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ORIGINAL CONTRIBUTION
Global airways – a novel Standard Tests for Asthma, allergic
Rhinitis, and chronic Rhinosinusitis (STARR-15)*
Abstract
Background: Global airway disease, with symptoms from both upper and lower airways, is a challenging problem for clinicians.
Our goal is to design one single standard test for the awareness of global airway diseases to be used in clinical setting.
Material and Methods: During 2019, rhinologists and pulmonologists generated a pool of items based on literature, patient-re-
ported outcome measures and clinical experience. The items were administered to 206 patients with known asthma, CRS, allergic
rhinitis, or a combination thereof. The patients also completed the Asthma Control Questionnaire (ACQ-5) and the Sino-Nasal Out-
come Test (SNOT-22). Using a mix of clinical knowledge and data-driven methods a global airways questionnaire was developed,
Results: Mean ACQ score was highest in patients with all three, whereas the highest SNOT-22 score was observed in patients with
CRS and asthma. After the development process, analysis of responses from 206 patients to 44 items on a new global airway’s
questionnaire led to identification of 15 items that form the STARR-15 questionnaire with three underlying domains (an allergic
rhinitis sub-factor, a CRS sub-factor and an asthma sub-factor).
Conclusion: STARR-15 represents the first global airways questionnaire, to be used when examining patients with upper and
lower airways symptoms. Future analyses are warranted to evaluate the clinical and psychometric properties of STARR-15.
Key words: allergic rhinitis, asthma, chronic rhinosinusitis, global airways, PROM’s, questionnaire
V. Backer1,2, K. Aanaes1, S. Hansen3, J. Petersen3,4, C. von Buchwald1
1 Department of ORL, Head and Neck Surgery and Audiology, Rigshospitalet, Copenhagen University, Copenhagen, Denmark
2 Center of Physical activity Research, Rigshospitalet, Copenhagen University, Copenhagen, Denmark
3 Center for Clinical research and Prevention, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen,
Denmark
4 Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
Rhinology 60: 1, 63 - 72, 2022
https://doi.org/10.4193/Rhin21.195
*Received for publication:
April 6, 2021
Accepted: October 19, 2021
63
Introduction
Patient-reported outcome measures (PROMs) are questionnaires
measuring patients’ views of their own health status (1, 2). PROMs
are self-completed questionnaires, in which patients are asked
about their own perspectives of their feelings, symptoms, and
anxiety before and after treatment (3, 4).
The asthma control questionnaire (ACQ) is the most widely used
PROM (5), especially in severe asthma, all countries including data
in International Severe asthma registry (ISAR) and the Nordic
severe asthma registry are recommended to use ACQ (6, 7); it in-
cludes a subdivision in scales, with a weighted value indicating
the level of control independent of severity of asthma, where
the original ACQ-7 has been reduced to the ACQ-5 (8). ACQ is
the only questionnaire fulfilling all essential characteristics,
including validity, responsiveness, stability, internal consistency,
and interpretability. ACQ does not have diagnostic potential,
the recall period is seven days, and the level of asthma control
is measured by a score of ACQ when used in patients with diag-
nosed asthma (9).
When examining patients with upper airway symptoms (e.g.,
nasal stenosis, nasal discharge, loss of smell and facial pain),
various questionnaires are available, including the most often
used Sino-Nasal Outcome Test (SNOT-22). SNOT-22 is a disease-
specific PROM used in chronic rhinosinusitis (CRS) and is consi-
dered the most suitable tool for assessing the level of severity
in patients diagnosed with CRS with or without nasal polyps
(CRSwNP and CRSsNP) (10, 11), but is however not restricted to
nasal symptoms only.
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Backer et al.
Disease of upper and lower airways is often present in the same
patients, so a considerable overlap between the two diseases
as well as inflammation exists and in such a degree that it is
named, global airways disease (12). The reason is that both disea-
ses and especially the moderate to severe level of disease often
are driven by type 2 inflammation (13, 14). Several different PROMs
are routinely used in clinical settings within both pulmonology
and rhinology, but no combined questionnaire exists covering
the global airway diseases. No sinonasal symptoms are included
in any of the asthma questionnaires used, whereas the SNOT-22
includes various symptoms, also some asthma-like symptoms.
