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PUBLISHED DATE: - 22-12-2024
DOI: -
https://doi.org/10.37547/tajiir/Volume06Issue12-05
PAGE NO.: - 30-50
DIAGNOSTIC ACCURACY OF THE ETDQ-7 IN
ADULTS AT UNIVERSITY OF BENIN
TEACHING HOSPITAL
Uchefe Atuyota Okiemute, FWACS
Department of Otorhinolaryngology University of Benin Teaching Hospital,
Benin City, Edo State, Nigeria
Obohwemu Oberhiri Kennedy, PhD
Department of Health, Wellbeing & Social Care, Global Banking
School/Oxford Brookes University, Birmingham, United Kingdom; and
PENKUP Research Institute, Birmingham, United Kingdom
Okolugbo Nekwu, FWACS
Department of Ear, Nose & Throat (ENT) Head & Neck Surgery, Delta State
University Teaching Hospital Oghara, Delta State, Nigeria
Okhaku Amina, FWACS
Department of Ear, Nose & Throat (ENT) Head & Neck Surgery, University
of Benin Teaching Hospital Benin City, Edo State, Nigeria
Corresponding Author: Obohwemu Kennedy Oberhiri, PhD
RESEARCH ARTICLE
Open Access
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INTRODUCTION
Bluestone defined Eustachian tube dysfunction
(ETD) as the abnormal function of the Eustachian
tube, a component of the tubotympanic system of
the ear that includes the middle ear cleft and
mastoid air cells, without reference to its
aetiopathogenesis, which may involve structural
or functional factors.1 Disruption in Eustachian
tube function results in middle ear effusion and its
sequelae or worsens the prognosis of pre-existing
middle ear disease.
As ETD progresses, fluid collects in the middle ear
cleft, causing otitis media with effusion or
secretory otitis media, potentially leading to other
middle ear pathologies and sequelae.1 Secretory
otitis media and other middle ear diseases
significantly contribute to the global burden of ear
diseases, with substantial economic and social
impacts.2 It is more prevalent in children under
five and those with craniofacial abnormalities.
Musa reported in 2014 that 8.1% of children with
cleft anomalies had ETD compared to 2.5% in the
control group, as well as in Aboriginal groups from
Australia and the Americas.3,4 Akpalaba and Ogisi
reported ETD in 57.6% of children with cerebral
palsy, compared to 14.3% in the control
population.5
Globally, over 80% of children under three have
experienced at least one middle ear infection, and
more than 40% have had three or more episodes
of acute otitis media.1,2 Shan et al. estimated ETD
prevalence in adults in the United States at 4.6%,
compared to <1% in the UK.6,7 Somefun et al.
reported a 2.6% prevalence of otitis media with
effusion in a hospital-based survey of adult
patients.8
In developing nations like Nigeria, all forms of
otitis media, including otitis media with effusion,
are significant causes of hearing loss.9 These
conditions impair speech development in children
and negatively impact social interaction and
Abstract
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earning potential in adults. Tympanostomy and
similar interventions can improve speech
development in children and sustain socio-
economic activities in adults, as shown in Alabi et
al.'s study.10
Bartolomeus Eustachio (1510
–
1574) discovered
the Eustachian tube in 1553.11 Anatomists refer to
it as the auditory or pharyngotympanic tube. Its
functions include ventilation, secretion clearance,
and pressure equalisation between the middle ear
and the pharynx.
In 2015, Schilder et al. classified ETD into:
1.
Dilatory ETD
2.
Patulous ETD
3.
Baro-challenged ETD12
The dilatory type was further subdivided into:
1.
Functional obstruction
2.
Dynamic subtype (muscular failure)
3.
Anatomic obstruction
Bluestone categorised ETD based on impairments
in pressure regulation, protective function, and
clearance.13 Impaired pressure regulation stems
from anatomical or functional obstructions, while
loss of protective function involves anomalies like
abnormally short or patent tubes. Clearance
failures result from impaired mucociliary action or
muscle activity.
These factors promote negative pressure build-up
in the middle ear, particularly during infections or
allergic
inflammation,
leading
to
fluid
accumulation. Diagnosing ETD relies on patient-
reported symptoms like ear fullness, autophony,
blockage, tinnitus, otalgia, and hearing loss, often
combined with physical examination findings.1,2
Risk factors include weight loss, chronic illnesses,
anxiety, and allergies, as noted by Ward et al.14
Pneumatic otoscopic findings may reveal
increased or decreased tympanic membrane
mobility, retraction, and prominent malleolar
folds.1
Assessment of Eustachian tube function includes
visual inspection of the nasopharyngeal opening
using indirect mirrors in adults or video
endoscopy
(nasopharyngoscopy).
Locally,
immittance tympanometry is the standard
investigation, estimating middle ear pressure,
volume, and eardrum compliance to infer tube
function. A negative tympanogram curve suggests
ETD.
