page 1 of 34 delphi process for core domain set for

34
Page 1 of 34 Core Domain Set for Tendinopathy: Survey Data Delphi process for Core Domain Set for Tendinopathy: Survey data. Context: 1. Synthesising research findings from clinical trials of human tendinopathy is currently difficult for a number of reasons, one of them being a lack of agreed upon core set of outcome measures (that are valid, responsive and feasible). 2. A critical and primary consideration of an outcome measure is that it targets/measures a health domain of the condition (tendinopathy in this case). 3. There are currently no core health domains for tendinopathy that are agreed upon. 4. Once there is an agreed Core Domain Set for Tendinopathy, then the task of agreeing to the outcome measures for each specific tendinopathy can commence. Methods: The development of the Core Domain Set is being developed as per the following process: 1. Literature review of domains and instruments previously used in tendinopathy (note that the instruments/measures used were only included in the survey to help put in context the domain. The survey was not about the measures, but rather the domains) 2. Structured enquiry with stakeholders on their views on domains of importance – survey and then meeting 3. Full participation of all stakeholders (including patients) in a consensus process to determine agreement on what should be – the Core Domain Set Results: The results of the expert survey are shown herein in Table 1 and 2. Table 1 shows the characteristics of the experts responding to the survey. Table 2 reports the % agreement, disagreement and unsure, the comments aligned to these responder levels, followed by a brief overview made by the committee and a proposal for the meeting. In summary, there are two domains that are above the 70% agreement threshold: Pain on Activity or Loading (a rating of pain when the patient is doing an activity or under load) Disability (this is a patient rating of the disability, or ability depending on anchors and wording/orientation, on a multi-item questionnaire) There was one domain that was above the 70% disagreement threshold: Range of Motion There were a number of domains in the 50-70% agreement range, which will need consideration, and they are: Agreement: Function, Patient rating of status, QoL, Physical Function, Sports Participation, Medication use*, Physical Activity*. Disagreement: pain on clinical stress test, sensory modality specificity, pain without specific context. *note that medication use and physical activity were 79% and 86% agreement, respective, in the minimal reporting standards, which will need to be reconciled at the meeting. The issue that comes into consideration is that minimal reporting standards will require valid and feasible measures, which are in common with the outcome measures for the domains. This ought be discussed. In addition, a cohort of patients in Australia were also surveyed on the Domains questionnaire. A summary of the patient responses to the survey is included in Table 3 (pages 33- & 34). Supplementary material Br J Sports Med doi: 10.1136/bjsports-2019-100894 –451. :444 54 2020; Br J Sports Med , et al. Vicenzino B

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Page 1 of 34

CoreDomainSetforTendinopathy:SurveyData

DelphiprocessforCoreDomainSetforTendinopathy:Surveydata.

Context:

1. Synthesisingresearchfindingsfromclinicaltrialsofhumantendinopathyiscurrentlydifficultfora

numberofreasons,oneofthembeingalackofagreeduponcoresetofoutcomemeasures(thatare

valid,responsiveandfeasible).

2. Acriticalandprimaryconsiderationofanoutcomemeasureisthatittargets/measuresahealth

domainofthecondition(tendinopathyinthiscase).

3. Therearecurrentlynocorehealthdomainsfortendinopathythatareagreedupon.

4. OncethereisanagreedCoreDomainSetforTendinopathy,thenthetaskofagreeingtothe

outcomemeasuresforeachspecifictendinopathycancommence.

Methods:

ThedevelopmentoftheCoreDomainSetisbeingdevelopedasperthefollowingprocess:

1. Literaturereviewofdomainsandinstrumentspreviouslyusedintendinopathy(notethatthe

instruments/measuresusedwereonlyincludedinthesurveytohelpputincontextthedomain.The

surveywasnotaboutthemeasures,butratherthedomains)

2. Structuredenquirywithstakeholdersontheirviewsondomainsofimportance–surveyandthen

meeting

3. Fullparticipationofallstakeholders(includingpatients)inaconsensusprocesstodetermine

agreementonwhatshouldbe–theCoreDomainSet

Results:

TheresultsoftheexpertsurveyareshownhereininTable1and2.Table1showsthecharacteristicsof

theexpertsrespondingtothesurvey.Table2reportsthe%agreement,disagreementandunsure,the

commentsalignedtotheseresponderlevels,followedbyabriefoverviewmadebythecommitteeanda

proposalforthemeeting.

