Tradução, validação e adaptação cultural do questionário "The Eustachian Tube Dysfunction Questionnaire-7" (ETDQ-7) para o português brasileiro (BR)

(1)

www.bjorl.org

Brazilian

Journal

of

OTORHINOLARYNGOLOGY

ORIGINAL

ARTICLE

Translation,

validation

and

cultural

adaptation

of

‘‘The

Eustachian

Tube

Dysfunction

Questionnaire-7’’

(ETDQ-7)

to

Brazilian

Portuguese

(BR)

夽

Fernanda

Pires

Gallardo,

Ektor

Tsuneo

Onishi

∗

,

Francisco

Iure

Lira,

Flávia

Barros

Suzuki,

José

Ricardo

Gurgel

Testa

UniversidadeFederaldeSãoPaulo(UNIFESP),SãoPaulo,SP,Brazil

Received14November2017;accepted20March2018 Availableonline19April2018

KEYWORDS Eustachian tube/pathophysiology; Otitis media/diagnosis; Surveysand questionnaires; Translation; Eustachian tube/therapy Abstract

Introduction:ChronicEustachiantubedysfunctioncancauseseveralsymptomsandmiddleear conditionsthatcanimpact patientquality oflife.Itisestimatedtobe relativelyfrequent, affectingapproximately5% ofadults.Thediagnostictoolsfor thisconditionarestill inade-quate.In2012,McCouletal.publishedaquestionnairefortheevaluationofEustachiantube dysfunctionnamedETDQ-7.Theyestablisheditsreplicabilityandvalidity.Thecutoffpointfor thediagnosisofchronicEustachiantubedysfunctionwasequaltoorgreaterthan14.5,with 100%sensitivityand100%speciﬁcity.

Objective:Totranslate,adaptandvalidatetheETDQ-7questionnairetoBrazilianPortuguese. Methods:We translated the questionnaire into Brazilian Portuguese and applied it to 50 patients,20ofwhomhadchronicEustachiantubedysfunction,and30controls.

Results:The resultsobtained with the North-Americanquestionnairewere conﬁrmed inits Brazilianversion. Thecut-offpoint forthediagnosis ofchronicEustachiantubedysfunction was≥14,alsoexhibitinghighsensitivityandspeciﬁcity,verysimilartothatofETDQ-7. Conclusion:It isrecommended that ETDQ-7be used to complementthe clinical historyof patientswithchronicEustachiantubedysfunction;itcanalsobeusedasanimportanttoolfor diagnosis,patientfollow-upandtreatmentmanagement.

© 2018 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/).

夽 _Please_cite_this_article_as:_Gallardo_FP,_Onishi_ET,_Lira_FI,_Suzuki_FB,_Testa_JR._Translation,_validation_and_cultural_adaptation_of_‘‘The EustachianTubeDysfunctionQuestionnaire-7’’(ETDQ-7)toBrazilianPortuguese(BR).BrazJOtorhinolaryngol.2019;85:456---64.

∗_{Corresponding}_author.

E-mail:ektoronishi@yahoo.com.br(E.T.Onishi).

PeerReviewundertheresponsibilityofAssociac¸ãoBrasileiradeOtorrinolaringologiaeCirurgiaCérvico-Facial. https://doi.org/10.1016/j.bjorl.2018.03.010

1808-8694/©2018AssociaçãoBrasileiradeOtorrinolaringologiaeCirurgiaCérvico-Facial.PublishedbyElsevierEditoraLtda.Thisisanopen accessarticleundertheCCBYlicense(http://creativecommons.org/licenses/by/4.0/).

(2)

PALAVRAS-CHAVE Tuba audi-tiva/ﬁsiopatologia; Otite média/diagnóstico; Inquéritose questionários; Traduc¸ão; Tubaauditiva/terapia

Tradução,validaçãoeadaptaçãoculturaldoquestionário‘‘TheEustachianTube DysfunctionQuestionnaire-7’’(ETDQ-7)paraoportuguêsbrasileiro(BR)

Resumo

Introdução: A disfunção crônica datuba auditiva pode causardiversos sintomas edoenças de orelha médiaeimpactar aqualidadede vidados pacientes. Estima-sequeé uma mor-bidaderelativamentefrequente,acometecercade5%dosadultos.Osinstrumentosdiagnósticos paraessaafecçãoaindasãoinsuficientes.Em2012McCouletal.publicaramumquestionário para a avaliação da disfunção da tuba auditiva denominado ETDQ-7. Eles demonstraram sua reprodutibilidade e validade. O ponto de corte para o diagnóstico de disfunção de crônicadatubaauditivafoi demaiorouigual a14,5com100%desensibilidadee100%de especificidade.

Objetivo: Traduzir,adaptarevalidaroquestionárioETDQ-7paraoportuguêsbrasileiro. Método: TraduzimosoquestionárioparaoportuguêsdoBrasileoaplicamosem50pacientes, 20comdisfunc¸ãocrônicadatubaauditivae30controles.