Subjectivity in diagnosing ETD from history-taking
can lead to variability among clinicians. The
disease-specific Eustachian tube dysfunction
questionnaire-7 (ETDQ-7), introduced by McCoul
et al. in 2012, offers a reproducible and validated
tool with 100% sensitivity and specificity.15 It
assesses symptoms like aural fullness, tinnitus, and
an
“underwater”
sensation,
providing
a
standardised diagnostic approach.16
There is limited evidence on the ETDQ-
7’s
validation in large African populations. However, it
has been translated and tested in several
languages, mostly within Caucasian populations,
yielding varied outcomes.17-21
Bartolomeo Eustachio first described the
Eustachian tube in 1553. Valsalva elaborated on its
anatomy in 1717.1 It originates embryologically
from the tubotympanic recess of the first
pharyngeal cleft and measures 36
–
44 mm in
adults.22,23 The tube begins in the anterior
tympanic recess of the petrous temporal bone
(Protympanum) and follows a pyriform course,
narrowing at the junction between its bony
posterior third and cartilaginous anterior two-
thirds (tubal isthmus). The tube opens into the
nasopharynx anterior to the Fossa of Rosenmuller
and remains closed at rest.23-25
The
cartilaginous
portion
is
lined
by
pseudostratified ciliated epithelium, interspersed
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with mucus glands, resembling the respiratory
tract. A wavy basement membrane underneath
serves as a mucosa reservoir, particularly near the
pharyngeal end. The shorter bony portion has
ciliated cuboidal epithelium with fewer mucus
glands and a thinner basement membrane.26
Dornhoffer et al. noted a fibrocartilaginous mass
linking bone and hyaline cartilage, while Bluestone
observed higher elastin content in adult cartilage,
aiding recoil to resting position after swallowing or
yawning.1,22 As shown in the diagram below, a 2-
dimensional frontal view of the Eustachian tube
lumen shows it divided into two compartments.
The medial, smaller compartment, known as
"Rudinger's safety canal," is usually patent and
contains gas and mucus. Below this canal is a larger
auxiliary gap with folds on its posteromedial wall,
called micro-turbinates, which play a role in
clearance.26
Fig. 1:
Illustration of the Eustachian tube ultrastructure from Dornhoffer JL, Leuwer R, Schwager K,
Wenzel S, Pahnke J. A practical guide to the eustachian tube. Berlin: Springer; 2014., showing Rüdinger’s
safety canal in humans. (Rsc) Rüdinger’s safety canal, (ll) lateral lamina of the tubal cartilage, (ml) medial
lamina of the tubal cartilage, (tvp) te
nsor veli palatini muscle, of (lateral) Ostmann’s fat pad, (lvp) levator
veli palatini muscle.
Three muscles surround the Eustachian tube:
1.
Tensor veli palatini (dilator tubae)
2.
Levator veli palatini (pump clearance
function)
3.
Salpingopharyngeus (no functional role in
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ETD)26
Neuronal control involves reflex arcs responding
to stimuli like pressure changes, with afferent
input via the glossopharyngeal and otic ganglia and
motor innervation from trigeminal and vagus
nerves. Blood supply comes from the internal
maxillary artery and its branches, while venous
drainage occurs via the pharyngeal plexus.
Lymphatics drain into retropharyngeal and deep
cervical nodes.
The Eustachian tube has three primary functions:
1.
Maintenance
of
ventilation/pressure
gradient
2.
Protection from nasopharyngeal sound
pressure and secretions
3.
Clearance of middle ear secretions
Optimal hearing requires equalised middle ear and
atmospheric pressures. The Hypomocholia model
describes a pivot mechanism enabling this.22
Doyle highlighted the role of mastoid air cells and
mucociliary mechanisms in preventing negative
pressure build-up.29
ETD arises from multiple factors, including genetic,
immunologic,
environmental,
and
social
influences.2
Pathophysiological
mechanisms
include:
1.
Anatomic obstruction: Causes include
inflammation, stenosis, or mass lesions.30
2.
Impaired pressure regulation: Often due to
functional obstruction from neurologic or
traumatic etiologies.31
–
35
3.
Loss of protective function: Results in
autophony and affects populations with Down’s
syndrome or after bariatric surgery.36
4.
Impaired clearance: Factors include ciliary
dysfunction due to smoking or inflammation.37
–
39
Limited research exists on ETD in African settings,
especially for adults. The ETDQ-
7’s validation in
Nigeria or Africa is sparse. Kirfi et al. reported a
1.5% ETD prevalence in a Kano prison
population,40 while Somefun et al. found a 2.6%
prevalence of otitis media with effusion in adults.8
Tympanometry studies are limited to tertiary
institutions,
restricting
population-based
prevalence data.41
–
45
Affordable diagnostic tools like ETDQ-7 could
benefit
resource-limited
settings
where
tympanometry is inaccessible. This study aims to
assess ETDQ-
7’s utility as a
diagnostic tool for ETD
in Nigeria.
