Braz. j. . vol.81 número6

(1)

www.bjorl.org

Brazilian

Journal

of

OTORHINOLARYNGOLOGY

ORIGINAL

ARTICLE

Translation

and

cross-cultural

adaptation

into

Brazilian

Portuguese

of

the

Vanderbilt

Head

and

Neck

Symptom

Survey

version

2.0 (VHNSS

2.0)

for

the

assessment

of

oral

symptoms

in

head

and

neck

cancer

patients

submitted

to

radiotherapy

夽

Eliane

Marc

¸on

Barroso

a,∗

_,

_André

_Lopes

_Carvalho

a,b,c

_,

_Carlos

_Eduardo

_Paiva

a,c,d

_,

João

Soares

Nunes

d

_,

_Bianca

_Sakamoto

_Ribeiro

_Paiva

a,c

a_Postgraduate_Program_in_Oncology,_Hospital_de_Câncer_de_Barretos,_Barretos,_SP,_Brazil b_Head_and_Neck_Department,_Hospital_de_Câncer_de_Barretos,_Barretos,_SP,_Brazil

c_Grupo_de_Pesquisa_em_Qualidade_de_Vida_Relacionada_à_Saúde_(GPQual)_---_CNPq,_Hospital_de_Câncer_de_Barretos,_Barretos,_SP,

Brazil

d_Department_of_Clinical_Oncology,_Breast_and_Gynecology_Division,_Hospital_de_Câncer_de_Barretos,_Barretos,_SP,_Brazil

Received5May2014;accepted1November2014 Availableonline8September2015

KEYWORDS Headandneck neoplasms; Qualityoflife; Translating; Oralhealth

Abstract

Introduction:Patientssubmittedtoradiotherapyforthetreatmentofheadandneckcancer haveseveralsymptoms,predominantlyoral.TheVanderbilt HeadandNeckSymptom Survey version2.0isanAmericantooldevelopedtoevaluateoralsymptomsinheadandneckcancer patientssubmittedtoradiotherapy.

Objective:TheaimofthepresentstudywastotranslatetheVanderbiltHeadandNeckSymptom Surveyversion2.0intoBrazilianPortugueseandcross-culturallyadaptthistoolforsubsequent validationandapplicationinBrazil.

Methods:Amethodusedforthetranslationandculturaladaptationoftools,whichincluded independenttranslations,synthesisofthetranslations,back-translations,expertcommittee, andpre-test,wasused.Thepre-testwasperformedwith37headandneckcancerpatients, whoweredividedintofourgroups,toassesstherelevanceandunderstandingoftheassessed items.Dataweresubmittedtodescriptivestatisticalanalysis.

夽 _Please_cite_this_article_as:_Barroso_EM,_Carvalho_AL,_Paiva_CE,_Nunes_JS,_Paiva_BSR._Translation_and_{cross-cultural}_adaptation_into_Brazilian PortugueseoftheVanderbiltHeadandNeckSymptomSurveyversion2.0(VHNSS2.0)fortheassessmentoforalsymptomsinheadandneck cancerpatientssubmittedtoradiotherapy.BrazJOtorhinolaryngol.2015;81:622---9.

∗_{Corresponding}_author.

E-mail:embarroso@uol.com.br(E.M.Barroso).

http://dx.doi.org/10.1016/j.bjorl.2015.08.014

(2)

Results:Theoverallmeanofthecontentvalidityindexwas0.79forsemanticandidiomatic equivalence,anditwashigherthan0.8forculturalandconceptualequivalence.The cogni-tiveinterviewshowedthatpatientswereabletoparaphrasetheitems,andconsideredthem relevantandeasilyunderstood.

Conclusion: Thetool was translated andcross-culturally adaptedto beused in Brazil.The authorsbelievethistranslationissuitedforvalidation.

PALAVRAS-CHAVE Neoplasiasdecabec¸a epescoc¸o;

Qualidadedevida; Traduc¸ão;

Saúdebucal

Traduçãoeadaptaçãoculturalparaoportuguês(Brasil)doinstrumentoVanderbilt HeadandNeckSymptomSurveyversion2.0(VHNSS2.0)paraavaliaçãodesintomas oraisempacientescomcâncerdecabeçaepescoçosubmetidosàradioterapia

Resumo

Introdução: Pacientes submetidos à radioterapia para tratamento de câncer de cabeça e pescoço apresentam diversossintomas,compredominância desintomas orais.OVanderbilt HeadandNeckSymptomSurveyversion2.0éuminstrumentoamericanoquefoidesenvolvido paraavaliarsintomasoraisempacientescomcâncerdecabeçaepescoçosubmetidosà radioter-apia.

