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Investigation of the incidence of Eustachian tube dysfunction in patients with sinonasal disease

Authors:
ORIGINAL CONTRIBUTION
Investigation of the incidence of Eustachian tube
dysfunction in patients with sinonasal disease*
Abstract
Background: Rhinosinusitis is characterised by inflammation affecting the respiratory mucosa of the nose and sinuses. Since the
Eustachian tube and the middle ear cavity are also lined by the same mucosa, it is likely that the pathophysiological processes
that give rise to rhinosinusitis will also affect these areas. Eustachian tube dysfunction (ETD) is a common condition, but it is often
dismissed as a "minor" symptom in rhinology patients.
Objective: The aim of this study was to determine the frequency of otologic symptoms in patients attending the rhinology clinic.
The seven-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7), a validated disease-specific instrument was used to assess
symptoms with respect to ETD7.
Study design: 119 patients attending the rhinology outpatient clinic completed ETDQ-7, a SNOT 22 and had their PNIF measured.
Results: The results showed a significantly higher rate of ETD (p<0.01 paired t-test) in the rhinology patients (mean score 3.1, SD
1.64) as compared to a control population (mean 1.3, SD 0.3).
Conclusion: Eustachian tube dysfunction is more common in rhinology patients then the general population, and within the
rhinology population. The classification of this as a "minor" symptom of rhinosinusitis should be re-evaluated and the effect of
treatment of sinonasal disease on ETD needs to be investigated.
Key words: Eustachian tube dysfunction, paranasal sinuses, rhinosinusitis, questionnaire
C.E. Rennie1, M. Gutierrez2, Y. Darby1, V.J. Lund1
1 Royal National Throat Nose and Ear Hospital, ENT, London, United Kingdom
2 University of North Carolina, Medical student, North Carolina, USA
Rhinology Online, Vol 1: 85 - 89, 2018
http://doi.org/10.4193/RHINOL/18.050
*Received for publication:
August 12, 2018
Accepted: August 14, 2018
Published: August 19, 2018
85
Introduction
Rhinosinusitis is characterised by inflammation affecting the
respiratory mucosa of the nose and sinuses. The Eustachian tube
and the middle ear cavity are also lined by the same mucosa.
It is therefore, likely that the pathophysiological processes that
give rise to rhinosinusitis will also affect these areas.
Although the connection between these adjacent areas has
been realised for decades, there is a lack of research examining
this interaction and the effects of any interventions. Most stu-
dies in this area focus on otitis media with effusion in children
(1-3).
Eustachian tube dysfunction (ETD) is a common symptom, it is
estimated to have a prevalence of 0.9% in the UK population 4),
however it is often dismissed as a "minor" symptom in rhinology
patients. This may in part be due to the difficulty diagnosing
ETD as its symptoms are often vague and non-specific, also
there is a perceived lack of efficacy of any treatment for ETD. Un-
til recently there has been no consensus on the definition and
diagnosis of this disorder (5,6). The lack of definition of ETD along
with the paucity of outcome measures has hampered our ability
to determine the epidemiology and efficacy of treatments for
ETD.
86
Eustachian tube dysfunction in sinonasal disease
The development of the first international consensus on the
definition, clinical presentation and diagnosis of ETD should
enable better studies of the epidemiology of Eustachian tube
dysfunction, psychosocial impact, and treatment (6).
The Eustachian tube has three main functions:
1. Pressure equalisation and ventilation of the middle ear
2. Mucociliary clearance of secretions from the middle ear
3. Protection of the middle ear from sounds as well as from
pathogens and secretions from the nasopharynx (7,8).
In health the Eustachian tube is normally closed but is pulled
open briefly by the paratubal muscles during swallowing or
yawning, which enables the above functions to take place (9,10).
Disruption of this intermittent opening leads to ETD with the
typical symptoms of ear fullness, ‘popping’ or crackling’, discom-
fort or pain, muffled hearing or tinnitus (5,11).
Over the last 40 years there have been a number of attempts
to develop an objective measure for ETD (12) however, as yet no
single test has been found to be a reliable diagnostic tool (13,14).
The recently developed Eustachian Tube Dysfunction Question-
naire (ETDQ- 7) scores symptoms of Eustachian tube dysfunction
and is currently the only patient-reported outcomes tool to have
undergone initial validation studies (6).
Therefore, in this study we use the ETDQ-7 to determine the
incidence of Eustachian tube dysfunction symptoms in patients
attending a tertiary referral rhinology clinic. The ETDQ-7 is short
and simple to use, and the respondent burden is minimal. It has
been shown to be reliable and valid for the cross-sectional as-
sessment of ETD-related symptoms in adults. We have compa-
red the results in our rhinology population to literature quoted
values for ETD patient and control groups from the validation
studies.
