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1 Preprint: Please note that this article has not completed peer review. Measurement properties of the Musculoskeletal Health Questionnaire (MSK-HQ): a between country comparison CURRENT STATUS: UNDER REVIEW David Høyrup Christiansen [email protected]Corresponding Author ORCiD: https://orcid.org/0000-0001-7458-3921 Gareth McCray Institite for Primary Care and Health Sciences, Keele University Trine Nøhr Winding Deparment of Occupational Medicine, Danish Ramazzini Centre, University Clinic, Herning Johan Hviid Andersen Deparment of Occupational Medicine, Danish Ramazzini Centre, University Clinic, Herning Kent Jacob Nielsen Deparment of Occupational Medicine, Danish Ramazzini Centre, University Clinic, Herning Sven Karstens Deparment of Computer Science;Therapeutic Sciences,Trier University Jonathan C Hill Institute for Primary Care and Health Sciences, Keele University DOI: 10.21203/rs.2.19546/v2 SUBJECT AREAS Health Economics & Outcomes Research KEYWORDS patient reported outcomes, usability, psychometrics, responsiveness, interpretability

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Page 1: Measurement properties of the Musculoskeletal Health ... · symptoms, functional ability and quality of life, and are typically administered via questionnaire. A wide range of questionnaires

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Preprint:Pleasenotethatthisarticlehasnotcompletedpeerreview.

MeasurementpropertiesoftheMusculoskeletalHealthQuestionnaire(MSK-HQ):abetweencountrycomparisonCURRENTSTATUS:UNDERREVIEW

DavidHøyrupChristiansen

[email protected]:https://orcid.org/0000-0001-7458-3921

GarethMcCrayInstititeforPrimaryCareandHealthSciences,KeeleUniversity

TrineNøhrWindingDeparmentofOccupationalMedicine,DanishRamazziniCentre,UniversityClinic,Herning

JohanHviidAndersenDeparmentofOccupationalMedicine,DanishRamazziniCentre,UniversityClinic,Herning

KentJacobNielsenDeparmentofOccupationalMedicine,DanishRamazziniCentre,UniversityClinic,Herning

SvenKarstensDeparmentofComputerScience;TherapeuticSciences,TrierUniversity

JonathanCHillInstituteforPrimaryCareandHealthSciences,KeeleUniversity

DOI:10.21203/rs.2.19546/v2

SUBJECTAREASHealthEconomics&OutcomesResearch

KEYWORDSpatientreportedoutcomes,usability,psychometrics,responsiveness,interpretability

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AbstractBackground:TheMusculoskeletalHealthQuestionnaire(MSK-HQ)hasbeendevelopedtomeasure

musculoskeletalhealthstatusacrossmusculoskeletalconditionsandsettings.However,theMSK-HQ

needstobefurtherevaluatedacrosssettingsanddifferentlanguages.

Objective:Theobjectiveofthestudywastoevaluateandcomparemeasurementpropertiesofthe

MSK-HQacrossDanish(DK)andEnglish(UK)cohortsofpatientsfromprimarycarephysiotherapy

serviceswithmusculoskeletalpain.

Methods:MSK-HQwastranslatedintoDanishaccordingtointernationalguidelines.Measurement

invariancewasassessedbydifferentialitemfunctioning(DIF)analyses.Test-retestreliability,

measurementerror,responsivenessandminimalclinicallyimportantchange(MCIC)wereevaluated

andcomparedbetweenDK(n=153)andUK(n=166)cohorts.

Results:TheDanishversiondemonstratedacceptablefaceandconstructvalidity.Outofthe14MSK-

HQitems,threeitemsshowedDIFforlanguage(pain/stiffnessatnight,understandingconditionand

confidenceinmanagingsymptoms)andthreeitemsshowedDIFforpainlocation(walking,

washing/dressingandphysicalactivitylevels).IntraclassCorrelationCoefficientsfortest-retestwere

0.86(95%CI0.81to0.91)forDKcohortand0.77(95%CI0.49to0.90)fortheUKcohort.The

systematicmeasurementerrorwas1.6and3.9pointsfortheDKandUKcohortsrespectively,with

randommeasurementerrorbeing8.6and9.9points.Receiveroperatingcharacteristic(ROC)curves

ofthechangescoresagainstpatients’ownjudgmentat3monthsexceeded0.70inbothcohorts.

AbsoluteandrelativeMCICestimateswere8-10pointsand26%fortheDKcohortand6-8pointsand

29%fortheUKcohort.

Conclusions:ThemeasurementpropertiesofMSK-HQwereacceptableacrosscountries,butseem

moresuitedforgroupthanindividuallevelevaluation.Researchersandcliniciansshouldbeaware

thatsomediscrepancyexitsandshouldtaketheobservedmeasurementerrorintoaccountwhen

evaluatingchangeinscoresovertime.

