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

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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.

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Publié le 01 janvier 2012
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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:naokom-tky@umin.ac.jp
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.

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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.

Page2of7

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.related.
P
<
0.05wasconsideredasstatisticallysignificant.
ThereliabilityandvalidityoftheoriginalversionofStatisticalanalyseswereperformedusingSASsoftware
FACT-Hep,anotherhepatobiliarycancer-specificscale,has(SASforWindows,release9.1;SASInstituteInc.,CaryNC,
beendemonstrated[10].FACT-Hepisa45-itemself-reportUSA).
instrumentthatcomprises27FACTGeneral(FACT-G)
itemsandan18-itemhepatobiliarysubscale.TheJapanese
versionofthe18-itemhepatobiliarysubscalewasusedin
Results
thisstudyasacomparisoninstrument.Allitemsarescored
Participants
from0to4,withhigherscoresindicatingbetterQOL.Responseswereobtainedfrom192patients(eightnon
responders),and139completedthetest-retestquestion-
Dataanalysis
nairetwoweeksafterthefirstassessment.
Multi-traitscalinganalyses[15]evaluatedthescalestruc-Socio-demographicandclinicalcharacteristicsatbaseline
turesofQLQ-HCC18.ThistechniqueisusedtotestforareshowninTable1.Mostpatientsweremale(64.1%),had
itemconvergentanddiscriminantvalidity,andisbasedongoodperformancestatus(86.5%)andhadgoodliverfunc-
theexaminationofitem-scalecorrelations.ThePearsontion(66.2%).
correlationsofanitemwithitsownscale(correctedfor
overlap)andotherscaleswerecalculated.Evidenceofitem
convergentvaliditywasdefinedasacorrelationabove0.40
withitsownscale.Evidenceofitemdiscriminantvalidity
Table1Socio-demographicandclinicalcharacteristicsof
wasbasedonacomparisonofcorrelationofanitemwith
thestudysubjects(n=192)
itsownscaleandwithotherscales.Scalingsuccessforany
Malegender122(63.5)
scaleisdefinedasthenumberofconvergentcorrelation
Age,y*68.1(8.5)
coefficientssignificantlyhigherthanthediscriminantcorrel-
ationcoefficientdividedbythetotalnumberofcorrelations.
Employedfulltimeorpart-time77(40.1)
Themeanscaleanditemscoreswerealsocalculated,anda
Postcompulsoryeducationorabove155(80.7)
frequencyanalysiswasperformed.
Marriedorlivingwithpartner151(78.6)
Thefollowingpsychometricaspectswereassessed:reli-
KarnofskyPerformancestatus
ability,i.e.,internalconsistencyandtest-retestreliability;
80-100166(86.5)
validity:knowngroupcomparison,andcorrelationanalyses
Comorbidliverdisease
withtheFACT-Hep.
Theinternalconsistencyreliabilityofthemulti-item
HepatitisCvirus126(65.6)
questionnairescaleswasassessedbyCronbach

salphaco-
HepatitisBvirus38(19.8)
efficient.Preferablereliabilitywasindicatedbycoefficient
Otherorunknown28(14.6)
greaterthan0.70.Thetest-retestreliabilityofthescales
Child-Pughclass
andsingleitemswasassessedbytheintra-classcorrelation
A127(66.1)
coefficient.Scalediscriminantvalidity(clinicalvalidity)
B53(27.6)
wastestedbyknowngroupcomparisonstoassesswhether
thequestionnairescoreswereabletodiscriminatebetween
C12(6.3)
subgroupsofpatientsdifferinginclinicalstatusbyusing
Cancerstage
theStudentt-test.TheKarnofskyPerformanceStatus
StageI/II161(83.9)
(KPS)andChild-Pughgradeforclinicalparameterswere
StageIII/IV31(16.1)
employedtoformmutuallyexclusivepatientsubgroups.
Timesincediagnosis,month*39.6(34.5)
HigherscoresinKPSsignifybetterperformancestatus.
Pastmedicalhistory

Liverfunctionbecomesworseinalphabeticalorderof
Child-PughgradeA,B,C.Wehypothesizedthatscoresof
Hepatectomy48(25.0)
QLQ-HCC18arelowinpatientswithbetterperformance
Percutaneousablation137(71.4)
status(KPS80

100)andbetterliverfunction(Child-Pugh
Chemoembolization64(33.3)
classA).Convergentvaliditywastestedfirstbymulti-trait
Systemictherapy1(0.5)
analyses,andwethenconductedanotherconvergentvalid-
Nomedicalhistory13(6.8)
itytestbycorrelationanalyseswithFACT-Hep.Pearson

s
Valuesarenumbers(%)otherwisespecified.*Datawasexpressedasmean
correlationcoefficientwasusedtoexaminethecorrelation
(standarddeviation).