Resultados: Os resultados obtidosno questionário americano foram confirmados na versão brasileira.Opontodecorteparaodiagnósticodedisfunçãocrônicadatubaauditivafoimaior ouiguala14,tambémcomaltasensibilidadeeespecificidade,muitosemelhanteaoETDQ-7. Conclusão:Recomenda-sequeoETDQ-7sejausadocomoumcomplementonahistóriaclínica do paciente comdisfunção crônicada tuba auditivae pode ser usado também como uma importante ferramenta para fins de diagnóstico, seguimento de pacientes e manejos no tratamento.

© 2018 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Publicado por Elsevier Editora Ltda. Este é um artigo Open Access sob uma licença CC BY (http:// creativecommons.org/licenses/by/4.0/).

Introduction

Themiddleearisanaeratedcavitywithinthepetrous por-tion of thetemporal bone, that is periodically ventilated when the EustachianTube (ET) opens. The ET is situated betweenthenasopharynxandtheMiddleEar(ME).Itsmain functionistoequalizethemiddleearpressurewiththatof theexternalenvironmentwhennecessarythroughthe open-ingofitsostiuminthenasopharynx.1_Among_other_functions

isthemiddleearprotectionandtheclearanceofmiddleear secretionstothenasopharynx.1---3

Eustachiantube dysfunction(ETD) existswhenthereis a failure in the tubal mechanism to open or close prop-erly, leadingto MEpressure deregulation,nasopharyngeal secretion reﬂuxinto the tympaniccavity and impairment ofdrainageofMEcontentsintothenasopharynx.4_This

dys-function can cause several otologic pathologic processes, leadingtosymptomssuchasotalgia,auralfullnessor sensa-tionofpressureintheears,hearingloss,tinnitus,vertigo, andimbalance,andothers.4---6

ETD is common and affects up to 5% of adults. When chronic (symptom persistence for morethan 3 months)it can have asigniﬁcant impactonthe qualityof life.1 _This

conditionhasawidevarietyofsignsandsymptoms. Theclinicalevaluationofthesesymptomsissubjective, basedessentiallyonpatients’complaints, physical exami-nationand someancillarytests,suchastympanometryor pneumatic otoscopy,that help to establish the diagnosis, but thereisno tooltoprovide objectivemeasurementof symptomintensityandmorbidity,7_or_to_allow_comparisons

beforeandafterclinicalorsurgicaltreatments.

Considering chronic ETD as a disease with an impact ontheaffectedindividual’squalityoflife,andtakinginto accountthat thediagnosis ismainly clinicaland that sev-eralnewtreatmentsforthisconditionhavebeenproposed, McCouletal.,in2012,developedaquestionnairetoassess thesymptomsofchronicETD,consistingofsevenitemswith ascaleofgraduatedresponsesrangingfrom1to7,with‘‘1’’ correspondingtotheabsenceofthesuggestedsymptomand ‘‘7’’,tomaximumsymptomseverity.This questionnaireis knownas‘‘Eustachian Tube Dysfunction Questionnaire-7’’ (ETDQ-7). It wasdeveloped based mainly on other ques-tionnairesknownintheliterature,suchastheOM-6(Otitis Media-6ItemQuality-of-life), SNOT-20(20-ItemSino-Nasal OutcomesTest), amongothers.Itsvalidity,reproducibility andaccountabilityhavebeenpreviouslydemonstrated.8

Similartoqualityoflifequestionnaires,symptomscores allowthequantitativemeasurementofsubjectivequestions andhaveadvantagesovertheclinicalhistoryalone.These scorescanprovideamoreaccurateestimateoftheassessed diseasemorbidity,aswellasinformationnotidentiﬁedby thephysicianduringtheusualanamnesis.Additionally,they allowforaformalandvaliddocumentationofpatienthistory for recording purposes and subsequent comparisons after theproposedtreatments.9

As this questionnaire was originally written in English, touseitinourcountryweneedtotranslateitinto Brazil-ianPortuguese. However,a simpletranslation maynotbe effective, due to cultural differences between peoples. Therefore,itisnecessarytoperformthetranslation, cultu-raladaptationandvalidationoftheETDQ-7fortheBrazilian reality.

(3)

Objective

Totranslate,adaptandvalidatetheETDQ-7questionnaire intoBrazilianPortuguese.

Methods

Ethicalconcerns

Allethicalcare wastakenintoaccount,based on Resolu-tion466/12oftheNationalHealthCouncil.Thisprojectwas approvedbytheResearchEthicsCommitteeofUniversidade FederaldeSãoPaulo(UNIFESP)---EscolaPaulistadeMedicina (EPM)undernumber1690/2016,andtheFreeandInformed ConsentForm(FICF)wasobtained,whichwaswritten utiliz-ingeasilyunderstandableandobjectivelanguageandsigned byallparticipantsinvolvedinthestudy.

Place

This study wasdeveloped at the Postgraduate Programin Otorhinolaryngology, UNIFESP/EPM, at the Otorhinolaryn-gology Outpatient Clinic of Hospital São Paulo, with the authorizationoftheHeadoftheOutpatientClinicandthe teachingandresearchcoordinatorofHospitalSãoPaulo.