Methods
Patients were prospectively and consecutively enrolled from the
clinical practice of the senior author (VJL) over a 6 month period
in the latter half of the year to minimise effects of seasonal al-
lergy (Appendix). All subjects were outpatients who were refer-
red with chronic rhinologic symptoms (>3months) to a tertiary
referral centre and participated as part of an institutional audit.
All patients included in this study were at least 18 years old. All
had symptoms and signs consistent with a diagnosis of chronic
rhinosinusitis (15) but patients with known otological disease and
previous ear surgery were excluded. Each patient completed
an ETDQ-7, a SNOT 22, a visual analogue score (VAS) for nasal
obstruction, and had their peak nasal inspiratory flow (PNIF)
measured as part of their initial assessment. The ETDQ-7 is com-
prised of seven questions on ETD symptoms each of which is
scored out of 7 for severity over the last month (Table 1). This dif-
fers from the SNOT 22 questionnaire, which scores 22 symptoms
of rhinosinusitis out of 5 over the previous 2 weeks.
Results
A total of 119 patients were enrolled for the study, 65 female
and 54 male, with a mean age of 52. Over half (54%) of the
patients had had previous endoscopic sinus surgery, which is
typical of the tertiary referral practice. There was also a wide
range of pathologies within the patient group also reflecting the
nature of a tertiary referral practice (Figure 1).
The ETDQ-7 results for the rhinology patients were compared to
the results quoted in the literature for control populations and
patients with ETD (Table 2, Figures 2 and 3) (11). The overall ETDQ-
7 score among the 119 rhinology patients was significantly
greater than the score among the literature control group (P <
0.001). The mean (standard deviation) overall score was 2.8 (1.6)
for the rhinology patients, 4.0 (1.1) for the ETD group and 1.3
(0.3) for the control group. The mean individual score for each of
the seven items of the ETDQ-7 was significantly greater for the
rhinology group compared to the control group. As expected
the rhinology patients scored highest on Question 4 of the
ETDQ-7 “ear symptoms when you have a cold or sinusitis?”.
Table 1. Eustachian tube dysfunction questionnaire ETDQ-7.
Figure 1. Distribution of pathology within the rhinology patient group.
87
Rennie et al.
nus surgery (17). Maniakas et al. also confirmed that for most CRS
patients, ETD symptoms will decrease post-endoscopic sinus
surgery to a level comparable with a non-CRS population (16).
The use of the ETDQ-7 has the potential to enhance clinical care
by highlighting the impact of ETD as well as guiding and evalu-
ating appropriate management. Further prospective testing of
patients being treated for ETD may establish the ETDQ-7 in the
assessment of treatment outcomes.
Limitations of this study
A potential confounding factor is that a small number of the
rhinology patients in this cohort had systemic disease with
known otological manifestations, which could bias these results.
As expected higher ETDQ-7 scores were seen in patients with
primary ciliary dyskinesia (PCD), eosinophilic granulomatosis
with polyangitis (EGPA) and immunodeficiency (Figure 4) who
nonetheless were suffering from chronic rhinosinusitis. There-
fore, further analysis was undertaken excluding these patients
and the results still demonstrated significantly higher scores in
the rhinology population as compared to control groups.
In validity studies the optimal total item score cutpoint of ≥14.5
versus <14.5 (for categorising a patient as having ETD) provided
100% sensitivity and 100% specificity. This equated to an ETDQ-
7 mean item score of ≥2.1 to indicate the presence of ETD. 74
of the 119 rhinology patients in this study had total item scores
≥14.5, meaning that 62% of these rhinology patients would be
diagnosed as having ETD based on this outcome measure.
SNOT 22 scores of >28.5 were associated with higher ETDQ-7
scores, which is not surprising as the SNOT 22 has 3 otological
questions pertaining to ear fullness, dizziness and ear pain/
pressure which overlaps with the ETDQ-7 questions 1, 2 and
3. (Table 2) There is also an overlap between Question 4 of the
ETDQ-7 (“ear symptoms when you have a cold or sinusitis”) with
symptoms of rhinosinusitis. The SNOT-22 alone had a moderate
specificity and sensitivity for detecting ETD on validity tes-
ting11, although the ETDQ-7 performed significantly better as a
disease-specific instrument.
VAS scores >5 for nasal obstruction were associated with higher
ETDQ-7 scores and NIPF scores < 80 were also associated with
higher ETDQ-7 scores.
Discussion
These results illustrate that ETD, as manifested by otologic
symptoms, is common in patients attending the rhinology clinic.
