ORIGINAL ARTICLE
The Empty Nose Syndrome 6-Item Questionnaire (ENS6Q): a validated
6-item questionnaire as a diagnostic aid for empty nose syndrome patients
Nathalia Velasquez, MD1,∗ , Andrew Thamboo, MD, MHSc1,∗ , Al-Rahim R. Habib, MSc2 ,
Zhenxiao Huang, MD, PhD3 and Jayakar V. Nayak, MD, PhD1
Background: Empty nose syndrome (ENS) is considered an
acquired condition that remains difficult to diagnose objectively. Defining specific symptoms that can be reliably
associated with this disorder would be essential to identifying possible ENS patients. We sought to validate an ENSspecific, 6-item questionnaire as an adjunct to the standard
Sino-Nasal Outcome Test 22 (SNOT-22) questionnaire to
discriminate patients suspected of having ENS.
testing was 0.969. The ENS6Q statistically significantly discriminated between ENS and control patients and between ENS and chronic rhinosinusitis without polyposis (CRSsNP) patients, without significant
differences between CRSsNP and controls. The areaunder-the-curve (AUC) threshold score comparison further supported the ability of the ENS6Q to differentiate
ENS from CRSsNP patients.
Methods: The Empty Nose Syndrome 6-item Questionnaire (ENS6Q) paired 6 common ENS symptoms (nasal suffocation, nasal burning, nasal openness, crusting, dryness,
and impaired air sensation through nasal cavities) with testing on 75 patients divided in 3 patient cohorts: ENS; chronic
rhinosinusitis without polyposis; and healthy controls. Participants answered 2 rounds of both the SNOT-22 questionnaire and ENS6Q within 48 hours of each other. No changes
in treatments occurred in the test interval between questionnaires. Internal consistency, test-retest reliability, validity, and area under the curve were assessed to differentiate
between patient cohorts using the 2 instruments.
Conclusion: The ENS6Q is the first validated, specific,
adjunct questionnaire to the SNOT-22 to more reliably
C 2016
identify patients suspected of developing ENS. "
Results: We found high internal consistency for ENS6Q
and SNOT-22 questionnaire at 0.93 (95% CI, 0.900.95) and 0.94 (95% CI, 0.94-0.96), respectively. The
test-retest reliability between timepoints for ENS6Q
ARS-AAOA, LLC.
Key Words:
empty nose syndrome; ENS; nasal airway; paradoxical nasal
obstruction; questionnaire; SNOT-22; SNOT-25; survey;
upper airway; validated
How to Cite this Article:
Velasquez N, Thamboo A, Habib A-RR, Huang Z, Nayak
JV. The Empty Nose Syndrome 6-item Questionnaire:
a validated 6-item questionnaire as a diagnostic aid for
empty nose syndrome patients. Int Forum Allergy Rhinol.
2016;XX:1–8.
he use of validated questionnaires in clinical management has helped physicians identify individuals with
various conditions. Currently, in the field of rhinology, the
Sino-Nasal Outcome Test 22 (SNOT-22) is arguably the
most commonly used validated questionnaire.1 Since its
validation in 2009,2 the SNOT-22 has provided clinicians
with the ability to track the impact of sinonasal problems
on the quality of life (QoL) of patients. The values provided by the questionnaire also allow the clinician to quantify the effect of intervention (medical, surgical, etc.). The
SNOT-22 is best used in the setting of chronic rhinosinusitis (CRS); however, but, as with other conditions, such as
T
1 Division
of Rhinology, Department of Otolaryngology–Head and Neck
Surgery, Stanford University School of Medicine, Palo Alto, CA;
2 Sydney Medical Program, University of Sydney, Sydney, NSW,
Australia; 3 Department of Otolaryngology–Head and Neck Surgery,
Beijing Tongren Hospital, Capital Medical University, Beijing, China
Correspondence to: Jayakar V. Nayak, MD, PhD, Department of
Otolaryngology–Head and Neck Surgery, Stanford University School of
Medicine, 801 Welch Road, Stanford, CA 94305; e-mail:
jnayak@stanford.edu
Potential conflict of interest: None provided.
The first 2 authors (N.V. and A.T.) contributed equally to this work.
The abstract and manuscript received the Clinical Science Research Award
at the American Rhinologic Society (ARS) section of the 2016 Combined
Otolaryngology Sections Meeting (COSM). Chicago, IL.