This research aims to compare the accuracy of the
ETDQ-7 with that of tympanometry in identifying
Eustachian tube dysfunction in adults with an
intact tympanic membrane. Specifically, it seeks to
determine the sensitivity and specificity of the
ETDQ-7 in the adult population presenting to
UBTH, Benin City.
METHODOLOGY
STUDY POPULATION
The study population included all adult patients
aged 18 years and above who presented to the
ENT, Head and Neck Surgery Clinics at the
University of Benin Teaching Hospital (UBTH),
Benin City, during the study period, along with
volunteering staff and students.
ELIGIBILITY CRITERIA
Inclusion Criteria (Study Group)
All adult patients attending the ENT Clinic at UBTH
were recruited if they met the following criteria:
1.
At least 18 years of age.
2.
Had at least two of the following complaints
in one or both ears over one month:15
o
Aural fullness.
o
Sensation of clogged or muffled hearing.
o
Features of persistent or recurrent middle
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ear effusion, evidenced by tympanic membrane
retraction or an air-fluid level observed one month
apart.
o
Symptoms exacerbated by changes in
ambient pressure, such as descending stairs,
driving on a slope, or diving into a swimming pool.
Inclusion Criteria (Control Group)
The control group included healthy volunteers or
patients without otologic complaints or abnormal
otoscopic findings. Participants could present with
unrelated complaints (e.g., voice disturbances or
intraoral lesions) and were matched with the study
group for age and sex.
Exclusion Criteria
Participants were excluded if they met any of the
following criteria:
1.
Age below 18 years.
2.
Active ear discharge.
3.
Persistent tympanic membrane perforation,
foreign bodies, or wax in the ear canal impeding
tympanometry recording.
4.
Lack of consent to participate in the study.
5.
History of rhinosinusitis within the last
month or nasal/nasopharyngeal obstructive
pathology mimicking eustachian tube dysfunction.
STUDY DESIGN AND DURATION
This was a prospective diagnostic accuracy study
of the ETDQ-7 in detecting eustachian tube
dysfunction, using tympanometry as the reference
standard. The study followed the Standards for
Reporting Diagnostic Accuracy Studies (STARD)
2015 guidelines46 and spanned nine months, from
December 2022 to August 2023.
SAMPLE SIZE DETERMINATION
Sample size was calculated using Cochran's
formula for a diagnostic test with a binary outcome
and a reference standard47-49:
n = v
2
p(1-p)/E
2
Where n=desired sample size
Z = desired confidence level, 1.96 corresponds to
95% confidence interval.
p=anticipated sensitivity/specificity of the test,
which is set to 80% as desired to be able to
adequately power the study.
48
p=1
–
p
E= acceptable margin of error set at 10%
N= (1.96)
2
x (0.8) x (1-0.8) / (0.1)
2
= (3.8416) x (0.8) x (0.2) / (0.01)
= ~62 persons
Accounting for a 10% attrition rate, the final
sample size was adjusted to 75 per group, for a
total of 150 participants.
SAMPLING TECHNIQUE
Participants were recruited consecutively from the
ENT, Head and Neck Surgery Clinic at UBTH. They
were assigned to either the study or control group
based on inclusion criteria.
METHOD OF DATA COLLECTION
Initial Clinical Assessment
Participants were briefed about the study and its
voluntary nature. Informed written consent was
obtained before recruitment. Detailed history and
ENT examinations were performed to determine
eligibility, including otoscopic examination for
mobile
tympanic
membranes,
tympanic
membrane retraction, or fluid levels for the study
group, and normal findings for the control group
(see Appendix I).
Administration of ETDQ-7
Participants were assigned to study or control
groups, and the ETDQ-7 questionnaire (see
Appendix II) was administered to ensure
consistency and minimize observer bias. The
participants who did not understand English were
interviewed using a pidgin English version (see
Appendix III). Scores ≥14.5 indicated eustachian
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tube dysfunction, while scores <14.5 did not.
Tympanometric Measurements
Tympanometry was conducted after ensuring an
intact tympanic membrane and selecting an
appropriate ear tip size. The test involved altering
ear canal pressure from +200 daPa to -400 daPa
while recording middle ear pressure, ear canal
volume, and static admittance (see Appendix IV).
Tympanograms with middle ear pressure < -100
daPa were diagnostic for eustachian tube
dysfunction.
DATA ANALYSIS
Data were analysed using IBM-SPSS version 26.
Descriptive statistics, sensitivity, specificity,
predictive values, and likelihood ratios were
computed. Receiver Operating Characteristics
(ROC) curves were used to estimate the area under
the curve (AUC). A p-value <0.05 was considered
statistically significant.
