health Care Directives (Advance Directives) or Living Will and Durable Power of Attorney for Health Care
Many patients have an interest in discussing living wills, but their wishes tend to be passive and unspoken. Physicians are encouraged to initiate and facilitate conversations about living wills and durable power of attorney designate with all COPD patients at routine outpatient visits. In patients with severe disease, it is also helpful to discuss specific treatment preferences. Treatment preferences may include home care only, hospitalization for comfort care, initiation of full life support if there is a reasonable chance for recovery to functional independence, or continuation of indefinite life support in a chronic nursing facility. Objectives of Discussion 1. To encourage physicians to discuss health care directives with COPD patients 2. To give patients control over their end-of-life care decisions 3. To reassure that patients' wishes will be carried out at the end of their life 4. To increase the number of COPD patients who have written health care directives 5. To increase the number of patients with severe COPD who have discussed specific treatment preferences and goals of care 6. To name a durable power of attorney for health care or an appropriate surrogate decision-maker. Plan for Discussion For the patient with moderate to severe COPD, at a routine office visit ask the question, "Do you have a living will?" Action: If yes, ask what it consists of (especially whether there is a designation of durable power of attorney and who that person is) and request that a copy be placed in the patient's medical record. Action: If no, offer the patient written information on health care directives, encourage him/her to fill out a health care directive including designation of power of attorney for health care and offer to discuss any questions at the next office visit. For the patient with severe COPD, at a routine office visit ask the question, "What are your treatment preferences in regards to hospitalization, life support (including CPR, endotracheal intubation and non-invasive ventilation), and end-of-life care?" Action: Encourage the patient to discuss these treatment preferences with family or health care surrogate and record them in a health care directive.

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Action: Document the patient's treatment preferences in the patient's medical record and request that a copy of the health care directive be placed in the patient's medical record. For more information on living wills, please consult your state's statutes outlining requirements for health care directives. (Emanuel, 1991; Hansen-Flaschen, 1997; Heffner, 1996) See the ICSI Palliative Care guideline for more information regarding end-of-life care. Supporting evidence is of classes: D, R

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Appendix A Estimated Comparative Daily Dosage for Inhaled Corticosteroids


Estimated Comparative Daily Dosage for Inhaled Corticosteroids
All Daily Dosing Should be Divided Into Two Doses Except for Mometasone and Triamcinolone Drug Mometasone furoate (Asmanex) 220 mcg/inhalation Beclomethasone dipropionate Low Dose 220 mcg (1 inhalation) 1 dose per day 40-160 mcg Medium Dose 440-660 mcg (2-3 inhalations) 1 dose per day 160-320 mcg (4-8 puffs - 40 mcg) (2-4 puffs - 80 mcg) High Dose 880 mcg (4 inhalations) 1 dose per day 320-640 mcg (8-16 puffs - 40 mcg) (4-8 puffs - 80 mcg)

HFA (hydrofluoroalkane) (1-4 puffs - 40 mcg) formulation with (1-2 puffs - 80 mcg) strengths of 40 mcg/puff and 80 mcg/puff (Qvar) Budesonide DPI 200 mcg/dose (Pulmicort) For nebulization: strengths 0.25 mg/2 mL and 0.5 mg/2 mL Flunisolide (Aerobid) 250 mcg/puff Flunisolide Hemihydrate (Aerospan) 80 mcg/inhalation Fluticasone (Flovent) HFA: 44, 110, 220 mcg/puff DPI (Rotadisk) or Diskus: 50, 100, 250 mcg/dose Combination Product fluticasone propionate/salmeterol DPI (Advair) Triamcinolone acetonide 100 mcg/puff (Azmacort) 200-400 mcg (1-2 inhalations) 0.25 mg daily 500-1,000 mcg (2-4 puffs) 160-320 mcg (2-4 inhalations) 88-264 mcg (2-6 puffs - 44 mcg) OR (2 puffs - 110 mcg)

400-600 mcg (2-3 inhalations) 0.5 mg/day (as 0.25 mg twice daily or 0.5 mg daily) 1,000-2,000 mcg (4-8 puffs) 320-480 mcg (4-6 inhalations) 264-660 mcg (2-6 puffs - 110 mcg)

600-1600 mcg (3-8 inhalations) 1.0 mg/day (as 0.5 mg twice daily or 1.0 mg daily) 2,000 mcg (8 puffs) 480-640 mcg (6-8 inhalations) 660-1760 mcg (6-16 puffs - 110 mcg) OR (3-8 puffs - 220 mcg) (6-20 inhalations - 100 mcg) OR (2-8 inhalations - 250 mcg) 500 mcg fluticasone/50 mcg salmeterol one inhalation every 12 hrs

(2-6 inhalations - 50 mcg) (3-6 inhalations 100 mcg) 100 mcg fluticasone/50 mcg salmeterol one inhalation every 12 hrs 400-1,000 mcg (4-10 puffs) divided 3-4 times daily 250 mcg fluticasone/50 mcg salmeterol one inhalation every 12 hrs

1,000-2,000 mcg 2,000 mcg (10-20 puffs) divided 3-4 (20 puffs) divided 3-4 times daily times daily

NOTES: The most important determinant of appropriate dosing is the clinician's judgment of the patient's response to therapy. The clinician must monitor the patient's response on several clinical parameters and adjust the dose accordingly. The stepwise approach to therapy emphasizes that once control of COPD is achieved, the dose of medication should be carefully titrated to the minimum dose required to maintain control, thus reducing the potential for adverse effect. MDI dosages are expressed as the actuator dose (the amount of drug leaving the actuator and delivered to the patient), which is the labeling required in the United States. This is different than the dosage expressed as the valve dose (the amount of drug leaving the valve, all of which is not available to the patient), which is used in many European countries and in some scientific literature. Dry powder inhaler (DPI) doses are expressed as the amount of drug in the inhaler following activation.

Sources: Drugs Facts and Comparisons, 06/2005; Thomson Micromedex Health Care Series 2006

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Appendix B Medicare Standard for Oxygen Coverage


Oxygen Therapy Medicare Standards for Oxygen Coverage include the following parameters: Laboratory Evidence Testing must be performed either with the patient in a chronic stable state as an outpatient, or within two days prior to discharge from an inpatient facility to home. If the test is not taken under these conditions, additional documentation must be obtained from the physician.
PaO2
55 mm Hg or less 55-59 mm Hg

SaO2
88% or less 89%

Additional Documentation
None Congestive Heart Failure/Edema EKG evidence of P pulmonale with P wave greater than 3 mm in lead I, II, III, or AVF Hematocrit greater than 56%

60 mm Hg

90% or greater

Coverage rare or unlikely; requires extensive physician documentation for approval

Requires recertification and retesting 61-90 days after the initial start of therapy. May qualify as a system by itself or as a complement to stationary oxygen system. If the patient qualifies for reimbursement under the oxygen coverage guidelines noted previously, and the patient is mobile within the home.

Portable Oxygen

Oxygen Prescription Oxygen for patients with COPD is covered under Medicare. The prescription for home oxygen therapy must include: flow rate: liters/minute flow rate must be increased during exercise and sleep, duration of need: specific number of months or indefinitely, laboratory evidence, blood gas or oximetry required while at rest on room air, and acceptable PaO2 or SaO2. Severe primary lung disease (includes COPD, emphysema, chronic bronchitis) Secondary conditions related to lung disease Significant hypoxemia in the chronic stable state

Diagnosis

Additional medical documentation: other forms of treatment have been tried and have not been successful and oxygen therapy is still required Start of therapy: within one month of last visit

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Appendix C Summary of Structure and Services Pulmonary Rehabilitation Program


Disciplines involved in pulmonary rehabilitation can include, but are not limited to the following: Physicians Respiratory Therapists Occupational Therapists Recreational Therapists Dieticians Exercise Physiologists Social Workers Nurses Physical Therapists Cardiorespiratory Technicians Clerics Pharmacists Psychologists Psychiatrists

Interventions can generally be divided into education, exercise/conditioning, psychosocial/psychological aspects and medical intervention. Education Basic lung anatomy and physiology/COPD pathophysiology Breath retraining 1. Diaphragmatic breathing 2. Pursed-lip breathing Diet and nutrition Energy conservation Safe travel Airway management Benefits of exercise Safe use of oxygen Role of medications 1. How medications work 2. Long-term control: medications that prevent symptoms 3. Stress importance of using medications Skills of using medications 1. Metered dose inhaler (MDI) use (patient should demonstrate correct inhaler technique) 2. Small volume nebulizer (SVN) 3. Spacer/holding chamber use

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Appendix C Summary of Structure and Services Pulmonary Rehabilitation Program

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Symptom assessment and knowledge of when to seek medical help Smoking cessation Environmental irritant avoidance Respiratory and chest therapy techniques

Exercise/Conditioning Lower extremity training/exercise Upper extremity training/exercise Inspiratory muscle training/exercise Emphasis on in-home exercise as lifestyle change Counseling 1. Stress management 2. Coping skills, anxiety, panic control Medication Patients may benefit from antidepressants. Indications for Referral Symptomatic COPD (characterized by airway obstruction and reduced expiratory airflow) Functional limitations that affect quality of life Has a medical regimen that has been maximized, e.g. bronchodilator, oxygen therapy Able to learn about the disease; patients who are mentally capable of learning about their disease have improved outcome including decreased anxiety and fear Motivated to participate in a pulmonary rehabilitation program Patients with conditions that might interfere with the patient undergoing a rehabilitation program, e.g. coronary artery disease, cognitive impairment interfering with learning, severe psychiatric disturbances. Patients with conditions that might place the patient at risk during exercise training; many patients with COPD are older with a history of cigarette smoking and are at risk for heart disease. Cardiac and pulmonary stress testing should be routinely performed to exclude silent cardiac disease and assure safety during exercise training.