Insummary,therearetwodomainsthatareabovethe70%agreementthreshold:

• PainonActivityorLoading(aratingofpainwhenthepatientisdoinganactivityorunderload)

• Disability(thisisapatientratingofthedisability,orabilitydependingonanchorsand

wording/orientation,onamulti-itemquestionnaire)

Therewasonedomainthatwasabovethe70%disagreementthreshold:

• RangeofMotion

Therewereanumberofdomainsinthe50-70%agreementrange,whichwillneedconsideration,and

theyare:

Agreement:Function,Patientratingofstatus,QoL,PhysicalFunction,SportsParticipation,Medication

use*,PhysicalActivity*.

Disagreement:painonclinicalstresstest,sensorymodalityspecificity,painwithoutspecificcontext.

*notethatmedicationuseandphysicalactivitywere79%and86%agreement,respective,intheminimal

reportingstandards,whichwillneedtobereconciledatthemeeting.Theissuethatcomesintoconsiderationis

thatminimalreportingstandardswillrequirevalidandfeasiblemeasures,whichareincommonwiththeoutcome

measuresforthedomains.Thisoughtbediscussed.

Inaddition,acohortofpatientsinAustraliawerealsosurveyedontheDomainsquestionnaire.A

summaryofthepatientresponsestothesurveyisincludedinTable3(pages33-&34).

Supplementary material Br J Sports Med

doi: 10.1136/bjsports-2019-100894–451.:444 54 2020;Br J Sports Med, et al. Vicenzino B

Page 2 of 34

CoreDomainSetforTendinopathy:SurveyData

Table1:Participantcharacteristicsofthehealthprofessionalscompletingthesurvey.28ofthe30

contactedresponded(93%responserate)

Characteristic N(%)

SexMale(%) 18(64%)

Role:

Clinicianonly 0

Researcher/Scientistonly 5(18%)

ClinicianandResearcher 23(82%)

Casespermonth:

0(Iamaclinician/scientist) 5(18%)

Atleast4 1(4%)

Between5and10 2(7%)

Between11and15 7(25%)

Morethan16 13(46%)

Yearsmanagingtendonproblem: /27

Atleast4 0

Between5and10 2(4%)

Between11and15 6(22%)

Morethan16 19(70%)

Highestacademicqualification(/26):

Master 1(4%)

PhD 23(88%)

ClinicalDoctorate 2(8%)

Healthcareprofession(somecitedmorethanone~):

Physiotherapy 13

Sportsphysician 5

Orthopaedicsurgery~ 4

Rheumatology~ 3

SportandExerciseMedicine~ 3

Radiology 1

Humanmovementscientist~ 1

Epidemiology~ 1

Surgery 1

Currentlyhavetendonproblem: 8(29%)

Pasthistoryoftendonproblem: 19(68%)

Country(wherework):

Australia 8(29%)

UnitedKingdom 5(18%)

Netherlands 5(18%)

Canada 2(7%)

USA 2(7%)

Denmark 2(7%)

Qatar 1(4%)

Sweden 1(4%)

HongKong 1(4%)

Norway 1(4%)

Supplementary material Br J Sports Med

doi: 10.1136/bjsports-2019-100894–451.:444 54 2020;Br J Sports Med, et al. Vicenzino B

Page 3 of 34

CoreDomainSetforTendinopathy:SurveyData

Table2:Surveydata.

Orderofagreeordisagree:1.

PercentAgree/Disagree/Unsure:93%/0%/7%

Domainasonsurvey:PainonActivityorLoading

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thedomainaslistedonthesurvey:Thisdomain

wasreportedon60occasionsin45papers(37%),assomeauthorsusedmultipleloadingtests(e.g.;oftenthehop,jump

andsquat).*Thetypesofoutcomemeasuresusedbyauthorsforthisdomainwereusuallya10cmline(VisualAnalogue

Scale)anda11pointNumericalRatingScales(0to10)bywhichtheparticipant(patientsorcontrols)reportedthelevelof

painoncertaintasksthatareknowntoaggravatetendons.Someexampleoftasksarehopping,jumping,squatting,

gripping,lifting.

Committee’scomments:Stronglysupportwithnodisagreement.

