Michigan Quality Improvement Consortium Guideline General Principles for the Diagnosis and Management of Asthma July 2014 The following guideline recommends general principles and key clinical activities for the diagnosis and management of asthma. Eligible Population Key Components Recommendation and Level of Evidence Detailed medical history and physical exam to determine that symptoms of recurrent episodes of airflow obstruction are present. Use spirometry (FEV1, FEV6, FVC, FEV1/FVC) in all patients ≥ 5 years of age to determine that airway obstruction is at least partially reversible [C]. Wheezing Consider alternative causes of airway obstruction. History of cough Goals of therapy are to achieve control by [A]: (worse particularly at Reducing impairment: chronic symptoms, need for rescue therapy and maintain near-normal lung function and activity level. night), recurrent Reducing risk: exacerbations, need for emergency care or hospitalization, loss of lung function or reduced lung growth in children, or adverse wheeze, recurrent effects of therapy. difficulty in breathing, Assessment and Assess asthma severity to initiate therapy using severity classification chart for impairment [B] and risk [C]. recurrent chest monitoring tightness Assess asthma control to monitor and adjust therapy [B]. (Use asthma control chart, for impairment and risk. Step up if necessary; step down Symptoms occur or if possible.) worsen in the presence Obtain spirometry (FEV1, FEV6, FVC, FEV1/FVC) to confirm control, and at least every 1-2 years [B], more frequently for not well-controlled asthma. of exercise, viral Schedule follow-up care: within 1 week, or sooner, if acute exacerbation; at 2- to 6-week intervals while gaining control [D]; monitor control at infection, inhalant 1- to 6-month intervals, at 3-month interval if a step-down in therapy is anticipated[D]. allergens, irritants, Assess asthma control, medication technique, written asthma action plan, patient adherence and concerns at every visit. changes in weather, Children and adults with the following: Diagnosis and management goals strong emotional Education expression (laughing or crying hard), stress, menstrual cycles Symptoms occur or worsen at night, awakening the patient Control environmental factors and comorbid conditions Medications (See link to national age-specific guidelines1 for treatment recommendations) Referral 1 Develop written action plan in partnership with patient [B]. Update annually, more frequently if needed. Provide self-management education [A]. Teach and reinforce: self-monitoring to assess control and signs of worsening asthma (either symptoms or peak flow monitoring) [B]; using written asthma action plan; taking medication correctly (inhaler technique and use of devices); avoiding environmental and occupational factors that worsen asthma. Tailor education to literacy level of patient; appreciate potential role of patient's cultural beliefs and practices in asthma management [C]. Recommend measures to control exposures to allergens and pollutants or irritants that make asthma worse [A]. Consider allergen immunotherapy for patients with persistent asthma and when there is clear evidence of a relationship between symptoms and exposure to an allergen to which the patient is sensitive [B]. Treat comorbid conditions (e.g., allergic bronchopulmonary aspergillosis [A], gastroesophageal reflux [B], obesity [B], obstructive sleep apnea [D], rhinitis and sinusitis [B], chronic stress or depression [D]). Inactivated influenza vaccine for all patients over 6 months of age [A] unless contraindicated. Intranasal influenza vaccine not for use in persons with asthma. Initial treatment should be based on the severity of asthma, both impairment and risk. Inhaled corticosteroids (ICS) are the most effective long-term control therapy [A]. Optimize ICS use before advancing to other therapies. Re-evaluate in 2 - 6 weeks for control. Modify treatment based on level of control. Consider step down if well-controlled for 3 months. Warning for use of Long-acting beta-agonists (LABA). See Black Box Warning: Do not use LABA as monotherapy. Use only with an asthma controller such as inhaled corticosteroids. Use for the shortest duration possible. Only use if not controlled on medium-dose ICS. Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both. Refer to an asthma specialist for consultation or comanagement if there are difficulties achieving or maintaining control (See national age-specific guidelines1); immunotherapy or omalizumab is considered; additional testing is indicated; or if the patient required 2 bursts of oral corticosteroids in the past year or a hospitalization [D]. NHLBI 2007 EPR3: Guidelines for the Diagnosis and Management of Asthma. Stepwise Approach for Managing Asthma Long Tern, Figures 13 and 16. Levels of Evidence for the most significant recommendations: A = randomized controlled trials; B = controlled trials, no randomization; C = observational studies; D = opinion of expert panel This guideline lists core management steps. It is based on the 2007 National Asthma Education and Prevention Program Expert Panel Report 3, Guidelines for the Diagnosis and Management of Asthma. National Heart, Lung and Blood Institute (www.nhlbi.nih.gov) MQIC.ORG Approved by MQIC Medical Directors July 2008, 2010, 2012, 2014 Adopted and Approved by Priority Health 10/2014 40 FIGURE 11. CLASSIFYING ASTHMA SEVERITY AND INITIATING THERAPY IN CHILDREN Guidelines for the Diagnosis and Management of Asthma Key: FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; ICS, inhaled corticosteroids; ICU, intensive care unit; N/A, not applicable Notes: ■ Level of severity is determined by both impairment and risk. Assess impairment domain by caregiver’s recall of previous 2–4 weeks. Assign severity to the most severe category in which any feature occurs. ■ Frequency and severity of exacerbations may fluctuate over time for patients in any severity category. At present, there are inadequate data to correspond frequencies of exacerbations with different levels of asthma severity. In general, more frequent and severe exacerbations (e.g., requiring urgent, unscheduled care, hospitalization, or ICU admission) indicate greater underlying disease severity. For treatment