ETHICAL CONSIDERATION
Ethical clearance was obtained from the UBTH
Ethical Review Committee. Written informed
consent was collected from all participants. Study
procedures adhered to the Helsinki Declaration on
ethical principles for medical research involving
human subjects, as well as UBTH COVID-19 safety
measures50.
RESULTS
The
sociodemographic
characteristics
of
participants are illustrated in Table I below. The
mean age of study participants is 43.52 ± 14.16
years, while the control group had a mean age of
42.51 ± 16.27 years. There is no statistical
difference between the two groups (P-value =
0.685). Most participants in both the study and
control groups are within the age range of 38-47
years, accounting for 29.4% of each group. This is
followed by those aged 38-57 years, with 20.0% in
each group. Participants aged 18-27 years, 28-37
years, 58-67 years, and 68 years and above
accounted for 17.3%, 13.3%, 17.3%, and 2.7%
respectively in each group. No statistically
significant differences were observed between the
two groups (P-value = 1.000).
Table I: Sociodemographic characteristics of study participants.
Parameter
Study group
(n =75)
Control group
(n =75)
Statistics P value
Age
18-27
13 (17.3)
13 (17.3)
0.000
a
1.000
28-37
10 (13.3)
10 (13.3)
38-47
22 (29.4)
22 (29.4)
48-57
15 (20.0)
15 (20.0)
58-67
13 (17.3)
13 (17.3)
68 and above
2 (2.7)
2 (2.7)
MEAN±SD
43.52 ± 14.16
42.51 ± 16.27
0.165
b
0.685
Sex
Male
32 (42.7)
32 (42.7)
0.000
a
1.000
Female
43 (57.3)
43 (57.3)
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Religion
Christian
74 (98.7)
73 (97.4)
1.183
a
1.000
Islam
1 (1.3)
1 (1.3)
African traditional
religion
0 (0.0)
1 (13)
Occupation
3.263
a
0.804
Artisan
8 (10.7)
12 (16.0)
Business
27 (36.0)
21 (28.0)
Public servant
20 (26.7)
20 (26.7)
Farmer
4 (5.2)
6 (8.0)
Retired
3 (4.0)
5 (6.7)
Students
11 (14.7)
10 (13.3)
Unemployed
2 (2.7)
1 (1.3)
Ethnicity
2.726
a
0.763
Bini
29 (39.7)
33 (44.0)
Esan
9 (12.0)
10 (13.3)
Estako
3 (4.0)
2 (2.7)
Urhobo
7 (9.3)
7 (9.3)
Igbo
12 (16.0)
6 (8.0)
Others
15 (20.0)
17 (22.7)
P-value < 0.05 is significant, a= chi-square, b= Student T-test
EUSTACHIAN TUBE DYSFUNCTION QUESTIONNAIRE-7 RESULTS
The prevalence of ETD, using an ETDQ-7 score greater than 14.5, is 53.3% in the study group and 22.7%
in the control group. There are significant statistical differences between the two groups (p-value <
0.001). Tympanometry findings with middle ear pressure less than -100 daPa show a prevalence of
26.7% in the study group and 10.7% in the control group. This difference is statistically significant (p-
value = 0.010), as shown in Table II below.
Table II: Prevalence of Eustachian tube dysfunction using ETDQ-7 and Tympanometry
Parameter
Study group
(n =75)
Control
group
(n =75)
Statistics P value
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EDQ-7 (Total)
13.153
F
<0.001*
7-14.4
35 (46.7)
58 (71.0)
14.5-21.4
21 (28.0)
17 (17.0)
21.5-28.4
16 (21.3)
6 (6.0)
28.5 and above
3 (4.0)
6 (6.0)
EDTQ-7
14.969
a
<0.001*
Normal
35 (46.7)
58 (77.3)
Abnormal
40 (53.3)
17 (22.7)
Tympanometry
6.323
a
0.010*
Normal
55 (73.3)
67 (89.3)
Abnormal
20 (26.7)
8 (10.7)
P-value < 0.05 is significant, a= chi-
square, F= Fisher’s exacts
TYMPANOMETRY RESULTS
The mean right ear canal volume was 1.37 ± 0.46 for the study group and 1.36 ± 0.38 for the control group
(p-value = 0.888). The mean right middle ear pressure was -40.73 ± 60.41 for the study group and -45.33
± 55.28 for the control group (p-value = 0.639). Right ear static admittance/maximum compliance was
0.85 ± 0.65 for the study group and 0.77 ± 0.62 for the control group (p-value = 0.468).
