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The information contained in this ICSI Health Care Guideline is intended primarily for health profes-sionals 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 opinionrelated to any specific facts or circumstances. If you are not one of the expert audiences listedabove you are urged to consult a health care professional regarding your own situation and anyspecific medical questions you may have. In addition, you should seek assistance from a healthcare professional in interpreting this ICSI Health Care Guideline and applying it in your individualcase.
This ICSI Health Care Guideline is designed to assist clinicians by providing an analytical frameworkfor the evaluation and treatment of patients, and is not intended either to replace a clinician’sjudgment or to establish a protocol for all patients with a particular condition. An ICSI Health CareGuideline rarely will establish the only approach to a problem.
Copies of this ICSI Health Care Guideline may be distributed by any organization to theorganization’s employees but, except as provided below, may not be distributed outside of theorganization 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 maybe used by the medical group in any of the following ways:
• copies may be provided to anyone involved in the medical group’s process for developing andimplementing clinical guidelines;
• the ICSI Health Care Guideline may be adopted or adapted for use within the medical grouponly, 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 HealthCare Guideline is incorporated into the medical group’s clinical guideline program.
All other copyright rights in this ICSI Health Care Guideline are reserved by the Institute for ClinicalSystems Improvement. The Institute for Clinical Systems Improvement assumes no liability forany adaptations or revisions or modifications made to this ICSI Health Care Guideline .
Health Care GuidelineICSII NSTITUTE FOR C LINICAL
S YSTEMS I MPROVEMENT
Executive Summary – March 2005
Diagnosis and Management of Asthma
Scope and Target Population:This guideline addresses the diagnosis and outpatient management of acute and chronic asthmain all patients over five years of age who present with asthma-like symptoms or have beendiagnosed with asthma.
Clinical Highlights for Individual Clinicians:1. Conduct interval evaluations of asthma including medical history and physical
examination, assessment of asthma triggers and allergens, measurement of pulmonaryfunction, and consideration of consultation and/or allergy testing.
2. Regularly assess asthma control.3. Match medical intervention with asthma severity and adjust to correspond with change
over time.4. Achieve effective control of chronic persistent asthma through use of inhaled corticosteroid
therapy5. Provide asthma education to patients and parents of pediatric patients. Education should
include basic facts about asthma, how medications work, inhaler technique, a written actionplan including home peak flow rate monitoring or a symptom diary, environmental controlmeasures, and emphasis on the need for regular follow-up visits.
Priority Aims:1. Promote the accurate assessment of asthma severity through the use of objective measures
of lung function.2. Promote long-term control of persistent asthma through the use of inhaled corticosteroid
drug therapy.3. Promote the partnership of patients with asthma and/or their parents with health care
professionals through education and the use of written action plans.
Additional Background:
This guideline closely follows the recommendations of the: National Asthma Education ProgramExpert Panel Report 2, Guidelines for the Diagnosis and Management of Asthma. NIHPublication No. 97-4051. U.S. Department of Health and Human Services, Public HealthService/National Institutes of Health/National Heart, Lung and Blood Institute.
Health Care Guideline:
Diagnosis and Outpatient Management of Asthma
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.
Seventh Edition March 2005
Work Group LeaderRichard Sveum, MDAllergy, Park Nicollet Health Services
Work Group MembersAllergyMary Keating, MDCentraCareFamily MedicineMichael Rethwill, MD HealthPartners Medical GroupPediatricsKent duRivage, MD HealthPartners Medical GroupPulmonary MedicineKeith Harmon, MD Park Nicollet Health ServicesCertified Physician Assistant Eunice Weslander, PA-CHealthPartners Central MN ClinicsNursingShirley Nordahl, CPNP Allina Medical ClinicHealth EducationJanet Malkiewicz, RN AE-CHealthPartners Medical GroupRespiratory Therapist/Asthma EducatorMarlis O'Brien, RRT, CPFT, AE-CMayo Health System - Franciscan SkempPharmacist/Asthma EducatorBrian Bach, RPh, AE-CMayo Health System - Franciscan SkempMeasurement AdvisorBeth Green, MBA, RRTICSIFacilitator Linda Setterlund, MAICSI
www.icsi.org
I ICSI NSTITUTE FOR C LINICAL S YSTEMS I MPROVEMENT
Copyright © 2005 by Institute for Clinical Systems Improvement 1
A = AnnotationDefinitions and symptoms of asthma
1
A
noPrevious
diagnosis of asthma?
2
A
Establishdiagnosis of
asthma
3
A
Acute asthma?
4
A no
Interval evaluation:• Medical history• Assess asthma triggers/allergens• Physical examination• Measure pulmonary function - spirometry - PEFR• Consider consultation and/or allergy testing
6
A
Assess asthma severity7
A
Step care of pharmacologic treatment:• mild intermittent• mild persistent• moderate persistent• severe persistent
8
A
Asthma education:• basic facts about asthma• how medications work• inhaler technique• written action plan based on home peak flow rate monitoring or symptom diary• environmental control measures• emphasize need for regular follow-up visits
9
A
Schedule regularfollow-up visits
10
A
Management of acute asthma:• β2 agonists• Corticosteroids• Action plan• Follow-up for chronic management
5
A
yes
yes
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Algorithms and Annotations ................................................................................................................1-26
Algorithm ..............................................................................................................................................1
ForewordScope and Target Population ..........................................................................................................3Clinical Highlights and Recommendations ....................................................................................3Priority Aims ..................................................................................................................................3Related ICSI Scientifi c Documents ................................................................................................3Brief Description of Evidence Grading ..........................................................................................4Disclosure of Potential Confl ict of Interest ....................................................................................4
Annotations ...........................................................................................................................................5-24Appendices ............................................................................................................................................25-26
Annotation Appendix A – Asthma Action Plan ..............................................................................25-26Supporting Evidence ..............................................................................................................................27-38
Evidence Grading System .....................................................................................................................28-29References .............................................................................................................................................30-31Conclusion Grading Worksheets ...........................................................................................................32-38
Conclusion Grading Worksheet – Appendix A – Annotation #8 (Leukotriene Receptor Antagonists [LTRAs]) ..........................................................................32-35Conclusion Grading Worksheet – Appendix B – Annotation #9 (Asthma Education) ...................................................................................................................36-38
Support for Implementation ................................................................................................................39-47Priority Aims and Suggested Measures ................................................................................................40
Measurement Specifi cations ...........................................................................................................41-44Key Implementation Recommendations ...............................................................................................45Knowledge Products .............................................................................................................................45Recommended Resources .....................................................................................................................46-47
Table of Contents
Diagnosis and Outpatient Management of AsthmaSeventh Edition/March 2005
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Foreword
Scope and Target Population
This guideline addresses the diagnosis and outpatient management of acute and chronic asthma in all patients over five years of age who present with asthma-like symptoms or have been diagnosed with asthma.
Clinical Highlights and Recommendations1. Conduct interval evaluations of asthma including medical history and physical examination, assessment
of asthma triggers and allergens, measurement of pulmonary function, and consideration of consultation and/or allergy testing. (Annotation #6)
2. Regularly assess asthma control. (Annotation #7)
3. Match medical intervention with asthma severity and adjust to correspond with change over time. (Annotation #8 and Table 8A)
4. Achieve effective control of chronic persistent asthma through use of inhaled corticosteroid therapy. (Table #8A)
5. Provide asthma education to patients and parents of pediatric patients. Education should include basic facts about asthma, how medications work, inhaler technique, a written action plan including home peak flow rate monitoring or a symptom diary, environmental control measures, and emphasis on the need for regular follow-up visits. (Annotation #9)
Priority Aims1. Promote the accurate assessment of asthma severity through the use of objective measures of lung func-
tion.
2. Promote long-term control of persistent asthma through the use of inhaled corticosteroid drug therapy.
3. Promote the partnership of patients with asthma and/or their parents with health care professionals through education and the use of written action plans.
Related ICSI Scientific DocumentsOther ICSI guidelines whose scope and/or recommendations are closely related to the content of this guide-line are:
1. Emergency and Inpatient Management of Asthma
2. Chronic Obstructive Pulmonary Disease
3. Rhinitis
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Evidence GradingIndividual 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 InterestIn 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 website at http://www.icsi.org.
Diagnosis and Outpatient Management of Asthma Foreword Seventh Edition/March 2005
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Algorithm Annotations
1. Definition and Symptoms of AsthmaDefinition of asthmaAsthma is a chronic inflammatory disorder of the airways. It is characterized by:
1. Airway inflammatory cells, including eosinophils, macrophages, mast cells, epithelial cells and activated lymphocytes that release various cytokines, adhesion molecules and other mediators.
2. Inflammation resulting in an acute, subacute or chronic process that alters airway tone, modulates vascular permeability, activates neurons, increases secretion of mucus, and alters airway structure reversibly or permanently.
3. Airway hyperresponsiveness in response to allergens, environmental irritants, viral infections and exercise.
4. Airflow obstruction caused by acute bronchial constriction, edema, mucus plugs, and frequently permanent remodeling.
A. Symptoms
1. Wheezing
2. Breathlessness
3. Cough, productive or dry
4. Chest discomfort
B. Pattern of symptoms
1. Perennial/seasonal
2. Episodic/continual
3. Diurnal
C. Severity of symptom classification
1. Number of symptom episodes per week
2. Number of nocturnal symptoms per month
3. Objective measures of lung function (FEV1, PEF, PEF variability)
Symptoms of asthmaSymptoms suggestive of asthma include episodic wheezing and cough with nocturnal, seasonal or exertional characteristics. Infants and children with frequent episodes of "bronchitis" are likely to have asthma. Atopic and positive family histories for asthma, particularly when associated with previously mentioned symptoms, should encourage one to consider a diagnosis of asthma.
Eliciting symptoms should emphasize characterizing the current classification scheme that describes frequency per week, changes in physical activity, diurnal variation, and seasonal variation. It is important to recognize that patients with asthma are heterogeneous, falling into every age group, from infancy to older age, and presenting a spectrum of signs and symptoms that vary in degree and severity from patient to patient as well
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as within an individual patient over time (National Asthma Education and Prevention Program [NAEPP], 1997; National Asthma Education and Prevention Program [NAEPP], 2002).
Supporting evidence is of classes: M, R
2. Previous Diagnosis of Asthma?
Key Points:
• At each evaluation, it is important to consider whether or not a previous diag-nosis was correct.
• History and physical consistent with diagnosis.
• Diagnosis confirmed by spirometry.
• Response to therapy consistent with symptoms.Diagnostic spirometry and a methacholine challenge test, if necessary, are important to clinching the diag-nosis. The patient's history and response to therapy should guide other diagnostic tests when considering alternative diagnoses. Follow-up pulmonary function tests every one to two years in mild asthmatics will reconfirm the diagnosis and objectify serial change and level of control. More frequent monitoring should be considered for the moderate and severe persistent categories.
Spirometry is the cornerstone of the laboratory evaluation that enables the clinician to demonstrate airflow obstruction and establish a diagnosis of asthma with certainty. Spirometry is essential for assessing the severity of asthma in order to make appropriate therapeutic recommendations. The use of objective measures of lung function is recommended because patient-reported symptoms often do not correlate with the vari-ability and severity of airflow obstruction. Testing should be performed in compliance with the American Thoracic Society standards. Obstructive and restrictive ventilatory defects can generally be determined using FEV1/FVC ratio (American Thoracic Society, 1991).
Supporting evidence is of class: R
3. Establish Diagnosis of Asthma
Key Points:
• The diagnosis of asthma is based on the patient's medical history, physical examination, pulmonary function tests and laboratory test results.
• Spirometry is recommended for the diagnosis of asthma.A. Asthma triggers
1. Viral respiratory infections
2. Environmental allergens
3. Exercise, temperature, humidity
4. Occupational and recreational allergens or irritants
5. Environmental irritants (perfume, tobacco smoke, wood-burning stoves)
6. Drugs (aspirin, NSAID, beta blocker) and food (sulfites)
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B. Other historical components
1. Emergency room visits and hospitalization
2. Medication use (especially oral steroids)
3. Lung function, PEFR variability
4. Associated symptoms, e.g., rhinitis, sinusitis, gastroesophageal reflux (GERD)
C. Clinical testing
1. Accurate spirometry is recommended in every patient 5 years of age or older at the time of diag-nosis.
2. Additional studies done, tailored to the specific patient.
• allergy testing (skin testing, in vitro specific IgE antibody testing)
• chest radiography, to exclude alternative diagnosis
• bronchial provocation testing if spirometry is normal or near normal
• sinus x-rays or CT scan
• GERD evaluation
• CBC with eosinophils, total IgE, sputum exam
Spirometry is generally valuable in children 5 years of age or older, however some children cannot conduct the maneuver depending on developmental ability. Spirometry measurements (FEV1, FVC, FEV1/FVC) before and after the patient inhales a short-acting bronchodilator should be undertaken for patients in whom the diagnosis of asthma is being considered. Airflow obstruction is indicated by reduced FEV1 and FEV1/FVC values relative to reference or predicted values. Significant reversibility is indicated by an increase of 12 percent or greater and 200 mL in FEV1, after inhaling a short-acting bronchodilator.
Methacholine challenge testing may provide a useful confirmatory diagnostic test in patients with normal or near-normal spirometry. Investigation into the role of allergy, at least with a complete history, should be done in every patient, given high prevalence of positive skin tests among individuals with asthma and the benefits of limiting exposure to known allergens. Eosinophil count and IgE may be elevated in asthma, however, neither test has sufficient specificity or sensitivity to be used alone in a diagnosis. The chest x-ray and electrocardiogram are usually normal in asthma but may be useful to exclude other pulmonary or cardiac conditions. Sputum examination may be helpful if sputum eosinophilia or infection are suspected.
There are several clinical scenarios in children that have a frequent association with asthma and should strongly suggest asthma as a possible diagnosis. These include recurrent pulmonary infiltrates (especially right middle lobe infiltrates) that clear radiologically within two to three days, and the diagnosis of pneu-monia without fever. Asthma may cause some radiologic uncertainty since mucus plugging and atelectasis may be interpreted as infiltrates.