purposes, patients with ≥2 exacerbations described above may be considered the same as patients who have persistent asthma, even in the absence of impairment levels consistent with persistent asthma. FIGURE 14. CLASSIFYING ASTHMA SEVERITY AND INITIATING TREATMENT IN YOUTHS 12 YEARS OF AGE AND ADULTS Assessing severity and initiating treatment for patients who are not currently taking long-term control medications Key: EIB, exercise-induced bronchospasm, FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; ICU, intensive care unit Notes: The stepwise approach is meant to assist, not replace, the clinical decisionmaking required to meet individual patient needs. • Level of severity is determined by assessment of both impairment and risk. Assess impairment domain by patient’s/caregiver’s recall of previous 2–4 weeks and spirometry. Assign severity to the most severe category in which any feature occurs. • At present, there are inadequate data to correspond frequencies of exacerbations with different levels of asthma severity. In general, more frequent and intense exacerbations (e.g., requiring urgent, unscheduled care, hospitalization, or ICU admission) indicate greater underlying disease severity. For treatment purposes, patients who had ≥2 exacerbations requiring oral systemic corticosteroids in the past year may be considered the same as patients who have persistent asthma, even in the absence of impairment levels consistent with persistent asthma. • Managing Asthma Long Term 43 FIGURE 12. ASSESSING ASTHMA CONTROL AND ADJUSTING THERAPY IN CHILDREN Key: EIB, exercise-induced bronchospasm, FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; ICU, intensive care unit; N/A, not applicable Notes: ■ The level of control is based on the most severe impairment or risk category. Assess impairment domain by patient’s or caregiver’s recall of previous 2–4 weeks. Symptom assessment for longer periods should reflect a global assessment, such as whether the patient’s asthma is better or worse since the last visit. ■ At present, there are inadequate data to correspond frequencies of exacerbations with different levels of asthma control. In general, more frequent and intense exacerbations (e.g., requiring urgent, unscheduled care, hospitalization, or ICU admission) indicate poorer disease control. Managing Asthma Long Term 41 44 FIGURE 15. ASSESSING ASTHMA CONTROL AND ADJUSTING THERAPY IN YOUTHS ≥12 YEARS OF AGE AND ADULTS Guidelines for the Diagnosis and Management of Asthma *ACQ values of 0.76–1.4 are indeterminate regarding well-controlled asthma. Key: EIB, exercise-induced bronchospasm; ICU, intensive care unit Notes: • • • The stepwise approach is meant to assist, not replace, the clinical decisionmaking required to meet individual patient needs. The level of control is based on the most severe impairment or risk category. Assess impairment domain by patient’s recall of previous 2–4 weeks and by spirometry/or peak flow measures. Symptom assessment for longer periods should reflect a global assessment, such as inquiring whether the patient’s asthma is better or worse since the last visit. At present, there are inadequate data to correspond frequencies of exacerbations with different levels of asthma control. In general, more frequent and intense exacerbations (e.g., requiring urgent, unscheduled care, hospitalization, or ICU admission) indicate poorer disease control. For treatment purposes, patients who had ≥2 exacerbations requiring oral systemic corticosteroids in the past year may be considered the same as patients who have not-well-controlled asthma, even in the absence of impairment levels consistent with not-well-controlled asthma. ATAQ = Asthma Therapy Assessment Questionnaire© ACQ = Asthma Control Questionnaire© ACT = Asthma Control Test™ Minimal Important Difference: 1.0 for the ATAQ; 0.5 for the ACQ; not determined for the ACT. Before step up in therapy: — Review adherence to medication, inhaler technique, environmental control, and comorbid conditions. — If an alternative treatment option was used in a step, discontinue and use the preferred treatment for that step. 42 FIGURE 13. STEPWISE APPROACH FOR MANAGING ASTHMA LONG TERM IN CHILDREN, 0–4 YEARS OF AGE AND 5–11 YEARS OF AGE Guidelines for the Diagnosis and Management of Asthma LABA or Montelukast Oral corticosteriods ICS FIGURE 16. STEPWISE APPROACH FOR MANAGING ASTHMA IN YOUTHS ≥12 YEARS OF AGE AND ADULTS Key: Alphabetical order is used when more than one treatment option is listed within either preferred or alternative therapy. ICS, inhaled corticosteroid; LABA, longacting inhaled beta2-agonist; LTRA, leukotriene receptor antagonist; SABA, inhaled short-acting beta2-agonist Notes: • • • • • • Managing Asthma Long Term • The stepwise approach is meant to assist, not replace, the clinical decisionmaking required to meet individual patient needs. If alternative treatment is used and response is inadequate, discontinue it and use the preferred treatment before stepping up. Zileuton is a less desirable alternative due to limited studies as adjunctive therapy and the need to monitor liver function. Theophylline requires monitoring of serum concentration levels. In step 6, before oral corticosteroids are introduced, a trial of high-dose ICS + LABA + either LTRA, theophylline, or zileuton may be considered, although this approach has not been studied in clinical trials. Step 1, 2, and 3 preferred therapies are based on Evidence A; step 3 alternative therapy is based on Evidence A for LTRA, Evidence B for theophylline, and Evidence D for zileuton. Step 4 preferred therapy is based on Evidence B, and alternative therapy is based on Evidence B for LTRA and theophylline and Evidence D zileuton. Step 5 preferred therapy is based on Evidence B. Step 6 preferred therapy is based on (EPR—2 1997) and Evidence B for omalizumab. Immunotherapy for steps 2–4 is based on Evidence B for house-dust mites, animal danders, and pollens; evidence is weak or lacking for molds and cockroaches. Evidence is strongest for immunotherapy with single allergens. The role of allergy in asthma is greater in children than in adults. Clinicians who administer immunotherapy or omalizumab should be prepared and equipped to identify and treat anaphylaxis that may occur. 45