This has been confirmed recently in a combined multi-centre
cohort of 131 patients with CRS based on responses to the
SNOT-22 questions on ear fullness and ear pain (16). Therefore,
the classification of ETD as a "minor" symptom of rhinosinusitis
should be re-evaluated.
What remains to be determined is if treatment for sinus
symptoms will improve the symptoms of Eustachian tube dys-
function? An earlier retrospective questionnaire study by Stoikes
et al. suggests the ETD symptoms associated with CRS improve
or resolve in the majority of patients undergoing endoscopic si-
Table 2. Eustachian Tube Dysfunction Scores by Item. SD = standard
deviation. * Literature values given by McCoul et al. (11).
Figure 2. Mean ETDQ-7 scores. There was a significantly higher rate of
ETD symptoms (p<0.01 paired t-test) in the rhinology patients (mean
score 3.1, SD 1.64) as compared to a control population (mean 1.3, SD
0.3). The error bars show the standard deviation.
Item Rhinology
patients
Mean (SD)
Control
Group*
Mean (SD)
ETD
Group *
Mean (SD)
1. Pressure 2.6 (1.8) 1.1 (0.4) 4.3 (1.5)
2. Pain 2.3 (1.7) 1.3 (0.6) 3.2 (1.7)
3. Feeling clogged 2.8 (1.9) 1.2 (0.5) 4.8 (1.5)
4. Cold/sinusitis
problems 3.4 (2.8) 2.2 (1.1) 5.0 (1.6
5. Crackling or
popping 2.8 (2.0) 1.1 (0.4) 4.0 (1.8)
6. Ringing 2.6 (2.1) 1.1 (0.3) 3.2 (2.1)
7. Feeling muffled 3.1 (2.1) 1.3 (0.3) 4.8 (1.5)
Figure 3. Mean ETDQ-7 scores by item.
88
Eustachian tube dysfunction in sinonasal disease
The recent consensus document on ETD recommends that the
diagnosis of ETD be based on the presentation with symptoms
of pressure disequilibrium in either ear, specifically symptoms of
‘aural fullness’ or ‘popping or discomfort/pain (6). Evidence of ne-
gative pressure in the middle ear could be supported on clinical
assessment, either by:
1. otoscopic evidence of tympanic membrane retraction and/or
2. tympanogram indicating negative middle ear pressure.
Unfortunately neither in this study nor that of Maniakas et al. (17)
the rhinology patients have not been assessed for evidence of
negative pressure in the middle ear. However, the ETDQ-7 is a
valid and reliable disease-specific symptom score for adult pa-
tients with ETD. The criterion validity for the test was established
by the exclusive presence of normal tympanograms in control
subjects and abnormal tympanograms in subjects with ETD. The
advantage of the ETDQ-7 is that it is quick and easy to adminis-
ter in the clinical setting and is simple for the patients to fill out.
Another limitation of the study related to the ETDQ-7 is that the
questions are based on disease burden and timing of events.
In addition, whether they may be intermittent is not represen-
ted and therefore, the questionnaire may underestimate the
incidence of ETD. Furthermore, there is a possibility of bias by
comparing our patients with historical controls from the United
States rather than providing our own control data.
Conclusion
Symptoms of eustachian tube dysfunction are prevalent in the
rhinology patient population and are often overlooked in sino-
nasal-orientated outpatient consultations. The development of a
consensus on the definition and diagnosis of ETD and its adopti-
on by the ENT community should lead to an improvement in the
diagnosis of ETD and will provide the basis for further research
into the epidemiology and treatment of ETD. The development
and validation of disease specific patient recorded outcome
measures such as the ETDQ-7 allows comparison of the efficacy
of treatments for ETD and an understanding of the interaction
between the nose and Eustachian apparatus could lead to a bet-
ter overall management of our patients.
Key Points
Symptoms of eustachian tube dysfunction are more com-
mon in rhinology patients then in the general population.
The ETDQ-7 is a simple easy to use validated disease speci-
fic outcome measure for ETD.
The classification of this as a "minor" symptom of rhinosinu-
sitis should be re-evaluated.
The effect of treatment of sinonasal disease on ETD needs
to be investigated.
Authorship contribution
MG, YD and CR were involved in the design and data collection
for the study, VJL designed the study and edited the manuscript
and approved the final version. CR processed the results, drafted
the manuscript, reviewed the available literature and approved
the final version.
Availability of data and materials
Curated by first author and available on reasonable request.
Conflict of interest
The authors declare that they have no competing interests.
