# Presentation: 756943

## A program of the

- Center for Managing
- Chronic Disease,
- University of Michigan.

## Primary Care and Asthma	

- Most common chronic disease of childhood
- Primary care providers are expected to manage most cases of asthma
- There are disincentives to frequent referral to specialists

**Notes:**

 4.8 million children in the U.S. have asthma
Most cases of asthma -- perhaps 80% -- can be successfully managed by the
   generalist in the office

Primary care pediatricians are under pressure to limit referrals and
    emergency care visits

Better management of asthma in the office can reduce referrals to specialists
   and trips to the emergency department

## Modern Paradox

- Understanding of the pathogenesis and treatment of asthma has increased
- Understanding the steps to control asthma has increased
- However, morbidity and mortality from asthma around the world is at an alarmingly high level

**Notes:**
As we have developed more effective treatments for asthma, we have not seen  a  corresponding  decrease  in  morbidity and mortality

References:
Surveillance for Asthma--United States, 1960-1995 (CDC Surveillance Summaries). MMWR. 1998;47:1022-1025. 
Surveillance for Asthma--United States, 1960-1995 (CDC Surveillance Summaries). MMWR. 1998;47(SS-1):1-26. 

## Some Possible Explanations

- Patients and families are not recognizing the symptoms of asthma
- Clinicians are not making the diagnosis
- Clinicians are either not providing state of the art care, or, if they are, patients are not adhering to the recommended programs

**Notes:**
  Many factors contribute to the under diagnosis and under treatment of asthma

  Education of both providers and patients is the key to improving asthma care

## Barriers To Achieving Optimal Care

- Patients treat asthma as an acute episodic illness rather than a chronic disease
- Physicians assume that patients will put aside their own beliefs, concerns, and goals to follow the treatment plan.

**Notes:**
Patient need better understanding of the role of inflammation in asthma-- 
that is -- it’s there even without symptoms

Physicians might assume that the patient’s goals and concerns are the same as the clinician’s goals

## Key Points

- 1. The key elements of assessment and monitoring are severity, control, and responsiveness to treatment.
- 2. Appropriate asthma management requires the proper use of long term control *and* quick relief  medications.
- 3. Because asthma symptoms are variable, families need to recognize symptoms and adjust medications at home according to the clinician’s assessment of control and his/her written action plan for the patient.

**Notes:**
 There are five main points we will emphasize over the next 2 sessions. 

## Key Points

- 4. Good communication between patient and clinician helps identify patient concerns, makes patient teaching more effective and promotes patient self-confidence to follow the treatment plan
- 5. Patient education can be efficiently and effectively accomplished in several standard primary care visits

**Notes:**
Studies show that good clinician communication and patient teaching does ot take more time.  In fact good clinician educators take less time in a patient visit because their communications are more focused and efficient.

References:
N. Clark et al., Pediatrics Vol. 101, No. 5, pp.831-836, May 1998

## Guidelines

## A Lot Going On Beneath The Surface

**Notes:**
	With asthma, what we see is the tip of the iceberg, the symptoms. 
	At the base of the iceberg is the airway inflammation. 
	This inflammation underlies the bronchial hyperresponsiveness of asthma, the air flow obstruction, and the culmination of the inflammatory process is the tip of the iceberg, the symptoms.
	*Active inflammation of the airways can be present for 6 to 8 weeks following a sever respiratory infection.
	*Airflow obstruction results from bronchoconstriction, bronchial edema, mucus hypersecretion, and inflammatory cell recruitment including eosinophils, a key inflammatory cell.

## Benchmarks of good asthma control

- No coughing or wheezing
- No shortness of breath or rapid breathing
- No waking up at night
- Normal physical activities
- No school absences due to asthma
- No missed time from work for parent or caregiver

**Notes:**
 Parents and physicians sometimes allow asthma to limit activity or expectations

This slide lists benchmarks of good asthma control

Which leads us to key point #1.  I will now turn the presentation over to
_________________.

## 

TREATMENT OF ASTHMA

- TREATMENT OF ASTHMA

##  Key Point #1

- The key elements of assessment and monitoring are severity, control, and responsiveness to treatment.

## CLASSIFYING ASTHMA SEVERITY AND INITIATING TREATMENT IN CHILDREN 0-4 YEARS OF AGE  Assessing severity and initiating therapy in children who are not currently taking long-term control medication

| 
Components of Severity
 |  | Classification of Asthma Severity (0-4 years of age) |  |  |  |
| --- | --- | --- | --- | --- | --- |
|  |  | 
Intermittent | Persistent |  |  |
|  |  |  | Mild | Moderate | Severe |
| 

Impairment

 | 
Symptoms | 
≤ 2 days/week | >2 days/week 
but not daily | 
Daily | 
Throughout the day   |
|  | Nighttime awakenings | 0 | 1-2x/month | 3-4x/month | >1x/week |
|  | Short-acting beta2-agonist use for symptom control (not prevention of EIB) | ≤ 2 days/week
 | >2 days/week 
but not daily | Daily | Several times per day |
|  | Interference with normal activity | None | Minor limitation | Some limitation | Extremely limited |
| 

Risk
 | 
Exacerbations requiring oral systemic corticosteroids | 0-1/year  | ≥ 2 exacerbations in 6 months requiring oral systemic corticosteroids, or ≥ 4 wheezing episodes/1 year lasting >1 day AND risk factors for persistent asthma |  |  |
|  |  | Consider severity and interval since last exacerbation.
Frequency and severity may fluctuate over time.  
Exacerbations of any severity may occur in patients in any severity category.  |  |  |  |
|  
Recommended Step for Initiating Treatment |  | Step 1 | Step 2 | Step 3   and consider short course of oral systemic corticosteroids |  |
|  |  | In 2-6 weeks, depending on severity, evaluate level of asthma control that is achieved. If no clear benefit is observed in 4-6 weeks, consider adjusting therapy or alternative diagnosis. |  |  |  |

- CLASSIFYING ASTHMA SEVERITY AND INITIATING TREATMENT IN CHILDREN 0-4 YEARS OF AGE  Assessing severity and initiating therapy in children who are not currently taking long-term control medication

- Key: EIB, exercise-induced bronchospasm

**Notes:**
The stepwise approach is meant to assist, not replace the clinical decision making 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.  System 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.  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. For treatment purposes, patients who had ≥2 exacerbations requiring oral systemic corticosteroids in the past 6 months, or ≥4 wheezing episodes in the past year, and who have risk factors for persistent asthma may be considered the same as patients who have persistent asthma, even in the absence of impairment levels consistent with persistent asthma.

The text below is a narration of the table for the visually impaired using an electronic reading device:

Title of table is classification of Asthma severity and initiating treatment in children 0—4 years of age:  Assessing severity and initiating therapy in children who are not currently taking long term control medication.
The components of severity are impairment and risk.  Impairment is subdivided into symptoms, nighttime awakenings, short-acting beta two agonist use for symptom control not including the prevention of exercise induced bronchospasm, and interference with normal activity.  Risk involves the number of exacerbations requiring oral systemic corticosteroids.
For a severity classification of "Intermittent," asthma symptoms are less than or equal to 2 days per week.  
Nighttime awakenings are 0.  
Use of short-acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is less than or equal to 2 days per week.
No interference with normal activity.
Risk is classified as intermittent if exacerbations requiring oral systemic corticosteroids occur 0 to 1 per year.
Recommended step for initiating treatment is Step 1.
For a severity classification of "Persistent mild," asthma symptoms are greater than 2 days per week, but not daily.
Nighttime awakenings are 1 to 2 times per month.
Use of short-acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is greater than  2 days per week, but not daily.
Minor limitation with normal activity.
Risk is classified as persistent mild if exacerbations requiring oral systemic corticosteroids occur greater than or equal to 2 exacerbations in 6 months requiring oral systemic corticosteroids, or more than or equal to 4 wheezing episodes in l year lasting more than 1 day and risk factors for persistent asthma.
Recommended step for initiating treatment is Step 2.
For a severity classification of "Persistent Moderate," asthma symptoms are daily
Nighttime awakenings are 3 to four times per month.
Use of short-acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is daily.
Some limitation with normal activity.
Risk is classified as persistent moderate if exacerbations requiring oral systemic corticosteroids occur greater than or equal to 2 exacerbations in 6 months requiring oral systemic corticosteroids, or more than or equal to 4 wheezing episodes in l year lasting more than 1 day and risk factors for persistent asthma
Recommended step for initiating treatment is Step 3 and consider short course of oral systemic corticosteroids.
For a severity classification of "persistent severe," asthma symptoms are throughout the day.
Nighttime awakenings are more than 1 time per week.
Use of short-acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is several times per day.
Extreme limits with normal activity.
Risk is classified as persistent severe if exacerbations requiring oral systemic corticosteroids occur greater than or equal to 2 exacerbations in 6 months requiring oral systemic corticosteroids, or more than or equal to 4 wheezing episodes in l year lasting more than 1 day and risk factors for persistent asthma.
Recommended step for initiating treatment is Step 3 and consider short course of oral systemic corticosteroids.
For all classifications:  in determining risk ,consider severity and interval since last exacerbation.
Frequency and severity may fluctuate over time.
Exacerbations of any severity may occur in patients in any severity category.
For all classifications of severity, in 2-6 weeks, depending on severity, evaluate level of asthma control that is achieved.  If no clear benefit is observed is 4-6 weeks, consider adjusting therapy or alternative diagnosis.