The mean left ear canal volume was 1.39 ± 0.41 for the study group and 1.32 ± 0.38 for the control group
(p-value = 0.285). The mean left middle ear pressure was -52.68 ± 67.64 for the study group and -35.78
± 34.98 for the control group (p-value = 0.066). Left ear static admittance/maximum compliance was
0.71 ± 0.69 for the study group and 0.79 ± 0.49 for the control group (p-value = 0.440). The tympanometry
readings showed no significant differences between the findings in both groups (p-values > 0.05). These
findings are represented in Table III.
Table III: Mean and standard deviations of findings of ETDQ7 and tympanometry readings
S/
N
Items
Study group
(n =75)
Control group
(n =75)
Statistics
P value
ETDQ 7 Questions
1
Pressure in the ears?
1.88 ± 1.41
1.49 ± 1.30
3.043
b
0.083
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2
Pain in the ears?
2.20 ± 1.73
1.63 ± 1.64
4.328
b
0.039
3
A feeling that your ears are
clogged or ‘‘under water’’?
2.63 ± 1.75
1.56 ± 1.34
17.637
b
<0.001*
4
Ear symptoms when you have a
cold or sinusitis?
2.03 ± 1.46
1.44 ± 1.22
7.116
b
0.008*
5
Crackling or popping sounds in
the ears?
1.91 ± 1.47
1.35 ± 1.08
7.037
b
0.009*
6
Ringing in the ears?
2.92 ± 1.99
2.25 ± 1.83
4.537
b
0.008*
7
A feeling that your hearing is
muffled?
2.91 ± 1.74
1.95 ± 1.75
11.363
b
0.001*
ETDQ7 TOTAL
16.47 ± 7.53
11.68 ± 7.99
14.330
b
<0.001*
Tympanometry findings
Right ear
Ear canal volume
1.37 ± 0.46
1.36 ± 0.38
0.020
b
0.888
Middle ear pressure
-40.73
±
60.41
-45.33 ± 55.28
0.221
b
0.639
Static Admittance/Maximum
Compliance
0.85 ± 0.65
0.77 ± 0.62
0.530
b
0.468
Left ear
Ear canal volume
1.39 ± 0.41
1.32 ± 0.38
1.153
b
0.285
Middle ear pressure
-52.68
±
67.64
-35.78 ± 34.98
3.424
b
0.066
Static Admittance/Maximum
Compliance
0.71 ± 0.69
0.79 ± 0.49
0.600
b
0.440
P-value < 0.05 is significant, b= Student T-test
The total questionnaire item score from the study population was 16.47 ± 7.53, compared to 11.68 ± 7.99
in the control group. Only items 1 and 2 were found to be statistically not significant.
The diagnostic accuracy of the ETDQ-7, compared to tympanometry as the standard in the study group,
showed a sensitivity of 90% and a specificity of 60%. The positive predictive value was calculated to be
45.0%, while the negative predictive value was as high as 94.0%. The positive likelihood ratio was 2.2,
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and the negative likelihood ratio was 0.17. These findings are represented in Tables IV and V below.
Table IV: 2 x 2 table of ETDQ 7 compared to Tympanometry as standard in study group
Parameters
Tympanometry
Total
Detected
Not detected
ETDQ 7
Detected
18 (24.0)
22 (29.3)
40 (53.3)
Not detected
2 (2.7)
33 (44.0)
35 (46.7)
Total
20 (26.7)
55 (73.3)
100 (100.0)
KEY
: TP (true positives) = 24.0, FN (false negatives) = 2.7, TN (true negatives) = 44.0, FP (false positives)
= 29.3
Sensitivity = TP/TP+FN 24.0/ (24.0 + 2.7) = 0.90= 90%
Specificity = TN/TN+FP 44.0 / (44.0 + 29.3) = 0.60= 60%
Positive predictive value = TP/TP+FP = 24.0/ (24.0 + 29.3) = 0.45 = 45%
Negative predictive value = TN/TN+FN 44.0 / (44.0 + 2.7) = 0.94= 94%
Positive likelihood ratio = [TP/(TP+FN)]/[FP/(FP+TN)] = [24.0 / (24.0+2.7)] / [29.3 / (29.3+44.0)] = 2.2
Negative likelihood ratio = [FN/(TP+FN)]/[TN/(FP+TN)] = [2.7 / (24.0+2.7)] / [44.0 / (29.3+44.0)] = 0.17
Diagnostic accuracy = TP + TN/TP +FP + FN +TN = 24 + 44 / 24 + 2.7 +44 +29.3 = 68/100 = 68%
The ETDQ-7 when compared to tympanometry as standard in the control group had Sensitivity of 87%
and Specificity of 85%. The Positive predictive value was calculated to be 41% while the Negative
predictive was as high as 98%. Positive likelihood ratio of 5.9 and Negative likelihood ratio of 0.14. These
findings are represented in Table VI below.
