Page 50 - Demo

48Chapter2ADDITIONALINFORMATIONNo specific funding support wasused for thisproject The authorshaveno conflictsofinterestrelevanttothisarticletodisclose ThestudywasreviewedbytheEthicsCommitteeonthebasisoftheDutchCodeofConductforHealthResearchtheDutchCodeofConductforResponsibleUsetheDutchPersonalDataProtectionActandtheMedicalTreatmentAgreementAct(FilenumberCMO2018-4935)ThisstudydidnotfallwithintheremitoftheMedicalResearchInvolvingHumanSubjectsAct(WMO)TheEthicsCommitteepassedapositivejudgementonthestudy WrittenpatientconsentwasobtainedAPPENDIXTheobliquediameterdifferenceindex(ODDI)andcranialproportionindex(CPI)describedintheplagiocephalometrymethodbyvan Vlimmerenetalwasusedinthisstudytoexcludeasymmetricalcranialshapes1Thegeneralexclusioncriteriapresentedin thatstudy wereapplicable forsoft tissueonlyHowever,since thesofttissue(CT-ST)shapesinthisstudyweremoreproneforartefactsthehardtissue(CT-HT) shapes wereinsteadused to determine exclusionBecauseit was expectedthat theeffectof ODDIand CPIcanbestructurallydifferent whenmeasuredon CTHT,acorrelationandoffsetfactorbetweentheartefact-freeCT-STandCT-HTwascalculatedfortheODDIandCPImeasurementsIntotal97CT-scanswereusedtodeterminetheODDIandCPIonboththeCT-HTandtheCT-STshapesandapossiblecorrelationandoffsetwasinvestigatedThemeanODDIwas1031(SD=23)fortheCT-HTscansand1028(SD=22)forthecorrespondingCT-STscansThepairedcorrelationshowedastatisticallysignificant(p<0001)andstrongpositivecorrelationforboththeODDI(r=0968)andCPI(r=0984)TherewasastatisticallysignificantaveragedifferencefortheODDI(t96=4456p<0001)butnostatisticalsignificantaveragedifferencefortheCPI(t96=1961p=0053) ThereforeonlyanoffsetfortheODDIwasappliedwhichwasbasedonthedifferenceofthemean(+03)ThisresultedinanewODDIof1048andaCPIof90tobeusedasacut-offfortheCT-HTscansSupplementarymaterialrelatedtothisarticlecanbefoundintheonlineversionatdoihttps//doiorg/101016/jijom201910012