## ASSESSING ASTHMA CONTROL AND ADJUSTING THERAPYIN CHILDREN 0-4 YEARS OF AGE

| 

Components of Control |  | Classification of Asthma Control (0-4 years) |  |  |
| --- | --- | --- | --- | --- |
|  |  | Well Controlled | Not Well Controlled | Very Poorly Controlled |
| 

Impairment | Symptoms | ≤ 2 days/week | >2 days/week | Throughout the day |
|  | Nighttime awakenings | ≤ 1x/month | >1x/month | >1x/week |
|  | Interference with normal activity | None | Some limitation | Extremely limited |
|  | Short-acting beta2-agonist use for symptom control (not prevention of EIB) | ≤ 2 days/week | >2 days/week | Several times per day |
| 

Risk | Exacerbations requiring oral systemic corticosteroids | 0-1/year | 2-3/year | >3/year |
|  | Treatment-related adverse effects | Medication side effects can vary in intensity from none to very troublesome and worrisome. The level of intensity does not correlate to specific levels of control but should be considered in the overall assessment of risk. |  |  |
| 

Recommended Action for Treatment
 |  | Maintain current treatment
Regular follow up every 1-6 months
Consider step down if well controlled for at least 3 months | Step up (1 step) and
Reevaluate in 2-6 weeks
If no clear benefit in 4-6 weeks, consider alternative diagnoses or adjusting therapy
For side effects, consider alternative treatment options | Consider short course of oral systemic corticosteroids
Step up (1-2 steps), and 
Reevaluate in 2 weeks
If no clear benefit in 4-6 weeks, consider alternative diagnoses or adjusting therapy
For side effects, consider alternative treatment options |

- ASSESSING ASTHMA CONTROL AND ADJUSTING THERAPYIN CHILDREN 0-4 YEARS OF AGE

**Key:**  EIB, exercise-induced bronchospasm

**Notes:**
The stepwise approach is meant to assist, not replace, the clinical decision making required to meet individual patient needs.

The level of control is based on the most severe impairment or risk category.  Assess impairment domain by caregiver’s recall of previous 2-4 weeks. 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.

Before step up in therapy:
Review adherence to medications, inhaler technique, and environmental control
If alternative treatment option was used in a step, discontinue it and use preferred treatment for that step.

The text below is a narration of the table for the visually impaired using an electronic reading device:

Title of table is assessing asthma control and adjusting therapy in children 0-4 years of age
The components of severity are impairment and risk.  Impairment is subdivided into symptoms, nighttime awakenings, interference with normal activity, and short-acting beta two agonist use for symptom control not including the prevention of exercise induced bronchospasm..  Risk involves the number of exacerbations requiring oral systemic corticosteroids and treatment-related adverse effects.
For a classification of "Well Controlled," symptoms are less than or equal to 2 days per week.
Nighttime awakenings are less than or equal to 1 time per month.
No interference with normal activity.
Short acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is less than or equal to 2 days per week.
Risk is classified as well controlled if exacerbations requiring oral systemic corticosteroids occur  0-1 times per year.
In regards to treatment related adverse effects, medication side effects can vary in intensity from none to very troublesome and worrisome. The level of intensity does not correlate to specific levels of control but should be considered in the overall assessment of risk.
The recommended action for treatment is maintain current treatment, regular follow up every 1 to 6 months, consider step down if well controlled for at least 3 months.
For a classification of "Not Well Controlled, " symptoms are greater than or equal to 2 days per week.
Nighttime awakenings are greater than one time per month.
Some limitation with normal activity.
Short acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is greater than two days per week.
Risk is classified as not well controlled if exacerbations requiring oral systemic corticosteroids occurs 2 to 3 time per year.
In regards to treatment related adverse effects, medication side effects can vary in intensity from none to very troublesome and worrisome. The level of intensity does not correlate to specific levels of control but should be considered in the overall assessment of risk.
Recommended action for treatment is to step up one step and reevaluate in 2 to 6 weeks.  If no clear benefit in 4 to 6 weeks, consider alternative diagnoses or adjusting therapy.  For side effects, consider alternative treatment options.
For a classification of asthma control "Very Poorly Controlled," symptoms are throughout the day.
Nighttime awakenings are greater than one time per week.
Extreme limitation with normal activity.
Short acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is several times per day.
Risk is classified as very poorly controlled if exacerbations requiring oral systemic corticosteroids occur more than  3 times per year.
Treatment related adverse effects, medication side effects can vary in intensity from none to very troublesome and worrisome. The level of intensity does not correlate to specific levels of control but should be considered in the overall assessment of risk.
Recommended action for treatment is to consider short course of oral systemic corticosteroids.
Step up 1 to 2 steps, and reevaluate in 2 weeks.
If no clear benefit in 4 to 6 weeks, consider alternative diagnoses or adjusting therapy
For side effects, consider alternative treatment options. 

## CLASSIFYING ASTHMA SEVERITY AND INITIATING TREATMENTIN CHILDREN 5-11 YEARS OF AGEAssessing severity and initiating therapy in children who are not currently taking long-term control medication  

| 
Components of Severity
 |  | Classification of Asthma Severity (5-11 years of age) |  |  |  |
| --- | --- | --- | --- | --- | --- |
|  |  | 
Intermittent | Persistent |  |  |
|  |  |  | Mild | Moderate | Severe |
| 

Impairment

     | 
Symptoms | 
≤ 2 days/week | 
>2 days/week but not daily | 
Daily | 
Throughout the day   |
|  | Nighttime awakenings | ≤ 2x/month | 3-4x/month | >1x/week 
but not nightly | Often 7x/week |
|  | Short-acting beta2-agonist use for symptom control (not prevention of EIB) | ≤ 2 days/week
 | >2 days/week but not daily  | Daily | Several times per day |
|  | Interference with normal activity | None | Minor limitation | Some limitation | Extremely limited |
|  | 
Lung function | Normal FEV1 between exacerbations
FEV1 > 80% predicted
FEV1/FVC >85% | FEV1 = >80% predicted
FEV1/FVC >80% | FEV1 = 60-80%     predicted
FEV1/FVC =75-80% | FEV1< 60% predicted
FEV1/FVC <75%
 |
| 

Risk
 | 
Exacerbations requiring oral systemic corticosteroids | 0-1/year (see note) | ≥ 2/year (see note) |  |  |
|  |  | Consider severity and interval since last exacerbation.
Frequency and severity may fluctuate over time for patients in any severity category

Relative annual risk of exacerbations may be related to FEV1 |  |  |  |
|   Recommended Step for Initiating Treatment |  | Step 1 | Step 2 | Step 3, medium-dose ICS option            Step 3, medium-dose ICS option
                                                                   or step 4
and consider short course of oral systemic corticosteroids |  |
|  |  | In 2-6 weeks,, evaluate level of asthma control that is achieved, and adjust therapy accordingly |  |  |  |

- CLASSIFYING ASTHMA SEVERITY AND INITIATING TREATMENTIN CHILDREN 5-11 YEARS OF AGEAssessing severity and initiating therapy in children who are not currently taking long-term control medication

**Key**: EIB, exercise-induced bronchospasm; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; ICS, inhaled corticosteroids

**Note:**  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.

**Notes:**
The stepwise approach is meant to assist, not replace the clinical decision making 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.

The text below is a narration of the table for the visually impaired using an electronic reading device:
Title of table is classifying Asthma severity and initiating treatment in children 5-11 years of age:  Assessing severity and initiating therapy in children who are not currently taking long term control medication.
The Key for this table is: EIB is exercise induced bronchospasm; FEV! Is forced expiratory volume in 1 second; FVC is forced vital capacity; ICS is inhaled corticosteroids.
The components of severity are impairment and risk.  Impairment is subdivided into symptoms, nighttime awakenings, short-acting beta two agonist use for symptom control not including the prevention of exercise induced bronchospasm, interference with normal activity and lung function.  Risk involves the number of exacerbations requiring oral systemic corticosteroids.
For a severity classification of "Intermittent," asthma symptoms are less than or equal to 2 days per week.  
Nighttime awakenings are less than or equal to 2 times per month.  
Use of short-acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is less than or equal to 2 days per week.
No interference with normal activity.
Lung function is normal FEV1 between exacerbations, FEV1 is greater than 80% predicted and FEV1 / FVC is greater than 85%.
Risk is classified as intermittent if exacerbations requiring oral systemic corticosteroids occur 0 to 1 per year.
Recommended step for initiating treatment is Step 1.
For a severity classification of "Persistent mild," asthma symptoms are greater than 2 days per week, but not daily.
Nighttime awakenings are 3 to 4 times per month.
Use of short-acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is greater than 2 days per week, but not daily.
Minor limitation with normal activity.
Lung function is FEV1 equals greater than 80% predicted and FEV1/FVC is greater than 80%.
Risk is classified as persistent mild if exacerbations requiring oral systemic corticosteroids occur greater than or equal to 2  times per year.
Recommended step for initiating treatment is Step 2.
For a severity classification of "Persistent Moderate," asthma symptoms are daily.
Nighttime awakenings are more than 1 time per week, but not nightly.
Use of short-acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is daily.
Some limitation with normal activity.
Lung function is FEV1 equals 60 to 80% predicted, and FEV1/FEV equals 75 to 80%.
Risk is classified as persistent moderate if exacerbations requiring oral systemic corticosteroids occur greater than or equal to 2 times per year.
Recommended step for initiating treatment is step3, medium dose ICS option, and consider short course of oral systemic corticosteroids.
For a severity classification of "persistent severe," asthma symptoms are throughout the day.
Nighttime awakenings are often 7 times per week.
Use of short-acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is several times per day.
Extreme limits with normal activity.
Lung function is FEV1 is less than 60% predicted, and FEV1/FVC is less than 75%.
Risk is classified as persistent severe if exacerbations requiring oral systemic corticosteroids occur greater than or equal to 2 times per year.
Recommended step for initiating treatment is step 3, medium dose ICS option, or Step 4, and consider short course of oral systemic corticosteroids.
For all classifications:  in determining risk ,consider severity and interval since last exacerbation.
Frequency and severity may fluctuate over time.
Relative annual risk of exacerbations may be related to FEV1.
For all classifications of severity, in 2-6 weeks, depending on severity, evaluate level of asthma control that is achieved
Note:  At present, there are inadequate data to correspond frequencies of exacerbations with different levels of asthma severity.  In general, more frequent and intense exacerbations (for example,  requiring urgent, unscheduled care, hospitalization, or ICU admission) indicate greater underlying disease severity.  For treatment purposes, patients who had greater than or equal to 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. 