Sample

Fifty patients were evaluated in an observational, descriptive, analytical and cross-sectional study at the Otorhinolaryngology Outpatient Clinic of the Hospital (EPM/UNIFESP),fromJuly2016toMarch2017.

Procedures

In the ﬁrst phase of the study, the ETDQ-7 questionnaire wastranslated into Brazilian Portuguese. This translation required ﬁve main steps: (1) Translation; (2) Back-translation;(3)Reviewbyatranslationandback-translation committee;(4)Pre-testofequivalencebybilingual individ-ualsand(5)Re-assessmentof theweightof thescores,if relevant,asproposed by Guillemin.10 _The _translation_and

back-translation phases were performed by two bilingual

individuals.Thetranslationandback-translationcommittee consistedofthesameindividualswhocarriedoutthe above-mentionedphasesandathirdone,whowasalsobilingual. After the ﬁnal conciliation of the versions, the questions wereculturallyadaptedsothattheywouldbecomeclearer and more understandable to patients. The questionnaire consistsof7items,havingaminimumscoreof7pointsand amaximumof49points(Table1).Afterthetranslationwas ﬁnished,therecruitmentphasestarted.

Fifty patients were evaluated in an observational, descriptive,analyticalandcross-sectionalstudycarriedout attheOtorhinolaryngologyOutpatientClinicofHospitalSão Paulo(EPM/UNIFESP),fromJuly2016toMarch2017.

Allpatientswereaged18yearsorolder,agreedto par-ticipateinthestudyandsignedtheinstitutionalEthicsand ResearchCommittee’sFICF,whichwaswrittenusing objec-tiveandeasilyunderstoodlanguage.

Allpatientsunderwentacompleteanamnesis,including degree of schooling; considering that an adequate under-standingofthequestionnairewasessential,thetranslated ETDQ-7 questionnairewasused.Allsubjectsalsoreceived a complete otorhinolaryngological clinical examination, fiberoptic nasopharyngolaryngoscopy and tympanometry. Thirty daysafterthefirst consultation,thesame patients wererecruitedtofilloutthequestionnaireagainandwere submittedtoacompleteotorhinolaryngologicalexamination andfiberopticnasolaryngoscopy,withouttympanometryat thattimeandwithouttreatmentduringthatperiod(similar totheoriginalstudydesign).

Theinclusioncriteriawere:

ChronicETDgroup:PatientswithclinicalsymptomsofETD

for more than 3months, having at least twoof the fol-lowing symptomsin one or both ears in the lastmonth: sensationofauralfullnessorpressure,hearinglossor muf-ﬂedhearing, recurrentor persistentmiddle eareffusion orinabilitytoadjustearpressureafterchangesin atmo-spheric pressure. Otoscopy showing tympanic retraction and/orpresenceofretrotympanicﬂuidandtympanometry compatiblewithnegativepressureinthemiddleear(type Bor C tympanometry curvetracings). The alterations in tympanometrywereusedasthegoldstandardforpatient selection.

Control group: Patients without ETD complaints, with

otorhinolaryngologicalexamination andnormalﬁberoptic

Table1 QuestionnaireforevaluationofEustachianTubeDysfunctionconsistingof7items,translatedintoBrazilianPortuguese. Originalquestionnaire

Duringthepast1month,howmuchofaproblemwaseachofthe following?

Noproblem Moderateproblem Severeproblem

1.Pressureintheears? 1 2 3 4 5 6 7

2.Painintheears? 1 2 3 4 5 6 7

3.Afeelingthatyourearsarecloggedor‘‘underwater’’? 1 2 3 4 5 6 7

4.Earproblemswhenyouhaveacoldorsinusitis? 1 2 3 4 5 6 7

5.Cracklingorpoppingsoundsintheears? 1 2 3 4 5 6 7

6.Ringingintheears? 1 2 3 4 5 6 7

7.Afeelingthatyourhearingismufﬂed? 1 2 3 4 5 6 7

(4)

nasopharyngolaryngoscopy. The tympanometry without alterations(typeAtympanometrycurvetracings)wasused asthegoldstandardtoverifytheabsenceofETDinthese patients.

Exclusioncriteriawere:patientsyoungerthan18years of age, patientrefusal toparticipate in thestudy and/or refusal to sign the FICF, ETD symptoms for less than 3 months, presence of tympanic membrane lesions (such asgranulomas,polypsandtympanosclerosis),which could affect the examination results, head and neck surgery in theprevious threemonths,head andneck radiation ther-apy,historyoftumorsintheregion,signsofacutesinonasal diseases, adenoid hypertrophy, craniofacial syndromes, includingDown’sSyndrome,palatine ﬁssures,ciliary dysk-inesias,orothersystemicimmunodeﬁciencies.