BackgroundPaininmusclesandjointsisoneoftheWesternWorld’schiefpublichealthconcernsandaleading

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causeofreducedfunctionalandworkingcapacity[1].Inordertodevelopeffectivetreatments,andto

evaluatetheireffects,reliableandvalidmeasurementtoolsareessential.Thehealth-related

consequencesofmusculoskeletaldisorders,suchasbackandkneepain,canrarelybeidentifiedor

measuredusingdiagnosticimagingorotherobjectivemeasurementmethods[2-5].Therefore,patient

reportedoutcomesmeasures(PROMs)areincreasinglyusedtosupporttheassessment,treatment

andmonitoringofpersonswithmusculoskeletaldisorders[6].PROMsrevealaperson’sperceived

symptoms,functionalabilityandqualityoflife,andaretypicallyadministeredviaquestionnaire.A

widerangeofquestionnairesformusculoskeletaldisordershavebeendeveloped.However,these

questionnairesaretypicallylimitedtospecificpartsofthebody,e.g.painintheshoulderandarm[7],

neckandback[8,9],hipandknee[10].Although,region-specificquestionnairesinspecificpatient

populationandclinicaltrialsservesitspurposewell,theycanoftenbedifficulttoadministratefor

healthcareprofessionals(e.g.generalpractitionersandphysiotherapists)inprimarycare,whosee

patientswithdiversemusculoskeletaldisorders,oftenpresentingwithconcurrentpainfromseveral

locations[11].Although,moregeneralmusculoskeletalquestionnairesexist[12,13],theseare

relativelycomprehensiveinlengthandthereforelesssuitedtoevaluatechangesovertime,because

oftheburdenofadministrationandpatientcompletionatmultipletimepoints.Inaddition,someonly

coverasmallnumberofhealth-relateddomains(e.g.painandfunction)[13],andtherebymaynotbe

sensitivetothemultidimensionalityoftreatmenttargetsinherentinmanagingmusculoskeletal

disorders.

Asaconsequence,VersusArthritis(https://www.versusarthritis.org)fundedcollaborationbetweenthe

universitiesofOxfordandKeeletodeveloptheMusculoskeletalHealthQuestionnaire(MSK-HQ)in

2012[14].TheMSK-HQaimstocapturepatientandclinicianprioritisedkeyoutcomesacrossarange

ofmusculoskeletalconditions.Theinstrumentconsistsof14itemsandcoversanumberofhealth-

relateddomains,includingsymptoms,physicalfunctioning,dailyactivitiesandwork,physicalwell-

being,confidencetomanagesymptoms,conditionunderstandingandsocialactivities.Eachitemon

theMSK-HQisansweredona5-pointverbalratingscale(responsescodedfrom‘notatall’=4to

‘extremely’=0,exceptforitems12‘understandingcondition’and13‘confidenceinmanaging

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symptoms’,whichhavetheresponseoptionsinthereverseorder).Scoresaresummed,rangingfrom

0to56,where56isthebestpossiblestateofmusculoskeletalhealth.Therelativelybriefformat

makestheMSK-HQmoresuitabletomonitorandcomparemusculoskeletalhealthstatusacross

variousconditionsandthroughouttheclinicalpathway.TheoriginalversionoftheMSK-HQhas

demonstratedhighcompletionrates,goodtest-retestreliabilityandstrongconvergentvaliditywith

referencestandardsinfourdifferentMSKcohorts[14].However,aquestionnaire’susabilityand

measurementpropertiescannotnecessarilybetransferredtoothercountries,languagesand

healthcaresystems[15-17].Therefore,carefultranslation,cross-culturaladaptation,testingand

validationarenecessaryinordertotakeaccountanyculturalandcomprehensibility-related

differencesbetweenthecountries.Although,cross-culturaladaptationandwithincountryevaluation

oftenareperformedwithPROMs,assessmentofmeasurementinvariancewithrespecttolanguage

andpatientscharacteristics,aswellasdirectcomparisonofmeasurementpropertiesacrosscountries

arelessfrequent.Theobjectivesofthepresentstudywereto1)translateandcross-culturaladapt

theMSK-HQforuseinaDanish-speakingpopulation,and2)evaluateandcomparemeasurement

propertiesoftheMSK-HQacrossDanish(DK)andEnglish(UK)cohortsofpatientsconsultingprimary

carephysiotherapyserviceswithmusculoskeletalpain.

MethodsTranslationandcross-culturaladaptation

WetranslatedtheMSK-HQintoDanishinaccordancewithinternationalstandards[18].Thiswas

doneinclosecollaborationwiththelicenseholderoftheMSK-HQquestionnaire,OxfordUniversity

InnovationLtd(http://innovation.ox.ac.uk)andarepresentativeoftheresearchgroup,whodeveloped

thequestionnaire(JCH).AprofessionalEnglishlanguagetranslatorspecialisinginmedicaltranslation

andabilingualphysiotherapist,bothDanishnativespeakers,translatedthequestionnairefrom

EnglishintoDanish.Subsequently,theirtranslationswerecomparedataconsensusmeetinginthe

projectgroupwithparticipationofbothtranslators.AprofessionalnativeEnglish-speakingtranslator

back-translatedthequestionnairefromDanishintoEnglish,withoutanypriorknowledgeofthe

originalversion.Theback-translationwascomparedtotheoriginalversion.Afterwards,the

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translationreportwasreviewedbyJCHandapproved.Finally,weperformedcognitivedebriefing

interviewswith13patientswithmusculoskeletaldisordersrecruitedinonephysiotherapyclinicinthe

CentralDenmarkRegion.Theresultsofthecognitivedebriefingwerepresentedandreviewedinthe

projectgroupandthefinalversionofthequestionnairewascompleted.

Designandstudypopulations

Thestudywasaprospectivecomparativestudyencompassingtwoconsecutivelyrecruitedcohortsof

patientswithmusculoskeletaldisordersinprimaryphysiotherapypracticeinDKandUK.

