(1) Overview material |
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(2) Focus |
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| he expert panel organized the literature review
and updated recommendations for managing asthma long term and for managing
exacerbations around four essential components of asthma care, namely:
assessment and monitoring, patient education, control of factors
contributing to asthma severity, and pharmacologic treatment. Subtopics
were developed for each of these four broad categories. | |
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(3) Goal |
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| In response to a recommendation by the National
Asthma Education and Prevention Program (NAEPP) Coordinating Committee, an
Expert Panel was convened by the National Heart, Lung, and Blood Institute
(NHLBI) to update the asthma guidelines. | |
| Advances in science have led to an increased
understanding of asthma and its mechanisms as well as improved treatment
approaches. To help health care professionals bridge the gap between
current knowledge and practice, the NAEPP of the National Heart, Lung, and
Blood Institute (NHLBI) has previously convened three Expert Panels | |
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(4) Users/Setting |
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(5) Target population |
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(6) Developer |
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| National Heart, Lung, and Blood Institute
National Asthma Education and Prevention Progra | |
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(7) Funding source/sponsor |
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| National Heart, Lung, and Blood Institute
National Asthma Education and Prevention Progra | |
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| Expert Panel members and consultant
reviewers completed financial disclosure forms that are summarized
below | |
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(8) Evidence collection |
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| The steps used to develop this
report include: (1) completing a comprehensive search of the literature;
(2) conducting an indepth review of relevant abstracts and articles; (3)
preparing evidence tables to assess the weight of current evidence with
respect to past recommendations and new and unresolved issues; (4)
conducting thoughtful discussion and interpretation of findings; (5)
ranking strength of evidence underlying the current recommendations that
are made; (6) updating text, tables, figures, and references of the
existing guidelines with new findings from the evidence review; (7)
circulating a draft of the updated guidelines through several layers of
external review, as well as posting it on the NHLBI Web site for review
and comment by the public and the NAEPP CC, and (8) preparing a
final-report based on consideration of comments raised in the review
cycle. Two timeframes were used for
the searches, dependent on topic: January 1, 2001, through March 15,
2006, for pharmacotherapy (medications), peak flow monitoring, and
written action plans, because these topics were recently reviewed in the
EPRandamp;mdashUpdate 2002; and January 1, 1997, through March 15, 2006,
for all other topics, because these topics were last reviewed in the
EPRandamp;mdash2 1997The combined number of titles
screened from cycles 1, 2, and 3 was 15,444. The number of abstracts and
articles reviewed for all three cycles was 4,747. Of these, 2,863 were
voted to the abstract Keep list following the abstract-review step. A
database of these abstracts is posted on the NHLBI Web site. Of these
abstracts, 2,122 were advanced for full-text review, which resulted in
1,654 articles serving as a bibliography of references used to update
the guidelines, available on the NHLBI Web site. Articles were selected
from this bibliography for evidence tables and/or citation in the text.
In addition, articles reporting new and particularly relevant findings
and published after March 2006 were identified by Panel members during
the writing period (March 2006andamp;ndashDecember 2006) and by comments
received from the public review in February 2007The literature review was
conducted in three cycles over an 18-month period (September 2004 to
March 2006). Search strategies for the literature review initially were
designed to cast a wide net but later were refined by using publication
type limits and additional terms to produce results that more closely
matched the framework of topics and subtopics selected by the Expert
Panel. The searches included human studies with abstracts that were
published in English in peer-reviewed medical journals in the MEDLINE
database.Panel members identified,
with input from a librarian, key text words for each of the four
components of care. A separate search strategy was developed for each of
the four components and various key subtopics when deemed appropriate.
The key text words and Medical Subject Headings (MeSH) terms that were
used to develop each search string are found in an appendix posted on
the NHLBI Web site. | |
| The combined number of titles
screened from cycles 1, 2, and 3 was 15,444. The number of abstracts and
articles reviewed for all three cycles was 4,747. Of these, 2,863 were
voted to the abstract Keep list following the abstract-review step. A
database of these abstracts is posted on the NHLBI Web site. Of these
abstracts, 2,122 were advanced for full-text review, which resulted in
1,654 articles serving as a bibliography of references used to update
the guidelines, available on the NHLBI Web site. Articles were selected
from this bibliography for evidence tables and/or citation in the text.
In addition, articles reporting new and particularly relevant findings
and published after March 2006 were identified by Panel members during
the writing period (March 2006andamp;ndashDecember 2006) and by comments
received from the public review in February 2007 | |
| Two timeframes were used for
the searches, dependent on topic: January 1, 2001, through March 15,
2006, for pharmacotherapy (medications), peak flow monitoring, and
written action plans, because these topics were recently reviewed in the
EPRandamp;mdashUpdate 2002; and January 1, 1997, through March 15, 2006,
for all other topics, because these topics were last reviewed in the
EPRandamp;mdash2 1997 | |
| The literature review was
conducted in three cycles over an 18-month period (September 2004 to
March 2006). Search strategies for the literature review initially were
designed to cast a wide net but later were refined by using publication
type limits and additional terms to produce results that more closely
matched the framework of topics and subtopics selected by the Expert
Panel. The searches included human studies with abstracts that were
published in English in peer-reviewed medical journals in the MEDLINE
database.Panel members identified,
with input from a librarian, key text words for each of the four
components of care. A separate search strategy was developed for each of
the four components and various key subtopics when deemed appropriate.
The key text words and Medical Subject Headings (MeSH) terms that were
used to develop each search string are found in an appendix posted on
the NHLBI Web site. | |
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(9) Recommendation grading criteria |
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| The Expert Panel agreed to specify the level of
evidence used to justify the recommendations being made. Panel members
only included ranking of evidence for recommendations they made based on
the scientific literature in the current evidence review. They did not
assign evidence rankings to recommendations pulled through from the
EPRandamp;mdash2 1997 on topics that are still important to the diagnosis
and management of asthma but for which there was little new published
literature. These andamp;ldquopull throughandamp;rdquo recommendations are
designated by EPRandamp;mdash2 1997 in parentheses following the first
mention of the recommendation. For recommendations that have been either
revised or further substantiated on the basis of the evidence review
conducted for the EPRandamp;mdash3: Full Report 2007, the level of
evidence is indicated in the text in parentheses following first mention
of the recommendation. Evidence
Category A: Randomized controlled trials (RCTs), rich body of data.
Evidence is from end points of well-designed RCTs that provide a
consistent pattern of findings in the population for which the
recommendation is made. Category A requires substantial numbers of
studies involving substantial numbers of participants. Evidence Category
B: RCTs, limited body of data. Evidence is from end points of
intervention studies that include only a limited number of patients,
post hoc or subgroup analysis of RCTs, or meta-analysis of RCTs. In
general, category B pertains when few randomized trials exist; they are
small in size, they were undertaken in a population that differs from
the target population of the recommendation, or the results are somewhat
inconsistent. Evidence Category C: Nonrandomized trials and
observational studies. Evidence is from outcomes of uncontrolled or
nonrandomized trials or from observational studies. Evidence Category D:
Panel consensus judgment. This category is used only in cases where the
provision of some guidance was deemed valuable, but the clinical
literature addressing the subject was insufficient to justify placement
in one of the other categories. The Panel consensus is based on clinical
experience or knowledge that does not meet the criteria for categories A
through C.In addition to
specifying the level of evidence supporting a recommendation, the Expert
Panel agreed to indicate the strength of the recommendation. When a
certain clinical practice "is recommended," this indicates a strong
recommendation by the panel. When a certain clinical practice "should,
or may, be considered,"this indicates that the recommendation is less
strong. This distinction is an effort to address nuances of using
evidence ranking systems. For example, a recommendation for which
clinical RCT data are not available (e.g., conducting a medical history
for symptoms suggestive of asthma) may still be strongly supported by
the Panel. Furthermore, the range of evidence that qualifies a
definition of "B" or "C" is wide, and the Expert Panel considered this
range and the potential implications of a recommendation as they decided
how strongly the recommendation should be
presented. | |
| Evidence
Category A: Randomized controlled trials (RCTs), rich body of data.
