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Consumer acoustic reflectometry: Accuracy in diagnosis of otitis media with effusion in children Togay Muderris a, *, Alper Yazıcı b , Sami Bercin c , Go ¨ khan Yalc ¸ıner a , Ergun Sevil a , Muzaffer Kırıs c a Ataturk Education and Research Hospital, Department of Otorhinolaryngology, Head and Neck Surgery, Ankara, Turkey b Bozu ¨yu ¨k State Hospital, Bilecik, Turkey c Yıldırım Beyazıt University, Department of Otorhinolaryngology, Head and Neck Surgery, Ankara, Turkey 1. Introduction Otitis media with effusion (OME), is a condition characterized by collection of fluid within the middle ear, without signs and symptoms of acute infection [1,2]. It is one of the most common disorders in childhood and most cases are detected between 1 and 8 years of age [1–3]. It is the most common cause of acquired hearing loss in childhood and if untreated, might end up in serious consequences in the form of poor speech and intellectual development and permanent anatomical distortions within the middle ear cavity [4]. Therefore, correct and early diagnosis and appropriate treatment of OME in children is imperative [5]. Symptoms of OME are neither sensitive nor specific and most children with OME are asymptomatic [6]. The physical examina- tion may potentially be inaccurate and subjective impressions of the appearance of the tympanic membrane are difficult to quantify and grade on a purely clinical basis [6]. For this reason, numerous tools have been developed to improve diagnostic accuracy. Among them, pneumatic otoscopy and tympanometry has generally proved to be equal in terms of sensitivity and specificity in detecting OME but has the disadvantage of requiring hermetic seal in the ear canal [7]. Thus, their reliability is greatly affected by the cooperation of the child. Acoustic reflectometry (AR) was introduced in 1984 as a method of improving the diagnosis of OME, particularly in children [8]. AR determines the probability of OME by measuring the response of tympanic membrane to a sound emitted by a lightweight portable instrument [7]. AR does not require an air tight fit in the ear canal and is hence generally reliable even with struggling or crying children. There are different types of AR devices, such as; first generation AR, second generation known as spectral gradient AR (SG-AR) and consumer models. Newer second International Journal of Pediatric Otorhinolaryngology 77 (2013) 1771–1774 ARTICLE INFO Article history: Received 6 April 2013 Received in revised form 14 August 2013 Accepted 18 August 2013 Available online 28 August 2013 Keywords: Otitis media with effusion Acoustic reflectometry Tympanometry ABSTRACT Objective: Acoustic reflectometry is a technique based on a sonar that enables the diagnosis of middle ear effusion. We aimed to evaluate the accuracy and diagnostic value of consumer type acoustic reflectometry device for determining middle ear effusion in children. Methods: Acoustic reflectometry and tympanometries of 84 children, from 3 to 14 years of age, were done the day before they underwent adenoidectomy/adenotonsillectomy and myringotomy ventila- ventilation tube insertion under general anesthesia in the operating room with diagnosis of middle ear effusion. Their test results and the results of myringotomies, which is the golden standard technique in determination of otitis media with effusion, were compared. Specificity, sensitivity, positive and negative predictive values of both instruments in detecting middle ear fluid were determined. Results: Otitis media with effusion was detected in 106 ears (63.1%) during myringotomy. The sensitivity and specificities of acoustic reflectometry were found to be 83.33% and 68.18%, and tympanometry were 84.48% and 84.62%, respectively. The positive predictive value was 75.12% for acoustic reflectometry and 88.56% for tympanometry, and negative predictive values of acoustic reflectometry and tympanometry were 87.66% and 89.2%, respectively. The sensitivity of the AR was comparable to tympanometry (p > 0.01), however the specificity, PPV and NPV of AR were lower than tympanometry (p < 0.001). Conclusions: Consumer type acoustic reflectometry is highly sensitive, objective and easy to perform technique for detecting otitis media with effusion, and it may help us to diagnose otitis media with effusion in early stages if used by family practitioners or parents. ß 2013 Elsevier Ireland Ltd. All rights reserved. * Corresponding author at: Ataturk Education and Research Hospital, Department of Otorhinolaryngology, Head and Neck Surgery, 06800 Bilkent, Ankara, Turkey. Tel.: +90 5323076476. E-mail address: [email protected] (T. Muderris). Contents lists available at ScienceDirect International Journal of Pediatric Otorhinolaryngology journal homepage: www.elsevier.com/locate/ijporl 0165-5876/$ – see front matter ß 2013 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijporl.2013.08.019

Consumer acoustic reflectometry: Accuracy in diagnosis of otitis media with effusion in children

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Page 1: Consumer acoustic reflectometry: Accuracy in diagnosis of otitis media with effusion in children