DKcohort

Participants

Consecutiveadult(≥18years)consultersreferredtophysiotherapywithamusculoskeletaldisorder

wereinvitedtoparticipateinsixphysiotherapy(PT)clinicsintheCentralDenmarkRegion.

ParticipantshadtobeabletounderstandandspeakDanishwellenoughtocompletequestionnaires,

withnofurtherinclusioncriteriaapplied.IntheperiodJanuary-July2017atotalof180patients

agreedtoparticipate,ofwhom27wereexcludeddueto‘noshow’/cancelations(n=9),withdrawal

(n=5),otherdiagnosisthanmusculoskeletal(n=2),otherreasons(n=4)ordidnotcompletebaseline

questionnaire(n=7),leaving153patientsforanalysis.

Datacollection

Atfirstcontact,thepatientwasinformedabouttheproject.Ifthepatientagreedtoparticipate,ane-

mailwithalinktoanelectronicquestionnairewassenttothepatient(baseline).Thequestionnaire

includedtheDanishversionsoftheMSK-HQ,thegenericEQ-5D-5L[19-21]andvalidatedreference

standardmeasuresdependingonthepainregionfromwhichthepatient’smainproblemoriginated;

ShortenedDisabilitiesoftheArm,ShoulderandHand(Q-DASH)[22,23],NeckandBackdisability

Indexes(ODIandNDI)[24-26],Pain,stiffnessandfunctionmodulesofKneeinjuryandHipDisability

OsteoarthritisOutcomeScores(KOOSandHOOS)[27-29].AnappointmentwasmadeforafirstPT

consultation(test-retest)5-7dayslater.Immediatelybeforethisappointment,thepatientoncemore

completedthequestionnaire.Follow-upquestionnairesweresentaftersixand12weeksbye-mail.In

addition,inretestandfollow-upquestionnaires,patientswereaskedtoratetheoverallchangein

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theirconditionona7-pointscale(muchbetter,better,slightlybetter,unchanged,slightlyworse,

worse,muchworse).Atotalof134patients(88%)completedthetest-retestquestionnaire(median

timeinterval6days[Interquartilerange3-8days]).Follow-upquestionnaireswerecompletedby118

patients(77%)atsixweeksand128patients(84%)at12weeks.ForcomparisonwiththeUKcohort

onlytheresultsofthe12-weekfollow-upareincludedinthepresentstudy.

UKcohort

Participants

TheUKcohortwasdrawnfromtheprimarycarephysiotherapysampleusedastheoriginalvalidation

cohortfortheMSK-HQ.Thedetailsofmaterialsandmethodshavepreviouslybeendescribed

elsewhere[14].Briefly,thecohortincluded210consecutiveconsultersincommunitymusculoskeletal

physiotherapyclinicsinfiveUKWest-Midlandstowns.Ofthose166(78%)withtest-retestdatawere

availableforthepresentstudy.

Datacollection

ParticipantscompletedtheEnglishpaperversionoftheMSK-HQandtheEQ-5D-5Lindexbeforethe

startoftreatmentatthefirstclinicvisit(baseline)andagainatthesecondvisit,typically2weeks

later(test–retest).Follow-upquestionnaireswerecompletedat12weeksby133(80%)patients.A

transitionquestiononoverallchangeintheconditionona5-pointscale(muchbetter,slightlybetter,

unchanged,slightlyworse,muchworse)wascompletedbypatientsattest-retestand12-weekfollow-

up.

Statisticalanalysis

Descriptivestatistics

Descriptivestatisticswerecalculatedforallvariablesandcomparedbetweenthetwocohorts.Sum

scoreswerecalculatedatalltimepointsandrawscoreswerecalculatedifnomorethan

3itemsweremissingintherespectivescore;otherwise,thescorewasleftmissing.Possiblefloorand

ceilingeffectswereexaminedandsucheffectswereconsideredtobepresentifmorethan15%ofthe

respondentsachievedthehighestorthelowestsumscore,respectively.

Constructvalidity

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AsnoreferencestandardmeasureswerecollectedfortheUKprimarycarecohort[14],weonly

assessedconstructconvergentvalidityfortheDanishversionoftheMSK-HQ.Thiswasdoneby

correlationanalysesbetweentheMSK-HQscoresandtherelevantreferencestandardmeasures

scoresatbaseline(Q-DASH,ODI,NDIandWOMACscorescalculatedfromKOOSandHOOS).Likewise

longitudinalconvergentvaliditywasassessedbycorrelationanalysesbetweenMSK-HQandreference

standardmeasureschangescoresatthreemonths.Basedonfindingsfromtheoriginalvalidation

studyoftheMSK-HQ[14]andpreviousliteratureofhealthoutcomeresearch[30-32],weexpected

correlationsbetweenMSK-HQandrelevantreferencestandardmeasurestobeatmoderatetostrong

(r=≥0.5).