Psychosocial/Psychological aspects

Relative contraindications for participation in pulmonary rehabilitation

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Appendix C Summary of Structure and Services Pulmonary Rehabilitation Program

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Types of Rehabilitation Programs


Type of Program
Hospital or Community-based Outpatient Pulmonary Rehabilitation

Advantages
Widely available Less costly Less intrusive to family

Disadvantages
Potential transportation issues Long-term benefits have not been demonstrated Inability to observe home plan Potential inability for multidisciplinary team to participate Patient may not have access to exercise equipment Lack of supervision by trained personnel

Home Program

Transportation not an issue

Familiar surroundings may facilitate better adherence to goals Long-term benefits have been demonstrated

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ICS I
I NSTITUTE FOR C LINICAL S Y S T E M S I M P ROV E M E N T

Supporting Evidence:

Chronic Obstructive Pulmonary Disease


Availability of references References cited are available to ICSI participating member groups on request from the ICSI office. Please fill out the reference request sheet included with your guideline and send it to ICSI.

Document Drafted Jan Jun 2000 First Edition Dec 2001 Second Edition Jan 2003 Third Edition Jan 2004 Fourth Edition Begins Jan 2005 Fifth Edition Jan 2006

Scott Copeman, RRT Respiratory Therapy Mayo Clinic Tom Dashiell, MD Internal Medicine HealthEast Clinics Beth Duffy, RRT Respiratory Therapy, Health Education HealthPartners Medical Group Jane Gendron Measurement Advisor ICSI

Contact ICSI at: 8009 34th Avenue South, Suite 1200; Bloomington, MN 55425; (952) 814-7060; (952) 858-9675 (fax) Online at http://www.ICSI.org
Copyright 2007 by Institute for Clinical Systems Improvement 2

Sixth Edition Begins Feb 2007

Released in January 2007 for Sixth Edition. The next scheduled revision will occur within 12 months.

Original Work Group Members


Janine Graham, RN, CCM Case Management, Health Education Aspen Medical Group Allen Horn, MD Family Practice CentraCare James Mickman, MD Pulmonary & Critical Care Medicine HealthPartners Medical Group Ashok M. Patel, MD Pulmonary & Critical Care Medicine, Work Group Leader Mayo Clinic Jeff Rabatin, MD Pulmonary & Critical Care Medicine Mayo Clinic Mary Stadick, MA Facilitator ICSI Suzanne Tschida, PharmD Pharmacy, Health Education HealthPartners Medical Group Catherine Youngman, RN Nursing, Health Education HealthPartners Medical Group

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Evidence Grading System


I. CLASSES OF RESEARCH REPORTS A. Primary Reports of New Data Collection: Class A: Class B: Class C: Randomized, controlled trial Cohort study Non-randomized trial with concurrent or historical controls Case-control study Study of sensitivity and specificity of a diagnostic test Population-based descriptive study Cross-sectional study Case series Case report Meta-analysis Systematic review Decision analysis Cost-effectiveness analysis Consensus statement Consensus report Narrative review Medical opinion

Class D:

B. Reports that Synthesize or Reflect upon Collections of Primary Reports: Class M:

Class R:

Class X:

II. CONCLUSION GRADES Key conclusions (as determined by the work group) are supported by a conclusion grading worksheet that summarizes the important studies pertaining to the conclusion. Individual studies are classed according to the system defined in Section I, above, and are assigned a designator of +, -, or to reflect the study quality. Conclusion grades are determined by the work group based on the following definitions: Grade I: The evidence consists of results from studies of strong design for answering the question addressed. The results are both clinically important and consistent with minor exceptions at most. The results are free of any significant doubts about generalizability, bias, and flaws in research design. Studies with negative results have sufficiently large samples to have adequate statistical power. Grade II: The evidence consists of results from studies of strong design for answering the question addressed, but there is some uncertainty attached to the conclusion because of inconsistencies among the results from the studies or because of minor doubts about generalizability, bias, research design flaws, or adequacy of sample size. Alternatively, the evidence consists solely of results from weaker designs for the question addressed, but the results have been confirmed in separate studies and are consistent with minor exceptions at most. Grade III: The evidence consists of results from studies of strong design for answering the question addressed, but there is substantial uncertainty attached to the conclusion because of inconsistencies among the results from different studies or because of serious doubts about generalizability, bias, research design flaws, or adequacy of sample size. Alternatively, the evidence consists solely of results from a limited number of studies of weak design for answering the question addressed.

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Grade Not Assignable: There is no evidence available that directly supports or refutes the conclusion. The symbols +, , , and N/A found on the conclusion grading worksheets are used to designate the quality of the primary research reports and systematic reviews: + indicates that the report or review has clearly addressed issues of inclusion/exclusion, bias, generalizability, and data collection and analysis; indicates that these issues have not been adequately addressed; indicates that the report or review is neither exceptionally strong or exceptionally weak; N/A indicates that the report is not a primary reference or a systematic review and therefore the quality has not been assessed.

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Sixth Edition/January 2007

References
Alsaeedi A, Sin DD, McAlister FA. The effects of inhaled corticosteroids in chronic obstructive pulmonary disease: a systematic review of randomized placebo-controlled trials. Am J Med 2002;113:59-65. (Class M) American Association for Respiratory Care (AARC). AARC Clinical Practice Guideline. Respir Care 1996;41:629-36. (Class R) American Thoracic Society (ATS). ATS statement: standards for the diagnosis and care of patients with COPD. Am J Respir Crit Care Med 1995;152:S77-S120. (Class R) American Thoracic Society. Lung function testing: selection of reference values and interpretative strategies. Am Rev Respir Dis 1991;144:1202-18. (Class R) American Thoracic Society. Pulmonary rehabilitation-1999. Am J Respir Crit Care Med 1999;159:166682. (Class R) American Thoracic Society. Standardization of spirometry. Am J Respir Crit Care Med 1995;152:110736. (Class R) Amsden GW, Baird IM, Simon S, Treadway G. Efficacy and safety of azithromycin vs levofloxacin in the outpatient treatment of acute bacterial exacerbations of chronic bronchitis. Chest 2003;123:77277. (Class A) Anthonisen NR, Manfreda J, Warren CPW, et al. Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med 1987;106:196-204. (Class A) Arcasoy SM, Kotloff RM. Lung transplantation. N Engl J Med 1999;340:1081-91. (Class R) Bando K, Paradis IL, Keenan RJ, et al. Comparison of outcomes after single and bilateral lung transplantation for obstructive lung disease. J Heart Lung Transplant 1995;14:692-98. (Class C) Bartlett EE. At last, a definition. Pat Educ Couns 1985;7:323-24. (Class not assignable) Bauldoff GS, Hoffman LA. Teaching COPD patients upper extremity exercises at home. Perspect Resp Nurs 1997;8:3-4. (Class not assignable) Berg BW, Dillard TA, Rajagopal KR, et al. Oxygen supplementation during air travel in patients with chronic obstructive pulmonary disease. Chest 1992;10:638-41. (Class D) Berry MJ, Rejeski WJ, Adair NE, et al. A randomized, controlled trial comparing long-term and shortterm exercise in patients with chronic obstructive pulmonary disease. J Cardiol Rehab 2003;23:60-68. (Class A) Blosser SA, Maxwell SL, Reeves-Hoche MK, et al. Is an anticholinergic agent superior to 2 agonist in improving dyspnea and exercise limitation in COPD? Chest 1995;108:730-35. (Class A) Bone RC, Pierce AK, Johnson RL. Controlled oxygen administration in acute respiratory failure in chronic obstructive pulmonary disease: a reappraisal. Am J Med 1978;65:896-902. (Class D) Boothman-Burrell D, Delany SG, Flannery EM, et al. The efficacy of inhaled corticosteroids in the management of non-asthmatic chronic airflow obstruction. NZ Med J 1997;110:370-73. (Class A) Boushy SF, Kohen R, Billig DM, Heiman MJ. Bullous emphysema: clinical, roentgenologic and physiologic study of 49 patients. Dis Chest 1968;54:17-24. (Class D) Bower JS, Brook CJ, Zimmer K, et al. Performance of a demand oxygen saver system during rest, exercise, and sleep in hypoxemic patients. Chest 1988;94:77-80. (Class D)

