• Education for a partnership in asthma care.
• Control of environmental factors and comorbid conditions that affect asthma.
• Medications.
• Managing asthma long term in children 0-4 years of age and 5-11 years of age.
• Managing asthma long term in youths >12 years of age and adults.
• Managing asthma long term—special situations
• Managing exacerbations of asthma.

Overview of Assessing and Monitoring Asthma Severity, Control, and Responsiveness in Managing Asthma

Key Differences from 1997 and 2002 Expert Panel

• The key elements of assessment and monitoring are refined to include the separate, but related, concepts of severity, control, and responsiveness to treatment. Classifying severity is emphasized for initiating therapy; assessing control is emphasized for monitoring and adjusting therapy. Asthma severity and control are defined in terms of two domains: impairment and risk.
• The distinction between the domains of impairment and risk for assessing asthma severity and control emphasizes the need to consider separately asthma's effects on quality of life and functional capacity on an ongoing basis (i.e., in the present) and the risks it presents for adverse events in the future, such as exacerbations and progressive loss of pulmonary function. These domains of asthma may respond differentially to treatment.

Key Points

• The functions of assessment and monitoring are closely linked to the concepts of severity, control, and responsiveness to treatment:
  • Severity: the intrinsic intensity of the disease process. Severity is measured most easily and directly in a patient not receiving long-term-control therapy.
  • Control: the degree to which the manifestations of asthma (symptoms, functional impairments, and risks of untoward events) are minimized and the goals of therapy are met.
  • Responsiveness: the ease with which asthma control is achieved by therapy.
• Both severity and control include the domains of current impairment and future risk:
  • Impairment: frequency and intensity of symptoms and functional limitations the patient is experiencing or has recently experienced
  • Risk: the likelihood of either asthma exacerbations, progressive decline in lung function (or, for children, reduced lung growth), or risk of adverse effects from medication
• The concepts of severity and control are used as follows for managing asthma:
  • During a patient's initial presentation, if the patient is not currently taking long-term control medication, asthma severity is assessed to guide clinical decisions on the appropriate medication and other therapeutic interventions.
  • Once therapy is initiated, the emphasis thereafter for clinical management is changed to the assessment of asthma control. The level of asthma control will guide decisions either to maintain or adjust therapy.
  • For population-based evaluations, clinical research, or subsequent characterization of the patient's overall severity, asthma severity can be inferred after optimal therapy is established by correlating levels of severity with the lowest level of treatment required to maintain control. For clinical management, however, the emphasis is on assessing asthma severity for initiating therapy and assessing control for monitoring and adjusting therapy.

Diagnosis of Asthma

Key Differences from 1997 and 2002 Expert Panel

• Discussions have been added on the use of spirometry, especially in children, and on the criteria for reversibility.
• Information has been added on vocal cord dysfunction (VCD) and cough variant asthma as an alternative diagnosis. Reference has been added to updated information in another component on comorbid conditions that may complicate diagnosis and treatment of asthma (e.g., allergic bronchopulmonary aspergillosis (ABPA), obstructive sleep apnea (OSA), and gastroesophageal reflux disease [GERD]).

Recommendations

The Expert Panel recommends that the clinician trying to establish a diagnosis of asthma should determine that (EPR—2 1997):

• Episodic symptoms of airflow obstruction are present.
• Airflow obstruction is at least partially reversible.
• Alternative diagnoses are excluded.

Medical History

The Expert Panel recommends that a detailed medical history of the new patient who is thought to have asthma should address the items listed in the table below. (EPR—2 1997)

*Eczema, hay fever, or a family history of asthma or atopic diseases are often associated with asthma, but they are not key indicators.

Pulmonary Function Testing (Spirometry)

The Expert Panel recommends that spirometry measurements—forced expiratory volume in 1 second (FEV₁), forced expiratory volume in 6 seconds (FEV₆), forced vital capacity (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, including children >5 years of age (EPR—2 1997).

The Expert Panel recommends that office-based physicians who care for asthma patients should have access to spirometry, which is useful in both diagnosis and periodic monitoring. Spirometry should be performed using equipment and techniques that meet standards developed by the American Thoracic Society (ATS) (EPR—2 1997).

The Expert Panel recommends that when office spirometry shows severe abnormalities, or if questions arise regarding test accuracy or interpretation, further assessment should be performed in a specialized pulmonary function laboratory. (EPR—2 1997).