Patients with upper and lower airway disease happen to be
examined and treated by either rhinologists or pulmonologists,
and identifying co-morbidities are often lacking in both clinical
settings (15). As diseases simultaneously occur in global airways,
patients should be evaluated at both upper and lower airways,
as better disease control are gained, when both upper and lower
airways are treated.
The objective of this study was to take the first steps towards
developing one single standardised questionnaire (Standard
Test for Asthma, allergic Rhinitis, and chronic Rhinosinusitis,
entitled STARR-15)) comprising of symptoms of both upper and
lower airways in patients with known disease with the goal of
providing increased awareness of the global airway disease. In
this study, we describe the development process using a sample
of 206 patients.
Methods
The development of a global airway’s questionnaire was con-
ducted in several phases. First, identification of potential items
was performed and put together to form a first version of the
questionnaire (item identification phase and pilot phase), then a
sample of patients completed the questionnaire (data collection
phase), and their responses were analyzed to form a reduced
form of the questionnaire (item reduction phase). This reduced
questionnaire underwent further statistical analyses. All phases
are described in detail below. In all phases, we used a mix of
data-driven approaches and our clinical experience to guide
the analyses. The project was approved by the Capital Region in
Denmark with project no VD-2018-383, the Local ethical com-
mitee no FSP 21064988, and informed consent was obtained
from all patients.
Item identification and pilot phase
Item identification was performed by the authors through brain-
storms and face-to-face meetings. Items from existing measures
such as the ACQ and the SNOT-22 were reviewed and conside-
red for inclusion. This process generated a pool of 55 candidate
items. A Likert scale with six response options was selected (“no
problem”, “very mild problem”, “mild or slight problem”, “mode-
rate problem”, “severe problem”, “problem as bad as it can be”).
This first version of the questionnaire underwent pilot testing in
eleven patients with asthma, CRS, allergic rhinitis, or a combi-
nation of the diseases. The patients were interviewed by one of
the authors immediately after completing the questionnaire to
explore the items’ comprehensiveness, relevance, and clarity.
Data collection
Patients above the age of 18 years, who could read and write
Danish, were followed in a specialist clinic, and had prior to the
inclusion been diagnosed with asthma, CRS, or allergic rhinitis
(or with a combination of these diseases) were included. All
patients were diagnosed by a specialist trained in global airways
diseases. The patients were managed in the clinic and was diag-
nosed at the time of referral; CRS was diagnosed according to
the EPOS2020 guidelines, thus all patients diagnosed with CRS
had a sinus CT scan a nasal endoscopy and symptoms registe-
red; allergic rhinitis was based on symptoms and a skin prick
test; asthma was diagnosed based on symptoms and a mannitol
provocation or response to beta2-agonist. All with asthma had
lung function performed and skin prick test measured at the
time of referral.
Patients were recruited from respiratory and ear-nose-throat
(ENT) outpatient clinics, at five different sites in the Copenhagen
County of Denmark. All patients completed the new question-
naire as well as the ACQ-5 and SNOT-22 questionnaires.
Item reduction phase
A reduction in the number of items was performed in several
steps, using a mix of data-driven approaches but also using our
clinical experience. First, we applied two a priori defined exclu-
sion criteria: 1) any item with less than 20% of subjects indica-
ting a symptom to be “a moderate problem”, “a severe problem”,
or “problem as bad as it can be” to avoid floor and ceiling effects
(16); or 2) one of any two items whose Pearson’s correlation coef-
ficient was 0.70 or higher to avoid including items with the same
meaning.
Statistical analyses
To assess the questionnaire’s ability to discriminate between
patients suffering from asthma, CRS, allergic rhinitis or a combi-
nation thereof, we compared item means between the disease
groups and evaluated associations by a Kruskal-Wallis test.
Using PROC IRT in SAS, we fitted unconstrained graded response
models (GRM) treating item responses as ordinal variables.