CommentsofAgreeresponders:

1.Acriticalpartofassessment

2.Certainlyamainstayinlowerlimbandelbowtendinopathy.Lesssureoftheuniversalityinshoulder

tendinopathybeyondactivitiesofdailyliving.

3.Differencesbetweenupperandlowerlimbmaycauseproblems

4.Iagreethatpainonactivityandloadingshouldbeincludedasoneofthecoredomainsetfortendinopathy.

However,theintensityofactivityandloadingmightdifferinsubjectswithdifferentlevelofparticipation.To

standardizethemagnitudeofhabitualloadingisessentialbutdifficult.e.g.thetrainingintensity/competitiontime

neededtoberecordedandincludedasco-variate.Tostandardizetheintensityofloadingduringcertain

provocativetestmaybepossible.Inthisconnection,singe-leggeddeclinedtestisbeingusedasaprovocativetest

forindividualwithpatellartendinopathy.Theintensityofpainisquantifywhensubjectperformssingle-legged

squatttoapre-setangle.Nevertheless,notallsubjectwouldhavepainbeingproducedatthepre-setangle.

Hence,Iagreethatpainonactivity/painunderpre-definedloadingshouldbeincludedasoneofthecoredomain

set.

5.Ithinkitisimportant,asIfrequentlyuseitasmeasureforprogressionintheclinicalsetting.However,itmight

bemoreimportantwhetherapatientthinksthisisrelevant.

6.IngeneralIagree-fortendonssuchasachillesandpatellartendinopathyandalsotenniselbow(grip),testsfor

painonactivityorloadingisalreadyfairlywelldefinedandveryuseful.Forothertendons,suchtestsmayneed

furtherdevelopmentandstandardisationtobeabletorecommend.Theseverityoftheconditionwillalsoinfluence

abilitytoreproducepainduringafunctionaltestinclinic-sometimesthepainiscumulativeandonlyreproducible

afteralongrunorahillrunningsession(e.g.forproximalhamstringtendinopathy),butasweusemultipledomains

inexamination,thisoneisusefulasaseverityguide.

7.Painiswhatpatientspresenttouswith!Onehastobeverycarefulwithpainintrials-becausetendonpainis

relapsingandremittingtoadegree(i.e.ifyoutrainmorethereismorepainandifyourestthereisless).Alsopain

canstaystaticwhistfunctionimproves(ordisabilityrecedes)althoughthereisanimprovement.

8.Seemsmoresensitivetochangeandpatientunderstandsthedomain

9.Tendinopathyusuallyandmostlypresentsasapainrelatedtoloadingmusculoskeletalcondition,sothisisan

importantdomain.Itrelatesdirectlytowhatmightbeviewedasthecurrentclinical'diagnosis'oftendinopathy(ie,

tendonlocalisedpainrelatedto/associatedwithloading)

10.Theclinicaldefinitionoftendinopathyshouldincludepain,localchanges,anddecreasedlevelsofability(i.e.

disability)inducedbythecondition

11.Thistypeofinjuryisrelatedtoloadingandmanyhavenopainatrest.

12.Veryimportantinfo.Painduringasoecifictypeofloading-likepainduringwalkig,runningandjumping.

13.Veryimportantmeasure-andthemainreasonthatpatientsseesportsphysicians

14.VERYimportant.Thisisacorecomplaintofpatients.

15.Yes-oncetheloadingtestsareappropriateloadingtestsasdeemedatalaterdatefollowingfurtherwork.

CommentsofDisagreeresponders:none

CommentsofUnsureresponders:

16.NotsureofthisisrelevantforALLsubjectswithtendinopathyoronlyforpatientswithspecificactivitiessuchas

athletes.

Supplementary material Br J Sports Med

doi: 10.1136/bjsports-2019-100894–451.:444 54 2020;Br J Sports Med, et al. Vicenzino B

Page 4 of 34

CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:2.

PercentAgree/Disagree/Unsure:86%/7%/7%

Domainasonsurvey:Disability

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedin75papers(/122;

62%).*Thetypesofoutcomemeasuresthatareusedbyauthorsforthisdomainare:(a)allpatientrated(completedby

thepatient);(b)askaseriesofquestionsabouthowthetendonproblemaffectsarangeofactivities(e.g.,daytoday

activities,sport,recreation)toscoredisability(orthelimitstofunction/doingthings);and(c)giveonenumberto

representthepatient'sproblem.SomeofthemeasuresthatareusedareVISA-A,-P,-G;DisabilityoftheArm,Shoulderand

Hand(DASHandquickDASH);PatientRatedTennisElbowEvaluation(PRTEE);FootandAnkleOutcomeScore(FAOS);

WesternOntarioandMcMasterUniversityOAIndex(WOMAC);RolesMaudsleyScore.