Table V: 2 x 2 Table of ETDQ 7 compared to Tympanometry as standard in control group
Parameters
Tympanometry
Total
Detected
Not detected
ETDQ 7
Detected
7 (9.4)
10 (13.3)
17 (22.7)
Not detected
1 (1.3)
57 (76.0)
58 (77.3)
Total
8 (10.7)
67 (89.3)
100
(100.0)
KEY
: TP true positives = 9.4, FN false negatives = 1.3, TN true negatives = 76.0, FP false positives = 13.3
Sensitivity = TP/TP+FN 9.4/ (9.4 + 1.3) = 0.87= 87%
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Specificity = TN/TN+FP 76.0/ (76.0 + 13.3) = 0.85= 85%
Positive predictive value = TP/TP+FP = 9.4/ (9.4 + 13.3) = 0.41 = 41%
Negative predictive value = TN/TN+FN 76.0/ (76.0 + 1.3) = 0.98= 98%
Positive likelihood ratio = [TP/(TP+FN)]/[FP/(FP+TN)] = [9.4/(9.4+1.3)]/[13.3/(13.3+76.0)]= 5.9
Negative likelihood ratio = [FN/(TP+FN)]/[TN/(FP+TN)] = [1.3/(9.4+1.3)]/[76.0/(13.3+76.0)]= 0.14
Diagnostic accuracy = TP + TN/TP +FP + FN +TN = 9.4 + 76 / 9.4 + 1.3 +76 +13.3 = 85.4/100 = 85.4%
Receiver Operating Characteristics Curves
The Receiver Operating Characteristics Curves were generated for the control and the study group using
the SPSS program from the diagnostic accuracy data, the information gleaned from the ROC curves were
used to calculate the Area Under the Curve (AUC) their corresponding p-values and the confidence
intervals, and are as follows:
ROC for study group
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Table VI: AUC for study group
Area
Standard error
P value
Confidence interval
Upper
Lower
0.747
0.058
0.001
0.634
0.861
ROC for control group
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Table VII: AUC for control group
Area
Standard error
P value
Confidence interval
Upper
Lower
0.801
0.081
0.006
0.642
0.961
DISCUSSION
SOCIODEMOGRAPHICS
The mean age for the study group was 43.52 years
± 14.16, while the control group had a mean age of
42.51 ± 16.27. Both groups were matched
appropriately with no statistically significant
difference (P-value = 0.685). Nearly half (49.4%) of
the participants were in the 38
–
57 age bracket.
This finding aligns with studies conducted in other
populations, including McCoul et al. (mean ages
49.8 ± 13.9 for the study group and 53.4 ± 11.2 for
controls) and van Roeyen et al., who reported
mean ages of 45 years and 36 years for obstructive
and patulous Eustachian Tube Dysfunction (ETD),
respectively. Herrera et al. also reported a mean
study group age of 43 years, while Al Kholawi et al.
documented a younger group with a mean age of
31 years.
51-54
Combined, 80% of participants in the current
study were aged 18
–
57 years, reflecting the
general population, as corroborated by the 2006
Nigerian census, which reported 59.3% of the
population in the 16
–
64 age bracket. These
findings suggest that the study sample mirrors the
broader demographic distribution in the region.
The prevalence of ETD based on ETDQ-7 scores
greater than 14.5 was 53.3% in the study group
and 22.7% in the control group, highlighting the
tool's utility in detecting the condition. This result
aligns with Tangbumrungtham et al., who reported
48.5% prevalence.
55
Newman et al. documented a
higher prevalence of 66.7% in patients with
coexisting temporomandibular joint disease
(TMJD), while Wu et al. and Marino et al. reported
lower prevalences of 47.6% and 43.92%,
respectively,
in
patients
with
chronic
rhinosinusitis and ETD symptoms.
56-58
These
disparities may be due to differences in
methodology, sample size, or the potential causal
relationships between chronic rhinosinusitis and
ETD, as well as overlapping symptoms between
ETD and TMJD.
EUSTACHIAN
TUBE
DYSFUNCTION
QUESTIONNAIRE-7
The mean total item score for the study group was
16.47 ± 7.53, compared to 11.68 ± 7.99 for the
control group. McCoul et al. reported significantly
higher scores of 29.3 ± 11.7 in cases and 9.1 ± 4.0
in controls. Similarly, Danish and Brazilian
versions yielded scores of 30.83 ± 13.1 and 48.0 ±
11.0 for cases and 13.5 ± 9.52 and 22.0 ± 3.2 for
controls, respectively.
15,16,20
Variations in scores
may stem from differences in translation, patient
comprehension, sample sizes, or study designs.
Unlike the current study, many previous studies
employed cohort or cross-sectional designs rather
than dividing participants into case and control
groups.
