Measuring Asthma Control

with Patient-Completed
Questionnaires
Aaron Donnell, MD
Chicago Family Asthma & Allergy, SC
Children’s Community Physicians
Association Member
 Measuring Asthma Control with
Patient Questionnaires

Disclosure of Conflict of Interest Information

I have the following relationship that exists related to this

presentation:
„ Speaker for GlaxoSmithKline, who supported development of
the Asthma Control Test (ACT) and Asthma Control
Questionnaire (ACQ). The content of today’s talk does not
include pharmaceutical product information from those
presentations.

Disclosure information stated above is current as of 09/09/09

 Measuring Asthma Control with
Patient Questionnaires
Objectives
„ Discuss the assessment and measurement
of asthma “impairment” and its
application to asthma “control”.
„ Discuss patient-completed questionnaires
(ACQ, ATAQ, and ACT) as tools to assess
impairment in school-aged children and
adults.
 NHLBI NAEPP EPR-3 2007
Guidelines for the Diagnosis and
Management of Asthma

“Control: the degree to which the

manifestations of asthma (symptoms,
functional impairments, and risks of
untoward events) are minimized and the
goals of therapy are met.”
 EPR-3 2007 Guidelines
„ Both asthma severity and asthma control can be
broken down into two domains: impairment and
risk.
„ Impairment:
„ The frequency and intensity of symptoms
„ The functional limitations that a patient is experiencing
or has recently experienced.
„ Risk: the likelihood of either
„ Asthma exacerbations, or
„ Progressive loss of pulmonary function over time
 EPR-3 2007 Guidelines
„ Asthma severity:
„ Typically assessed at the time of disease presentation.
„ Details a chronic status that represents the individual
patient’s potential impairment and risk.
„ Asthma control :
„ More volatile status that can be consistently
inconsistent for some asthmatics.
„ Represents a point in time where impairment and risk
can be evaluated and measured.
 EPR-3 2007 Guidelines
Controlling 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 inhaled
short acting beta-agonists for quick relief of symptoms.
„ Maintain (near) “normal” pulmonary function.
„ Maintain normal activity levels (including exercise, other
physical activity and attendance at work or school).
„ Meet patients’ and families’ expectations of and
satisfaction with asthma care.
EPR-3 2007 Guidelines
EPR-3 2007 Guidelines
EPR-3 2007 Guidelines
Patient-Completed Questionnaires

„ ATAQ

„ “Answer The Asthma Questions!”

„ ACQ

„ “Another Clinic Quandary”

„ ACT

„ “Application for Cat Take-away”

Patient-Completed Questionnaires

„ ATAQ

„ “Asthma Therapy Assessment

Questionnaire”
„ ACQ

„ “Asthma Control Questionnaire”

„ ACT

„ “Asthma Control Test”

Asthma Control Questionnaire
(ACQ)
 Asthma Control Questionnaire (ACQ)
Goals of development:
1. Include symptoms that asthma clinicians consider to be most
important for assessing adequacy of asthma control.
2. Include a measure of:
a) Short-acting beta2-agonist use and
b) Airway caliber.
3. Be applicable to all adults with asthma.
4. Be reliable (reproducible when the clinical state is stable and able to
discriminate between patients with different levels of asthma
control).
5. Be sensitive to small but clinically important changes in asthma
control.
6. Be valid (actually measure asthma control).
7. Be short and easy to complete.
Juniper EF, et al. 1999b.
 Asthma Control Questionnaire (ACQ)
One hundred asthma specialists asked to
rate symptoms in order of importance for
evaluating asthma control.

Juniper EF, et al. 1999b.

 Asthma Control Questionnaire (ACQ)
„ Top five scoring elements of control from asthma specialists’
answers included in ACQ:
„ Awoken at night by symptoms
„ Limitation of normal daily activities
„ Waking in the morning with symptoms
„ Dyspnoea
„ Wheeze
„ Included a measure of short-acting beta2-agonist use and
airway caliber (most preferred pre-bronchodilator FEV1 %
predicted).
„ Patients recall their experiences during the previous 7 days
and respond to each question using a 7-point scale.

Juniper EF, et al. 1999b.

 Asthma Control Questionnaire (ACQ)

Juniper EF, et al. 1999b.

 Asthma Control Questionnaire (ACQ)

Juniper EF, et al. 1999b.

 Asthma Control Questionnaire (ACQ)

Juniper EF, et al. 1999b.