Differential Diagnosis of Asthma

The Expert Panel recommends consideration of alternative diagnoses, as appropriate. Box 3-3 in the original guideline document lists examples of possible alternative diagnoses for asthma that may be considered during the evaluation of medical history, physical examination, and pulmonary function. Additional studies are not routinely necessary but may be useful when considering alternative diagnoses (EPR—2 1997):

• Additional pulmonary function studies
• Bronchoprovocation
• Chest x ray
• Allergy testing
• Biomarkers of inflammation

Initial Assessment: Characterization of Asthma and Classification of Asthma Severity

Key Differences from 1997 and 2002 Expert Panel

• The severity classification for asthma changed the category of mild intermittent to intermittent in order to emphasize that even patients who have intermittent asthma can have severe exacerbations. A note of emphasis has also been added that acute exacerbations can be mild, moderate, or severe in any category of persistent asthma.
• Severity classification is defined in terms of two domains—impairment and risk—to emphasize the need to consider separately asthma's effects on quality of life and functional capacity on an ongoing basis (i.e., in the present) and the risks asthma presents for adverse events in the future, such as exacerbations and progressive loss of pulmonary function. These domains of asthma may respond differentially to treatment.
• A new emphasis on using FEV₁/FVC has been added for to classifying severity in children because it may be a more sensitive measure than FEV₁.

Recommendations

The Expert Panel recommends that clinicians use information obtained from the diagnostic evaluation, and any additional information, if necessary, to (EPR—2 1997):

• Identify precipitating factors
• Identify comorbid conditions that may aggravate asthma
• Assess the patient's knowledge and skills for self-management
• Classify asthma severity

Classify Asthma Severity

The Expert Panel recommends that clinicians classify asthma severity by using the domains of current impairment and future risk (Evidence B— secondary analyses of clinical trials, and Evidence C—observational studies, for assessing impairment; Evidence C, for distinguishing intermittent versus persistent asthma by risk of exacerbations; Evidence D, for distinguishing different categories of persistent asthma by varying frequencies of exacerbations).

Periodic Assessment and Monitoring of Asthma Control Essential for Asthma Management

Key Differences from 1997 and 2002 Expert Panel

• Periodic assessment of asthma control is emphasized.
• This update (EPR—3: Full Report 2007) makes a stronger distinction than previous guidelines between classifying asthma severity and assessing asthma control. Interpretation of previous asthma guidelines raised questions about applying the severity classifications once treatment is established and also resulted in placing more emphasis on severity than on ongoing monitoring of whether therapeutic goals were met. This update (EPR—3: Full Report 2007) clarifies the issue:
  • For initiating treatment, asthma severity should be classified, and the initial treatment should correspond to the appropriate severity category.
  • Once treatment is established, the emphasis is on assessing asthma control to determine if the goals for therapy have been met and if adjustments in therapy (step up or step down) would be appropriate.
• Assessment of asthma control includes the two domains of impairment and risk.
• Peak flow monitoring: The recommendation to assess diurnal variation was deleted. New text was added regarding the patients most likely to benefit from routine peak flow monitoring. Emphasis was added that evidence suggests equal benefits to either peak flow or symptom-based monitoring; the important issue continues to be having a monitoring plan in place.
• Parameters for lung function, specifically FEV₁/FVC, were added as measures of asthma control for children.
• Minimally invasive markers and pharmacogenetic approaches for monitoring asthma. New text was added. These approaches have gained increasing attention in clinical research, and some applications may be useful in the near future for the clinical management of asthma. The concepts are introduced here, although most require further evaluation before they can be recommended as tools for routine asthma management.

Recommendations

Goals of Therapy: Asthma Control

The Expert Panel recommends that asthma control be defined as follows (Evidence A):

Asthma Control

• Reduce impairment
  • Prevent chronic and troublesome symptoms (e.g., coughing or breathlessness in the daytime, in the night, or after exertion)
  • Require infrequent use (<2 days a week) of short-acting beta₂-agonists (SABA) for quick relief of symptoms
  • Maintain (near) "normal" pulmonary function
  • Maintain normal activity levels (including exercise and other physical activity and attendance at work or school)
  • Meet patients' and families' expectations of and satisfaction with asthma care
• Reduce risk
  • Prevent recurrent exacerbations of asthma and minimize the need for emergency department (ED) visits or hospitalizations
  • Prevent progressive loss of lung function; for children, prevent reduced lung growth
  • Provide optimal pharmacotherapy with minimal or no adverse effects

See figures 3–5a, b, and c in the original guideline document for classification of asthma control in three different age groups. Specific discussion of measures for assessment can also be found in the original guideline document.