In this study, "muffled hearing" had the highest
score among cases (2.91 ± 1.74), while "pressure"
was the lowest (1.88 ± 1.41). Herrera et al.
similarly found "muffled hearing" to be the
highest-scored item (4.4 ± 2.7) and "ear pain" the
lowest (2.0 ± 1.7). Menezes et al. also observed
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"muffled hearing" as the highest and "pain" as the
lowest. Conversely, the Danish and original studies
by McCoul et al. reported "ear symptoms during
colds or sinusitis" as the highest and "pain" as the
lowest.
21,51,59
Interestingly, the Saudi Arabian version of ETDQ-7
reported "muffled hearing" as the lowest-scored
item, with no statistically significant difference
from controls (P = 0.356), a result attributed to age
differences in the study population.
53
In the
current study, most p-values for mean item scores
between the study and control groups were
statistically significant, except for "pressure" and
"pain" (P = 0.083 and 0.039, respectively). Herrera
et al. similarly noted overlap between ETDQ-7
symptoms and conditions such as TMJD, Ménière’s
disease, and superior semicircular canal
dehiscence. Teixeira et al. suggested that items like
"muffled sounds" and "clogged hearing" may
introduce redundancy.
51,59
DIAGNOSTIC PERFORMANCE
In the study group, ETDQ-7 demonstrated a
sensitivity of 90%, higher than the 87% achieved
with tympanometry, suggesting the tool's utility in
detecting ETD. However, its specificity was 60%,
lower than McCoul et al.'s findings of 100%
sensitivity and specificity.
15
Smith et al. reported
80.7% sensitivity and 24.6% specificity, while
Herrera et al. documented 73% sensitivity and
43% specificity. Lin et al. observed near-perfect
values (100% sensitivity and 99.9% specificity).
17
Differences across studies may arise from
methodological variations, such as whether
objective tests preceded the questionnaire. McCoul
et al. noted that larger populations might yield
different accuracy rates.
15
Smith et al. recommended administering objective
tests after the questionnaire to minimize selection
bias, a methodology also applied in this study.
60,61
Despite ETDQ-7's moderate diagnostic accuracy,
caution is necessary when interpreting results, as
a low positive predictive value (PPV) of 45% in the
study group indicates a high false-positive rate.
Conversely, the negative predictive value (NPV) of
94% suggests strong reliability in ruling out ETD.
LIKELIHOOD RATIOS
In the study group, the positive likelihood ratio
(LR+) of 2.2 implies that individuals with a positive
test are 2.2 times more likely to have ETD than
those with a negative test. Although not conclusive,
this provides some evidence supporting positive
results. The negative likelihood ratio (LR−) of 0.17
indicates that participants with a negative test are
83% less likely to have ETD, bolstering confidence
in negative results.
In the control group, sensitivity was 87%, with a
specificity of 80%. The NPV was 98%, reinforcing
the test's utility in ruling out ETD. However, the
PPV was 41%, highlighting a substantial risk of
false positives. The LR+ of 5.9 and LR− of 0.14
support the test's classification ability, but the
prevalence of ETD in this group (22.7%)
necessitates caution. These findings align with
STARD guidelines, which emphasize context-
specific interpretations of diagnostic metrics.
46
DIAGNOSTIC ACCURACY
The overall diagnostic accuracy was 68% for the
study group and 85.4% for the control group,
reflecting ETDQ-7's limitations in distinguishing
ETD subtypes and ruling out differentials such as
TMJD. The receiver operating characteristic (ROC)
curve analysis showed an area under the curve
(AUC) of ~0.75 (CI = 0.63
–
0.86) for cases and
~0.80 (CI = 0.64
–
0.96) for controls. This indicates
moderate diagnostic accuracy, comparable to
Herrera et al.'s AUC of 0.57 and Teixeira et al.'s AUC
of <0.68 (CI = 0.53
–
0.83).55,100 In contrast,
McCoul et al. reported an AUC of 1, while van
Roeyen et al. and Lin et al. documented AUC values
of ~0.95 and ~0.98, respectively.
17,18,52
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These results suggest that ETDQ-7 performs better
in ruling out ETD than diagnosing it, especially in
symptomatic
populations.
Smith
et
al.
recommended using ETDQ-7 as a supplementary
tool rather than a standalone diagnostic method.
61
LIMITATIONS
Several factors may influence ETDQ-7's accuracy
in local settings. These include sample size,
potential machine error, symptom variability over
time, and inter-operator variability. While
participant comprehension appeared sufficient,
administering the questionnaire in local dialects or
pidgin English may yield different results. Further
research is needed to explore test-retest reliability
and alternative study designs. Additionally,
incorporating
objective
tests
such
as
tympanometry remains critical to confirm ETDQ-7
findings, as suggested by Teixeira et al. and Smith
et al.
59,60
RECOMMENDATIONS
1.
The
Eustachian
Tube
Dysfunction
Questionnaire-7 (ETDQ-7) should be utilized
as a primary screening tool within community
settings to identify individuals who may need
further evaluation at specialized reference
facilities.