Figure 4. Mean ETDQ-7 score by diagnosis. The number of patients
with each diagnosis is as follows; Polyps (CRSwNP) 69, No polyps
(CRSsNP) 28, EGPA (Eosinophilic granulomatosis with polyangitis) 3,
Immunodeficiency 2 and PCD (Primary ciliary dyskinesia) 1.
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Valerie J Lund
RNTNEH
Grays Inn Road
London WC1X 8DA
United Kingdom
Tel: +44 (0)7860 873 726
E-mail: v.lund@ucl.ac.uk
Inclusion and exclusion criteria for control group and ETD group
McCoul et al (11).
“Patients were diagnosed as having ETD if they had a retracted or
poorly mobile tympanic membrane on pneumatic otoscopy, with
a history of at least two of the following symptoms in one or both
ears over the previous 1 month period: aural fullness or pressure,
a sensation of clogged or muffled hearing, recurrent or persistent
middle ear effusion (defined as an effusion present on examinations
at least 1 month apart), or the inability to rapidly self-equilibrate
middle ear pressure following changes in ambient atmospheric
pressure. Abnormal impedance audiometry was used as a criterion
standard to verify the diagnosis at the time of enrolment.
Exclusion criteria included surgery of the head or neck within 3
months; a history of radiation therapy to the head and neck; sino-
nasal malignancy; evidence of acute upper respiratory infection,
including sinusitis and acute otitis media; adenoid hypertrophy;
nasal polyposis; cleft palate or history of cleft palate repair; cranio-
facial syndrome, including Down syndrome; cystic fibrosis; ciliary
dysmotility syndrome; or other systemic immunodeficiency.
A second group of patients who did not meet these inclusion criteria
and who had presented with medical complaints not related to ETD
were consecutively enrolled for use as a control group. Presenting
complaints for these patients included voice disturbance, tonsil hy-
pertrophy, and intraoral lesions. All of these patients had a normal
examination of the tympanic membrane, middle ear, nasal cavity,
and nasopharynx. Normal impedance audiometry was used as a
criterion standard to verify the absence of ETD.
APPENDIX
... Background: Eustachian tube dysfunction (ETD) has been associated with inflammatory conditions (1) . Many studies have identified a high prevalence of ETD in patients with chronic rhinosinusitis (CRS) (2) . ...
... These criteria include symptoms of nasal obstruction or rhinorrhoea lasting more than 12 weeks in duration with endoscopic or radiological evidence of nasal polyps; or other mucosal changes within the osteomeatal complex and/or mucopurulent discharge from the middle meatus (3) . Eustachian tube dysfunction [ETD] is thought to be associated with sinonasal conditions such as rhinosinusitis (1) . Given previous studies have estimated the prevalence of ETD in the general population to be 0.9% (4) and in CRS patients to be as high as 48.5% (2) , this represents a common and significant health issue. ...
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Background: Eustachian tube dysfunction (ETD) has been associated with inflammatory conditions (1). Many studies have identified a high prevalence of ETD in patients with chronic rhinosinusitis (CRS) (2). However, there is a paucity of higher-level evidence assessing the impact of endoscopic sinus surgery (ESS) on patients with ETD concurrent disease. Methods: Systematic review and meta-analysis of non-randomised studies on the impact of ESS on ETD in patients with CRS, based on the eustachian tube dysfunction questionnaire (ETDQ-7) scores. PRISMA guidelines were followed according to a priori study protocol (PROSPERO Registration number: CRD42021245677). A random-effects model was employed. Results: 21 results were obtained using our search strategy. Four studies met our inclusion criteria. 501 patients were identified in the included studies. The prevalence of ETD in CRS patients in our review was 55.1%. Pooled estimates showed a statistically significant reduction in ETDQ-7 scores. Conclusions: The evidence to date suggests there is a high prevalence of concurrent ETD in CRS patients, the symptoms of which improved following ESS for CRS in this patient group. However, the current evidence base is comprised of uncontrolled case series. High-quality, randomised controlled studies with long-term follow-up are lacking.
... Twothirds of patients had an ETDQ-7 score of >14.5, which indicates clinically significant ETD. Also, Rennie et al. [22] found that ETD was significantly higher in rhinology patients (mean score 3.1 ± 1.64) as compared to a control population (mean 1.3 ± 0.3). In Saudi Arabia, Alshehri et al. [4] estimated higher prevalence among public in Jeddah than reported in the current study which was 42.5%. ...