∗
Both authors contributed equally to this work.
Received: 22 April 2016; Revised: 13 July 2016; Accepted: 22 July 2016
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International Forum of Allergy & Rhinology, Vol. 00, No. 0, August 2016
DOI: 10.1002/alr.21842
View this article online at wileyonlinelibrary.com.
Velasquez et al.
TABLE 1. Participants’ ratings of their perceived nasal symptoms considering the severity and frequency of each problem
using the ENS6Q
No problem/not
applicable
Very mild
Mild
Moderate
Severe
Extremely
severe
Dryness
0
1
2
3
4
5
Sense of diminished nasal airflow (cannot feel air flowing through your nose)
0
1
2
3
4
5
Suffocation
0
1
2
3
4
5
Nose feels too open
0
1
2
3
4
5
Nasal crusting
0
1
2
3
4
5
Nasal burning
0
1
2
3
4
5
Symptom
ENS6Q = Empty Nose Syndrome 6-item Questionnaire.
nasal obstruction, rhinitis, or rhinoconjunctivitis,3–5 separate, validated, disease-specific questionnaires have been
constructed to help better quantify the effect of these specific sinonasal conditions on QoL.
Empty nose syndrome (ENS) is a term first coined by Kern
and Stenkvist in 1994 to describe the acquired disorder.6
ENS appears to most commonly arise as a postsurgical
phenomenon secondary to loss of inferior turbinate tissue
or volume. This diagnosis is most often associated with
the presence of paradoxical nasal obstruction despite an
objectively patent nasal airway,7 although a wide constellation of prominent symptoms are also espoused by ENS
patients, including dyspnea, nasal and pharyngeal dryness,
facial or nasal pain, crusting, hyposmia, and depression.8
Currently, there is no validated questionnaire for ENS,
which can cause profound QoL derangements in patients.
The most commonly used outcome survey for ENS is
probably the Sino-Nasal Outcome Test 25 (SNOT-25),9
which has been used in several earlier studies.7–10 The
SNOT-25 aimed to assess ENS-specific symptoms,9
leveraging the SNOT-20 scoring system, with the added
parameters of “dryness,” “difficulty with nasal breathing,”
“suffocation,” “nose is too open,” and “nasal crusting.”
However, the addition of the 5 subjective symptoms
was never validated in this specific population for the
SNOT-25. Moreover, the SNOT-20 system has largely
fallen out of favor and into disuse due to the wider
acceptance of the validated SNOT-22 scoring system. In
addition, by incorporating 5 additional (nonvalidated)
items into the original questionnaire, the SNOT-25 test
final score cannot differentiate ENS from other sinonasal
problems such as CRS. Given these disadvantages, a
validated, disease-specific questionnaire to more reliably
and accurately diagnose ENS was needed.
In this study we share the results of this effort, a
validated questionnaire that we have termed the Empty
Nose Syndrome 6-item Questionnaire (ENS6Q). This tool
can aid in making the diagnosis of ENS, and provides a
quantifiable outcome measure for QoL in ENS patients.
Methods
This study was undertaken at the Sinus and Endoscopic
Skull Base Center at Stanford University. After institutional
review board approval, a prospective study was conducted
at the Stanford Sinus Center, which manages individuals
with ENS. We assembled the 6 questions in the ENS6Q
diagnostic aid (Table 1) based on our growing clinical experience with evaluating ENS patients, some which were
understandably carried over from the SNOT-25 test. We
considered 4 of the questions from the SNOT-25 on “dryness,” “suffocation,” “nose feels too open,” and “nasal
crusting” to also be valid for use in the ENS6Q. We clarified past questions regarding the quality of nasal breathing
and/or nasal congestion, to specify the “sense of diminished airflow (cannot feel air flowing through your nose)”
in these complex patients. Finally, we added the question
on “nasal burning,” given that it is a common symptom
expressed by patients in our practice.
We then administered the ENS6Q to 3 patient cohorts:
15 patients with ENS; 30 with chronic rhinosinusitis without polyposis (CRSsNP); and 30 healthy controls without
past sinonasal surgery. These sample numbers were based
on the available ENS patients in the practice at time of
study initiation (n = 15), with double the number of tested
non-ENS cohorts (30 patients each). As the exact prevalence of ENS patients is unknown, a formal power analysis
to calculate the sample size could not be designed.