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References

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Sixth Edition/January 2007

British Thoracic Society, COPD Guidelines Group of the Standards of Care Committee. BTS guidelines for the management of chronic obstructive pulmonary disease. Thorax 1997;52(Suppl 5):S1-S27. (Class R) Brusasco V, Hodder R, Miravitlles M, et al. Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD. Thorax 2003;58:399404. (Class A) Burge PS, Jones PW, Anderson JA, et al. Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial. BMJ 2000;320:1297-1303. (Class A) Calverley P, Pauwels R, Vestbo J, et al. Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet 2003;361:449-56. (Class A) Cambach WS, Wagenaar RC, Koelman TW, et al. The long-term effects of pulmonary rehabilitation in patients with asthma and chronic obstructive pulmonary disease: a research synthesis. Arch Phys Med Rehabil 1999;80:103-11. (Class M) Carskadon MA, Dement WC. Respirations during sleep in the aged human. J Gerontol 1981;136:42023. (Class D) Cazzola M, Noschese P, Centanni S, et al. Salmeterol/fluticasone propionate in a single inhaler device versus theophylline + fluticasone propionate in patients with COPD. Pulm Pharmacol Ther 2004;17:14145. (Class A) Celli BR. Current thoughts regarding treatment of COPD. Med Clin North Am 1996;80:589-609. (Class R) Celli BR, MacNee W. Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur Respir 2004;23:932-46. (Class R) Centers for Disease Control. Prevention and control of influenza. MMWR 1999;48 [RR-4]. (Class R) Centers for Disease Control. Prevention of pneumococcal disease: recommendations of the advisory committee on immunization practices (ACIP). MMWR 1997;46 [RR-8]. (Class R) Chodosh S, McCarty J, Farkas S, et al. Randomized, double-blind study of ciprofloxacin and cefuroxime axetil for treatment of acute bacterial exacerbations of chronic bronchitis. Clin Infect Dis 1998;27:72229. (Class A) Clark CJ. The place of education in the management of chronic lung disease. Monaldi Arch Chest Dis 1994;49:68-70. (Class R) Costello J. Prospects for improved therapy in chronic obstructive pulmonary disease by the use of levalbuterol. J Allerg Clin Immunol 1999;104:S61-8. (Class R) Couch RB. Prevention and treatment of influenza. N Engl J Med 2000;343:1778-87. (Class R) Cummins RO, Schubach JA. Frequency and types of medical emergencies among commercial air travelers. JAMA 1989;261:1295-99. (Class D) Dahl R, Greefhorst LAPM, Nowak D, et al. Inhaled formoterol dry powder versus impratropium bromide in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2001;164:778-84. (Class A) Dale LC, Glover ED, Sachs DPL, et al. Bupropion for smoking cessation*/predictors of successful outcome. Chest 2001;199:1357-64. (Class A) Davies L, Angus RM, Calverley PMA. Oral corticosteroids in patients admitted to hospital with exacerbations of chronic obstructive pulmonary disease: a prospective randomised controlled trial. Lancet 1999;354:456-60. (Class A) Institute for Clinical Systems Improvement

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References

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Sixth Edition/January 2007

Devine EC, Pearcy J. Meta-analysis of the effects of the psychoeducational care in adults with COPD. Pat Educ Couns 1996;29:167-78. (Class M) Dillard TA, Beninati WA, Berg BW. Air travel in patients with chronic obstructive pulmonary disease. Arch Intern Med 1991;151:1793-95. (Class D) Dillard TA, Berg WB, Rajagopal KR, et al. Hypoxemia during air travel in patients with chronic obstructive pulmonary disease. Ann Int Med 1989;111:362-67. (Class D) Donado JR, Nicholas SH. Outpatient management. Resp Care Clin North Am 1998;4:391-417. (Class R) Donohue JF, van Noord JA, Bateman ED, et al. A 6-month, placebo-controlled study comparing lung function and health status changes in COPD patients treated with tiotropium or salmeterol. Chest 2002;122:47-55. (Class A) Dorinsky PM, Reisner C, Fergusen GT, et al. The combination of ipratropium and albuterol optimizes pulmonary function reversibility testing in patients with COPD. Chest 1999;115:966-71. (Class A) Dunn WF, Nelson SB, Hubmayr RD. Oxygen-induced hypercarbia in obstructive pulmonary disease. Am Rev Respir Dis 1991;144:526-30. (Class C) Easton PA, Jadue C, Dhingra S, et al. A comparison of the bronchodilating effects of a 2 andernergic agent (albuterol) and an anticholinergic agent (ipratropium bromide), given by aerosol alone or in sequence. N Engl J Med 1986;315: 735-39. (Class A) Emanuel LL, Barry MJ, Stoeckle JD, et al. Advance directives for medical care a case for greater use. N Engl J Med 1991;324:889-95. (Class D) European Respiratory Society (ERS). Optimal assessment and management of chronic obstructive pulmonary disease. Eur Resp J 1995;8:1398-1420. (Class R) Ferguson GT, Enright PL, Buist AS, et al. Office spirometry for lung health assessment in adults: a consensus statement from the national lung health education program. Chest 2000;117:1146-61. (Class R) Folgering H, Rooyakkers J, Herwaarden CV. Education and cost/benefit ratios in pulmonary patients. Monaldi Arch Chest Dis 1994;49:166-68. (Class R) Gibson RL, Comer PB, Beckman RW, et al. Actual tracheal oxygen concentration with commonly used oxygen therapy. Anesthesiology 1976;44:71-73. (Class D) Gibson PG, Coughlan J, Wilson AJ, et al. Self-management education and regular practitioner review for adults with asthma. Cochrane Library, 1999. (Class M) Gimeno F, van Veenen R, Steenhuis EJ. Ear oximetry studies during sleep in patients with severe COPD in a stable state. Ann Allerg 1986;56:142-44. (Class D) Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2006. (Class R) Grosbois JM, Lamblin C, Lemaire B, et al. Long-term benefits of exercise maintenance after outpatient rehabilitation program in patients with chronic obstructive pulmonary disease. J Cardiopulm Rehabil 1999;19:216-25. (Class C) Hanania NA, Darken P, Horstman D, et al. The efficacy and safety of fluticasone propionate (250 ug)/ salmeterol (50 ug) combined in the diskus inhaler for the treatment of COPD. Chest 2003;124:834-43. (Class A) Hansen-Flaschen J. Advanced lung disease. Palliation and terminal care. Clin Chest Med 1997;18:64555. (Class R) Institute for Clinical Systems Improvement