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Objective To investigate the prevalence of eustachian tube dysfunction (ETD) in elderly adults in the United States and its association with other upper aerodigestive inflammatory processes. Study Design Cross-sectional study. Setting Population based. Subjects and Methods In total, 147,805 patients without malignancy were compared to 13,804 demographically matched patients with malignancy of the upper aerodigestive tract (UADT) by querying the Surveillance, Epidemiology, and End Results (SEER)–Medicare linked database for patients aged 66 to 99 years between 2003 and 2011. The prevalence of ETD and inflammatory diseases among these patients was compared. Association between ETD, other upper aerodigestive inflammatory processes, and UADT malignancies was evaluated. Results The prevalence of ETD was 5.44% among patients without malignancy and 9.08% in those with cancer (odds ratio [OR], 1.73; 95% CI, 1.63-1.84). Patients with ETD in the control population were more likely (OR, 95% CI) to be diagnosed with chronic rhinitis (5.00, 4.70-5.33), chronic sinusitis (4.20, 3.98-4.43), allergic rhinitis (4.27, 4.08-4.47), and gastroesophageal reflux disease (GERD) (2.42, 2.31-2.53). Patients with ETD and chronic rhinitis (1.43, 1.24-1.65), chronic sinusitis (1.57, 1.38-1.78), and acute otitis media (1.33, 1.08-1.65) were associated with higher rates of UADT malignancy. Conclusion Over 5% of patients older than 65 in the United States are diagnosed with ETD in the absence of UADT malignancy. Associations between ETD and chronic rhinitis, chronic sinusitis, allergic rhinitis, and GERD in the absence of UADT malignancy suggest that some patients may benefit from treatment of inflammatory disease as a cause of ETD.
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Objective We assessed how eustachian tube dysfunction (ETD) changed with endoscopic sinus surgery (ESS) and identified factors associated with improvement. Study Design Retrospective chart review. Setting Academic center. Subjects and Methods Patients undergoing ESS for chronic rhinosinusitis with and without nasal polyposis (CRSwNP, CRSsNP) or recurrent acute rhinosinusitis (RARS) completed the Eustachian Tube Dysfunction Questionnaire 7 (ETDQ-7) preoperatively and postoperatively at 2 weeks, 6 weeks, 3 months, and 6 months. Included in analyses were demographics, comorbidities, Sinonasal Outcome Test 22 (SNOT-22), radiographic score, endoscopy score, procedure, and medication use. Regression analysis identified factors associated with improvement, defined as ΔETDQ-7 >3.5. Results In total, 302 patients were studied. ETD prevalence was 68% in CRSsNP, 48% in CRSwNP, and 88% in RARS. Patients with ETD had a mean baseline ETDQ-7 of 25.8 ± 8.0 and improved postoperatively at 2 weeks (19.9 ± 8.1, P < .001), 6 weeks (17.8 ± 9.3, P < .001), 3 months (16.8 ± 8.5, P < .001), and 6 months (16.4 ± 7.9, P < .001). At 6 months, ETD improved in 89% of patients with CRSsNP, 68% with CRSwNP, and 78% with RARS. On multivariate analysis, ETD improvement was associated with higher preoperative ETDQ-7 score (adjusted odds ratio [aOR], 1.12; 95% confidence interval [CI], 1.04-1.22; P = .030), higher preoperative SNOT-22 score (aOR, 1.02; 95% CI, 1.02-1.08; P = .001), higher preoperative SNOT-22 ear subscore (aOR, 1.27; 95% CI, 1.02-1.65; P = .034), posterior ethmoidectomy (aOR, 1.59; 95% CI, 1.22-4.92; P = .025), and postoperative corticosteroid spray use (aOR, 1.57; 95% CI, 1.17-1.66; P = .008). Conclusion ETD symptoms often improve following ESS. Factors associated with improvement include higher preoperative disease burden, posterior ethmoidectomy, and postoperative corticosteroid spray. Level of Evidence 4
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Background: Symptoms of Eustachian tube (ET) dysfunction are seldom assessed in patients with chronic rhinosinusitis (CRS). The Sino-Nasal Outcome Test (SNOT-22) quality-of-life tool includes two questions that specifically screen for symptoms of ET dysfunction (Ear Fullness; Ear Pain). Objective: The purpose of this study was to determine the extent to which these ET symptoms were present in patients with CRS, and whether these symptoms respond to endoscopic sinus surgery (ESS). Methodology: SNOT-22 data collected prospectively at time of recruitment into IRB-approved clinical trials or case-control studies in CRS was pooled to provide a cross section of the frequency and severity of ET dysfunction. When applicable to the trials, the SNOT-22 was repeated at least 3 months following ESS. Results: Five trials rendering 131 patients were available for assessment. The control group comprised of 251 participants from two case-control studies. Ear Fullness of equal/greather than 1 was reported in 80/131 CRS patients compared to 45/251 control patients. Ear Pain of equal/greather than 1 was reported in 39/131 CRS patients compared to 33/251 control patients. Following ESS, mean Ear Fullness and Ear Pain scores decreased to 1.17 and 0.73, respectively. Conclusion: Symptoms suggestive of ET dysfunction are frequent in CRS, and for most patients the symptoms will decrease post-ESS to a level comparable with a non-CRS population. Patients whose ET symptoms do not respond to ESS may represent a target population for emerging therapeutic options for ET dysfunction.