International Journal of Pediatric Otorhinolaryngology 77 (2013) 1771–1774

Contents lists available at ScienceDirect

International Journal of Pediatric Otorhinolaryngology

journa l homepage: www.e lsev ier .com/ locate / i jpor l

Consumer acoustic reflectometry: Accuracy in diagnosis of otitis

media with effusion in children

Togay Muderris a,*, Alper Yazıcı b, Sami Bercin c, Gokhan Yalcıner a, Ergun Sevil a,Muzaffer Kırıs c

a Ataturk Education and Research Hospital, Department of Otorhinolaryngology, Head and Neck Surgery, Ankara, Turkeyb Bozuyuk State Hospital, Bilecik, Turkeyc Yıldırım Beyazıt University, Department of Otorhinolaryngology, Head and Neck Surgery, Ankara, Turkey

A R T I C L E I N F O

Article history:

Received 6 April 2013

Received in revised form 14 August 2013

Accepted 18 August 2013

Available online 28 August 2013

Keywords:

Otitis media with effusion

Acoustic reflectometry

Tympanometry

A B S T R A C T

Objective: Acoustic reflectometry is a technique based on a sonar that enables the diagnosis of middle ear

effusion. We aimed to evaluate the accuracy and diagnostic value of consumer type acoustic

reflectometry device for determining middle ear effusion in children.

Methods: Acoustic reflectometry and tympanometries of 84 children, from 3 to 14 years of age, were

done the day before they underwent adenoidectomy/adenotonsillectomy and myringotomy � ventila-

ventilation tube insertion under general anesthesia in the operating room with diagnosis of middle ear

effusion. Their test results and the results of myringotomies, which is the golden standard technique in

determination of otitis media with effusion, were compared. Specificity, sensitivity, positive and negative

predictive values of both instruments in detecting middle ear fluid were determined.

Results: Otitis media with effusion was detected in 106 ears (63.1%) during myringotomy. The sensitivity

and specificities of acoustic reflectometry were found to be 83.33% and 68.18%, and tympanometry were

84.48% and 84.62%, respectively. The positive predictive value was 75.12% for acoustic reflectometry and

88.56% for tympanometry, and negative predictive values of acoustic reflectometry and tympanometry

were 87.66% and 89.2%, respectively. The sensitivity of the AR was comparable to tympanometry

(p > 0.01), however the specificity, PPV and NPV of AR were lower than tympanometry (p < 0.001).

Conclusions: Consumer type acoustic reflectometry is highly sensitive, objective and easy to perform

technique for detecting otitis media with effusion, and it may help us to diagnose otitis media with

effusion in early stages if used by family practitioners or parents.

� 2013 Elsevier Ireland Ltd. All rights reserved.

1. Introduction

Otitis media with effusion (OME), is a condition characterizedby collection of fluid within the middle ear, without signs andsymptoms of acute infection [1,2]. It is one of the most commondisorders in childhood and most cases are detected between 1 and8 years of age [1–3]. It is the most common cause of acquiredhearing loss in childhood and if untreated, might end up in seriousconsequences in the form of poor speech and intellectualdevelopment and permanent anatomical distortions within themiddle ear cavity [4]. Therefore, correct and early diagnosis andappropriate treatment of OME in children is imperative [5].Symptoms of OME are neither sensitive nor specific and most

* Corresponding author at: Ataturk Education and Research Hospital, Department

of Otorhinolaryngology, Head and Neck Surgery, 06800 Bilkent, Ankara, Turkey.

Tel.: +90 5323076476.

E-mail address: [email protected] (T. Muderris).

0165-5876/$ – see front matter � 2013 Elsevier Ireland Ltd. All rights reserved.

http://dx.doi.org/10.1016/j.ijporl.2013.08.019

children with OME are asymptomatic [6]. The physical examina-tion may potentially be inaccurate and subjective impressions ofthe appearance of the tympanic membrane are difficult to quantifyand grade on a purely clinical basis [6]. For this reason, numeroustools have been developed to improve diagnostic accuracy. Amongthem, pneumatic otoscopy and tympanometry has generallyproved to be equal in terms of sensitivity and specificity indetecting OME but has the disadvantage of requiring hermetic sealin the ear canal [7]. Thus, their reliability is greatly affected by thecooperation of the child.

Acoustic reflectometry (AR) was introduced in 1984 as amethod of improving the diagnosis of OME, particularly in children[8]. AR determines the probability of OME by measuring theresponse of tympanic membrane to a sound emitted by alightweight portable instrument [7]. AR does not require an airtight fit in the ear canal and is hence generally reliable even withstruggling or crying children. There are different types of ARdevices, such as; first generation AR, second generation known asspectral gradient AR (SG-AR) and consumer models. Newer second

Page 2: Consumer acoustic reflectometry: Accuracy in diagnosis of otitis media with effusion in children

T. Muderris et al. / International Journal of Pediatric Otorhinolaryngology 77 (2013) 1771–17741772

generation professional acoustic reflectometries has been provedto be comparable to tympanometry in detecting OME in children[9]. However, to our best knowledge, there are few reports havebeen published evaluating the diagnostic value of consumer modelAR.