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References

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Sixth Edition/January 2007

Heffner JE, Fahy B, Hilling L, et al. Attitudes regarding advance directives among patients in pulmonary rehabilitation. Am J Respir Crit Care Med 1996;154:1735-40. (Class D) Hoch CC, Reynolds CF III, Monk TH, et al. Comparison of sleep-disordered breathing among healthy elderly. Sleep 1990;13:502-11. (Class C) Hodgkin JE. Prognosis in chronic obstructive pulmonary disease. Clin Chest Med 1990;11:555-69. (Class R) Hosenpud JD, Bennett LE, Keck BM, et al. Effect of diagnosis on survival benefit of lung transplantation for end-stage lung disease. Lancet 1998;351:24-27. (Class C) Houtmeyers E, Gosselink R, Gayan-Ramirez G, et al. Effects of drugs on mucus clearance. Eur Resp J 1999;14:452-67. (Class R) Hvizdos KM, Goa KL. Tiotropium bromide. Drugs 2002;62:1195-1203. (Class R) Institute for Clinical Systems Improvement. Lung volume reduction surgery for emphysema. #23, 2003. (Class R) Institute for Clinical Systems Improvement (ICSI). Pulmonary rehabilitation for chronic obstructive disease, technology assessment report. ICSI, 1997. (Class R) Institute for Clinical Systems Improvement. Tobacco Use Prevention and Cessation for Adults. January 2000. (Class R) Ketelaars CAJ, Huyer-Aby Saad H, Halfens RJG, et al. Process standards of nursing care for patients with COPD: validation of standards and criteria by the Delphi technique. J Nurs Care Qual 1994;9:7886. (Class C) Knight H, Mullman RP, Gur RC, et al. Clinical significance of sleep apnea in the elderly. AARD 1987;136:845-50. (Class C) Kory RC, Bergmann JC, Sweet RD, et al. Comparative evaluation of oxygen therapy techniques. JAMA 1962;179:123-28. (Class D) Kottakis J, Cioppa GD, Creemers J, et al. Faster onset of bronchodilation with formoterol than with salmeterol in patients with stable, moderate to severe COPD: results of a randomized, double-blind clinical study. Can Respir J 2002;9:107-15. (Class A) Lacasse Y, Guyatt GH, Goldstein RS. The components of a respiratory rehabilitation program. Chest 1997;111:1077-88. (Class M) Laros CD, Gelissen HJ, Bergstein PGM, et al. Bullectomy for giant bullae in emphysema. J Thorac Cardiovasc Surg 91:63-70, 1986. (Class D) Lien D, Turner M. Recommendations for patients with chronic respiratory disease considering air travel: a statement from the Canadian thoracic society. Can Respir J 1998;5:95-100. (Class R) Little SA, Elkholy MM, Chalmers GW, et al. Predictors of nocturnal oxygen desaturation in patients with chronic obstructive pulmonary disease. Res Med 1999;93:202-07. (Class C) Lopez-Majano V, Dutton RE. Regulation of respiratory drive during oxygen breathing in chronic obstructive lung disease. Am Rev Respir Dis 1973;108:232-40. (Class C) Lung Health Study Research Group. Effect of inhaled triamcinolone on the decline in pulmonary function in chronic obstructive pulmonary disease. New Engl J Med 2000;343:1902-09. (Class A) Maisel AS, Krishnaswamy P, Nowak RM, et al. Rapid measurement of b-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med 2002;347:161-67. (Class B)

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References

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Man WD, Polkey MI, Donaldson N, et al. Community pulmonary rehabilitation after hospitalization for acute exacerbations of chronic obstructive pulmonary disease: randomised controlled study. BMJ 2004;329:1209. (Class A) Matera MG, Caputi M, Cazzola M. A combination with clinical recommended dosages of salmeterol and ipratropium is not more effective than salmeterol alone in patients with chronic obstructive pulmonary disease. Respir Med 1996;90:497-99. (Class A) Matera MG, Cazzola M, Vinciguerra A, et al. A comparison of the bronchodilating effects of salmeterol, salbutamol and ipratropium bromide in patients with chronic obstructive pulmonary disease. Pulm Pharmacol 1995;8:267-71. (Class A) McCrory DC, Brown C, Gelfand SE, Bach PB. Management of acute exacerbations of COPD: a summary and appraisal of published evidence. Chest 2001;119:1190-1209. (Class M) McCullough PA, Nowak RM, McCord J, et al. B-type natriuretic peptide and clinical judgment in emergency diagnosis of heart failure: analysis from breathing not properly (BNP) multinational study. Circulation 2002;106:416-22. (Class B) McEvoy CE, Niewoehner DE. Corticosteroids in chronic obstructive pulmonary disease: clinical benefits and risks. Clin Chest Med 2000;21:739-52. (Class R) Medical Research Council Working Party, The. Long-term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Lancet 1981;1:681-85. (Class A) Michalets EL. Update: clinically significant cytochrome P-450 drug interactions. Pharmacotherapy 1998;18:84-112. (Class R) Moayyedi P, Congleton J, Page RL, et al. Comparison of nebulised salbutamol and ipratropium bromide with salbutamol alone in the treatment of chronic obstructive pulmonary disease. Thorax 1995;50:83437. (Class A) Murphy TF, Sethi S. Bacterial infection in chronic obstructive pulmonary disease. Am Rev Respir Dis 1992;146:1067-83. (Class R) Narsavage GL. Promoting function in clients with chronic lung disease by increasing their perception of control. Holistic Nurs Prac 1997;17-25. (Class R) National Emphysema Treatment Trial Research Group. A randomized trial comparing lung-volumereduction surgery with medical therapy for severe emphysema. N Engl J Med 2003;348:2059-73. (Class A) Niewoehner DE, Erbland ML, Deupree RH, et al. Effect of systemic glucocorticoids on exacerbations of chronic obstructive pulmonary disease. N Engl J Med 1999;340:1941-47. (Class A) Niewoehner DE, Rice K, Cote C, et al. Prevention of exacerbations of chronic obstructive pulmonary disease with tiotropium, a once-daily inhaled anticholinergic bronchodilator: a randomized trial. Ann Intern Med 2005;143:317-26. (Class A) Nelson HS. Clinical experience with levalbuterol. J Allerg Clin Immunol 1999;104:S77-84. (Class R) Nocturnal Oxygen Therapy Trial Group. Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Ann Intern Med 1980;93:391-98. (Class A) O'Driscoll BR, Taylor RJ, Horsley MG, et al. Nebulised salbutamol with and without ipratropium bromide in acute airflow obstruction. Lancet 1989;1:1418-20. (Class A) Oostenbrink JB, Rutten-van Mlken MJ, Van Noord JA, Vincken W. One-year cost-effectiveness of tiotropium versus ipratropium to treat chronic obstructive pulmonary disease. Eur Respir J 2004;23:24149. (Class M)

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References

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Paggiaro PL, Dahle R, Bakran I, et al. Multicentre randomised placebo controlled trial of inhaled fluticasone propionate in patients with chronic obstructive pulmonary disease. International COPD Study Group. Lancet 1998;351:773-80. (Class A) Parvez L, Vaidya M, Sakhardande S, et al. Evaluation of antitussive agents in man. Pulmon Pharmacol 1996;9:299-308. (Class R) Patakas D, Andreadis D, Mavrofridis E, et al. Comparison of the effects of salmeterol and ipratropium bromide on exercise performance and breathlessness in patients with stable chronic obstructive pulmonary disease. Resp Med 1998;92:1116-21. (Class A) Patrick DM, Dales RE, Stark RM, et al. Severe exacerbations of COPD and asthma: incremental benefit of adding ipratropium to usual therapy. Chest 1990;98:295-97. (Class A) Pauwels RA, Buist AS, Calverley P, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: NHLBI/WHO Global initiative for chronic obstructive lung disease (Global Initiative for Chronic Obstructive Lung Disease) workshop summary. Am J Respir Crit Care Med 2001;163:1256-76. (Class R) Petty T. The National Mucolytic Trial: results of a randomized, double-blind, placebo-controlled study of iodinated glycerol in chronic obstructive bronchitis. Chest 1990;97:75-83. (Class A) Rennard S, Serby CW, Ghafouri M, et al. Extended therapy with ipratropium is associated with improved lung function in patients with COPD. Chest 1996;110:62-70. (Class M) Resnikoff P, Ries A. Pulmonary rehabilitation and adjunctive measures. Resp Care Clin North Am 1998;4:475-91. (Class R) Rubin BK. An in vitro comparison of the mucoactive properties of guaifenesin, iodinated glycerol, surfactant, and albuterol. Chest 1999;169:195-200. (Class C) Rubin BK, Ramirez OE, Ohar JA. Iodinated glycerol has no effect on pulmonary function, symptom score, or sputum properties in patients with stable chronic bronchitis. Chest 1996;109:348-52. (Class A) Scherer YK, Schmieder LE, Shimmel S. The effects of education alone and in combination with pulmonary rehabilitation on self-efficacy in patients with COPD. Rehab Nurs 1998;23:71-77. (Class C) Scherer YK, Shimmel S. Using self-efficacy theory to educate patients with COPD. Rehab Nurs 1996;21:262-66. (Class D) Scott VL, Frazee LA. Retrospective comparison of nebulized levalbuterol and albuterol for adverse events in patients with acute airflow obstruction. Am J Therapeutics 2003;10:341-47. (Class C) Senderovitz T, Vestbo J, Frandsen J, et al. Steroid reversibility test followed by inhaled budesonide or placebo in outpatients with stable chronic obstructive pulmonary disease. Respir Med 1999;93:71518. (Class A) Shim CS, Williams Jr MH. Aerosol beclomethasone in patients with steroid-responsive chronic obstructive pulmonary disease. Am J Med 1985;78:655-58. (Class A) Sin DD, Tu JV. Inhaled corticosteroids and the risk of mortality and readmission in elderly patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2001;164:580-84. (Class B) Soffer M, Tashkin DP, Shapireo BJ, et al. Conservation of oxygen supply using a reservoir nasal cannula in hypoxemic patients at rest and during exercise. Chest 1985;88:663-68. (Class C) Steuart GW. The specialist in health education: training for the future. Int J Health Educ 1966;9:16569. (Class X) Turner MO, Patel A, Ginsburg S, FitzGerald M. Bronchodilator delivery in acute airflow obstruction: a meta-analysis. Arch Intern Med 1997;157:1736-44. (Class M) Institute for Clinical Systems Improvement