Somepatientsunderwentmultipletreatments.

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Psychometrictesting
70orlower)reportedsignificantlyhigher(worse)scores
Weinitiallyperformedmulti-traitscalinganalysesfortheforallscalesexceptforabdominalswellingandsexual
putativescalestructure,andtheresultsshowedthattheori-interestthanthosewithbetterperformancestatus(KPS
ginaltwo-itemscaleofbodyimageandjaundicehadlowof80

100).Patientswithworseliverdisease(Child-Pugh
convergentanddiscriminantvalidity.AfterdiscussionwithclassesBandC)reportedsignificantlyhigher(worse)
theoriginalauthorofQLQ-HCC18(JMB)wedecidedtoscoresforallscalesexceptforbodyimageandpainthan
splitthescaleintosingleitems.Thetestswerethenper-thosewithbetterliverfunction(Child-PughclassA).
formedontheremainingscalesandfoursingleitems.ResultsofconvergentvalidityareshowninTable6.The
Resultsofthemulti-traitscalinganalysesareshowninQLQ-HCC18Japaneseversionscaleshadanacceptable
Table2.Asummaryofthemulti-traitscalinganalysisandcorrelation(coefficientvalueover0.40)withsimilaritems
internalconsistencyisshowninTable3.TheconvergentinFACT-Hepexceptforitemsofweightloss,appetiteand
correlationcoefficientofthescalesforfatigue,nutritionandactivity.
fevervariedfrom0.23to0.75,andthescalingsuccessrate
rangedfrom87%to100%.Cronbach

salphacoefficientof
Discussion
thesescaleswassatisfactory,rangingfrom0.68to0.78.TheThisstudydescribespsychometrictestingoftheJapanese
convergentcorrelationcoefficientofthescalesforpainwasversionoftheQLQ-HCC18questionnaire,whichisan
0.25,andthescalingsuccessratewas50%.Cronbach

salphaHCC-specificmoduleofEORTCQLQ-C30.Theoverall
coefficientofthisscalewas0.37.resultsshowthatthisquestionnaireisreliableandhas
Theresultsofthedescriptivestatisticsoftheputativeacceptablemeasurementpropertiesforusewiththe
scales/singleitemsandtest-retestreliabilityontheques-QLQ-C30toassesshealth-relatedQOLinJapanese
tionnaireareshowninTable4.Theintra-classcorrelationpatientswithHCC.
coefficientsofthescalesvariedbetween0.67and0.88.AssessmentofQOLincancerpatientsisoptimallyper-
Ninety-fourpercentofthepatientsanswered

notatall

toformedwithacombinationofagenericquestionnaireand
item36,whichaskedpatientswhethertheywereconcernedadisease-specificquestionnairetoensurethatcommon
bytheirskinoreyesbeingyellow.Responsestoitem48,problemsareuniformlydetectedandreportedaswellas
whichaskedaboutsexualfunction,weremissinginsevenspecificissuesrelatedtodiseasesiteandtreatment.This
patients(3.6%).frameworkforQOLassessmenthasbeenadoptedand
ResultsoftheknowngroupcomparisonsareshowninpopularizedbytheEORTCQualityofLifeGroupandthe
Table5.Patientswithpoorerperformancestatus(KPSofFunctionalAssessmentofChronicIllnessTherapy

7.5055.00.29

0.290.32
0.320.35
0.240.14

Table2Item-scalecorrelationsformulti-traitscalinganalysesoftheEORTCQLQ-HCC18
HypothesizedscalesoftheEORTCQLQ-HCC18

ItemFatigueNutritionPainFever
Fatigue
Item46Haveyoubeenlessactivethanyouwouldliketobe?0.68

Item45Haveyoufounditdifficulttokeepgoingortofinishthingsyoustarted?0.75

†Item47Haveyouneededtosleepduringtheday?0.44
Nutrition
Item31Didyoufeelthirsty?
Item32Haveyouhadproblemswithyoursenseoftaste?
Item42Haveyouworriedaboutgettingenoughnourishment?
Item43Haveyoufeltfulluptooquicklyafterbeginningtoeat?
Item44Haveyouworriedaboutyourweightbeingtoolow?
PaniItem38Haveyouhadpaininyourshoulder?
Item39Haveyouhadabdominalpain?
evFerItem40Haveyouhadfevers?
Item41Haveyouhadchills?
Correlationsmarked

werecorrectedforoverlap.