In this study, we aimed to evaluate the diagnostic value of theconsumer model AR to determine the reliability of AR devices indiagnosis of OME. For this purpose, we compared the results of theoperative findings of the patients who underwent myringotomyfor OME (the gold standard method of identifying middle eareffusion) with the results of regular tympanometry and consumertype AR.

2. Materials and methods

In this prospective research, 84 consecutive children whounderwent otomicroscopic myringotomy (with or without venti-lation tube insertion) because of OME between February 2009 andApril 2011 in our clinic were included to the study. Local ethicalcommunity approval and informed patient consents wereobtained. During preoperative physical examination the daybefore surgery, all cerumen and epithelial remnants were cleanedfrom outer ear canal and acoustic reflectometries and tympano-metry measurements were performed. All physical examinations,AR measurements and operations were performed by threeotolaryngologist (TM, AY, ES). AR measurements were performedin sitting position with the Ear CheckTM Middle Ear Monitorconsumer model acoustic reflectometer (MDI Instruments Inc.,Woburn, MA, USA) (Fig. 1) and tympanometry measurements wereperformed with OTOflex 100TM (GN Otometrics, Denmark)tympanometry device. The consumer model AR device that weused presents the results as categorically growing risk of effusion(1–5). This result is also simplified to trichotomized, color-codedclassification (1 = green, ‘‘fluid unlikely’’; 2 = yellow, ‘‘monitor’’; 3–5 = red, ‘‘consult doctor’’) for improving ease-of-use. The devicegives an error signal when it cannot obtain a valid reading (e.g. ifthe tympanic membrane is perforated or if the ear canal isblocked). In the case of an error sign in the first recording, the ear[(Fig._1)TD$FIG]

Fig. 1. Consumer type acoustic reflectometry

was examined up to three times. At the end, a valid signal wasobtained from all of the patients. In this research, values 1 and 2were considered as negative and values 3–5 as positive.Tympanogram results were evaluated in three types (A–C). A typeB tympanogram was accepted as a predictor of effusion while typeA and C tympanograms were considered as negative test resultsrepresenting normal ears. During myringotomy, any amount ofmiddle ear effusion was considered positive for OME.

Sensitivity (ability to find true positives and avoid falsenegatives), specificity (ability to find true negatives and avoidfalse positives), positive (PPV) (probability of OME when the test ispositive) and negative predictive values (NPV) (probability ofnormal ear when the test is negative) of AR and tympanometrywere calculated with their respective 95% confidence intervals (CI).SPSS for Windows 17 (SPSS Inc. Chicago, IL.) was used forcalculations and statistical analysis. Chi-square analysis was donefor statistical confirmation of the data.

3. Results

This study included 84 children, 16 (19%) girls, 68 (81%) boys;between the ages of 3–14, with a mean of 8.2 � 2.1. All of thechildren underwent adenoidectomy/adenotonsillectomy and myr-ingotomy � ventilation tube insertion under general anesthesia inthe operating room. OME was detected in 106 ears (63.1%) duringmyringotomy, and ventilation tubes were inserted to these ears. Noeffusion was observed among the rest 62 ears. No cases of retractedtympanic membranes (negative middle ear pressure) without OMEwas encountered on otomicroscopy, which may due to maskventilation during general anesthesia which causes positive pressurein the middle ear. The AR results of patients are presented in Table 1and tympanometry results of the patients are presented in Table 2.The specificity, sensitivity, PPV and NPV’s of AR device andtympanometry are summarized in Table 3.

The sensitivity of the AR was comparable to tympanometry(p > 0.01), however the specificity, PPV and NPV of AR were lowerthan tympanometry (p < 0.001).

4. Discussion

Acoustic reflectometry is a relatively new technique based on asonar that enables the diagnosis of middle ear effusion [10]. Theold, first generation acoustic otoscopes are no longer commerciallyavailable [7]. The second generation method, spectral gradientacoustic reflectometry (SG-AR), analyses the frequency spectrumof reflected sound rather than the sound intensity which isassumed to improve diagnostic accuracy and reliability. SG-AR hasbeen shown in many researches to be equal to tympanometry andpneumatic otoscopy in predicting OME [7]. Recently, easy to useconsumer type AR devices has become available for use. Althoughthere are numerous researches about the diagnostic value of SG-AR, fewer researches were done about consumer type AR device.