Committee’scomments:

Strongsupportfortheconceptofdisability,withsomecommentssurroundingaspectsofterminology(ability,

function,disability)andissuesofmeasurement(specifictoatendon,orsportetc,validity?)

CommentsofAgreeresponders:

1.Disability-intermsofwhetherornotyouareabletocompleteyoursport/activityisprobablysecondonlyto

paininimportance

2.Disabilitybeingacompositemeasurethatassociatesthelevelofability/functionoftheindividualwiththeir

condition(painstate).

3.disabilityisakeyfactorinthecondition

4.Disabilityisdefinedas:aphysicalormentalconditionthatlimitsaperson'smovements,senses,oractivities.our

shoulderresearchhttps://bjsm.bmj.com/content/52/4/269https://www.ncbi.nlm.nih.gov/pubmed/28106306

hasidentifiedthatbioandpsychosocialfactorsareimportanttomeasure

5.Disabilityisoneofthemostimportantindicatorsoftheimpactoftendinopathyonavarietyofactivities.

6.Idon'tthinkthattendinopathyisdisabling-rather,annoyingandfunctionallydifficult.However,Irecognizethat

outcomesmeasurementsusethistermanditsdefinitionissomewhatfluid.

7.Itishowtheinjuryaffectsthepatientthatisthecoreofpatientcenteredtreatments.

8.Itwouldbegoodtohaveconsistentmeasuresusedinthefutureaswellasdevelopmoreifthereisagap

9.Limitationoffunctionisoneoftheprimaryreasonsapersonwithtendonrelatedissuespresentstoahealth

professionalforassistance.

10.Mainreasonforpresentationinmostcases.

11.PROMSimportant.Theoutcomemeasureslistedarevaluable(declaredinterest,IwaspartofVISA-PandVISA-

Ateams)

12.Tendinopathyisclinicallyrelevant,anddoescausedisability

13.Tendon,isthekeycomponentofthemuscle-tendon-boneunit,andisthecontrollerofthelocalmotionsystem.

Tendinopathyisadiseasethatcausesgreatimpactonindividual'sability.Thisdiseaseisnotassociatedwithlife-or-

deathbutessentiallyisadiseasethatlinktoindividual'sabilityonmotion.

14.Vitalinformationalongwithpainonspecifiedcircumstances

CommentsofDisagreeresponders:

15.Iratherfocusonexactlywhattypeofexercise/loadingthepatientcannottolerate.

16.Relevantasadomainbutnotsensitivenorreliabletomeasure.Patientsstrugglewithratingit,andtoolsare

oftennotsensitivetomanypatientssymptomsnorchange

CommentsofUnsureresponders:

none

Supplementary material Br J Sports Med

doi: 10.1136/bjsports-2019-100894–451.:444 54 2020;Br J Sports Med, et al. Vicenzino B

Page 5 of 34

CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:3.

PercentAgree/Disagree/Unsure:11%/75%/14%

Domainasonsurvey:RangeofMotion

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedin19papers(16%).

*Thiswasusuallymeasuredwithaspecialinstrument(goniometer,inclinometer,ordynamometer),butalsovisuallyina

fewreports.Notethatthisisasoledomainhere.Inanotherdomain('clinicalexaminationfindings')itisincludedina

combinedscore.

Committee’scomments:

CommentsandresponsesareconsistentwithROMnotbeingcore

CommentsofAgreeresponders:

1.asabove

2.Basedprimarilyonaneliteathletepopulation,whereobjectivemeasuresoffunctionareimportantoutcomesof

treatment.

3.tendinopathy,inandofitself,doesnotBLOCKrangeofmotion,butpainrelateddecreasesoccur.

CommentsofDisagreeresponders:

4.Again,usuallypoorcorrelationwithoutcomeandfunction.

5.Generallynot,yettheremaybeacaseintheshoulder.

6.IseeROMasIseestrength+imaging-itsanicetohave-butnotamusthavedomain.Forthesamereasons-I

thinkyoucanhaveawellsetupandusefulstudywithoutROMmeasures.