Objetivo: TraduziroVanderbiltHeadandNeckSymptomSurveyversion2.0eadaptá-lo cul-turalmenteparasubsequentevalidac¸ãoeaplicac¸ãonoBrasil.

Método: Ummétododetraduçãoeadaptaçãocultural deinstrumentosfoiutilizado,oqual incluitraduçõesindependentes,síntesedastraduções,retrotraduções,comitêdeespecialistas epré-teste.Opré-testefoirealizadoem37pacientescomcâncerdecabeçaepescoçodivididos emquatrogruposparaavaliararelevânciaeentendimentodositens.Dadosforamsubmetidos àanáliseestatísticadescritiva.

Resultados: A média geral do índice de validade de conteúdo foi 0,79 para as equivalên-ciassemânticas eidiomáticas;emaiorque0,8 paraasequivalências culturaleconceitual. A entrevistacognitivamostrou queospacientesforamcapazesdeparafrasear ositenseos consideravamrelevanteedefácilentendimento.

Conclusão:OinstrumentofoitraduzidoeadaptadoculturalmenteaoBrasil.Nósacreditamos queestatraduc¸ãoestáaptaparaavalidac¸ão.

Introduction

Head and neck cancer (HNC) includes tumors that affect thelips,oralcavity,oropharynx,nasopharynx,hypopharynx, larynx, nasal cavity and paranasal sinuses, thyroid gland, and salivary glands.1 _These _cancers _account _for

approxi-mately 10% of malignant tumors.2 _In _Brazil, _for _the _years

2012/2013,approximately20,000caseswereestimatedonly

fortumorsintheoralcavityandlarynx.3

Therapeutic options for HNC, including radiotherapy,

contribute to significant adverse symptoms and loss of

function.4 _Such _symptoms _may _occur _immediately, _soon

afterthetreatment, ormayappearlater.5 _The_oral

alter-ations are prominent, and include mucositis, dysphagia,

tasteandmucosalsensitivityalterations,xerostomia,teeth

alterations, and excess mucus.5---9 _With _the _exception _of

xerostomia, mucositis, and dysphagia, these alterations

havebeenlittlediscussedintheliteratureandarebelieved

tobeunderreported.9_Half_of _surviving_HNC_patients_have

problems and complications five years after the primary

treatment, which include pain, problems with teeth,

problems with chewing and swallowing,10 _or _high _scores

for symptomssuch asxerostomia, mucusproduction, and

swallowingalterationsrelatedtotreatment.11

The xerostomia resulting from HNC treatment causes

damage to oral health12 _and _has _a _negative _impact _on

thequalityof life(QoL)of thesepatients.6 _In _addition_to

hyposalivation,whichcontributestotheonsetofmucositis,

some patients may have an excessiveamount of mucus11

thatobstructs theairway,resultinginalterationsin

sleep-ing,coughing, andchoking.9 _Another_common_symptom_in

patientstreatedforHNCisthealterationoftaste,8_a_direct

result of the effect of radiation on the taste buds, and

alterationsinsaliva.13 _HNC_treatment_also_contributes_to_a

worseningof dentalhealth.14 _Patients_submitted_to

radio-therapyhad worsedentalstatus whencomparedtothose

submittedtochemotherapy.15_In_the_Brazilian_population,_a

longitudinalstudyshowedthatinpatientswithoralcancer,

the most common problems were related to difficulties

in chewing, swallowing, pain, and reduced salivary flow,

suggestingtheimportanceofdentalmonitoringofpatients

(3)

Some of the toxicities associated with treatment for

patients with HNC can be minimized, but are inevitable,

highlighting the importance of identifying andcontrolling

adverseeffectsrelatedtotreatmentbythehealthteam.8

Thetoolstoidentifyandevaluatethesealterationsresulting

fromthetreatmentcanserveasdiagnostictools,helpingto

establishthemostappropriateconductforthecareplanof

thesepatients.