Evidence is from end points of well-designed RCTs that provide a
consistent pattern of findings in the population for which the
recommendation is made. Category A requires substantial numbers of
studies involving substantial numbers of participants. Evidence Category
B: RCTs, limited body of data. Evidence is from end points of
intervention studies that include only a limited number of patients,
post hoc or subgroup analysis of RCTs, or meta-analysis of RCTs. In
general, category B pertains when few randomized trials exist; they are
small in size, they were undertaken in a population that differs from
the target population of the recommendation, or the results are somewhat
inconsistent. Evidence Category C: Nonrandomized trials and
observational studies. Evidence is from outcomes of uncontrolled or
nonrandomized trials or from observational studies. Evidence Category D:
Panel consensus judgment. This category is used only in cases where the
provision of some guidance was deemed valuable, but the clinical
literature addressing the subject was insufficient to justify placement
in one of the other categories. The Panel consensus is based on clinical
experience or knowledge that does not meet the criteria for categories A
through C. | |
| In addition to
specifying the level of evidence supporting a recommendation, the Expert
Panel agreed to indicate the strength of the recommendation. When a
certain clinical practice "is recommended," this indicates a strong
recommendation by the panel. When a certain clinical practice "should,
or may, be considered,"this indicates that the recommendation is less
strong. This distinction is an effort to address nuances of using
evidence ranking systems. For example, a recommendation for which
clinical RCT data are not available (e.g., conducting a medical history
for symptoms suggestive of asthma) may still be strongly supported by
the Panel. Furthermore, the range of evidence that qualifies a
definition of "B" or "C" is wide, and the Expert Panel considered this
range and the potential implications of a recommendation as they decided
how strongly the recommendation should be
presented. | |
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(10) Method for synthesizing evidence |
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| Evidence tables were
prepared for selected topics. It was not feasible to generate evidence
tables for every topic in the guidelines. Furthermore, many topics did not
have a sufficient body of evidence or a sufficient number of high-quality
studies to warrant the preparation of a table. The Panel decided to
prepare evidence tables on those topics for which an evidence table would
be particularly useful to assess the weight of the
evidenceandamp;mdashe.g., topics with numerous articles, conflicting
evidence, or which addressed questions raised frequently by clinicians.
Summary findings on topics without evidence tables, however, also are
included in the updated guidelines text. Evidence tables were prepared
with the assistance of a methodologist who served as a consultant to the
Expert Panel. Within their respective committees, Expert Panel members
selected the topics and articles for evidence tables. The evidence tables
included all articles that received a andamp;ldquoyesandamp;rdquo vote
from both the primary and secondary reviewer during the systematic
literature review process. The methodologist abstracted the articles to
the tables, using a template developed by the Expert Panel. The Expert
Panel subsequently reviewed and approved the final evidence tables. A
total of 20 tables, comprising 316 articles are included in the current
update (see figure 1andamp;ndash1). Evidence tables are posted on the
NHLBI Web site. | |
| The first opportunity for
discussion of findings occurred within the andamp;ldquotopic
teams.andamp;rdquo Teams then presented a summary of their findings during
a conference call to all members of their respective committee. A full
discussion ensued on each topic, and the committee arrived at a consensus
position. Teams then presented their findings and the committee position
to the full Expert Panel at an in-person meeting, thereby engaging all
Panel members in critical analysis of the evidence and interpretation of
the data. A series of conference calls for each of the 10 committees as
well as four in-person Expert Panel meetings (held in October 2004, April
2005, December 2005, and May 2006) were scheduled to facilitate discussion
of findings and to dovetail with the three cycles of literature review
that occurred over the 18-month period. Potential conflicts of interest
were disclosed at the initial meeting. | |
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(11) Pre-release review |
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| n addition to review by consultants, an
early draft of the guidelines was circulated to a panel of guidelines
end-users (the Guidelines Implementation Panel) appointed specifically for
their review and feedback on ways to enhance guidelines utilization by
primary care clinicians, health care delivery organizations, and
third-party payors.a draft of the guidelines was posted on
the NHLBI Web Site for review and comment by the NAEPP Coordinating
Committee and to allow opportunity for public review and comment before
the guidelines were finalized and released. | |
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(12) Update plan |
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(13) Definitions |
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| Asthma severity the
intrinsic intensity of disease
Exacerbations of asthma acute or subacute episodes of progressively worsening shortness of
breath, cough, wheezing, and chest tightness?or some combination of
these symptoms. Exacerbations are characterized by decreases in
expiratory airflow that can be documented and quantified by simple
measurement of lung function (spirometry or PEF). Exacerbations of
asthma can vary widely among individuals and within individuals, from
very rare to frequent. Although the classification of severity focuses
on the frequency of exacerbations, it is important to note that the
severity of disease does not necessarily correlate with the intensity
of exacerbations, which can vary from mild to very severe and
life-threatening. Patients at any level of severity, even intermittent
asthma, can have severe exacerbations.
The level of asthma control (well controlled, not well
controlled, or poorly controlled) the
degree to which both dimensions of the manifestations of
asthma?impairment and risk?are minimized by therapeutic intervention.
The level of control at the time of followup assessment will determine
clinical actions?that is, whether to maintain or adjust therapy. In
previous guidelines
The Expert Panel recommends that asthma control be
defined as follows (Evidence A): Asthma Control Reduce impairment ? Prevent chronic and troublesome
symptoms (e.g., coughing or breathlessness in the daytime, in the
night, or after exertion) ? Require infrequent use (andlt;2 days a
week) of SABA for quick relief of symptoms ? Maintain (near) ?normal?
pulmonary function ? Maintain normal activity levels (including
exercise and other physical activity and attendance at work or school)
? Meet patients? and families? expectations of and satisfaction with
asthma care ? Reduce risk ? Prevent recurrent exacerbations of asthma
and minimize the need for ED visits or hospitalizations ? Prevent
progressive loss of lung function; for children, prevent reduced lung
growth ? Provide optimal pharmacotherapy with minimal or no adverse
effects
Reducing impairment Prevent chronic and troublesome symptoms (e.g., coughing or
breathlessness in the daytime, in the night, or after exertion) ?
Require infrequent use (?2 days a week) of SABA for quick relief of
symptoms (not including prevention of EIB) ? Maintain (near) normal
pulmonary function ? Maintain normal activity levels (including
exercise and other physical activity and attendance at work or school)
? Meet patients? and families? expectations of and satisfaction with
asthma care
Reducing risk Prevent
recurrent exacerbations of asthma and minimize the need for ED visits
or hospitalizations ? Prevent progressive loss of lung function; for
children, prevent reduced lung growth ? Provide optimal
pharmacotherapy with minimal or no adverse effects
minimal or intermittent impairment, but a persistent
risk of exacerbation more than two
exacerbations a year that require oral systemic corticosteroids,
without symptoms between them
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(14) Recommendations and rationale |
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| Selecting Initial Therapy - Conditonal - 0?4 Years of Age: Initiating Long-Term Control Therapy. The
Expert Panel concludes that initiating daily long-term control therapy:
and#14; Is recommended for reducing impairment and risk of exacerbations
in infants and young children who had four or more episodes of wheezing
in the past year that lasted more than 1 day and affected sleep AND who
have risk factors for developing persistent asthma: either (1) one of
the following: parental history of asthma, a physician diagnosis of
atopic dermatitis, or evidence of sensitization to aeroallergens OR (2)
two of the following: evidence of sensitization to foods, ?4 percent
peripheral blood eosinophilia, or wheezing apart from colds (Evidence
A). | |
| 0?4 Years of Age | |
| four or more episodes of wheezing in
the past year that lasted more than 1 day and affected sleep | |
| parental history of asthma | |
| a physician diagnosis of atopic
dermatitis, or evidence of sensitization to aeroallergen | |
| evidence of sensitization to foods
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| ?4 percent peripheral blood
eosinophilia, or wheezing apart from colds | |
| initiating daily long-term control therapy:
initiating daily long-term control therapy is recommended
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| reducing impairment and risk of exacerbations
in infants and young children | |
| "is recommended" | |
| (Evidence A) | |
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| Selecting Initial Therapy (2) - Conditonal - 0?4 Years of Age: Initiating Long-Term Control Therapy. The
Expert Panel concludes that initiating daily long-term control therapy:
Should be considered for reducing impairment in infants and young
children who consistently require symptomatic treatment more than 2 days
per week for a period of more than 4 weeks (Evidence D).
| |
| consistently require symptomatic
treatment more than 2 days per week for a period of more than 4 weeks
| |
| 0?4 Years of Age | |
| initiating daily long-term control therapy:
Should be considered | |
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| should be considered | |
| (Evidence D) | |
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| Selecting Initial Therapy (3) - Conditonal - 0?4 Years of Age: Initiating Long-Term Control Therapy. The
Expert Panel concludes that initiating daily long-term control therapy:
Should be considered for reducing risk in infants and young children who
have a second asthma exacerbation requiring systemic corticosteroids
within 6 months (Evidence D). Recognition of these children and
treatment with daily low-dose ICS therapy can significantly reduce
overall symptom burden and the frequency of exacerbations, even though
such treatment will not alter the underlying severity of asthma in later
childhood | |
| a second asthma
exacerbation requiring systemic corticosteroids within 6 months | |
| 0?4 Years of Ag | |
| initiating daily long-term control therapy:
Should be considered | |
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| for reducing risk | |
| Recognition of these children and treatment
with daily low-dose ICS therapy can significantly reduce overall
symptom burden and the frequency of exacerbations, even though such
treatment will not alter the underlying severity of asthma in later
childhood (Guilbert et al. 2006) | |
| should be considered | |
| (Evidence D) | |
| | | |
| Selecting Initial Therapy (4) - Conditonal - 0?4 Years of Age: Initiating Long-Term Control Therapy. The
Expert Panel concludes that initiating daily long-term control therapy:
May be considered for use only during periods of previously documented
risk for a child (Evidence D). If daily long-term control therapy is
discontinued after the season of increased risk, written asthma action
plans indicating specific signs of worsening asthma and actions to take
should be reviewed with the caregivers, and a clinic contact should be
scheduled 2?6 weeks after discontinuation of therapy to ascertain
whether adequate control is maintained satisfactorily (Evidence D).