The diagnosis of ENS was made in patients presenting
with nasal discomfort and/or paradoxical nasal obstruction despite wide open nasal passages who met the following criteria: (i) a positive history of inferior turbinate
reduction with objective endoscopic and/or computed tomography (CT) evidence of inferior reduction; (ii) a positive
“cotton test”; and (iii) candidacy for an inferior turbinate
augmentation procedure. 7 The cotton test involves placement of dry cotton in the region of the deficient (or absent) inferior turbinate tissue in the un-anesthetized inferior meatus to simulate the bulk and tubular contour of
a native turbinate in the lateral nasal wall. The patient’s
International Forum of Allergy & Rhinology, Vol. 00, No. 0, August 2016
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ENS6Q Diagnostic Aid for ENS
TABLE 2. Demographic comparison of age, gender, race, and ethnicity between participants with ENS and CRSsNP,
and controls
Age (years)
ENS (n = 15)
CRSsNP
(n = 30)
Controls
(n = 30)
p-value
44.87 ± 12.35
48.10 ± 16.35
39.93 ± 13.66
0.100
Gender
0.431
Male
7 (46.7%)
12 (40.0%)
17 (56.7%)
Female
8 (53.3%)
18 (60.0%)
13 (43.3%)
Race or ethnicity
0.949
Caucasian
10 (66.7%)
18 (60.0%)
15 (50.0%)
1 (6.7%)
2 (6.7%)
3 (10.0%)
0
0
0
Asian
3 (20.0%)
8 (26.7%)
8 (26.7%)
Middle Eastern
1 (6.7%)
2 (6.7%)
10 (3.0%)
0
0
1 (3.3%)
15 (100%)
21 (70%)
0
0.077
Septoplasty
8 (53.3%)
9 (30%)
0
0.083
IT reduction
15 (100%)
12 (40%)
0
0.003
2 (13.3%)
15 (50%)
0
0.026
Hispanic
Black or African American
Native Hawaiian/Other Pacific Islander
Previous sinonasal interventions
ESS
CRSsNP = chronic rhinosinusitis without nasal polyposis; ENS = empty nose syndrome; ESS = endoscopic sinus surgery; IT = inferior turbinate.
symptoms are then reevaluated and an almost instantaneous, striking reduction in detrimental nasal symptoms,
with a concomitant subjective improvement in the patient’s
sense of nasal airflow, supports the diagnosis of ENS.8
To be included in the study, patients diagnosed with ENS
based on the aforementioned criteria could not present active CRS symptoms at the time of diagnosis. CRSsNP patients were diagnosed based on the current guidelines of the
American Rhinologic Society/International Consensus
Statement of Allergy and Rhinology.11 Healthy controls
had no history of sinusitis or previous sinonasal surgery,
and were recruited from the preoperative skull base surgery
clinic. Participants completed 2 independent rounds of
both the SNOT-22 questionnaire and ENS6Q 5 days apart
(primary vs secondary). No changes in treatment plan,
such as medication alteration or surgery, occurred between the primary and secondary administration of the
questionnaires.
as each individual question within the ENS6Q. The values
were considered to be continuous in the analysis. A twoway mixed model was used to evaluate absolute agreement
accounting for random reviewer effects and mixed measurement effects. Given this, the nonparametric KruskalWallis test was used to assess the validity of the ENS6Q to
distinguish clinical diagnostic groups. Receiver operating
characteristic (ROC) curves were constructed to compare
the ability of the ENS6Q to differentiate clinical diagnosis
of ENS, CRSsNP, and controls, when compared with the
SNOT-22. The area-under-the-curve (AUC) statistic and
corresponding CIs were reported to compare ROC curves.
The best cut-off score was reported that maximized the
sensitivity and minimized the false-positive rate. Statistical
R
SPSS Statistics version
analysis was performed with IBM"
20.0 (IBM SPSS, Armonk, NY).
Results
Statistical Analysis
Participants included in the study cohort were summarized
by count, absolute frequency, and 95% confidence interval
(CI) for pertinent sociodemographic and clinical characteristics. This included age, gender, diagnosis, and ethnicity.