Symptom assessment is often considered within the

physicalandfunctionaldomainsofQoLevaluation

question-naires,sothereissomedifficultyindifferentiatingsymptom

researchtoolsfromQoLassessment.17_In_patients_with_HNC,

themost usedand validatedtools in Brazilto assessQOL

aretheUniversityofWashingtonQOL(UW-QOL),18_the

FACIT-HN,19_and_the_EORTC-HN35,20_whereas_for_symptom_research

inHNCitistheMDASI-HN.21_Overall,_the_tools_used_for_QOL

assessment comprise problems such as dysphagia,

xeros-tomia, and mucositis. However, they fail to report oral

symptomssuchasmucosalsensitivity,excessmucus,dental

problems,andtheirfunctionalimplications.TheVanderbilt

HeadandNeckSymptomSurvey(VHNSS)2.09,22,23_is_an

Amer-icansymptomassessment toolspecificallyusedinpatients

withHNCwhosetreatmentincludesradiotherapythatmore

broadly assesses oral health components, with a specific

domain for dental health and its functional implications.

Itcontains50itemsdistributedinto13domains:nutrition,

swallowing/foodintake,xerostomia,mucositis,pain,excess

mucus, speech/communication, hearing, taste and smell

alterations, dental health, mucosal sensitivity, and range

of motion. The answer options are graded on a scale of

0---10,sothatzero(0)signifiesnoproblemandten(10)is

themaximumpresenceofaspecificproblem.Thereliability

measuredbyCronbach’s˛issuitable,rangingfrom0.70to

0.94.22 _Therefore,_the_VHNSS_2.0_was_selected_for

transla-tionandcross-culturaladaptationintoBrazilianPortuguese.

Methods

Thiswasadescriptive,cross-sectionalstudy,usingamethod

oftranslation and cross-culturaladaptation of the

assess-menttool,performedinthefollowingfivesteps:

Translationand cross-cultural adaptation process: The

process of translation and cross-cultural adaptation of

the VHNSS 2.0 into Brazilian Portuguese was performed

according tothe internationalguidelines.24,25 _Consent_and

authorization in writing wasobtained via email from the

authoroftheoriginaltool,Dr.BarbaraA.Murphy,andthe

studywasapprovedbytheResearchEthicsCommittee

(pro-tocol No. 644/2012). Fig. 1 summarizes the steps of the

translationandcross-culturaladaptationprocess.

Translation:CarriedoutbythreenativeBrazilian

individ-ualsfluentinEnglish,ofwhomtwowerefromthehealthcare

area(physicians),whereasthethirdtranslatorwasnot.

Synthesisoftranslations:Thethreetranslatedversions

weresynthesizedintoasingleversion(T123),inaconsensus

meeting attendedby threeofthe authors (EMB,CEP, and

BSRP).

Back translation: Performed by American Journal

Experts, a company specialized in translations, which

received and complied with the guidelines that the two

back-translatorsshouldbe nativeAmericanEnglish

speak-ersandshouldbeunawareoftheoriginalversion.Theback

translationswereevaluatedandforwardedtotheauthorof

theoriginaltool.

ExpertCommittee: The versions were evaluatedbyan

expert committee in thefieldof health assessment tools,

consisting ofa head-and-neckoncologysurgeon,two

clin-ical oncologists, one nurse, one dentist, and a university

professor of linguistics. The aim of the committee was

to assess the translated version and compare it to the

original one, regarding semantic, idiomatic, cultural, and

conceptual equivalence, scoring ‘‘1’’(one) for the

equiv-alent items,‘‘0’’ (zero)for the items theydidnot know,

and‘‘−1’’(minusone)forthenon-equivalentitems.They

alsohadautonomytosuggestculturalchangestheydeemed

important.Theequivalencecalculationwasmadeusingthe

mean of theitems of the contentvalidity index(CVI)for

eachoneofthem,consideredequivalentwhen>0.8.26

Addi-tionally,thesuggestionsmadebythecommitteeweretaken

intoconsideration,discussedatameetingattendedbyfour

oftheauthors(EMB,CEP,BSRP,JSN),whichyieldedanew

version(T4).

Translator 1 Translator 2 Translator 3

VHNSS 2.0 Synthesis of

the translation Version T123

Back-translator 1 Back-translator 2

Pre-test 5 patients Pre-test

32 patients

Version T4 Expert committee

Version T5

Final version VHNSS 2.0

(4)

Table1 ModificationssuggestedforVHNSS2.0itemsbytheexpertcommitteeandtranslators.