## ASSESSING ASTHMA CONTROL AND ADJUSTING THERAPY IN CHILDREN 5-11 YEARS OF AGE

- ASSESSING ASTHMA CONTROL AND ADJUSTING THERAPY IN CHILDREN 5-11 YEARS OF AGE

| 
Components of Control |  | Classification of Asthma Control ( 5-11 years of age) |  |  |
| --- | --- | --- | --- | --- |
|  |  | Well Controlled | Not Well Controlled | Very Poorly Controlled |
| 

Impairment | Symptoms |  ≤ 2 days/week but not more than once on each day | >2 days/week or multiple times on  
≤ 2 days/week  | Throughout the day |
|  | Nighttime awakenings | ≤ 1x/month | ≥ 2x/month | ≥ 2x/week |
|  | Interference with normal activity | None | Some limitation | Extremely limited |
|  | Short-acting beta2-agonist use for symptom control (not prevention of EIB) | ≤ 2 days/week | >2 days/week | Several times per day |
|  | Lung function
FEV1 or peak flow
FEV1/FEV
 | 
>80% predicted/ personal best
>80% | 
60-80% predicted/ personal best
75-80% | 
<60% predicted/personal best
<75% |
| 

    Risk | Exacerbations requiring oral systemic corticosteroids | 0-1/year | ≥ 2/year (see note) |  |
|  |  | Consider severity and interval since last exacerbation |  |  |
|  | Reduction in lung growth | Evaluation requires long-term follow up. |  |  |
|  | Treatment-related adverse effects | Medication side effects can vary in intensity from none to very troublesome and worrisome.  The level of intensity does not correlate to specific levels of control but should be considered in the overall assessment of risk. |  |  |
| 

    Recommended Action for Treatment |  | Maintain current step.
Regular follow up every 1-6 months.
Consider step down if well controlled for at least 3 months. | Step up at least 1 step and 
Reevaluate in 2-6 weeks.
For side effects: consider alternative treatment options. | Consider short course of oral systemic corticosteroids,
Step up 1-2 steps, and
Reevaluate in 2 weeks.
For side effects, consider alternative treatment options. |

**Key**: EIB, exercise-induced bronchospasm; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity

|  |
| --- |

**Note:**  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.

**Notes:**
The stepwise approach is meant to assist, not replace, the clinical decision making 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/caregiver’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 persistent asthma, even in the absence of impairment levels consistent with persistent asthma.

Before step up in therapy:
Review adherence to medications, inhaler technique, environmental control, and comorbid conditions.
If alternative treatment option was used in a step, discontinue it and use the preferred treatment for that step.

The text below is a narration of the table for the visually impaired using an electronic reading device:

Title of table is assessing asthma control and adjusting therapy in children 5-11 years of age
The Key for this table is: EIB is exercise induced bronchospasm; FEV1 Is forced expiratory volume in 1 second; FVC is forced vital capacity.
The components of control are impairment and risk.  Impairment is subdivided into symptoms, nighttime awakenings, interference with normal activity,  short-acting beta two agonist use for symptom control not including the prevention of exercise induced bronchospasm, and lung function.  Risk involves the number of exacerbations requiring oral systemic corticosteroids and treatment-related adverse effects, reduction in lung growth and treatment related adverse effects.
For a classification of "Well Controlled," symptoms are less than or equal to 2 days per week, but not more than once on each day.
Nighttime awakenings are less than or equal to 1 time per month.
No interference with normal activity.
Short acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is less than or equal to 2 days per week.
Lung function, FEV1 or peak flow is greater than 80% predicted or personal best and FEV1/FEV is greater than 80%.
Risk is classified as well controlled if exacerbations requiring oral systemic corticosteroids occur  0-1 times per year.
For the risk of reduction in lung growth, evaluation requires long term follow up.  
In regards to treatment related adverse effects, medication side effects can vary in intensity from none to very troublesome and worrisome. The level of intensity does not correlate to specific levels of control but should be considered in the overall assessment of risk.
The recommended action for treatment is maintain current treatment, regular follow up every 1 to 6 months, consider step down if well controlled for at least 3 months.
For a classification of "Not Well Controlled, " symptoms are greater than 2 days per week or multiple times on less than or equal to 2 days per week
Nighttime awakenings are greater than or equal to 2 times per month.
Some limitation with normal activity.
Short acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is greater than two days per week.
Lung function, FEV1 or peak flow is greater than 60 to 80% predicted or personal best and FEV1/FEV is 75 to 80%.
Risk is classified as not well controlled if exacerbations requiring oral systemic corticosteroids occurs greater than or equal to 2 times per year.  Severity and interval since last exacerbation should be considered.
For the risk of reduction in lung growth, evaluation requires long term follow up.  
In regards to treatment related adverse effects, medication side effects can vary in intensity from none to very troublesome and worrisome. The level of intensity does not correlate to specific levels of control but should be considered in the overall assessment of risk.
Recommended action for treatment is to step up at least one step and reevaluate in 2 to 6 weeks.   For side effects, consider alternative treatment options.
For a classification of asthma control "Very Poorly Controlled," symptoms are throughout the day.
Nighttime awakenings are greater than or equal to 2 times per week.
Extreme limitation with normal activity.
Short acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is several times per day.
Lung function, FEV1 or peak flow is less than 60% predicted or personal best and FEV1/FEV is less than 75%.
Risk is classified as very poorly controlled if exacerbations requiring oral systemic corticosteroids occur greater than or equal to 2 times per year.  Severity and interval since last exacerbation should be considered.
For the risk of reduction in lung growth, evaluation requires long term follow up
In regards to treatment related adverse effects, medication side effects can vary in intensity from none to very troublesome and worrisome. The level of intensity does not correlate to specific levels of control but should be considered in the overall assessment of risk.
Recommended action for treatment is to consider short course of oral systemic corticosteroids.
Step up 1 to 2 steps, and reevaluate in 2 weeks.
For side effects, consider alternative treatment options.
Note:  At  present, there are inadequate data to correspond frequencies of exacerbations with different levels of asthma severity.  In general, more frequent and intense exacerbations (for example, requiring urgent, unscheduled care, hospitalization, or ICU admission) indicate greater underlying disease severity.  For treatment purposes, patients who had greater than or equal to  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. 

## 

CASE STUDIES OF ASTHMA SEVERITY

- CASE STUDIES OF ASTHMA SEVERITY

**Notes:**
Let’s look at a few case studies.  You will find a copy of the handouts in your binder.

## Case Study 1

- A 3 year-old boy is brought by his mother for evaluation of worsening asthma symptoms.
- He was diagnosed with asthma several months ago by your partner.  The patient has been using an inhaled short-acting bronchodilator (2-agonist) as needed for symptoms of wheezing and shortness of breath.  The patient and his mother now report that he has daytime symptoms approximately 3 times per week but no nighttime symptoms.
- What level of control does this patient have?

**Notes:**
Answer:  Mild persistent asthma since he has greater than 2 days/week with symptoms

## Case Study 2

- A 19 year-old college student comes in for a routine follow-up visit for asthma.
- She was diagnosed when she was 8 years old.  She “feels fine” and is not bothered by her asthma.  On further questioning, you learn that she is doing poorly in her first class of the day because she has difficulty waking up in time to attend lecture.  She states that sometimes this results from staying up late to talk with friends, but at other times she “tosses and turns all night coughing.”  She thinks that she is having trouble sleeping twice a week.
- What level of control does this patient have?

**Notes:**
Answer:  Moderate persistent asthma since she has nights with symptoms 3-4 times/month.

## Case Study 3A 6 year-old boy with a history of asthma comes to your office for the first time in August for a school physical exam.  He has no asthma symptoms now, but his mom states that usually “around the change of seasons” he starts wheezing and coughing often.  The symptoms occur everyday, but only during the day.  What level of control does this patient have? 

**Notes:**
Answer:  Moderate persistent asthma since he has daily symptoms during that season.  He may be mild persistent or mild intermittent during the rest of the year.

## Key Point #2

- Appropriate asthma management requires the proper use of long term control *and* quick relief  medications.

## Selecting Appropriate Medications

- Quick-relief medications
- Short-acting beta-agonists
- Inhaled anticholinergics
- Systemic corticosteroids
- Long-term control medications
- Daily inhaled corticosteroids
- Leukotriene modifiers
- Long-acting, inhaled 2-agonists (should not be used alone)
- Cromolyn sodium and nedocromil

**Notes:**
The NHLBI guidelines distinguish between quick relief medications and long term control medications.
Note that cromolyn sodium is not as effective as those listed above as long-term control medications.

## Stepwise Approach for Managing Asthmain Children 0-4 Years of Age

- Step 1
***Preferred:***
- SABA PRN

- Intermittent
- Asthma

- Step 2
***Preferred:***
- Low-dose ICS
*Alternative*:
- Cromolyn or Montelukast

- Step 3
***Preferred:***
- Medium-dose ICS

- Step 4
***Preferred:***
- Medium-dose ICS +
- either LABA or Montelukast

- Step 5
***Preferred:***
- High-dose ICS +
- either LABA or Montelukast

- Step 6
-   ***Preferred:***
-   High-dose
- ICS +
-  either LABA   or Montelukast
-  Oral systemic     Corticosteroids

- Persistent Asthma: Daily Medication                                                                                 Consult with asthma specialist if step 3 care or higher is required.                         Consider consultation at step 2.

- Quick-Relief Medication for All Patients                                                                                                                                                         SABA as needed for symptoms. Intensity of treatment depends on severity of symptoms.
- With viral respiratory infection: SABA q 4-6 hours up to 24 hours (longer with physician consult). Consider short course of oral systemic corticosteroids if exacerbation is severe or patient has history of previous severe exacerbations.
- Caution: Frequent use of SABA may indicate the need to step up treatment. See text for recommendations on initiating daily long-term-control therapy.

**Key: Alphabetical order is used when more than one treatment option is listed within either preferred or alternative therapy.**  ICS, inhaled corticosteroid; LABA, inhaled long-acting beta2-agonist; SABA, inhaled short-acting beta2-agonist

- Patient Education and Environmental Control at Each Step

- Step up if needed
- (first, check adherence, inhaler technique, and environmental control)
*** ***
- Step down if possible
- (and asthma is well controlled at least 3 months)

***Assess control***

**Notes:**
The stepwise approach is meant to assist, not replace, the clinical decision making 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.