Tools

In addition to the clinical otorhinolaryngological exami-nation, all patients underwent ﬁberoptic nasopharyngo-laryngoscopy (Scholly LUT, serial number: 354959) and tympanometry(InteracusticmodelAz7),ofwhichdevices belongedtotheOtorhinolaryngologyOutpatientClinicofthe HospitalSãoPaulo.

Statisticalmethod

Thestatisticalanalysisofallthedatacollectedinthisstudy wasinitiallycarriedoutusingdescriptivestatisticsthrough mean, median, minimum and maximum values, standard deviation,absoluteandrelativefrequencies(percentage), aswellasthetwo-dimensionalscatterplot.

The reliability study of the ETDQ-7 (Seven-item Eustachian Tube Dysfunction Questionnaire) regarding the test---retest aspect was carried out using Goodman

and Kruskal gamma () coefﬁcients11 _and _Spearman’s

correlation.11 _Internal _consistency _was _assessed _through

Cronbach’salphacoefﬁcient12_and_the_{discriminatory}

valid-itybetweenpatientandcontrolwasassessedthroughthe ReceiverOperatingCharacteristicCurve(ROC)curve.

The level of signiﬁcance ˛=5% was used for all the conclusions obtained at the statistical analyses. The data wereenteredintoExcel2010forWindowsspreadsheetsfor theadequatestorageoftheinformation.Statistical analy-seswerecarriedoutusingthestatisticalprogramRversion 3.3.2.

Results

Thesampleselectedforthisstudyconsistedof50 individu-als,20(40.0%)patientsand30(60.0%)controls(Table2).

The patients’ group comprised 8 (40.0%) men and 12 (60.0%)women.Theirmeanagewas43years,rangingfrom 18to74years,withastandarddeviationof15.2years.Most ofthem,12(60%)patients,hadﬁnishedHighSchoolor Col-lege/University.Regardingthetypeoftympanometrycurve tracing,typeBwasobservedin12(60%)patientsandtype C,in8(40.0%)patients.

The control group consisted of 11 (36.7%) menand 19 (63.3%) women. Their mean age was 41.5 years, ranging from 28 to 78 years, with a standard deviation of 13.8 years.Mostofthem,22individuals(73.3%),hadﬁnishedHigh SchoolorCollege/University.Allsubjectsinthisgrouphad bilateraltypeAtympanometrycurvetracings.

ThevalidationoftheETDQ-7(TheSeven-itemEustachian TubeDysfunctionQuestionnaire)wasanimportantresearch objectofthisstudy.

Tables3---5disclosetheanswersofpatientsandcontrols tothisquestionnaireattwodifferenttimes:inthebeginning (‘‘before’’)andonemonthlater(‘‘after’’).The reapplica-tionof the questionnaire wasintended toinvestigate the

Table2 Distributionofthemaincharacteristicsinthepatientandcontrolgroups.

Patient Control Total

Gender Male 8 40% 11 36.7% 19 38% Female 12 60% 19 63.3% 31 62% Total 20 100% 30 100% 50 100% Age(years) n 20 30 50 Mean 43_.0 41_.5 42_.1 Median 39.5 35.0 36.0 Minimum 18 28 18 Maximum 74 78 78 Standarddeviation 15.2 13.8 14.2 Levelofschooling

ElementarySchool,incomplete 4 20% 3 10% 7 14%

ElementarySchool,complete 4 20% 4 13.3% 8 16%

HighSchool,incomplete --- --- 1 3.3% 1 2.0%

HighSchool,complete 7 35% 3 10% 10 20%

CollegeorUniversity,complete 5 25% 19 63.3% 24 48%

(5)

Table3 Distributionofallindividuals’answerstotheETDQ-7questionnaire,beforeandafter.

1 2 3 4 5 6 7 Question1 Before 25 50% 6 12% 4 8.0% 3 6.0% 3 6.0% 5 10% 4 8.0% After 26 52% 6 12% 3 6.0% 2 4.0% 3 6.0% 8 16% 2 4.0% Question2 Before 37 74% 6 12% 2 4.0% 3 6.0% 1 2.0% --- --- 1 2.0% After 39 78% 6 12% 3 6.0% 1 2.0% --- --- 1 2.0% --- ---Question3 Before 34 68% 2 4.0% 1 2.0% 4 8.0% 3 6.0% 2 4.0% 4 8.0% After 33 66% 3 6.0% 4 8.0% 4 8.0% 1 2.0% 4 8.0% 1 2.0% Question4 Before 24 48% 6 12% 4 8.0% 5 10% 1 2.0% 6 12% 4 8.0% After 23 46% 6 12% 4 8.0% 4 8.0% 3 6.0% 5 10% 5 10% Question5 Before 36 72% 6 12% 1 2.0% --- --- 1 2.0% 3 6.0% 3 6.0% After 35 70% 6 12% 2 4.0% --- --- 3 6.0% 1 2.0% 3 6.0% Question6 Before 25 50% 8 16% 6 12 --- --- 2 4.0% 1 2.0% 8 16% After 28 56% 7 14% 4 8.0% 1 2.0% 2 4.0% 4 8.0% 4 8.0% Question7 Before 29 58% 5 10% 3 6.0% 5 10% 4 8.0% 2 4.0% 2 4.0% After 29 58% 5 10% 4 8.0% 3 6.0% 3 6.0% 4 8.0% 2 4.0%

Question1,Pressureintheears;Question2,Painintheears;Question3,Afeelingthatyour earsarecloggedor‘‘underwater’’; Question4,Earproblemswhenyouhaveacoldorsinusitis;Question5,Cracklingorpoppingsoundsintheears;Question6,Ringingin theears;Question7,Afeelingthatyourhearingismufﬂed.