7.Limitstorangeofmotionarenotacommonfeaturetoalltendoncomplaints-Ifeelresponsetoloadingismore

tendonspecificandhencefeelthatrangeofmotionshouldnotbeincludedinacoredomainset

8.Oftenlowinterobserverreliability,tellsmenothingaboutimpactorconsequencesofthedisabilityforaspecific

person.

9.oftennotrelevant

10.Patientsdonotcomplainabouttheirrestricted(orincreased)ROM.

11.Pleaseseequalificationtoquestion11.

12.Relatedtopainandswellingofparatenon.

13.ROMhasnotbeenconsistentlyrelatedtotendinopathyinjury.

14.ROMnotrelevantinmosttendons,althoughdecreasedDFassociatedwithtendonpain

15.Toomanyothervariables

CommentsofUnsureresponders:

16.Also,itdependsontheaimofthepaper.Itmaynotberequiredundertheinclusion/exclusioncriteria.Itcanbe

usedasanoutcomesincertaintendinopathictendon.However,whichjointrangetobeincludedissport-specific

asidefromtendonspecific.E.g,kneeflexion/extensionandankledorsiflexionrangemightbeimportantfor

volleyballplayerswithpatellartendinopathy.However,badmintonrequiresgoodrangeofhiprange(IR/ER)for

appropriatealignmentofthekneeduringforward/backwardlounging.

17.Hardlyeveranissueforpeopleinthelowerlimb,butmaybeintheshoulder.Dependsonthescopeofthis.

18.seeabove.

Supplementary material Br J Sports Med

doi: 10.1136/bjsports-2019-100894–451.:444 54 2020;Br J Sports Med, et al. Vicenzino B

Page 6 of 34

CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:4.

PercentAgree/Disagree/Unsure:68%/11%/21%

Domainasonsurvey:Function

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedin8papers(7%).*This

domainisspecificallyabouttheparticipantratingtheirleveloffunctioninonescore(e.g.,PatientSpecificFunctionScale,

wherein100%isfullfunctionand0%isunabletousethelimbsuchasinaslingforthearmandnotweightbearingona

leg).Itdoesnotaskaboutthepain,justaboutthefunction.

Committee’scomments:

Nine(/14)commentsfromtheagreeresponders(approx70%agreementhere,thirdhighestagreedto

domain)forFunction,withmanyofthecommentsfordisagreeandunsure(andsomeintheagree)indicating

thefocuswasmoreontendonrelatedpain,whichassomepointoutiscoveredindisability.Thisdomainis

justfunction-thatis,whatistheleveloffunctioning(disregardingpain)asinhowmuchcantheydo.

CommentsofAgreeresponders:

1.FullreturntofunctionisgenerallyamaingoalbothfortreatingMD/PTandpatient.

2.Ifitiswellspecifieditaddsvalueforsure-especiallyinathtletes

3.Ifrelatedtocertsintendon

4.Keyreasonpatientspresent.

5.Overlapswithdisability.Oneortheother.

6.PartofthetriadasdescribedinArthroscopy.1998Nov-Dec;14(8):840-3.Overusetendonconditions:timeto

changeaconfusingterminology.MaffulliN1,KhanKM,PudduG.

7.tailoredtoeachtendon

8.TheleveloffunctionanindividualisabletoattainisapartoftheICFframeworkandshouldbecapturedfora

loadrelatedconditionliketendinopathy.

9.Yesbecauseweaimtorehabilitatefunction

CommentsofDisagreeresponders:

10.Iconsiderthedomain'disability'toprovidesynergisticinformation.

11.Ithinkthisisonlyrelevantwhenthepainistakenintoaccount(likeinallVISAscoresforexample).Someone

canhaveaperfectfunctionwithalotofpain,soasisolatedmeasureitislessvaluable.

CommentsofUnsureresponders:

12.Markedlylessspecificthanthemoretendon-relatedinstrumentsthathavebeendevelopedoverthelast2

decadesorso.

13.ThePSFScanbeusefulfortrackingchangeinaspecificfunctionforoneindividual,buttherearedifficultiesas

patientsoftenfinditverydifficulttoseparatepainandfunctionasmostoftenthereasonfortheirinabilityto

performataskisthepain.Also,itisimportanttoquestionregardingthesameparticularfunction/sovertime,as

givenablankPSFStorateatdifferenttimepoints,patientswilloftenfillindifferenttasks,resultingindifficulties

withcomparability.