If clear benefit is not observed within 4-6 weeks and patient/family medication technique and adherence are satisfactory, consider adjusting therapy or alternative diagnosis.

Studies on children 0-4 years of age are limited. Step 2 preferred therapy is based on Evidence A. All other recommendations are based on expert opinion and extrapolation from studies in older children.

The text below is a narration of the table for the visually impaired using an electronic reading device:

## Stepwise Approach for Managing Asthmain Children 5-11 Years of Age

- Stepwise Approach for Managing Asthmain Children 5-11 Years of Age

- Step 1
***Preferred:***
- SABA PRN

- Intermittent
- Asthma

- Step2
***Preferred:   ***Low-dose ICS*** ****Alternative:* Cromolyn, LTRA, Nedocromil, or Theophylline

- Step 4
***Preferred:***
- Medium-dose ICS + LABA
*Alternative:*
- Medium-dose ICS+ either
- LTRA or Theophylline

- Step 5
***Preferred:***
- High-dose ICS + LABA
*Alternative:*
- High-dose ICS + either LTRA or Theophylline

- Step 6
-   ***Preferred:***
-   High-dose
- ICS + LABA + oral systemic corticosteroid
*Alternative:*
-  High-dose ICS + either LTRA or Theophylline + oral systemic corticosteroid

-                    Persistent Asthma: Daily Medication                                                                                 Consult with asthma specialist if step 4 care or higher is required.                         Consider consultation at step 3.

- Quick-Relief Medication for All Patients
- SABA as needed for symptoms. Intensity of treatment depends on severity of symptoms: up to 3 treatments at 20-minute intervals as needed. Short course of oral systemic corticosteroids may be needed
- Caution: Increasing  use of SABA or use >2 days a week for symptom relief (not prevention of EIB) generally indicates inadequate control and the need to step up treatment.

**Key: Alphabetical order is used when more than one treatment option is listed within either preferred or alternative therapy.**  ICS, inhaled corticosteroid; LABA, inhaled long-acting beta2-agonist; LTRA, leukotriene receptor antagonist; SABA, inhaled short-acting beta2-agonist

**Each step: Patient education, environmental control, and management of comorbidities.***
- Steps 2-4: Consider subcutaneous allergen immunotherapy for patients who have allergic asthma

- Step 3
***Preferred:***
- EITHER:
- Low-dose ICS + either LABA,  LTRA, or Theohylline OR medium dose ICS
***          ***

- *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 should be prepared and equipped to identify and treat anaphylaxis that may occur.

- Step up if needed
- (first, check adherence, inhaler technique, and environmental control, and comorbid conditions)
*** ***
- Step down if possible
- (and asthma is well controlled at least 3 months)

***Assess control***

**Notes:**
The stepwise approach is meant to assist, not replace, the clinical decision making 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.

Theophylline is a less desirable alternative due to the need to monitor serum concentration levels.

Step 1 and step 2 medications are based on Evidence A. Step 3 ICS + adjunctive therapy and ICS are based on Evidence B for efficacy of each treatment and extrapolation from comparator trials in older children and adults – comparator trials are not available for this age group; steps 4-6 are based on expert opinion and extrapolation from studies in older children and adults.

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 should be prepared and equipped to identify and treat anaphylaxis that may occur.

The text below is a narration of the table for the visually impaired using an electronic reading device:

Title of table is Stepwise approach for managing asthma in children 5-11 years of age

The key for the table is ICS is inhaled corticosteroid; LABA is inhaled long acting beta 2 agonist;  LTRA is leukotriene receptor antagonist; SABA is inhaled short acting beta 2 agonist.  Alphabetical order is used when more than one treatment option is listed within either preferred or alternative therapy.  
The slide is organized into six distinct steps for patient education and environmental control.
Quick relief medication for all patients is SABA, as needed for symptoms.  Intensity of treatment depends on severity of symptoms.  Up to 3 treatments at 20 minute intervals as needed.  Short course of oral systemic corticosteroids may be needed.
Caution:  Increasing use of SABA or use more than 2 days a week for symptom relief, not prevention of EIB, generally indicates inadequate control and the need to step up treatment.
For intermittent asthma, step 1 is recommended.  The preferred treatment of step 1 is SABA PRN.
Persistent Asthma, which requires daily medication, corresponds with steps 2 through 6.
If step 4 care or higher is required, consult with asthma specialist.
Consultation should be considered at step 3.
Step 2, preferred treatment  is Low dose ICS.
Alternative is cromolyn, LTRA, Nedocromil, or theophylline.
For step 3, preferred treatment is either low dose ICS plus either LABA, LTRA, or theophylline, or medium dose ICS.  .
For Step 4, preferred treatment is medium dose ICS plus  LABA.
Alternative is medium dose ICS plus either LTRA or theophylline.
For step 5, preferred treatment is High dose ICS plus LABA.
Alternative is high dose ICS plus either LTRA or theophylline.
For step 6, preferred treatment is high dose ICS plus LABA plus oral systemic corticosteroid.
Alternative is high dose ICS plus either LTRA or theophylline plus oral systemic corticosteroid.

For all asthma management, step up if needed.
First, however, assess control.  Check adherence, inhaler technique, environmental control, and comorbid conditions..
Step down if possible, and asthma is well controlled at least 3 months.

Note that for each step, include patient education, environmental control, and management of comorbidities.
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 should be prepared and equipped to identify and treat anaphylaxis that may occur.
For steps 2-4: Consider subcutaneous allergen immunotherapy for patients who have allergic asthma 

Title of table is Stepwise approach for managing asthma in children 0-4 years of age

The key for the table is ICS is inhaled corticosteroid; LABA is inhaled long acting beta 2 agonist; SABA is inhaled short acting beta 2 agonist.  Alphabetical order is used when more than one treatment option is listed within either preferred or alternative therapy.  
The slide is organized into six distinct steps for patient education and environmental control.
Quick relief medication for all patients is SABA, as needed for symptoms.  Intensity of treatment depends on severity of symptoms.
With viral respiratory infection:  SABA q 4 to 6 hours up to 24 hours, longer with physician consult.  Consider short course of oral systemic corticosteroids if exacerbation is severe or patient has history of previous severe exacerbations.
Caution:  Frequent use of SABA may indicate the need to step up treatment.  See text for recommendations on initiating daily long term control therapy.
For intermittent asthma, step 1 is recommended.  The preferred treatment of step 1 is SABA PRN.
Persistent Asthma, which requires daily medication, corresponds with steps 2 through 6.
If step 3 care or higher is required, consult with asthma specialist.
Consultation should be considered at step 2.
Step 2, preferred treatment  is Low dose ICS.
Alternative is cromolyn or montelukast.
For step 3, preferred treatment is medium dose ICS.
For Step 4, preferred treatment is medium dose ICS plus either LABA or montelukast.
For step 5, preferred treatment is High dose ICS plus either LABA or montelukast.
For step 6, preferred treatment is high dose ICS plus either LABA or montelukast.  Also listed are oral systemic corticosteroids.
For all asthma management, step up if needed.
First, however, assess control.  Check adherence, inhaler technique and environmental control.
Step down if possible, and asthma is well controlled at least 3 months.

## Inhaled Steroids In Children

- Most potent and effective long-term anti-inflammatory medications currently available
- Reduce the need for quick-relief medications
- Fewer side effects than steroid tablets or syrup

- Long term studies have failed to demonstrate long-term inhibition of growth.
- Rinsing the mouth after inhaling steroids and using spacer devices decrease local side effects and systemic absorption.

**Notes:**
 There is still considerable controversy about the possibility that inhaled    steroids may inhibit growth

Families should also understand that poorly controlled asthma can lead to    impaired growth as well and that risks and benefits have been weighed    carefully in developing the treatment plan

It is reassuring for patients to know that once the asthma is brought under    good control, the dose of inhaled steroids will be reduced if at all possible

Reference:
Peterson, Soren.  Steroids and Grownth. 2001. Am J Resp Crit Care Med.

## Key Point #3

- Because asthma symptoms are variable, families need to recognize symptoms and adjust medications at home according to the clinician’s assessment of control and his/her written action plan for the patient.

## Key Features of an Asthma Action Plan

- Written plan should be keyed to severity and level of control and should include:
- Daily management as well as early recognition and actions for exacerbations
- Medication names (trade and generic)
- How much to take and when to take it

**Notes:**
There are many asthma action plans that can be useful.  Here are key features to include in any successful action plan.

## Asthma Action Plan Examples

**Notes:**
Here are two examples.
This treatment plan is popular because the simple analogy (traffic light) is easy to understand.
Directions are clear.