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0

References

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

UN Environment Programme. Handbook of International Treaties for Protection of the Ozone Layer (5th ed) Part II The Montreal Protocol on Substances that Delete the Ozone Layer. UN Environmental Programme: Nairobi 2000. (Website www.unep.org/ozone/handbook2000.shtml) (Class not assignable) U.S. Department of Health and Human Services. Treating tobacco use and dependence. Clinical practice guideline. June 2000. (Class R) U.S. Food and Drug Administration Consumer Information Report/Relenza October 2000. Available at: http://www.fda.gov/cder/consumerinfo/ (Class not assignable) Van Andel AE, Reisner C, Menjoge SS, et al. Analysis of inhaled corticosteroid and oral theophylline use among patients with stable COPD from 1987 to 1995. Chest 1999;115:703-07. (Class D) van Noord JA, Aumann JL, Janssens E, et al. Effects of tiotropium with and without formoterol on airflow obstruction and resting hyperinflation in patients with COPD. Chest 2006;129:509-17. (Class A) Vaswani SK, Creticos PS. Metered dose inhaler: past, present, and future. Ann Allergy Asthma Immunol 1998;80:11-21. (Class R) Vaz Fragoso CA, Miller MA. Review of the clinical efficacy of theophylline in the treatment of chronic obstructive pulmonary disease. Am Rev Respir Dis 1993;147:S40-S47. (Class R) Ward JJ, Hess DR, Helmholz HF. Humidity and aerosol therapy. In GG Burton, JE Hodgkin, JJ Ward (eds): In Respiratory Care: A Guide to Clinical Practice. New York: Lippincott 1997. (Class not assignable) Watson PB, Town GI, Holbrook N, et al. Evaluation of a self-management plan for COPD. Eur Resp J 1997;10:1267-71. (Class A) Weitzenblum E, Sutegeau A, Erhart M, et al. Long-term oxygen therapy can reverse the progression of pulmonary hypertension in patients with chronic obstructive pulmonary disease. Am Rev Respir Dis 1985;131:493-98. (Class C) Wilt TJ, Niewoehner D, Kim C, et al. Use of spirometry for case finding, diagnosis, and management of chronic obstructive pulmonary disease (COPD). Evid Rep Technol Assess (Summ). 2005. (Class M)

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Work Group's Conclusion: Albuterol and ipratropium are equipotent as bronchodilators, improving dyspnea and exercise tolerance equally well. Salmeterol is a long-acting bronchodilator that is a suitable agent for scheduled administration.

Conclusion Grade: II

Conclusion Grading Worksheet A Annotation #11 (Pharmacological Management)

Institute for Clinical Systems Improvement Sixth Edition/January 2007

Author/ Year

Qual- Population Studied/Sample Size Primary Outcome Measure(s)/Results (e.g., p-value, Authors' Conclusions/ ity confidence interval, relative risk, odds ratio, likeliWork Group's Comments (italicized) + , , hood ratio, number needed to treat) A combination of clinical recommended dosages of salmeterol and ipratropium is not more effective than salmeterol alone in patients with chronic obstructive pulmonary disease. Respir Med 1996;90:497-499. Matera MG, RCT A -12 male patients, stable COPD -No differences between groups at baseline (before -Fifty micrograms salmeterol has a longer Caputi M, -Included: smoking history>10 any of the treatments) duration of action than 40g ipratropium Cazzola M pack-yrs; >40 yrs old -Peak response for salmeterol (28.8%) was greater with no benefit of adding ipratropium to (1996) -Excluded: history of asthma, al- than for ipratropium (26.0%) but equivalent to salsalmeterol. Salmeterol should be considered lergic rhinitis, or atopy; total meterol plus ipratropium (28.0%) an attractive alternative to other bronchodilablood eosinophil count -All active treatments produced significant brontors and endorsed as a first-line agent. >400mm3 chodilation effect from 15 to 360 minutes after -Four treatments: treatment vs. placebo (p<0.05); only salmeterol and NOTES: FEV1 values were between 16% and a. salmeterol hydroxynaphthoate salmeterol plus ipratropium had significant increase 62% of predicted values after bronchodilator (50g) plus placebo over placebo for 12-hour monitoring period (p<0.05) drugs had been withheld for 24 hrs and 12 b. ipratropium bromide (40g) -Mean areas under FEV1 response-time curves were: hrs, respectively; design was single-blind, plus placebo 2.67 for salmeterol, 1.06 for ipratropium, and 2.71 balanced, cross-over, randomized trial done c. salmeterol (50g) plus for salmeterol plus ipratropium; areas for active on four non-consecutive days ipratropium (40g) treatments were all greater than for placebo (p<0.05); d. placebo plus placebo salmeterol and salmeterol plus ipratropium were Work Groups Comments: small patient -FEV1 measured at baseline and greater than ipratropium alone (p<0.05); no differpopulation; patient selection criteria not defor 12 hours after treatment ence between two salmeterol groups scribed; not drug company funded

Design Type

Class

Chronic Obstructive Pulmonary Disease

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Institute for Clinical Systems Improvement Sixth Edition/January 2007

Conclusion Grading Worksheet A Annotation #11 (Pharmacological Management)

Author/ Year

Design Type

Class

Qual- Population Studied/Sample Size Primary Outcome Measure(s)/Results (e.g., p-value, Authors' Conclusions/ ity confidence interval, relative risk, odds ratio, likeliWork Group's Comments (italicized) + , , hood ratio, number needed to treat) Comparison of the effects of salmeterol and ipratropium bromide on exercise performance and breathlessness in patients with stable chronic obstructive pulmonary disease. Respir Med 1998;92:1116-1121. Patakas D, RCT A -15 patients, stable COPD, -No differences in pulmonary function values before -The inhaled adrenergic agent salmeterol, Andreadis D, mean age 64.6 yrs any of the treatments when given in conventional doses, produces Mavrofridis E, -Included: FEV1 <65% of pre-FVC, FEV1, and inspiratory flow at 50% FVC im- significant improvements in the airflow ob& Argyropoudicted, less then 20% reversibil- proved after salmeterol and ipratropium but not after struction, in the recovery from post-exercise lou P (1998) ity on beta-adrenergic inhalation, placebo (p<0.05 for all comparisons to placebo; no oxyhemoglobin desaturation, and the dyspdiffusing capacity of lung for difference between two treatments) neic sensation in patients with COPD. The CO 65% of predicted normal -Resting arterial O2 saturation (SaO2) and nadir SaO2 effects were similar to those produced after value during exercise after ipratropium or salmeterol not the inhalation of the anticholinergic agent -Excluded: coronary heart disdifferent from placebo; SaO2 recovery time shorter ipratropium bromide. ease, left ventricular dysfuncafter both active treatments (vs. placebo) (both tion, severe hypertension, disp<0.05) NOTES: patients were asked to not take ease of major organ system that -Distance walked increased after ipratropium and theophylline and anticholinergic compounds affected exercise performance salmeterol (both p<0.01); distance walked with for 48 hrs before the study and no inhaled -3 study days, 24 hrs apart breathlessness score zero increased after salmeterol bronchodilators on the morning of the study -Three treatments: (p<0.05) only, distance walked at Borg breathlessdays; design was randomized, cross-over (it a. 6 puffs placebo ness scale score of 5 increased after both treatments was not stated whether assessment was b. 6 puffs ipratropium bromide (both p<0.05); maximum Borg breathlessness scale blinded) (120g) score during exercise did not improve significantly c. 2 puffs salmeterol (50g) with active treatment Work Groups Comments: small patient -Pulmonary function assessed -Rest and exercise heart rate and blood pressure valpopulation; patient selection criteria not debefore treatment and 30 min af- ues were not significantly different after active treat- scribed; not drug company funded ter; progressive incremental ment (vs. after placebo) treadmill test after function test -No adverse effects after salmeterol, ipratropium, or placebo