Cross-culturalvalidityandmeasurementinvariance

Measurementinvarianceaccordingtolanguage,categoriesofage,painsite,durationofpain,and

workstatus,wasassessedbyDifferentialitemfunctioning(DIF)analysisofbaselineratingsofthetwo

cohorts.DIFistheassessmentoftheextenttowhichitemsfunctiondifferentlybetweenvarious

groups,whenthescoresamongthosegroupsarecorrectedfor.UniformdichotomousDIFontheraw

scoreswasassessedinthispaperviatheMantel-Haenszel(MH)statisticcalculatedintheR3.4.1[33]

packagedifR[34].Itempurificationwasusedandadjustmentformultiplecomparisonswasmadevia

Holm’smethod.TheassessmentoftheeffectsizefortheDIFwasmadeontheETSDeltascaleforthe

dichotomouscategories(i.e.,country,duration,workstatus)[35].NotethatMSK-HQitemswere

dichotomisedsuchthatthetwolowerimpactcategories(‘notatall’and‘slightly/rarely’)opposedthe

threehigherimpactcategories.Furthermore,fortheassessmentofpainlocation,‘neck’was

collapsedwith‘back’asthereweretoofewinstancesofneckpaintocalculatetheMHstatistic

robustly.

Measurementerrorandreliability

Astest-retestwasadministereddifferentlyinthetwocohortswithrespecttotimeintervaland

initiationoftreatment,werestrictedtheanalysistopatientswhoreportedtheirconditiontobe

‘stable’betweenadministrations.SystematicmeasurementerrorbetweenMSK-HQscoresatbaseline

andretestwasanalysedbyBland-Altmanplotandpairedt-testfortheDKandUKcohorts.Further

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randomerrorswereestimatedbystandarderrorofmeasurement(SEM)andminimaldetectable

change(MDC=1.96×√2×SEM)wascalculated.Cronbach’salphawascalculatedtoassessinternal

consistency.Theintraclasscorrelationcoefficient(ICC2.1)wasusedtoassesstest-retestreliability,

andforsingleitemsCohen’sKappawithquadraticweightswasused.Confidenceintervals(95%CI)

forKappavalueswereobtainedusingnon-parametricbootstrapmethods(1000replications).

Sensitivitytochange,responsivenessandinterpretability

ToevaluatesensitivitytochangeMSK-HQchangescoresfrombaselinetothreemonthsandeffect-

sizestatistics(i.e.,meanchange/standarddeviationatbaseline)werecalculatedandcompared

betweenthetwocohorts.ForresponsivenesstheMSK-HQ'sabilitytodiscriminatebetween

unchangedpatientswascalculatedandcomparedbetweencohortsbyreceiver-operating-

characteristic(ROC)curveanalyseswithlargeimprovement(muchbetter,betterversusalittle

better,unchanged,littleworse)andsmallimprovement(muchbetter,better,littlebetterversus

unchanged),usingthetransitionquestionasexternalanchor.Responsivenesstoworseningwasnot

analysed,asonlyfewpatientsratedtheirconditiontobe‘worse’or‘muchworse’.Minimalclinically

importantchange(MCIC)valueswereestimatedbythePythagoras'Theorem(a^2+b^2=c^2)to

choosethechangescoreclosesttotheupperleft-handcorner,whichbestdiscriminatedbetween

improvedandunchangedpatients[36].AsMCICvaluescanbeaffectedbybaselinescores,analysis

wasrepeatedwithrelativechangescores(i.e.,changescoresexpressedaspercentagesofthe

baselinescores)[37].Finally,asakeyvisonforthedevelopmentoftheMSK-HQwastoproducea

singlemusculoskeletalhealthmeasuresuperiortogenerichealthtools,wecomparedeffectsize

estimatesandareasundertheROCcurvefortheMSK-HQandtheEQ-5Dchangescores[38].The

statisticalpackageSTATAversion15wasused.

ResultsTranslationandcross-culturaladaptation

Inthetranslationprocessafewitemshadtobeslightlyrephrasedandtheresponsecategory

‘severely’waschangedto‘alot’tofittheDanishlanguage.Afewotherissueswereraisedduring

translation.Thetwodifferentconstructs;painandstiffnessusedinitem1anditem2ledtosome

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discussionintheprojectgroup,aswellasthedifferentconstructsinitem12‘understanding

condition’anditem13‘confidenceinmanaging’.However,cognitivedebriefinginterviewswithpilot

patients(fivemalesandeightfemales,32–59yearsofage)withvariousmusculoskeletaldisorders

revealednodifficultieswithrespecttotheabove-mentionedconcerns.Ingeneral,patientsfoundthe

DanishversionoftheMSK-HQeasytocomplete(2-6min)anditemswerewellunderstood,thusno

furtherchangeswereneeded.Patientsdidnotseemtodistinguishbetweenpainandstiffness,and

mostpatientsfoundtheitemsregardingunderstandingtheircondition(item12)andconfidencein

managing(item13)tobeimportant.TheDanishversionoftheMSK-HQisavailableonlicence

request:https://process.innovation.ox.ac.uk/clinical.

Descriptivestatistics

Thepatientcharacteristicsofbothcohortsarepresentedintable1.Thetwocohortswerefairly

similarwithrespecttodistributionofpainsites.ThepatientsintheDKcohortwereslightlyyounger,

includedmorewomen,andhadahigherpercentageofpatientswhowereworking.Nofloororceiling

effectswereobservedatanytimepoint.IntheDanishcohortmissingdatawasreplacedbymean

itemscoresfortwopatientswholefttwoitemsunansweredandtwopatientswholeftthreeitems

unansweredatbaseline,andtwopatientswholeftoneitematretestandfollow-up.FortheUKcohort

meanitemscorewascalculatedfortwopatientsleavingoneitemunanswered.