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A recent systematic review of treatments of Eustachian tube dysfunction commissioned by the UK NIHR Health Technology Assessment (HTA) Programme revealed that an important limitation with the available evidence is a lack of consensus on the definition and diagnosis of this disorder.1 The HTA report recommended that key to advancing research in this field is achieving consensus on diagnostic criteria for Eustachian tube dysfunction (to identify eligible patients for future trials) and on important clinical outcomes. To address this need, an international forum of scientists and physicians with expertise in the field of Eustachian tube disorders met at a workshop in Amsterdam on 21 June 2014 and was tasked to come to an agreement on the definition, clinical presentation and diagnosis of Eustachian tube dysfunction, and areas for future research. This study summarises the outcomes of that meeting.
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Background: Eustachian tube dysfunction (ETD) is the inability of the Eustachian tube (ET) to adequately perform at least one of its functions: to protect the middle ear from sources of disease, to ventilate the middle ear, and to help drain secretions away from the middle ear. There are a number of treatment options for ETD, but there is little consensus about management. Objectives: To determine the clinical effectiveness of interventions for adult ETD and to identify gaps in the evidence to inform future research. Data sources: Twelve databases were searched up to October 2012 for published and unpublished studies in English (e.g. MEDLINE from 1946, EMBASE from 1974, Biosis Previews from 1969 and Cumulative Index to Nursing and Allied Health Literature from inception). References of included studies, relevant systematic reviews and regulatory agency websites were checked. Review methods: A systematic review was undertaken. Controlled studies evaluating prespecified treatments for adult patients diagnosed with ETD were eligible. Uncontrolled studies with at least 10 participants were included for interventions where no controlled studies were found. Outcomes included change in symptoms severity/frequency (primary outcome), quality of life, middle ear function, hearing, clearance of middle ear effusion, early ventilation tube extrusion, additional treatment, adverse events and complications. All aspects of the review process were performed using methods to reduce reviewer error and bias. Owing to heterogeneous data, a quantitative synthesis could not be performed, and results were reported in a narrative synthesis. Results: Nineteen studies were included: three randomised controlled trials (RCTs) and two non-RCTs evaluating pharmacological interventions or mechanical devices for middle ear pressure equalisation; and 13 case series and one retrospective controlled before-and-after study evaluating surgical interventions. None was conducted in the UK. All studies were small (11 to 108 participants). Most non-surgical studies reported including mixed populations of adults and children. All except two studies were at high risk of bias, and subject to multiple limitations. Based on a single RCT, nasal steroids showed no improvement in symptoms or middle ear function for patients with otitis media with effusion and/or negative middle ear pressure. Very short-term improvements in middle ear function were observed in patients receiving directly applied topical decongestants or a combination of antihistamine and ephedrine. Single trials found two pressure equalisation devices were each associated with significant short-term improvements in symptoms, middle ear function and/or hearing. Eustachian tuboplasty (seven case series) and balloon dilatation (three case series) were associated with improved outcomes. Positive results were also reported for myringotomy (two case series), directly applied topical steroids (one case series) and laser point coagulation (one controlled before-and-after study). High rates of co-interventions were documented. Minor complications of surgery and pharmacological treatments but no serious adverse effects were reported. Limitations: The evidence was limited in quantity and overall was of poor quality. No data were identified on several interventions despite extensive searches. Conclusions: It is not possible to draw conclusions regarding the effectiveness of any of the interventions for the treatment of adults with an ETD diagnosis, and there is insufficient evidence to recommend a trial of any particular intervention. Further research is needed to address lack of consensus on several issues, including the definition of ETD in adults, its relation to broader middle ear ventilation problems and clear diagnostic criteria. Study registration: This study is registered as PROSPERO CRD42012003035. Funding: The National Institute for Health Research Health Technology Assessment programme.