Chronic Obstructive Pulmonary Disease

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Institute for Clinical Systems Improvement Sixth Edition/January 2007

Conclusion Grading Worksheet A Annotation #11 (Pharmacological Management)

Author/ Year

Design Type

Class

Qual- Population Studied/Sample Size Primary Outcome Measure(s)/Results (e.g., p-value, Authors' Conclusions/ ity confidence interval, relative risk, odds ratio, likeliWork Group's Comments (italicized) + , , hood ratio, number needed to treat) A comparison of the bronchodilating effects of salmeterol, salbutamol [albuterol], and ipratropium bromide in patients with chronic obstructive pulmonary disease. Pulm Pharmacol 1995;8:267-271. Matera MG, RCT A -16 males, moderate to severe -No differences between baseline values before any of -On average, salmeterol compares very faCazzola M, COPD, ages 62-73 yrs the treatments vorably with ipratropium bromide in terms Vincigierra A, -Included: current or former -At 15 min after inhalation increased FEV1 of 15% of effects on lung function at clinically recet al. (1995) heavy smoker; chronic cough was observed for 8 of 16 after albuterol, 4 of 16 after ommended doses. Salmeterol has a slower with or without sputum, or salmeterol, and 7 of 16 after ipratropium onset of effect but a longer duration of action dyspnea when walking, or both; -Mean peak bronchodilation occurred 30 min after than ipratropium and albuterol, which, beno change in symptom severity albuterol (range 15-120 min), 3 hrs after salmeterol cause of prolonged dosing intervals, may enor treatment in past 4 wks; no (range 30-360 min), and 2 hrs after ipratropium hance compliance. The individual results, signs of respiratory tract infec(range 15-300 min) however, showed that salmeterol resulted in tion in past month or during -Change from baseline for salmeterol exceeded that the best improvement in FEV1 for 8 patients trial; not taking oral corticoster- for placebo (p<0.05) for 12 hrs (vs. 6 hrs for while ipratropium was best for the remaining oids; FEV1 between 15-69% of ipratropium and 3 hrs for albuterol); similar pattern 8. predicted after beta-agonists of responses for FEV1, FVC, and FEF50 withheld for 24 hrs -Mean area under FEV1 vs. time curve was larger NOTES: design was double-blind, multiple -Excluded: history of asthma, al- (p<0.05) after salmeterol than for ipratropium or al- cross-over, randomized; patients had not lergic rhinitis, or atopy; total buterol; area under ipratropium FEV1 curve was taken any inhaled bronchodilator for at least blood eosinophil count larger (p<0.05) than for albuterol 12 hours and oral theophylline for at least 24 >400mm3 hrs before study; avoided caffeinated bever-Four treatments: ages and smoking before and during investia. 50g salmeterol hygation droxynaphthoate b. 200g salbutamol [albuterol] Work Groups Comments: study suggests sulphate superiority of salmeterol as a scheduled dose c. 40g ipratropium bromide agent; small patient population; patient sed. placebo lection criteria not described; not drug company funded

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Conclusion Grading Worksheet A Annotation #11 (Pharmacological Management)

Author/ Year

Design Type

Class

Qual- Population Studied/Sample Size Primary Outcome Measure(s)/Results (e.g., p-value, Authors' Conclusions/ ity confidence interval, relative risk, odds ratio, likeliWork Group's Comments (italicized) + , , hood ratio, number needed to treat) Comparison of nebulised salbutamol [albuterol] and ipratropium bromide with salbutamol alone in the treatment of chronic obstructive pulmonary disease. Thorax 1995;50:834837. Moayyedi, P, RCT A -Patients admitted as emergen-Albuterol (n=33) and combination (n=29) groups -The combination of albuterol and ipratroCongleton J, cies with acute exacerbation of were comparable at baseline in age, ht, wt, smoking, pium bromide appeared to give no additional Page RL, COPD; 70 enrolled, 62 suitable arterial O2 and CO2 tensions, FEV1, and FVC benefit compared with albuterol alone during Pearson SB, for analysis -Length of stay (10.5 days for albuterol group and the routine inpatient treatment of an acute & Muers MF -Included: not taking regular 11.8 days for combination group) and days on nebu- exacerbation of COPD. (1995) nebulized bronchodilators; over lizers (8.5 days and 8.2 days, respectively) were 45 yrs; smoking history of >10 comparable as were days on aminophylline and anti- NOTES: Of 70 enrolled, 3 withdrew, 2 were pack yrs; FEV1 <65% predicted, biotics; days on steroids differed with fewer days on ineligible (reversibility >20%), 1 withdrawn history of exertional dyspnea for steroids for albuterol only (0.1 and 0.6, respectively, because of newly diagnosed carcinoma, 2 >3 yrs p=0.05) withdrawn due to side effects; patients were -Excluded: history suggestive of -Changes in FEV1 and FVC values with respect to blinded to medication as were doctors who asthma; peripheral eosinophiia baseline at day 3, day 7, day 14, and day of discharge performed spirometer tests; 3 deaths during >10%; >20% reversibility of did not differ between groups (except FVC day 3admission (1 in albuterol group, 2 in combiFEV1 to 400g salbutamol [al- day1, p=0.05) nation group) buterol] -No difference in subjective assessment of improve-Randomized to receive mebument Work Groups Comments: patient selection lized salbutamol [albuterol] criteria not described; not drug company (5mg) 4x/day or salbutamol [alfunded; not intention-to-treat analysis; 11% buterol] (5mg) plus ipratropium loss to follow-up; applications of these find(500g) 4x/day ings to a general, stable population should -Spirometer values before treatbe cautioned as the study was done in a setment, days 3 & 7, then weekly ting of acute exacerbation and on day of discharge; daily subjective symptom score

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Author/ Year

Design Type -Ninety-day administration of ipratropium resulted in improvements in baseline lung function (FEV1 & FVC) and acute response to bronchodilator therapy. Effects on symptoms and quality of life were small, consistent with small changes in lung function. Patients treated with -agonists experienced minimal changes in baseline lung function and lung function after short-term administration of bronchodilator decreased over time. NOTES: the included trials were part of drug development programs conducted by one pharmaceutical company; continued use of stable doses of theophylline, inhaled steroids, or oral steroids (10 mg/day) was allowed; regular use of inhaled bronchodilators other than study drug was not permitted; increase in or addition of oral steroids was allowed but limited to 2 periods of 5 days; residual bronchodilator effects may have been present despite withholding for 12 hours Work Groups Comments: the included trials were all funded by Boehringer Ingelheim Pharmaceuticals, the maker of ipratropium

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Authors' Conclusions/ Work Group's Comments (italicized)

Conclusion Grading Worksheet A Annotation #11 (Pharmacological Management)

Class

Qual- Population Studied/Sample Size Primary Outcome Measure(s)/Results (e.g., p-value, ity confidence interval, relative risk, odds ratio, likeli+ , , hood ratio, number needed to treat) Extended therapy with ipratropium is associated with improved lung function in patients with COPD. Chest 1996;110:62-70. Rennard SI, MetaM N/A -7 clinical trials lasting at least -Total of 1,836 patients; 80% of patients in ipratroSerby CW, Analy90 days comparing ipratropium pium group (n=744) and 77% of patients in Ghafouri M, sis with a -agonist (metaproterenol agonist groups (n=701) completed 3 months Johnson PA, or albuterol) -Groups reported to be similar at baseline & Friedman -Included: diagnosis of COPD; -Pooled data for changes from baseline: M (1996) 40 yrs old; smoking history Ipratropium -agonist 10 pack-yrs; relatively stable; FEV1, mL 28 (p<0.01) -1 (NS) FEV165% (5 trials) or 75% FVC, mL 131 (p<0.01) 20 (NS) (2 trials) of predicted; FEV1 Changes from baseline for -agonist group were sig<70% of FVC nificantly less than for ipratropium group (p<0.05 -Excluded: history of asthma, for FEV1, p<0.01 for FVC) allergic rhinitis, or atopy; ele-90-day therapy was associated with a decrease in vated blood eosinophil count; number of patients who responded acutely (15% >10 mg prednisone/day; use of change in FEV1 & FVC) to bronchodilator; reduccromolyn sodium tion in responsiveness was greater for -agonist -2 trials required 15% imgroup (p<0.001) provement in FEV1 following -Current smokers improved similarly when treated isoproterenol inhalation with ipratropium and -agonists; ex-smokers showed -3 trials administered drugs by greater improvement when treated with ipratropium nebulizer, 4 by metered-dose in- and minimal improvement or worsening when haler treated with -agonists (no p-values reported) -Baseline lung function before -Symptom scores unchanged for the overall study treatment and at 90 days detergroup; improvement in shortness of breath noted for mined after withholding all ex-smokers treated with ipratropium (p=0.005); qualbronchodilators for 12 hours ity of life scores improved slightly for the entire group; greater improvement in quality of life for exsmokers treated with ipratropium (p=0.0003)