Table4 Distributionofpatients’answerstotheETDQ-7questionnaire,beforeandafter.

1 2 3 4 5 6 7 Question1 Before 2 10% 2 10% 2 10% 2 10% 3 15% 5 25% 4 20% After --- --- 4 20% 1 5.0% 2 10% 3 15% 8 40% 2 10% Question2 Before 9 45% 5 25% 1 5.0% 3 15% 1 5.0% --- --- 1 5.0% After 11 55% 5 25% 2 10% 1 5.0% --- --- 1 5.0% --- ---Question3 Before 5 25% 1 5.0% 1 5.0% 4 20% 3 15% 2 10% 4 20% After 3 15% 3 15% 4 20% 4 20% 1 5.0% 4 20% 1 5.0% Question4 Before 2 10% 2 10% 1 5.0% 5 25% 1 5.0% 6 30% 3 15% After --- --- 2 10% 2 10% 4 20% 3 15% 4 20% 5 25% Question5 Before 9 45% 4 20% --- --- --- --- 1 5.0% 3 15% 3 15% After 8 40% 4 20% 1 5.0% --- --- 3 15% 1 5.0% 3 15% Question6 Before 3 15% 4 20% 2 10% --- --- 2 10% 1 5.0% 8 40% After 5 25% 3 15% 1 5.0% 1 5.0% 2 10% 4 20% 4 20% Question7 Before 4 20% 2 10% 2 10% 4 20% 4 20% 2 10% 2 10% After 4 20% 1 5.0% 4 20% 2 10% 3 15% 4 20% 2 10%

(6)

Table5 Distributionofcontrols’answerstotheETDQ-7questionnaire,beforeandafter.

1 2 3 4 5 6 7 Question1 Before 23 76.7% 4 13.3% 2 6.7% 1 3.3% --- --- --- --- --- ---After 26 86.7% 2 6.7% 2 6.7% --- --- --- --- --- --- --- ---Question2 Before 28 93.3% 1 3.3% 1 3.3% --- --- --- --- --- --- --- ---After 28 93.3% 1 3.3% 1 3.3% --- --- --- --- --- --- --- ---Question3 Before 29 96.7% 1 3.3% --- --- --- --- --- --- --- --- --- ---After 30 100% --- --- --- --- --- --- --- --- --- --- --- ---Question4 Before 22 73.3% 4 13.3% 3 10.0% --- --- --- --- --- --- 1 3.3% After 23 76.7% 4 13.3% 2 6.7% --- --- --- --- 1 3.3% --- ---Question5 Before 27 90.0% 2 6.7% 1 3.3% --- --- --- --- --- --- --- ---After 27 90.0% 2 6.7% 1 3.3% --- --- --- --- --- --- --- ---Question6 Before 22 73.3% 4 13.3% 4 13.3% --- --- --- --- --- --- --- ---After 23 76.7% 4 13.3% 3 10.0% --- --- --- --- --- --- --- ---Question7 Before 25 83.3% 3 10.0% 1 3.3% 1 3.3% --- --- --- --- --- ---After 25 83.3% 4 13.3% --- --- 1 3.3% --- --- --- --- ---

---Question1,Pressureintheears;Question2,Painintheears;Question3,Afeelingthatyourearsare cloggedor‘‘underwater’’; Question4,Earproblemswhenyouhaveacoldorsinusitis;Question5,Cracklingorpoppingsoundsintheears;Question6,Ringingin theears;Question7,Afeelingthatyourhearingismufﬂed.

Table6 EstimatesoftheGoodmanandKruskalGamma()coefﬁcientsbetweentheanswerstotheETDQ-7questionnairein thebeforeandaftermoments.

Patient+control Patient Control

Gama() p Gama() p Gama() p

Question1 0.915 <0.001 0.748 <0.001 0.962 <0.001 Question2 0.915 <0.001 0.915 <0.001 1.000 0.122 Question3 0.980 <0.001 0.946 <0.001 --- ---Question4 0.955 <0.001 0.877 <0.001 1.000 <0.001 Question5 0.951 <0.001 0.835 <0.001 1.000 0.046 Question6 0.989 <0.001 0.986 <0.001 0.976 <0.001 Question7 0.954 <0.001 0.846 <0.001 1.000 0.003

Question1,Pressureintheears;Question2,Painintheears;Question3,Afeelingthatyourearsare cloggedor‘‘underwater’’; Question4,Earproblemswhenyouhaveacoldorsinusitis;Question5,Cracklingorpoppingsoundsintheears;Question6,Ringingin theears;Question7,Afeelingthatyourhearingismufﬂed.