Eigen values were used to assess dimensionality and latent trait
parameter estimates and item characteristic curves were ob-
tained. We estimated factor scores using maximum a posteriori
estimation and used the criterion that items were assigned to
the factor on which the item had a higher factor load. Factor
scores were compared using F-statistics among the patients
with different underlying diseases to evaluate their ability to dif-
65
STARR-15
clinical variables are shown in Table 1 and Supplementary Table
1. Dividing the total population into five categories, led to 54
(28%) patients having a CRS diagnosis only, 39 (20%) an asthma
diagnosis only, 29 (15%) a combination of CRS and asthma, 54
(28%) asthma with allergic rhinitis, and 18 (9%) patients having
all three conditions (Table 1). Mean ACQ-5 score was highest in
patients with all three conditions [1.84 (SD=1.24)], whereas the
highest SNOT-22 score was observed in patients with CRS and
asthma [62 (SD=22)] (Table 1).
Item reduction phase
The patients’ responses to the 44 included items are presented
in Table 2. Based on these responses in the 206 patients, we
observed that items 3, 4, 5, 6, 7, 8, 9, 10, 20, 21, 24, 25, 26, 42, 43
met exclusion criterion 1 (floor and ceiling effects), and items 13
and 14, items 14 and 17, items 16 and 17, items 18 and 19, items
23 and 27, items 24 and 28, item 38 and 39, items 42 and 43, and
items 31, 33, 34, 35, 36, 38 met exclusion criterion 2 (correlated
items) (data not shown).
Despite some items fulfilling the exclusion criteria, our clinical
knowledge overruled some findings based on significant clinical
importance of the items. The authors decided to keep items 25
and 26 (“wheezing” and “chest tightness”) despite the fact that
fewer than 20% indicated these symptoms to be moderate, se-
vere, or as bad as can be. Further, it was decided not to consider
items 1 (“headache”,) 29 (“common cold”), and 38 (“tiredness”)
since they were deemed too unspecific, and items 18 (“dry
mucous membranes”) and 19 (“morning dryness in the throat”)
since they were not considered as relevant for the diseases
compared to some of the other items. Two sets of items (items
6 and 21 “itchy eyes” and “itchy nose”, respectively and items 23
and 27 “shortness of breath” and “shortness of breath/difficult
to breath”, respectively) were combined to form one item each
ferentiate between patients. Internal consistency was evaluated
using Cronbach’s α. To test the discriminant validity, we also
analyzed the association between the factor scores and ACQ-5
and SNOT-22 scores using simple linear regression evaluated by
the R2 and Root Mean Square Errors (RMSE). During the analysis,
patients with allergic rhinitis only, were excluded as this disease
could not be grouped during the process of 5 disease categories
(n=12) and 3 disease categories (n=5). We used SAS Enterprise
Guide 7.1 to analyze our data, and all reported p-values were
two-sided with an α of 0.05.
Results
First, the modifications to the list of items resulting from the
pilot phase are presented, followed by a presentation of the
results obtained from the data collection and item reduction
phases.
Pilot testing
After the pilot testing in 11 patients, modifications were made
to the list of the original 55 items. First, an additional response
category was added to some items (“not relevant”), and two
items were combined (“facial pain” and “facial pressure” to form
one item). Some items were deleted (“middle ear problems”, “de-
afness”, “decreased sense of taste”, “use of nasal rinse with saline”,
“avoid social contact”, “frequent infections”, “frustration”, “rest-
lessness”, ”irritation”, “administration of Xylometazoline drops”)
due to the more general character of these questions. After the
pilot phase, the questionnaire consisted of 44 items that formed
the questionnaire that was completed in the full patient sample.
Data collection
At total of 207 patients were included during 2019–2020. Out of
these, 206 returned their response. Patient demographics and
Tabel 1. Characteristics of the study population according to disease group.