Constructvalidity

Thecorrelationcoefficients(SpearmanRho)betweentheDanishMSK-HQandrelevantreference

standardmeasureswere0.63(CI,0.38to0.79)fortheQ-DASH,0.71(CI,0.53to0.88)fortheODI,

0.60(CI,0.25to0.81)fortheNDI,andfortheWOMAC0.84(CI,0.73to0.91).Correspondingvalues

forchangescoreswere0.65(CI,0.38to0.82)fortheQ-DASH,0.74(CI,0.54to0.86)fortheODI,0.52

(CI,0.05to0.80)fortheNDI,andfortheWOMAC0.70(CI,0.50to0.83).

Crossculturalvalidityandmeasurementinvariance

Withregardstocountrydifferences,threeitemsshowedstatisticallysignificantlevelsofDIF,allwith

largeeffectsizesaccordingtotheETSDeltascale[35],thesewereitems2(pain/stiffnessatnight;

lowerthanexpectedinUK–MH=8.54,p=0.04),12(understandingcondition;lowerthanexpected

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inDK-MH=11.37,p=0.01),and13(confidenceinmanaging;lowerthanexpectedinDK-MH=

15.21,p=0.001).Withregardstopainlocation,threeitemsshowedstatisticallysignificantlevelsof

DIF,items3,4and5.Item3(walking;hardestforlowerextremities,moderateforback/neckand

easiestforupperextremities-MH=38.71,adj.p<0.001),item4(washing/dressing;harderforupper

extremities,easierforlowerextremitiesandback/neck-MH=11.34,adj.p=0.04),item5(physical

activitylevels;easierforupperextremities,harderforlowerextremitiesandback/neck-MH=14.57,

adj.p=0.01).Withregardstoagegroup,paindurationandworkingstatus,noitemsexhibited

statisticallysignificantDIF.

Measurementerrorandreliability

Of134patientsintheDKcohortand165patientsintheUKcohortwithretestMSK-HQdataavailable,

98and82patientsreportedtheirconditiontobe‘stable’betweenbaselineandretest,respectively

andwerethususedtocalculatethereliabilitystatisticspresentedintable2.Whencomparedtothe

UKcohort,smallersystematicandrandomerrorswereobservedintheDanishcohortandICCvalues

wereslightlyhigher.Internalconsistencywashighforbothcohorts.Themedian(range)weighted

kappawithsquaredweightsacrossthe14itemsfortheDKcohortwas0.69(0.54to0.84)as

comparedto0.67(0.31to0.80)intheUKcohort.Detailsofthetest-retestreliabilityofsingleitemsof

theMSK-HQareavailableinAppendixA.

Sensitivitytochange,responsivenessandinterpretability

At12weeksfortheDKcohortmeanchangescoreswere9.1(95%CI,7.7to10.6);ES1.1(CI0.9to

1.2)fortheMSK-HQandmeanEQ-5D-5Lindexscoreswere0.08(CI,0.06to0.10);ES0.7(CI,0.5to

0.8).ThecorrespondingvaluesfortheUKcohortweremeanscore8.9(CI,7.4to10.5);ES0.9(CI,0.8

to1.1)fortheMSK-HQandfortheEQ-5D-5Lindexmeanscore0.11(CI,0.07to0.14);ES0.5(CI0.3

to0.6).Thecorrelations(SpearmanRho)betweenthetransitionquestionofchangeinmaincomplaint

andMSK-HQchangescoreswere-0.66(CI,-0.75to-0.55)and-0.54(CI,-0.65to-0.40)fortheDKand

UKcohorts,respectively.Table3presentstheROCanalysesandMCICestimatesaccordingtothetwo

cutpointsofpatientperceivedimportantchangeinmaincomplaint.Although,ROCAUCdiffered

betweentheDKandUKcohorts,thesedifferencesdidnotreachstatisticalsignificance.TheMCIC

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estimateforabsolutechangeat12weekswaslargerfortheDKcohort,whereasforthepercentages

ofchangetheoppositewastrue.ThepercentagesreachingtheMCICthresholdfor‘large

improvement’were48%intheDKcohortand47%intheUK-cohort,whereasthecorresponding

valuesfor‘smallimprovements’were57%and56%,respectively.Figure1illustratestheROC

curvesrepresentingchangescoresfortheMSK-HQascomparedtoEQ-5D-5Lindexat12weeks.For

bothcohortstheMSK-HQproducedhigherROCAUCsthantheEQ-5D-5L.FortheDKcohortthe

differencebetweenMSK-HQandEQ-5D-5LROCareasindexreachedborderlinestatisticalsignificance

forbothlargeimprovement(p=0.05)andsmallimprovement(p=0.06).

DiscussionThisisthefirststudytoevaluateandcomparemeasurementpropertiesofthenewMSK-HQtool

acrossdifferentinternationalcohortsofmusculoskeletalpatientsconsultingprimarycare

physiotherapyservices.TheMSK-HQwastranslatedandcross-culturaladaptedtoDanishspeaking

population.TheDanishversionoftheMSK-HQdemonstratedgoodfacevalidityandconstructvalidity

wasconfirmedbymoderatetostrongcorrelationswithrelevantreferencestandardmeasures.Inthe

DIFanalysisthreeitemsdisplayedmeasurementinvarianceforlanguage(pain/stiffnessatnight,

understandingcondition,confidenceinmanaging)andthreeforpainlocation(walking,

washing/dressing,physicalactivitylevels),whereasnodifferenceswereobservedforage,pain

durationandworkingstatus.ForbothcohortstheMSK-HQdemonstratedgoodinternalconsistency,

acceptablelevelsofreliabilityandresponsivenesswithreliabilitycoefficientsandROCestimates

exceeding0.70[15].