## SAMPLE LONG TERM TREATMENT PLAN FOR MILD PERSISTENT ASTHMA

- SAMPLE LONG TERM TREATMENT PLAN *FOR MILD PERSISTENT ASTHMA*

**CLINICAL CONDITION**

- Baseline Plan
- &
- When asthma
- is under control

- At the **FIRST** sign
- of a cold
- or mild
- asthma attack

- For rapidly
- worsening
- asthma
- (severe attack)

- When there is no
- cough or wheeze
- for 3 months

- For cough or
- wheeze with
- exercise

**PEAK FLOW**
- (% predicted) FEV1/FVC

**MEDICATION**
*Reliever:*
- Inhaled short-acting
- beta2-agonist
- Albuterol

*Controller:*
- 1) Inhaled low dose
-          corticosteroid
-     Beclomethasone, 42 mcg

- Corticosteroid Tablet or Syrup

- Above 80%

- 75 to 80%

- Below 75%

- Over 80%
- for 3 months

- 1-4 puffs
- 2x/day

- 0

*         **or*
- 2) Leukotriene modifier

- 2 puffs
- as needed

## SAMPLE LONG TERM TREATMENT PLAN FOR MILD PERSISTENT ASTHMA

- SAMPLE LONG TERM TREATMENT PLAN *FOR MILD PERSISTENT ASTHMA*

**CLINICAL CONDITION**

- Baseline Plan
- &
- When asthma
- is under control

- At the **FIRST** sign
- of a cold
- or mild
- asthma attack

- For rapidly
- worsening
- asthma
- (severe attack)

- When there is no
- cough or wheeze
- for 3 months

- For cough or
- wheeze with
- exercise

**PEAK FLOW**
- (% predicted) FEV1/FVC

**MEDICATION**
*Reliever:*
- Inhaled short-acting
- beta2-agonist
- Albuterol

*Controller:*
- 1) Inhaled low dose
-          corticosteroid
-     Beclomethasone, 42 mcg

- Corticosteroid Tablet or Syrup

- Above 80%

- 75 to 80%

- Below 75%

- Over 80%
- for 3 months

- 2 puffs
- every 4 hr

- 2-6 puffs
- every 20 minutes
- for 3 doses
- then 2-4 puffs
- every 4 hr

- 2 puffs
- 5-10 minutes
- before exercise

- 1-4 puffs
- 2x/day

- 1-4 puffs
- 2x/day

- 1-4 puffs
- 2x/day

- 0

- 0

- 0

- Begin with
- 1-2 mg/kg/day
**NOTIFY MD**

*         **or*
- 2) Leukotriene modifier

- 2 puffs
- as needed

- 2 puffs
- as needed

- 0

- 1 tablet*
- per day

- * If patients develops symptoms when corticosteroid discontinued, either resume corticosteroids or try leukotriene modifier

## Review of Key Points Covered

- 1. The key elements of assessment and monitoring are severity, control, and responsiveness to treatment.
- 2. Appropriate asthma management requires the proper use of long term control *and* quick relief  medications.
- 3. Because asthma symptoms are variable, families need to recognize symptoms and adjust medications at home according to the clinician’s assessment of control and his/her written action plan for the patient.

**Notes:**
We’ve covered key points 1-3 
Next segment covers 4-5
We will now take a short break.

## Major Indoor Triggers

- Tobacco smoke
- Dust mites
- Animal dander
- Cockroach allergens
- Indoor mold
- Wood smoke
- Formaldehyde
- Volatile organic compounds

## END OF SESSION 1- SEGMENT 1

## Key Point #4

- 	Good communication between patient and clinician helps identify patient concerns that may block adherence, makes patient teaching more effective and promotes patient self-confidence to follow the treatment plan

## Background

- Excellence in medical treatment is worthless if the patient doesn’t take the medicine
- Compliance is closely linked to clinician communication and patient education
- Most clinicians believe they are good communicators, but most patients feel clinician communication and education is inadequate

**Notes:**
First, a little background.......
Clinician communication and patient education is central to a patient’s compliance with the clinician’s recommendations.

## Recent Medicine Adherence Studies

**Notes:**
This slide shows some recent studies demonstrating poor compliance in asthma
Reference: 
 Jonasson G. et al. Asthma drug adherence in a long term clinical trial.  Arch Dis Child.    2000;83:330-3.

## Implications

- Studies consistently show that less than 50% of patients adhere to daily medication regimens
- Clinicians cannot predict better than chance which patients will be compliant
- Therefore, _all_ patients need to be educated to ensure compliance
- Communicating well and providing education are as important as prescribing the right medicine

**Notes:**
 * Studies have shown that physicians think they can predict who will comply, but studies show that they cannot.
*  Assume that every patient is at risk for noncompliance and needs help to    adhere to the long-term treatment plan

## Aims of the Following Discussion

- To provide a theoretical framework - a way to think about clinician-patient communication
- To demonstrate strategies that clinicians can use to improve communication and help patients be responsive to recommendations

**Notes:**
Here are the objectives for the next few slides.

## Health Belief Model

-     These beliefs influence willingness to follow preventive or therapeutic recommendations
- I am **susceptible** to this health problem
- The threat to my health is **serious**
- The **benefits** of the recommended action outweigh the **costs**
- I am **confident** that I can carry out the recommended actions successfully

**Notes:**
Research in psychology has demonstrated that this model can be used to   predict and explain health behavior, and that action is strongly related to the    four beliefs presented.
When the clinician focuses communications on these points, patients have    been shown to follow therapeutic advice more closely.
* A recent study showed that parents who believed more strongly that their children with asthma were vulnerable were more likely to seek care from a general pediatrician during any acute episode and keep their children home from school regardless of the actual severity of the episode

 Reference:

## Beliefs About Susceptibility

- Some families resist accepting the diagnosis because they believe that:
- Because an older relative was crippled by asthma, their child will also be crippled
- Asthma is psychologically caused or feigned by the child
- Resisting the diagnosis reduces the likelihood that the family will follow the treatment plan

**Notes:**
* These susceptibility beliefs are sometimes the main concern when patients   come to see the clinicians, and advice from the clinician can help dispel them. 

## Beliefs About Seriousness

- If the family thinks asthma is not serious, they are less likely to follow the treatment plan
- If the family overestimates the seriousness of asthma, they may follow the plan, but prevent the child from taking part in normal physical activities

**Notes:**
Families need to learn to use objective indicators of asthma’s seriousness.   These can include frequency and severity of symptoms, peak flow    monitoring, etc.  The physician can provide criteria as listed in the asthma action plan so the family can gain a better perspective on the severity of disease.

## Beliefs About Benefits and Costs

- The benefits of therapy, obvious to the clinician, are often unclear to patients or irrelevant to their personal goals
- Perceived costs of therapy include:
- Financial burden of care
- Fear that medicines will harm the child
- Regimen seen as time-consuming and hard to carry out

**Notes:**
The benefits of the therapy can be explicitly tied to the patient’s personal    goals, e.g. to play basketball, to sleep through the night, etc.  In this way the   “costs” of following the therapeutic plan are reduced and the physician’s    recommendations are seen as a way to reach one’s personal goals.

## Fears About Asthma Medicines

- 39% Believe medicines are addictive
- 36% Believe medicines are not safe to take
-          over a long period
- 58% Believe regular use will reduce
-          effectiveness

**Notes:**
Fears about asthma medicines are an example of a perceived cost of therapy that blocks compliance

These figures are based on research conducted in a study of 445 families    where a child has asthma

Reference:

## Beliefs About Ability to Carry Out Recommendations

- Research in psychology shows that when you are confident you can do something successfully:
- You do it more often
- You are more persistent in the face of difficulty.
- Many families lack confidence that they can manage an asthma attack at home

**Notes:**
You have probably experienced this yourselves, for example when learning   a new sport or a musical instrument

For example, many families go immediately to the emergency department   even for mild asthma episodes instead of beginning appropriate treatment at home

Explicit efforts to build patient confidence for self management are central   to asthma control

## Implications

- 	Therefore, the clinician must establish open communications that permit these health beliefs to be identified and discussed.

**Notes:**
Families are often reluctant to bring up their beliefs or concerns;  it is    important to identify them so they can be dealt with and they do not act as “background noise” distracting the patient from hearing what the clinician is communicating

## Barriers To Effective Communications

- Feel they are wasting the clinician’s valuable time
- Omit details they deem unimportant
- Are embarrassed to mention things they think will make them look bad

- Don’t understand medical terms
- May believe the clinician has not really listened and therefore doesn’t have the information needed to make a good treatment decision

- Studies show that patients often:

## Video Presentation

## Strategies

- Non-verbal attentiveness
- Addressing immediate concerns
- Reassuring messages
- GOAL/PURPOSE
*Relaxing and reassuring patients so they pay attention to what is being said.*

**Notes:**
Now let’s review the purpose of each strategy shown in the videotape.  Let  me emphasize these have been evaluated as part of a clinical trial with   pediatricians. 
References:

## Strategies

- Interactive conversation
- Eliciting underlying fears
- GOAL/PURPOSE
*Improving the exchange of ideas and feelings and gathering information needed for diagnosis and treatment decisions*

## Strategies

- Tailoring messages
- Planning for decision making
- Goal setting
- GOAL/PURPOSE
*Preparing patients to carry out the treatment at home*

## Strategies

- Non-verbal encouragement
- Verbal praise
- GOAL/PURPOSE
*Building self confidence needed to carry out the plan.*

## Key Point #5

- 	Good communication and patient education can be efficiently and effectively accomplished in several standard primary care visits

## Efficacy Trial (MD-Asthma Study)

- _Design_:  		Controlled trial
- _Intervention_:	Asthma education seminar
- _Participants_:	83 pediatricians
- _Evaluation_:	Asthma care of 637 patients
- 				(2 year follow-up)

**Notes:**
To see if this worked, we conducted a controlled trial...

## Results from Parents

- Parents reported that the intervention pediatrician
- was more reassuring
- asked more about asthma management at home
- was more likely to set a goal for child to be active
- Parents reported increased use of written plans

## Results from Pediatricians

- Compared with controls, physicians who received the intervention showed:
- Increased use of written plans
- Increased use of inhaled anti-inflammatory therapy
- More attention to patient fears
- No additional time for patient visit

## Patient Outcomes

- The study allowed separation of the effects of drug therapy from the effects of good communication and patient education
- Patients whose physicians provided education plus inhaled corticosteroids did better than those who received corticosteroids alone:
- Reduced emergency room visits
- Reduced hospitalizations
- Reduced days with symptoms

## Effectiveness Trial (PACE Study)

- _Design_:  		Controlled trial
- _Intervention_:	Asthma education seminar
- _Participants_:	101 primary care providers
- _Evaluation_:	Asthma care of 870 patients
- 				(1 year follow-up)

**Notes:**
To see if this worked, we conducted a controlled trial...

## Results

- Pediatricians were more confident in
- developing short term goals
- reviewing long term plans
- Parents reported that the intervention pediatrician
- tried to find out about parents’ biggest concerns
- was more likely to encourage child to be active
- was more likely ask if child was meeting goals
- p<0.05 for all analyses

## Patient Outcomes

- Patients whose physicians participated in the PACE seminar had
- Reduced emergency room visits
- Reduced days of daytime symptoms in the Fall
- Reduced days with decreased activity due to asthma (Spring, Summer, Winter, & Fall)
- No impact on average patient visit time

## In Summary

- Good communication between patient and clinician helps identify patient concerns that may block adherence, makes patient teaching more effective and promotes patient self-confidence to follow the treatment plan
- Good communication and patient education can be efficiently and effectively accomplished in several standard primary care visits

## Session 2, Segment 1 

- Patient Education Messages

## Key Points

- 1. The key elements of assessment and monitoring are severity, control, and responsiveness to treatment.
- 2. Appropriate asthma management requires the proper use of long term control *and* quick relief  medications.
- 3. Because asthma symptoms are variable, families need to recognize symptoms and adjust medications at home according to the clinician’s assessment of control and his/her written action plan for the patient.