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| periods of previously documented
risk for a child | |
| 0?4 Years of Age | |
| initiating daily long-term control therapy:
May be considered | |
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| may be considered | |
| (Evidence D) | |
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| 5?11 Years of Age: Initiating Long-Term Control
Therapy. - Conditonal - 5?11 Years of Age: Initiating Long-Term
Control Therapy. The Expert Panel recommends daily long-term control
therapy for children who have persistent asthma | |
| 5?11 Years of Age | |
| persistent asthma | |
| The Expert Panel recommends daily long-term control
therapy | |
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| The Expert Panel recommends | |
| (Evidence A) | |
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| Adjusting Therapy - Conditonal - The
Expert Panel recommends that, if a child is already taking long-term
control medication, treatment decisions are based on the level of asthma
control that has been achieved: therapy should be stepped up if
necessary to achieve control | |
| already
taking long-term control medication | |
| therapy should be stepped up if necessary to achieve
control | |
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| The Expert Panel recommends | |
| Evidence B?extrapolated from studies
in youths and adults | |
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| control of the impairment domain is not achieved
and maintained - Conditonal - The Expert Panel recommends the
following actions if control of the impairment domain is not achieved
and maintained at any step of care: Patient adherence and technique in
using medications correctly should be assessed and addressed as
appropriate (Evidence C). | |
| if control
of the impairment domain is not achieved and maintained | |
| Patient adherence and technique in using medications
correctly should be assessed and addressed as appropriate
| |
| Other factors that diminish control of asthma
impairment should be addressed as possible reasons for poor response
to therapy and targets for intervention ( | |
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| The Expert Panel recommends | |
| (Evidence C) | |
| | | |
| control of the impairment domain is not achieved
and maintained - Conditonal - If patient adherence, inhaler technique, and
environmental control measures are adequate, and asthma is not well
controlled, a step up in treatment may be needed | |
| patient adherence | |
| inhaler technique | |
| environmental control measures | |
| a step up in treatment may be needed | |
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| recommends | |
| Evidence B?extrapolated | |
| | | |
| Address the risk domain (0-4 years) - Conditonal - The Expert Panel recommends the following actions if control
of the risk of exacerbations is not achieved or maintained (Evidence D):
0?4 years of age: If there is a history of one or more exacerbations,
review adherence to medications and control of environmental exposures,
review the patient?s written asthma action plan to confirm that it
includes oral prednisone for patients who have histories of severe
exacerbations, and consider stepping up therapy to the next level
(Evidence D) | |
| control of the risk of
exacerbations is not achieved or maintained (a history of one or more
exacerbations) | |
| 0?4 years of age | |
| review adherence to medications and control of
environmental exposures | |
| review the patient?s written asthma action
plan to confirm that it includes oral prednisone for patients who have
histories of severe exacerbations | |
| consider stepping up therapy to the next level
| |
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| The Expert Panel recommends | |
| (Evidence D) | |
| | | |
| Address the risk domain.(5-11 years)
- Conditonal - The Expert Panel recommends the following
actions if control of the risk of exacerbations is not achieved or
maintained (Evidence D) 5?11 years of age: If the history of
exacerbations suggests poorer control than does the assessment of
impairment, the following actions are recommended: reassess the
impairment domain, review adherence to medications and control of
environmental exposures, review the patient?s written asthma action plan
to confirm that it includes oral prednisone for patients who have a
history of severe exacerbations, and consider a step up in therapy,
especially for children who have reduced lung function | |
| 5?11 years of age | |
| the history of exacerbations
suggests poorer control than does the assessment of impairment | |
| reassess the impairment domain | |
| review adherence to medications and control of
environmental exposures | |
| review the patient?s written asthma action plan to
confirm that it includes oral prednisone for patients who have a
history of severe exacerbations | |
| consider a step up in therapy, especially for
children who have reduced lung function | |
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| Address the risk domain with regard to side
effects - Conditonal - The Expert Panel recommends consideration
of alternative and/or adjunctive therapies within the step of care the
patient is receiving if the patient experiences troublesome or
debilitating side effects. In addition, confirm efforts to control
environmental exposures | |
| patient
experiences troublesome or debilitating side effects | |
| consideration of alternative and/or adjunctive
therapies within the step of care the patient is receiving
| |
| confirm efforts to control environmental
exposures | |
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| The Expert Panel recommends | |
| (Evidence D | |
| | | |
| Consider referral to an asthma specialist.
- Conditonal - The Expert Panel recommends referral to an
asthma specialist for consultation or comanagement of the patient if
(Evidence D): ? There are difficulties achieving or maintaining control
of asthma. ? A child 0?4 years of age requires step 3 care or higher
(step 4 care or higher for children 5?11 years of age) to achieve and
maintain control or if additional education is indicated to improve the
patients? management skills or adherence. Referral may be considered if
a child 0?4 years of age requires step 2 care or a child 5?11 years of
age requires step 3 care. ? The patient has had an exacerbation
requiring hospitalization. ? Immunotherapy or other immunomodulators are
considered, or additional tests are indicated, to determine the role of
allergy. | |
| difficulties achieving or
maintaining control of asthma | |
| The patient has had an exacerbation
requiring hospitalization. | |
| Immunotherapy or other
immunomodulators are considered, or additional tests are indicated, to
determine the role of allergy | |
| referral to an asthma specialist for consultation or
comanagement of the patient | |
| Empty | |
| Empty | |
| The Expert Panel recommends | |
| (Evidence D) | |
| | | |
| Consider referral to an asthma specialist.
- Conditonal - A child 0?4 years of age requires step 3 care or
higher (step 4 care or higher for children 5?11 years of age) to achieve
and maintain control or if additional education is indicated to improve
the patients? management skills or adherence. Referral may be considered
if a child 0?4 years of age requires step 2 care or a child 5?11 years
of age requires step 3 care | |
| 0?4
years of age | |
| requires step 3 care or higher to
achieve and maintain control | |
| if additional education is indicated
to improve the patients? management skills or adherence | |
| Expert Panel recommends referral to an asthma
specialist for consultation or comanagement of the patient
| |
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| the Expert Panel recommends | |
| (Evidence D) | |
| | | |
| Consider referral to an asthma specialist.
- Conditonal - A child 0?4 years of age requires step 3 care or
higher (step 4 care or higher for children 5?11 years of age) to achieve
and maintain control or if additional education is indicated to improve
the patients? management skills or adherence. Referral may be considered
if a child 0?4 years of age requires step 2 care or a child 5?11 years
of age requires step 3 care | |
| 5?11
years of age | |
| requires step 4 care or higher
| |
| additional education is indicated to
improve the patients? management skills or adherence | |
| recommends referral to an asthma specialist for
consultation or comanagement of the patient | |
| Empty | |
| Empty | |
| recommends | |
| Empty | |
| | | |
| Consider referral to an asthma specialist.
- Conditonal - Referral may be considered if a child 0?4 years
of age requires step 2 care or a child 5?11 years of age requires step 3
care. | |
| 0?4 years of age | |
| requires step 2 care | |
| Referral | |
| Empty | |
| Empty | |
| may be considered | |
| Empty | |
| | | |
| Consider referral to an asthma specialist.