Differential Diagnostic Possibilities for Asthma
1. Upper airway disease
• allergic rhinitis and sinusitis
2. Obstruction involving large airways
• foreign body in trachea or bronchus
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• vocal cord dysfunction
• vascular rings or laryngeal webs
• laryngotracheomalacia, tracheal stenosis or bronchostenosis
• enlarged lymph nodes or tumor (benign or malignant)
• bronchiectasis of various causes, including cystic fibrosis
3. Obstruction of small airways
• viral bronchiolitis or obliterative bronchiolitis
• cystic fibrosis
• bronchopulmonary dysplasia
• pulmonary infiltrates with eosinophilia
• chronic obstructive pulmonary disease (chronic bronchitis or emphysema)
4. Other causes
• pulmonary embolism
• congestive heart failure
• cough secondary to drugs (angio-tension-converting enzyme [ACE] inhibitors)
• aspiration from swallowing mechanism dysfunction or gastroesophageal reflux
• recurrent cough not due to asthma
It is important to identify infant or early childhood diseases that might superficially resemble asthma but in reality are not asthmatic in pathophysiology. These symptoms should stimulate investigation of clinical etiologies other than asthma (failure to thrive, vomiting/choking, chronic bacterial infections, cardiovascular and pulmonary abnormalities).
An important under-recognized alternative diagnosis is vocal cord dysfunction. Patients have recurrent breathlessness and wheezing, usually inspiratory, but they can also have expiratory wheezing. It is often monophasic and loud over the glottis. Respiratory failure can occur with alveolar hypoventilation, requiring emergent intubation. It also coexists in patients who have asthma. The flow-volume loop and video image can help make the diagnosis.
4. Acute Asthma?Symptoms of an acute asthma episode include progressive breathlessness, cough, wheezing or chest tight-ness. An acute asthma episode is characterized by a decrease in expiratory airflow that can be documented and quantified by measurement of lung function (spirometry or PEFR). The algorithm is intended for treat-ment of outpatients. Critically ill patients are beyond the scope of this guideline. See ICSI's Emergency and Inpatient Management of Asthma.
Indications for emergency care include:
• Peak flow less than 50% predicted normal
• Failure to respond to a beta agonist
• Severe wheezing or coughing
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• Extreme anxiety due to breathlessness
• Gasping for air, sweaty, or cyanotic
• Rapid deterioration over a few hours
• Severe retractions and nasal flaring
• Hunched forward
5. Management of Acute Asthma
Key Points:
• Patients experiencing an acute asthma exacerbation need a focused history and physical examination and measurement of airflow.
• Treatment is begun with inhaled short-acting ß2-agonists administered by meter dose inhaler (MDI)/spacer or nebulizer.
• Further intensification of therapy is based on severity, response, and prior history, but typically includes a short course of oral corticosteroids.
• Decision to hospitalize must be individualized.
• All patients should receive follow-up and short-term education.The following is an outline of management:
Review history and physical exam which may include:
• History
- Severity of symptoms, limitations, and sleep disturbance
- Duration of symptoms
- Current medical treatment plan
- Adherence to medical treatment plan
- Rescue medication use:
recent use of short-acting ß2-agonists
number of bursts of oral steroids in past year
- Review asthma action plan and daily charting of peak flows
- Previous ER visits or hospitalization
- Record triggers:
URI
Bronchitis, pneumonia
Exposure to allergens or irritants
Exercise
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• Physical exam
- Vital signs
- Auscultation of chest
- FEV1 or peak flow rate
- O2 saturation (pulse oximetry)
- Use of accessory muscles
- Alertness
- Color
• Laboratory studies
Treatment with bronchodilators should not be delayed for laboratory studies. Tests which may be useful include:
- Arterial Blood Gases (ABG's)
- Chest X-Ray (CXR)
- Complete Blood Count (CBC)
- Electrocardiogram (EKG)
- Electrolytes
- Theophylline concentration
• Assess severity
Assessment is based on history and physical exam.
TreatmentUsual initial treatment is with short-acting ß2-agonist (albuterol) administered by nebulizer or MDI/spacer.
Alternatives:
Epinephrine: (1:1000)
Adult: 0.3-0.5 mg subq or IM q 20 min up to 3 doses
Pediatrics: 0.01 mg/kg up to 0.3-0.5 mg subq or IM every 20 min up to 3 doses
Ipratropium added to nebulized ß2-agonist (albuterol)
• Nebulized dose for adults and those over 12 years of age is 0.5 mg every 4 hr. Not FDA approved for any indication in those under 12 years of age.
• Ipratropium is not currently FDA-approved for use in asthma.
Levalbuterol
• Dose for adolescents 12 years of age and over and adults is 0.63 mg (via nebulizer) TID (every 6-8 hr); may increase to 1.25 mg via neb TID (every 6-8 hr) if patient does not exhibit adequate response.
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• Dose for children 6-11 years of age is 0.31 mg (via nebulizer) TID. Routine dosing should not exceed 0.63 mg TID.
Assess Response
Good response:
peak flow or FEV1 greater than 70% predicted normal
no wheezing on auscultation
Incomplete response:
peak flow or FEV1 50-70% predicted normal
mild wheezing
Consider hospitalization, particularly for high-risk patients:
• past history of sudden severe exacerbation
• prior intubation for asthma
• two or more hospitalizations for asthma in the past year
• three or more emergency care visits for asthma within the past year
• hospitalization or an emergency care visit for asthma within the past month
• use of more than 2 canisters per month of inhaled short-acting ß2-agonists
• current use of systemic corticosteroids or recent withdrawal from systemic corticoste-roids
• difficulty perceiving airflow obstruction or its severity
• comorbidity, as from cardiovascular disease or chronic obstructive pulmonary disease
• serious psychiatric disease or psychosocial problems
• low socioeconomic status and urban residence
• illicit drug use
• sensitivity to Alternaria
Poor response:
peak flow or FEV1 less than 50% predicted
no improvement in respiratory distress
strongly consider hospitalization
continue inhaled ß2-agonist every 60 minutes
start oral prednisone unless contraindicated
Adult: short course "burst" 40-60 mg/day as single or 2 divided doses for 3 to 10 days Pediatric: short course "burst" 1-2 mg/kg day in 2 divided doses, maximum 60 mg/day for 3 to 10 days
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Home treatment and revised asthma action plan
Medications
• Inhaled ß2-agonist every 2-6 hours
• Initiate or increase anti-inflammatory medication:
inhaled corticosteroids
cromolyn/nedocromil
consider leukotriene modifiers
• Strongly consider systemic corticosteroids in patients with acute asthma exacerbation. Corti-costeroids aid symptom resolution and prevent asthma relapse (Chapman, 1991; Fanta, 1983; Harris, 1987; Scarfone, 1993).
• Antibiotics are not recommended for the treatment of acute asthma except for those patients with signs of acute bacterial infection, fever and purulent sputum.
Education
• Teach or check inhaler technique/teach nebulizer use
• Explain medications
• Review action plan
• Monitor peak flow
• Reinforce trigger control
Follow-up
• All patients need return appointment for management of asthma
• Review and discuss signs and symptoms requiring emergent care
(National Asthma Education and Prevention Program Expert Panel, 1997; National Asthma Education and Prevention Program Expert Panel Report: Guidelines for the Diagnosis and Outpatient Management of Asthma, 2002)
Supporting evidence is of classes: A, M, R
6. Interval Evaluation• Interval evaluation of asthma should include the following:
- Medical history
- Assess asthma triggers/allergens
- Physical examination
- Measure pulmonary function
- Consider specialty consultation
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Medical History• Disruption of usual activities (work, school, home)
• Sleep disturbance
• Level of usage of short-acting ß2-agonist
• Adherence to medical treatment plan
• Interval exacerbation of symptoms (either treated by self or a health care provider)
• Symptoms suggesting comorbid conditions or alternative diagnosis
• Side effects of medications
Reassessment of medical history can elicit factors that effect overall asthma control and sense of well-being (Juniper, 1993). The key symptoms that should alert the clinician include disruptive daytime symptoms and disturbances of sleep. It is also the consensus of the Expert Panel that symptoms early in the morning that do not improve fifteen minutes after short-acting ß2-agonist are a predictor of poor control. The quan-tity of short-acting ß2-agonist that is being used should be discussed since overuse can be a marker of the potentially fatality-prone asthmatic (Spitzer, 1992). The use of a quality of life tool or questionnaire can assist to elicit history (Juniper, 1992).
Supporting evidence is of classes: C, D
Assess asthma triggers/allergens• Inquire about exposure to triggers and allergens (e.g., occupational, pets, smoke)
• Allergy testing is recommended for patients with persistent asthma who are exposed to perennial indoor allergens
Studies of emergency room visits and near death show allergens as a factor in asthma exacerbation. Asthma triggers in the workplace also need to be considered. About 15 percent of asthma in adults is work related (Blanc, 1987; Malo, 1992; O'Hollaren, 1991; Pollart, 1988).
The differential diagnosis, as previously discussed, can range from common to rare. The most common contributing disorders that exacerbate asthma are allergic rhinitis and sinusitis (Corren, 1992; Rachelefsky, 1984). Another common condition to consider is gastroesophageal reflux disease (GERD). Reflux is three times more common in asthmatics, and treating GERD leads to improved asthma control (Harper, 1987).
Supporting evidence is of classes: A, C, D
Physical Examination• Assess signs associated with asthma, concurrent illness or medication side effects
• Height in children
• Head, eyes, ears, nose, throat, lungs, heart, skin
It is important to discuss any potential medication side effects as this often has a direct relationship to compli-ance. Common side effects from inhaled steroids include oral candidiasis and dysphonia. ß2-agonists may cause tachycardia, tremor or nervousness. Individuals on long-term oral corticosteroids or frequent bursts of steroids need to be monitored for complications of corticosteroids use such as osteoporosis, hypertension, diabetes and Cushing's syndrome.
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The height of individuals on corticosteroids should be monitored over time. The potential effect on linear growth in children is important because these drugs tend to be used over long periods of time. Cumulative data in children suggest that low-to-medium doses of inhaled corticosteroids may have the potential of decreasing growth velocity, but this effect is not sustained in subsequent years of treatment, is not progres-sive, and may be reversible (Childhood Asthma Management Program Research Group, The, 2000; NAEPP Update, 2002).
Inhaled glucocorticoids used to treat asthma have been shown to have deleterious effects on bone mineral density and markers of bone mineral metabolism. The risk of fracture attributable to inhaled or nasal gluco-corticoids is uncertain (Lung Health Study Research Group, The, 2000).
The remainder of the physical exam either supports or refutes conditions and comorbidities discussed above (see history).
Supporting evidence is of classes: A, M
Measure Pulmonary FunctionIt is important to measure pulmonary function at each follow-up visit. The two main methods are spirometry and peak expiratory flow rate (PEFR). Spirometry is more precise and yields more information than PEFR. It is helpful to verify the accuracy of the peak flow meter. It is useful when certain physical limitations affect accuracy of PEFR (example: very young or elderly, neuromuscular or orthopedic problems) (Miles, 1995; Enright, 1994).
Spirometry recommended:
• for initial diagnosis or to reassess or confirm diagnosis
• after treatment is initiated or changed, and once symptoms and PEFR have stabilized, to docu-ment attainment of "near normal pulmonary function"
• at least every 1 to 2 years to assess maintenance of airway function; more often as severity indicates
Regular monitoring of pulmonary function is particularly important for asthma patients who do not perceive their symptoms until obstruction is severe (Kikuchi, 1994; Connolly, 1992).
PEFR
• Used for follow-up, not for diagnosis
PEFR provides a simple, quantitative and reproductive measure of severity of airflow obstruction. The results are more reliable if the same type, and preferably the patient's own meter are used.
During interval assessment the clinician should question the patient and review records to evaluate the frequency, severity and causes of exacerbation. Triggers that may contribute should be reviewed. All patients on chronic maintenance medication should be questioned about exposure to inhalant allergens.
Supporting evidence is of classes: C, R
Consider Specialty Consultation• Adults with severe persistent asthma, consider for moderate persistent asthma
• Children with moderate to severe persistent asthma, consider for mild persistent asthma
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• Poorly controlled or complex asthma including previous life-threatening asthma exacerbation, or asthma exacerbations requiring more than 2 bursts of oral corticosteroids in 1 year, or asthma complicated by other medical or psychosocial conditions
• Additional diagnostic evaluations and/or testing, e.g., allergy skin testing, bronchoprovocation
• Allergy testing is recommended for patients with persistent asthma who are exposed to perennial indoor allergens
• Evaluation and treatment of allergy, e.g., address occupation-related asthma, environmental coun-seling, immunotherapy
• Patients who require additional or intensive asthma education not otherwise available
• For patients with moderate to severe persistent asthma, who are exposed to perennial indoor aller-gens, Omalizumab is available. They should be managed by an allergy specialist.
Referral to an asthma specialist should be considered when a patient's symptoms are severe or are not responding to standard care. Referral is also necessary when specialized testing, such as allergy testing or bronchoprovocation are needed. There is evidence that referral to an asthma specialist can reduce repeat visit to the emergency room (Zieger, 1991).
Supporting evidence is of class: C
7. Assess Asthma SeverityThe classification of asthma as mild intermittent, mild persistent, moderate persistent or severe persistent is based on the clinical characteristics as well as objective assessment of lung function through FEV1 or peak flow monitoring. The presence of one of the features of severity is sufficient to place a patient in that category and an individual's classification may change over time. Patients at any level of severity can have mild, moderate or severe exacerbations. Some patients with intermittent asthma experience severe and life-threatening exacerbations separated by long periods of normal lung function and no symptoms (National Asthma Education and Prevention Program, 1997; National Asthma Education and Prevention Program, 2002).
Step 1: Mild Intermittent
• symptoms twice a week or less
• asymptomatic and normal PEF between exacerbations
• exacerbations are brief (few hours to a few days)
• nighttime symptoms twice a month or less
• FEV1 or PEF 80% predicted or greater and PEF variability 20% predicted or less
Step 2: Mild Persistent
• symptoms twice a week or more but once a day or less
• exacerbations may affect activity
• nighttime symptoms twice a month or more
• FEV1 or PEF 80% predicted or greater and PEF variability 20-30% predicted
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Step 3: Moderate Persistent
• daily symptoms
• daily use of inhaled short-acting beta2-agonists
• exacerbations affect activity
• exacerbations twice a week or more; may last days
• nighttime symptoms once a week or more or 4 times per month
• FEV1 or PEF between 60-80% predicted
• PEF variability 30% or greater
Step 4: Severe Persistent
• continual symptoms
• limited physical activity
• frequent exacerbations
• frequent nighttime symptoms
• FEV1 or PEF 60% predicted or less and PEF variability 30% predicted or greater
Supporting evidence is of classes: M, R
8. Step Care of Pharmacologic Treatment
Key Points:
• Achieve effective control of chronic persistent asthma through use of inhaled corticosteroid therapy.
The aim of asthma therapy is to maintain control of asthma with the least amount of medication and hence minimize the risk for adverse effects. The stepwise approach to therapy in which the dose and number of medications and frequency of administration are increased as necessary and decreased when possible is used to achieve this control. Since asthma is a chronic inflammatory disorder of the airways with recurrent exacerbations, therapy for persistent asthma emphasizes efforts to suppress inflammation over the long-term and prevent exacerbations. See tables 8A, 8B, 8C, and 8D.