Thestudybenefittedfromprospectivelycollecteddataintwocomparablephysiotherapycohortswith

highcompletionratesonquestionnaires.Thestudyhadsomelimitations.Noformalsamplesize

calculationforthepresentstudywasperformed,butasbothcohortsexceededtheCOSMIN

recommendationsofatleast100individualsforquantitativePROMstudies[15],webelievethe

samplesizesofthetwocohortstobeadequate.Itshouldalsobenotedthatdataofthetwocohorts

wascollectedandadministrateddifferently.Thus,onlylimitedpopulationdescriptorsacrossthetwo

cohortswereavailable,withdatabeinglesscompleteinthecomparativeUKcohortforthevariables

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painsiteanddurationofsymptoms.ThequestionnairesintheUKcohortwerepaperbasedwhereas

questionnairesintheDKcohortwerecompletedonline.AsstudiescomparingpaperVs,online

administeredpatient-reportedoutcomemeasuresindicatethesetwoassessmentmethodsarehighly

comparable[39],itisunlikelytohaveaffectedourresults.

Thehighcompletionrate,acceptablefaceandconstructvalidityobservedconfirmedearlierpromising

findingsfromtheinitialvalidationstudy[14].IntermsofreliabilityandmeasurementserrortheDK

versionseemstoperformslightlybetterthantheUKversioninourstudy.Wealsoobserveda

significantlylargersystematicmeasurementerroroftest-retestscoresofMSK-HQfortheUKcohort.

Thesefindingsmay,inpart,beexplainedbydifferencesinstudydesigns.TheDKcohortpatients

completedtest-retestquestionnaireswitha6daysintervalbeforeanytreatmentwasinitiated,

whereaspatientsintheUKcohortcompleteditwithina2weeksinterval.Although,thesedifferences

werelevelledoutbyrestrictingtest-retestanalysisto‘stable’patientsonly,itispossiblethatthe

longertimeintervalcouldhaveresultedinmoreimprovementamong‘stable’patientsintheUK-

cohort.Itcouldbearguedthatrestrictinganalysisto‘stable’patientswouldinevitablyproducelower

MDCestimates,thanif'unstable'patientswereincluded.Howeverinourcase,ifallavailablepatients

hadbeenincludeditwouldonlyhaveincreasedtheMDCestimatebyapproximatelyonepoint(results

notshown),andthereforenothavechangedtheoverallconclusionofthestudy.Anotherlimitationof

thepresentstudywasthatclassificationofimprovedorunchangedpatientswerebasedonasingle

transitionscalequestionasexternalanchor(i.e.improvementinoverallcondition),whichmight

measurevaryingaspectsoftheoutcome[32].Theuseofseveralanchorscoveringdifferentaspects

oftheoutcome(e.g.pain,functionandpatientsatisfaction)mighthaveproducedotherresults.

Furthermore,notethatalternativemethodstoderiveMCICestimatesdoexist[40,41]howeverwe

chosetousetheROCcurvemethodtopreservecomparabilitywithotherstudiesinthefieldand

communicabilitywithreadersunfamiliarwithalternativemethods.

ThreeMSK-HQitemsexhibitedDIFacrosscountries.Item2‘pain/stiffness’atnightwasscoredlower

(i.e.morepain/stiffness)inUKpatientsalthoughnodifferenceswerefoundforthesimilaritem1

‘pain/stiffness’duringtheday.DKpatientshadloweritemscoreswithregardstounderstanding

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conditionandconfidenceinmanaging(item12and13).Thesedifferencesmayeitherimply

translationalproblems,culturaldifferencesortruedifferencesbetweencohorts.Thisshouldbe

furtherinvestigatedthroughqualitativeinquiriestoexplorehowpatientsunderstandandinterpret

thesequestionsacrosscountries.Although,thesetwoitemsweredeemedimportantandrelevantby

patients,theyhavepreviouslyshowntocorrelatepoorlywiththetotalMSK-HQscore[14].Hence,it

couldbediscussedwhethertoincludetheseitemsintheoverallsumscoreortousethesequestions

separatelytofacilitatepatientcommunicationandsharedclinicaldecisionmaking.Thefindingsthat

noMSK-HQitemsdifferedforage,paindurationandworkingstatusaddstotheperviousresultsfrom

thevalidationstudyontheoriginalversion[14].Withregardstopainlocation,thelowerscoresfound

initem3‘walking’forextremitiesandback/neckpatients,whencomparedtoupperextremity

patientswasnotanunexpectedfinding,andseemsinlinewiththeoppositepatternforitem4

‘washing/dressing’.Itcouldbespeculatedthatthehigherscoresfoundforupperextremitiespatients

foritem5‘physicalactivitylevels’,maybeduetoexamplesgiven(goingforawalkorjogging),as

thesedonotincludedphysicalactivitiesrelatedtoupperextremities.Addingridingyourbikeor

playingtennis/golfcouldbeapotentialsolutiontothisdiscrepancybetweenpainsites.