Item Originalversion Adaptedversion Justification

Title Survey(pesquisa) Questionnaire(questionário) Moreadequatewordforthe Brazilianculture

1stInstruction AppropriateBox(caixa apropriada)

Chosenoption(opc¸ãoescolhida) Clearerandmoreinformal

1 Icurrentlyhaveafeedingtube inplace

(Euatualmentetenhoumtubo dealimentac¸ãocolocado)

Areyouusingatubetobefed?

(Vocêestáusandoumasonda parasealimentar?)

Clearerandmoreinformal

2ndInstruction ...Ingeneral,a‘‘0’’indicates theleastamountofproblems withaparticularsymptomand ‘‘10’’indicatesthemost problems.(Emgeral‘‘0’’indica amenorquantidadedeproblema comsintomaparticulare‘‘10’’ indicaomaiordosproblemas)

Ingeneral‘‘0’’indicatesthe absenceofasymptom(problem) and‘‘10’’indicatesthe

maximumpresenceofsymptom (problem)(Emgeral,‘‘0’’indica aausênciadeumsintoma (problema)e‘‘10’’indicaa presenc¸amáximadeumsintoma (problema)

Thesubstitutionoftheterm ‘‘amount’’by‘‘presence’’ makesthesentencemost objective

3 ‘‘likeEnsureTM_or_BoostTM_’’ (comoEnsureTM _or_BoostTM_’’₎_e LiquidSupplement

(suplementolíquido)

‘‘likeEnsureTM_,_NutrenTM_, SustagemTM_’’_(como_EnsureTM_, NutrenTM_,_SustagemTM₎ Dietaryliquidsupplement

(suplementoalimentarliquido)

ProductsavailableinBrazil. Dietaryliquidsupplementwas added,asitisknowninBrazil

5 Trouble(problema) Difficulty(dificuldade) Adaptationtoitem4 6 Trouble(problema) Difficulty(dificuldade).

Removalofthewordthin(ralos) andEnsure,substitutedbyjuice (sucos)

Removalofthewordthin,which isnotcommonlyusedinBrazil andsubstitutionofEnsureby juice,atypicalBraziliandrink 15 Swallowing(deglutic¸ão) Swallow(engolir) Moreinformaltranslationof

deglutition 16 Abilitytosleep(capacidadede

dormir)

Sleep(sono) Makestheitemmoreobjective

17 Abilitytotalk

(capacidadedefalar)

Talk(falar) Makestheitemmoreobjective

18,19,20,21 Mucous(muco) Secretion(secrec¸ão) Moreinformalword 27 Average(média) Remoc¸ãodapalavraaverage

(média)

Makestheitemmoreobjective

32 Hearing(audic¸ão) Hear(ouvir) Moreinformalword,culturally

appropriate 34 Ihavelessdesiretoeat(Eu

tenhomenosdesejodecomer)

Youfeellesslikeeating(Você sentemenosvontadedecomer)

Moreinformalword,culturally appropriate

37,38 Anexplanatoryparenthesison

abilitytosmell(capacidadede sentircheiro)wasadded

Facilitatesunderstanding

39,40,41,42 Nonapplicable(nãoaplicável) Cannotbeapplied(nãose aplica).

Facilitatesunderstanding

44,45,46,47,48 Remoc¸ãodapalavralining

(mucosa)

Technicalwordofdifficult understanding,culturally appropriate

48 Theexpression‘‘Cannotbe

applied’’(nãoseaplica)was added.

Becauseeventuallysomeone mightnothaveanyteethand theitemdoesnotapply 49 Limitationsintheability

(limitac¸ãonacapacidade)and jaw(mandíbula)

Difficuly(dificuldade)and

mouth(boca)

Wordofdifficultunderstanding, culturallyappropriate

50 Limitationsintheability

(limitac¸ãonacapacidade)

Difficuly(dificuldade) Culturallyadequate

(5)

Table2 ModificationssuggestedfortheanswerstoVHNSS2.0bythecommitteeofexpertsandtranslators.