Based on data comparing LTRAs to inhaled corticosteroids, inhaled corticosteroids are the preferred treat-ment option for mild persistent asthma in adults, and by extrapolation until published data become available, for children. LTRAs are an alternative, although not preferred, treatment.
(Bleecker, 2000; Ducharme, 2002; National Asthma Education and Prevention Program, 1997; Szefler, 2005)
[Conclusion Grade I: See Conclusion Grading Worksheet – Appendix A – Annotation #8 (Leukotriene Receptor Antagonists [LTRAs])]
Managing asthma during pregnancy is the same treatment used for non-pregnant asthma patients (NAEPP Update, 2005).
NOTE: Annual influenza vaccinations are recommended for patients with persistent asthma (National Asthma Education and Prevention Program, 1997).
Supporting evidence is of classes: A, M, R
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Table 8A.Stepwise Approach for Managing Asthma in Adults and Children Older than 5 Years of Age
Step Long-Term ControlStep 1 - Mild Intermittent• symptoms ≤ 2 times a week• asymptomatic and normal PEF between exacerbations• exacerbations are brief (few hours to a few days)• nighttime symptoms ≤ 2 times a month• FEV1 or PEF ≥ 80% predicted and PEF variability
≤ 20%
No daily medications needed
Step 2 - Mild Persistent• symptoms ≥ 2 times a week but ≤ 1 time a day• exacerbations may affect activity• nighttime symptoms ≥ 2 times a month• FEV1 or PEF ≥ 80 percent predicted and PEF
variability 20-30%
Daily medication:• Inhaled corticosteroids (low dose) (preferred)
OR
• Leukotriene modifiers, theophylline, nedocromil or cromolynStep 3 - Moderate Persistent• daily symptoms• daily use of inhaled short-acting ß2-agonists• exacerbation affects activity• exacerbations >2 week, may last days• nighttime symptoms >1 time a week• FEV1 or PEF ≥ 60% - ≤ 80% predicted• PEF variability ≥ 30%
Daily medications:• Inhaled corticosteroid (low or medium dose) plus inhaled long-acting
β2 agonist (preferred)
OR
• Inhaled corticosteroid (medium dose) plus leukotriene modifier,theophyline, or oral long-acting β2
Step 4 - Severe Persistent• continual symptoms• limited physical activity• frequent exacerbations• frequent nighttime symptoms• FEV1 or PEF ≤ 60 % and PEF variability
≥ 30 %
Daily medications:Inhaled corticosteroid(medium dose or high dose)PLUS: Long-acting β2 agonist (preferred)
and/OR Leukotriene modifier
and/OR Theophylline
Recommended for uncontrolled asthma:• Oral corticosteroids
(See Table 8D)Step down:Review treatment every 1-6 months; a gradual stepwisereduction in treatment may be possible.
Step up:If control not maintained, consider step up. First review patientmedication technique, adherence and environmental control (avoidance ofallergens or other factors that contribute to asthma severity)
Quick relief:• Short-acting bronchodilator: inhaled ß2-agonists as needed for symptoms with MDI spacer/holding chamber• Intensity of treatment will depend on severity of exacerbation.• Use of short-acting inhaled ß2-agonists on a daily basis, or increasing use, indicates the need for additional long-term control
therapy.Education:Step 1:• Teach basic facts about asthma• Teach inhaler/spacer/holding chamber technique• Discuss role of medications• Develop self-management plan• Develop action plan for when and how to take rescue actions, especially for patients with a history of severe exacerbations• Discuss appropriate environmental control measures to avoid exposure to known allergens and irritantsStep 2:• Teach self-monitoring• Refer to group education if available• Review and update self-management planStep 3:• Refer to individual education/counseling
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Table 8B.Usual Dosages for Long-Term Medications
Medication Dosage Form Adult Dose Child Dose Comments
Inhaled Corticosteroids (refer to Table 8C)SystemicCorticosteroidsMethylprednisolone
Prednisolone
Prednisone
2, 4, 8, 16, 32 mgtablets
5 mg tablets,5 mg/5 cc,15 mg/5 cc
1, 2.5, 5, 10, 20, 50 mgtablets5 mg/5 cc
• Divided 7.5-60mg daily in asingle dose ordivided qid asneeded for control
• Short-course"burst" 40-60 mgper day as singleor 2 divided dosesfor 3-10 days
• 0.25-2 mg/kgdaily in singledose or qid asneeded for control
• Single course:"burst" 1-2mg/kg/day,maximum 60mg/day, for 3-10days
(Applies to all three systemiccorticosteroids)
• For long-term treatment ofsevere persistent asthma,administer single dose ina.m. either daily or onalternate days (alternate-day therapy may produceless adrenal suppression).If daily doses are required,one study suggestsimproved efficacy and noincrease in adrenalsuppression whenadministered at 3:00 p.m.(Beam et al. 1992)
• Short courses or "bursts”are effective forestablishing control wheninitiating therapy orduring a period of gradualdeterioration.
• The burst should becontinued until patientachieves 80% PEFpersonal best or symptomsresolve. This usuallyrequires 3-10 days but mayrequire longer. There is noevidence that tapering thedose followingimprovement preventsrelapse if sufficient dosesof inhaled corticosteroidsare used simultaneously.
Cromolyn and NedocromilCromolyn
Nedocromil
MDI 800 µg/puffNebulizer solution -20 mg/ampule
MDI 1.75 mg/puff
2-4 puffs tid-qid1 ampule tid-qid
2-4 puffs bid-qid
1-2 puffs tid-qid1 ampule tid-qid
1-2 puffs bid-qid
• One dose prior to exerciseor allergen exposureprovides effectiveprophylaxis for 1-2 hours.
• See cromolyn above.
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Table 8B. (cont)Usual Dosages for Long-Term Medications (continued)
Medication Dosage Form Adult Dose Child Dose Comments
Long-Acting ß2-Agonists
Salmeterol
Formoterol Fumarate DPI
Fluticasone propionate/salmeterol DPI
Sustained-ReleaseAlbuterol
InhaledDPI 50 µg/inhalation
12 µg/dose(single use capsule byinhalation)
Dosage strengths andadult dose (oneinhalation) q 12 hr forall three strengths) withthe strengths:100 µg fluticasone/50µgsalmeterol250 µg fluticasone/50µgsalmeterol500 µg fluticasone/50µgsalmeterol
Tablet4 mg tablet
1 inhalation q 12 hours
1 capsule by inhalationBID
1 inhalation BID
4 mg q 12 hours
1 inhalation q 12 hours
1 capsule by inhalationBID
1 inhalation BID
0.3-0.6 mg/kg/day, notto exceed 8 mg/day
• May use one dose nightly forsymptoms.
• Should not be used forsymptom relief or forexacerbations.
• FDA approved for children 5years of age and older.
• FDA approved for children 4years of age and older.
MethylxanthinesTheophylline Liquids, sustained-
release tablets, andcapsules
Starting dose 10mg/kg/day up to 300mg/day max
Starting dose 10mg/kg/day; usual max:• <1 year of age: 0.2
(age in weeks) + 5 =mg/kg/day
• >1 year of age: 16mg/kg/day
• Adjust dosage to achieve serumconcentration of 5-15 µg/mLat a steady-state (at least 48hours on same dosage).
• Due to wide interpatientvariability in theophyllinemetabolic clearance, routineserum theophyline levelmonitoring is important.
• Average adult dose 600-900mg/day
Leukotriene ModifiersMontelukast 4 mg granules
4 mg tablet**5 mg tablet**10 mg tablet
10 mg/qhs 4 mg/qd evening or qhs(2-5 years of age)5 mg/qd evening or qhs(6-14 years of age)10 mg/qd evening or qhs(15 years of age andolder)
Zafirlukast 10 mg tablet20 mg tablet
40 mg daily(20 mg bid)(≥ 12 years of age)
10 mg bid(7-11 years of age)
• For zafirlukast,administration with mealsdecreases bioavailability; takeat least 1 hour before or 2hours after meals.
Zileuton 600 mg tablet 2,400 mg daily (one 600mg tablet, qid)
600 mg tablet QID(12 years of age andolder)
• For zileuton, monitor hepaticenzymes (ALT).
* This list is not all-inclusive; for discussion of other factors, see package inserts.** Children’s dose – chewable tablets.
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Table 8C.
Estimated Comparative Daily Dosage for Inhaled CorticosteroidsADULTS
Drug Low Dose Medium Dose High DoseBeclomethasonedipropionate HFA(Hydrofluoroalkane)formulation withstrengths of 40 µg/puffand 80 µg/puff)
80 mg-240 mg(2-6 puffs - 40 µg)(1-3 puffs - 80 µg)
240 µg- 480 µg(6-12 puffs - 40 µg)(3-6 puffs - 80 µg)
> 480 µg(> 12 puffs - 40 µg)(> 6 puffs - 80 µg)
Budesonide DPI200 µg/dose
200-600 µg(1-3 inhalations)
600-1200 µg(3-6 inhalations)
> 1200 µg(> 6 inhalations)
Flunisolide250 µg/puff
500-1,000 µg(2-4 puffs)
1,000-2,000 µg(4-8 puffs)
>2,000 µg(>8 puffs)
FluticasoneMDI: 44, 110, 220µg/puff
88-264 µg(2-6 puffs - 44 µg) OR(2 puffs - 110 µg)
264-660 µg(2-6 puffs - 110 µg)
>660 µg(>6 puffs - 110 µg) OR(>3 puffs - 220 µg)
Combination Product –fluticasonepropionate/salmeterolDPI
100 µg fluticasone/50 µgsalmeterol – oneinhalation q 12 hr
250 µg fluticasone/50 µgsalmeterol – oneinhalation q 12 hr
500 µg fluticasone/50 µgsalmeterol – one inhalationq 12 hr
Triamcinolone acetonide100 µg/puff
400-1,000 µg(4-10 puffs)
1,000-2,000 µg(10-20 puffs)
>2,000 µg(>20 puffs)
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 doseaccordingly. The stepwise approach to therapy emphasizes that once control of asthma is achieved, the dose ofmedication should be carefully titrated to the minimum dose required to maintain control, thus reducing thepotential for adverse effect.
• Some dosages may be outside package labeling.• MDI dosages are expressed as the actuater dose (the amount of drug leaving the actuater and delivered to the
patient), which is the labeling required in the United States. This is different from the dosage expressed as thevalve dose (the amount of drug leaving the valve, all of which is not available to the patient), which is used inmany European countries and in some of the scientific literature. DPI doses are expressed as the amount of drug inthe inhaler following activation.
• Budesonide is the preferred inhaled for pregnant women corticosteroid because more data are available on usingbudesonide in pregnancy than are available on other inhaled corticosteroids, and the data are reassuring. It isimportant to note that there are no data indicating that the other inhaled corticosteroid preparations are unsafeduring pregnancy.
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Table 8C. (cont)
Estimated Comparative Daily Dosage for Inhaled CorticosteroidsCHILDRENDrug Low Dose Medium Dose High DoseBeclomethasonedipropionate HFA40 µg/puff80 µg/puff
84-336 µg
80-160 µg(2-4 puffs - 40 µg)(1-2 puffs- 80 µg)
336-672 µg
160-320 µg(4-8 puffs - 40 µg)(2-4 puffs - 80 µg)
> 672 µg
> 320 µg(> 8 puffs - 40 µg)(> 4 puffs - 80 µg)
Budesonide DPI200 µg/dose
For nebulization:strengths 0.25 mg/2 mLand 0.5 mg/2 mL
200-400 µg(1-2 inhalations)
0.5 mg
400-800 µg(2-4 inhalations - 200 µg)
1.0 mg/day
> 800 µg(> 4 inhalations - 200 µg)
2.0 mg/day
Flunisolide250 µg/puff
500-750 µg(2-3 puffs)
1,000-1,250 µg(4-5 puffs)
>1,250 µg(> 5 puffs)
FluticasoneMDI: 44, 110, 220µg/puff
88-176 µg(2-4 puffs - 44 µg)
176-440 µg(4-10 puffs - 44 µg) OR(2-4 puffs - 110 µg)
> 440 µg(> 4 puffs - 110 µg) OR(> 2 puffs - 220 µg)
Triamcinolone acetonide100 µg/puff
400-800 µg(4-8 puffs)
800-1,200 µg(8-12 puffs)
> 1,200 µg(> 12 puffs)
NOTES:• The most important determinant of appropriate dosing is the clinician's judgement of the patient's response to
therapy. The clinician must monitor the patient's response on several clinical parameters and adjust the doseaccordingly. The stepwise approach to therapy emphasizes that once control of asthma is achieved, the dose ofmedication should be carefully titrated to the minimum dose required to maintain control, thus reducing thepotential for adverse effect.
• The reference point for the range in the dosages for children is data on the safety of inhaled corticosteroids inchildren, which, in general, suggest that the dose ranges are equivalent to beclomethasone dipropionate 200-400µg/day (low dose), 400-800 µg/day (medium dose), and > 800 µg/day (high dose).
• Some dosages may be outside package labeling.• MDI dosages are expressed as the actuater dose (the amount of drug leaving the actuater and delivered to the
patient), which is the labeling required in the United States. This is different from the dosage expressed as thevalve dose (the amount of drug leaving the valve, all of which is not available to the patient), which is used inmany European countries and in some of the scientific literature. DPI doses are expressed as the amount of drug inthe inhaler following activation.
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Table 8D.Usual Dosages for Quick-Relief Medications
Medication Dosage Form Adult Dose Child Dose Comments
Short-Acting Inhaled Beta2-Agonists
Albuterol
Albuterol HFA
Pirbuterol
MDIs90 µg/puff, 200puffs90 µg /puff, 200puffs200 µg /puff, 400puffs
• 2 puffs 5minutes prior toexercise
• 2 puffs tid-qidprn
• 1-2 puffs 5minutes prior toexercise
• 2 puffs tid-qidprn
• An increasing use or lack of expected effectindicates diminished control of asthma.
• Not generally recommended for long-termtreatment. Regular use on a daily basisindicates the need for additional long-termcontroller therapy.
• Differences in potency exist so that allproducts are essentially equal in efficacy ona per puff basis.
• May double usual dose for mildexacerbations.
• Nonselective agents (i.e., epinephrine,isoproterenol, metaproterenol) are notrecommended due to their potential forexcessive cardiac stimulation, especially inhigh doses.
