DIAGNOSTIC ACCURACY OF THE ETDQ-7 IN ADULTS AT UNIVERSITY OF BENIN TEACHING HOSPITAL

Abstract

Background: Diagnoses of Eustachian tube dysfunction in Benin City are typically made clinically or with tympanometry. The Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) is a scoring system with potential as an alternative tool, particularly useful in resource-challenged settings. This novel tool may not have been previously investigated in this environment for its accuracy.

Objective: The study aimed to compare the diagnostic accuracy of the Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) to tympanometry (used as the reference standard) in identifying adult patients with Eustachian tube dysfunction at the ENT clinic of the University of Benin Teaching Hospital.

Methodology: This was a hospital-based, prospective diagnostic accuracy study using a case-control design. A total of 150 study participants were recruited, including 75 case participants and 75 controls. The ETDQ-7 instrument was administered to all participants, followed by tympanometry for each. Data were analyzed using the IBM Statistical Package for the Social Sciences (IBM SPSS) version 26.

Results: The diagnostic accuracy of the ETDQ-7 in the study group was found to be 68%, while in the control group, it was 85.4%. The Area Under the Curve (AUC) for the study group was approximately 0.75, and for the control group, it was approximately 0.80.

Conclusion: The ETDQ-7 demonstrates moderate accuracy for the diagnosis of Eustachian tube dysfunction, making it a useful tool for adoption as a screening method. Its ease of administration, noninvasive nature, and reproducibility make it particularly advantageous in settings where resources are limited. However, due to its moderate specificity, it is best utilized as a preliminary screening tool rather than a definitive diagnostic method.

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Uchefe, O. A., Obohwemu, K. O., Okolugbo, N., & Okhaku, A. (2024). DIAGNOSTIC ACCURACY OF THE ETDQ-7 IN ADULTS AT UNIVERSITY OF BENIN TEACHING HOSPITAL. The American Journal of Interdisciplinary Innovations and Research, 6(12), 30–50. https://doi.org/10.37547/tajiir/Volume06Issue12-05
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Abstract

Background: Diagnoses of Eustachian tube dysfunction in Benin City are typically made clinically or with tympanometry. The Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) is a scoring system with potential as an alternative tool, particularly useful in resource-challenged settings. This novel tool may not have been previously investigated in this environment for its accuracy.

Objective: The study aimed to compare the diagnostic accuracy of the Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) to tympanometry (used as the reference standard) in identifying adult patients with Eustachian tube dysfunction at the ENT clinic of the University of Benin Teaching Hospital.

Methodology: This was a hospital-based, prospective diagnostic accuracy study using a case-control design. A total of 150 study participants were recruited, including 75 case participants and 75 controls. The ETDQ-7 instrument was administered to all participants, followed by tympanometry for each. Data were analyzed using the IBM Statistical Package for the Social Sciences (IBM SPSS) version 26.

Results: The diagnostic accuracy of the ETDQ-7 in the study group was found to be 68%, while in the control group, it was 85.4%. The Area Under the Curve (AUC) for the study group was approximately 0.75, and for the control group, it was approximately 0.80.

Conclusion: The ETDQ-7 demonstrates moderate accuracy for the diagnosis of Eustachian tube dysfunction, making it a useful tool for adoption as a screening method. Its ease of administration, noninvasive nature, and reproducibility make it particularly advantageous in settings where resources are limited. However, due to its moderate specificity, it is best utilized as a preliminary screening tool rather than a definitive diagnostic method.


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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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otorhinolaryngology. 2010 May 1;76(3):340-6.

43.

Nwosu C, Uju Ibekwe M, Obukowho Onotai L.
Tympanometric findings among children with
adenoid hypertrophy in Port Harcourt, Nigeria.
International Journal of Otolaryngology. 2016
Aug 2;2016.

44.

Fasunla AJ, Ijitola JO, Nwaorgu OG.
Tympanometric Patterns of Children with
Allergic Rhinitis Treated at a Tertiary Health
Institution.

OTO

open.

2017

Nov;1(4):2473974X17742648.

45.

Mulwafu W, Ensink R, Kuper H, Fagan J. Survey
of ENT services in sub-Saharan Africa: little
progress between 2009 and 2015. Global
health action. 2017 Jan 1;10(1):1289736.

46.

Cohen JF, Korevaar DA, Altman DG, Bruns DE,
Gatsonis CA, Hooft L, Irwig L, Levine D, Reitsma
JB, de Vet HC, Bossuyt PM. STARD 2015
guidelines for reporting diagnostic accuracy
studies: explanation and elaboration. Current
Pediatrics. 2022 Jul 14;21(3):209-28.

47.

Buderer NM. Statistical methodology: I.
Incorporating the prevalence of disease into
the sample size calculation for sensitivity and
specificity. Academic Emergency Medicine.
1996 Sep;3(9):895-900.