0.420.300.450.4802.1

002.390.

40.3.203

†500.†0.50†.540†04.4†30.2

01.5480.

0.461.30

0.300.23
0.180.18
0.310.51
0.300.27
0.040.28

0.25

0.11
0.25

0.36

0.270.52

0.190.52

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Table3ConvergentanddiscriminantvalidityandinternalconsistencyreliabilityfortheEORTCQLQ-HCC18
ScaleNo.ofitemsperConvergentvalidityDiscriminativevalidityScaling

Scalingsu
{
ccessInternalconsistencyreliability
scale(rangeofcorrelations)(rangeofcorrelations)successrate(Cronbach

s
α
)
Fatigue30.44-0.750.14-0.579/91000.78
Nutrition50.23-0.540.04-0.5113/15870.68
Pain20.250.11-0.483/6500.37
Fever20.520.15-0.466/61000.68
{

Numberofconvergentcorrelationssignificantlyhigherthandiscriminantcorrelationsdividedbytotalnumberofcorrelations.
Scalingsuccessrateisthepreviouscolumnasapercentage.
(FACIT)Organization.Forpatientswithprimaryandsec-
ondarylivertumors,cholangiocarcinomaorpancreatic
Table4DescriptivestatisticsoftheEORTCQLQ-C30and
cancer,theFACITsystemhasdevelopedasinglehepato-
theQLQ-HCC18andtest-retestreliability
biliary-pancreaticmodule[10].TheEORTCQOLGroup
ScaleScore*Intraclasscorrelationcoefficient

has,however,focusedinmoredepthonthespecific
TheQLQ-HCC18
clinicalexperienceswithineachdiseasesiteandtherefore
Scales
{
developedseparatemodulesforpancreatic,primaryand
Fatigue25.6±22.20.82
secondarylivercancer.Theseparatemodulesmaybe
Nutrition12.7±14.10.88
clinicallymoresensitivethanasinglequestionnaire,al-
Pain13.5±17.10.80
thoughthishasnotyetbeenformallyexamined.Asecond
advantageoftheEORTCQLQ-HCC18isthatitprovides
Fever5.3±12.90.67
subscalescoresfordifferentdomainsoffunctioning.
Singleitems
FACT-Hepgeneratesonlyatotalscore,whichmay
BodyImage1(item33)34.0±31.90.73
obscurefindingsinparticularproblemareas.EORTC
BodyImage2(item35)21.1±27.70.70
QLQ-HCC18possessesamulti-dimensionalQOLassess-
Jaundice1(item36)2.77±2.450.79
mentthatmaybemoreusefulforclinicianstodirectther-
apy.AfinaladvantageoftheEORTCQLQmoduleisthatit
Jaundice2(item37)22.2±27.40.82
wasspecificallydevelopedforuseininternationaltrials;a
AbdominalSwelling15.8±23.60.78
largedatabasewillsoonbeavailabletofacilitatecompari-
}‖SexualInterest12.6±25.20.77
sonsacrossstudies,andthereissomeassuranceofcross-
TheQLQ-C30
culturalsuitability.
Scales
Inthisstudy,wetestedthereliabilityandvalidity,includ-
Physical
}
84.9±16.9-
inginternalconsistencyreliability,test-retestreliability,
Role
}
84.1±22.3-
convergentanddiscriminantvalidity,knowngroupcom-
}
parison,oftheJapaneseversionofQLQ-HCC18.Inthe
Cognitive84.2±17.0-
descriptivestatisticsandfrequencyanalyses,theitemasses-
}Emotional79.6±20.5-
singproblemsrelatedtojaundiceshowedlowscores.This
Social
}
86.1±20.6-
wasbecausefewpatientswerejaundicedatthetimeofthe
GlobalQOL
}
66.5±21.63-
datacollection.Inaddition,becausetheJapanesebelongto
Fatigue
{
30.9±21.5-
aracewithayellowishskincomplexion,jaundicetendsto
Nausea/Vomiting
{
1.74±6.4-
bemasked.Theresultsofmulti-traitscalinganalyses
{
(convergentanddiscriminantvalidity),hadagoodscaling
Pain12.8±20.6-
successrateandacceptableCronbach

salpha(internal
{Singleitems
consistencyreliability)exceptforthescaleforpain,which
Dyspnea15.8±21.6-
hadalowscalingsuccessrateandalowCronbach

salpha.
SleepDisturbance21.5±27.5-
Onereasonforthismaybebecauseshoulderandabdom-
AppetiteLoss12.7±22.5-
inalpainarenotnecessarilyrelatedsymptomsthatoccur
Constipation14.2±23.9-
simultaneously.Furthermore,althoughpainscaleshave
beencreatedinanticipationofpaincausedbycancertreat-
Diarrhea7.81±16.4-
mentandprogression,fewpatientshadadvancedcancer.
FinancialImpact14.6±23.3-
Thenutritionscalehadahighrateofsuccess.However,the
Datawereexpressedasmean±stan
{
darddeviation.*Scorerange0to1
}
00.