Asthma Control Questionnaire (ACQ)

THE Question about

Questionnaires:
But how do we know if it’s
any good?
 Brief Interlude:
Asthma Quality of Life Questionnaire (AQLQ)
„ “Gold standard” for asthma-specific disease quality of life
measurement = great way to validate new questionnaires
„ The AQLQ(S) is a 32-item, disease-specific questionnaire that uses
standardized activities to measure limitations.
„ Strong measurement properties and validity for measurements of
functional impairment in adults with asthma.
„ Patients score their experiences during the last 2 weeks on a 7-point
scale (1: severe impairment to 7: no impairment).
„ Contains 12 items on symptoms, 11 items on activity limitations, 5
items on emotional functions, and 4 items concerning environmental
stimuli.
„ A score change of 0.5 points is considered to be clinically important
and is termed the minimal important difference.

Juniper EF, et al. 1994.

Juniper EF, et al. 1999.
 Back to the ACQ

„ Validated against the Asthma Quality of Life

Questionnaire (AQLQ) and Medical Outcomes Survey
Short Form-36 (SF-36).
„ Final score: the mean of the scores for the 7 items.
„ Value less than or equal to 0.75: ‘‘Well-Controlled’’, using
the Gaining Optimal Asthma Control (GOAL)
classification.
„ Value of greater than or equal to 1.50: ‘‘Not Well-
Controlled’’.

Juniper EF, et al. 1999b.

Juniper EF, et al. 2006.
 Asthma Control Questionnaire (ACQ)

Example adult patient:

„ Uses albuterol on average 2 puffs daily.

„ Uses albuterol for very mild wheezing or shortness of

breath on early waking or with exercise.
„ Once a week middle of the night chest tightness.

„ FEV1% 90% predicted in your office.

Result: 1 (two puffs albuterol) + 1 (“very mild” waking

symptoms) + 1 (limited activity “very slightly”) + 2
(wheezing “little of the time”) + 2 (shortness of breath “a
little”) + 2 (nocturnal waking “few minutes”/week) + 1
(FEV1 90-95%) = 10, 10/7 =
1.42 (indeterminate)
 Asthma Control Questionnaire (ACQ)

„ A shortened ACQ was developed in 2006 that left out

the SABA and FEV1% data.
„ Also correlated well with the AQLQ(S).
„ More efficient for primary care settings by removing
need to perform FEV1%.
„ Modern LABA use confounded FEV1% predictability.
„ Removed concern that difficulty with spirometry
technique could alter control assessment.
„ 5 questions reduces dilution of each independent
variable in determining control.

Ehrs, P-O, et al, 2006.

 Asthma Control Questionnaire (ACQ)

Example adult patient:

„ Uses albuterol on average 2 puffs daily.

„ Uses albuterol for very mild wheezing or shortness of

breath on early waking or with exercise.
„ Once a week middle of the night chest tightness.

„ FEV1% 90% predicted in your office.

Result: 1 (“very mild” waking symptoms) + 1 (limited

activity “very slightly”) + 2 (wheezing “little of the
time”) + 2 (shortness of breath “a little”) + 2 (nocturnal
waking “few minutes”/week) = 8, 8/5 =
1.6 (Not Well Controlled)
 Asthma Control Questionnaire (ACQ)
Criticisms:
„ Most patients’ scores are less than or equal to 2.5, with scores of
greater than or equal to 4 only occurring with severe exacerbations.
„ The 7-point response scales may be more complex and time-
consuming than is necessary.
„ ACQ values of 0.76–1.4 are indeterminate regarding well-controlled
asthma.
„ Good and bad: although the ACQ includes pre-bronchodilator
FEV1%, an element of impairment measurement and a good
predictor for future exacerbations, change in this component may be
outweighed by the remaining six components.
„ Developed using only 50 asthmatic individuals in a homogeneous
Caucasian population, variations due to ethnic diversity or
population size may affect applicability.

Juniper EF, et al. 1999b.

Asthma Therapy Assessment
Questionnaire
(ATAQ)
 Asthma Therapy Assessment Questionnaire
(ATAQ)
„ 4-question, 4-point survey covering the last 4 weeks:
„ Work, school, or daily activities.

„ Night-time waking.

„ Patient self-assessment of control.

„ Short acting beta2-agonist use.

„ Each element dichotomized: one point is bad, zero is good.

„ 0 = well-controlled.
„ 1-2 = not well-controlled.
„ 3-4 = very poorly controlled.
„ Originally analyzed in Kaiser Permanente population in Portland,
Oregon, age 18 and older, with 5,181 participants who reported
doctor-diagnosed asthma and had taken asthma medications within
the past 12 months.

Vollmer WM, et al, 1999.

 Asthma Therapy Assessment Questionnaire (ATAQ)

Vollmer WM, et al, 1999.