- Conditonal - Referral may be considered if a child 0?4 years
of age requires step 2 care or a child 5?11 years of age requires step 3
care | |
| 5?11 years of age | |
| requires step 3 care | |
| Referral may be considered | |
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| may be considered | |
| Empty | |
| | | |
| Followup - Imperative - The Expert Panel recommends that regular followup
contact is essential (Evidence B). | |
| regular followup contact is essential
| |
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| (Evidence B) | |
| | | |
| Maintaining control - Conditonal - The
Expert Panel recommends that once well-controlled asthma is achieved and
maintained for at least 3 months, a reduction in pharmacologic therapy?a
step down? can be considered helpful to identify the minimum therapy for
maintaining well-controlled asthma (Evidence D). | |
| well-controlled asthma is achieve | |
| well-controlled asthma is maintained for
at least 3 months, | |
| a reduction in pharmacologic therapy?a step down?
can be considered | |
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| Empty | |
| can be considered | |
| (Evidence D) | |
| | | |
| Pharmacologic Issues for Children 0?4 Years of
Age - Conditonal - If there is no clear response within 4?6
weeks, the therapy should be discontinued and alternative therapies or
alternative diagnoses considered | |
| no
clear response within 4?6 weeks | |
| therapy should be discontinued | |
| alternative therapies or alternative diagnoses
considered | |
| Empty | |
| treatment of young children is often in the
form of a therapeutic trial | |
| The Expert Panel recommends | |
| Evidence D | |
| | | |
| Pharmacologic Issues for Children 0?4 Years of
Age - Conditonal - If there is a clear and positive response for at
least 3 months, a step down in therapy should be undertaken to the
lowest possible doses of medication required to maintain asthma control
| |
| a clear and positive response for
at least 3 months | |
| a step down in therapy should be undertaken
| |
| Empty | |
| Empty | |
| Empty | |
| Treatment for young children,
especially infants, has not been studied adequately. Recommendations
are based on expert opinion, limited data, and extrapolations from
studies in older children and adults | |
| | | |
| Step 1 Care, Children 0?4 Years of Age
- Conditonal - The Expert Panel recommends the following
treatment for intermittent asthma: and#14; SABA taken as needed to treat
symptoms is usually sufficient therapy for intermittent asthma (EPR?2
1997). If effective in relieving symptoms, intermittent use of SABA can
continue on an as-needed basis. Increasing use, however, may indicate
more severe or inadequately controlled asthma and thus a need to step up
therapy. | |
| intermittent asthma | |
| SABA taken as needed to treat symptoms
| |
| Empty | |
| usually sufficient therapy for intermittent
asthma | |
| The Expert Panel recommends | |
| Empty | |
| | | |
| managing exacerbations due to viral respiratory
infections - Conditonal - If the symptoms are mild, SABA (every
4?6 hours for 24 hours, longer with a physician consult) may be
sufficient to control symptoms and improve lung function.
| |
| (URI) symptoms are mild | |
| SABA (every 4?6 hours for 24 hours, longer
with a physician consult) | |
| Empty | |
| to control symptoms and improve lung function. | |
| The Expert Panel recommends | |
| Empty | |
| | | |
| managing exacerbations due to viral respiratory
infections - Conditonal - If this therapy needs to be repeated more
frequently than every 6 weeks, consider a step up in long-term care.
| |
| this therapy (SABA every 4?6 hours
for 24 hours, longer with a physician consult ) | |
| consider a step up in long-term care
| |
| Empty | |
| Empty | |
| The Expert Panel recommends | |
| Empty | |
| | | |
| managing exacerbations due to viral respiratory
infections - Conditonal - If the viral respiratory infection provokes a
moderate-to-severe exacerbation, a short course of oral systemic
corticosteroids should be considered (1 mg/kg/day prednisone or
equivalent for 3?10 days) | |
| viral
respiratory infection provokes a moderate-to-severe exacerbation,
| |
| a short course of oral systemic corticosteroids
should be considered | |
| Empty | |
| Empty | |
| The Expert Panel recommends | |
| Empty | |
| | | |
| managing exacerbations due to viral respiratory
infections - Conditonal - For those patients who have a history of severe
exacerbations with viral respiratory infections, consider initiating
oral systemic corticosteroids at the first sign of the infection.
| |
| history of severe exacerbations
with viral respiratory infections, | |
| consider initiating oral systemic
corticosteroids at the first sign of the infection. | |
| Empty | |
| Empty | |
| The Expert Panel recommends | |
| Empty | |
| | | |
| asthma action plan - Conditonal - The
Expert Panel recommends that a detailed written asthma action plan be
developed for those patients who have intermittent asthma and a history
of severe exacerbations | |
| intermittent
asthma | |
| history of severe exacerbations
| |
| develop a detailed written asthma action plan
| |
| Empty | |
| Empty | |
| The Expert Panel recommends | |
| Evidence B | |
| | | |
| PERSISTENT ASTHMA - Conditonal - Daily
long-term control medication at step 2 or above is recommended for
children who had four or more wheezing episodes in 1 year and risk
factors for persistent asthma | |
| children who had four or more wheezing episodes in 1 year | |
| risk factors for persistent asthma
| |
| Daily long-term control medication at step 2
or above | |
| Empty | |
| Empty | |
| The Expert Panel recommends | |
| Evidence A | |
| | | |
| PERSISTENT ASTHMA - Conditonal - Consider daily therapy for children who have a
second exacerbation requiring oral systemic corticosteroids in 6 months
or children who consistently require symptomatic treatment andgt;2 days
a week for andgt; 4 weeks | |
| children
who have a second exacerbation requiring oral systemic corticosteroids
in 6 months | |
| children who consistently require
symptomatic treatment andgt;2 days a week for andgt; 4 weeks | |
| Consider daily therapy | |
| Empty | |
| Empty | |
| The Expert Panel recommends | |
| Evidence D | |
| | | |
| PERSISTENT ASTHMA - Conditonal - To gain more rapid control of asthma, a course of
oral systemic corticosteroids may be necessary for the patient who has
an exacerbation at the time long-term control therapy is started or in
patients who have moderate or severe asthma with frequent interference
with sleep or normal activity | |
| patient has
an exacerbation at the time long-term control therapy is started
| |
| moderate or severe asthma with
frequent interference with sleep or normal activity | |
| a course of oral systemic corticosteroids may
be necessary | |
| Empty | |
| To gain more rapid control of asthma, | |
| The Expert Panel recommends | |
| Empty | |
| | | |
| PERSISTENT ASTHMA - Conditonal - If no clear response occurs within 4?6 weeks and
medication technique and adherence are satisfactory, the treatment
should be discontinued and a change in therapy or alternative diagnoses
should be considered. | |
| no clear
response occurs within 4?6 weeks | |
| medication technique and adherence
are satisfactory | |
| treatment should be discontinued and a change
in therapy or alternative diagnoses should be considered
| |
| Empty | |
| Empty | |
| The Expert Panel recommends | |
| Evidence D | |
| | | |
| PERSISTENT ASTHMA - Conditonal - If there is a clear and positive response for at
least 3 months, a step down in therapy should be undertaken to the
lowest possible doses of medication required to maintain asthma control
( | |
| a clear and positive response for
at least 3 months | |
| a step down in therapy should be undertaken to
the lowest possible doses of medication required to maintain asthma
control | |
| Empty | |
| Empty | |
| The Expert Panel recommends | |
| Evidence D | |
| | | |
| PERSISTENT ASTHMA - Imperative - SABA should be taken as needed to relieve symptoms
| |
| SABA should be taken as needed to relieve
symptoms | |
| Empty | |
| Empty | |
| Empty | |
| | | |
| PERSISTENT ASTHMA - Imperative - Giving daily therapy only during specific periods
of previously documented risk for a child may be considered | |
| Giving daily therapy only during specific
periods of previously documented risk | |
| Empty | |
| it is possible that children who have specifically
defined periods of increased risk for symptoms and exacerbations
(e.g., during the seasons in which viral respiratory infections are
common) may require daily long-term control therapy only during this
historically documented period of risk. | |
| Evidence D | |
| | | |
| Step 2 Care, Children 0?4 Years of Age
- Conditonal - If an alternative treatment is selected and
adequate asthma control is not achieved and maintained in 4?6 weeks,
then discontinue that treatment and use the preferred medication before
stepping up therapy. | |
| alternative
treatment is selected | |
| adequate asthma control is not
achieved and maintained in 4?6 weeks | |
| discontinue that treatment | |
| use the preferred medication before stepping
up therapy | |
| Empty | |
| Empty | |
| recommends | |
| Empty | |
| | | |
| Step 2 Care, Children 0?4 Years of Age
- Conditonal - Therefore, it is the opinion of the Expert Panel
that low-dose ICS is the preferred daily long-term control therapy for
infants and young children who have never before been treated with
long-term control therapy. This medication should be prescribed in the
form of a therapeutic trial, and response should be monitored carefully.