48.

Altman D, Machin D, Bryant T, Gardner M,
editors. Statistics with confidence: confidence
intervals and statistical guidelines. John Wiley
& Sons; 2013 Jun 3.

49.

Bewick V, Cheek L, Ball J. Statistics review 14:
Logistic regression. Critical care. 2005
Feb;9(1):1-7.

50.

World Medical Association. World Medical
Association Declaration of Helsinki: ethical
principles for medical research involving
human

subjects.

Jama.

2013

Nov

27;310(20):2191-4.

51.

Herrera M, Eisenberg G, Plaza G. Clinical
assessment of Eustachian tube dysfunction
through the Eustachian tube dysfunction
questionnaire (ETDQ-7) and tubomanometry.
Acta Otorrinolaringologica (English Edition).
2019 Sep 1;70(5):265-71

52.

Van Roeyen S, Van de Heyning P, Van Rompaey
V. Responsiveness of the 7-item Eustachian
tube dysfunction questionnaire. J Int Adv Otol.
2016 Apr 1;12(1):106-8.

53.

Alkholaiwi F, Alnatheer AM, Theyab RS,
Alyousef M, Aldrees T, Dahmash AB,
Alghonaim Y. Cross-Cultural Adaptation,
Validation, and Arabic Translation of the


background image

THE USA JOURNALS

THE AMERICAN JOURNAL OF INTERDISCIPLINARY INNOVATIONS AND RESEARCH (ISSN- 2642-7478)

VOLUME 06 ISSUE12

49

https://www.theamericanjournals.com/index.php/tajiir

Eustachian Tube Dysfunction Questionnaire
(ETDQ-7).

International

Archives

of

Otorhinolaryngology. 2023 Jan 20;26:636-42.

54.

Population of Benin city, 2020. Available at:

http://populationstat.com/nigeria/benin-city

,

[Accessed 28th of April,2021].

55.

Tangbumrungtham N, Patel VS, Thamboo A,
Patel ZM, Nayak JV, Ma Y, Choby G, Hwang PH.
The prevalence of Eustachian tube dysfunction
symptoms

in

patients

with

chronic

rhinosinusitis. InInternational Forum of
Allergy & Rhinology 2018 May (Vol. 8, No. 5,
pp. 620-623).

56.

Wu AW, Walgama ES, Higgins TS, Borrelli M,
Vardanyan N, Hopp S, Shamsian A, Hopp ML.
Eustachian tube quality of life and severity of
disease in patients with chronic rhinosinusitis.
American Journal of Rhinology & Allergy. 2020
Jul;34(4):532-6.

57.

Newman AC, Omrani K, Higgins TS, Ting JY,
Walgama ES, Wu AW. The prevalence of

eustachian tube dysfunction symptoms in
temporomandibular joint disorder patients.
The Laryngoscope. 2020 Apr;130(4):E233-6.

58.

Marino MJ, Ling LC, Yao WC, Luong A, Citardi
MJ. Eustachian tube dysfunction symptoms in
patients treated in a tertiary rhinology clinic.
InInternational forum of allergy & rhinology
2017 Dec (Vol. 7, No. 12, pp. 1135-1139).

59.

Teixeira MS, Swarts JD, Alper CM. Accuracy of
the ETDQ-7 for identifying persons with
Eustachian tube dysfunction. Otolaryngology-
Head and Neck Surgery.2018 Jan;158(1):83-9.

60.

Smith ME, Bance ML, Tysome JR. Advances in
Eustachian tube function testing. World
Journal of Otorhinolaryngology-Head and Neck
Surgery. 2019 Sep 1;5(03):131-6.

61.

Smith ME, Cochrane IL, Donnelly N, Axon PR,
Tysome JR. The performance of patient-
reported outcome measures as diagnostic
tools for eustachian tube dysfunction. Otology
& Neurotology. 2018 Oct 1;39(9):1129-38.

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[ ]


background image

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

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Wu AW, Walgama ES, Higgins TS, Borrelli M, Vardanyan N, Hopp S, Shamsian A, Hopp ML. Eustachian tube quality of life and severity of disease in patients with chronic rhinosinusitis. American Journal of Rhinology & Allergy. 2020 Jul;34(4):532-6.

Newman AC, Omrani K, Higgins TS, Ting JY, Walgama ES, Wu AW. The prevalence of eustachian tube dysfunction symptoms in temporomandibular joint disorder patients. The Laryngoscope. 2020 Apr;130(4):E233-6.

Marino MJ, Ling LC, Yao WC, Luong A, Citardi MJ. Eustachian tube dysfunction symptoms in patients treated in a tertiary rhinology clinic. InInternational forum of allergy & rhinology 2017 Dec (Vol. 7, No. 12, pp. 1135-1139).

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