Validation of the Japanese version of the EORTC hepatocellular carcinoma-specific quality of life questionnaire module (QLQ-HCC18)

Mikoshiba Naoko, Tateishi Ryosuke, Tanaka Makoto, Sakai Tomoko, Blazeby, Kokudo Norihiro, Koike Kazuhiko, Kazuma, Kazuma Keiko

Description

This study examined the measurement properties of the Japanese version of the European Organisation for Research and Treatment of Cancer (EORTC) Hepatocellular Carcinoma-Specific Quality of Life Questionnaire (QLQ-HCC18). Methods EORTC quality of life (QOL) translation guidelines were followed to create a Japanese version of the EORTC QLQ-HCC18. This was then administered to 192 patients with hepatocellular carcinoma along with the EORTC QLQ-C30 and FACT-Hep questionnaires. Tests for reliability and validity were conducted including comparison of scores between the EORTC and FACT questionnaire and detailed assessment of the new scales and items in clinically distinct groups of patients. Results Multi-trait scaling analysis confirmed three putative scales in the QLQ-HCC18, fatigue, fever and nutrition. Cronbach’s alpha for these scales were between 0.68 and 0.78. The QLQ-HCC18 scales correlated with scales measuring similar items in the FACT-Hep and the questionnaire was stable over time with an intra-class correlation score of 0.70 for almost all scales. The questionnaire had the ability to distinguish between patients with different Karnofsky Performance Status, and Child-Pugh liver function class. Conclusions The Japanese version of EORTC QLQ-HCC18 is a reliable supplementary measure to use with EORTC QLQ-C30 to measure QOL in Japanese patients with hepatocellular carcinoma.

Sujets

• Hepatocellular carcinoma
• Quality of life
• Questionnaire

Informations

• Publié par: biomed
• Publié le: 01 janvier 2012
• Nombre de lectures: 9
• Langue: English

Extrait

Mikoshiba
etal.HealthandQualityofLifeOutcomes
2012,
10
:58
http://www.hqlo.com/content/10/1/58

RESEARCH

OpenAccess

ValidationoftheJapaneseversionoftheEORTC
hepatocellularcarcinoma-specificqualityoflife
questionnairemodule(QLQ-HCC18)
NaokoMikoshiba
1*
,RyosukeTateishi
2
,MakotoTanaka
1
,TomokoSakai
1
,JaneMBlazeby
3
,NorihiroKokudo
4
,
KazuhikoKoike
2
andKeikoKazuma
1

Abstract
Background:
ThisstudyexaminedthemeasurementpropertiesoftheJapaneseversionoftheEuropean
OrganisationforResearchandTreatmentofCancer(EORTC)HepatocellularCarcinoma-SpecificQualityofLife
Questionnaire(QLQ-HCC18).
Methods:
EORTCqualityoflife(QOL)translationguidelineswerefollowedtocreateaJapaneseversionofthe
EORTCQLQ-HCC18.Thiswasthenadministeredto192patientswithhepatocellularcarcinomaalongwiththe
EORTCQLQ-C30andFACT-Hepquestionnaires.Testsforreliabilityandvaliditywereconductedincluding
comparisonofscoresbetweentheEORTCandFACTquestionnaireanddetailedassessmentofthenewscalesand
itemsinclinicallydistinctgroupsofpatients.
Results:
Multi-traitscalinganalysisconfirmedthreeputativescalesintheQLQ-HCC18,fatigue,feverandnutrition.
Cronbach
’
salphaforthesescaleswerebetween0.68and0.78.TheQLQ-HCC18scalescorrelatedwithscales
measuringsimilaritemsintheFACT-Hepandthequestionnairewasstableovertimewithanintra-classcorrelation
scoreof0.70foralmostallscales.Thequestionnairehadtheabilitytodistinguishbetweenpatientswithdifferent
KarnofskyPerformanceStatus,andChild-Pughliverfunctionclass.
Conclusions:
TheJapaneseversionofEORTCQLQ-HCC18isareliablesupplementarymeasuretousewithEORTC
QLQ-C30tomeasureQOLinJapanesepatientswithhepatocellularcarcinoma.
Keywords:
EORTCQLQ-HCC18,FACT-Hep,Hepatocellularcarcinoma,Qualityoflife,Questionnaire