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

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Institute for Clinical Systems Improvement Sixth Edition/January 2007

Conclusion Grading Worksheet A Annotation #11 (Pharmacological Management)

Author/ Year

Design Type

Class

Qual- Population Studied/Sample Size Primary Outcome Measure(s)/Results (e.g., p-value, Authors' Conclusions/ ity confidence interval, relative risk, odds ratio, likeliWork Group's Comments (italicized) + , , hood ratio, number needed to treat) A comparison of the bronchodilating effects of a beta-2 adrenergic agent (albuterol) and an anticholinergic agent (ipratropium bromide) given by aerosol alone or in sequence. N Engl J Med 1986;315:735-739. Easton PA, RCT A -11 patients with COPD; mean -Mean smoking history of 56 pack-years -Albuterol and ipratropium bromide are equiJadue C, age 70 years (range 59-79) -Baseline FEV1 values comparable before all protopotent in maximal doses; the addition of Dhingra S, & -Included: clinical diagnosis of cols (as were other measures) ipratropium to a high dose of albuterol is of Anthonisen chronic bronchitis, emphysema -Mean changes in FEV1 in response to albuterol no practical value. NR (1986) or both; history of cigarette alone and to ipratropium alone were not significantly smoking; evidence of severe air- different; effect of adding a second agent did not differ NOTES: design was randomized, doubleflow obstruction (FEV1<1.5L from that of placebo blind, cross-over done on 4 consecutive days; and need for long-term bron-Pattern of mean changes in specific airway conduc- patients allowed to continue oral medications chodilator therapy) tance was the same as for FEV1 including theophyllines at usual dosage and -Excluded: history suggestive of -Similar lessening of hyperinflation with either times; aerosol bronchodilators were disconasthma; eosinophilia; exacerba- agent alone; negligible additional change when either tinued 6 hrs before start of each protocol; tion of airflow obstruction or agent was inhaled second when used as the initial agent the dosage exany change in medications in -No side effects reported by any patient; no evidence ceeded that recommended by manufacturer preceding 2 months of tremor and no increase in heart rate over baseline for single-dose but cumulative amount given -4 protocols: during any protocol was not greater than recommended daily a. 400g albuterol + 200g at maximum 15 min + 200g at 30 min + 80g ipratropium at 90 min Work Groups Comments: 8 puffs of alb. same with placebo at 90 min buterol was well-tolerated without side efc. 80g ipratropium + 40g at fects and provided up to 45% improvement 30 min + 200g albuterol at in FEV1; small patient population; not drug 120 min company funded d. same with placebo at 120 min -Spirometry at baseline, before 2nd inhalant, after 2nd inhalant -Blinded outcome assessment

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Institute for Clinical Systems Improvement Sixth Edition/January 2007

Conclusion Grading Worksheet A Annotation #11 (Pharmacological Management)

Author/ Year

Design Type

Class

Qual- Population Studied/Sample Size Primary Outcome Measure(s)/Results (e.g., p-value, Authors' Conclusions/ ity confidence interval, relative risk, odds ratio, likeliWork Group's Comments (italicized) + , , hood ratio, number needed to treat) Is an anticholinergic agent superior to a 2- agonist in improving dyspnea and exercise limitation in COPD? Chest 1995;108:730-735. Blosser SA, RCT A -Volunteers with COPD (ATS -Of 27 volunteers, 19 were eligible and 15 completed -There were no significant measurable differMaxwell SL, criteria) the study; ages ranged from 53 to 72 yrs ences in exercise ability or exertional dyspReeves-Hoche -Included: FEV1 <55% of pre-12-minute walk distance after 1 wk of treatment was nea in subjects with severe stable COPD inMK, Localio dicted; >15% improvement over not significantly different (755.7m for ipratropium haling standard doses of either albuterol or AR, & Zwilbaseline following albuterol and vs. 751.0 m for albuterol); both improved signifiipratropium for 1 week. lich CW ipratropium; able to walk for 12 cantly over baseline (p0.01); no difference between (1995) min; able to withhold inhaled week 1 and week 2 regardless of treatment NOTES: study design was double-blinded bronchodilators (6-12 hrs) prior -Mean dyspnea after 12-min walk did not differ from two-period crossover; metaproterenol allowed to visits; theophylline levels baseline after 1 wk of ipratropium but was different during treatment and washout phases; mediwithin 5% of baseline during after 1 wk of albuterol (p=0.02); dyspnea scored cation canisters weighed at end of 7-day study; corticosteroid dose undaily, oxygen cost, and mean number of rescue period to quantitate use; patients were rechanged 1 month prior and dur- puffs did not differ between the 2 treatment groups; ported to be generally compliant; multiing study significantly more rescue puffs during washout variate analysis was used to account for cor-Excluded: unstable angina, week than albuterol week (p=0.003) or ipratropium relation among measurements of distance CHF, narrow-angle glaucoma, week (p=0.01) walked, dyspnea on walking, peak flow, and BPH -Mean FEV1 after week of albuterol was not different FEV1 within subjects and for the sequence of -Two 7-day treatment phases (2 from baseline FEV1 nor from FEV1 after a week of administration of drugs puffs 4x/day of albuterol or ipratropium; FEV1 after ipratropium was improved ipratropium) with 7-day washout over baseline (p=0.03) Work Groups Comments: small patient between -7 subjects preferred albuterol, 7 preferred ipratropopulation therefore may not have sufficient pium, and 1 had no preference statistical power to detect significant differ-In a multivariate analysis there was no significant ences; not intention-to-treat analysis; no difference between overall effects of the 2 drugs baseline comparisons; funded by Glaxo, the makers of albuterol

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Institute for Clinical Systems Improvement Sixth Edition/January 2007

Conclusion Grading Worksheet A Annotation #11 (Pharmacological Management)

Author/ Year

Design Type

Class

Qual- Population Studied/Sample Size Primary Outcome Measure(s)/Results (e.g., p-value, Authors' Conclusions/ ity confidence interval, relative risk, odds ratio, likeliWork Group's Comments (italicized) + , , hood ratio, number needed to treat) The combination of ipratropium and albuterol optimizes pulmonary function reversibility testing in patients with COPD. Chest 115:966-71, 1999. Dorinsky PM, RCT A -Data from 2 trials; total of -Patients had moderate to severe COPD (FEV1 of -Use of a combination of ipratropium broReisner C, 1067 COPD outpatients en0.95L or 35.6% of predicted) mide and albuterol sulfate resulted in greater Ferguson GT, rolled; 852 completed study -Groups were comparable at baseline and remained pulmonary function test response rates than Menjoge SS, -Included: smoking history of comparable and within 6% of day 1 baseline on sub- either agent alone. The superior response Serby CW, & >10 pack-years, regular use of at sequent test days rates were reproducible throughout a 3-month Witek TJ least 2 bronchodilators during 3 -Majority of patients from each treatment group had test period. (1999) mos before trial, FEV1 65% of clinically significant improvement in FEV1 (defined predicted and 70% of FVC as 12% or 15% improvement) on the test days with NOTES: Both trials randomized, multicen-Excluded: asthma or allergic significantly more showing improvement from the ter, double-blind, parallel group, phase III rhinitis, atopy, total blood eosi- ipratropium and albuterol (combined) group (p<0.05) trials; patients could take 2 extra doses of nophil count >500/mm3, require at all test times and on all test days except Day 57 investigational drug/day to control exacerbalong-term O2 use or >10mg (at 60 and 120 min) and Day 85 (at 60 and 120 min) tions; maintenance doses of theophylline prednisone/day in month before (based on 852 patients); there was a significant de(except 24 hrs before testing) and inhaled entering study, MI in past yr, cline in the percentage of patients who responded to steroids (except 12 hrs before testing) alheart failure in past 3 yrs, cartherapy on Day 85 vs. Day 1 in the combined therlowed if the dosage had been stabilized for at diac arrhythmia requiring drug apy group (p<0.05) least 1 month before baseline studies and was therapy -A significantly greater number of patients responded stable throughout study; oral corticosteroids -Randomly assigned to receive 2 with a 12% or 15% improvement in FEV1 on 2 or were permitted if the patient had been stabiinhalations of ipratropium and more test days if they received the combination ther- lized for 1 month on a total daily dose albuterol, ipratropium only, or apy vs. either agent alone (p<0.05); the difference equivalent to 10 mg/day of prednisone with albuterol only 4 times/day for between protocol was most pronounced at 30 min af- stable dosage throughout study 85 days; doses of 18g/inhalater administration tion of ipratropium and Work Groups Comments: compliance with 90g/inhalation of albuterol the treatment was not reported; 215 were lost -Return visits every 2 wks to follow-up; not intention-to-treat analysis; -Pulmonary function testing on patient selection criteria not described; addidays 1, 29, 57, and 85 before tional arms should have compared higher drug admin. And at 15, 30, 60, doses of individual drugs to the combination; and 120 min after drug admin funded by Boehringer Ingelheim Pharmaceuticals, the maker of Combivent