Physician reported diagnoses
Five groups*
Physician reported diagnoses
Three groups**
Total CRS only Asthma
only
CRS and
asthma
Asthma
and AR
Asthma,
CRS, AR
p CRS only
(± AR)
Asthma
only
(± AR)
Asthma
and CRS
(±AR)
p
Number of
respondents 206 54 (28%) 39 (20%) 29 (15%) 54 (28%) 18 (9%) 61 (30%) 93 (46%) 47 (23%)
Male 107 (52%) 39 (72%) 9 (23%) 14 (48%) 30 (56%) 9 (50%) 0.004 42 (69%) 39 (42%) 23 (49%) 0.004
Age (years) 47 (17) 47 (19) 46 (17) 51 (16) 44 (14) 60 (12) 0.004 46 (19) 45 (15) 54 (15) 0.003
BMI (kg/m2)26 (5) 26 (6) 25 (3) 25 (4) 26 (5) 28 (6) 0.42 26 (6) 26 (5) 26 (5) 0.90
ACQ-5 score 1.15 (1.21) 0.21
(0.74)
1.34
(1.03)
1.72
(1.27)
1.54
(1.14)
1.84
(1.24) <0.001 0.19
(0.69)
1.45
(1.10)
1.77
(1.25) <0.001
SNOT-22 score 52 (19) 59 (16) 42 (15) 62 (22) 44 (17) 58 (14) <0.001 59 (16) 43 (16) 51 (19) <0.001
Values are n (%) or mean (sd), AR: allergic rhinitis, *12 patients with AR only not included, **5 patients with AR only and AR and CRS not included.
66
Backer et al.
Table 2. Item response frequencies on the full questionnaire. Items marked in blue were retained on the reduced questionnaire, including18 items.
Item
content
Response value
Item
full Q
Item
reduced
Q
During the past 12 weeks, how often
have you been bothered by the fol-
lowing symptoms:
No
problem
A very
mild
problem
Mild or
slight
problem
A
moderate
problem
A severe
problem
Problem
as bad as
can be
Not
relevant
1 Headache 36% 21% 14% 23% 5% 2%
2 1 Facial pain / pressure#63% 11% 6% 13% 6% 1%
3 Ear pain#74% 12% 7% 4% 4% 0%
4 2 Ear fullness pressure#63% 16% 11% 5% 2% 1%
5 Dizziness#57% 20% 11% 8% 3% 0%
6 3 Itchy eyes* 40% 28% 16% 13% 3% 0%
7 Red eyes 64% 19% 9% 7% 2% 0%
8 Itchy skin 55% 18% 15% 8% 2% 1%
9 Itchy ears 67% 13% 12% 8% 2% 0%
10 Ichty palate 70% 16% 8% 4% 1% 1%
11 Need to blow nose#17% 23% 21% 18% 16% 5%
12 4 Sneezing#28% 30% 17% 19% 4% 1%
13 5 Runny nose#33% 21% 16% 17% 11% 3%
14 6 Nasal blockage#28% 17% 11% 18% 17% 10%
15 7 Decreased sense of smell#51% 11% 7% 13% 9% 8%
16 8 Post nasal discharge#35% 20% 14% 13% 12% 6%
17 Thick nasal discharge#44% 16% 15% 10% 11% 5%
18 Dry mucous membranes 45% 20% 15% 13% 6% 2%
19 Morning dryness in the throat 43% 15% 11% 17% 11% 4%
20 Nose bleeding 75% 13% 5% 4% 2% 0%
21 3 Itchy nose* 54% 23% 12% 8% 2% 1%
22 9 Cough#24% 24% 18% 14% 14% 5%
23 10 Shortness of breathe** 35% 20% 18% 12% 11% 4%
24 Phlegm or expectoration 52% 15% 12% 9% 9% 1%
25 11 Wheezing*** 44% 24% 13% 11% 7% 1%
26 12 Chest tightness *** 62% 14% 11% 8% 4% 1%
27 10 Shortness of breath / difficulties
breathing ** 35% 20% 18% 16% 8% 4%
28 13 Productive cough 30% 22% 14% 17% 12% 3%
29 Common cold 34% 18% 21% 14% 9% 2%
30 14 Snoring 37% 17% 15% 13% 13% 6%
31 Difficulty falling asleep#43% 21% 14% 11% 5% 4%
32 Symptoms at night 48% 16% 12% 10% 8% 4%
33 Wake up at night#33% 24% 14% 13% 13% 5%
34 15 Lack of a good night’s sleep#31% 22% 13% 17% 11% 5%
35 Shortened sleep 36% 20% 13% 18% 7% 5%
36 Wake up tired#22% 24% 17% 20% 9% 7%
37 Tendency to fall asleep during the day 46% 17% 17% 11% 6% 3%
38 Tiredness 21% 24% 19% 18% 12% 5%
39 Reduced concentration#43% 24% 15% 11% 5% 2%
40 16 Difficulties doing sports / training /
physical activity 28% 18% 14% 13% 7% 4% 15%
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STARR-15
Items marked in bold were kept for analysis. *Items were combined to form one item. **Items were combined to form one item.***Items were kept
in the questionnaire despite fewer than <20% of patients indicating the symptom to be moderate, severe, or the worst possible symptom, # Indicates
items on SNOT-22.