Treatment should be stopped if a clear beneficial effect is not obvious
within 4?6 weeks and the patient/family medication technique and
adherence are satisfactory. If a clear and positive response exists for
at least 3 months (and given the high rates of spontaneous remission of
symptoms in this age group), the need for ICS therapy should be
reevaluated. A step down to intermittent therapy, as needed for
symptoms, may then be considered | |
| infants and young children who have never before been treated with
long-term control therapy | |
| low-dose ICS is the preferred daily long-term
control therapy | |
| Empty | |
| At present, few studies of medications have
been conducted in children younger than 3 years of age. ICSs have been
shown to be effective in long-term clinical studies with infants and
young children (Bisgaard et al. 2004; Guilbert et al. 2006). In
contrast, cromolyn has demonstrated inconsistent symptom control in
children younger than 5 years of age (Tasche et al. 2000). Montelukast
has shown some effectiveness in children 2?5 years of age (Knorr et
al. 2001) and, in young children who have a history of exacerbations,
can reduce symptoms associated with exacerbations and the amount of
ICSs used during exacerbations, although montelukast was not shown to
reduce requirements for oral systemic corticosteroid to control
exacerbations (Bisgaard et al. 2005). | |
| it is the opinion of the
Expert Panel | |
| Evidence D | |
| | | |
| Step 2 Care, Children 0?4 Years of Age
- Conditonal - A trial of montelukast in children 2 years of age
or older can be considered in situations in which inhaled medication
delivery is suboptimal due to poor technique or adherence.
| |
| 2 years of age or older | |
| inhaled medication delivery is
suboptimal due to poor technique or adherence | |
| A trial of montelukast can be considered
| |
| Empty | |
| Empty | |
| can be considered | |
| Empty | |
| | | |
| Step 2 Care, Children 0?4 Years of Age
- Imperative - Preferred treatment for step 2 care is daily ICS
at a low dose | |
| daily ICS at a low dose | |
| Empty | |
| Empty | |
| Evidence A based on studies of
individual drug efficacy in this age group; comparator trials are not
available | |
| | | |
| Step 2 Care, Children 0?4 Years of Age
- Imperative - Alternative, but not preferred, treatments include
(listed in alphabetical order) cromolyn (Evidence B?extrapolated from
studies in older children) and montelukast (Evidence A). If an
alternative treatment is selected and adequate asthma control is not
achieved and maintained in 4?6 weeks, then discontinue that treatment
and use the preferred medication before stepping up therapy. | |
| cromolyn (Evidence B?extrapolated from
studies in older children) | |
| montelukast (Evidence A) | |
| Empty | |
| Empty | |
| EvidenceB, A) | |
| | | |
| Step 2 Care, Children 0?4 Years of Age
- Imperative - Theophylline is not recommended as alternative
treatment (EPR?2 1997) because of its erratic metabolism during viral
infections and febrile illness in children less than 5 years of age and
the need to closely monitor and control serum concentrations. | |
| Theophylline is not recommended
| |
| Empty | |
| because of its erratic metabolism during viral
infections and febrile illness in children less than 5 years of age
and the need to closely monitor and control serum concentrations. | |
| Empty | |
| | | |
| Step 3 Care, Children 0?4 Years of Age
- Conditonal - The Expert Panel recommends increasing the dose
of ICS, for children 0?4 years of age whose asthma is not well
controlled on low doses of ICS, to ensure that an adequate dose is
delivered (due to the inherent difficulty and variability of delivering
aerosols) before adding adjunctive therapy | |
| children 0?4 years of age | |
| asthma is not well controlled on low
doses of ICS | |
| increasing the dose of ICS before adding
adjunctive therapy | |
| Empty | |
| to ensure that an adequate dose is delivered
(due to the inherent difficulty and variability of delivering
aerosols) | |
| Expert Panel recommends i | |
| Evidence D | |
| | | |
| Step 3 Care, Children 0?4 Years of Age
- Imperative - Medium-dose ICS is the preferred step 3 treatment
| |
| Medium-dose ICS | |
| Empty | |
| Empty | |
| Evidence D | |
| | | |
| Step 4 Care, Children 0?4 Years of Age
- Imperative - Medium-dose ICS AND either (listed in alphabetical
order) LABA or montelukast is the preferred treatment for step 4 | |
| Medium-dose ICS AND LABA | |
| Medium-dose ICS AND montelukast
| |
| Empty | |
| Empty | |
| Evidence D | |
| | | |
| Step 4 Care, Children 0?4 Years of Age
- Imperative - Theophylline is not recommended as add-on therapy
| |
| Theophylline is not recommended
| |
| Empty | |
| No data were found on add-on therapy in
children 0?4 years of age whose asthma is not well controlled on
medium-dose ICS. In the opinion of the Expert Panel, and extrapolating
from studies in older children and adults, adding a noncorticosteroid
long-term control medication to the medium dose of ICS may be
considered before increasing the dose of ICS to high dose, to avoid
the potential risk of side effects with high doses of medication. The
LABA DPI preparation is difficult to administer correctly to the
majority of children less than 4 years of age; studies are needed to
determine if the recently released LABA HFA will be convenient to
administer in this age group. Montelukast (an LTRA) in combination
with lower doses of an ICS can be considered for add-on therapy in
these children. Theophylline is not recommended as add-on therapy due
to the erratic metabolism of theophylline during viral infections and
febrile illness (See figure 4?4a.), which are common in this age
group, and the need for careful monitoring of serum concentration
levels | |
| Empty | |
| | | |
| Step 5 Care, Children 0?4 Years of Age
- Imperative - High-dose ICS AND either LABA or montelukast is
the preferred treatment | |
| High-dose ICS AND LABA | |
| High-dose ICS AND montelukast | |
| Empty | |
| Empty | |
| Evidence D | |
| | | |
| Step 6 Care, Children 0?4 Years of Age
- Imperative - High-dose ICS AND either LABA or montelukast AND
oral systemic corticosteroids may be given for step 6 | |
| High-dose ICS AND LABA AND oral systemic
corticosteroids | |
| High-dose ICS AND montelukastA AND oral systemic
corticosteroids | |
| Empty | |
| Empty | |
| Evidence D | |
| | | |
| Treatment: Special Issues for Children 5?11
Years of Age - Conditonal - The Expert Panel recommends that,
when initiating daily long-term control therapy for mild or moderate
persistent asthma, the choice of medication includes consideration of
treatment effectiveness, the domain of particular relevance to the
patient?s asthma (impairment, risk, or both), the individual patient?s
history of previous response to therapies, the ability of the patient
and family to use the medication correctly, anticipated patient and
family adherence to the treatment regimen, and cost | |
| when initiating daily long-term control therapy for
mild or moderate persistent asthma, | |
| the choice of medication includes
consideration of treatment effectiveness | |
| the choice of medication includes the domain of
particular relevance to the patient?s asthma (impairment, risk, or
both) | |
| the choice of medication includes
consideration of the individual patient?s history of previous response
to therapies, | |
| the choice of medication includes
consideration of the ability of the patient and family to use the
medication correctly | |
| the choice of medication includes consideration of
anticipated patient and family adherence to the treatment regimen
| |
| the choice of medication includes consideration of
cost | |
| Empty | |
| Empty | |
| The Expert Panel recommends | |
| Evidence D | |
| | | |
| Treatment: Special Issues for Children 5?11
Years of Age - Imperative - The Expert Panel recommends that the clinician
prepare a written asthma action plan for the student?s school or
childcare setting. | |
| clinician prepare a written asthma action plan
for the student?s school or childcare setting | |
| Empty | |
| Nonrandomized studies and observational studies have
demonstrated the usefulness of written asthma action plans and peak
flow monitoring in schools (Barbot et al. 2006; Borgmeyer et al. 2005;
Byrne et al. 2006; Erickson et al. 2006) | |