Internal consistency, defined as the intercorrelation between questionnaire items, was measured using Cronbach’s
α. Test-retest reliability was measured using the intraclass
coefficient for total SNOT-22 and ENS6Q scores, as well
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International Forum of Allergy & Rhinology, Vol. 00, No. 0, August 2016
The study cohort consisted of 75 individuals with mean age
of 44.2 ± 1.7 years and included 36 (48.0%) males and 39
(52.0%) females. ENS was diagnosed in 15 (20.0%) participants, as noted previously, and CRSsNP was identified
in 30 (40.0%) participants. A total of 30 (40.0%) healthy,
non-CRS and non-ENS individuals were included for comparison. No significant differences were found for age, gender, race, or smoking status between individuals with ENS
or CRSsNP and controls (Table 2).
Velasquez et al.
TABLE 3. Comparison of participant responses on SNOT-22 and ENS6Q to assess validity for differentiation of individuals
with ENS and CRSsNP, and controls
CRSsNP
Controls
Kruskal-Wallis
ENS (n = 15)
(n = 30)
(n = 30)
p-value
Total SNOT-22
50.2 ± 26.6
33.4 ± 18.3
17.9 ± 16.2
<0.001a
Total ENS6Q
18.9 ± 7.5
4.7 ± 4.3
1.8 ± 2.8
<0.001a
Dryness
3.8 ± 1.1
1.4 ± 1.5
0.7 ± 1.1
<0.001a
Lack of air sensation going
through your nasal cavities
3.8 ± 1.3
1.2 ± 1.5
0.3 ± 0.5
<0.001a
Suffocation
2.5 ± 2.2
0.4 ± 0.9
0.2 ± 0.6
<0.001a
Nose feels too open
3.3 ± 1.4
0.2 ± 0.6
0.1 ± 0.4
<0.001a
Nasal crusting
2.7 ± 1.8
1.0 ± 1.2
0.3 ± 1.0
<0.001a
Nasal burning
2.9 ± 1.8
0.7 ± 1.1
0.1 ± 0.4
<0.001a
Total SNOT-22
49.4 ± 28.2
31.4 ± 16.9
17.3 ± 17.9
0.002
Total ENS6Q
19.5 ± 7.5
3.6 ± 3.3
1.3 ± 2.4
<0.001a
Dryness
3.7 ± 1.4
1.2 ± 1.3
0.5 ± 0.9
<0.001a
Lack of air sensation going
through your nasal cavities
4.0 ± 1.4
0.9 ± 1.2
0.4 ± 0.9
<0.001a
Suffocation
2.7 ± 2.1
0.3 ± 0.9
0.2 ± 0.6
<0.001a
Nose feels too open
3.5 ± 1.5
0.2 ± 0.5
0.03 ± 0.2
<0.001a
Nasal crusting
2.8 ± 1.9
0.6 ± 0.9
0.2 ± 0.7
<0.001a
Nasal burning
2.9 ± 1.6
0.6 ± 1.0
0.1 ± 0.3
<0.001a
Primary evaluation
ENS-specific questions
Secondary evaluation
ENS-specific questions
a
Statistically significant.
CRSsNP = chronic rhinosinusitis without nasal polyposis; ENS = empty nose syndrome; ENS6Q = Empty Nose Syndrome 6-item Questionnaire; SNOT-22 = Sino-Nasal
Outcome Test 22.
Within the ENS patient cohort, 53% underwent septoplasty, 100% had turbinoplasty (with a wide variety
of reduction procedures), and 13.3% had endoscopic sinus surgery (ESS). The CRSsNP cohort had fewer inferior
turbinate reduction procedures (40%, p = 0.003), but had
more ESS procedures (50%, p = 0.026), compared with
the ENS cohort (Table 2).
With respect to the 5 questions in the SNOT-25 referring to ENS, we made 2 major alterations to the ENSspecific symptoms tested. First, based on our experience,
the term “difficulty with nasal breathing” was not clear to
our participants. Therefore, we modified this item to “lack
of air sensation going through your nasal cavity.” Second,
we added “nasal burning” to the ENS6Q, based on this
common complaint from patients in our practice. Consequently, our adjunct survey to the SNOT-22 for identifying
ENS patients was constructed (Table 1).
At primary and secondary evaluations, total SNOT-22
scores differed significantly between the ENS, CRSsNP and
control participants (Table 3). With regard to the ENS6Q,
individuals with ENS reported significantly higher symptom scores in their responses at both the primary and secondary evaluations (p < 0.001; Table 3). The overall Cronbach α coefficient value for ENS6Q and SNOT-22 was 0.93
(95% CI, 0.90-0.95) and 0.94 (95% CI, 0.94-0.96), respectively, suggesting strong internal consistency between
the questionnaires. Intraclass correlation coefficients (ICCs)
evaluating test-retest reliability showed significant absolute
agreement between the primary and secondary responses on
ENS-specific items among all participants, with the ENS6Q
ICC for all groups being 0.969 (95% CI, 0.950-0.980)
(Table 4).