Measures for Periodic Assessment and Monitoring of Asthma Control

The Expert Panel recommends that ongoing monitoring of asthma control be performed to determine whether all the goals of therapy are met—that is, reducing both impairment and risk (Evidence B); see figures 3–5 a, b, and c in the original guideline document for assessing asthma control for different age groups.

The Expert Panel recommends that the frequency of visits to a clinician for review of asthma control is a matter of clinical judgment; in general, patients who have intermittent or mild persistent asthma that has been under control for at least 3 months should be seen by a clinician about every 6 months, and patients who have uncontrolled and/or severe persistent asthma and those who need additional supervision to help them follow their treatment plan need to be seen more often (EPR—2 1997).

Monitoring Signs and Symptoms of Asthma

The Expert Panel recommends that every patient who has asthma should be taught to recognize symptom patterns that indicate inadequate asthma control (Evidence A) (See also the NGC summary of the NAEPP guideline Education for a Partnership in Asthma Care).

The Expert Panel recommends that symptoms and clinical signs of asthma should be assessed at each health care visit through physical examination and appropriate questions (EPR—2 1997).

The Expert Panel recommends that the detailed symptoms history should be based on a short (2 to 4 weeks) recall period (EPR—2 1997).

The Expert Panel recommends that assessment of the patient's symptom history should include at least four key symptom expressions (Evidence B, extrapolation from clinical trials; and Evidence C, from observational studies):

• Daytime asthma symptoms (including wheezing, cough, chest tightness, or shortness of breath)
• Nocturnal awakening as a result of asthma symptoms
• Frequency of use of SABA for relief of symptoms
• Inability or difficulty performing normal activities (including exercise) because of asthma symptoms

Monitoring Pulmonary Function

The Expert Panel recommends that, in addition to assessing symptoms, it is also important to assess pulmonary function periodically (Evidence B, extrapolation from clinical trials; and Evidence C, from observational studies).

Spirometry

The Expert Panel recommends the following frequencies for spirometry measurements: (1) at the time of initial assessment (Evidence C); (2) after treatment is initiated and symptoms and peak expiratory flow (PEF) have stabilized, to document attainment of (near) "normal" airway function; (3) during a period of progressive or prolonged loss of asthma control; and (4) at least every 1 to 2 years to assess the maintenance of airway function (Evidence B, extrapolation from clinical trials). Spirometry may be indicated more often than every 1 to 2 years, depending on the clinical severity and response to management (Evidence D). These spirometry measures should be followed over the patient's lifetime to detect potential for decline and rate of decline of pulmonary function over time (Evidence C).

Peak Flow Monitoring

The Expert Panel recommends the following:

• If peak flow monitoring is performed, the written asthma action plan should use the patient's personal best peak flow as the reference value (EPR—Update 2002).
• Consider long-term daily peak flow monitoring for:
  • Patients who have moderate or severe persistent asthma (Evidence B).
  • Patients who have a history of severe exacerbations (Evidence B).
  • Patients who poorly perceive airflow obstruction and worsening asthma (Evidence D).
  • Patients who prefer this monitoring method (Evidence D).
• Long-term daily peak flow monitoring can be helpful to (EPR—Update 2002):
  • Detect early changes in disease states that require treatment.
  • Evaluate responses to changes in therapy.
  • Afford a quantitative measure of impairment.
• Peak flow monitoring during exacerbations will help determine the severity of the exacerbations and guide therapeutic decisions in the home, school, clinicians' office, or ED (See the NGC summaries of the NAEPP guidelines Education for a Partnership in Asthma Care and Managing Exacerbations of Asthma).
• Consider home peak flow monitoring during exacerbations of asthma for:
  • Patients who have a history of severe exacerbations (Evidence B).
  • Patients who have moderate or severe persistent asthma (Evidence B).
  • Patients who have difficulty perceiving signs of worsening asthma (Evidence D).