14.tricky.Goodquestions.Willruleoutmanystudies.Isaonenumberscorevalid?

Supplementary material Br J Sports Med

doi: 10.1136/bjsports-2019-100894–451.:444 54 2020;Br J Sports Med, et al. Vicenzino B

Page 7 of 34

CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:5.

PercentAgree/Disagree/Unsure:61%/14%/25%

Domainasonsurvey:Patientperceptionofconditionstatus

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedin37papers(30%).

*Twoexamplesofthetypesofoutcomemeasuresreportedbyauthorswere:globalratingofchange(e.g.,areyoubetter,

sameorworsethanimmediatelybeforetreatment),andpatientperceptionofstatusofcondition(e.g.,isyourcurrent

conditionsatisfactory,whenyoutakeyourgeneralfunctioningandcurrentpainintoconsideration).

Committee’scomments:

Thishasthe4thhighestagreement,7thhighestofunsureandamongthelowestofthedisagree(20th/24).

Thereweremanycomments(11)bythosewhoagreedtotheeffectthatthismeasurereflectedthepatient's

overallperceptionoftheircondition,asopposedto2commentsbythosewhodidnotagreewhoindciated

themeasureistoosubjectiveorthetermisdifficulttounderstand,whilethe4commentsfromtheunsure

responsesthattendedtomirrorthedisagreecomments.Thedomaincouldberewordedto'patientoverall

assessmentofcondition'asthismightaccommodatecommentsherein-asitmoreclearlydescribesthe

overallratingbythepatientoftheirconditionandleavessilentatthisconceptuallevelifthisisachangeover

timeoraglobalratingofthecondition(consideringweareworkingtowardsaparsimoniouscoredomainset).

CommentsofAgreeresponders:

1.Asinglenumerical/categoricalassessmentofthepatient'sstatus(withtheirtendinopathy)providesanoverall

assessmentfromtheirperspective.Theywillinherentlyapportiondifferentaspectsoftheirconditionavaluein

comingtoasingleassessmentnumberorcategory.Inourpatientconsultationmeetings(focusgroups)wherewe

discussoutcomemeasures-patientsfavourtheGROC-iehowareyounowcomparedtobeforetreatment(eg,

better,same,worse-acrossseveralcategories).

2.Asubjectmayshowchangesatimaging,andnotmanifestanysymptoms.Inthesedaysofpatientsbased

outcomes,theperceptionofthepatientisofcapitalimportance

3.Alsousefullforresposivenessstudies

4.asabove

5.aslongasitisnotusedinisolation

6.Embracespatientresponsetoalldomainsofmanagement...

7.IthinkaGROCisuseful-icanbeusedtocompareaccrossmanydiseasesandconditionsthroughoutthewhole

ofmedicineandiseasyininterpretforbothcliniciansandpatients.Itishoweveranitemthatonlyreallyhasuseat

followupmomentsandnotduringabaselinemeasure

8.Patientefficacyorrecoveryexpectationsisanimportantconsideration.

9.Stronglyagree-theseareoftenthesortofquestionsthatpatientsseemtofindeasiesttorelateto.

10.Thisisadefiniteforme.Althoughwemaythinkweknowwhatisimportanttopatientsiedisability,pain,etc,

wecannotknowthisforallpatients.Thismeasurethereforeinmyopinionispatientcenteredandimportant.

11.Thisisessential

CommentsofDisagreeresponders:

12.Idon'tunderstandtheterm,honestly.Howthepatientperceivestheircondition?Thinkingonthisfurther,I

amassumingthisiscomingfromsomeoftheworkstatingthatpatientswhohaveatendencytocatastrophizeare

thosewhopresentforcare.Istilldon'tthinkthisshouldbeincluded.

13.patientperceptionistoosubjective.Thereareunknownelementsthatmightinfluencetheoutcome/changes

inthisoutcome.theunknownelementincludepersonality,moodetc

CommentsofUnsureresponders:

14.Depends.Thefirstexampleisverydifferentthanthesecond.Ratingofchangeonalikertscale/similaris

seeminglymorereliableandthanothers.Thesecondsampleismoredifficultforpatientstoanswer

15.Ibelievethatthe(perceived)ratingofchangeisimportantwhenassessingtherapy.Notsurewhetherthe

perceivedstatusofconditionisofaddedvaluetootherscores.Itmaybeimportanttocheckwhetherthereisan

overlapofthisquestionwithotherquestionse.g.oncopingstrategies.