Answerstoitems Originalversion Adaptedversion Justification

22 Nopain/severe

pain(Nehuma dor/Dorintensa)

Never/Always(Nunca/Sempre) Theitemreferstothefactofhavingornot lesionsandnottheintensityofpain.Theanswer wasadequatetothequestion

32,39 None/Severe

(Nenhum/Grave)

None/Alot(Nenhum/Muito) Theword‘‘grave’’wouldnotbeappropriatein thiscontext,culturallyadequate

42 Notatall/Severe

(Nenhum/Grave)

None/Alot(Nenhum/Muito) Theword‘‘grave’’wouldnotbeappropriatein thiscontext,culturallyadequate

14,49,50 Never/Severe

(Nunca/Grave)

Never/Always(Nunca/Sempre) Answersmixedtheconceptsoffrequencyand intensity.Itwasdecidedtomaintainonlythe frequencyconcept

VHNSS2.0,VanderbiltHeadandNeckCancerSymptomSurveyversion2.0.

Pre-test

In order to assess the clarity and understanding of the T4 version, a pilot test was performed, which included patientswithHNC(oral cavity,larynx,oropharynx,and/or hypopharynx)hadbeensubmittedtooncologictreatment, including radiotherapy, for more than six months previ-ouslyandwhoagreedtoparticipatebysigningtheinformed consent. Patients with cognitive or mental impairment that prevented them from providing correct information wereexcluded.Sociodemographicinformationwasobtained throughaninterviewandclinicaldatafrommedicalrecords. The32patientswhomettheinclusioncriteriaweredivided intofour groups based ondomains,27 _with _the _first_group

evaluating items 1---17, the second group items 18---31,

the third group items 32---43, andthe fourth group items

44---50.Patientsanswered astructuredinterview

individu-allytoassesstheimportanceandunderstandingofitemsand

answers,whethertheywouldaskthequestion differently,

andthemeaningoftheitem,27_thus_ensuring_that_each_item

wasadequateandunderstoodbythepatients.Furthermore,

fivepatientswereenrolledatthisstagetotestthecultural

adaptationsofsixitems(5,10,14,27,38,43),asthe

ques-tionrelatedtothemeaningshowedtheywerenotclearfor

thesepatients.

Statisticalanalysis

Dataareshownthroughdescriptivestatisticsfor

sociodemo-graphicandclinical characteristics,aswellasfortheCVI,

usingSPSSv.20software.

Results

Theprocessoftranslationandcross-culturaladaptationof

theVHNSS2.0toolintotheBrazilianPortugueselanguageis

describedbelow.Itisnoteworthythattheback-translation

processshowedthattheinitialversioninPortuguese

corre-spondedtotheEnglishversion.Thesuggestionsgivenbythe

expertcommitteewerediscussedandincorporatedintothe

toolinordertoadaptittoBrazilianculture.

Tables 1 and2 describe themain cultural adjustments

withinthe items and tool responses. The main alteration

wastheperson:intheoriginaltool,allitemsareinthe1st

personsingular,whereasthetranslatedversionwasadapted

Table3 MeanoftheCVIoftheitems.

Equivalence CVIofitems CVIofanswers toitems

Semantic/idiomatic 0.79 0.96

Cultural 0.86 0.98

Conceptual 0.89 0.98

CVI,contentvalidityindex.

tothe2ndpersonsingulartoprovidemoreclarityandallow thetooltobebothself-applied,aswellastobeappliedby aninterviewer.

TheCVI,whichwascalculatedasthemeanoftheitems for each equivalence given by the raters, was 0.79 for idiomatic andsemanticequivalenceof theitemsand>0.8 fortheotherequivalences(Table3).

Pre-testinterview

A total of 37 patients participated in this stage, with a

median ageof 60 years,ofwhom 32(86.5%) weremales,

21 (56.8%)Caucasians, 27 (73%)married, 26(70.3%) were

barely literate or had not finished elementary school, 23

(62.2%) were fromthe state of São Paulo, 31 (84%) were

professionally inactive, eight (21.6%) were current

smok-ersand27(73%)ex-smokers,two(5.4%)consumedalcohol

and 21were ex-alcohol drinkers(56.8%), 29(78.5%) were

Catholics,and24(65%)hadnoassociatedcomorbidity.The

clinicalcharacteristicsaredescribedinTable4.