Item
content
Response value
Item
full Q
Item
reduced
Q
During the past 12 weeks, how often
have you been bothered by the fol-
lowing symptoms:
No
problem
A very
mild
problem
Mild or
slight
problem
A
moderate
problem
A severe
problem
Problem
as bad as
can be
Not
relevant
41 Limitations in your domestic daily
activities (including vacuum, cleaning,
mowing the lawn)
47% 20% 11% 10% 7% 3% 2%
42 Difficulties doing work work / school 46% 21% 10% 6% 3% 2% 13%
43 17 Absence from work or school 59% 11% 6% 4% 3% 1% 17%
Yes No Not
relevant
44 18 Seasonal variation in symptoms 69% 9% 22%
*Denotes statistical significance by a Kruskal-Wallis test
0
1
2
3
4
5
Item mean
CRS only Asthma only CRS and asthma Asthma and allergy Asthma, CRS and allergy
0
1
2
3
4
5
Item mean
CRS (+/- allergic rhinitis) Asthma (+/- allergic rhinitis) CRS and asthma (+/- allergic rhinitis)
Figure 1. Item means on the reduced questionnaire according to disease group. Figure 1A include all 5 groups, and 1B three groups, with same ques-
tionnaire response.
68
Backer et al.
based on considerations that they covered the same underlying
construction. The highest endorsed response value on the two
items was chosen as response value on the combination item.
For any two items that showed pearson’s correlations > 0.70, the
authors went through the pairwise items and discussed which
should be kept for analysis based on clinical importance. which
resulted in retaining items 13 (“runny nose”), 14 (“nasal blocka-
ge”), 16 (“postnasal discharge”). For Items 31, 33, 34, 35, 36, and
38 that were all correlations > 0.70, the authors decided to retain
item 34 (“lack of a good night’s sleep”).
The above-mentioned modifications led to a modified version
of the questionnaire with 18 items that underwent further statis-
tical analyses and marked in blue in Table 2.
Statistical testing of the final questionnaire
The reduced questionnaire including 18 items was first analyzed
with respect to item means. In Figure 1, item means are illustra-
ted according to underlying disease (A with all five and B with
three groups). Means of items 2, 4, 9, 11, 12, 15, and 17 were not
significantly different among the disease groups in five catego-
ries, whereas means of items 1, 3, 5, 6, 7, 8, 10, 13, 14, 16, and
18 were significantly different. The patients’ responses to ACQ-5
and SNOT-22 are seen in Supplementary Figure 1.
Item response theory analyses
We fitted a model using the 18 items with responses on the
6-point Likert scale. The item characteristics curves indicated a
large overlap in the probability of endorsing response catego-
ries “very small problem”, “a small problem”, “moderate problem”
and “severe problem” across the latent trait suggesting limited
discriminative ability about the latent trait of these response
categories (data not shown). We therefore fitted a model where
we combined the six response categories to form a 3-point
Likert scale with the options “no problem”, “a small problem” (this
was a combination of the previous categories “a very small pro-
blem”, ”a small problem”, and “a moderate problem”) and “a large
problem” (this was a combination of the previous categories “a
severe problem” and “problem as bad as it can be”). Based on the
eigen values, this model appeared to have 3 underlying factors.