Peak Flow Versus Symptom-Based Monitoring Action Plan

The Expert Panel recommends the following:

• Either peak flow monitoring or symptom monitoring, if taught and followed correctly, may be equally effective (Evidence B).
• Whether peak flow monitoring, symptom monitoring, or a combination of approaches is used, self-monitoring is important to the effective self-management of asthma (Evidence A).
• Provide to all patients a written asthma action plan that includes daily treatment and recognizing and handing worsening asthma, including self-adjustment of medications in response to acute symptoms or changes in PEF measures. Written action plans are particularly recommended for patients who have moderate or severe persistent asthma, a history of severe exacerbations, or poorly controlled asthma (Evidence B).

Monitoring Quality of Life

The Expert Panel recommends that several key areas of quality of life and related loss of physical function should be assessed periodically for each person who has asthma (Evidence C). These include:

• Any work or school missed because of asthma
• Any reduction in usual activities (either home/work/school or recreation/exercise)
• Any disturbances in sleep due to asthma
• Any change in caregivers' activities due to a child's asthma (for caregivers of children who have asthma)

See figure 3-7 in the original guideline document for sample questions that characterize quality-of-life concerns for persons who have asthma.

Monitoring History of Asthma Exacerbations

The Expert Panel recommends that, during periodic assessments, clinicians should question the patient and evaluate any records of patient self-monitoring (See figure 3-7 in the original guideline document) to detect exacerbations, both those that are self-treated and those treated by other health care providers (Evidence C).

Monitoring Pharmacotherapy for Adherence and Potential Side Effects

The Expert Panel recommends monitoring the following factors at each visit: patient's adherence to the regimen, inhaler technique, and side effects of medications (Evidence C). (See sample questions in figure 3-7 in the original guideline document for assessing the patient's adherence to, concerns about, or adverse experiences with the drug regimen. See the NGC summary of the NAEPP guideline Education for a Partnership in Asthma Care for further discussion of patient's adherence to treatment.)

Monitoring Patient–Provider Communication and Patient Satisfaction

The Expert Panel recommends that health care providers should routinely assess the effectiveness of patient–clinician communication (Evidence D). (See figure 3-7 in the original guideline document for sample questions.)

The Expert Panel recommends that two aspects of patient satisfaction should be monitored: satisfaction with asthma control and satisfaction with the quality of care (Evidence D). See figure 3-2, 3-7, and 3-8 for examples of questions to use in monitoring patient satisfaction.

Monitoring Asthma Control With Minimally Invasive Markers and Pharmacogenetics

The Expert Panel recommends some minimally invasive markers for monitoring asthma control—such as spirometry and airway hyperresponsiveness—that are appropriately used, currently and widely, in asthma care (Evidence B). Other markers, such as sputum eosinophils and fractional exhaled nitric oxide (FeNO), are increasingly used in clinical research and will require further evaluation in adults and children before they can be recommended as a clinical tool for routine asthma management (Evidence D).

Methods for Periodic Assessment and Monitoring of Asthma Control

Clinician Assessment

The Expert Panel recommends that patients who have intermittent or mild or moderate persistent asthma (i.e., requiring steps 1, 2, 3, or 4 treatment) that has been under control for at least 3 months should be seen by a clinician about every 6 months. Patients who have uncontrolled and/or severe persistent asthma (i.e., requiring steps 5 or 6 treatment) and those who need additional supervision to help them follow their treatment plan should be seen more often (EPR—2 1997).

Patient Self-Assessment

The Expert Panel recommends that clinicians should encourage patients to use self assessment tools to determine from the perspective of the patient and/or the patient's family whether the asthma is well controlled (EPR—2 1997).

Referral to an Asthma Specialist for Consultation or Co-management

The Expert Panel recommends referral for consultation or care to a specialist in asthma care (usually, a fellowship-trained allergist or pulmonologist; occasionally, other physicians who have expertise in asthma management, developed through additional training and experience) when (Evidence D):