Specifically, among participants with ENS, the strongest
absolute agreements between test and retest measurements
International Forum of Allergy & Rhinology, Vol. 00, No. 0, August 2016
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ENS6Q Diagnostic Aid for ENS
TABLE 4. Intraclass correlation coefficients (ICC) evaluating test-retest reliability between participant responses on
ENS-specific items at primary and secondary timepoints
ENS (n = 15)
ENS6Q
ICC (95% CI)
CRSsNP (n = 30)
Controls (n = 30)
ICC (95% CI)
ICC (95% CI)
Dryness
0.919 (0.874–0.948)
0.875 (0.756–0.938)
0.847 (0.701–0.924)
Lack of air sensation going through your nasal cavities
0.928 (0.888–0.954)
0.920 (0.919–0.964)
0.425 (0.081–0.678)
Suffocation
0.926 (0.885–0.952)
0.851 (0.711–0.926)
0.667 (0.405–0.827)
Nose feels too open
0.963 (0.941–0.976)
0.940 (0.879–0.971)
0.800 (0.624–0.899)
Nasal crusting
0.951 (0.862–0.983)
0.584 (0.291–0.777)
0.839 (0.692–0.920)
Nasal burning
0.954 (0.869–0.984)
0.842 (0.697–0.921)
0.642 (0.371–0.812)
Empty Nose Syndrome 6-item Questionnaire (ENS6Q) for all groups 0.96 (0.950-0.980), CI = confidence interval; CRSsNP = chronic rhinosinusitis without nasal polyposis;
ENS = empty nose syndrome.
FIGURE 1. Receiver operating characteristics curve analysis comparing ENS6Q, SNOT-22, and SNOT-22+ENS6Q scores between patients with ENS vs
healthy participants. ENS = empty nose syndrome; ENS6Q = Empty Nose Syndrome 6-item Questionnaire; SNOT-22 = Sino-Nasal Outcome Test 22.
were found for the 3 questions regarding “nasal burning”
(ICC, 0.954), “nasal crusting” (ICC, 0.951), and “suffocation” (ICC, 0.920, Table 4).
The ROC curve was used to quantify the diagnostic value of SNOT-22 and ENS6Q in ENS patients.
As seen in Figures 1 and 2, ENS6Q surpassed both
SNOT-22 and SNOT-22+ENS6Q in its ability to discriminate ENS from CRSsNP and healthy patients, with AUCs
of 0.97 (95% CI, 0.93-1.00), 0.67 (95% CI, 0.50-0.85),
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International Forum of Allergy & Rhinology, Vol. 00, No. 0, August 2016
and 0.80 (95% CI, 0.65-0.94), respectively. The ENS6Q
cut-off score to reliably associate/predict ENS was determined to be 10.5 out of a total possible score of 30
(Table 5). When analyzing each of the ENS6Q items individually, “nose feels too open” and “lack of air sensation going through nasal cavities” were found to be the
most predictive symptoms of ENS with AUCs of 0.95 (95%
CI, 0.87-1.00) and 0.93 (95% CI, 0.83-1.00), respectively
(Table 5).
Velasquez et al.
FIGURE 2. Receiver operating characteristics curve analysis comparing ENS6Q, SNOT-22, and SNOT-22+ENS6Q scores between patients with ENS vs
CRSsNP participants. CRSsNP = chronic rhinosinusitis without polyposis; ENS = empty nose syndrome; ENS6Q = Empty Nose Syndrome 6-item Questionnaire;
SNOT-22 = Sino-Nasal Outcome Test 22.
TABLE 5. AUCs for predicting threshold score for ENS diagnosis*
AUC
95% CI
Cut-off
score
Sensitivity
Specificity
LR+
Total SNOT-22
0.678
0.503-0.853
32.5
66.7%
62.1%
1.76
Total ENS6Q score
0.975
0.930-1.000
10.5
86.7%
96.6%
25.50
Dryness
0.894
0.781-1.000
2.5
86.7%
83.3%
5.19
Lack of air sensation going through your nasal cavities
0.930
0.831-1.000
2.5
93.3%
86.7%
7.02
Suffocation
0.818
0.668-0.967
1.5
60.0%
90.0%
6.00
Nose feels too open
0.959
0.878-1.000
1.5
93.3%
96.7%
28.27
Nasal crusting
0.819
0.668-0.970
2.5
60.0%
93.3%
8.95
Nasal burning
0.864
0.736-0.993
2.5
73.3%
93.3%
10.94
*Proposed threshold score comparison between SNOT-22 and ENS6Q scores between healthy participants and individuals with ENS.