Article
The Health Technology Assessment programme commissioned a wide-ranging review of treatments for adult Eustachian tube dysfunction. Treatments range from advice and observation and pharmacological treatments, to surgical options. 1) To assess the evidence for interventions for adults with a clinical diagnosis of Eustachian tube dysfunction, 2) to identify priorities for future research. Systematic review (PROSPERO registration CRD42012003035) adhering to PRISMA guidance. An extensive search of 15 databases including MEDLINE, EMBASE and CENTRAL (up to October 2012). Controlled and uncontrolled studies of interventions for adult Eustachian tube dysfunction were included. Because of insufficient data, the protocol was amended to also include controlled studies with mixed adult/child populations. Risk of bias was assessed. Narrative synthesis was employed due to high clinical heterogeneity. Interventions assessed were pharmacological treatments (2 RCTs, 1 CCT, 159 patients); mechanical pressure equalisation devices (1 RCT, 1 CCT, 48 patients); and surgery, including laser tuboplasty (7 case series, 192 patients), balloon dilatation (3 case series, 103 patients), myringotomy without grommet insertion (2 case series, 121 patients), transtubal steroids (1 case series, 11 patients) and laser coagulation (1 retrospective controlled study, 40 patients). All studies had high risk of bias except two pharmacological trials; one had low risk and one unclear risk. No evidence was found for many treatments. The single high quality RCT (N = 91; 67% adults) showed no effect of nasal steroids and favoured placebo for improved middle ear function (RR 1.20, 95% CI 0.91 to 1.58) and symptoms (p = 0.07). Other studies showed improvements in middle ear function for mechanical devices, antihistamine/ephedrine and nasal decongestant but they had significant methodological weaknesses including insufficient length of follow-up. None of the surgical studies were adequately controlled and many reported high levels of cointervention. Therefore observed benefits for tuboplasty and balloon dilatation in symptoms, middle ear function or hearing could not be reliably attributed to the interventions assesed. There was variability in definitions of the condition. Eustachian tube dysfunction is a poorly defined condition. Due to the limited and poor quality evidence it is inappropriate to make conclusions on the effectiveness of any intervention; the evidence base is insufficient to guide recommendations for a trial of any particular intervention. Consensus on diagnostic criteria for Eustachian tube dysfunction is required to inform inclusion criteria of future trials. This article is protected by copyright. All rights reserved.
Article
To determine the role played by the tensor veli palatini and levator veli palatini muscles (mTVP and mLVP, respectively) in eustachian tube (ET) opening. Prospective study. Research laboratories at a tertiary care hospital. Fifteen healthy adults with normal middle ears and documented ET openings. Submental and ground surface electrodes were placed. After anesthetizing and decongesting the nasal passages, paired electromyographic needle electrodes were inserted into both the mTVP and mLVP on the test side. A microphone was placed into the ipsilateral ear canal and the probe from a sound generator was introduced into the opposite nostril. A 45° telescope was used on the test side to video-record the soft palate and ET movements while the individual swallowed. Concurrent recordings of the ET openings by sonotubometry, the electromyographic activity for the LVP, TVP, and submental muscles, and video of the nasopharyngeal orifice of the ET during swallowing. During swallowing, the median peak amplitude and duration of ET openings by sonotubometry were 30.6 mV and 196 milliseconds, respectively. For the mLVP and mTVP, the median peak amplitudes were 0.33 and 0.82 mV, and peak durations were 131 and 85 milliseconds, respectively. The mean onsets of muscle activity referenced to the sonotubometry peak amplitude were -0.28, -0.24, and -0.14 milliseconds for the mLVP, mTVP, and submental muscles, respectively. Video recording of ET movements were consistent with the timing of these events. The mTVP activity had a shorter duration but greater amplitude than the mLVP activity and was associated with peak ET opening by sonotubometry. The mLVP activity occurred before that of the mTVP, the submental muscle group, and peak ET opening. The mLVP contractions were associated with movements of the soft palate, anterior ET orifice, and rotation of the ET cartilage.
Article
Eustachian tube dysfunction (ETD) is a common condition that is associated with otologic and rhinologic symptoms. The complete assessment of ETD is limited without a valid symptom score. We developed and conducted initial validation of the seven-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7), a disease-specific instrument to assess symptoms with respect to ETD. Validation study. The ETDQ-7 was developed using standard survey methodology. The ETDQ-7 was completed by a group of 50 consecutive adult patients diagnosed with ETD and 25 non-ETD patients who served as a control group. Tympanometry was used as a criterion standard to distinguish the two groups. A subset of respondents repeated the ETDQ-7 at a time point 4 weeks later. Content validity for the ETDQ-7 was established by focus group and review of the literature. Reliability testing indicated acceptable internal consistency for the entire instrument (Cronbach α = .71). The test-retest reliability indicated good correlation between the two questionnaires completed by the same patient 4 weeks apart (r = 0.78). The ETDQ-7 was able to discriminate between patients with ETD and those without (P < .001), indicating excellent discriminant validity. The ETDQ-7 is a valid and reliable symptom score for use in adult patients with ETD that may facilitate clinical practice by highlighting the impact of ETD. Further testing is needed to determine its usefulness in assessing treatment response.