## Key Points

- 4. Good communication between patient and clinician helps identify patient concerns, makes patients teaching more effective and promotes patient self-confidence to follow the treatment plan
- 5. Patients education can be efficiently and effectively accomplished in several standard primary care visits

## Session 2, Segment 2 

- Discussion of Program Cases

## Case Presentation #1

- 	During an office visit with a new patient, Mrs.Wallace tells you that every time her two-year-old daughter Jennifer has a cold, she has severe coughing and wheezing that lasts for two or three weeks. She had four such colds in the last year; the most recent occurred a month ago. Jennifer does not have any symptoms now, but Mrs. Wallace is worried and asks you for help.
- What treatment plan would you recommend to Mrs. Wallace for Jennifer’s asthma?
- What do you think would be the greatest challenge in getting Mrs. Wallace to follow the treatment plan?

## Case Presentation #2

*	*Tom Platt is six years old and coughs and wheezes several times a week. The symptoms occur when he runs or is near a cat, but are mild and usually subside within an hour. The Platt family does not have any pets in their home. Mrs. Platt has never had to take Tom to the emergency room, but she tries to keep him from running too much to prevent these symptoms.
- What treatment plan would you recommend to Mrs. Platt for Tom’s asthma?
- What do you think would be the greatest challenge in getting Mrs. Platt to follow the treatment plan?

## Case Presentation #3

*	*Angela Mendez is 10 months old, and has repeated episodes of wheezing and difficulty breathing. When you prescribed albuterol syrup, her symptoms got better, but she was fussy, couldn’t sleep, and vomited. Mrs. Mendez is getting frustrated.  You have already completed an extensive work up and have ruled out other causes for the breathing difficulties.
- What treatment plan would you recommend to Mrs. Mendez for Angela’s asthma?
- What do you think would be the greatest challenge in getting Mrs. Mendez to follow the treatment plan?

## Session 2, Segment 3

- Coding and Reimbursement

## Goals

- To demonstrate how quality asthma education and counseling can be documented and coded
- To help physicians receive appropriate reimbursement for the quality asthma care they provide

## Education and Counseling should be Properly Reimbursed

- Pediatricians generally undercharge
- Documentation and coding not covered in residency curricula
- Perception that it is not important in capitated arrangements

**Notes:**
Despite the time physicians invest for education and counseling, pediatricians tend to undercharge for services they provide, due to poor documentation and coding.

Despite the importance of documentation and coding, these topics are not a common component of pediatric residency curricula.  Many physicians learn “on the job” or delegate this responsibility to office staff.  

There may be a perception that accurate coding is not necessary since reimbursement is based on predetermined contracts based on “cover lives” in managed care arrangements.  However, these rates are derived, in part, from the claims generated by the codes submitted by physicians.  

Under-coding leads to undercompensation and as a result, less revenue per covered patient life.  On the other hand, over-coding can lead to physicians getting “dropped” by managed care organizations since they might be perceived as not being “cost-effective.”

## Topics for this Segment

- What has to be documented in the chart
- What diagnosis and billing codes to submit
- Other codes and rules

## Definitions

- _CPT Code_:  “what we did”
- _C_urrent _P_rocedural _T_erminology
- Codes have relative value based on resources used
- _ICD 9-CM Code_:  “what was the problem”
- _I_nternational _C_lassification of _D_iseases
- Modified for United States payment systems
- Codes for the problem or situation

## Selecting the CPT Code

- The asthma visit will fall under one of five different CPT codes
- Coding should be based on what was performed and documented.
- “If it wasn’t documented, it didn’t happen.”
- Poor documentation can lead to denial of payment by carriers

**Notes:**
Visits will fall under one of five CPT codes.  One is reimbursed less and five is the most involved and reimbursed the most.

## Two General CPT Coding Strategies

- Select the CPT Code based on _complexity_
- history (4 types)
- exam (4 types)
- medical decision making (4 types)
- Select the CPT Code based on _time_

## Coding Based on Complexity:  History

- Four levels of history
- Problem Focused
- Expanded Problem Focused
- Detailed
- Comprehensive

**Notes:**
OPTIONAL SLIDE

## Coding Based on Complexity: Exam

- Four levels of exam
- Problem Focused
- Expanded Problem Focused
- Detailed
- Comprehensive

**Notes:**
OPTIONAL SLIDE

## Coding Based on Complexity:  Medical Decision Making

**Notes:**
OPTIONAL SLIDE

There are 4 types of medical decision making, which are based on the number of diagnosis, the amount of data and the complication risk.

## CPT code based on complexity

- For a _new_ patient, each of the 3 components determine which of five CPT codes to select
- For an _established_ patient, only 2 of the 3 components must be performed to the degree specified for the CPT code.
- The least involved component will determine the overall CPT code

## CPT Codes for the New Patient

**Notes:**
For example, for a new patient, to code a LEVEL 4 asthma visit, you would need to perform a comprehensive history, a comprehensive exam and the medical decision making would have to be of moderate complexity.

## CPT Codes for the Established Patient

**Notes:**
For an established patient, you only have to fulfill 2 out of the 3 categories.

## Level 4 Visit Based on Complexityfor the Established Patient

- History
- H.P.I with 4 or more elements
- ROS of 2 to 9 systems
- Either family, social or past medical history
- Exam
- 5 to 7 areas
- Medical Decision Making
- moderate complexity

**Notes:**
In your handout of coding models, you will see 5 different levels and 3 componenets.

Lets look at the level 4 visit in detail.  Here are the components:

For a new patient, you’d need to fulfill all 3 of these components.

For an established patient, you only need to fulfill 2 out of the 3 components.

## Coding Based on Time

- Time is a factor only when counseling or coordination of care accounts for greater than 50% of the total face-to-face time with a patient.
- Document
- total duration of counseling
- total duration of visit
- topics covered for counseling or coordination

**Notes:**
Remember, there are two strategies:  Coding based on complexity and coding based on time.

## Coding Based on Time

**Notes:**
So for an established patient, if you spent 15 minutes of face to face time during the visit and 8 minutes was spent on counseling and coordination of care, you could justify a level 3 visit.  

## The Asthma f/u visit for Counseling

- _Scenario_:  Dr. Esser’s follow-up visit (15 min)
- _History_: 1 or 2 months after first asthma attack
- _Exam_:  No distress.  Clear lung exam.
- _Decision-making_: Straight-forward; albuterol p.r.n. and long-term controller.  Discussed what happens in asthma attack, how medicines work, when to call doctor, established action plan, patient demonstrated how to use MDI with spacer.

**Notes:**
Lets analyze Dr. Esser’s first visit on the video.  

## What was Documented

- “JC is 9 y.o girl recently diagnosed with asthma.  Doing well.  Some daytime/nighttime sx. PE:  Alert, no distress. T=37.3 C. Wt: 35.2 kg. Lungs clear. A/P:  Mild persistent asthma, Discussed meds & management.  Albuterol p.r.n.; low dose steroid 2 puffs, bid; f/u in 1 month.”

## Strategy:  Coding Based on Time

- Based on Complexity
- History -- Level 2
- Exam -- Level 2
- Decision-Making -- Level 2 or 3
- Overall:  Level 2
- Based on Time
- Documentation of some topics covered
- However:  No documentation of overall or counseling time

**Notes:**
Here it might be a good idea to code based on time.  However, there was no documentation of the time spent on counseling or the overall time. 

## Effect of Documentation

- “JC is 9 y.o girl recently diagnosed with asthma. Doing well.  Some daytime/nighttime sx. PE:  Alert, no distress. T=37.3 C. Wt: 35.2 kg. Lungs clear. A/P:  Mild persistent asthma, Discussed meds & management.  Albuterol p.r.n. low dose steroid 2 puffs, bid; f/u in 1 month f/u in 1 month.
*Total time 15 min, 10 min spent discussing *what happens in asthma attack, how meds work, established action plan, pt. demonstrated how to use MDI with spacer.”

**Notes:**
What if this was documented, with this extra line in italics?  This now justifies the Level 3 code.  If it was 25 minutes and 13 minutes spent in counseling, it justifies a Level 4 code. 

## Physician

- ’

- s Record

## Coding Based on Time 

- In general for asthma follow-up visits where education is main point of visit, coding based on time more accurately captures the value of what was accomplished
- If counseling takes up greater than 50% of session, visit can be coded based on time
- Documentation and coding makes a difference

## Short-term Effects

- A visit for established patient could be a Level 3 visit if you spent total time of 15 minutes and >7.5 minutes was spent in counseling regardless of level of history and physical examination
- A visit for established patient could be a Level 4 visit if you spent total time of 25 minutes and >12.5 minutes was spent in counseling regardless of level of history and physical examination

## Asthma Teaching Code

- 94664:  Revised to read: Demonstration and/or evaluation of patient utilization of an aerosol generator, nebulizer, metered dose inhaler or IPPB device.
- can be reported only one time per day
- can be claimed when office staff perform demo under supervision

## Overall Effects

- Assume
- 1250 patients in panel
- 100 asthma patients (8% prevalence)
- Each patient with just two counseling sessions
- Poor documentation and coding
-  Level 2 (Complexity) could be Level 4 (Time)
- $69.19 lost per visit
- $13,838.00 lost per year

## For the Asthma Counseling Visit

- CPT coding strategies & documentation requirements
- ICD-9 code selection
- Modifier (-25) codes

**Notes:**
OPTIONAL SLIDE
We’ve talked about the CPT coding strategies, but there are some other tips that might be helpful

## ICD-9 Codes

- Describes the diagnosis for the visit (3 to 5 digits)
- In general, a five digit diagnosis has greater likelihood of reimbursement
- Don’t forget to add other diagnosis to help support the severity of illness (hypoxemia)

**Notes:**
OPTIONAL SLIDE

The ICD-9 codes are also important...