Three separate factors were therefore calculated with factor
loads seen in Supplementary Table 2A. One factor comprised of
four items (items 1, 2, 15, 17) that could not be categorized into
a clinically meaningful dimension. We therefore decided to test
a new model without these items; however, based on clinical im-
portance, item 1 (“facial pain”) was retained leading to a model
with 15 items (Supplementary Table 2B). The eigen values and
scree plot suggested three underlying dimensions explaining
58% of the variance (Supplementary Figure 2). Factor loads are
seen in Supplementary Table 2B and item characteristics curves
in Supplementary Figure 3.
Factor 1 was labelled “Asthma factor”, Factor 2 “CRS factor”, and
Factor 3 “Allergic rhinitis factor”. Cronbach’s alpha was 0.73, 0.76,
and 0.63 for the three factors, respectively, suggesting accepta-
ble internal consistency for the “Asthma factor” and “CRS factor”.
The ability of the three factors to differentiate between patients
with CRS only, asthma only, CRS and asthma, asthma and allergy,
and a combination of all three diseases is seen in Figure 2, where
2A represent all 5 groups, and 2B the 3 merged disease groups
(numbers in Supplementary Table 3). CRS only patients scored
lower on the asthma factor compared to the other disease
groups, whereas patients with CRS either alone or in combinati-
on with asthma and/or allergic rhinitis scored higher on the CRS
factor. The asthma patients scored low on the CRS factors, alt-
hough a substantial overlap exists (Figure 2 A and B). There was
little difference among patients on the allergic rhinitis factor.
The associations between the asthma factor scores and the
ACQ-5 as well as the CRS factor and SNOT-22 scores are seen
in Figure 3 (A: the 5 groups and B: 3 groups). The asthma factor
score explained (R2-value) 0.35-0.58 of the variances in ACQ-
5 for patients with asthma alone or in combination with CRS
and/or allergic rhinitis. However, the association was weaker
as illustrated by a smaller R2 (0.12) and larger residual variance
(RMSE=0.90) for patients with CRS only. When comparing the
Figure 2. Factor scores from the IRT model against disease groups. Figure
A include all five groups, whereas figure B include the 3 merged groups.
69
STARR-15
STARR-15 questionnaire resulting from the above analyses and
to be validated further using another patient sample is shown in
Supplementary Table 2B and in Table 3.
CRS factor to SNOT-22 there was a larger variation in the associ-
ation depending on the disease group. Weakest association was
observed for CRS only patients (R2 = 0.10) (Figure 4). The final
Figure 3. The asthma factor from the IRT model against ACQ-5 score. Figure 3A include the 5 disease groups, and 3B the merged 3 disease groups.
Figure 4. CRS sub-factor from the IRT model against SNOT-22. Figure A include all 5 disease groups, and Figure B the 3 groups of merged disease.
70
Backer et al.
Discussion
In this survey, we examined a bucket of upper and lower respi-
ratory questions and complains, in a relevant group of patients
diagnosed in secondary care prior to inclusion, and we succee-
ded in the development of global airways standard test with 15
items. The 15 items were selected resulting from analyses using
a data-driven approach and by applying our knowledge from
more than 20 years in the clinic. Interestingly these 15 included
symptoms are in alliance with symptoms suggested by GINA (17),
EPOS2020 (18) and ARIA (19). All patients were suffering from either
allergic rhinitis, CRS and/or asthma and were diagnosed in rhi-
nology or pulmonology setting, with interest in global airways.
We found a large overlap in the responses to this questionnaire
among patients with the three diseases, which supports the
concept of global airway disease possibly with similar inflam-
matory mechanisms; however, this complicates the diagnostic
potential of a global airway questionnaire. On the other hand,
this STARR-15 tool provides the clinician with a reasonable
indication of upper and lower airway symptoms. In case of one
or more positive responses occurs, patients should thus be exa-
mined systematically to identify global airway disease (20).
The median ACQ-5 score was over 1.5 and the median SNOT22
score was above 60 point, and the majority of the patients had
CRSwNP (>90%) indicating somewhat uncontrolled diseases
with current respiratory symptoms during both 1 and 2 weeks.
Furthermore, more than half of the asthma patients suffered
from upper airway diseases as well, and likewise more than half
of the patients with CRS, suffered from lower airway disease.