Background
countriessuchasJapan,wherecadavericdonororgansare
Hepatocellularcarcinoma(HCC)isthemostcommonscarce,applicationoflivertransplantationislimited[7,8].
malignancyintheworld,accountingformorethanhalfaThus,mostpatientswithHCCundergorepeatednon-
millionnewcasesannually[1,2].Thehighestincidencetransplanttreatmentssuchassurgicalresection,percutan-
ratesareineasternandsouth-easternAsia,westernandeousradiofrequencyablationandembolization.Although
centralAfrica[2].Theincidenceislowinmostdevelopedsurvivaldataandinformationaboutthesideeffectsof
countries,however,Japanhasaveryhighprevalenceoftreatmentarewidelyavailable,muchlessisknownabout
HCC,and70%arecausedbyhepatitisCviruses[3].howtreatmentforHCCimpactsuponthepatients
’
quality
Althoughthe5-yearsurvivalratesofupto60to70%canoflife(QOL).Giventhetimecourseofthedisease,and
beachievedinwell-selectedpatients,therecurrenceratetheburdenofrepeatedtreatment,thereareincreasing
remainsveryhigh[4,5].The5-yearrecurrencerateafterconcernsaboutQOLassociatedwithHCC.Whendecid-
potentiallycurativeliverresectionisupto80%[4-6].Iningupontreatment,considerationofQOLoutcomes
couldbeasimportantassurvival.However,thereareno
*Correspondence:[e-mail]
HCC-specificQOLquestionnairesinJapan.
1
DepartmentofAdultNursing,DivisionofHealthSciencesandNursing,
Atpresent,therearetwodisease-specificQOLquestion-
GraduateSchoolofMedicine,TheUniversityofTokyo,7-3-1Hongo
Bunkyo-ku,Tokyo113-0033,Japan
nairesforevaluatingtheQOLofpatientswithHCC.Oneis
Fulllistofauthorinformationisavailableattheendofthearticle
C©o2m01m2onMsikAotstrhiibbuatieotnalL.;icliecnesnes(ehettpB:i/o/cMreedatiCveenctoramlmLtodn.sT.ohrisg/ilsicaennsOeps/ebny/A2c.0c)e,sswhairctihclepedrismtirtisbuuntreedsturinctdeedrtuhsee,tdeirsmtrsibouftitohne,Carneadtive
reproductioninanymedium,providedtheoriginalworkisproperlycited.

Mikoshiba
etal.HealthandQualityofLifeOutcomes
2012,
10
:58
http://www.hqlo.com/content/10/1/58

theEuropeanOrganizationforResearchandTreatmentof
Cancer(EORTC)QualityofLifeGroupquestionnaire,the
QLQ-HCC18,andtheotheristheFunctionalAssessment
ofCancerTherapy(FACT)Hepatobiliary(FACT-Hep)
questionnaire[9,10].Astheyaredisease-specific,theyare
combinedwithgenericquestionnairessuchastheQLQ-
C30andFACTgenericquestionnaires,respectively,to
produceagenericandaspecificQOLassessment[11,12].
ThemajordifferencebetweenFACT-HepandEORTC
QLQ-HCC18isthatFACT-Heptargetsnotonlypatients
withHCCbutalsopatientswithpancreatic,biliaryand
metastaticlivercancer,whereastheQLQ-HCC18is
designedspecificallyforpatientswithHCC.Currently
thereisalackofpublisheddatademonstratingthemeas-
urementpropertiesofEORTCQLQ-HCC18.
Theobjectiveofthisstudy,therefore,wastodevelopa
JapaneseversionofEORTCQLQ-HCC18,andtovalidate
itsmeasurementpropertiesinpatientswithHCC.
Methods
TranslationoftheJapaneseversionofEORTCQLQ-HCC18
TheEORTCguidelinesfortranslationoftheQLQ-HCC18
wasfollowedandauthorizedbytheEORTC[13].This
includedaforward/backwardtranslationofEORTCQLQ-
HCC18.TheoriginalEnglishversionwastranslatedinto
Japanesebytwoindependenttranslatorswhowerenative
JapanesespeakerswithproficiencyinEnglish.Theresearch
coordinatorcomparedthetwoforwardtranslationsand
checkedthemforanydiscrepancies.Thediscrepancies
betweenthetwotranslationswerediscussedwiththetrans-
latorsuntilweagreedononeprovisionalforwardtransla-
tion.Thisforwardtranslationwasthenbacktranslatedinto
Englishbytwoindependenttranslatorswhowerenative
speakersofEnglishwithproficiencyinJapanese.The
EnglishbacktranslationsandtheoriginalEnglishversion
werecomparedtoassurethattherewerenodifferencesin
themeaningofthequestionsinthequestionnaires.The
provisionalJapaneseversionwaspilottestedon10patients
diagnosedwithHCCwhohadsatisfiedthefollowingeligi-
bilitycriteria:(1)age
>
20years;(2)abilitytocommunicate
inJapanese;(3)abilitytoparticipateinthisstudy,asjudged
byanattendingdoctor;(4)confirmationofmedicaldiagno-
sis;(5)nootherconcurrentmalignancy;and(6)consentto
participateinthisstudy.Thepilottestwasconducted
accordingtothemanualprovidedbyEORTC[13]as
ofJune2008.Theaveragetimenecessaryforcomplet-
ingtheQLQ-HCC18waslessthan5minutesandthe
questionnairewaswellunderstandableandacceptable
inmostpatients.Resultsofthetranslationandthe
pilotstudywerereviewedbytheEORTCtranslation
coordinatorandtheoriginalauthorofQLQ-HCC18,
toensurethecontentandapplicabilitywasmain-
tained,andtheEORTCQLQ-HCC18Japaneseversion
wasauthorizedbytheEORTCQualityofLifeGroup.