| Evidence C | |
| | | |
| Treatment: Special Issues for Children 5?11
Years of Age - Imperative - The Expert Panel recommends that physical activity
at play or in organized sports is an essential part of a child?s life,
and full participation in physical activities should be encouraged
| |
| full participation in physical activities should
be encouraged | |
| Empty | |
| Empty | |
| Empty | |
| | | |
| Step 1 Care, Children 5?11 Years of Age
- Conditonal - Manage moderate or severe exacerbations due to
viral respiratory infections, especially common in children, with a
short course of oral systemic corticosteroids. | |
| moderate or severe exacerbations due to viral
respiratory infections | |
| short course of oral systemic corticosteroids
| |
| Empty | |
| Empty | |
| Empty | |
| Empty | |
| | | |
| Step 1 Care, Children 5?11 Years of Age
- Conditonal - Consider initiating systemic corticosteroids at
the first sign of infection in children who have a history of severe
exacerbations with viral respiratory infections | |
| history of severe exacerbations with viral
respiratory infections | |
| Consider initiating systemic corticosteroids
at the first sign of infection | |
| Empty | |
| Empty | |
| Consider | |
| Evidence D | |
| | | |
| Step 1 Care, Children 5?11 Years of Age
- Conditonal - Provide a detailed written asthma action plan for
those patients who have intermittent asthma and a history of severe
exacerbations | |
| patients who have
intermittent asthma and a history of severe exacerbations | |
| Provide a detailed written asthma action plan
| |
| Empty | |
| Empty | |
| The Expert Panel recommends | |
| Evidence B | |
| | | |
| Step 1 Care, Children 5?11 Years of Age
- Imperative - The Expert Panel recommends the following therapy
for intermittent asthma (step 1 care): SABA, taken as needed to treat
symptoms, is usually sufficient therapy for intermittent asthma. | |
| SABA, taken as needed to treat symptoms
| |
| Empty | |
| Empty | |
| Empty | |
| | | |
| PERSISTENT ASTHMA - Conditonal - To
gain more rapid control of asthma, consider a course of oral systemic
corticosteroids for the patient who has an exacerbation at the time
long-term control therapy is started or in patients who have moderate or
severe asthma with frequent interference with sleep or normal activity
| |
| has an exacerbation at the time
long-term control therapy is started | |
| patients who have moderate asthma with
frequent interference with sleep or normal activity | |
| patients who have .severe asthma with
frequent interference with sleep or normal activity | |
| consider a course of oral systemic
corticosteroids | |
| Empty | |
| Empty | |
| The Expert Panel recommends | |
| Empty | |
| | | |
| PERSISTENT ASTHMA - Conditonal - Consider treating patients who had two or more
exacerbations requiring oral systemic corticosteroids in the past year
the same as patients who have persistent asthma, even in the absence of
an impairment level consistent with persistent asthma | |
| two or more exacerbations requiring oral systemic
corticosteroids in the past year t | |
| Consider treating as patients who have
persistent asthma | |
| Empty | |
| Empty | |
| The Expert Panel recommend | |
| Evidence D | |
| | | |
| PERSISTENT ASTHMA - Imperative - Use daily long-term control medication. | |
| Use daily long-term control medication
| |
| Empty | |
| Empty | |
| Evidence A | |
| | | |
| PERSISTENT ASTHMA - Imperative - SABA, taken as needed to relieve symptoms, is
recommended | |
| SABA, taken as needed to relieve symptoms,
| |
| Empty | |
| Empty | |
| Evidence A | |
| | | |
| PERSISTENT ASTHMA - Imperative - Giving daily therapy only during specific periods
of previously documented risk for a child may be considered | |
| Giving daily therapy only during specific periods
of previously documented risk | |
| Empty | |
| Empty | |
| Evidence D | |
| | | |
| Step 2 Care, Children 5?11 Years of Age
- Imperative - Daily low-dose ICS is the preferred step 2
treatment | |
| Daily low-dose ICS | |
| Empty | |
| High-quality evidence demonstrates the
effectiveness of ICS as initial therapy for children who have
persistent asthma | |
| Evidence A | |
| | | |
| Step 2 Care, Children 5?11 Years of Age
- Imperative - Alternative treatments at this step include
(listed in alphabetical order) cromolyn, LTRA, nedocromil, and
theophylline | |
| cromolyn | |
| LTRA | |
| nedocromil | |
| Empty | |
| Empty | |
| Empty | |
| Empty | |
| Evidence B | |
| | | |
| Step 3 Care, Children 5?11 Years of Age
- Imperative - Low-dose ICS plus the addition of some form of
adjunctive therapy or medium-dose ICS are equivalent options in step 3
care, based on extrapolation from studies in adults | |
| Low-dose ICS plus LABA | |
| Low-dose ICS plus LTRA | |
| Low-dose ICS plus theophylline
| |
| Empty | |
| Two trials demonstrated that children 4?11
years of age who had asthma not completely controlled by ICS achieved
improved lung function and symptom control with the addition of LABA
compared to placebo (Russell et al. 1995; Zimmerman et al. 2004). FDA
approval for the combination in 4- to 11-year-old children, however,
is based primarily on safety and extrapolation of efficacy from
adolescents and adults (Malone et al. 2005; Van den Berg et al. 2000).
To date, studies have not shown a reduction in significant asthma
exacerbations from the addition of LABA to ICS treatment in children
(Bisgaard 2003). One negative study of LABA in combination with ICS in
children who had mild or moderate persistent asthma failed to
establish a need in the study participants, at baseline, for more
therapy than low-dose ICS, and thus did not sufficiently address the
question of combination therapy with LABA (Verberne et al. 1998). | |
| One trial of medications for children compared
the addition of montelukast to budesonide, 400 mcg/day, and reported a
slight increase in lung function (PEF, although not FEV1) and a
reduction in as-needed SABA use (Simons et al. 2001) | |
| A small trial in 36 children, 6?18 years of
age, reported a small improvement in PEF, but not FEV1 or bronchial
reactivity, from the addition of theophylline to ICS (Suessmuth et al.
2003). Because of the risk of toxicity, multiple drug interactions,
and the need to monitor serum concentrations regularly, with no
significant beneficial effect over other adjunctive treatments,
theophylline would be considered the less desirable option for
adjunctive therapy. | |
| Evidence B?extrapolation | |
| | | |
| Step 3 Care, Children 5?11 Years of Age
- Imperative - Increasing the dose of ICS to medium dose | |
| the benefits from ICS in the
impairment domain may begin to plateau at low doses, | |
| Empty | |
| Empty | |
| Empty | |
| | | |
| Step 4 Care, Children 5?11 Years of Age
- Conditonal - In the opinion of the Expert Panel, if the
add-on therapy initially administered does not lead to improvement in
asthma control, discontinue it and use a trial of a different add-on
therapy before stepping up. | |
| add-on
therapy initially administered does not lead to improvement in asthma
control | |
| discontinue it and use a trial of a different
add-on therapy before stepping up | |
| Empty | |
| Empty | |
| Empty | |
| opinion of the Expert Panel | |
| | | |
| Step 4 Care, Children 5?11 Years of Age
- Imperative - Medium-dose ICS AND LABA is the preferred step 4
treatment | |
| Medium-dose ICS AND LABA | |
| Empty | |
| Empty | |
| Evidence B? extrapolated from studies
in youths ?12 years and adults) | |
| | | |
| Step 4 Care, Children 5?11 Years of Age
- Imperative - Alternative, but not preferred, treatment is
medium-dose ICS AND either LTRA or theophylline | |
| medium-dose ICS AND either LTRA or
theophylline | |
| Empty | |
| No data specifically address the comparative
effects of the various choices of treatments to add on to ICS in
children andlt;11 years of age. Based on comparative studies in older
children and adults (Evidence A), the preferred add-on treatment is
LABA. If the physician has concerns regarding use of LABA, an LTRA can
be given a therapeutic trial first. If a trial of LTRA is deemed
ineffective, then the LTRA should be discontinued, and theophylline
could be added. Theophylline is a less desirable option because of its
safety profile and the need to monitor serum concentration levels.