‘‘test---retest reliability’’. As summarized in Table 6, we observedasigniﬁcantreliabilityofthequestionnaireinthe test---retest, sincethe estimates of thegamma () coefﬁ-cientsofGoodmanandKruskalwerecloseto1(one).

The test---retestreliability assessment wasalso carried outwiththeoverallscore(sumofanswerstotheseven ques-tionsoftheETDQ-7questionnaire).Asitcanbeobserved, theoverallscorewassimilarinthe‘‘before’’and‘‘after’’ moments(Table7).

Spearman’scorrelationcoefﬁcient(s)wasalsoestimated betweenthe overall scores in the ‘‘before’’ and‘‘after’’ moments.Theresultsshowedastrongcorrelationbetween the moments, both in the group as a whole (s=0.977,

p<0.001)andseparately:patient(s=0.943,p<0.001)and control(s=0.913,p<0.001)(Fig.1).

Thequestionnaireinternalconsistencywasinvestigated using Cronbach’s alpha, considering all questions and excludingeachoneofthem(Table8).

(7)

Table7 SummarymeasuresoftheoverallscoreobtainedintheETDQ-7questionnaire,beforeandafter.

Patient+control(n=50) Patient(n=20) Control(n=30)

Before After Before After Before After

Mean 16.0 15.6 26.9 26.3 8.8 8.4 Median 10.0 9.0 27.0 26.0 8.0 7.0 Minimum 7.0 7.0 10.0 12.0 7.0 7.0 Maximum 48.0 41.0 48.0 41.0 22.0 20.0 Standard-deviation 11.0 10.5 9.5 8.5 3.2 2.8 50 45 40 35 35 30 30 25 25 20 20 15 15 10 10 5 5 40 45 50

Overall score, after

Ov er all score , bef o re patient control

Figure1 Two-dimensionaldispersiondiagramoftheoverall scorebeforeandafter,accordingtothegroup.

In brief, considering all the questions, internal consis-tency was adequate when grouping patients and controls (Cronbach’s˛=0.762),andalsoseparately:patient (Cron-bach’s˛=0.746)andcontrol(Cronbach’s˛=0.762).

Thequestionnaire’sdiscriminatoryvalidityregardingthe overall score between patient and control was evaluated throughtheReceiverOperatingCharacteristic(ROC)Curve (Fig.2).Theoverallscoremeasuredattheﬁrstmomentwas used. 1.0 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0.0 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1-Specificity Sensitivity Cutoff point = 14

Area under the curve = 0,980

Figure2 ROCcurveconsideringtheoverallscoreattheﬁrst momentandgroup(patient,control).

Basedoninformationfromthiscurve,weconcludedthat anoverallscore≥14(cutoffpoint)hasanimportant discrim-inatorypowerbetweenpatientsandcontrols(Table9).

Discussion

Todaythere is muchinterest in the Eustachiantube. The conceptthattheEustachiantubeisnotjustastatictube,

Table8 Cronbach’salphaestimateswiththeexclusionofeachquestion.

Cronbach’salphawithquestionexclusion

Patient+control(n=50) Patient(n=20) Control(n=20)

Question1 0.676 0.675 0.676 Question2 0.743 0.698 0.743 Question3 0.792 0.646 0.792 Question4 0.639 0.697 0.639 Question5 0.713 0.766 0.713 Question6 0.749 0.775 0.749 Question7 0.750 0.731 0.750

(8)

Table9 Distributionoftheoverallscoreattheﬁrstmoment,accordingtothegroup.

Overallscore Patient Control Patient+control

≥14 19 95% 1 3.3% 20 66.7%

<14 1 5% 29 96.7% 30 33.3%

Total 20 100% 30 100% 50 100%

Sensitivity,19/20=0.950;Speciﬁcity,29/30=0.967;positivepredictivevalue,19/20=0.950;negativepredictivevalue,29/30=0.967.

butratheradynamicorgan,hasgainedacceptance,andwith improved clariﬁcation of its pathophysiology, new treat-mentshavebeendevelopedworldwide.Itisagreedthatthe EThasuniquefunctionsandthatfailureofthesefunctions comprisesthesyndromewecall‘‘EustachianTube Dysfunc-tion’’(ETD).ETDisafrequententityanditschronicitycan generatea rangeof symptoms that affect patientquality oflife,whichcanalsoleadtoinfectionsandhearingloss, leadingtoanevengreatermorbidity.1,4

In an attempt to improve patient management and follow-up,in2012McCouletal.developedaquestionnaire for the evaluation of chronic ETD symptomsconsisting of seven items with a scale of responses graded from 1 to 7,with‘‘1’’indicatingabsenceofthesuggestedsymptom and‘‘7’’,maximumsymptomseverity.Thisquestionnaireis knownasthe‘‘EustachianTubeDysfunction Questionnaire-7’’(ETDQ-7).8_The_{questionnaire}_was_developed_with_seven

items,eachdealingwithonerelevantsymptom(mostoften mentionedinpatients’complaints);itwasalsodesignedto beeasytoapplyandpractical.Itwasmodeledafterexisting questionnairesforthemanagementofpatientswithchronic otitis and patients with chronic rhinosinusitis, mainly the OM-6andSNOT22.