• Spacer/holding chambers arerecommended with MDI
Albuterol
Levalbuterolnebulization
DPINebulizer solution5 mg/mL (0.5%)Premixed Vials2.5 mg/3 mL(0.088%)1.25 mg/3mL(0.042%)0.63 mg/3 mL and1.25 mg/3 mL
1.25-5 mg (.25-1 cc)in 2-3 cc of saline q4-8 hours
12 yrs and older is0.63 mg to 1.25 mgTID
0.05 mg/kg (min1.25 mg, max 2.5mg) in 2-3 cc ofsaline q 4-6 hours
6-11 years is 0.31mg to 0.63 mg TID
• May mix with cromolyn or ipratropiumnebulizer solutions. May double dose formild exacerbations.
• Routine dosing should not exceed 0.63 mgTID in children
Anticholinergics
IpratropiumMDIs18 µg/puff, 200puffs
Nebulizer/solution.25 mg/mL(0.025%)
2-6 puffs q 6 hours
0.25-0.5 mg q 6hours
1-2 puffs q 6 hours
0.25 mg q 6 hours
• Evidence is lacking for anticholinergiceproducing added benefit to ß2-agonists inlong-term asthma therapy.
Systemic Corticosteroids (Applies to all three systemic corticosteroids)Methylprednisolone
Prednisolone
Prednisone
2, 4, 8, 16, 32 mgtablets
5 mg tabs, 5 mg/5cc, 15 mg/5 cc
1, 2.5, 5, 10, 20 25mg tabs; 5 mg/cc;5 mg/5 cc
• short course"burst": 40-60mg/day assingle or 2divided dosesfor 3-10 days
• Short course"burst": 1-2mg/kg/day,maximum 60mg/day, for3-10 days
• Short courses or "bursts" are effective forestablishing control when initiating therapyor during a period of gradual deterioration.
• The burst should be continued until patientachieves 80% PEF personal best orsymptoms resolve. This usually requires 3-10 days but may require longer. There is noevidence that tapering the dose followingimprovement prevents relapse if sufficientdoses of inhaled corticosteroids are usedsimultaneously.
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9. Asthma Education
Key Points:
• Patient education is essential for successful management of asthma. It should begin at the time of diagnosis and be ongoing.
The following patient education is recommended:
• Basic facts about asthma
- The contrast between asthmatic and normal airways
- What happens to the airways in an asthma attack
• How medications work and the need for adherence
- Long-term control: medications that prevent symptoms, often by reducing inflammation
- Quick relief: short-acting bronchodilator relaxes muscles around airways
- Stress the importance of long-term control medications and not to expect quick relief from them
• Inhaler technique
- Metered dose inhaler (MDI) or nebulizer use (patient should repeat demonstration)
- Spacer/holding chamber use with MDI
- Dry powder inhaler
• Written action plan including home peak flow monitoring
When and how to take actions
- Symptom monitoring and recognizing early signs of deterioration.
- Responding to changes in asthma severity. A written Asthma Action Plan including daily medications and instructions should be offered to all patients with asthma.
Review and refine the plan at follow-up visits.
- Home peak flow monitoring is recommended for patients with moderate to severe persistent asthma, or anyone with a history of severe exacerbations.
- Discuss plan for children at school including management of exercise- induced bronchospasm.
- Assess adherence to pharmacotherapy and environmental control measures.
Data are insufficient to support or refute the benefits of using written asthma action plans compared to medical management alone. However, a Cochrane review of 25 studies compared self-management interventions by adults with acute asthma episodes. Some had written action plans, others did not. The self-management interventions with written action plans had the greatest benefits, including reduced emergency department visits and hospitalizations and improved lung function (NAEPP update 2002).
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The NAEPP EPR-2 continues to recommend the use of written action plans as part of an overall effort to educate patients in self-management is beneficial especially for patients with moderate or severe persistent asthma and patients with a history of severe exacerbations.
• Environmental control measures
- Identifying and avoiding exposure to allergens or other environmental triggers
• Emphasize need for regular follow-up visits and asthma treatment adherence
Supervised self-management (using patient education and adjustments of anti-inflammatory medica-tion based on PEF or symptoms coupled with regular medical review, utilization and adherence to medication) reduces asthma morbidity. This reduction includes lost work days, unscheduled office visits, and ER and hospital admissions (Gibson, 2000; Ignatio-Garcia, 1995; Lahdensuo, 1996).
[Conclusion Grade I: See Conclusion Grading Worksheet – Appendix B – Annotation #9 (Asthma Educa-tion)]
A sample Asthma Action Plan is attached in Annotation Appendix A, "Asthma Action Plan."
See Minnesota Department of Health Action Plan at http://www.mnasthma.org/AAP/
Supporting evidence is of classes: A, M, R
10. Schedule Regular Follow-Up VisitsAsthma is a chronic inflammatory lung disease and all chronic diseases need regular follow-up visits. Prac-titioners need to assess whether or not control of asthma has been maintained and if a step down in therapy is appropriate. Further, practitioners need to monitor and review the daily self-management and action plans, the medications, and the patient's inhaler and peak flow monitoring techniques.
The exact frequency of clinician visits is a matter of clinical judgement
Severity Regular follow-up visit
Mild Intermittent 6-12 months Mild Persistent 6 months Moderate Persistent 3 months Severe Persistent 1 to 2 months and as often as needed to establish control
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25
How
to u
se th
e pe
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of th
e sc
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sthm
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Sui
te 2
00Fa
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, VA
220
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709
(703
)385
-440
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dditi
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Rea
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Child
ren
With
Ast
hma
by T
hom
as F
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The
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To b
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Annotation Appendix A – Asthma Action Plan
Diagnosis and Outpatient Management of Asthma Seventh Edition/March 2005
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26
Diagnosis and Outpatient Management of Asthma Annotation Appendix A – Asthma Action Plan Seventh Edition/March 2005
Gre
en Z
one:
All
Cle
arPe
rson
al b
est p
eak
flow
Peak
flow
(80-
100%
of p
erso
nal b
est)
Sym
ptom
s:•
No
sym
ptom
s of a
sthm
a•
Abl
e to
par
ticip
ate
in u
sual
act
iviti
es•
No
slee
p di
stur
banc
e by
ast
hma
such
as c
ough
ing,
whe
ezin
g, sh
ortn
ess o
fbr
eath
or c
hest
tigh
tnes
s
Med
icat
ions
:N
ame
Dos
eTi
me
Med
icat
ion
side
effe
cts:
Inha
ler,
spac
er, n
ebul
izer
or r
otoc
aps
Part
icip
atio
n in
runn
ing,
pla
ying
and
spor
ts; t
ake
befo
re e
xerc
ise
Dia
ry c
an b
e us
ed w
ith p
eak
flow
met
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d/or
sym
ptom
sEn
viro
nmen
tal c
ontr
ol o
f ast
hma
trig
gers
,e.
g., c
igar
ette
smok
e, e
xerc
ise,
illn
ess,
cold
air,
anim
als,
etc.
Yello
w Z
one:
Cau
tion
Peak
flow
(50-
80%
of p
erso
nal b
est)
Early
war
ning
sign
s of a
cute
ast
hma
epis
ode:
•C
ough
ing
•Ru
nny,
stuf
fy o
r con
gest
ed n
ose
•Sn
eezi
ng•
Not
slee
ping
or e
atin
g w
ell
•T i
red,
wea
k or
low
ene
rgy
•Itc
hy o
r wat
ery
eyes
•D
rop
in p
eak
flow
met
er re
adin
g
Sym
ptom
s of a
cute
ast
hma
epis
ode:
•Ra
pid
brea
thin
g•
Whe
ezin
g•
F req
uent
, tig
ht c
ough
•D
iffic
ulty
bre
athi
ng o
ut•
Suck
ing
in th
e ch
est s
kin
betw
een
the
ribs
Begi
n or
incr
ease
med
icat
ions
if w
arni
ngsi
gns o
r sym
ptom
s bec
ome
wor
se o
r las
tm
ore
than
12
hour
s. If
unsu
re, c
all y
our c
linic
.
Med
icat
ions
:N
ame
Dos
eTi
me
Med
icat
ion
side
effe
cts:
If no
sym
ptom
relie
f with
in 3
0 m
inut
es o
fgi
ving
med
icat
ion
and
peak
flow
is
%,
add
oral
ster
oid
Red
Zon
e: M
edic
al A
lert
Peak
flow
:(le
ss th
an 5
0% o
f per
sona
l bes
t)
Seve
re sy
mpt
oms r
equi
ring
imm
edia
tem
edic
al c
are:
•Fl
ared
nos
trils
•H
unch
ed b
ody
•Pr
olon
ged
shor
tnes
s of b
reat
h no
t re-
lieve
d by
med
icat
ion
or o
nly
brie
f rel
ief
Med
icat
ion
inst
ruct
ions
:
Giv
e or
al st
eroi
d:
Cal
l clin
ic #
Cal
l 911
if y
ou o
bser
ve th
ese
sym
ptom
s:•
Gas
ping
for a
ir w
ith sw
eatin
g•
Ext
rem
e an
xiet
y du
e to
diff
icul
ty
bre
athi
ng•
Con
ditio
n ra
pidl
y ge
tting
wor
se
Ast
hma
in sc
hool
or d
ay c
are
Nex
t ast
hma
appo
intm
ent a
nd h
ow m
uch
time
will
be
need
ed
Patie
nt N
ame
Dat
e of
Birt
hPr
ovid
er S
igna
ture
Dat
e
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.
27Copyright © 2005 by Institute for Clinical Systems Improvement
Released in March 2005 for Seventh Edition. The next scheduled revision will occur within 24 months.
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
I ICSI NSTITUTE FOR C LINICAL S YSTEMS I MPROVEMENT
Document Drafted Adults: Mar – Jun 1994Peds: May – Aug 1993
First Edition Jun 1998
Second Edition Jul 1999
Third Edition Jul 2000
Fourth Edition Jul 2001
Fifth Edition Jul 2002
Sixth Edition Jun 2003
Seventh Edition Begins April 2005
➤
Supporting Evidence:
Diagnosis and Outpatient Management of Asthma
Original Work Group MembersShirley Nordahl, PNPNursingAllina NorthJane NorstromHealth EducationInstitute for Research & Education HealthSystem MinnesotaMichael Rethwill, MDFamily PracticeHealthPartnersHyacinth RobertsBuyers Health Care Action Group RepresentativeHoneywell
Kent duRivage, MDPediatricsHealthPartnersJane GendronMeasurement AdvisorICSIKeith Harmon, MDPulmonary MedicineHealthSystem MinnesotaJames Li, MDAllergy, Work Group LeaderMayo Clinic
William Schoenwetter, MDAllergyHealthSystem MinnesotaRichard Sveum, MDAllergyHealthSystem MinnesotaEunice Weslander, PA-CFamily PracticeCentral MN Group HealthMargaret White, RN, MSFacilitatorICSI
Institute for Clinical Systems Improvement
www.icsi.org
28
I. CLASSES OF RESEARCH REPORTS
A. Primary Reports of New Data Collection:
Class A: Randomized, controlled trial
Class B: Cohort study
Class C: Non-randomized trial with concurrent or historical controls Case-control study Study of sensitivity and specificity of a diagnostic test Population-based descriptive study
Class D: Cross-sectional study Case series Case report
B. Reports that Synthesize or Reflect upon Collections of Primary Reports:
Class M: Meta-analysis Systematic review Decision analysis Cost-effectiveness analysis
Class R: Consensus statement Consensus report Narrative review
Class X: Medical opinion
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 ø 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.
Evidence Grading System
Diagnosis and Outpatient Management of Asthma Seventh Edition/March 2005
Institute for Clinical Systems Improvement
www.icsi.org
29
Grade Not Assignable: There is no evidence available that directly supports or refutes the conclusion.
The symbols +, –, ø, 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, generaliz-ability, and data collection and analysis;
– indicates that these issues have not been adequately addressed;
ø 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.