Cromolyn has not been demonstrated to be effective as add-on therapy. | |
| Evidence B?extrapolated from studies
in youths ?12 years of age and adults | |
| | | |
| Step 5 Care, Children 5?11 Years of Age
- Imperative - High-dose ICS AND LABA is the preferred step 5
treatment | |
| High-dose ICS AND LABA | |
| Empty | |
| Empty | |
| Evidence B?extrapolated | |
| | | |
| Step 5 Care, Children 5?11 Years of Age
- Imperative - Alternative, but not preferred, add-on treatments
include LTRA or theophylline | |
| add-on treatments LTRA or theophylline
| |
| Empty | |
| Empty | |
| Evidence B?extrapolated | |
| | | |
| Step 6 Care, Children 5?11 Years of Age
- Conditonal - When well-controlled asthma is achieved, make
persistent attempts to reduce oral systemic corticosteroids. High-dose
ICS therapy is preferable to oral systemic corticosteroids.
| |
| well-controlled asthma is achieved
| |
| make persistent attempts to reduce oral systemic
corticosteroids | |
| Empty | |
| Empty | |
| Empty | |
| Empty | |
| | | |
| Step 6 Care, Children 5?11 Years of Age
- Imperative - High-dose ICS AND LABA AND oral systemic
corticosteroids long term is the preferred treatment | |
| High-dose ICS AND LABA AND oral systemic
corticosteroids | |
| Empty | |
| Empty | |
| Evidence D | |
| | | |
| Step 6 Care, Children 5?11 Years of Age
- Imperative - Alternative, but not preferred, add-on treatments
are either an LTRA or theophylline AND oral systemic corticosteroids
| |
| LTRA or theophylline AND oral systemic
corticosteroids ( | |
| theophylline AND oral systemic corticosteroids
| |
| Empty | |
| Empty | |
| Evidence D | |
| | | |
| Step 6 Care, Children 5?11 Years of Age
- Imperative - Recommend consultation with an asthma specialist.
| |
| Recommend consultation with an asthma
specialist. | |
| Empty | |
| Empty | |
| Empty | |
| | | |
| PULMONARY FUNCTION TESTING (SPIROMETRY)
- Conditonal - The Expert Panel recommends that spirometry
measurements?FEV1, forced expiratory volume in 6 seconds (FEV6 ), FVC,
FEV1 /FVC?before and after the patient inhales a short-acting
bronchodilator should be undertaken for patients in whom the diagnosis
of asthma is being considered, including children ?5 years of age
| |
| patients in whom the diagnosis of
asthma is being considered | |
| children ?5 years of age | |
| FEV1 before and after the patient inhales a
short-acting bronchodilator | |
| forced expiratory volume in 6 seconds (FEV6 )
before and after the patient inhales a short-acting bronchodilator
| |
| FVC before and after the patient inhales a
short-acting bronchodilator | |
| FEV1 /FVC before and after the patient inhales
a short-acting bronchodilator | |
| Empty | |
| These measurements help to determine whether
there is airflow obstruction, its severity, and whether it is
reversible over the short term (Bye et al. 1992; Li and O'Connell
1996). (See box 3?2 for further information.) Patients? perception of
airflow obstruction is highly variable, and spirometry sometimes
reveals obstruction much more severe than would have been estimated
from the history and physical examination. | |
| Empty | |
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| | | |
| PULMONARY FUNCTION TESTING (SPIROMETRY)
- Conditonal - The Expert Panel recommends that office-based
physicians who care for asthma patients should have access to
spirometry, which is useful in both diagnosis and periodic monitoring.
Spirometry should be performed using equipment and techniques that meet
standards developed by the ATS | |
| office-based physicians who care for asthma patients | |
| have access to spirometry | |
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| PULMONARY FUNCTION TESTING (SPIROMETRY)
- Conditonal - The Expert Panel recommends that when office
spirometry shows severe abnormalities, or if questions arise regarding
test accuracy or interpretation, further assessment should be performed
in a specialized pulmonary function laboratory | |
| office spirometry shows severe abnormalities | |
| questions arise regarding test
accuracy or interpretation | |
| urther assessment should be performed in a
specialized pulmonary function laboratory | |
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| CLASSIFY ASTHMA SEVERITY - Imperative - The Expert Panel recommends that clinicians
classify asthma severity by using the domains of current impairment and
future risk (Evidence B?secondary analyses of clinical trials, and
Evidence C?observational studies, for assessing impairment; Evidence C,
for distinguishing intermittent versus persistent asthma by risk of
exacerbations; Evidence D, for distinguishing different categories of
persistent asthma by varying frequencies of exacerbations). | |
| classify asthma severity by using the domains of
current impairment and future risk | |
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| (Evidence B?secondary analyses of clinical
trials, and Evidence C?observational studies, for assessing
impairment; Evidence C, for distinguishing intermittent versus
persistent asthma by risk of exacerbations; Evidence D, for
distinguishing different categories of persistent asthma by varying
frequencies of exacerbations) | |
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| CLASSIFY ASTHMA SEVERITY - Imperative - Assessment of severity requires assessing the
following components of current impairment: Symptoms ? Nighttime
awakenings ? Need for SABA for quick relief of symptoms ? Work/school
days missed ? Ability to engage in normal daily activities or in desired
activities ? Quality-of-life assessments Lung function, measured by
spirometry: FEV1, FVC (or FEV6), FEV1/FVC (or FEV6 in adults). | |
| ASSESS: Nighttime awakenings
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| ASSESS: Need for SABA for quick relief of
symptoms | |
| ASSESS: Work/school days missed
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| ASSESS: Ability to engage in normal daily
activities or in desired activities | |
| ASSESS: Quality-of-life | |
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| MEASURES FOR PERIODIC ASSESSMENT AND MONITORING
OF ASTHMA CONTROL - Imperative - The Expert Panel recommends that ongoing
monitoring of asthma control be performed to determine whether all the
goals of therapy are met?that is, reducing both impairment and risk
(Evidence B); see figures 3?5 a, b, and c for assessing asthma control
for different age groups | |
| Monitor asthma control | |
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| to determine whether all the goals of therapy
are met?that is, reducing both impairment and risk | |
| Evidence B | |
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| MEASURES FOR PERIODIC ASSESSMENT AND MONITORING
OF ASTHMA CONTROL - Imperative - The Expert Panel recommends that the frequency of
visits to a clinician for review of asthma control is a matter of
clinical judgment; in general, patients who have intermittent or mild
persistent asthma that has been under control for at least 3 months
should be seen by a clinician about every 6 months, and patients who
have uncontrolled and/or severe persistent asthma and those who need
additional supervision to help them follow their treatment plan need to
be seen more often | |
| Monitor asthma control | |
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| The assessment measures for control
monitor six areas described in this section and are recommended based
on the opinion of the Expert Panel and review of the scientific
literature. | |
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| Monitoring Signs and Symptoms of Asthma
- Conditonal - The Expert Panel recommends the following: ? If
peak flow monitoring is performed, the written asthma action plan should
use the patient?s personal best peak flow as the reference value
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| peak flow monitoring is performed,
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| the written asthma action plan should use the
patient?s personal best peak flow as the reference value
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| Monitoring Signs and Symptoms of Asthma
- Imperative - The Expert Panel recommends that every patient who
has asthma should be taught to recognize symptom patterns that indicate
inadequate asthma control (Evidence A) (See also ?Component 2: Education
for a Partnership in Asthma Care.?). Either symptom and/or PEF
monitoring should be used as a means to determine the need for
intervention, including additional medication, in the context of a
written asthma action plan. | |
| Teach patients to recognize symptom
patterns that indicate inadequate asthma control | |
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| Evidence A | |
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| Monitoring Signs and Symptoms of Asthma
- Imperative - The Expert Panel recommends that symptoms and
clinical signs of asthma should be assessed at each health care visit
through physical examination and appropriate questions | |
| Assess symptoms and clinical signs of
asthma at each health care visit | |
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| Monitoring Signs and Symptoms of Asthma
- Imperative - The Expert Panel recommends that the detailed
symptoms history should be based on a short (2?4 weeks) recall period
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| Base detailed symptom history on a short
(2-4 week) recall period | |
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| Patients? detailed recall of symptoms
decreases over time; therefore, the clinician may choose to assess
over a 2-week, 3-week, or 4-week recall period. | |
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| Monitoring Signs and Symptoms of Asthma
- Imperative - The Expert Panel recommends that assessment of the
patient?s symptom history should include at least four key symptom
expressions | |
| Assess: Daytime asthma symptoms (including
wheezing, cough, chest tightness, or shortness of breath)
| |
| Assess: Nocturnal awakening as a result of
asthma symptoms | |
| Assess: Frequency of use of SABA for relief
of symptoms | |
| Assess: Inability or difficulty performing
normal activities (including exercise) because of asthma symptoms
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| Evidence B, extrapolation from
clinical trials; and Evidence C, from observational studies | |
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| Monitoring Signs and Symptoms of Asthma
- Imperative - The Expert Panel recommends that, in addition to
assessing symptoms, it is also important to assess pulmonary function
periodically (Evidence B, extrapolation from clinical trials; and
Evidence C, from observational studies). | |
| assess pulmonary function periodically
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| Evidence B, extrapolation from
clinical trials; and Evidence C, from observational studies | |
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| Monitoring Signs and Symptoms of Asthma
- Imperative - The Expert Panel recommends the following
frequencies for spirometry measurements: (1) at the time of initial
assessment (Evidence C); (2) after treatment is initiated and symptoms
and PEF have stabilized, to document attainment of (near) ?normal?
airway function; (3) during a period of progressive or prolonged loss of
asthma control; and (4) at least every 1?2 years to assess the
maintenance of airway function (Evidence B, extrapolation from clinical
trials). Spirometry may be indicated more often than every 1? 2 years,
depending on the clinical severity and response to management (Evidence
D). These spirometry measures should be followed over the patient?s
lifetime to detect potential for decline and rate of decline of
pulmonary function over time (Evidence C). | |
| Perform spirometry: at the time of initial
assessment (Evidence C) | |
| Perform spirometry: after treatment is
initiated and symptoms and PEF have stabilized, to document attainment
of (near) ?normal? airway function; | |
| Perform spirometry: during a period of
progressive or prolonged loss of asthma control; | |
| Perform spirometry: at least every 1?2 years to
assess the maintenance of airway function (Evidence B, extrapolation
from clinical trials | |
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| Evidence D | |
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| Monitoring Signs and Symptoms of Asthma
- Imperative - Consider long-term daily peak flow monitoring for:
? Patients who have moderate or severe persistent asthma (Evidence B). ?