 Asthma Therapy Assessment Questionnaire
(ATAQ)
„ Validated for good correlation with generic and disease-specific
indices of quality of life: Short-Form Health Survey [SF-36] and
Standardized AQLQ.
„ Significant association between number of control problems in the
past 4 weeks and 3 different measures of self-reported acute health
care utilization for asthma in the past year: doctor visits, emergency
department care, and hospitalizations.
„ The proportion of individuals reporting each measure increased
significantly as the number of “control problems” increased.
„ The proportion reporting hospitalization for asthma in the past
year increased from 2% to 24% comparing a score of 0 to 4,
respectively.
„ The proportion reporting two or more outpatient visits for acute
attacks increased from 19% to 72% comparing a score of 0 to 4,
respectively.
Vollmer WM, et al, 1999.
Asthma Therapy Assessment Questionnaire
(ATAQ)
Example adult patient:
„ Uses albuterol on average 2 puffs daily.
„ Uses albuterol for very mild wheezing or shortness of breath on
early waking or with exercise.
„ Once a week middle of the night chest tightness.
„ FEV1% 90% predicted in your office.
1. In the past 4 weeks did you miss any work, school, or normal daily
activities because of your asthma? (1 point for YES)
2. In the past 4 weeks, did you wake up at night because of your asthma? (1
point for YES)
3. Do you believe your asthma was well controlled in the past 4 weeks? (1
point for NO)
4. Do you use an inhaler for quick relief from asthma symptoms? If yes, what
is the highest number of puffs in 1 day you took of this inhaler? (1 point for
more than 12)
Asthma Therapy Assessment Questionnaire
(ATAQ)
Example adult patient:
„ Uses albuterol on average 2 puffs daily.
„ Uses albuterol for very mild wheezing or shortness of breath on
early waking or with exercise.
„ Once a week middle of the night chest tightness.
„ FEV1% 90% predicted in your office.

Result: 1 (Missed activity) + 1 (nocturnal waking) + 1

(doesn’t feel well-controlled) + 0 (less than 12 puffs/day
albuterol) = 3
3 is Very Poorly Controlled (3-4)
 Asthma Therapy Assessment Questionnaire
(ATAQ)
Criticisms:
„ Good:

„ Very simple to use.

„ Good validity data.

„ Negative:

„ Smaller scale makes degrees of change difficult to

assess.
„ Less reports of its use in clinical practice and clinical
trials.
„ An ATAQ developed for children and adolescents,
but 20 questions difficult in office setting.

Skinner EA, et al. 2004.

Asthma Control Test
(ACT)
 Asthma Control Test (ACT)

In developing the Asthma Control Test

(ACT), the investigators sought to:
„ Produce a questionnaire that reflected the
multidimensional nature of asthma control.
„ Demonstrate its performance against criterion
measures of asthma control.

Nathan RA, et al. 2004

 Asthma Control Test (ACT)
„ Four primary care clinicians and seven asthma specialists specified
the essential components of asthma control defined a criterion
measure of asthma control.
„ Each survey item asked the respondent to consider the last 4 weeks
(n=407, ages 12-94).
„ The asthma specialist interviewed and examined the patient and
rated the level of asthma control on a NHLBI guideline-based
5-point scale:
„ Not controlled at all
„ Poorly controlled
„ Somewhat controlled
„ Well controlled
„ Completely controlled

Nathan RA, et al. 2004

 Asthma Control Test (ACT)
„ Validation methods categorized patients into groups
known to differ in asthma control derived from 3
criterion measures.
„ Specialist’s rating of control

„ FEV1% predicted

„ Whether the specialist changed the patient’s

therapy as a result of the visit: stepped down
therapy, no change in therapy, and stepped up
therapy.

Nathan RA, et al. 2004

 Asthma Control Test (ACT)
„ Forward stepwise logistic regression analyses
showed 5 items correlating with specialist
assessment:
„ Shortness of breath
„ Patient’s rating of asthma control
„ Use of rescue medication
„ Role limitations due to asthma
„ Nocturnal asthma symptoms
„ Similar reliability in scoring methods using 5 point
scale for each item or dichotomous 0-1 scale for each
item

Nathan RA, et al. 2004

 Asthma Control Test

Asthma Control Test is a trademark of QualityMetric Incorporated. See www.asthmacontroltest.com.