Therefore, it is important, to develop an easy-to-use tool,
which can enlighten the clinician of double disease. The ACQ
questionnaire is widely used in asthma and allergy clinics as
the most valid and robust tool (5), furthermore ACQ was used in
the present study, as ACQ correlated with level of GINA in real
life setting (21) and are used in severe asthma clinic, although
it might be troublesome in an ENT clinic or in a general clinic
where the patients do not have any knowledge of asthma,
as they have respiratory symptoms only, but no diagnose of
asthma. Moreover, the SNOT-22 score is not specific enough and
consequently, an asthma patient can obtain a higher SNOT-22
score without having CRS. In a former study of CRS performed
in specialist ENT clinic out-side hospital, we found 40% had
asthma, of whom 50% did not know about having asthma on
top of CRS (15), similarly in patients referred for nasal surgery in
hospital setting (22). The ENT surgeon was not aware of current
double disease, which support the need for focus on global
airways. We developed a 15-item questionnaire, STARR-15, that
is thought to be used in clinic setting to screen for possible
co-morbidity. Traditionally pulmonologist use to be more aware
of allergic rhinitis symptoms (23) and need of treatment of airway
allergies, whereas the knowledge of CRS are limited. It is evident
that the upper and lower airways influence on another and both
should be optimally treated, this awareness of triple disease is
also important in general praxis, where the majority of patients
are taken care of. Of the 15-item questionnaire, three items
pointed in the direction of variable upper airway disease, related
to histamine induced symptoms, five turned out to point in
the direction of chronic upper respiratory disease, and lastly six
pointed in the direction of lower airway disease. Interestingly,
Table 3. The STARR-15 questionnaire.
Item During the past 12 weeks, how have you been
bothered by the following symptoms:
No problem A moderate problem A severe problem
1 Itchy eyes or nose
2 Sneezing
3 Runny nose
4 Seasonal variation in symptoms
5 Facial pain
6 Nasal blockage
7 Decreased sense of smell
8 Postnasal discharge
9 Snoring
10 Productive cough
11 Cough
12 Dyspnea/shortness of breath/difficulties breathing
13 Wheezing
14 Chest tightness
15 Difficulties doing sports
71
STARR-15
cough was included both as productive cough as part of the
claims among the patients suffering of CRS and cough as part
of asthma. This is also knowledge supported by the clinical and
scientific experience (24, 25), where the productive cough might
be due post-nasal drip, where the dry cough might be signs of
hyperresponsiveness. Some questions, which were less associ-
ated with the new STARR-15 questionnaire developed through
analysis of 49 items were the questions concerning sleep, night-
time awakenings, and daytime sleepiness. Questions concerning
sleep are of importance, as nighttime awakenings in asthma are
related with substantial uncontrolled disease. Sleep could have
been importance in evaluation of severity of both asthma and
CRS, but the current questionnaire did not support the pos-
sibility of grading the severity of the global airway’s diseases.
Likewise, another question, which was erased during analysis
was “exercise” or “physical activity”. However, all three patient
categories complain of exercise limitation to some degree by
responding on the question “difficulties doing sport” which
was included in the STARR-15, on behalf of the asthma group.
Physical limitations is in alliance with the symptoms suggested
in both GINA guidelines (17) and EPOS2020 (18). Lastly, “facial pain”
was also eliminated from the questionnaire, during the analysis.
However, facial pain is a diagnostic criterion in the EPOS2020
evaluation of patients with CRS (18, 20). We therefore included this
question, independent of the deletion through the analyses.
When testing patients, it seems to be possible to screen for
upper and lower airway disease by the STARR-15 questionnaire,
it was however, not possible in the current set-up to diagnose
the two or three diseases, as the diagnosis was already known.
Furthermore, although the primary aim was to include a severity
score in the current global airway questionnaire, the STARR-15
test was not able to examine the degree of disease severity.
