Editorial
A New Tool to Address an Asthma Research Gap
Bruce G. Bender, PhD Denver, Colo
Symptom measures are essential to asthma research because
they allow patients to directly report on their asthma-related
symptoms. In an era of patient-centered research, they reach
into the world of patient experience and perspective. A large
number of different symptom diaries have been employed by
clinical researchers, and one might assume that among the
many available choices is a symptom diary to fit any research
need. However, a 2012 National Heart Lung and Blood
Institute asthma outcomes workshop report concluded that
many symptom questionnaires were inadequately described in
reports that presented limited information about psychometric
properties including validity, reliability, sensitivity, applicability
to subpopulations, or clinically important score changes.1 No
questionnaires met the full criteria outlined by the NHLBI
workshop report. The contribution by Globe et al2 in this issue
addresses many of these issues with statistical analyses that
examine reliability, construct validity, and responsiveness of the
Asthma Symptom Diary (ASD), along with a preliminary
“exploratory analysis” of the concept of the minimally impor-
tant difference. ASD questions were developed through a
qualitative interview study and address wheezing, shortness of
breath, cough, chest tightness, and nighttime wakening. The
ASD also introduces features that begin to distinguish it from
other symptom questionnaires including a combination of
questions about symptom changes in morning versus evening
symptoms, and a scoring strategy that averages 7 days of
symptoms.
The authors conclude that the ASD meets symptom-reporting
standards set by the Food and Drug Administration and the
NHLBI workshop report. However, more work is needed: (1)
Establishing the value of any questionnaire as an outcome
measure requires a convergence of information gathered through
multiple studies in varied settings with diverse patient groups.
The current and one previous report on the ASD are an excellent
start, but we need more information about the performance of
this instrument across patient groups, geographic areas, and
clinical settings. (2) Although the Globe et al study shows that
ASD scores correlate with other scales over 28 days, it does
Department of Pediatrics, National Jewish Health, Denver, Colo
No funding was received for this work.
Conflicts of interest: B. G. Bender has received consultancy fees from Teva; has
received research support from the National Institutes of Health; and has received
lecture fees from Merck.
Received for publication August 7, 2015; accepted for publication August 10, 2015.
Corresponding author: Bruce G. Bender, PhD, National Jewish Health, 1400 Jackson
Street, Denver, CO 80112. E-mail: benderb@njhealth.org.
J Allergy Clin Immunol Pract 2016;4:67.
2213-2198
Ó 2015 American Academy of Allergy, Asthma & Immunology
http://dx.doi.org/10.1016/j.jaip.2015.08.012
not establish the ADS’s capacity to assess long-term changes in
the course of disease- or treatment-related differences in
randomized trials. (3) To facilitate data collection, scoring,
and transfer, the ASD was developed for administration on an
electronic device. This provides an excellent capability, but
some researchers will likely choose a paper-and-pencil
administration, and therefore researchers need to understand
if the psychometric properties of the electronic ASD remain
the same with paper-and-pencil administration. (4) The
NHLBI workshop report emphasizes that validation of any
questionnaire should include an examination of the relation-
ship between the questionnaire and measures of lung func-
tion. The authors report FEV1% predicted at baseline but not
correlations with ASD scores over time. (5) Of particular
importance and underscored by the NHLBI workshop report
is the need to demonstrate the validity of the ASD among
subpopulations of vulnerable patients. Beyond race, health
disparities impact people with low socioeconomic status,3
educational level,4 health literacy backgrounds,5 and English
language proficiency.6 In the cohort of patients in the Globe
et al study, 71% were Caucasian, all but 6% had graduated
from high school, 62% had completed at least some college
education, and 46% had earned a college or graduate degree.
Therefore, the investigators who have skillfully developed the
ASD can deliver the full utility of this symptom questionnaire
by establishing that patients from various health-disparities
backgrounds are able to complete the ASD and that the
resulting scores reflect meaningful changes in disease over
time and with effective treatment. Establishing these proper-
ties will assure that this instrument can be used across a wide
range of clinical and research settings, contributing substan-
tially to day-to-day clinical care.
REFERENCES
1. Krishnan JA, Lemanske RF Jr, Canino GJ, Elward KS, Kattan M, Matsui EC,
et al. Asthma outcomes: symptoms. J Allergy Clin Immunol 2012;129(Suppl):
S124-35.
2. Globe G, Wiklund I, Lin J, Chen W-H, Martin M, Mattera MS, et al.
Psychometric properites of the Asthma Symptom Diary (ASD), a diary for use
in clinical trials of persistent asthma. J Allergy Clin Immunol Pract 2016;4:
60-6.
3. Nguyen AB, Moser R, Chou WY. Race and health profiles in the United States:
an examination of the social gradient through the 2009 CHIS adult survey. Public
Health 2014;128:1076-86.
4. Meyer PA, Penman-Aguilar A, Campbell VA, Graffunder C, O’Connor AE,
Yoon PW, et al. Conclusion and future directions: CDC Health Disparities and
Inequalities Report—United States, 2013. MMWR Surveill Summ 2013;62-
(Suppl 3):184-6.
5. Sarkar M, Asti L, Nacion KM, Chisolm DJ. The role of health literacy in pre-
dicting multiple healthcare outcomes among hispanics in a nationally represen-
tative sample: a comparative analysis by english proficiency levels. J Immigr
Minor Health 2015.
6. Douglas J, Delpachitra P, Paul E, McGain F, Pilcher D. Non-English speaking is
a predictor of survival after admission to intensive care. J Crit Care 2014;29:
769-74.
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