convergentvalidityoftheitemtermed

concernaboutlow
Datawereassessedin130patie

nts.HigherscoreindicateslowerQO
}
L.Data
weight

wasbelowthestandardvalue.Thenutritionscale
wereassessedin185patients.Datawereassessedin127patients.Higher
scoreindicateshigherQOL.
wasassumedtoinvolveproblemscausedbyimpairedliver

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††21.0±17.8
10.8±11.4
11.6±15.7
4.3±10.2

54.7±25.9
24.9±22.0
25.6±20.7
11.5±23.0

<
0.00122.0±20.432.7±24.1
<
0.00110.9±12.016.2±17.1
0.00312.3±17.215.9±16.8
0.0033.5±9.18.7±17.7

Page6of7

t-test
pavule

1000.00.20.17020.

01.0403.00.220.0004.00.03

Table5Knowngroupcomparisonofdifferencesinmeanscoresofscalesanditems
KarnofskyPerformancestatusscoreChild-Pughgrade
100-80
<
80t-testABandC
n=166n=26pvaluen=127n=65
Scales
Fatigue
Nutrition
PianFerveSingleitems
BodyImage1(item33)30.7±29.655.1±38.80.00429.7±30.342.6±33.6
BodyImage2(item35)19.5±26.532.1±33.30.0319.7±25.324.1±32.0
Jaundice1(item36)1.2±6.212.8±28.40.040.8±5.16.7±19.7
Jaundice2(item37)17.7±23.451.3±33.0
<
0.00116.5±23.733.3±30.6
Abdominalswelling14.1±21.227.0±34.00.0713.1±21.521.0±26.7
Sexualinterest12.0±24.1
{
16.7±31.60.479.3±21.1
}
19.0±30.9

Datawereexpressedasmean±standarddeviationunlessotherwisespecified.*p
<
0.05,

HigherscoreindicatesworseQOL
{
missingin7,
}
missingin5,

missingin2.
function,butitemsregardingweightlossmayalsohaveconfirmedgoodcorrelationsbetweenthegroupsformost
beenaffectedbycancerprogression.Patientsincludedinscales/singleitemsinthetwoquestionnaires(QLQ-HCC18
theoriginalarticleandpatientsinthisstudyhadalmostandFACT-Hep).However,correlationsbetweenitemsof
identicalliverfunction,buttheextentofcancerprogressionweightloss,appetite,andactivityinFACT-Hepandcorre-
differed,andmanyofourpatientshadcancerthatwasspondingscalesinQLQ-HCC18werelow.Thismayhave
detectedatanearlierstage.Theresultsoftest-retestreliabil-occurredbecauseofthereversescoringusedinappetite
ityshowedgoodintra-classcorrelationcoefficientsformostandactivityitemsinFACT-Hepwhichmayhaveledto
scales.Resultsofknowngroupcomparisonsshowedthatconfusion.
themodulehadtheabilitytoassessdifferencesbetweenWhiletheresultsshowtheJapaneseversionofEORTC
groupswithdifferentclinicalcharacteristicsinalmostallofQLQ-HCC18isareliableinstrument,somecautionis
thescales,showingthemodulehasclinicalvalidity.Wenecessary.First,theseresultsontheQLQ-HCC18are
Table6Pearson

scorrelationcoefficientsbetweenscalesintheQLQ-HCC18andtheFACT-Hep
TheFACT-Hep
TheAbdominalWeightAppetite

AppearanceFatigueActivity

JaundiceFeverItchingTasteChillThirstyAbdominal
QLQ-HCC18SwellingLossPain
Fatigue0.330.260.20.42*
0.59*0.26
0.260.30.43*0.320.170.370.42*
BodyImage10.31
0.32

1.7
0.46*

0.080.170.30.30.250.250.230.450.38
(item33)
BodyImage2
0.39
0.01

0.05
0.4*
0.10.070.180.310.20.30.120.230.47
(item35)
Jaundice10.250.19

0.070.2

0.130.73
0.53*
0.30.120.180.560.280.3
(item36)
Jaundice20.250.05

0.050.310.45

0.010.180.28
0.83*
0.330.260.350.37
(item37)
Nutrition0.32
0.340.31
0.320.380.230.310.280.26
0.44*
0.23
0.68*
0.33
Pain
0.32
0.110.140.280.320.140.210.260.340.150.20.3
0.40*
Fever0.250.260.130.180.250.090.29
0.72*
0.350.18
0.61*
0.220.27
Abdominal
0.43*
0.070.030.160.290.060.230.30.30.150.280.240.42*
Swelling
SexualInterest0.260.14

0.060.250.240.080.060.120.120.060.120.130.24

{*indicatesPearson

scorrelationcoefficientlargerthan0.4,
_
Underlineindicatesapairofscalesthatshouldcorrelatetheoretically,

Reversescoring,
{
Datawere
assessedin185patients.