At the first moment, 32 patients participated in the

pre-test and were divided by domain and age,

answer-ing questions related to the understanding of the items,

witheachgroupcontainingeightpatients,equallydivided

betweenthoseagedupto60yearsoldorolder.Thepatients

considered the items important, easily understood, and

wereable tounderstandthe answers.In sixitems(5, 10,

14, 27, 38, 43) with the question ‘‘Could you tell me in

your ownwordswhat itmeans foryou?’’, 25%of patients

understoodincorrectly.Therefore,thesewerediscussedat

aconsensusmeetingandbasedonthecomments,theywere

reformulatedasfollows:

Items5and10:removaloftheword‘‘solid’’,aspatients

(6)

Table4 Clinicalcharacteristicsofpatientsparticipatingin thepre-test.

Variable Frequency(n) Percentage(%)

Histologicaltype

SCC 37 100.0

TNM

I 3 8.1

II 2 5.4

III 15 40.5

IV 16 43.2

‘‘Missing’’ 1 2.7

Location

Oralcavity 6 16.2

Hypopharynx 4 10.8

Oropharynx 13 35.1

Larynx 13 35.1

Oralcavityandlarynx 1 2.7

Surgery

Yes 21 56.8

No 16 43.2

Lymphadenectomy

No 6 31.6

Yes 13 68.4

Chemotherapy

No 11 29.7

Yes 26 70.3

ECOG

0 26 70.3

1 11 29.7

TNM,classificationofmalignanttumors;ECOG,Eastern Cooper-ativeOncologyGroup.

Item14:substitutingtheword‘‘problem’’with‘‘feeling,’’ astheyconsideredthedrymouthafeelingandnota prob-lem.

Item38:changeoftheorderofwordsinthesentenceto makeitmoredirect.

Items 27 (‘‘The relief of your pain with analgesics had been:Notapplicable,sinceIdonotuseanalgesics’’)and43 (‘‘Haveyouhadproblemswithyourdentures?Not applica-ble,becauseIdonotweardentures’’)werenotchanged, because the authors that participated in the consensus meeting(EMB,CEP,BSRP)consideredthatthesuggestions madebypatientstothesetwoitemsdidnotaddrelevant information.Theseitemswerereappliedtofivepatientsto confirmthatthechangeswereappropriate.Therefore,the processoftranslationandcross-culturaladaptationended, resultingintheBrazilianPortugueseversionoftheVHNSS 2.0tool,whichinBrazilisknownasthe‘‘Questionáriode sintomasem CâncerdeCabec¸aePescoc¸odeVanderbilt’’ (VHNSS2.0).

Discussion

Themethodusedinthisstudyallowedthetranslationand cross-culturaladaptationoftheVHNSS2.0tooltothe Brazil-iancultureandwillallowitsuseintheassessmentoforal

symptomsrelatedtotreatment thatincludesradiotherapy ofpatientswithHNCandtheirfunctionalimplications.Itis worthmentioningthatthisisthefirsttoolinBrazilian Por-tuguesethat includes adomain that evaluates the dental statusinthispopulation.

During the process of cross-cultural adaptation of the tool,the change from the first tothe second person sin-gularresultedinatoolthatcanbeself-appliedor applied byan interviewer, asa previous validationstudy in Brazil showed that 77% of Brazilians prefer assessment tools to beapplied by interviewers,with the given reasons being mainlypersonal preference anddifficulty reading.28

Addi-tionally,the influence of social and educationallevels on

HNCincidence mustbe considered.A meta-analysisstudy

of41articlesevaluatedtheassociation betweenoral

can-cerandsocioeconomicstatus,andfoundthatindividualsof

lowsocioeconomicstatus,includingloweducationallevel,

lowerincome,andloweroccupationalclass,aremorelikely

tohavethedisease.29

InBrazil,theincidenceofHNCis2.5higherinindividuals

whohaveloweducationallevel.30_A_study_carried_out_in_São

Paulofoundthat45.4%and43.6%ofpatientswithHNCwere

illiterateorhadnotfinishedelementaryschoolintheyears

2000and2006,respectively.31_Therefore,_a_tool_that_can_also

beappliedbyaninterviewermeetsthispopulation’sneeds,

whichinthisstudycomprisedthe70.3%ofpatientswhowere

barelyliterateorhadnotfinishedelementaryschool,with

amedianincomeofoneminimumwage.