Patients who have a history of severe exacerbations (Evidence B). ?
Patients who poorly perceive airflow obstruction and worsening asthma
(Evidence D). ? Patients who prefer this monitoring method (Evidence D).
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| Consider long-term daily peak flow
monitoring for: Patients who have moderate or severe persistent asthma
(Evidence B) | |
| Consider long-term daily peak flow
monitoring for: Patients who have a history of severe exacerbations
(Evidence B). | |
| Consider long-term daily peak flow
monitoring for: Patients who poorly perceive airflow obstruction and
worsening asthma (Evidence D). ? | |
| Consider long-term daily peak flow
monitoring for: Patients who prefer this monitoring method (Evidence
D). | |
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| Monitoring Signs and Symptoms of Asthma
- Imperative - Provide to all patients a written asthma action
plan that includes daily treatment and recognizing and handing worsening
asthma, including self-adjustment of medications in response to acute
symptoms or changes in PEF measures. Written action plansare
particularly recommended for patients who have moderate or severe
persistent asthma, a history of severe exacerbations, or poorly
controlled asthma (Evidence B) | |
| Provide to all patients a written asthma action
plan | |
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| (Evidence B) | |
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| Monitoring Signs and Symptoms of Asthma
- Imperative - The Expert Panel recommends that several key areas
of quality of life and related loss of physical function should be
assessed periodically for each person who has asthma (Evidence C). These
include: ? Any work or school missed because of asthma ? Any reduction
in usual activities (either home/work/school or recreation/exercise) ?
Any disturbances in sleep due to asthma ? Any change in caregivers?
activities due to a child?s asthma (for caregivers of children who have
asthma) | |
| Assess periodically: Any work or school
missed because of asthma | |
| Assess periodically:Any reduction in usual
activities (either home/work/school or recreation/exercise)
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| Assess periodically: Any disturbances in
sleep due to asthma | |
| Assess periodically: Any change in
caregivers? activities due to a child?s asthma (for caregivers of
children who have asthma) | |
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| Evidence C | |
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| Monitoring Signs and Symptoms of Asthma
- Imperative - The Expert Panel recommends that, during periodic
assessments, clinicians should question the patient and evaluate any
records of patient self-monitoring (figure 3?7) to detect exacerbations,
both those that are self-treated and those treated by other health care
providers (Evidence C). | |
| Inquire and evaluate: records of patient
self-monitoring (figure 3?7) to detect exacerbations,
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| Evidence C | |
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| Monitoring Signs and Symptoms of Asthma
- Imperative - The Expert Panel recommends monitoring the
following factors at each visit: patient?s adherence to the regimen,
inhaler technique, and side effects of medications (Evidence C) | |
| Monitor at each visit: patient?s adherence
to the regimen | |
| Monitor at each visit: inhaler technique,
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| Monitor at each visit: side effects of
medications | |
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| Evidence C | |
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| Monitoring Signs and Symptoms of Asthma
- Imperative - The Expert Panel recommends that health care
providers should routinely assess the effectiveness of patient?clinician
communication (Evidence D). | |
| routinely assess the effectiveness of
patient?clinician communication | |
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| Evidence D | |
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| Monitoring Signs and Symptoms of Asthma
- Imperative - The Expert Panel recommends that two aspects of
patient satisfaction should be monitored: satisfaction with asthma
control and satisfaction with the quality of care (Evidence D | |
| Monitor: satisfaction with asthma control
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| Monitor: satisfaction with the quality of
care | |
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| Evidence D | |
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| Referral to an Asthma Specialist for
Consultation or Comanagement - Conditonal - The Expert Panel
recommends referral for consultation or care to a specialist in asthma
care (usually, a fellowship-trained allergist or pulmonologist;
occasionally, other physicians who have expertise in asthma management,
developed through additional training and experience) when (Evidence D):
? Patient has had a life-threatening asthma exacerbation. ? Patient is
not meeting the goals of asthma therapy after 3?6 months of treatment.
An earlier referral or consultation is appropriate if the physician
concludes that the patient is unresponsive to therapy. ? Signs and
symptoms are atypical, or there are problems in differential diagnosis.
? Other conditions complicate asthma or its diagnosis (e.g., sinusitis,
nasal polyps, aspergillosis, severe rhinitis, VCD, GERD, COPD). ?
Additional diagnostic testing is indicated (e.g., allergy skin testing,
rhinoscopy, complete pulmonary function studies, provocative challenge,
bronchoscopy). ? Patient requires additional education and guidance on
complications of therapy, problems with adherence, or allergen
avoidance. ? Patient is being considered for immunotherapy. ? Patient
requires step 4 care or higher (step 3 for children 0?4 years of age).
Consider referral if patient requires step 3 care (step 2 for children
0?4 years of age). ? Patient has required more than two bursts of oral
corticosteroids in 1 year or has an exacerbation requiring
hospitalization. ? Patient requires confirmation of a history that
suggests that an occupational or environmental inhalant or ingested
substance is provoking or contributing to asthma. Depending on the
complexities of diagnosis, treatment, or the intervention required in
the work environment, it may be appropriate in some cases for the
specialist to manage the patient over a period of time or to comanage
with the PCP. In addition, patients who have significant psychiatric,
psychosocial, or family problems that interfere with their asthma
therapy may need referral to an appropriate mental health professional
for counseling or treatment. | |
| Patient
has had a life-threatening asthma exacerbation | |
| Patient is not meeting the goals of
asthma therapy after 3?6 months of treatment. An earlier referral or
consultation is appropriate if the physician concludes that the
patient is unresponsive to therapy. | |
| igns and symptoms are atypical, or
there are problems in differential diagnosis. ? | |
| Other conditions complicate asthma
or its diagnosis (e.g., sinusitis, nasal polyps, aspergillosis, severe
rhinitis, VCD, GERD, COPD) | |
| Additional diagnostic testing is
indicated (e.g., allergy skin testing, rhinoscopy, complete pulmonary
function studies, provocative challenge, bronchoscopy) | |
| Patient requires additional
education and guidance on complications of therapy, problems with
adherence, or allergen avoidance. | |
| Patient is being considered for
immunotherapy. | |
| Patient requires step 4 care or
higher (step 3 for children 0?4 years of age). | |
| Consider referral if patient
requires step 3 care (step 2 for children 0?4 years of age) | |
| Patient has required more than two
bursts of oral corticosteroids in 1 year or has an exacerbation
requiring hospitalization. | |
| Patient requires confirmation of a
history that suggests that an occupational or environmental inhalant
or ingested substance is provoking or contributing to asthma. | |
| patients who have significant
psychiatric, psychosocial, or family problems that interfere with
their asthma therapy | |
| referral for consultation or care to a
specialist in asthma care | |
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| Evidence D | |
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| Referral to an Asthma Specialist for
Consultation or Comanagement - Imperative - r | |
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| COST-EFFECTIVENESS - Imperative - The Expert Panel recommends that asthma
self-management education that is provided by trained health
professionals be considered for policies and reimbursements as an
integral part of effective asthma care; the education improves patient
outcomes (Evidence A) and can be cost-effective (Evidence B). | |
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| Clinical Decision Supports - Imperative - The Expert Panel recommends that: ? Prompts
encouraging guideline-based care be integrated into system-based
interventions focused on improving the overall quality of care rather
than used as a single intervention strategy | |
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| Evidence B | |
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| Clinical Decision Supports - Imperative - System-based interventions that address multiple
dimensions of the organization and delivery of care and clinical
decision support be considered to improve and maintain quality of care
for patients who have asthma | |
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| Evidence B and C | |
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(15) Potential benefits and harms |
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(16) Patient preferences |
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(17) Algorithm |
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(18) Implementation considerations |
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