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TheJapaneseversionofEORTCQLQ-HCC18was
usedinthisvalidationstudy.
Datacollection
Thisstudyrecruited200patientsdiagnosedwithHCCat
TheUniversityofTokyoHospital,oneofthelargestreferral
centersfortreatmentofHCCinJapan,andwrittenconsent
wasobtained.PatientswererecruitedbetweenJuly2008
andNovember2008.Theeligibilitycriteriawerethesame
asforpilottesting.Patientscompletedeachofthethree
questionnaires:EORTCQLQ-C30,QLQ-HCC18,and
FACT-Hep,andaquestionnaireaboutdemographiccharac-
teristics.Toconfirmtest-retestreliabilityoftheJapanese
versionofQLQ-HCC18,patientswithstablediseasewere
invitedtocompleteQLQ-HCC18forasecondtimeafter
twoweeks.Medicaldatawerecollectedbyreviewofmed-
icalcarerecords.Theresearchercheckedforabsent
responsesafterreceivingthequestionnaireandwherever
possibleaskedthepatientstorespondtothemissingitems.
Thisstudywasconductedwiththeapprovaloftheethics
committeeofTheUniversityofTokyo.
Measurements
TheEORTCQLQ-C30corequestionnaire(version3.0)is
agenericQOLmeasureforcancerpatients,andcomprises
aglobalhealthstatus/QOLscale,fivemulti-itemfunc-
tionalscales,threemulti-itemsymptomscalesandsingle
itemsfortheassessmentofsymptomsandthefinancial
impactofdiseaseandtreatment[11].Thereliabilityand
validityoftheJapaneseversionoftheEORTCQLQ-C30
hasbeendemonstrated[14].
EORTCQLQ-HCC18isan18-itemHCC-specificsupple-
mentalmoduledevelopedtoaugmentQLQ-C30andtoen-
hancethesensitivityandspecificityofHCC-relatedQOL
issues[9].EORTCQLQ-HCC18wasdevelopedinfour
stagesonthebasisoftheEORTCguidelinesforscaledevel-
opment[9].Briefly,itemswerecreatedduringphaseone
afterconductingaliteraturereviewandinterviewing32
patientswithHCCfromfourdifferentcountriesaswellas
10healthprofessionals.Inphasetwo,apreliminaryques-
tionnairewasconstructedusingtheEORTCitembankasa
reference.Inphasethree,apretestwasadministeredto158
patientswithHCCfromthreecountriestoexaminerecep-
tivityandrelevance.Theoriginalquestionnaireisfromthe
endofphasethree.Thehypothesizedscalestructureand
singleitemsaddressaspectsofchronicliverdisease
(nutrition,jaundice,fever,abdominalswelling),aswellas
QOLissuesspecifictotheprimarytumoranditstreatment
(fatigue,bodyimage,pain).
TheoriginalEnglishversioncontainssixmulti-item
scalesaddressingfatigue,bodyimage,jaundice,nutrition,
painandfever,aswellastwosingleitemsaddressing
sexuallifeandabdominalswelling.Thescalesanditems
arelinearlytransformedtoa0to100score,where100

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representstheworststatus.AninternationalfieldtestbetweensimilaritemsinFACT-HepandQLQ-HCC18.We
(thephase4partofquestionnairedevelopment)ishypothesizedthatifPearson
’
scorrelationcoefficientswere
currentlybeingconductedtoexaminethevalidityandmorethan0.40betweenscales,theywereconceptually
reliabilityofthescoresinseveralcountries.r