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ICS I
I NSTIT U T E F O R C L I N I C A L S YSTE M S I M P ROV E M E N T

Support for Implementation:

Chronic Obstructive Pulmonary Disease

This section provides resources, strategies and measurement specifications for use in closing the gap between current clinical practice and the recommendations set forth in the guideline. The subdivisions of this section are: Priority Aims and Suggested Measures - Measurement Specifications Key Implementation Recommendations Knowledge Products and Resources Other Resources Available

Copyright 2007 by Institute for Clinical Systems Improvement

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Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Priority Aims and Suggested Measures


1. Increase the quality and use of spirometry testing in the diagnosis of patients with COPD. Possible measure for accomplishing this aim: a. Percentage of spirometry tests performed that meet the ATS Statement of Standardization of Spirometry.

b. Percentage of patients with a diagnosis of COPD who received routine spirometry testing at the time of diagnosis. 2. Increase the number of patients with COPD who receive information on the options for tobacco cessation and information on the risks of continued smoking. Possible measures for accomplishing this aim: a. Percentage of patients with COPD whose physician inquired about smoking cessation (if patient a smoker) at every visit.

b. Percentage of patients with COPD who have documented assessment of readiness to attempt tobacco cessation. c. Percentage of patients with COPD who receive a prescription for medication to aid smoking cessation. Percentage of patients with COPD who quit (100% quit-rate goal). Percentage of patients with COPD who are non-tobacco users.

d. Percentage of patients who have a smoking cessation intervention. e. f.

3. Reduce COPD exacerbation requiring emergency department (ED) evaluation or hospital admission. Possible measures for accomplishing this aim: a. c. Number of ED encounters for patients with COPD in a one-month period. Number of patients with two or more hospitalizations within a 12-month period. b. Number of hospital admissions for patients with COPD in a one-month period. 4. Increase the appropriate use of pharmacotherapy prescribed for patients with COPD. Possible measures for accomplishing this aim: a. c. Percentage of patients with COPD who received an influenza vaccine in the previous 12 months. Percentage of patients with COPD who are hypoxemic and meet criteria for long-term home oxygen who are prescribed oxygen. b. Percentage of patients with COPD who have received a pneumococcal vaccine.

d. Percentage of patients with severe COPD who have been assessed for the need for long-term oxygen. e. Percentage of patients who have moderate to severe COPD who have a prescription for regular use of a scheduled bronchodilator.

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Priority Aims and Suggested Measures

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

5. Increase patients' education and management skills with COPD. Possible measures for accomplishing this aim: a. Percentage of patients with moderate or severe COPD who have been referred to a pulmonary rehabilitation or exercise program.

b. Percentage of patients with COPD instructed on the use of inhaler with spacer technique and with documentation that inhaler technique was observed by a doctor, nurse or other health care professional. c. Percentage of patients with COPD who express satisfaction with the supporting information about COPD and the level of their own participation in care.

d. Percentage of patients with COPD who have discussed health care directives (or advanced directives) and goals of care with their health care professional. 6. Increase the number of patients with COPD presenting with an acute exacerbation who have an oxymetric evaluation. Possible measures for accomplishing this aim: a. Percentage of patients presenting with a COPD exacerbation having an oxymetric evaluation. b. Percentage of patients with COPD who have an O2 saturation less than 88%, positive history of hypercapnia, questionable accuracy of oximetry, somnolence or other evidence of impending respiratory failure, who receive an ABG.

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Priority Aims and Suggested Measures

Chronic Obstructive Pulmonary Disease

Sixth Edition/January 2007

Measurement Specifications
Possible Success Measure #2a
Percentage of patients with COPD whose physician inquired about smoking cessation (if patient a smoker) at every visit.

Population Definition
Patients with COPD who have any indication on their charts that they are users of tobacco who presented to the clinic within a designated time period.

Data of Interest
# of patients with documentation that the physician asked about tobacco status and/or readiness to quit Total # of patients with COPD who are smokers

Numerator/Denominator Definitions
Numerator: Denominator: Any indication in the chart that the physician asked about a change in smoking status and/or readiness to quit. Patients with a diagnosis of chronic bronchitis: (491.8, 491.20, or 491.21) or asthma with COPD (493.2) or chronic emphysema (491.20) who have an indication in their charts that they are users of tobacco who present for a clinic visit within the reporting month.

Method/Source of Data Collection


Identify patients with a clinic visit in the reporting month who meet the inclusion criteria. Data may be collected by medical record review.

Time Frame Pertaining to Data Collection


Randomly selected cases may be reviewed monthly.

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Sixth Edition/January 2007

Key Implementation Recommendations


The following system changes were identified by the guideline work group as key strategies for health care systems to incorporate in support of the implementation of this guideline. 1. A model of patient education should be established in the clinics based upon individual learning needs assessments and including coordinated plans jointly developed by educators, patients and their families. Patient education should include core learning and needs objectives based upon individual needs. 2. Include COPD patients in a system of patient visit planning for establishing tobacco status at each visit and advice to quit if appropriate, as well as appropriate pharmacotherapy and assessment of hypoxemia.

Knowledge Products and Resources


Criteria for Selecting Resources
The following resources were selected by the Chronic Obstructive Pulmonary Disease guideline work group as additional resources for providers and/or patients. The following criteria were considered in selecting these resources. The site contains information specific to the topic of the guideline. The content is supported by evidence-based research. The content includes the source/author and contact information. The content clearly states revision dates or the date the information was published. The content is clear about potential biases, noting conflict of interest and/or disclaimers as appropriate.

Resources Available to ICSI Members Only


The following materials are available to ICSI members only. Also available is a wide variety of other knowledge products, including tool kits on CQI processes and Rapid Cycling that can be helpful. To obtain copies of these or other Knowledge Products, go to http://www.icsi.org/knowledge. To access these materials on the Web site, you must be logged in as an ICSI member.

Educational Resources
Pneumovax algorithm for (re)vaccination of persons with chronic disease or at high risk of infection

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Other Resources Available


Title/Description
Comprehensive websites for respiratory care professionals with links to a site tailored to COPD patients and their families. Includes information about the disease, symptoms, treatment and support.

Audience
Patients and professionals

Author/Organization
American Association for Respiratory Care

Web Sites/Order Information


Professional focus: http://www.aarc.org Patient focus: http://www.aarc.org/klein

Primarily provides support for Patients patients with COPD and other lung diseases, rather than a source of medical information. Includes a variety of resources on lung diseases compiled from many sources. Comprehensive Web site for COPD. Includes definition, diagnosis, risk factors, pathology. Also includes the management of stable COPD and acute exacerbation. Smoking cessation, pharmacological therapy, pulmonary rehab, nutrition and surgical options information is also presented. Guidelines for professionals in the diagnosis and treatment of COPD. Resources include pocket guides, patient guides, workshop reports, teaching and educational materials and newsletter. Health information on various diseases and conditions. Patient education resources based on current practice guidelines and standards of care. Provides information on conferences, products and resources for nurses on all aspects of end-of-life care. Most resources available for a fee. Evidence-based clinical practice guidelines Patients and professionals

American Lung Association (Minnesota Chapter)

http://www.alamn.org

American Thoracic Society

http://www.thoracic.org/COPD

Professionals and patients

Global Initiative for Chronic Obstructive Lung Disease

http://www.goldcopd.com

Patients Patients

Mayo Clinic Krames

http://www.mayohealth.org http://www.krames.com

Nurses who provide end-of-life care

American Association of Colleges of Nursing; End-of-Life Nursing Education Consortium Project American College of Chest Physicians

http://www.aacn.nche.edu/elnec/ index.htm

Professionals

http://www.chestnet.org

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