Thedistinctionbetweenformative(i.e.,theitemscausetheconstruct)andreflective(i.e.,the

constructcausesthatwhichismeasuredbytheitems)toolsisnotalwayseasytomakeandtoolscan

exhibitaspectsofbothconceptualframeworks[42].Notethatpreviously,theMSK-HQhadbeen

consideredtobeaformativetoolhoweveronfurtherreflectionwefeelthattoolismuchbetter

characterisedasbeingreflective.ThemeasurementpropertyestimatesobservedfortheMSK-HQin

thepresentstudydidnotdifferfrommostexistingregion-specificPROMs[7,9,10,43]andgeneral

musculoskeletalPROMs[44].ForPROMs,reliabilitycoefficients≥0.7areconsideredadequatefor

groupcomparisons,whereas≥0.9areneededtomonitorindividualpatients[45].Similartomost

musculoskeletalPROMs,theMSK-HQonlyexceedthefirstmentionedthreshold,andtherefore,at

present,maybemostsuitableforgroupevaluation.MDCvaluesformusculoskeletalPROMsare

commonlyreportedtorangefrom10to20%ofthescale,whichisinlinewithourfindingsforthe

MSK-HQ.Toensurethatachangescoreonanindividualpatientlevelisclinicallyrelevant,theMCIC

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shouldbegreaterthan,oratleastequalto,therandommeasurementerror(MDC)ofaninstrument.

ThiswasonlytrueintheDanishcohortofthepresentstudyandforthecut-off-leveloflarge

improvements,makingtheinterpretabilityofsmallchangesofindividualscoresoftheMSK-HQmore

challenging.AsMCICestimatesbasedonrelativescoreswereunaffectedbythecut-offlevelofthe

transitionquestionandrelativescoreshaveshowntobelesssensitivetobaselinescores[37];the

MCICpercentseemsthepreferablechoice.However,bothabsoluteandrelativeMCICvaluesvaried

betweenthetwocohorts.Thesedifferencesmaypartlyberootedintheuseofdifferentscalingof

transitionquestionofmaincomplaint(DKcohort7versus5responsecategories),whereastronger

correlationbetweenthetransitionquestionandMSK-HQchangescoresat12weekswasobserved.On

theotherhandtheproportionexceedingMCICthresholdsbetweentheDKcohortandUKcohortdid

notdiffersubstantially;largeimprovements(48%versus47%)andsmallimprovements(57%versus

55%).TheMSK-HQseemstodiscriminatewellbetweenunchangedandimprovedpatientsacrossthe

twocohorts.AkeyvisionoftheMSK-HQwastoproduceasinglebroadhealth-statusmeasuremore

sensitivetochangethangenerichealthtools.InbothcohortseffectsizesoftheMSK-HQwere

considerablylargerthanthoseoftheEQ-5D-5L,whichindicatessuperiorityoftheMSK-HQ.Whereas

fortheabilityofMSK-HQtodiscriminatebetweenimprovedandunchanged(i.e.responsiveness)a

patientat3months,superioritywasonlyobservedwithrespectintheDanishcohort.

ConclusionInthisstudyweperformedacross-countrycomparisonoftheMSK-HQquestionnaireamong

musculoskeletalpatientsconsultingprimarycarephysiotherapyservices.Although,somediscrepancy

forlanguageandpainsitelocationwasfoundforsingleitems,theMSK-HQgenerallyproduced

comparableresultsacrossthetwocohorts.TheDanishversionoftheMSK-HQappearstooutperform

theoriginalEnglishversionandhasshowntobeareliable,valid,sensitiveandresponsiveinstrument

tocaptureandmonitormusculoskeletalhealthstatus.

AbbreviationsMSK-HQ=TheMusculoskeletalHealthQuestionnaire

PROM=patientreportedoutcome

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DIF=Differentialitemfunctioning

ICC=IntraclassCorrelationCoefficients

SEM=standarderrorofmeasurement

MDC=minimaldetectablechange

MCIC=Minimalclinicallyimportantchange

CI=Confidenceintervals

SD=standarddeviation

DeclarationsEthicsapprovalandconsenttoparticipate

TheDKcohortstudywasapprovedbyTheDanishDataProtectionAgency(Jno.1-16-02-542-16).

AccordingtoDanishlaw,approvalbytheethicscommitteeandwritteninformedconsentwasnot

required.Theeligiblepatientswereprovidedwithinformationaboutthestudyanditspurpose,

includingthatparticipationwasvoluntary.FortheUKcohortethicswasobtainedseparatelyfromthe

UKNHSHealthResearchAuthorityNationalResearchEthicsServiceCommittee(approvalreference:

15/YH/0167and15/WA/0040).

Consentforpublication

Notapplicable.

AvailabilityofDataandMaterials

DKcohortdatacannotbemadepubliclyavailableaccordingtoDanishregulations.Dataarehowever

availablefromtheauthorsuponreasonablerequestandpermissionoftheDanishDataProtection

Agency.FortheUKcohortadditionaldatacanbeaccessedonrequestviatheKeeledatarepository

at:http://www.keele.ac.uk/pchs/publications/datasharingresources/

CompetingInterests

Wedeclarenocompetinginterests

Funding

ThestudywassupportedbythePracticeResearchFoundationofDanishPhysiotherapistsand

ArthritisResearchUK(GrantRef.21405).

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Authors’contribution

Allauthorsplannedanddesignedthestudy.DHCandGMperformedthestatisticalanalyses.DHC

draftedthemanuscript.Allauthorscontributedtointerpretationofdataandcriticalrevisionofthe

manuscript.Allauthorsreadandapprovedthefinalmanuscript.