Diagnosis and Outpatient Management of Asthma Evidence Grading System Seventh Edition/March 2005
Institute for Clinical Systems Improvement
www.icsi.org
30
References
American Thoracic Society. Lung function testing: selection of reference values and interpretive strate-gies. Am Rev Respir Dis 1991;144:1202-18. (Class R)
Blanc P. Occupational asthma in a national disability survey. Chest 1987;92:613-17. (Class C)
Bleecker ER, Welch MJ, Weinstein SF, et al. Low-dose inhaled fluticasone propionate versus oral zafir-lukast in the treatment of persistent asthma. J Allergy Clin Immunol 2000;105:1123-29. (Class A)
Chapman KR, Verbeek PR, White JG, et al. Effect of a short course of prednisone in the prevention of early relapse after the emergency room treatment of acute asthma. N Eng J Med 1991;324:788-94. (Class A)
Childhood Asthma Management Program Research Group, The. Long-term effects of budesonide or nedocromil in children with asthma. N Engl J Med 2000;343:1054-63. (Class A)
Connolly MJ, Crowley JJ, Charan NB, et al. Reduced subjective awareness of bronchoconstriction provoked by methacholine in elderly asthmatic and normal subjects as measured on a simple aware-ness scale. Thorax 1992;47:410-13. (Class C)
Corren J, Adinoff AD, Irvin CG. Changes in bronchial responsiveness following nasal provocation with allergen. J Allergy Clin Immunol 1992;89:611-18. (Class A)
Ducharme FM, Hicks GC. Anti-leukotriene agents compared to inhaled corticosteroids in the manage-ment of recurrent and/or chronic asthma in adults and children. Cochrane Database Syst Rev. 2002. (Class M)
Enright PL, Lebowitz MD, Cockroft DW. Physiologic measures: pulmonary function tests. Am J Respir Crit Care Med 1994;149:S9-S18. (Class R)
Fanta CH, Rossing TH, McFadden ER. Glucocorticoids in acute asthma: a critical controlled trial. Am J Med 1983;74:845-51. (Class A)
Gibson PG, Coughlan J, Wilson AJ, et al. Self-management education and regular practitioner review for adults with asthma. The Cochrane Library, 2:2000. (Class M)
Harper PC, Bergner A, Kaye MD. Antireflux treatment for asthma: improvement in patients with associ-ated gastroesophageal reflux. Arch Intern Med 1987;147:56-60. (Class D)
Harris JB, Weinberger MM, Nassif E, et al. Early intervention with short course prednisone to prevent progression of asthma in ambulatory patients incompletely responsive to bronchodilators. J Pediatr 1987;110:627-33. (Class A)
Ignatio-Garcia J, Gonzalez-Santos P. Asthma self-management education program by home monitoring of peak flow expiratory flow. Am J Respir Care Med 1995;151:353-59. (Class A)
Juniper EF, Guyatt GH, Epstein RS, et al. Evaluation of impairment of health related quality of life in asthma: development of a questionnaire for use in clinical trials. Thorax 1992;47:76-83. (Class D)
Juniper EF, Guyatt GH, Ferrie PJ, Griffith LE. Measuring quality of life in asthma. Am Rev Respir Dis 1993;147:832-38. (Class D)
Kikuchi Y, Okabe S, Tamura G, et al. Chemosensitivity and perception of dyspnea in patients with a history of near-fatal asthma. N Engl J Med 1994;330:1329-34. (Class C)
Lahdensuo A, Haahtela T, Herrala J, et al. Randomised comparison of guided self-management and traditional treatment of asthma over one year. BMJ 1996;312:748-52. (Class A)
Diagnosis and Outpatient Management of Asthma Seventh Edition/March 2005
Institute for Clinical Systems Improvement
www.icsi.org
31
Lung Health Study Research Group, The. Effect of inhaled triamcinolone on the decline in pulmonary function in chronic obstructive pulmonary disease. N Engl J Med 2000;343:1902-09. (Class A)
Malo JL, Ghezzo H, D'Aquino C, et al. Natural history of occupational asthma: relevance of type of agent and other factors in the rate of development of symptoms in affected subjects. J Allergy Clin Immunol 1992;90:937-44. (Class C)
Miles JF, Bright P, Ayres JG, et al. The performance of mini Wright peak flow meters after prolonged use. Resp Med 1995;89:603-05. (Class C)
NAEPP Expert Panel Report. Managing asthma during pregnancy: recommendations for pharmacologic treatment – 2004 update. J Allergy Clin Immunol 2005;115:34-46. (Class R)
National Asthma Education and Prevention Program Expert Panel Report 2. Guidelines for the Diag-nosis and Outpatient Management of Asthma. Publication # 97-4051. National Institutes of Health/ National Heart, Lung, and Blood Institute, April 1997. (Class R)
National Asthma Education and Prevention Program Expert Panel Report: Guidelines for the Diagnosis and Outpatient Management of Asthma. Update on Selected Topics – 2002. J Allergy Clin Immunol 2002;110:S141-S219. (Class M)
O'Hollaren MT, Yunginger JW, Offord KP, et al. Exposure to an aeroallergen as a possible precipitating factor in respiratory arrest in young patients with asthma. N Engl J Med 1991;324:359-63. (Class D)
Pollart SM, Reid MJ, Fling JA, et al. Epidemiology of emergency room asthma in northern California: association with IgE antibody to ryegrass pollen. J Allergy Clin Immunol 1988;82:224-30. (Class C)
Rachelefsky GS, Katz RM, Siegel SC. Chronic sinus disease with associated reactive airway disease in children. Pediatrics 1984;73:526-29. (Class D)
Scarfone RJ, Fuchs SM, Nager AL, et al. Controlled trial of oral prednisone in the emergency depart-ment treatment of children with acute asthma. Pediatrics 1993;2:513-18. (Class A)
Spitzer WO, Suissa S, Ernst P, et al. The use of beta-agonists and the risk of death and near death from asthma. N Engl J Med 1992;326:501-06. (Class C)
Szefler SJ, Phillips BR, Martinez FD, et al. Characterization of within-subject responses to fluticasone and montelukast in childhood asthma. J Allergy Clin Immunol 2005;115:233-42. (Class A)
Zieger RS, Heller S, Mellon MH, et al. Facilitated referral to asthma specialist reduces relapses in asthma emergency room visits. J Allergy Clin Immunol 1991;87:1160-68. (Class C)
Diagnosis and Outpatient Management of Asthma References Seventh Edition/March 2005
Institute for Clinical Systems Improvement
www.icsi.org
32
Conclusion Grading Worksheet – Appendix A – Annotation #8 (Leukotriene Receptor Antagonists [LTRAs])
Diagnosis and Outpatient Management of Asthma Seventh Edition/March 2005
Wor
k G
roup
's C
oncl
usio
n:B
ased
on
data
com
pari
ng L
TR
As
to in
hale
d co
rtic
oste
roid
s, in
hale
d co
rtic
oste
roid
s ar
e th
e pr
e-fe
rred
trea
tmen
t opt
ion
for
mild
per
sist
ent a
sthm
a in
adu
lts, a
nd b
y ex
trap
olat
ion
until
pub
lishe
d da
ta b
ecom
e av
aila
ble,
for
child
ren.
LT
RA
s ar
e an
alte
rnat
ive
– al
thou
gh n
ot p
refe
rred
– tr
eatm
ent.
Con
clus
ion
Gra
de:
I
Aut
hor/
Yea
rD
esig
nT
ype
Cla
ssQ
ual-
ity
+,–
,ø
Popu
latio
n St
udie
d/Sa
mpl
e Si
zePr
imar
y O
utco
me
Mea
sure
(s)/
Res
ults
(e.
g., p
-val
ue,
conf
iden
ce in
terv
al, r
elat
ive
risk
, odd
s ra
tio, l
ikel
i-ho
od r
atio
, num
ber
need
ed to
trea
t)
Aut
hors
' Con
clus
ions
/W
ork
Gro
up's
Com
men
ts (
italic
ized
)
Mal
mst
rom
et
al.,
1999
RC
TA
ø-A
ges
15 y
rs a
nd o
lder
; mal
esan
d fe
mal
es; h
ealth
y, n
onsm
ok-
ing;
ast
hma
for
≥1 y
r; F
EV
1 50
-85
% o
f pr
edic
ted;
incr
ease
of
≥15%
in a
bsol
ute
FEV
1 aft
er u
seof
inha
led β-
agon
ist (
at le
ast 2
of 3
vis
its);
day
time
asth
ma
sym
ptom
sco
re ≥
64 (
of 3
36po
ssib
le);
ave
rage
dai
ly u
se o
f≥1
puf
f of
sho
rt-a
ctin
g β-
agon
ist
-Exc
lude
d: u
se o
f in
hale
d an
dor
al c
ortic
oste
roid
s, c
rom
olyn
,or
ned
ocro
mil
with
in 4
wks
be-
fore
initi
al e
val;
use
of lo
ng-
actin
g β-
agon
ists
, ant
imus
cari
n-ic
s, o
r th
eoph
yllin
e w
ithin
2w
ks b
efor
e in
itial
eva
l; ha
d us
edlo
ng-a
ctin
g an
tihis
tam
ines
-2 w
k pl
aceb
o ru
n-in
, 12
wk
trea
tmen
t per
iod,
3 w
k w
asho
ut-R
ando
miz
ed to
mon
telu
kast
(10
mg
1X/d
ay [
even
ing]
), in
-ha
led
becl
omet
haso
ne (
200µ
g2X
/day
), o
r pl
aceb
o (3
:2:2
rat
io)
-Cli
nic:
FE
V1
-Hom
e: d
aily
dia
ry c
ard
for
sym
ptom
s, P
EFR
, and
nee
d fo
rsa
lbut
amol
-895
pat
ient
s ra
ndom
ized
(38
7 m
onte
luka
st, 2
51 b
e-cl
omet
haso
ne, 2
57 p
lace
bo);
trea
tmen
t com
plet
ed b
y91
.5%
, 92.
8%, a
nd 8
3.7%
, res
pect
ivel
y; t
otal
stu
dyco
mpl
eted
by
89.4
%, 9
0.4%
, and
81.
7%-G
roup
s si
mila
r at
bas
elin
e; m
ean
com
plia
nce
with
inha
led
med
icat
ion
(tre
atm
ent p
hase
) 88
%-9
0% f
oral
l gro
ups;
mea
n co
mpl
ianc
e w
ith o
ral m
edic
atio
n>
99%
for
all
grou
ps-O
utco
mes
: Plac
ebo
Mon
telu
kast
Bec
lom
etha
sone
FEV
1*0.
7%7.
4%a
13.1
%a
Sym
ptom
-0.1
7-0
.41a
-0.6
2a
Sco
re#
PE
FR
-am
0.8
l/m
in23
.8 l
/min
a39
.2 l
/min
a
PE
FR
-pm
0.3
l/m
in20
.8 l
/min
a32
.1 l
/min
a
Atta
cks^
27.3
%15
.6%
a10
.1%
a
a p<0.
001
com
pare
d w
ith p
lace
bo; *
mor
ning
val
ue,
% c
hang
e fr
om b
asel
ine;
#da
ytim
e sc
ore,
cha
nge
from
bas
elin
e; ^
perc
enta
ge o
f pa
tient
s-D
urin
g 3
wk
was
hout
, pat
ient
s sw
itche
d to
pla
cebo
retu
rned
to b
asel
ine
leve
ls-I
nitia
l res
pons
e gr
eate
r fo
r m
onte
luka
st g
roup
; eff
ect
of b
eclo
met
haso
ne s
urpa
ssed
mon
telu
kast
7-1
0 da
ysaf
ter
star
t of
ther
apy
-No
inte
ract
ions
bas
ed o
n ba
selin
e FE
V1,
sym
ptom
scor
e, n
eed
for β-
agon
ist,
or P
EFR
-Im
prov
emen
ts in
qua
lity
of li
fe g
reat
er w
ith m
onte
-lu
kast
and
bec
lom
etha
sone
(p<
0.00
1)-M
ost c
omm
on c
linic
al a
dver
se e
ffec
ts:
wor
seni
ngas
thm
a (p
<0.
05 f
or a
ctiv
e tr
eatm
ent v
s. p
lace
bo),
head
ache
, upp
er r
espi
rato
ry in
fect
ion
(bot
h N
S)
-Ora
l mon
telu
kast
ther
apy
has
been
sho
wn
tobe
eff
ectiv
e in
chr
onic
ast
hma,
pro
duci
ngsi
gnif
ican
t im
prov
emen
ts in
FE
V1
and
sig-
nifi
cant
alle
viat
ion
of d
aytim
e as
thm
a sy
mp-
tom
s. A
lthou
gh in
hale
d be
clom
etha
sone
had
a la
rger
ave
rage
eff
ect t
han
mon
telu
kast
,m
onte
luka
st h
ad a
mor
e ra
pid
initi
al r
e-sp
onse
. T
he tw
o ag
ents
eac
h pr
otec
ted
agai
nst w
orse
ning
epi
sode
s of
ast
hma.
NO
TE
S: u
se o
f im
mun
othe
rapy
was
per
mit-
ted
if it
had
bee
n st
arte
d ≥6
mos
bef
ore
ini-
tial e
valu
atio
n; r
un-i
n w
as s
ingl
e-bl
ind,
trea
tmen
t and
was
hout
was
dou
ble-
blin
d;du
ring
was
hout
som
e pa
tient
s co
ntin
ued
ac-
tive
trea
tmen
t and
oth
ers
switc
hed
to p
la-
cebo
; stu
dy d
one
at 3
6 ce
nter
s in
19
coun
-tr
ies;
pat
ient
s co
uld
use
shor
t-ac
ting
inha
led
β-ag
onis
t (sa
lbut
amol
) as
nee
ded;
if a
ddi-
tiona
l the
rapy
was
nee
ded
oral
cor
ticos
ter-
oids
wer
e gi
ven
(if
≥2 s
uch
epis
ode
patie
ntw
as d
ropp
ed f
rom
stu
dy);
com
plia
nce
mon
i-to
red
by w
eigh
ing
inha
lers
and
cou
ntin
g ta
b-le
ts; a
naly
sis
incl
uded
all
patie
nts
with
bas
e-lin
e an
d at
leas
t one
mea
sure
men
t aft
er r
an-
dom
izat
ion;
did
sam
ple
size
est
imat
ion
for
95%
pow
er to
det
ect d
iffe
renc
e of
6%
inch
ange
fro
m b
asel
ine
and
10%
in d
aytim
esy
mpt
om s
core
s (m
onte
luka
st v
s. p
lace
bo)
Institute for Clinical Systems Improvement
www.icsi.org
33
Conclusion Grading Worksheet – Appendix A – Diagnosis and Outpatient Management of Asthma Annotation #8 (Leukotriene Receptor Antagonists [LTRAs]) Seventh Edition/March 2005
Ble
eker
et a
l.,20
00R
CT
Aø
-Age
s 12
+; p
ersi
sten
t ast
hma
(≥6
mos
); p
redo
se F
EV
1 of
50-
80%
of
pred
icte
d no
rmal
and
in-
crea
se F
EV
1 ≥12
% f
rom
bas
elin
eaf
ter
180µ
g in
hale
d al
bute
rol ;
had
used
alb
uter
ol o
n sc
hedu
leor
as-
need
ed b
ases
dur
ing
4 w
ksbe
fore
scr
eeni
ng; n
o m
onte
lu-
kast
, zaf
irlu
kast
, or
zile
uton
with
in 2
wks
of
scre
enin
g-E
xclu
ded:
his
tory
of
life-
thre
aten
ing
asth
ma;
>3
burs
ts o
for
al o
r pa
rent
eral
cor
ticos
tero
ids
with
in 1
yr;
use
of
toba
cco
prod
ucts
in p
ast y
r or
sm
okin
ghi
stor
y of
>10
pac
k-yr
s; r
espi
ra-
tory
infe
ctio
n w
ithin
2 w
ks o
fsc
reen
ing,
cur
rent
evi
denc
e of
sign
ific
ant d
isor
ders
-8-1
4 da
y ru
n-in
with
res
cue
al-
bute
rol (
base
line
data
, com
pli-
ance
ass
essm
ent)
-Elig
ible
pat
ient
s ra
ndom
ized
toin
hale
d fl
utic
ason
e pr
opio
nate
(FP)
aer
osol
(88
µg)
or
oral
zaf
ir-
luka
st (
20 m
g); b
oth
2X/d
ay f
or12
wks
with
alb
uter
ol a
s ne
eded
-Hom
e: s
ympt
oms,
PE
FR,
al-
bute
rol u
se-C
lini
c:
FEV
1
-220
ran
dom
ized
to z
afir
luka
st, 2
31 to
FP;
gro
ups
sim
ilar
at b
asel
ine;
77%
of
zafi
rluk
ast a
nd 8
7% o
fpl
aceb
o gr
oups
fin
ishe
d pr
otoc
ol-O
utco
mes
(ch
ange
aft
er 1
2 w
ks o
f tr
eatm
ent)
:F
PZ
afir
luka
stFE
V1-
am (
L)
+0.