Thereasonthatledtothetranslationandcross-cultural

adaptation of a new toolwas primarily the fact that the

available tools in Brazil that evaluate symptoms related

to treatment in patients with HNC are associated with

toolsthatassesshealth-relatedQoL,anddonotincludea

complete assessment of dental and oral health and their

functional implications. It is noteworthy that a detailed

oralhealthassessmentisimportant,sincepatientstreated

forHNC,includingradiationtherapy,oftenhaveoral

alter-ations.Additionally, itmustbeconsideredthatdeveloping

newtoolstakestimeandcostsmoney.32

Symptomssuchasdysphagiaandxerostomiahavea

nega-tiveimpactonhealth-relatedQoL.6_Xerostomia_is_a_frequent

andimportantsymptom,reportedby52%ofpatientstreated

fororalandoropharyngealcancer;moreover,thefunctional

outcomemeasuredbytheMandibularFunctionImpairment

Questionnaire(MFIQ)isinfluencedbytheincapacitytowear

dentalprostheses.33 _It_is_noteworthy_that_40.7%_of

individ-ualsreportedchewingdifficultiesattributedtotheirteeth

ordentures,50%reportedthattheirteetharesensitive to

heat,cold,orsweets,and36%saidtheyhadfrailorchipped

teeth.9

Murphy et al. reported that 76% of patients

undergo-ingchemoradiotherapyorradiotherapyforHNChadsevere

painin themouthandthroat, resultingin lossoffunction

andincreaseduseof opioidsfor painreductionassociated

withmucosites.34 _Dental _problems _affect _a _large _number

ofpatientsand occurduetothe reductioninthesalivary

flowdirectlyassociatedwithalterationsindentalstructures

(enamel,dentin)causedbyradiation.35

The translation and cross-cultural adaptation method

usedin thisstudy hasbeen consolidated inliterature.24,25

Thetranslationprocessinvolvedindividualsfromthehealth

(7)

translatedtofacilitate the understanding by the patients

whowillanswerthetool.The choiceofusingtheservices

ofaspecializedcompanyfortheback-translationwasmade

tooptimizethe processwithprofessionalswhoarenative

English speakers and are also fluent in Portuguese. The

assessmentofequivalencebytheexpertcommitteeshowed

thatthePortugueseversionoftheVHNSS2.0isequivalent

totheEnglishversion.

One limitation of this study is the small sample size

used in the pre-test and the division by domains of the

appliedstructuredinterviews.Theloweducationallevelof

thepatientswithHNCinBrazilmayhindertheunderstanding

ofthequestionnaire,limitingitsself-application,although

thetoolalsohasbeenadaptedtoallowitsapplicationbyan

interviewer.

Conclusion

Translationand cultural adaptationof the VHNSS 2.0 tool

intoBrazilianPortuguesehasbeenperformed,providingan

important tool to assess oral symptoms in patients with

HNCsubmittedtotreatmentthatincludesradiotherapy.The

resultsdemonstratedthattheBrazilianversionoftheVHNSS

2.0toolis equivalenttotheoriginalin English,waseasily

understoodbypatients, andwasalsoadaptedtoBrazilian

culture.Therefore,thetoolisconsideredadequateforthe

validationstep,aprocessthatisunderway.

Authors’

contributions

EMB contributed to the study design, data collection,

and writing of the manuscript; ALC contributed to the

study design, analysis of equivalence, and reviewing of

themanuscript;CEPcontributedtothestudydesign,

par-ticipated in the discussions in the consensus meetings,

data analysis, and study review; JSN participated in the

committeeand discussionsat the consensusmeetingsand

contributedwithmanuscriptreview;andBSRPcontributed

to the study design, participated in the discussions in

theconsensus meetings, and contributedto dataanalysis

andstudy review.Allauthorsread andapproved thefinal

manuscriptversion.

Funding

This study was supported by Fundac¸ão de Amparo à

PesquisadoEstadodeSãoPaulo (FAPESP,Brazil)Case No.

2012/16768-2.

Conflicts

of

interest

Theauthorsdeclarenoconflictsofinterest.

Acknowledgements

TheauthorswouldliketothankDr.LucianodeSouzaViana,

JoséHumbertoTavaresGuerreiroFregnani,Dr.Juliana

Bal-binot Hilgert, Dr.OtoValley Araújo,and Dr.Namie Okino

Sawada,fortheircontributiontothetranslationprocessof

thetoolfromEnglishintoPortugueseandtheirparticipation

intheexpertcommittee.

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