Similartoqualityoflifequestionnaires,symptomscores allowthequantitativemeasurementofsubjectivequestions andhave advantages over theclinical historyalone.They provideaformalandvaliddocumentationofpatienthistory asarecordandmakepossiblesubsequentcomparisonsafter thetreatment.9

The present study aimed to translate, validate and culturallyadapttheETDQ-7questionnaireintoBrazilian Por-tuguese.The importanceofthisstudy reﬂectsthe lackof objective methods to detect and quantify the degree of severityofchronicETDinadults.7_The_need_for_a_validated

andspecific instrumentfor ETDis particularlyremarkable due to the lack of a widely accepted objective measure todetect the presence andseverity of thisdisorder. Sev-eral objective measures have been proposed, including audiometry,tympanometry,otoscopy,visualclassificationof endoscopicfindingsandtubomanometry.However,noideal modalityhasbeenidentifiedtodate.7_The_availability_of_a

symptom countcan helpthe physiciantorecordan accu-ratedescriptionofthediseasecondition.TheETDQ-7isfast andeasy toapply.Especiallyfor acountry suchasBrazil, wheretheresourcesarescarce,thequestionnaireshelpus toevaluatethepatientsataverylowcost.

Thecriterionvalidityinourstudywasestablishedbythe presenceofnormaltympanometryresultsincontrolsubjects andabnormalonesinindividualswithchronicETD,similar totheoriginalstudy.

The ETDQ-7 has shown to be reliable and valid for thecross-sectionalevaluation ofETD-relatedsymptomsin adults.Particularly,theabilityoftheETDQ-7todiscriminate

betweenthepatientandnon-patientgroupswasexcellent, showinga cutoffpoint ≥14.5 vs. <14.5 (patients vs. non-patients)withsensitivityandspeciﬁcityof100%.

In our study, we demonstrated a cutoff point ≥14 vs. <14(patientsvs.non-patients)withasensitivityof95%and speciﬁcityof97%,showingasigniﬁcantdiscriminatorypower betweenpatientsandcontrols.This minimaldifferencein ourwork when compared tothe original study may have beencausedbythefactthatwechosetouseanindexthat gaveusanintegerasacutoff,sincethescoresaregivenas integers.

In the original study, the retest (questionnaire reap-plication)of untreated patients at separate moments (30 days)showed goodtest---retest reliability, withthe retest beingperformedonlyinthegroupwithchronicETD, show-ing a Spearman’s correlation coefﬁcient of 0.78. In our study,Spearman’scorrelationcoefﬁcientwasalsoestimated among the overall scores in the ‘‘before’’ and ‘‘after’’ moments.Theresultsshowedastrongcorrelationbetween the moments, both in the group as a whole (s=0.977;

p<0.001), as well as separately: patient (s=0.943;

p<0.001) and control (s=0.913; p<0.001). No medical treatment was prescribed during this time. The patients agreednottoreceivetreatmentduringthisperiod,asthey werewaitingforthesurgicalprocedure(theyhadpreviously triedtheclinicaltreatment,withoutimprovement).

TheETDQ-7internalconsistencyreliabilitytestsyielded a Cronbach’s alpha coefﬁcient of 0.711 in the North-Americanstudyfortheentiretool(95%ConﬁdenceInterval: 0.570---0.818).Aninternalconsistencyevaluationafterthe eliminationofeachitemdidnotsubstantially improvethe observed internal consistency and, as a result, no items were added or removed from the tool. In our study, the questionnaire’sinternalconsistencywasalsoinvestigatedby Cronbach’salphaestimation,consideringallquestionsand excludingeachone,asintheoriginalstudy.

In short, considering all the questions, internal con-sistency wasadequate for patients and controls together (Cronbach’s˛=0.762),andalsoseparately:patient (Cron-bach’s ˛=0.746) and control (Cronbach’s ˛=0.762). Our resultswereverysimilartothoseoftheoriginalstudy.

ItisnoteworthythatourversionofETDQ-7isnotintended toevaluatethesymptomsoftheEustachiantubethatappear together with acute upper airway infections or neoplas-ticprocesses,sincethesepatientswereexcludedfromthe studygroup.AllpatientshadchronicsymptomsofETDand hadnotreceivedeither medicalor surgical treatment for theircondition,asintheoriginalstudy.