42+
0.20
*PE
FR-a
m (
L/m
in)
+49
.94
+11
.68*
PEFR
-pm
(L
/min
)+
38.9
1+
10.5
0*Sy
mpt
om s
core
-0.4
6-0
.19*
Sym
ptom
-fre
e da
ys (
%)
+28
.5+
15.6
*A
lbut
erol
(pu
ffs/
day)
-2.3
9-1
.45*
Res
cue-
free
day
s+
40.4
+24
.2*
# N
ight
aw
aken
ings
-0.2
8-0
.15*
*p<
0.00
1-5
6% o
f ph
ysic
ians
rat
ed tr
eatm
ent w
ith F
P as
"ef
-fe
ctiv
e" o
r "v
ery
effe
ctiv
e" c
ompa
red
with
41%
for
zafi
rluk
ast (
p<0.
001)
-4%
of
FP g
roup
and
6%
of
zafi
rluk
ast g
roup
had
an
exac
erba
tion
(NS)
-10%
in e
ach
grou
p ha
d ≥1
adv
erse
eve
nt c
onsi
dere
dpo
tent
ially
rel
ated
to tr
eatm
ent;
head
ache
, dry
mou
th, &
hoa
rsen
ess
wer
e m
ost c
omm
on
-The
clin
ical
eff
ectiv
enes
s of
a lo
w d
ose
o fFP
as
firs
t-lin
e th
erap
y in
pat
ient
s w
ith p
er-
sist
ent a
sthm
a w
ho a
re s
ympt
omat
ic o
n β 2
-ag
onis
ts a
lone
is s
uper
ior
to th
at o
f za
firl
u-ka
st.
NO
TE
S: c
oncu
rren
t use
of
med
icat
ions
that
mig
ht a
ffec
t the
cou
rse
of a
sthm
a or
inte
ract
with
zaf
irlu
kast
wer
e pr
ohib
ited;
ant
ihis
ta-
min
es, d
econ
gest
ants
, and
intr
anas
al m
edic
a-tio
ns f
or a
llerg
ic r
hini
tis w
ere
allo
wed
; dou
-bl
e-bl
ind
trea
tmen
t pha
se; p
atie
nts
with
asth
ma
exac
erba
tion
(req
uiri
ng c
ortic
oste
r-oi
ds)
duri
ng s
tudy
pha
se w
ere
with
draw
n;st
udy
desi
gned
with
≥80
% p
ower
to d
etec
tdi
ffer
ence
of
0.17
8 L
/min
in F
EV
1 bet
wee
ngr
oups
Institute for Clinical Systems Improvement
www.icsi.org
34
Bus
se e
t al.
for
the
Flut
icas
one
Prop
iona
t eC
linic
al R
e-se
arch
Stu
dy,
2001
RC
TA
ø-A
ges
15+
; ast
hma
diag
nose
dfo
r ≥6
mos
; pre
dose
FE
V1 5
0-80
% o
f pr
edic
ted
norm
al a
nd in
-cr
ease
in F
EV
1of
≥15%
aft
er 1
80µ
g al
bute
rol;
used
inha
led
oror
al s
hort
-act
ing β 2
-ago
nist
on
are
gula
r or
as-
need
ed b
asis
for
3m
os b
efor
e sc
reen
ing
-Exc
lude
d: u
se o
f IC
Ss in
pas
t2
mos
; use
of
toba
cco
prod
ucts
in p
ast y
ear;
sm
okin
g hi
stor
y of
≥10
pack
-yrs
; hos
pita
lized
for
asth
ma
in p
ast 3
mos
; res
pira
-to
ry tr
act i
nfec
tion
in p
ast 4
wks
; hyp
erse
nsiti
vity
to a
sthm
adr
ugs
-8-1
4 da
y ru
n-in
per
iod
(con
firm
elig
ibili
ty, b
asel
ine
data
); u
se o
fal
bute
rol a
s ne
eded
-Ran
dom
ized
(se
e N
OT
ES)
to88
µg
2X/d
ay F
P +
pla
cebo
cap
-su
le in
eve
ning
or
10 m
g or
alm
onte
luka
st i
n ev
enin
g +
2pu
ffs
plac
ebo
2X/d
ay f
or 2
4w
ks; i
nhal
ed a
lbut
erol
as
need
ed-C
linic
vis
its:
FE
V1,
adve
rse
even
ts; p
hysi
cian
rat
ing
of e
ffec
-tiv
enes
s, q
ualit
y of
life
, pat
ient
satis
fact
ion
with
med
icat
ion
-Hom
e (a
m/p
m):
sym
ptom
s,PE
FR, p
uffs
of
albu
tero
l, ni
ght-
time
awak
enin
gs, c
ompl
ianc
e
-271
in
FP g
roup
, 262
in
mon
telu
kast
gro
up;
grou
ps c
ompa
rabl
e at
bas
elin
e; s
tudy
com
plet
ed b
y72
% o
f FP
gro
up a
nd 7
1% o
f m
onte
luka
st g
roup
;re
port
ed c
ompl
ianc
e (i
nhal
er a
nd c
apsu
les)
≥91
%-O
utco
mes
(ch
ange
fro
m b
asel
ine)
:F
PM
onte
luka
stFE
V1 (
L)
0.51
0.33
*PE
FR-a
m (
L/m
in)
68.5
34.1
*PE
FR-p
m (
L/m
in)
53.9
28.7
*Sy
mpt
om s
core
-0.8
5-0
.60*
Alb
uter
ol (
puff
s/da
y)-3
.10
-2.3
1**p
<0.
001
-Phy
sici
ans
glob
al a
sses
smen
t fav
ored
FP
over
mon
-te
luka
st (
71%
rat
ed F
P ef
fect
ive
or v
ery
effe
ctiv
e vs
.53
% f
or m
onte
luka
st, p
<0.
001)
-Pat
ient
sat
isfa
ctio
n fa
vore
d FP
ove
r m
onte
luka
st(8
5% o
f pa
tient
s sa
tisfi
ed w
ith F
P vs
. 65%
for
mon
-te
luka
st, p
<0.
001)
; qua
lity-
of-l
ife
scor
es s
igni
fi-
cant
ly g
reat
er in
FP
patie
nts
(p<
0.00
1) e
spec
ially
asth
ma
sym
ptom
s an
d em
otio
nal f
unct
ion
dom
ains
-Adv
erse
eve
nts:
71%
of
FP p
atie
nts,
68%
of
mon
-te
luka
st p
atie
nts;
few
wer
e co
nsid
ered
dru
g re
late
d;m
ost c
omm
on (
poss
ibly
dru
g re
late
d) w
ere
head
-ac
he, s
ore
thro
at, h
oars
enes
s, o
ral p
hary
ngea
l can
-di
dias
is-A
sthm
a ex
acer
batio
ns:
4% o
f FP
gro
up, 8
% o
fm
onte
luka
st g
roup
-Low
-dos
e FP
is m
ore
effe
ctiv
e th
an m
onte
-lu
kast
as
firs
t-lin
e m
aint
enan
ce th
erap
y fo
rpa
tient
s w
ith p
ersi
sten
t ast
hma
who
are
un-
derr
ated
and
rem
ain
sym
ptom
atic
whi
le ta
k-in
g sh
ort-
actin
g β 2
-ago
nist
s al
one.
NO
TE
S: a
t ran
dom
izat
ion
patie
nts
had
tode
mon
stra
te th
at a
dditi
onal
ther
apy
was
war
-ra
nted
(un
med
icat
ed F
EV
1 of
50-8
0% o
f pr
e-di
cted
nor
mal
and
with
in 1
5% o
f sc
reen
ing
FEV
1, us
e of
alb
uter
ol o
n ≥6
of
7 da
ys b
e-fo
re r
ando
miz
atio
n, a
nd a
sthm
a sy
mpt
omsc
ore
≥2 [
0-5
scal
e] o
n ≥4
of
7 da
ys b
efor
era
ndom
izat
ion)
; use
of
med
iatio
ns f
or r
hini
-tis
was
allo
wed
; did
sam
ple
size
est
imat
ion
for
≥80%
pow
er to
det
ect d
iffe
renc
e of
6 p
er-
cent
age
poin
ts in
FE
V1 c
hang
e be
twee
n 2
trea
tmen
t gro
ups;
stu
dy c
ondu
cted
at 5
2si
tes
Conclusion Grading Worksheet – Appendix A – Diagnosis and Outpatient Management of Asthma Annotation #8 (Leukotriene Receptor Antagonists [LTRAs]) Seventh Edition/March 2005
Institute for Clinical Systems Improvement
www.icsi.org
35
Duc
harm
e &
Hic
ks, 2
002
Sys-
tem
atic
Rev
iew
M+
-Sea
rch
of c
linic
al tr
ials
dat
a-ba
ses;
con
tact
with
pha
rmac
euti-
cal c
ompa
nies
-Qua
lity
of s
tudi
es a
sses
sed
by2
mas
ked
revi
ewer
s-1
4 tr
ials
met
incl
usio
n cr
iteri
a(i
nclu
ding
Ble
eker
, 200
0, B
usse
2001
, an
d M
alm
stro
m,
1999
,[a
bove
]); a
ll R
CT
s ex
cept
one
;12
foc
used
on
adul
ts; i
nter
ven-
tion
dura
tion
of 4
to
37 w
ks;
incl
uded
mon
telu
kast
, pra
nlu-
kast
, zaf
irlu
kast
, bec
lom
etha
-so
ne, a
nd f
lutic
ason
e-1
0 tr
ials
had
hig
h qu
ality
(≥4
of 5
poi
nts)
; 11
with
app
ropr
iate
rand
omiz
atio
n m
etho
ds; 1
1do
uble
-blin
d; w
ithdr
awal
rat
esof
0%
-29%
-Pri
mar
y ou
tcom
e (r
esul
ts f
rom
11
tria
ls):
rat
e of
exac
erba
tions
req
uiri
ng s
yste
mic
cor
ticos
tero
ids;
pa-
tient
s tr
eate
d w
ith a
nti-
leuk
otri
enes
had
61%
in-
crea
sed
risk
of
exac
erba
tion
com
pare
d to
pat
ient
str
eate
d w
ith I
CSs
(R
R=
1.61
; 95
%C
I 1.
15-2
.25)
; n o
appa
rent
dif
fere
nce
due
to m
onte
luka
st v
s. z
afir
lu-
kast
, bec
lom
etha
sone
vs.
flu
ticas
one,
qua
lity
ofst
udie
s, p
ublis
hed
vs. u
npub
lishe
d da
ta, s
ourc
e of
fund
ing;
gre
ater
eff
ect i
n tr
ials
of
12-1
6 w
ks v
s 4-
6w
ks, p
atie
nts
with
mod
erat
e vs
. mild
ast
hma
-Oth
er o
utco
mes
: im
prov
emen
ts in
FE
V1,
PEFR
-am
, cha
nge
in s
ympt
om s
core
, nig
httim
e aw
aken
-in
gs, s
ympt
om-f
ree
days
, and
qua
lity
of li
fe a
ll fa
-vo
red
ICSs
; ant
i-le
ukot
rien
e th
erap
y as
soci
ated
with
grea
ter
risk
of
over
all w
ithdr
awal
s (R
R=1
.3; 9
5%C
I1.
1-1.
6) a
ppar
ently
due
to p
oor
asth
ma
cont
rol;
nodi
ffer
ence
in p
atie
nts
expe
rien
cing
"an
y ad
vers
e ef
-fe
cts"
-For
mos
t as
thm
a ou
tcom
es, I
CSs
at
400
mcg
/day
of
becl
omet
haso
ne-e
quiv
alen
t are
mor
e ef
fect
ive
than
ant
i-le
ukot
rien
e ag
ents
give
n in
the
usua
l lic
ense
d do
ses.
The
exa
ctdo
se-e
quiv
alen
ce o
f an
ti-le
ukot
rien
e ag
ents
in m
cg o
f IC
Ss r
emai
ns to
be
dete
rmin
ed.
Conclusion Grading Worksheet – Appendix A – Diagnosis and Outpatient Management of Asthma Annotation #8 (Leukotriene Receptor Antagonists [LTRAs]) Seventh Edition/March 2005
Institute for Clinical Systems Improvement
www.icsi.org
36
Conclusion Grading Worksheet – Appendix B – Annotation #9 (Asthma Education)
Diagnosis and Outpatient Management of Asthma Seventh Edition/March 2005
Wor
k G
roup
's C
oncl
usio
n: S
uper
vise
d se
lf-m
anag
emen
t (us
ing
patie
nt e
duca
tion
and
adju
stm
ents
of
anti-
infl
amm
ator
ym
edic
atio
n ba
sed
on P
EF
or s
ympt
oms
coup
led
with
reg
ular
med
ical
rev
iew
, util
izat
ion
and
adhe
renc
e to
med
icat
ion)
red
uces
asth
ma
mor
bidi
ty.
Thi
s re
duct
ion
incl
udes
lost
wor
k da
ys, u
nsch
edul
ed o
ffic
e vi
sits
, and
ER
and
hos
pita
l adm
issi
ons.
Con
clus
ion
Gra
de:
I
Aut
hor/
Yea
rD
esig
nT
ype
Cla
ssQ
ual-
ity
+,–
,ø
Popu
latio
n St
udie
d/Sa
mpl
e Si
zePr
imar
y O
utco
me
Mea
sure
(s)/
Res
ults
(e.
g., p
-val
ue,
conf
iden
ce in
terv
al, r
elat
ive
risk
, odd
s ra
tio, l
ikel
i-ho
od r
atio
, num
ber
need
ed to
trea
t)
Aut
hors
' Con
clus
ions
/W
ork
Gro
up's
Com
men
ts (
italic
ized
)
May
o, R
ich-
man
, & H
arri
s,19
90
RC
TA
ø-P
atie
nts
hosp
italiz
ed w
ith a
cute
asth
ma
exac
erba
tion;
18+
yrs
old;
>4
ER
vis
its
in p
ast
12m
os o
r >
1 ho
spita
lizat
ion
inpa
st 2
4 m
os-R
ando
miz
ed to
spe
cial
clin
icgr
oup
or r
outin
e cl
inic
gro
up;
afte
r 8
mon
ths,
19
patie
nts
from
rout
ine
grou
p se
lect
ed (
base
d on
mul
tiple
hos
pita
lizat
ions
) to
cros
s to
spe
cial
clin
ic g
roup
-104
ran
dom
ized
(47
to s
peci
al c
linic
, 57
to r
outin
ecl
inic
); 1
0 of
47
neve
r at
tend
ed s
peci
al c
linic
; aft
er 8
mon
ths
19 f
rom
rou
tine
clin
ic g
roup
join
ed s
peci
alcl
inic
gro
up (
n=56
with
1 lo
st to
fol
low
-up)
-Spe
cial
clin
ic, r
outin
e cl
inic
, and
cro
ss-o
ver
grou
pssi
mila
r at
bas
elin
e ex
cept
few
er in
cro
ss-o
ver
grou
pev
er r
equi
red
intu
batio
n-A
fter
enr
ollm
ent i
n sp
ecia
l clin
ic (
n=56
): le
ss u
seof
ora
l bet
a ag
onis
ts a
nd d
aily
pre
dnis
one,
gre
ater
use
of c
hron
ic in
hale
d co
rtic
oste
roid
s, b
rief
pre
dni-
sone
pul
ses,
res
ervo
ir s
pace
r de
vice
s, a
nd h
ome
peak
flow
mon
itors
-Spe
cial
clin
ic g
roup
(n=
47)
had
low
er h
ospi
tal u
seth
an r
outin
e cl
inic
(n=
57)
(0.4
vs.