## 25) 	Used on outpatient visits for two 			separate services

76)	Used on procedures when the same 		service is performed multiple times

59)	Used on procedures that should be billed 	separately from the office visit and other 	procedures

- 76)	Used on procedures when the same 		service is performed multiple times
- 59)	Used on procedures that should be billed 	separately from the office visit and other 	procedures

- How to Use Modifiers Effectively

## 25 Modifier

- Only used on outpatient visits
- Example:  Outpatient visit same day as a procedure such as child presents with wheezing and you determine nebulizer treatment is needed

## 76 Modifier

- Used on procedures
- Example:  Multiple nebulizer treatments given on the same day by the same physician

## 59 Modifier

- Used only on procedures
- Example:  Used on pulse ox when done at the same time as other procedures

## Counseling During a Well Child Visit

- Scenario:  During annual exam, several asthma topics are reviewed
- Can link the well child exam (code 99391) with an asthma visit (code 99213) using
- 	a -25 modifier

**Notes:**
OPTIONAL SLIDE

Also, you may find yourself covering a lot of asthma topics during a well-child exam.  This may go beyond what you normally cover during a well child exam. 

A -25 modifier is an additional code that says “this visit was different”  If you document the other topics covered, for example for a 99213 or Level 3 visit, you can add the 99213 claim along with the well child exam code with a -25 modifier.  

## Don’t Forget the Procedures

- Pulse oximetry  (94760)
- Spirometry  (94010)
- Nebulizer treatment  (94640)
- Teaching: Nebulizer, Metered Dose Inhaler etc. (94664)
- Flu shot  (90657, 90658, 90659)
- Prolonged Physician Services (99354, 99355)

**Notes:**
OPTIONAL SLIDE

Also, don’t forget the procedures that you do in the office.  Don’t forget to submit these codes as well.

## Tools

- Coding companion with asthma examples
- Visit template for documentation
- Other sources of information
- AAP 1-800-433-9046 Coding Questions
- AAP News - Coding Corner (monthly)
- AAP - _Coding for Pediatrics_, and
- AAP - Coding Companion - quarterly

**Notes:**
In addition, here are some tools that we have included in your tool kit.

Other sources of information include the AAP’s Coding for Pediatrics Manual and “coding corner” in the AAP News.   

## Take Home Messages

- For asthma visits focused on education, coding based on time more accurately captures the value of what was accomplished
- Pediatricians should receive appropriate reimbursement for the quality asthma care they provide
- Documentation and coding makes a difference

## Session 2, Segment 4

- Appendix

## 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

| 
Components of Severity
 |  | Classification of Asthma Severity (≥12 years of age) |  |  |  |
| --- | --- | --- | --- | --- | --- |
|  |  | 
Intermittent | Persistent |  |  |
|  |  |  | Mild | Moderate | Severe |
| Impairment

Normal FEV1/FVC:
 8-19 yr     85%
20-39 yr    80%
40-59 yr    75%
60-80 yr    70%    | Symptoms | ≤ 2 days/week | >2 days/week but not daily | Daily | Throughout the day  |
|  | Nighttime awakenings | ≤ 2x/month | 3-4x/month | >1x/week but not nightly | Often 7x/week |
|  | Short-acting beta2-agonist use for symptom control (not prevention of EIB) | ≤ 2 days/week
 | >2 days/week but not daily, and not more than 1x on any day | Daily | Several times per day |
|  | Interference with normal activity | None | Minor limitation | Some limitation | Extremely limited |
|  | 
Lung function | Normal FEV1 between exacerbations
FEV1 > 80% predicted
FEV1/FVC normal | FEV1 >80% predicted
FEV1/FVC normal | FEV1 >60% but <80% predicted
FEV1/FVC reduced 5% | FEV1< 60% predicted
FEV1/FVC reduced >5% |
| 
Risk | 
Exacerbations requiring oral systemic corticosteroids | 0-1/year (see note) | ≥ 2/year(see note) |  |  |
|  |  | Consider severity and interval since last exacerbation.
Frequency and severity may fluctuate over time for patients in any severity category
Relative annual risk of exacerbations may be related to FEV1 |  |  |  |
| Recommended Step for Initiating Treatment |  | Step 1 | Step 2 |                Step 3                                       Step 4 or 5
and consider short course of oral systemic corticosteroids |  |
|  |  | In 2-6 weeks, evaluate level of asthma control that is achieved and adjust therapy accordingly |  |  |  |

- CLASSIFYING ASTHMA SEVERITY AND INITIATING TREATMENTIN YOUTHS ≥ 12 YEARS OF AGE AND ADULTSAssessing severity and initiating treatment for patients who are not currently taking long-term control medications

**Key**: FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; ICU, intensive care unit

**Note:**  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.

**Notes:**
The stepwise approach is meant to assist, not replace the clinical decision making 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.

The text below is a narration of the table for the visually impaired using an electronic reading device:
Title of table is classifying Asthma severity and initiating treatment in youths greater than or equal to 12 years of age and adults:  Assessing severity and initiating treatment for patients who are not currently taking long term control medication.
The Key for this table is: FEV! Is forced expiratory volume in 1 second; FVC is forced vital capacity; ICU is intensive care unit.
The components of severity are impairment and risk.  Impairment is subdivided into symptoms, nighttime awakenings, short-acting beta two agonist use for symptom control not including the prevention of exercise induced bronchospasm, interference with normal activity and lung function.  Risk involves the number of exacerbations requiring oral systemic corticosteroids.
For a severity classification of "Intermittent," asthma symptoms are less than or equal to 2 days per week.  
Nighttime awakenings are less than or equal to 2 times per month.  
Use of short-acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is less than or equal to 2 days per week.
No interference with normal activity.
Lung function is normal FEV1 between exacerbations, FEV1 is greater than 80% predicted and FEV1 / FVC is normal.
Risk is classified as intermittent if exacerbations requiring oral systemic corticosteroids occur 0 to 1 time per year.
Recommended step for initiating treatment is Step 1.
For a severity classification of "Persistent mild," asthma symptoms are greater than 2 days per week, but not daily.
Nighttime awakenings are 3 to 4 times per month.
Use of short-acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is greater than 2 days per week, but not daily, and not more than 1 time on any day.
Minor limitation with normal activity.
Lung function is FEV1 is greater than 80% predicted and FEV1/FVC is normal.
Risk is classified as persistent mild if exacerbations requiring oral systemic corticosteroids occur greater than or equal to 2  times per year.
Recommended step for initiating treatment is Step 2.
For a severity classification of "Persistent Moderate," asthma symptoms are daily.
Nighttime awakenings are more than 1 time per week, but not nightly.
Use of short-acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is daily.
Some limitation with normal activity.
Lung function is FEV1 is greater than 60%, but less than 80% predicted, and FEV1/FEV reduced 5%.
Risk is classified as persistent moderate if exacerbations requiring oral systemic corticosteroids occur greater than or equal to 2 times per year.
Recommended step for initiating treatment is step3,  and consider short course of oral systemic corticosteroids.
For a severity classification of "persistent severe," asthma symptoms are throughout the day.
Nighttime awakenings are often 7 times per week.
Use of short-acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is several times per day.
Extreme limits with normal activity.
Lung function is FEV1 is less than 60% predicted, and FEV1/FVC is reduced greater than 5%.
Risk is classified as persistent severe if exacerbations requiring oral systemic corticosteroids occur greater than or equal to 2 times per year.
Recommended step for initiating treatment is step 4 or 5, and consider short course of oral systemic corticosteroids.
For all classifications:  in determining risk, consider severity and interval since last exacerbation.
Frequency and severity may fluctuate over time or patients in any severity category.
Relative annual risk of exacerbations may be related to FEV1.
For all classifications of severity, in 2-6 weeks,  evaluate level of asthma control that is achieved
And adjust therapy accordingly.
Note:  At present, there are inadequate data to correspond frequencies of exacerbations with different levels of asthma severity.  In general, more frequent and intense exacerbations (for example, requiring urgent, unscheduled care, hospitalization, or ICU admission) indicate greater underlying disease severity.  For treatment purposes, patients who had greater than or equal to 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. 

## ASSESSING ASTHMA CONTROL AND ADJUSTING THERAPY IN YOUTH ≥ 12 YEARS OF AGE AND ADULTS

| 
Components of Control |  | Classification of Asthma Control ( ≥ 12 years of age) |  |  |  |
| --- | --- | --- | --- | --- | --- |
|  |  | Well Controlled | Not Well Controlled |  | Very Poorly Controlled |
| 

    Impairment | Symptoms |  ≤ 2 days/week | >2 days/week |  | Throughout the day |
|  | Nighttime awakenings | ≤ 2x/month | 1-3x/week |  | ≥ 4x/week |
|  | Interference with normal activity | None | Some limitation |  | Extremely limited |
|  | Short-acting beta2-agonist use for symptom control (not prevention of EIB) | ≤ 2 days/week | >2 days/week |  | Several times per day |
|  | FEV1 or peak flow
 | >80% predicted/ personal best | 60-80% predicted/ personal best |  | <60% predicted/ personal best |
|  | Validated Questionnaires
             ATAQ
             ACQ
             ACT | 
0
≤ 0.75*
≥ 20 | 
1-2
≥ 1.5
16-19 |  | 
3-4
N/A
≤ 15 |
| 

    Risk | Exacerbations requiring oral systemic corticosteroids | 0-1/year                                ≥ 2/year (see note)
  |  |  |  |
|  | Progressive loss of lung function |  Evaluation requires long-term follow-up care. |  |  |  |
|  | Treatment-related adverse effects | Medication side effects can vary in intensity from none to very troublesome and worrisome.  The level of intensity does not correlate to specific levels of control but should be considered in the overall assessment of risk. |  |  |  |
| 

    Recommended Action for Treatment
 |  | Maintain current step.
Regular follow ups every 1-6 months to maintain control.
Consider step down if well controlled for at least 3 months. | Step up 1 step and
Reevaluate in 2-6 weeks.
For side effects, consider alternative treatment options. | Consider short course of oral systemic corticosteroids,
Step up 1-2 steps, and
Reevaluate in 2 weeks.
For side effects, consider alternative treatment options. |  |

- *ACQ values of 0.76-1.4 are indeterminate regarding well-controlled asthma.
** ****Key:** EIB, exercise-induced bronchospasm; ICU, intensive care unit.

|  |
| --- |

- Consider severity and interval since last exacerbation

**Note:**  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.

**Notes:**
The stepwise approach is meant to assist, not replace, the clinical decision making 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.