• Patient has had a life-threatening asthma exacerbation.
• Patient is not meeting the goals of asthma therapy after 3 to 6 months of treatment. An earlier referral or consultation is appropriate if the physician concludes that the patient is unresponsive to therapy.
• Signs and symptoms are atypical, or there are problems in differential diagnosis.
• Other conditions complicate asthma or its diagnosis (e.g., sinusitis, nasal polyps, aspergillosis, severe rhinitis, vocal cord dysfunction [VCD], gastroesophageal reflux disease [GERD], chronic obstructive pulmonary disease [COPD])
• Additional diagnostic testing is indicated (e.g., allergy skin testing, rhinoscopy, complete pulmonary function studies, provocative challenge, bronchoscopy).
• Patient requires additional education and guidance on complications of therapy, problems with adherence, or allergen avoidance.
• Patient is being considered for immunotherapy.
• Patient requires step 4 care or higher (step 3 for children 0 to 4 years of age). Consider referral if patient requires step 3 care (step 2 for children 0 to 4 years of age).
• Patient has required more than two bursts of oral corticosteroids in 1 year or has an exacerbation requiring hospitalization.
• Patient requires confirmation of a history that suggests that an occupational or environmental inhalant or ingested substance is provoking or contributing to asthma. Depending on the complexities of diagnosis, treatment, or the intervention required in the work environment, it may be appropriate in some cases for the specialist to manage the patient over a period of time or to comanage with the primary care provider (PCP).

Definitions:

Levels of Evidence

The system* used to describe the level of evidence is as follows:

Evidence Category A: Randomized controlled trials (RCTs), rich body of data.
Evidence is from end points of well-designed RCTs that provide a consistent pattern of findings in the population for which the recommendation is made. Category A requires substantial numbers of studies involving substantial numbers of participants.

Evidence Category B: RCTs, limited body of data.
Evidence is from end points of intervention studies that include only a limited number of patients, post hoc or subgroup analysis of RCTs, or meta-analysis of RCTs. In general, category B pertains when few randomized trials exist; they are small in size, they were undertaken in a population that differs from the target population of the recommendation, or the results are somewhat inconsistent.

Evidence Category C: Nonrandomized trials and observational studies.
Evidence is from outcomes of uncontrolled or nonrandomized trials or from observational studies.

Evidence Category D: Panel consensus judgment.
This category is used only in cases where the provision of some guidance was deemed valuable, but the clinical literature addressing the subject was insufficient to justify placement in one of the other categories. The Panel consensus is based on clinical experience or knowledge that does not meet the criteria for categories A through C.

*Source: Jadad AR, Moher M, Browman GP, Booker L, Sigouin C, Fuentes M, Stevens R. Systematic reviews and meta-analyses on treatment of asthma: critical evaluation. BMJ 2000;320(7234):537-40.

Strength of Recommendations

In addition to specifying the level of evidence supporting a recommendation, the Expert Panel agreed to indicate the strength of the recommendation. When a certain clinical practice "is recommended," this indicates a strong recommendation by the panel. When a certain clinical practice "should, or may, be considered," this indicates that the recommendation is less strong.

This distinction is an effort to address nuances of using evidence ranking systems. For example, a recommendation for which clinical RCT data are not available (e.g., conducting a medical history for symptoms suggestive of asthma) may still be strongly supported by the Panel. Furthermore, the range of evidence that qualifies a definition of "B" or "C" is wide, and the Expert Panel considered this range and the potential implications of a recommendation as they decided how strongly the recommendation should be presented.

Electronic copies: Available from the National Heart, Lung, and Blood Institute Web site.

Print copies: Available from NHLBI Information Center, P.O. Box 30105, Bethesda, MD 20824-0105; e-mail: nhlbiic@dgsys.com.

• Guidelines for the diagnosis and management of asthma. Summary report 2007. Bethesda (MD): National Heart, Lung, and Blood Institute; 2007. Available from the National Heart, Lung, and Blood Institute Web site.
• Overall methods used to develop this report. Electronic copies: Available from the National Heart, Lung, and Blood Institute Web site.
• Search strategies. Electronic copies: Available from the National Heart, Lung, and Blood Institute Web site.
• Evidence tables. Electronic copies: Available from the National Heart, Lung, and Blood Institute Web site.
• Lung diseases information. Information for health professionals. Electronic copies: Available from the National Heart, Lung, and Blood Institute Web site.

Print copies: Available from NHLBI Information Center, P.O. Box 30105, Bethesda, MD 20824-0105; e-mail: nhlbiic@dgsys.com.

Additional tools, including sample assessment questions, validated instruments for assessment and monitoring of asthma, and a sample patient self-assessment sheet can be found in the original guideline document.

Electronic copies: Available from the National Heart, Lung and Blood Institute Web site.

Print copies: Available from NHLBI Information Center, P.O. Box 30105, Bethesda, MD 20824-0105; e-mail: nhlbiic@dgsys.com.

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