1.2
adm
issi
ons
per
patie
nt [
p<0.
004]
and
3.1
vs.
6.7
re-
hosp
italiz
atio
n da
ys p
er p
atie
nt [
p<0.
02] )
-For
34
of 3
7 w
ho a
ttend
spe
cial
clin
ic r
e-ad
mis
sion
rate
per
pat
ient
per
mon
th d
ecre
ased
fro
m 0
.13
be-
fore
enr
ollm
ent t
o 0.
04 a
fter
(p=
0.00
3) a
nd r
e-ho
spita
lizat
ion
days
per
pat
ient
per
mon
th d
ecre
ased
from
0.7
3 to
0.2
6 (p
=0.
003)
; si
mila
r fi
ndin
gs f
orcr
oss-
over
gro
up-N
o de
aths
fro
m a
sthm
a in
spe
cial
clin
ic g
roup
; one
deat
h in
rou
tine
grou
p; 4
spe
cial
clin
ic p
atie
nts
re-
quir
ed i
ntub
atio
n in
32
mon
ths
follo
w-u
p
-A v
igor
ous
med
ical
reg
imen
and
inte
nsiv
eed
ucat
ion
prog
ram
was
abl
e to
dec
reas
e ho
s-pi
tal u
se a
mon
g a
grou
p of
adu
lt as
thm
atic
sw
ho h
ad p
revi
ousl
y re
quir
ed r
epea
ted
read
-m
issi
ons
for
acut
e as
thm
a ex
acer
batio
ns.
NO
TE
S: a
spe
cial
out
patie
nt a
sthm
a cl
inic
was
dev
elop
ed to
red
uce
re-a
dmis
sion
s fo
ras
thm
a ex
acer
batio
n; a
ll pa
tient
s tr
eate
d by
sam
e ph
ysic
ian;
clin
ic p
rogr
am in
clud
ed p
a-tie
nt e
duca
tion
and
indi
vidu
al m
edic
atio
nre
gim
ens
with
em
phas
is o
n se
lf-m
anag
e-m
ent;
hosp
ital u
sage
bef
ore
spec
ial c
linic
en-
rollm
ent w
as l
imite
d to
1 h
ospi
tal
whi
le u
s-ag
e af
ter
enro
llmen
t inc
lude
d ot
her
hosp
itals
in th
e ar
ea; n
o at
tem
pt w
as m
ade
to d
eter
-m
ine
wha
t ele
men
t of
the
prog
ram
, if
any,
was
ess
entia
l
Wor
k G
roup
's C
omm
ents
: d
iffer
ent o
bser
va-
tion
sche
dule
s; n
o st
atis
tics
for
drug
use
data
; po
pula
tion
was
lar
gely
His
pani
c; n
oda
ta o
n co
mpl
ianc
e w
ith p
rogr
ams
Institute for Clinical Systems Improvement
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37
Conclusion Grading Worksheet – Appendix B – Diagnosis and Outpatient Management of Asthma Annotation #9 (Asthma Education) Seventh Edition/March 2005
Aut
hor/
Yea
rD
esig
nT
ype
Cla
ssQ
ual-
ity+
,–,ø
Popu
latio
n St
udie
d/Sa
mpl
e Si
zePr
imar
y O
utco
me
Mea
sure
(s)/
Res
ults
(e.
g., p
-val
ue,
conf
iden
ce in
terv
al, r
elat
ive
risk
, odd
s ra
tio, l
ikel
i-ho
od r
atio
, num
ber
need
ed to
trea
t)
Aut
hors
' Con
clus
ions
/W
ork
Gro
up's
Com
men
ts (
italic
ized
)
Igna
cio-
Gar
cia
& G
onza
lez-
Sant
os,
1995
RC
TA
ø-P
atie
nts
from
one
out
patie
ntas
thm
a cl
inic
; 14
to 6
5 ye
ars
with
ast
hma
diag
nose
d ≥2
yrs
prio
r-R
ando
miz
ed to
exp
erim
enta
l(s
elf
man
agem
ent w
ith p
eak-
flow
rea
ding
s as
bas
is f
or tr
eat-
men
t pla
n pl
us e
duca
tion
pro-
gram
) or
con
trol
(sy
mpt
oms
and
spir
omet
ric
data
for
fol
low
ing
phys
icia
n's
trea
tmen
t pla
n)-M
edic
al r
egim
ens
tailo
red
toin
divi
dual
pat
ient
-Fol
low
-up:
1, 3
, 5, a
nd 6
mos
-Deg
ree
of il
lnes
s: m
orbi
dity
pa-
ram
eter
s, s
piro
met
ric
data
, con
-su
mpt
ion
of d
rugs
, rat
es a
t-ta
ined
by
peak
flo
w m
eter
ing
-Com
pare
d 6
mos
bef
ore
inte
r-ve
ntio
n w
ith 6
mos
aft
er
-94
enro
lled;
24
com
plet
ed in
itial
ass
essm
ent b
utla
ter
drop
ped
out o
r w
ere
excl
uded
for
pro
toco
l vio
-la
tions
(9
cont
rol,
15 e
xper
imen
tal)
-Ana
lysi
s ba
sed
on 7
0 pa
tient
s (3
2M, 3
8F),
mea
nag
e 42
(ra
nge
16-6
4); 3
5 ex
peri
men
tal,
35 c
ontr
ol;
grou
ps c
ompa
rabl
e at
bas
elin
e in
age
, gen
der,
soc
ial
clas
s, s
mok
ing,
yea
rs o
f as
thm
a, c
hron
ic b
ronc
hitis
-Aft
er in
terv
entio
n gr
oups
dif
fere
d (p
<0.0
5) in
day
slo
st f
rom
wor
k, e
xace
rbat
ions
, day
s on
ant
ibio
tics,
phys
icia
n co
nsul
tatio
ns, E
R a
dmis
sion
s, n
octu
rnal
wak
enin
g-C
ontr
ol g
roup
: fe
wer
exa
cerb
atio
ns a
nd p
hysi
cian
cons
ulta
tions
aft
er s
tudy
per
iod
(bot
h p<
0.01
)-E
xper
imen
tal g
roup
: fe
wer
day
s lo
st f
rom
wor
k,ex
acer
batio
ns, d
ays
on a
ntib
iotic
s, p
hysi
cian
con
sul-
tatio
ns, E
R a
dmis
sion
s af
ter
stud
y pe
riod
(al
lp<
0.01
)-F
EV
1, FV
C, a
nd F
EV
1/FV
C i
mpr
oved
ove
r st
udy
peri
od in
exp
erim
enta
l gro
up (
all p
<0.
003
fro m
base
line)
; con
trol
gro
up im
prov
ed F
EV
1 and
FEV
1/FV
C a
t fir
st f
ollo
w-u
p bu
t ret
urne
d to
war
dba
selin
e th
erea
fter
-Mea
n pe
ak e
xpir
ator
y fl
ow r
ate
(PE
FR)
high
er in
expe
rim
enta
l gro
up a
t all
follo
w-u
p vi
sits
(al
lp<
0.05
); m
ean
PEFR
and
mor
ning
PE
FR i
ncre
ased
sign
ific
antly
fro
m b
asel
ine
in e
xper
imen
tal g
roup
(p<
0.00
1); P
EFR
mor
e va
riab
le in
con
trol
gro
up-E
xper
imen
tal g
roup
use
d le
ss f
enot
erol
and
pre
dni-
sone
(bo
th p
<0.0
5) th
an c
ontr
ol a
nd d
ecre
ased
use
of
albu
tero
l, te
rbut
alin
e, f
enot
erol
, the
ophy
lline
, and
bude
soni
de d
urin
g st
udy
peri
od (
all p
<0.
05);
-Pea
k fl
ow m
onito
ring
ass
ocia
ted
with
an
educ
atio
n pr
ogra
m r
educ
ed m
orbi
dity
, im
-pr
oved
lung
fun
ctio
n, a
nd o
ptim
ized
the
use
of m
edic
atio
n in
adu
lt as
thm
a pa
tient
s.
NO
TE
S: o
ne p
hysi
cian
(un
blin
ded)
ass
esse
dpa
tient
s' c
ondi
tion
and
mod
ifie
d tr
eatm
ent a
tfo
llow
-up
visi
ts; b
efor
e in
terv
entio
n gr
oups
com
para
ble
in d
ays
lost
fro
m w
ork,
acu
teex
acer
batio
ns, d
ays
on a
ntib
iotic
s, p
hysi
cian
cons
ulta
tion
s, E
R a
dmis
sion
s, h
ospi
tal
ad-
mis
sion
s
Wor
k G
roup
's C
omm
ents
: L
ittle
info
rma-
tion
abou
t in
clus
ion/
excl
usio
n cr
iteri
a or
com
orbi
ditie
s; a
naly
sis
was
not
int
entio
n-to
-tre
at
Institute for Clinical Systems Improvement
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38
Aut
hor/
Yea
rD
esig
nT
ype
Cla
ssQ
ual-
ity+
,–,ø
Popu
latio
n St
udie
d/Sa
mpl
e Si
zePr
imar
y O
utco
me
Mea
sure
(s)/
Res
ults
(e.
g., p
-val
ue,
conf
iden
ce in
terv
al, r
elat
ive
risk
, odd
s ra
tio, l
ikel
i-ho
od r
atio
, num
ber
need
ed to
trea
t)
Aut
hors
' Con
clus
ions
/W
ork
Gro
up's
Com
men
ts (
italic
ized
)
Lah
dens
uo e
tal
., 19
96R
CT
Aø
-Adu
lts (
18+
) fr
om 3
out
patie
ntce
nter
s; m
ild to
mod
erat
ely
se-
vere
ast
hma;
incl
usio
n/ex
clus
ion
crite
ria
base
d on
pea
k fl
ow r
ate
and
med
icat
ions
(se
e N
OT
ES)
-Ran
dom
ized
to s
elf-
man
age-
men
t (pe
rson
al e
duca
tion
ses-
sion
s, d
aily
mor
ning
pea
k fl
owm
easu
rem
ents
with
med
icat
ion
plan
bas
ed o
n re
sults
) or
trad
i-tio
nal t
reat
men
t (in
fo. o
n in
hale
rus
e, n
o ch
ange
s in
med
icat
ions
on th
eir
own)
-Bas
elin
e an
d 3
follo
w-u
p vi
sits
over
12
mon
ths
-122
initi
ally
enr
olle
d, a
naly
sis
base
d on
115
with
at le
ast 4
mos
fol
low
-up
(56
self
-man
agem
ent,
59tr
aditi
onal
); m
ore
wom
en a
nd lo
wer
mea
n w
eigh
t in
self
-man
agem
ent g
roup
(p=
0.02
) ot
herw
ise
com
pa-
rabl
e at
bas
elin
e-
Out
com
e
Self
-mgm
t
Tra
ditio
nal
p A
dmis
sion
s fo
r 2
patie
nts
3 pa
tient
s a
sthm
aU
nsch
edul
ed
0.5
1.0*
0.04
ou
tpat
ient
vis
its*
Day
s of
f w
ork*
2.8
4.8
0.02
Cou
rses
of
0.4
0.9
0.00
9
antib
iotic
s*C
ours
es o
f 0.
41.
00.
006
pre
dnis
one*
Tot
al (
any
0.6
2.1
<0.
001
inc
iden
t cau
sed
by a
sthm
a)*
*mea
n nu
mbe
rs p
er p
atie
nt-I
ncid
ence
fre
e su
rviv
al (
p<0.
0001
) an
d qu
ality
of
life
(p=0
.009
) fa
vore
d se
lf-m
anag
emen
t gro
up(p
<0.
0001
) th
roug
hout
stu
dy p
erio
d-E
xplo
rato
ry a
naly
ses:
62%
adh
ered
to s
elf-
man
agem
ent i
nstr
uctio
ns f
or b
udes
onid
e do
se; 7
7%to
inst
ruct
ions
to s
tart
ora
l pre
dnis
olon
e; a
dher
ence
was
rel
ated
to s
ever
ity o
f sy
mpt
oms
-Gui
ded
self
-man
agem
ent,
usin
g pa
tient
edu
-ca
tion
and
adju
stm
ent o
f an
ti-in
flam
mat
ory
trea
tmen
t bas
ed o
n pe
ak e
xpir
ator
y m
eas-
urem
ents
, red
uced
by
half
or
mor
e th
e nu
m-
ber
of in
cide
nts
caus
ed b
y as
thm
a w
hen
com
pare
d w
ith tr
aditi
onal
trea
tmen
t and
im-
prov
ed q
ualit
y of
lif
e.
It i
s no
t po
ssib
le t
ode
term
ine
whe
ther
ear
ly tr
eatm
ent o
f in
-fl
amm
atio
n, p
eak
flow
mea
sure
men
t per
se,
patie
nt e
duca
tion,
or
impr
oved
com
plia
nce
ism
ost
impo
rtan
t.