The research of Linden et al. [11], which compared the results ofotomicroscopic myringotomy findings with SG-AR results, foundthe sensitivity and specificity of SG-AR 69% and 97% respectivelyand they recommended the use of SG-AR as a screening method ofOME. Also, Chianise et al. [12] investigated the accuracy of SG-ARand compared SG-AR with tympanometry. They reported thesensitivity and specificity of SG-AR as 47% and 90% respectively,and concluded that SG-AR is slightly less discerning thentympanometry in predicting the presence of OME.

In their study comparing the results of AR and tympanometry,Kemaloglu et al. [13] stated that; AR should not be proposed as abetter device then tympanometry, because its’ test efficiency wasnot higher than tympanometry. They concluded that both testdevices, AR and tympanometry, provided complementary data to

Page 3: Consumer acoustic reflectometry: Accuracy in diagnosis of otitis media with effusion in children

Table 1Results of consumer type AR and myringotomy.

Effusion (+) Effusion (�) Total

AR positive (3–5, red) 85 (83.33%) 17 (16.67%) 102

AR negative (1 and 2, green or yellow) 21 (31.82%) 45 (68.18%) 66

Total 106 62 168

Table 2Comparison of tympanometry and myringotomy results.

Effusion (+) Effusion (�) Total

Tympanometry type A 4 (11.11%) 32 (88.89%) 36

Tympanometry type B 98 (84.48%) 18 (15.52%) 116

Tympanometry type C 4 (25%) 12 (75%) 16

Tympanometry type A + C 8 (15.38%) 44 (84.62%) 52

Total 106 62 108

Table 3Sensitivity, specificity, positive (PPV) and negative (NPV) predictive values of acoustic reflectometry and tympanometry.

Sensitivity (95% CI) Specificity (95% CI) PPV (95% CI) NPV (95% CI)

Ear CheckTM monitor 83.33% (71.55–94.36) 68.18% (59.72–77.35) 75.12% (64.8–88.24) 87.66% (79.6–95.56)

Tympanometry 84.48% (75.5–95.68) 84.62% (76.77–94.08) 88.56% (78.11–96.24) 89.2% (81.32–94.45)

Reference method: otomicroscopic myringotomy with suction under general anesthesia.

T. Muderris et al. / International Journal of Pediatric Otorhinolaryngology 77 (2013) 1771–1774 1773

each other, therefore utilizing these devices together will provideus more satisfactory data.

Teppo and Revonta investigated the diagnostic accuracy of acustomer model AR in the hands of parents in detection of OMEin the hospital. They reported the sensitivity as 94% andspecificity as 92% in the hands of parents and concluded that‘‘where parents screened their children for OME in hospital,sensitivity and specificity were excellent’’. Same authors, inanother research, also assessed the diagnostic performance ofthree different AR devices (first generation acoustic otoscope,second generation professional model and consumer model) [7].Second generation professional and consumer type AR per-formed equally well in detecting middle ear fluid (specificities84% and 85%, sensitivities 83% and 77% respectively) in thatsurvey and they suggested that the consumer model proved tobe reliable and performed equally well as the professional modelfor detection of OME.

In our research, we used a consumer type AR device andcompared the results with tympanometry. We found thesensitivity and specificity of AR 83.33% and 68.18% respectively,and the sensitivity and specificity of tympanometry 84.48% and84.62%, respectively. Due to our results, we can say that AR is ashighly sensitive as tympanometry for effusion, but less sensitivethen tympanometry in normal ears. Also, positive and negativepredictive values of AR was lower than tympanometry. Sensitivity,specificity, PPV and NPV values obtained in this study withconsumer type AR were similar and comparable to those reportedin the literature [8,13–18].

The lack of blinding (i.e., the physician performing themyringotomy was aware of the test results) can be consideredas a limitation of the present study. Also, AR tests were done byphysicians in this study, and since physicians know in whatdirection to point the instrument and how to open the ear canal byretracting the ear lobe, technical success rate was perfect. Actualtechnical success rates would be lower if the AR device is used byparents, as previous studies showed [9]. Middle ear effusion iscaused by chronic glue ear or serous otitis media in our patient

series, rather than AOM as would be normally the case whenscreening sick children with upper respiratory tract infectionsymptoms. Thus, the results of this study should be generalized todetection of glue ear and to following-up resolution of OME afterAOM, rather than detection of AOM.

In conclusion; we can say that consumer type AR is a highlysensitive, objective and easy to perform technique for detectingOME. Although its specificity, PPV and NPV values are lowerthan tympanometry, it is very useful for assessing andscreening OME in children because of the ease and speed ofits operation irrespective of crying and lack of co-operationfrom children. We believe that remarkable amount of childrencould be prevented from complications of OME if it can bediagnosed in early stages. AR is very suitable for the diagnosisof OME in early stages since it can easily be used by familypractitioners or parents after a short tutorial on its use, andchildren may be referred to otolaryngologists very early forfurther treatment of OME.

References

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