2.
In settings with limited resources, the ETDQ-7
can be used to manage patients empirically,
serving as an alternative to more costly and
less accessible objective tests.
3.
The ETDQ-7 can also be adapted as a cost-
effective follow-up tool for patients who have
undergone interventions, helping to assess the
efficacy of these treatments over time.
4.
Conducting a population-based study could
provide valuable insights into the diagnostic
yield of the ETDQ-7 when used in conjunction
with objective tests, potentially enhancing its
overall utility.
CONCLUSION
The study demonstrated a statistically significant
improvement in the accuracy of the Eustachian
Tube Dysfunction Questionnaire-7 (ETDQ-7), with
its sensitivity surpassing that of tympanometry.
This
finding
underscores
the
ETDQ-7's
effectiveness in identifying individuals with
Eustachian tube dysfunction. The questionnaire's
ease of administration, non-invasive nature, and
reproducibility further enhance its practicality for
widespread use in various settings.
Moreover, the ETDQ-7's simplicity makes it
accessible for both healthcare providers and
patients, facilitating early detection and
management of Eustachian tube dysfunction
without the need for complex equipment or
procedures. This is particularly beneficial in
community and resource-limited settings where
advanced diagnostic tools may not be readily
available.
However, the study also revealed that the ETDQ-7
has lower specificity within the study group. This
limitation indicates that while the ETDQ-7 is highly
effective as a screening tool to identify potential
cases of Eustachian tube dysfunction, it may not be
as reliable for definitive diagnosis. Therefore, it is
recommended to use the ETDQ-7 primarily for
initial screening purposes, with positive cases
being referred for further evaluation using more
specific diagnostic methods.
CONFLICTS OF INTEREST
The publication of this article was supported by
PENKUP Foundation, a non-profit organisation
founded by the corresponding author.
FUNDING
This work was supported by the PENKUP
Foundation, a division of PENKUP International,
which provided funding for the publication of this
article.
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ACKNOWLEDGEMENT
The authors would like to acknowledge the
management and technical staff of PENKUP
Research Institute, Birmingham, UK, for their
excellent assistance and for providing medical
writing and editorial support in accordance with
Good Publication Practice (GPP3) guidelines.
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SUPPLEMENTARY MATERIALS
APPENDIX I: DATA COLLECTION SHEET
SECTION I
1.
Age in years: (as at last birthday) __________________________________________
2.
Sex M [ ] F[ ]
3.
Ethnicity: Bini [ ] Esan[ ] Etsako[ ] Igbo[ ] Yoruba[ ] Hausa[ ] Urhobo[
]
4.
Isoko [ ] Ijaw[ ] Itsekiri[ ] Others[ ]
5.
Occupation: ________________________________________________________
6.
Religion: Christianity [ ] Islam[ ] African traditional religion[ ]
7.
Others ______________________________________________________________
SECTION II
1.
Do you have Ear Discharge? Yes [ ] No [ ]
2.
If yes, for how long?
3.
Have you had surgery of the Head and Neck done? Yes [ ] No [ ]
4.
Does the participant snore while sleeping? Yes [ ] No [ ]
5.
If yes, for how long?
6.
How loud is it? Loud [ ] Very loud[ ] Embarrassing[ ]
THE USA JOURNALS
THE AMERICAN JOURNAL OF INTERDISCIPLINARY INNOVATIONS AND RESEARCH (ISSN- 2642-7478)
VOLUME 06 ISSUE12
50
https://www.theamericanjournals.com/index.php/tajiir
7.
Does the participant toss excessively in bed while asleep? Yes [ ] No [ ]
8.
Does he/she sometimes stop breathing while asleep? Yes [ ] No [ ]
9.
Does the participant mouth breathe during the day? Yes[ ] No [ ]
10.
Does the participant have recurrent nasal discharge? Yes [ ] No [ ]
11.
Does the participant have a history of Epistaxis? Yes [ ] No[ ]
12.
Does the participant have a history of Nasal blockage? Yes [ ] No[ ]
APPENDIX II: ENGLISH VERSION OF ETDQ-7
Total ETDQ-7 Score =
Over the past 1 month, how much has each of the
following been a problem for you?
No Problem
Moderate Problem
Severe
Problem
1. Pressure in the ears?
1
2
3
4
5
6
7
2. Pain in the ears?
1
2
3
4
5
6
7
3. A feeling that your ears are clogged or ‘‘under
water’’?
1
2
3
4
5
6
7
4. Ear symptoms when you have a cold or sinusitis?
1
2
3
4
5
6
7
5. Crackling or popping sounds in the ears?
1
2
3
4
5
6
7
6. Ringing in the ears?
1
2
3
4
5
6
7
7. A feeling that your hearing is muffled?
1
2
3
4
5
6
7