NO
TE
S:
stud
y w
as s
ingl
e-bl
ind;
elig
ible
patie
nts
had
a) m
orni
ng-e
veni
ng p
eak
flow
valu
e th
at v
arie
d by
>15
% in
2 d
ays
with
in1
wk
duri
ng p
ast
6 m
os, b
) op
timal
pea
kfl
ow ≥
250
l/min
, c)
anti-
infl
amm
ator
ytr
eatm
ent w
ith b
udes
onid
e (4
00-1
600µ
g/da
y)or
bec
lom
etha
sone
dip
ropi
onat
e (5
00-2
000
µg/
day)
in p
ast 6
mos
, d)
≥4 w
ks s
ince
last
cour
se o
f or
al c
ortic
oste
roid
s; s
ampl
e si
ze e
s-tim
atio
n of
60
per
grou
p ba
sed
on e
stim
ated
num
ber
of in
cide
nts
per
year
cau
sed
byas
thm
a (1
with
tra
ditio
nal
tx, 0
.47
with
sel
f-m
anag
emen
t); p
atie
nts
with
sev
ere
asth
ma
wer
e ex
clud
ed a
s m
ost a
lrea
dy h
ave
peak
flow
met
ers
Wor
k G
roup
's C
omm
ents
: L
ittle
info
rma-
tion
abou
t co
mor
bidi
ties;
ana
lysi
s w
as n
otin
tent
ion-
to-t
reat
Conclusion Grading Worksheet – Appendix B – Diagnosis and Outpatient Management of Asthma Annotation #9 (Asthma Education) Seventh Edition/March 2005
39
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
• Recommended Resources
I ICSI NSTITUTE FOR C LINICAL S YSTEMS I MPROVEMENT
Support for Implementation:
Diagnosis and Outpatient Management of Asthma
Copyright © 2005 by Institute for Clinical Systems Improvement
Institute for Clinical Systems Improvement
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40
Priority Aims and Suggested Measures
1. Promote the accurate assessment of asthma severity through the use of objective measures of lung func-tion.
Possible measures of accomplishing this aim:
a. Percentage of patients with asthma with spirometry or peak flow documented at the last visit.
b. Percentage of patients with asthma, for whom a peak flow meter is appropriate, who report using a home peak flow meter.
c. Percentage of patients with asthma with any assessment of asthma severity documented at the last visit.
2. Promote long-term control of persistent asthma through the use of inhaled corticosteroid drug therapy.
Possible measure of accomplishing this aim:
a. Percentage of patients with persistent asthma who are on inhaled corticosteroid medication.
3. Promote the partnership of patients with asthma and/or their parents with health care professionals through education and the use of written action plans.
Possible measures of accomplishing this aim:
a. Percentage of patients with asthma with an asthma action plan in the medical record.
b. Percentage of patients with asthma with education about asthma documented in the medical record.
Diagnosis and Outpatient Management of Asthma Seventh Edition/March 2005
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41
Measurement Specifications
Possible Success Measure #1a
Percentage of patients with asthma with spirometry or peak flow meter reading documented in the medical record at the last visit.
Population DefinitionPatients age 5 through 55 years diagnosed with asthma, continuously enrolled for 6 months.
Data of Interest# of patients with asthma with spirometry or peak flow meter reading documented at the last visit
total # of patients ages 5-55 with asthma
Numerator/Denominator DefinitionsNumerator: Documented is defined as any evidence in the medical record that spirometry or peak flow
reading was done at the last visit as recommended in the guideline.
Denominator: Patients with a diagnosis code of 493.00, 493.01, 493.10, 493.11, 493.90, 493.91, continuously enrolled for 6 months.
Method/Source of Data CollectionData may be collected electronically using the claims/encounter database or the enrollment database. Medical groups should identify patients with asthma seen at the clinic. Each medical group can then generate a list of all eligible patients with asthma seen during the target month/quarter. A random sample of 20 charts can be chosen from this list. The eligible patients are those who are 5-55 years old and have been diagnosed with asthma. The patient medical records are reviewed for any evidence that spirometry or peak flow meter reading was done at the last visit as recommended in the guideline.
Time Frame Pertaining to Data CollectionA minimum of 20 charts per month can be reviewed.
NotesIt is important to periodically assess pulmonary function. The main methods are spirometry or PEFR. Spirometry is more precise and yields more information than PEFR. It is helpful to verify the accuracy of the peak flow meter. It is useful when certain physical limitations affect accuracy of PEFR (e.g., very young or elderly, neuromuscular or orthopedic problems). PEFR provides a simple, quantitative and reproductive measure of severity of airflow obstruction. The results are more reliable if the same type and preferably the patient's own meter are used.
Diagnosis and Outpatient Management of Asthma Priority Aims and Suggested Measures Seventh Edition/March 2005
Institute for Clinical Systems Improvement
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42
Diagnosis and Outpatient Management of Asthma Priority Aims and Suggested Measures Seventh Edition/March 2005
Possible Success Measure #2a (children)
Percentage of children with persistent asthma who are on inhaled corticosteroids medication.
Population DefinitionChildren aged 17 and under with persistent asthma, continuously enrolled for 6 months.
Data of Interest# children in denominator who have one or more prescriptions for inhaled corticosteroids medications
# of children with persistent asthma
Numerator/ Denominator DefinitionsNumerator
Among the children in the denominator, the number who have one or more prescriptions for inhaled corti-costeroids medications:
- beclomethasone HFA (Vanceril®, Beclovent®, QVAR®) - flunisolide (Aerobid®)- triamcinolone (Azmacort®) - budesonide (Pulmicort®)- fluticasone (Flovent®, Advair®)
Denominator
Children with persistent asthma with a diagnosis code of 493.00, 493.01, 493.10, 493.11, 493.90, 493.91, continuously enrolled for 6 months.
Method/Source of Data CollectionThis measure may be collected electronically using the pharmacy data base, the claims/encounter data base, or the enrollment data base.
Time Frame of Data CollectionIt is suggested that data are collected quarterly.
NotesSince asthma is a chronic inflammatory disorder of the airways with recurrent exacerbations, therapy for persistent asthma emphasizes efforts to suppress inflammation over the long-term and prevent exacerba-tions.
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43
Diagnosis and Outpatient Management of Asthma Priority Aims and Suggested Measures Seventh Edition/March 2005
Possible Success Measure #2a (adults)
Percentage of adults with persistent asthma who are on inhaled corticosteroids medication.
Population DefinitionAdults age 18 through 39 with persistent asthma, continuously enrolled for 6 months.
Data of Interest# of adults in the denominator who have 1 or more prescriptions
for inhaled corticosteroids medications
# of adults with persistent asthma
Numerator/Denominator DefinitionsNumerator: Persons in the denominator who have 1 or more prescriptions filled for inhaled anti-inflam-
matory medications
Inhaled anti-inflammatory medications are:
- beclomethasone HFA - triamcinolone - fluticasone- flunisolide - budesonide - fluticasone propionatel salmeterol DPI
Denominator: Adults age 18 through 39 with persistent asthma with a diagnosis code of 493.00, 493.01, 493.10, 493.11, 493.90, 493.91, continuously enrolled for 6 months, identified by having received one or more refills of the following medications during the 6 month period:
- beclomethasone HFA - triamcinolone - fluticasone
- flunisolide - budesonide - fluticasone propionatel salmeterol DPI
Method/Source of Data CollectionData may be collected electronically using the pharmacy database, the claims/encounter database or the enrollment database.
Time Frame Pertaining to Data CollectionIt is suggested that data are collected quarterly.
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44
Diagnosis and Outpatient Management of Asthma Priority Aims and Suggested Measures Seventh Edition/March 2005
Possible Success Measure #3b
Percentage of patients with asthma with education about asthma documented in the medical record.
Population DefinitionPatients age 5 through 55 years diagnosed with asthma continuously enrolled for 6 months.
Data of Interest# of patients in the denominator with documentation in the record of education about asthma
total # of patients with asthma whose medical records are reviewed
Numerator/Denominator DefinitionsNumerator: Documented is defined as any evidence in the medical record that a clinician provided patient
(or parent) education related to:
- basic facts about asthma
- role of medications
- skills (in managing asthma)
- environmental control measures
- when and how to take actions
- need for follow-up visits
Denominator: Patients with a diagnosis code of 493.00, 493.01, 493.10, 493.11, 493.90, 493.91, continuously enrolled for 6 months.
Method/Source of Data CollectionData may be collected electronically using the claims/encounter database or the enrollment database. Medical groups should identify patients with asthma seen at the clinic. Each medical group can then generate a list of all eligible patients with asthma seen during the target month/quarter. The eligible patients are those who are 5-55 years old and have been diagnosed with asthma. A random sample of 20 charts can be chosen from this list. The patients' medical records will be reviewed for any evidence that a clinician provided patient education.
Time Frame Pertaining to Data CollectionA minimum of 20 charts per month can be reviewed.
NotesPatient education is essential for successful management of asthma. It should begin at the time of diagnosis and be ongoing.
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45
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. Facilitate timely and accurate diagnosis of asthma and asthma severity.
2. Educate providers in the use of spirometry as a diagnostic tool.
3. Educate providers and patients in the importance of developing and maintaining an asthma action plan and assessing adherence.
Knowledge Products
Resources and knowledge products are developed by the guideline work group, member and non-member organizations, or identified by ICSI staff as useful implementation tools.
1. Scientific Documents
• Related guidelines
- Emergency and Inpatient Management of Asthma
- Chronic Obstructive Pulmonary Disease
- Rhinitis
3. Educational Resources
• Improvement Case Report on Asthma: Family HealthServices Minnesota PA, Process Improvement Report #19
• HealthEast Case Improvement Report on Asthma, Process Improvement Report #4
• Asthma Toolkit – Action Plans; Assessment Surveys; Education (ideas for elementary classrooms); Flow Sheets, Information/Patient Education Modules, Manual for Families of Children with Special Needs; NAEPP Export Panel Report, Shingle; other tools.
ICSI has a wide varity 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.
Many of the materials listed in the Knowledge Products resource are only available to ICSI members.
Diagnosis and Outpatient Management of Asthma Seventh Edition/March 2005
Institute for Clinical Systems Improvement
www.icsi.org
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Recommended Resources
Title/Description Audience Author/Organization Websites/Order InformationA national nonprofit network of families whose desire is to overcome allergies and asthma through knowledge. This web-site provides accurate, timely, practical, and livable alternatives to suffering.
Patients Professionals
Allergy and Asthma Network/Mothers of Asthmatics
http://www.aanma.org
Offers comprehensive information for patients of all ages. In-depth information on medications, exacerbations, peak flow meters and control over environmental allergens. Español material as well.
Patients Professionals
ALA (American Lung Association)
http://www.lungusa.org/ Resources from the American Lung Association (ALA) are available from: American Lung Association of Minnesota, 490 Concordia Avenue, St. Paul, MN 55103. (651)227-8014. For clinics in Hennepin County contact the American Lung Association of Hennepin County, 4220 West Old Shakopee Road, Suite 101, Bloomington, MN 55437. (952)885-0338.http://www.alamn.org
The website offers asthma education resources for patients and providers. The site includes special sections for children and seniors, seasonal educational materials. Health Headlines are posted daily.
Patients Professionals
American Academy of Allergy, Asthma and Immunology (AAAAI)
http://www.aaaai.org/611 East Wells StreetMilwaukee, WI 53202(800) 822-2762
Focus is on improving the quality of life for people with asthma and allergies and their caregivers, through education, advocacy and research. Provides practical information, community-based services, support and referrals through a national network of chapters and educational groups.
Patients Professionals
Asthma and Allergy Foundation of America
http://www.aafa.org
Diagnosis and Outpatient Management of Asthma Seventh Edition/March 2005
Institute for Clinical Systems Improvement
www.icsi.org
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Criteria for Selecting WebsitesThe preceding websites were selected by the Diagnosis and Outpatient Management of Asthma guideline work group as additional resources for practitioners and the public. The following criteria were considered in selecting these sites.
• The site contains information specific to the particular disease or condition addressed in the guideline.
• The site contains information that does not conflict with the guideline's recommendations.
• The information is accurate and/or factual. The author of the material or the sponsor of the site can be contacted by means other than e-mail. For example, a nurse line or other support is provided.
• The material includes the source/author, date and whether the information has been edited in any way. The site clearly states revision dates or the date the information was placed on the internet.
• The site sponsor is an objective group without an obvious or possible bias. For example, the site does not promote a product, service or other provider.
• The coverage of the topic is appropriate for the guideline's target audience. It is clearly written, well-organized and easy to read. The site is easy to navigate.
Title/Description Audience Author/Organization Websites/Order InformationOffers asthma education that incorporates an awareness of indoor environmental asthma triggers (e.g., secondhand smoke, dust mites, mold, pet dander, and cockroaches) and actions that can be taken to reduce children's exposure to them in homes, schools and child care settings.
Patients Professionals
EPA (U.S. Environmental Protection Agency)
http://www.epa.gov/iaq
Offers information for healthcare professionals, schools and patients about asthma. An asthma action plan is also included in English and Spanish.
Patients and Professionals
Minnesota Department of Health
http://www.health.state.mn.us
Provides asthma health education resources for patients, school/day care providers and health professionals. Materials written in Spanish are available.
Patients Professionals
National Heart, Lung, and Blood Institute (NHLBI)
http://www.nhlbi.nih.gov
Brochure. Signs, symptoms, management, MDI use
Patients Mayo Clinic, Asthma
Mayo members call Mary Ann Djonne at (507) 284-8780
Your Child's Asthma Book, 26 pages
Patients Mayo Clinic Mayo members call Mary Ann Djonne at (507) 284-8780
Diagnosis and Outpatient Management of Asthma Recommended Website Resources Seventh Edition/March 2005
Summary of Changes – March 2005
Diagnosis and Management of Asthma
Algorithm, Clinical Highlights, Annotations
Title: Revised the title of this guideline to: Diagnosis and Outpatient Management of Asthma.This clearly differentiates it from the ER and Inpatient Management of AsthmaGuideline.
Added a bullet to Box #9 Asthma Education—how medications work. This was alsoadded to the Clinical Highlight #5 (provide asthma education) and revised as anindependent item in Annotation #9 Asthma Education.
*1: Added Objective measures of lung function (FEV1 PEF, PEF variability) to C—Severityof symptom classification.
Throughout the guideline, added administered by nebulizer or metered dose inhaler(MDI), either is acceptable.
*8: Added a statement and reference regarding Pregnancy in Asthma. Managing Asthmaduring pregnancy is the same treatment used for non-pregnant asthma patients. NAEPPUpdate, 2005. And, in table 8C, added a comment that Budesonide is the preferredinhaled corticosteroid for use in pregnancy.
Also added reference Characterization of within-subject responses to flucticasone andmontelukast in childhood asthma. Szefler, 2005. This recent article also supports thestatement, Inhaled corticosteroids are the preferred treatment option for mild persistentasthma in adults, and LTRA’s are an alternative.
Added a statement recommending annual influenza vaccinations for patients withpersistent asthma
ICSI has developed a new format for all guidelines. Key additions and changes are:• The annotation and discussion section have been combined. Any duplicated
statements have been removed.• Most of the annotations will have “Key Points” at the beginning. This informs the
reader of key recommendations, highlights, or information pertinent to the steps ofthe algorithm.
• References in support of recommendations or conclusions are listed in the body of theannotation. A complete list of references is included in the Supporting Evidencesection.
• Priority Aims only will be listed in the front of the guideline section. Both aims andmeasures are contained in the Support for Implementation section as usual.
Support for Implementation
Added new website from Minnesota Department of Health for asthma action plans
*An asterisk indicates any changes in clinical practice recommendation.