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

preliminaryasthisstudywasperformedinasingleinsti-
tutionusingtheJapaneseversion,fewpatientswithse-
verecirrhosisoradvanceddiseasewererecruited,andno
patienthadundergonelivertransplantation,whichmay
limitthegeneralizabilityofthefindings.
Second,thisstudydidnotaddresslongitudinalconstruct
validityandresponsivenessforclinicalvalidity.Infuture
work,theJapaneseversionofEORTCQLQ-HCC18should
beperformedinmulticenterfacilitiestoconfirmthe
generalizabilityofthefindingsandtoincreasethenumber
oflivertransplantationgroupsandmoreseverelyillpatients.
Furthermore,testingthesensitivityoftheinstrumentto
changesovertimeisneededtoevaluatetreatmenteffects.
Therearecurrentlyavarietyoftreatmentoptionsfor
patientswithHCC.MoleculartargetedtherapyforHCC
hasrecentlybeenintroduced[16],andthiswillleadto
increaseddemandforevaluatingtheQOLinmoredetail.
Inaddition,JapanesepatientswithHCCareolderthan
inothercountries,whichmaketheJapaneseversionof
QLQ-HCC18particularlyvaluablebecausetreatment
effectsonQOLaremoreimportantinolderpatients.
Conclusion
ThisstudyshowedthattheJapaneseversionoftheEORTC
QLQ-HCC18demonstratedevidenceforthemeasurement
propertiesofthequestionnaire.Theseresultssuggestthatit
wouldbeareliableinstrumentformeasuringQOLin
patientswithHCCinJapan.
Abbreviations
QOL:QualityofLife;EORTC:EuropeanOrganisationforResearchandTreatment
ofCancer;QLQ:Qualityoflifequestionnaire;HCC:Hepatocellularcarcinoma;
KPS:TheKarnofskyPerformanceStatus;RFA:Radiofrequencyablation.
Competinginterests
Theauthorsdeclarethattheyhavenocompetinginterests.
Acknowledgment
ThisstudyconductedasapartofaprojecttoimprovetheHRQOLofHCCpatients,
supportedbytheMinistryofHealth,LaborandWelfareofJapan.Wethankthose
whohelpedcollectingdata,TadashiGoto,ShuichiroShiina,YoshifumiBeck,Junichi
Arita,YoshihiroMise,andallthepatientswhoparticipatedinthisstudy.
Financialsupport
ThisstudywassupportedbyaresearchgroupfundedbytheMinistryof
Health,LabourandWelfare,Japan.
Authordetails
1
DepartmentofAdultNursing,DivisionofHealthSciencesandNursing,
GraduateSchoolofMedicine,TheUniversityofTokyo,7-3-1Hongo,Bunkyo-
ku,Tokyo113-0033,Japan.
2
DepartmentofGastroenterology,TheUniversity
ofTokyo,7-3-1Hongo,Bunkyo-ku,Tokyo113-0033,Japan.
3
Surgicalresearch
unit,SchoolofSocialandCommunityMedicine,UniversityofBristol,
CanyngeHall,39WhatleyRoad,BristolBS82PS,UK.
4
DepartmentofSurgery,
Hepato-Bilialy-PancreaticSurgeryDivision,ArtificialOrganandTransplantation
Division,TheUniversityofTokyo,7-3-1Hongo,Bunkyo-ku,Tokyo113-0033,
Japan.
Authors

contributions
NM,TS,MT,RT,JMB,NKandKKconceptualizedtherationaleanddesignofthe
study.NM,TS,MT,RT,JMBandKKconductedscaledevelopment.NMandTS
presentedthisstudytopatientsandcollecteddata.NM,TS,MT,RT,JMBandKK

Page7of7

conductedstatisticalanalysesandinterpretedthedata.NM,RT,JMBdraftedthe
manuscript.Allauthorsreadandapprovedthefinalmanuscript.
Received:4December2011Accepted:31May2012
Published:31May2012
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