AUC = area under the curve; CI = confidence interval; ENS, empty nose syndrome; ENS6Q = Empty Nose Syndrome 6-item Questionnaire; LR+ = likelihood ratio;
SNOT-22 = Sino-Nasal Outcome Test 22.
Discussion
In this report we have evaluated the validity, reliability, and interpretability of the ENS6Q in the context of
ENS patients. ENS is a challenging condition to diagnose
and can be overlooked by otolaryngologists and other
specialists because some of the cardinal symptoms, such
as nasal obstruction or shortness of breath, rarely correspond to the examination and/or endoscopic findings of
a widely patent nasal passage.8, 12 A high index of suspicion is required to make the diagnosis. Prior to this study,
our “gold standard” for the putative diagnosis of ENS
International Forum of Allergy & Rhinology, Vol. 00, No. 0, August 2016
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ENS6Q Diagnostic Aid for ENS
required a history of inferior turbinoplasty and a positive
cotton test. Subsequently, we felt that understanding and
validating symptoms experienced by ENS patients, and not
by those who are healthy or who have CRS, would help
otolaryngologists identify these often neglected patients.
In this study, we have developed and validated a diseasespecific questionnaire for ENS (ENS6Q) referencing the
previously reported SNOT-25,6, 9 which, in our experience,
also incorporated many of the most common complaints
described in this cohort of patients. We added the question on “nasal burning” as 1 of our 6 diagnostic questions
given the frequency of this reported symptom to our ENS
patient population, and also clarified somewhat vague questions regarding nasal congestion with the wording “sense
of diminished airflow (cannot feel air flowing through your
nose).” We believed that successful validation would provide a quantifiable outcome measure to strengthen a clinician’s suspected diagnosis of ENS, and also assess QoL. In
this study, we found ENS6Q to be a valid disease-specific
questionnaire in the evaluation and diagnosis of ENS, with
consistent test-retest internal reliability and consistency.
Furthermore, we have established a diagnostic score cutoff within the ENS6Q of 10.5, to assist with the rapid
translation of the scoring significance in the clinical setting.
The reliability of any instrument can be assessed by
its internal consistency—in our case, maintenance of the
score over time when the individual patient’s condition
does not change. In this study, internal consistency of the
ENS6Q was thoroughly evaluated. The Cronbach α value
of 0.93 for the ENS6Q demonstrates high internal consistency to a level necessary for clinical application, much like
the SNOT-22, which has an internal consistency value of
0.93.13 However, it is important to note that patients in this
study responded to the second questionnaire after 5 days
as compared with 10 to 14 days in the validation of the
SNOT-22, which may deviate the internal consistency to a
higher level; however, based on our experience, patients
have little recollection of their previous answers within
2 days after the original questionnaire. Moreover, 5 days
was chosen between test dates to minimize the delay in care
as no patients were allowed to start any form of medical
management until the second test was complete. Furthermore, our findings are supported by the high ICC found in
our results (0.96) when the ENS6Q was applied at different
timepoints, showing satisfactory test-retest reliability.
The ROC curve plays a central role in evaluating the diagnostic ability of the ENS6Q to discriminate between different disease states and provide the optimal cut-off values for
diagnosis.14 The AUC provides a measure of accuracy by
showing the capacity of this diagnostic test to discriminate
between the presence or absence of a determined condition and its associated sensitivity and specificity values.14, 15
When AUC = 0.5, the ROC curve corresponds to random
chance, whereas ROC = 1.0 indicates perfect accuracy.15 In
this study, the AUC for the total ENS6Q score was 0.975,
demonstrating the high accuracy of the cut-off score of
10.5 to discriminate patients with and without ENS, with a
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International Forum of Allergy & Rhinology, Vol. 00, No. 0, August 2016
sensitivity and specificity of 86.7% and 96.6%, respectively. Although there are no universal criteria to define
the ideal value for a valid method, some investigators have
defined a method as accurate when the sum of the sensitivity and specificity values is >120%.15 In the present study,
this sum was 183.3%, demonstrating the reliable accuracy
of the ENS6Q in diagnosing ENS patients.