Acknowledgments

Theauthorsthanktheclinicsthatparticipatedinthedatacollectionofthetwocohortstudiesand

patientsforparticipatinginthem.

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TablesTable1.Patientcharacteristics

VariablesDKcohort(n=153) UKcohort

(n=166)

Painsite

Back 45 (29.4) 47 (28.3)Neck 23 (15.0) 7 (4.2)Upperextremity 38 (24.8) 35 (21.1)Lowerextremity 47 (30.7) 57 (34.3)Other/unknown - - 20 (12.0)

Gender

Woman 97 (63.4) 92 (55.4)Men 56 (36.6) 74 (45.6)

Age

Yearsmean,(SD) 50.4 (13.8) 53.7 (15.7)

Workstatus

Working 96 (62.8) 94 (56.6)Notworking/Subsidedjob 6 (3.9)

7 (4.2)

Notworking/unemployed 14 (9.2)

5 (3.0)

Retired 26 (17.0) 52 (31.1)Onsickleave 11 (7.2) 7 (4.2)

Unknown - - 1 (0.1)

Durationofsymptoms

≤3months 62 (40.5) 77 (47.2)>3months 91 (59.4) 66 (39.8)Unknown - - 23 (13.9)

Baselinescore

MSK-HQ(0to56)mean,(SD) 32.3 (9.2)

30.5 (9.64)

EQ-5D-5Lindex(-0.6to1.0)mean,(SD) 0.69 (0.16)

0.55 (0.25)

Valuesarenumbers(percentages)unlessstatedotherwise.

Abbreviations:SD,standarddeviation

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Table2.MeasurementerrorandreliabilityofMSK-HQscoresfortheDKcohortandtheUKcohort

DK-cohort

(n=98)UK-cohort

(n=82)Measurementerror

MeanDifference(95%CI) 1.6 (0.7to2.5) 3.9 (2.7to5.1)

SEM(95%CI) 3.1 (2.7to3.6) 3.6 (3.1to4.1)

MDC(95%CI) 8.6 (7.6to10.1) 9.9 (8.7to11.3)

Reliability

ICC(95%CI) 0.86 (0.81to0.91) 0.80 (0.50to0.90)

Cronbach’sα(Baseline) 0.88 (0.85to0.91) 0.89 (0.86to0.89)

Abbreviations:CI,Confidenceinterval;SEM,Standarderrorofthemeasurement;MDC,MinimalDetectableChange;

Table3.ROCandMCICestimatesaccordingtopatientperceivedimportantchangeinmaincomplaint

Cutpoints n(%) ROCAUC(95%CI) MCICROCSensitivity/

specificity%

Largeimprovement

DKcohort 64(52.5)0.83(0.75to

0.90) 10 78/81

UKcohort 49(37.1)0.79(0.71to

0.87) 8 78/69

Smallimprovement

DKcohort 87(74.3)0.85(0.77to

0.92) 8 76/80

UKcohort 85(64.9)0.76(0.68to

0.85) 6 71/71

a)Largeimprovement(muchbetter,betterversusalittlebetter,unchanged,littleworse)

b)Smallimprovements(muchbetter,better,littlebetterversusunchanged)

MCICROC:Estimatedastheoptimalcut-offpointoftheROCcurveusingabsolutechangescores.

MCICpercent:Estimatedastheoptimalcut-offpointoftheROCcurveusingrelativechangescores.

Abbreviations:ROC,receiveroperatingcharacteristic;AUC,areaunderthecurve;CI,confidenceinterval.Appendix

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AppendixATest-retestreliabilityofsingleitemsoftheMSK-HQfortheDKandUKcohort

Item QuestionDKcohort(n=98)

UKcohort(n=82)

1 Pain/stiffnessduringtheday 0.73(0.63to0.81) 0.55(0.62to0.84)

2 Pain/stiffnessatnight 0.58(0.48to0.69) 0.68(0.55to0.78)

3 Walking 0.84(0.76to0.90) 0.74(0.62to0.84)

4 Washing/Dressing 0.64(0.44to0.80) 0.66(0.51to0.78)

5 Physicalactivitylevels 0.76(0.66to0.84) 0.69(0.56to0.79)

6 Work/dailyroutine 0.82(0.74to0.88) 0.61(0.48to0.71)

7 Socialactivitiesandhobbies 0.56(0.41to0.68) 0.59(0.43to0.73)

8 Needinghelp 0.78(0.66to0.87) 0.78(0.69to0.85)

9 Sleep 0.75(0.62to0.84) 0.80(0.71to0.87)

10 Fatigueorlowenergy 0.77(0.64to0.85) 0.75(0.63to0.83)

11 Emotionalwell-being 0.57(0.43to0.71) 0.78(0.69to0.85)

12 Understandingcondition 0.54(0.38to0.69) 0.31(0.13to0.48)

13 Confidenceinmanaging 0.58(0.45to0.70) 0.49(0.25to0.69)

14 Overallimpact 0.62(0.47to0.73) 0.58(0.43to0.69)

Valuesareweightedkappawithsquaredweights(95%Confidenceintervals)

Figures

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Figure1

Receiver-operating-characteristic(ROC)curvesrepresentingabsolutechangescoresofthe

MSK-HQandEQ-5D-5LFootnoteValuesareROCareaestimates(95%confidenceintervals).