Concordance between sinusitis and otitis media with effusion (OME) has been reported in 5-60% of patients. Since nasal diseases induce edema and lymphoid tissue hyperplasia in the nasopharyngeal mucosa, especially the adenoids, chronic infection of the adenoids has been reported to induce otitis media. In addition, deterioration in the mucosal barrier of the adenoids makes the latter vulnerable to bacterial infections, resulting in OME or sinusitis. We therefore evaluated adenoid local immunity and Eustachian tube function by sinusitis and the concordance between sinusitis and OME. We examined PNS series and tympanometry of 520 patients who had undergone adenotonsillectomies. In addition, local adenoidal immunity was evaluated in 10 children with OME and sinusitis, 11 with only sinusitis, 10 with only OME and 12 with no history of OME or sinusitis. Adenoid size, squamous metaplasia, IgA, BCL-6, and mucosal barrier were also determined. Of 520 patients, 80 (15.4%) had both OME and sinusitis. The incidence of Eustachian tube dysfunction differed significantly between patients with and without sinusitis (p=0.03). The incidence of squamous metaplasia differed significantly between patients with sinusitis plus OME and patients with sinusitis alone (p=0.01), and between patients with OME alone and those without both conditions (p=0.005). Patients with both sinusitis and OME differed significantly in IgA secretion (p=0.01) and Bcl-6 expression (p=0.02) from those with sinusitis alone, as did patients with OME alone and those without both conditions (p=0.02 and p=0.03, respectively). Sinusitis plus OME were present in 15.4% of patients. Eustachian tube dysfunction was present in 37.9% of sinusitis patients and in 28.4% of those without sinusitis. IgA, BCL-6 and squamous metaplasia were important in local adenoidal immunity.
Article
Rhinosinusitis is a significant and increasing health problem which results in a large financial burden on society. This evidence based position paper describes what is known about rhinosinusitis and nasal polyps, offers evidence based recommendations on diagnosis and treatment, and considers how we can make progress with research in this area. Rhinitis and sinusitis usually coexist and are concurrent in most individuals; thus, the correct terminology is now rhinosinusitis. Rhinosinusitis (including nasal polyps) is defined as inflammation of the nose and the paranasal sinuses characterised by two or more symptoms, one of which should be either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip), facial pain/pressure, +/- reduction or loss of smell; and either endoscopic signs of polyps and/or mucopurulent discharge primarily from middle meatus and/or; oedema/mucosal obstruction primarily in middle meatus, and/or CT changes showing mucosal changes within the ostiomeatal complex and/or sinuses. The paper gives different definitions for epidemiology, first line and second line treatment and for research. Furthermore the paper describes the anatomy and (patho)physiology, epidemiology and predisposing factors, inflammatory mechanisms, evidence based diagnosis, medical and surgical treatment in acute and chronic rhinosinusitis and nasal polyposis in adults and children. Evidence based schemes for diagnosis and treatment are given for the first and second line clinicians. Moreover attention is given to complications and socio-economic cost of chronic rhinosinusitis and nasal polyps. Last but not least the relation to the lower airways is discussed.
Article
The UK National Study of Hearing set out to ascertain the prevalence of hearing impairments of various magnitudes, the prevalence of ear disease and the associated risk factors, and to estimate the percentage of individuals requiring some form of management. A stratified sample of 2708 British adults, aged 18-80 years, was chosen from a sample of 48,313 adults, randomly selected from the electoral roll, for a full otological and audiological assessment. This paper deals primarily with the middle ear results. Otoscopically, 2.6% of British adults had inactive and 1.5% had active chronic otitis media. This condition was more common in older individuals and in those in manual occupations. For this purpose, presumptive otosclerosis was defined as a conductive component to the impairment (average air bone gap over 0.5, 1 and 2 kHz of 15 dB or greater) and with an intact tympanic membrane. The population prevalence for presumptive otosclerosis was 2.1%, for healed OM 1.7% and for Eustachian tube dysfunction 0.9%. This prevalence of otosclerosis was higher in those over 40 years, but only in those with air bone gaps of 30 dB or greater were women more likely to have the condition than men, by a factor of three. At most, 20% of individuals with any of the above middle ear conditions will have had ear surgery.
Article
The purpose of this paper is to present those tests of Eustachian tube function which the authors have found useful in the clinical routine.