In this study, “lack of air sensation going through the
nasal cavities” and “nose feels too open” were found to be
the symptoms with the highest predictive value for association with ENS, with AUCs of 0.930 (sensitivity 93.3%,
specificity 86.7%) and 0.959 (sensitivity 93.3%, specificity
96.7%), respectively. By extrapolation, these symptoms
correlate well with our endoscopic findings in that the loss
of turbinate tissue ultimately alters the meatal structure and
airflow patterns, contributing to actual and/or perceived reduction in airflow efficiency.16, 17 The meatus is contoured
by the inferior turbinate, septum, nasal floor walls, and
nasal vestibular bodies,18 providing both aerodynamics and
resistance to nasal upper airway airflow. In patients with
ENS, who partially or completely lack turbinate tissue and
associated structure, airflow resistance appears to be substantially compromised. Therefore, in our clinical experience, in substituting vague phrasing, such as “nasal congestion,” for “lack of air sensation,” patients were better able
to understand this terminology. However, numerically, patients also found it to be a statistically significant question,
as it is one of the most predictive items in the ENS6Q.
On the other hand, although the question regarding
“nose feels too open” may have slightly “outperformed”
the ENS6Q as a whole, it may be reasonable to query
whether this question alone would be sufficient to ask of
ENS patients. However, every candidate ENS patient is
fairly varied in their experience through this enigmatic disease process, and patients have a wide constellation of other
symptoms, including those in the questionnaire as well as
others. Given the wide variety of reported symptoms in the
disease presentation, evaluation of a single symptom would
be insufficient for a correct diagnosis, in favor of the easily completed, slightly more broad, 6-item questionnaire
presented herein.
The ENS6Q has the ability to aid in the clinical diagnosis
of ENS in patients who present with difficulty breathing and/or nasal discomfort. The questionnaire can be
completed in approximately 2 minutes and may be administered as an adjunct to, or independent of, the SNOT-22.
The established score cut-off point of 10.5 for the ENS6Q
provides a marker for the clinician to consider the performance of either the cotton test and/or assess the patient’s
sinus CT scan through a more discriminating lens, assessing
for objective findings of ENS, as recently described by
Thamboo and colleagues.19 Future studies in larger
populations utilizing this questionnaire will strengthen
its validation results. Additional layers of utility, such as
responsiveness and clinical interpretability (minimal clinically important difference), of the ENS6Q are now being
assessed in view of our encouraging validation results.
Velasquez et al.
However, because of its simplicity, this diagnostic aid
can be readily integrated into clinical activities and
patient-based research.
A potential limitation of our study design is that the
ENS6Q, by design, was not administered to all patients
complaining of nasal obstruction of varied etiologies. Our
initial study design explored patients with postoperative
CRSsNP as the primary comparison group, because both
the ENS and CRSsNP groups underwent previous sinus
surgery. As a major premise in our experience, ENS is
an iatrogenic condition in the vast majority of cases, and
therefore the ENS6Q should only be administered to patients who have undergone previous sinonasal surgery
and are without primary nasal obstruction. On the other
hand, patients may present with persistent septal deviation and/or inferior turbinate hypertrophy after previous
sinonasal surgery, which this study does not isolate as a
separate comparative group. However, ENS would only
be considered as a diagnosis of exclusion in patients when
other obvious causes of nasal obstruction have been ruled
out. For example, deviated septum with internal nasal valve
compromise or reversible turbinate hypertrophy after inferior turbinate decongestion would be expected to produce
standard nasal obstruction, and therefore the diagnosis of
ENS and/or administration of the ENS6Q, would not typically be considered. Thus, an additional study may be useful
to illustrate the capacity of the ENS6Q to differentiate between these latter 2 groups. This would also help to show
that patients with ENS have a constellation of symptoms,
beyond paradoxical nasal obstruction, that are nearly exclusive to this complex patient cohort, and would readily
differentiate them from patients with primary nasal obstruction and nasal obstruction despite previous sinonasal
surgery.
Conclusion
The ENS6Q is the first validated, specific, adjunct questionnaire to the SNOT-22 to more reliably identify patients
suspected of having empty nose syndrome.