Some limitations of the ETDQ-7 cited in the original study shouldbe mentioned. Response items are primarily concernedwithdisease severity. The timing of events, in particular,whetherthesymptomsareintermittentor con-tinuous,or worsens during a certaintime of day, arenot

(9)

representedinmostitems.Anotherpointtobeconsidered isthattheuseoftoolcannotcompareorclassifythedegrees ofseverityofthediseaseamongthepatientsorcomparethe degree ofseverity withthetympanometry curveﬁndings, andthus,furtherstudiesmustbeperformedtobetter eluci-datetheseissues.However,itcanbeofvalueincomparisons beforeandafterdifferenttreatmentsinthesamepatient. Finally,theoptimalretestperiodwasnotdeterminedforthe evaluationofETDsymptoms.TheretestperiodforETDQ-7 wasarbitrarilysetatonemonth,althoughadifferentrecall periodmighthaveresultedindifferentoverallresponses.

Toolsthatarespeciﬁcfordiseasesymptomscanbeused as measures for important clinical interventions. Useful attributesthatcontributetovalidityforoutcome measure-mentincluderesponsiveness,sensitivitytoclinicalchange, andcriterionvalidity.

TheETDQ-7hasbeentranslated,validatedandadapted toGerman,13_also_with_similar_results_to_that_of_the

North-Americanversion,anditisstronglysuggestedasanadjunct methodforthediagnosisandmanagementofpatientswith chronicETD.

A standardized symptom score can improve clinical management, highlighting the impact of ETD on patient qualityoflife,helpingtoguidetheadequatetreatment,and mayalsobeusefulinstudycomparisons.Furtherprospective testingofpatientsundergoingtreatmentforETDmay estab-lishtheusefulnessofETDQ-7intheevaluationoftreatment outcomes.

Conclusion

TheETDQ-7 wastranslated,validatedand adaptedtothe Brazilian reality. A standardized symptom score system canimprove clinicalcare, stressing theimpactof chronic ETD on the patient’s life and guiding adequate patient management.

Conﬂicts

of

interest

Theauthorsdeclarenoconﬂictsofinterest.

Acknowledgements

TotheCoordenac¸ãodeAperfeic¸oamentodePessoaldeNível Superior(CAPES,Brazil)forgrantingascholarship(Master’s Degree)tothemainauthor.

References

1.PoeD,Hanna BM.Eustachian tube dysfunction.In: PostTW, editor. UpToDate. Waltham, MA: UpToDate; 2017. Available from: https://www.uptodate.com/contents/eustachian-tube-dysfunction[cited31.07.17].

2.Bluestone CD.Studies in otitismedia: Children’s Hospitalof Pittsburgh-University of Pittsburgh progress report --- 2004. Laryngoscope.2004;114Pt3Suppl105:1---26.

3.HealyGB,RosbeKW.Otitismediaandmiddleeareffusions.In: SnowJBJr,BallengerJJ,editors.Ballenger’s otorhinolaryngol-ogyheadandnecksurgery.16thed.Hamilton,CA:BCDecker Inc.;2003.p.249---60.

4.BluestoneCD.Eustachiantube:structure,functionroleinotitis media.Hamilton,CA:BCDeckerInc.;2005.

5.Bluestone CD, Klein JO. Otitis media and Eustachian tube dysfunction. In: Bluestone CD,Stool SE, Alper CM, Arjmand EM, Casselbrant ML, Dohar JE, editors. Pediatric otolaryn-gology, vol. 1, 4th ed. Philadelphia: W.B. Saunders; 2003. p.474---686.

6.Bluestone CD. Anatomy and physiology of the Eustachian tube. In: Bailey BJ, editor. Head and neck surgery: oto-laryngology. 2nd ed. Philadelphia: Lippincott-Raven; 1998. p.1285---95.

7.SchilderAG,BhuttaMF,ButlerCC,HolyC,LevineLH,Kvaerner KJ,et al. Eustachian tube dysfunction:consensus statement ondeﬁnition,types,clinicalpresentationanddiagnosis.Clin Otolaryngol.2015;40:407---11.

8.McCoul ED, Anand VK, Christos PJ. Validating the clinical assessment of Eustachian tube dysfunction: The Eustachian Tube Dysfunction Questionnaire (ETDQ-7). Laryngoscope. 2012;122:1137---41.

9.Kosugi EM, Chen VG, Fonseca VM, Cursino MM, Mendes Neto JA, Gregorio LC. Translation, cross-cultural adapta-tion and validation of SinoNasal Outcome Test (SNOT): 22 to Brazilian Portuguese. Braz J Otorhinolaryngol. 2011;77: 663---9.

10.Guillemin F, Bombardier C, Beaton D. Cross-cultural adap-tation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993;46: 1417---32.

11.SiegelS.Estatísticanãoparamétricaparaciênciasdo compor-tamento.2aedPortoAlegre:Artmed;2006.p.448.

12.CortinaJM.Whatiscoefﬁcientalpha?Anexaminationoftheory andapplications.JApplPsychol.1993;78:98---104.

13.SchröderS,LehmannM,SudhoffH,EbmeyerJ.Assessmentof chronicobstructiveEustachiantubedysfunction:evaluationof theGermanversionoftheEustachianTubeDysfunction Ques-tionnaire.HNO.2014;62:160---4.