Validated Questionnaires for the impairment domain (the questionnaires do not assess lung function or the risk domain)
ATAQ=Asthma Therapy Assessment Questionnaire© (See sample in “Component 1: Measures of Asthma Assessment and Monitoring.”)
ACQ=Asthma Control Questionnaire © (user package may be obtained at www.qoltech.co.uk or juniper@qoltech.co.uk)
ACT=Asthma Control TestTM (See sample in “Component 1: Measures of Asthma Assessment and Monitoring.”)
Minimal Importance Difference: 1.0 for the ATAQ; 0.5 for the ACQ; not determined for the ACT.

Before step up in therapy:
Review adherence to medications, inhaler technique, environmental control, and comorbid conditions.
If alternative treatment option was used in a step, discontinue and use the preferred treatment for that step.
The text below is a narration of the table for the visually impaired using an electronic reading device:
Title of table is assessing asthma control and adjusting therapy in youth greater than or equal to 12 years of age and adults.
The Key for this table is: EIB is exercise induced bronchospasm; ICU is intensive care unit.
The components of control are impairment and risk.  Impairment is subdivided into symptoms, nighttime awakenings, interference with normal activity,  short-acting beta two agonist use for symptom control not including the prevention of exercise induced bronchospasm, FEV1 or peak flow and validated questionnaires.
 Risk involves the number of exacerbations requiring oral systemic corticosteroids, progressive loss of lung function, and treatment-related adverse effects.

For a classification of "Well Controlled," symptoms are less than or equal to 2 days per week..
Nighttime awakenings are less than or equal to 2 times per month.
No interference with normal activity.
Short acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is less than or equal to 2 days per week.
FEV1 or peak flow is greater than 80% predicted or personal best.
The ATAQ validated questionnaire is 0.
The ACQ validated questionnaire is less than or equal to .75, note that ACQ values of .76 thru 1.4 are indeterminate regarding well controlled asthma.
The ACT validated questionnaire is greater than or equal to 20.
Risk is classified as well controlled if exacerbations requiring oral systemic corticosteroids occur  0-1 times per year.
For the risk of reduction in lung growth, evaluation requires long term follow up.  
In regards to treatment related adverse effects, medication side effects can vary in intensity from none to very troublesome and worrisome. The level of intensity does not correlate to specific levels of control but should be considered in the overall assessment of risk.
The recommended action for treatment is maintain current treatment, regular follow up every 1 to 6 months, consider step down if well controlled for at least 3 months.
For a classification of "Not Well Controlled, " symptoms are greater than 2 days per  week. Nighttime awakenings are greater than or equal to 1 to 3  times per week.
Some limitation with normal activity.
Short acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is greater than two days per week.
 FEV1 or peak flow is greater than 60 to 80% predicted or personal best.
The ATAQ validated questionnaire is 1 to 2.
The ACQ validated questionnaire is greater than or equal to 1.5.
The ACT validated questionnaire is 16 to 19.
Risk is classified as not well controlled if exacerbations requiring oral systemic corticosteroids occurs greater than or equal to 2 times per year.  Severity and interval since last exacerbation should be considered.
For the risk of reduction in lung growth, evaluation requires long term follow up.  
In regards to treatment related adverse effects, medication side effects can vary in intensity from none to very troublesome and worrisome. The level of intensity does not correlate to specific levels of control but should be considered in the overall assessment of risk.
Recommended action for treatment is to step up one step and reevaluate in 2 to 6 weeks.   For side effects, consider alternative treatment options.
For a classification of asthma control "Very Poorly Controlled," symptoms are throughout the day.
Nighttime awakenings are greater than or equal to 4 times per week.
Extreme limitation with normal activity.
Short acting beta 2 agonist use for symptom control (not prevention of exercise induced bronchospasm) is several times per day.
FEV1 or peak flow is less than 60% predicted or personal best.
The ATAQ validated questionnaire is 3 to 4.
The ACQ validated questionnaire is not available.
The ACT validated questionnaire is less than or equal to 15.
Risk is classified as very poorly controlled if exacerbations requiring oral systemic corticosteroids occur greater than or equal to 2 times per year. .  Severity and interval since last exacerbation should be considered.
For the risk of reduction in lung growth, evaluation requires long term follow up
Treatment related adverse effects, medication side effects can vary in intensity from none to very troublesome and worrisome. The level of intensity does not correlate to specific levels of control but should be considered in the overall assessment of risk.
Recommended action for treatment is to consider short course of oral systemic corticosteroids.
Step up 1 to 2 steps, and reevaluate in 2 weeks.
For side effects, consider alternative treatment options.
Note:  At  present, there are inadequate data to correspond frequencies of exacerbations with different levels of asthma severity.  In general, more frequent and intense exacerbations (for example, requiring urgent, unscheduled care, hospitalization, or ICU admission) indicate greater underlying disease severity.  For treatment purposes, patients who had greater than or equal to  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. 

## Stepwise Approach for Managing Asthmain Youths ≥ 12 Years of Age and Adults

- Step 1
***Preferred:***
- SABA PRN

- Intermittent
- Asthma

- Step2
***Preferred:   ***Low-dose ICS*** ****Alternative:* Cromolyn, LTRA, Nedocromil, or Theophylline

- Step 4
***Preferred:***
- Medium-dose ICS + LABA
*Alternative:*
- Medium-dose ICS+either
- LTRA, Theophylline, or Zileuton

- Step 5
***Preferred:***
- High-dose ICS + LABA
- AND
- Consider Omalizumab for patients who have allergies

- Step 6
-   ***Preferred:***
-   High-dose
- ICS + LABA + oral  corticosteroid
* *AND
- Consider Omalizumab for patients who have allergies

- Step up if needed
- (first, check adherence, environmental control, and comorbid conditions)
*** ***
- Step down if possible
- (and asthma is well controlled at least 3 months)

-                    Persistent Asthma: Daily Medication                                                                                 Consult with asthma specialist if step 4 care or higher is required.                         Consider consultation at step 3.

**Key: Alphabetical order is used when more than one treatment option is listed within either preferred or alternative therapy.**  EIB, exercise-induced bronchospasm; ICS, inhaled corticosteroid; LABA, inhaled long-acting beta2-agonist; LTRA, leukotriene receptor antagonist; SABA, inhaled short-acting beta2-agonist

**Each step: Patient education, environmental control, and management of comorbidities.**
- Steps 2-4: Consider subcutaneous allergen immunotherapy for patients who have allergic asthma *

- Step 3
***Preferred:          ***
- Low dose
- ICS + LABA
- OR medium-dose ICS
*Alternative:*
- low-dose
- ICS + either LTRA, Theophylline, or Zileuton

- Quick-Relief Medication for All Patients
- SABA as needed for symptoms. Intensity of treatment depends on severity of symptoms: up to 3 treatments at 20-minute intervals as needed. Short course of oral systemic corticosteroids may be needed
- Caution: Increasing  use of SABA or use >2 days a week for symptom relief (not prevention of EIB) generally indicates inadequate control and the need to step up treatment.

- *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 should be prepared and equipped to identify and treat anaphylaxis that may occur.

***Assess control***

**Notes:**
The stepwise approach is meant to assist, not replace, the clinical decision making 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 systemic 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 for 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 should be prepared and equipped to identify and treat anaphylaxis that may occur.

The text below is a narration of the table for the visually impaired using an electronic reading device:
Title of table is Stepwise approach for managing asthma in youths greater than or equal to 12 years of age and adults.

The key for the table is EIB, is exercise induced bronchospasm; ICS is inhaled corticosteroid; LABA is inhaled long acting beta 2 agonist;  LTRA is leukotriene receptor antagonist; SABA is inhaled short acting beta 2 agonist.  Alphabetical order is used when more than one treatment option is listed within either preferred or alternative therapy.  
The slide is organized into six distinct steps for patient education and environmental control.
Quick relief medication for all patients is SABA, as needed for symptoms.  Intensity of treatment depends on severity of symptoms.  Up to 3 treatments at 20 minute intervals as needed.  Short course of oral systemic corticosteroids may be needed.
Caution:  Increasing use of SABA or use more than 2 days a week for symptom relief, not prevention of EIB, generally indicates inadequate control and the need to step up treatment.
For intermittent asthma, step 1 is recommended.  The preferred treatment of step 1 is SABA PRN.
Persistent Asthma, which requires daily medication, corresponds with steps 2 through 6.
If step 4 care or higher is required, consult with asthma specialist.
Consultation should be considered at step 3.
Step 2, preferred treatment  is Low dose ICS.
Alternative is cromolyn, LTRA, Nedocromil, or theophylline.
For step 3, preferred treatment is low dose ICS plus LABA, or medium dose ICS.
Alternative is low dose ICS plus either LTRA, theophylline, or zileuton.

For Step 4, preferred treatment is medium dose ICS plus  LABA.
Alternative is medium dose ICS plus either LTRA, theophylline, or zileuton.
For step 5, preferred treatment is High dose ICS plus LABA and consider omalizumab for patients who have allergies.
For step 6, preferred treatment is high dose ICS plus LABA plus oral systemic corticosteroid, and consider omalizumab for patients who have allergies.

For all asthma management, step up if needed.
First, however, assess control.  Check adherence, environmental control, and comorbid conditions..
Step down if possible, and asthma is well controlled at least 3 months.

Note that for each step, include patient education, environmental control, and management of comorbidities.  
For steps 2-4, consider subcutaneous allergen immunotherapy for patients who have allergic asthma.
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 should be prepared and equipped to identify and treat anaphylaxis that may occur.