References
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Rudmik L, Hopkins C, Peters A, et al. Patient-reported
outcome measures for adult chronic rhinosinusitis: a
systematic review and quality assessment. J Allergy
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Hopkins C, Gillett S, Slack R, et al. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin
Otolaryngol. 2009;34:447–454.
Stewart MG, Witsell DL, Smith TL, et al. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head
Neck Surg. 2004;130:157–163.
Schatz M, Meltzer EO, Nathan R, et al. Psychometric validation of the rhinitis control assessment test:
a brief patient-completed instrument for evaluating
rhinitis symptom control. Ann Allergy Asthma Immunol. 2010;104:118–124.
Juniper EF, Riis B, Juniper BA. Development and
validation of an electronic version of the Rhinoconjunctivitis Quality of Life Questionnaire. Allergy.
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Chhabra N, Houser SM. The diagnosis and management of empty nose syndrome. Otolaryngol Clin
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Velasquez N, Huang ZH, Humphreys IM, Nayak
JV. Inferior turbinate reconstruction using porcine
small intestine submucosal xenograft demonstrates
improved quality of life outcomes in patients with
empty nose syndrome. Int Forum Allergy Rhinol.
2015;5:1077–1081.
Jiang C, Wong F, Chen K, Shi R. Assessment of surgical results in patients with empty nose syndrome
using the 25-item Sino-Nasal Outcome Test evaluation. JAMA Otolaryngol Head Neck Surg. 2014;140:
453-458.
Hong HR, Jang YJ. Laryngoscope. 2016;126:1290–
1295.
Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al.
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Otolaryngol Head Neck Surg. 2015;152(2 Suppl):
S1-S39.
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2009;42:331–337.
Hopkins C, Gillet S, Slack R, et al. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin
Otolarygol. 2009;34:447–454.
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characteristic analysis for evaluating diagnostic
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of the area under the receiver operating characteristic
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Elad D, Naftali S, Rosenfeld M, Wolf M. Physical stresses at the air-wall interface of the human nasal cavity during breathing. J Appl Physiol.
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Nayak JV. The nasal vestibular body: anatomy, clinical features and treatment considerations. Eur Arch
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with empty nose syndrome. Int Forum Allergy Rhinol.
2016 Jul 13. [Epub ahead of print].
International Forum of Allergy & Rhinology, Vol. 00, No. 0, August 2016
8
Ear, Nose & Throat Associates
Steven Butler, MD
Brian Pelczar, MD
Cynthia Kennedy, MD
Sean Demars, MD
Cassidy Brophy, FNP
2900 12th Ave North 330W
Billings, MT 59101
Phone: (406) 238-6161
Fax: (406) 238-6171
ENTABillings.com
MontanaSinus.com
Sino-Nasal Outcome Test (SNOT-22) Questionnaire
Name: ______________________________________
DOB: ______________________
Date: ______________________
Below you will find a list of symptoms and social/emotional consequences of your nasal disorder. We would like to
know more about these problems and would appreciate your answering the following questions to the best of your
ability. There are no right or wrong answers, and only you can provide us with this information. Please rate your
problems as they have been over the past two weeks. Thank you for your participation.
A. Considering how severe the problem is when you experience it and how frequently it happens, please rate
each item below on how ”bad” it is by circling the number that corresponds with how you feel using this scale:
No
Problem
1. Need to blow nose
0
2. Sneezing
0
3. Runny nose
0
4. Nasal obstruction
0
5. Loss of smell or taste
0
6. Cough
0
7. Post-nasal discharge
0
8. Thick nasal discharge
0
9. Ear fullness
0
10. Dizziness
0
11. Ear pain
0
12. Facial pain/pressure
0
13. Difficulty falling asleep
0
14. Waking up at night
0
15. Lack of a good night’s sleep
0
16. Waking up tired
0
17. Fatigue
0
18. Reduced productivity
0
19. Reduced concentration
0
20. Frustrated/restless/irritable
0
21. Sad
0
22. Embarrassed
0
TOTALS (each column):
GRAND TOTAL SCORE (all columns together):
Very
Mild
Problem
Mild or
Slight
Problem
Moderate
Problem
Severe
Problem
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
Problem
as bad
as it can
be
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
Most
important
items
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
[
]
]
]
]
]
]
]
]
]
]
]
]
]
]
]
]
]
]
]
]
]
]
B. Please check off the most important items affecting your health in the last column (max of five items)