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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

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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:

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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

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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

Institute for Clinical Systems Improvement

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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

Diagnosis and Outpatient Management of Asthma Seventh Edition/March 2005


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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

http://www.icsi.org


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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)

Diagnosis and Outpatient Management of Asthma Algorithm Annotations Seventh Edition/March 2005


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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).




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17

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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18

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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19

Table 8B. (cont)Usual Dosages for Long-Term Medications (continued)


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)


> 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


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


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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24

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/


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


http://www.mnasthma.org/AAP/


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25

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Annotation Appendix A – Asthma Action Plan



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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

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Peak

flow

(80-

100%

of p

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nal b

est)

Sym

ptom

s:•

No

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s of a

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a•

Abl

e to

par

ticip

ate

in u

sual

act

iviti

es•

No

slee

p di

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e by

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as c

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or c

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s

Med

icat

ions

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me

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ion

side

effe

cts:

Inha

ler,

spac

er, n

ebul

izer

or r

otoc

aps

Part

icip

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n in

runn

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pla

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spor

ts; t

ake

befo

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d/or

sym

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gers

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g., c

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of p

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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


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:


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

http://www.ICSI.org


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



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


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)



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


www.icsi.org

32

Conclusion Grading Worksheet – Appendix A – Annotation #8 (Leukotriene Receptor Antagonists [LTRAs])


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)


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


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



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.



www.icsi.org

36

Conclusion Grading Worksheet – Appendix B – Annotation #9 (Asthma Education)


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


www.icsi.org

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


www.icsi.org

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


Support for Implementation:


Copyright © 2005 by Institute for Clinical Systems Improvement


www.icsi.org

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.



www.icsi.org

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


www.icsi.org

42


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.


www.icsi.org

43


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.


www.icsi.org

44


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.


www.icsi.org

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.


http://www.icsi.org/knowledge


www.icsi.org

46

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.


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.


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.


Asthma and Allergy Foundation of America

http://www.aafa.org


http://www.aanma.org

http://www.lungusa.org/

http://www.alamn.org

http://www.aaaai.org/

http://www.aafa.org


www.icsi.org

47

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.


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.


National Heart, Lung, and Blood Institute (NHLBI)

http://www.nhlbi.nih.gov

Brochure. Signs, symptoms, management, MDI use

Patients Mayo Clinic, Asthma

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Diagnosis and Outpatient Management of Asthma Recommended Website Resources Seventh Edition/March 2005

http://www.epa.gov/iaq

http://www.health.state.mn.us

http://www.nhlbi.nih.gov

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.