The strengths of the current questionnaire are that it is a
symptom-based test, asking for respiratory complains, without
naming allergy, CRS or asthma. The questionnaire is manageable
without an excess of questions and calculations. No arithmetic’s
are needed. This makes our questionnaire more usable in several
settings, that being upper or lower respiratory specialist clinics,
as well as in general practice. The focus is building up awareness
of co-morbidity in the global airways. We were inspired by the
paper “Developing a valid patient-reported outcome measure”
by Rothrock et al. (26) and their suggestion for how to develop
a PROM. Our starting point was that there’s a need for a new
PROM, and for the present study, we have completed the phases
of item generation, item improvement, consolidate revisions,
initial testing and analysis and finalization stages of the PROM
development. We still need to complete the phases of clinical
validation studies and the resulting ongoing instrument impro-
vement.
A limitation of our study is the selection of patients, who were
already followed and diagnosed by clinicians in either an ENT
with endoscopy setting or pulmonary with asthma provocation
and allergy testing setting. Referral were different in time, and
therefore, the absolute values measured at referral were not in-
cluded in the present study. This will most likely have resulted in
patients being more aware of symptoms related to their under-
lying disease in either upper or lower airways which will in turn
have affected their responses. The selection of patients without
a focus on allergic rhinitis only (five/five patients with AR only
were included) may also explain the low discriminative ability of
the allergic rhinitis sub-factor in our IRT analyses. Furthermore,
only three items were included in the allergic rhinitis sub-factor,
which may also have hampered the internal consistency that
was lower than for the other two sub-factors. In a subsequent/
future validation study, the questionnaire should be evaluated
in a group of patients newly referred to the GP or specialist
setting, and they should be undiagnosed, prior to filling out the
questionnaire. It will also be important to include a group of
patients with a broader distribution of severity of disease for all
three disease groups (allergic rhinitis, CRS, asthma) ranging from
no disease (healthy controls) to severe disease, although the
patients included had uncontrolled disease (ACQ 1.5 an SNOT22
60).
Another limitation of our first attempt to develop a global
airways questionnaire was the selection of too many response
categories to each item. Furthermore, although 200 patients
participated in the survey, it might have been too few for the
item response theory analyses. We used several questions con-
cerning seasonal variation suggested from the ARIA guidelines
(27), but in this kind of survey, it might have been better to ask for
seasonal variation as such or no variation, as we found no dif-
ferences between all the different questions of variation.
Several key validity indicators, such as reliability and respon-
siveness, were not considered in the present study. The focus
of the present study was to take the first steps in designing a
PROM that can set the focus of both upper and lower disease.
It is therefore important to continue developing this disease
management tool, to ensure one tool to cover all demands,
and a future validation study is therefore warranted. This will be
performed using another patient sample, and with a focus on
recruiting patients with different levels of severity of disease in
order to extend our understanding of how well the question-
naire performs. New analyses of the psychometric properties of
the sub-factors and the items will also be necessary to conduct
to evaluate the performance of the scale.
Conclusion
Our new PROMs questionnaire STARR-15, is designed to be
used in rhinology, pulmonology and allergology as well as GP
settings, when examining patients with Type 2 inflammation
associated respiratory complains as the STARR-15 can facilitate
72
Backer et al.
the awareness of the diseases being in both upper and lower
airways. In parallel with the introduction of biologics for Type
2 global airways inflammation the STARR-15 may have an impor-
tant role representing a PROM embracing the global airways.
Acknowledgements
The first author has received an unrestricted grant from Sanofi
Genzyme, of which we have involved epidemiologic and statisti-
cal help with the current analysis, with the focus of development
of the STARR-15 questionnaire.
Authorship contribution
VB, KA, CvB, SH have developed the project, VB and KA have
examined all patients. SH and JP have perfromed statistical
analysis. VB, KA, CvB, SH and JP have written and reviewed the
manuscript.
Conflict of interest
No conflict of interest.
Funding
The clinicians have gains from an unrestricted grant from Sanofi
Genzyme, whihc have been entirely used to cover costs of the
statistical analysis.
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Vibeke Backer, MD, DMSci
Department of ENT and Audiology
Rigshospitalet
Copenhagen University
Copenhagen
Denmark
Tel: +45-51212033
E-mail:
Nina.vibeke.backer@regionh.dk