 Asthma Control Test (ACT)
„ Value ≤19 predicting uncontrolled asthma:
„ Sensitivity 69.2%
„ Specificity 76.2%
„ Positive Predictive Value 56.1%
„ Negative Predictive Value 84.9%
„ Percent correctly classified per specialist 74.1%
„ Highest area under the ROC curve
„ Mean ACT scores differed significantly across defined
patient categories:
„ Specialist’s rating of control
„ Percent predicted FEV1 levels
„ Therapy was stepped up vs. stepped down or not changed

Nathan RA, et al. 2004

 Asthma Control Test (ACT)
„ Stronger correlation between the ACT scores and the
specialist’s rating of control than between FEV1 and the
specialist’s rating of control (confirming that asthma
control cannot be inferred from the clinical measure of
airway function alone).
„ Cutpoint for well-controlled asthma > 19 and poorly
controlled asthma < 16.
„ A change in ACT score of 1.88 corresponds to a change
of one level in physician rating of asthma control.
„ In a comparative study, ACT and ACQ showed similar
reproducibility, discriminate validity, and sensitivity or
specificity for detecting poorly controlled asthma.
Nathan RA, et al. 2004
Schatz M, et al. 2006
 Asthma Control Test (ACT)
Example adult patient:
„ Uses albuterol on average 2 puffs daily.
„ Uses albuterol for very mild wheezing or shortness of breath on
early waking or with exercise.
„ Once a week middle of the night chest tightness.
„ FEV1% 90% predicted in your office.

Result: 4 (“little of the time” kept from getting much done

work, school, home) + 2 (shortness of breath “once a
day”) + 2 (“two or three nights a week” awake or early
morning) + 2 (rescue “one or two times per day”) + 3
(self-rating “somewhat controlled”)
13 is uncontrolled (95% specificity)
 Childhood Asthma Control Test
(C-ACT)
„ Kids may speak when spoken to: studies how child-
reported asthma symptom reports correlate better with
FEV1 and quality-of-life measures than parent reports.
„ For C-ACT development, children 4-11 years old were
asked about the present, because children 4-6 years of
age had difficulty recalling beyond 1 day.
„ Younger children tended to use more extreme responses
and had difficulties understanding a neutral state, so a 4-
point scale was chosen.

Guyatt GH, et al. 1997.

Lara M, et al. 1998.
Liu AH, et al. 2007.
 Childhood Asthma Control Test
(C-ACT)
„ Similar validation techniques to ACT
„ Cutoff for uncontrolled asthma found best at < 20.
„ Significant correlation to criteria defined:
„ “Somewhat or poorly controlled”
„ Requiring step up in therapy
„ <80% FEV1
„ <80% FEV1/FVC
„ Sensitivity 68%
„ Specificity 74%
„ Positive Predictive Value 52%
„ Negative Predictive Value 85%

Liu AH, et al. 2007.

Childhood Asthma Control Test
Childhood Asthma Control Test
 Asthma Control Test (ACT)
„ Validated for administration at home:
„ Confirmed optimal cutoff for well-controlled > 19 and
poorly controlled asthma as 16
„ Significantly correlated with findings on the ATAQ and
Mini-AQLQ
„ Validated for administration by interactive telephone calls
using speech recognition technology.
„ Score < 16 significantly related to emergency hospital care
and oral corticosteroid and beta-agonist dispensing
„ Concordance between C-ACT < 19 and FeNO > 20 ppb.
„ Studies confirm its use as a complement, not a replacement,
to such objective measures.
Schatz M, et al. 2007.
Schatz M, et al. 2007.
Piacentini G, et al. 2009
 Real-world Evaluation of Asthma
Control and Treatment (REACT)
„ New tool to compute the risk of having uncontrolled
asthma based on patient attitudes toward medical
professionals and asthma treatment.
„ Believed that their physician recognized lifestyle compromises
due to asthma.
„ Not satisfied with their treatment regimen.
„ Took asthma medication more frequently than prescribed.
„ May improve communication between asthmatic
patients and their physicians by identifying patient
concerns regarding their treatment and quality of life.

Jones C, et al. 2009.

Summary: Positive Aspects for Q’s
„ Encourages guideline-based asthma
evaluation respect to identifying control.
„ Encourage patient and parent disease self-
awareness.
„ Rapid assessments are helpful measuring
tools.
„ Validation allows standardized
comparisons between patients and
individual patient visits.
Summary: Negative Aspect for Q’s
„ According to the NHLBI Guidelines:

“Some patients, however, appear to perceive the

severity of airflow obstruction poorly.”
„ May unconsciously accommodate to their symptoms.
„ May mistakenly attribute symptoms to other causes:
„ Aging
„ Obesity
„ Lack of fitness
„ Another measure may identify that the degree of airflow obstruction is
poorly recognized or perceived by the patient:
„ Spirometry
„ A trial of therapy with improved quality of life (“I did not realize how
much better I could feel until my asthma was treated.”)

1. Bijl-Hofland et al. 2000.

2. Kikuchi et al. 1994.
Questions for Me?
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