16.I'mnotconvincedofthisbecauseitisnotparticularlyobjective

17.Maybenotimportant.Moreimportanttoknowifremainingpainaftertreatmentduringwalking,runningor

jumping.

Supplementary material Br J Sports Med

doi: 10.1136/bjsports-2019-100894–451.:444 54 2020;Br J Sports Med, et al. Vicenzino B

Page 8 of 34

CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:6.

PercentAgree/Disagree/Unsure:57%/11%/32%

Domainasonsurvey:QualityofLife

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedby21authors(17%).

*Thetypesofoutcomemeasuresreported:EQ-5D,AQoL,SF-36,internationalHipOutcomeTool(iHOT-33),SF-36,

WesternOntarioRotatorCuffIndex(WORC),Foot&AnkleOutcomeScore(FAOS).

Committee’scomments:

Approx60%agreeand30%unsurehavingcommentsthatessentiallyagreewithQoL,butmanystipulatingthe

needforspecficityofmeasuresforthetendinopathypopulation.5thand4thhighestproportionofagreement

andunsureasopposedto21/24fordisagree,tendstosupportthisdomainascore.

CommentsofAgreeresponders:

1.Absolutelyimportant.

2.Althoughnotcommonlyutilised,itdoesgenerallyreflectapatient'sstatusagainsttheirnormalleveloffunction.

Someinstrumentsabovearelessspecifictotendon-relatedlimitationstofunctionorperformance.

3.asabove

4.Comparisontootherdisabilitiespossible

5.especiallyfordemonstratingtheimpactoftponADL/QOLimportanttogettp'ontheagenda'

6.Howtheinjuryisaffectingtheindividualisofimportancesincepatientshavedifferentgoals,activity

requirementsandexpectations.

7.Inmostcasesnotveryspecificandhardtocompleteforthispatientgroup,butimportantforfunding

8.QoLisanimportantoutcomemeasureforevaluation(cost-effectiveness)researchwhenappropriateoutcome

measuresareused.InadditiontothegeneralQoLquestionnairesitisnecessarytohaveamorespecific

anatomy/lesionbasedscore.IamtoounfamiliarwiththeWORC,IHOT-33,andFAOStojudgethese.

9.Reallyimportantandhasnotbeendonewellinthepast

10.ultimatelyitisthevalueapersonplacesontheirqualityoflifethatdeterminestheimpactofthecondition

11.Yes-butneedtocreatemorespecifictendonspecificqualityoflifemeasures?

12.Yes,itmightbeofimportancetoshowhowsometendonconditionsaffectsdailylife.

CommentsofDisagreeresponders:

13.Notinthecore.

14.Toosubjectiveanddifficulttoassess

CommentsofUnsureresponders:

15.Dependsonthepatientpopulation.MyresponsesaremainlybasedonthepopulationIworkwith,(elite)

athletes.Forathletes,IdonotthinkthegeneralQoLinstrumentsareappropriate(andthereforeathletesfindthem

irrelevantandcumbersome).

16.dependsonthetendon,reductionofactivityinanAchillesmayresultinanOKQoL,samenottrueinglut

tendon

17.Dependsonwhichtendon.Overallnotsensitiveinmanypatients

18.QoLisanimportantdomainbutisperhapsreflectedinotherdomainssuchasfunctionandquestionssuchas

theGROC.Iwouldbehappytoincludeifthemajoritydecidestoinclude.

19.Qualityoflifemaybeaffected

20.Yesinplaces-IliketheEQ5Dbecauseitisaquickeasytomeasureassessment.SF36becomesmoredifficult

butpossible;asdosomeoftheothersmentioned.

Supplementary material Br J Sports Med

doi: 10.1136/bjsports-2019-100894–451.:444 54 2020;Br J Sports Med, et al. Vicenzino B

Page 9 of 34

CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:7.

PercentAgree/Disagree/Unsure:18%/61%/21%

Domainasonsurvey:Painelicitedwithclinicianappliedstresstest

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedin9papers(7%).

*Cliniciansappliedaspecialstressororthopaedictestandtheparticipant(patientorcontrol)reporttheintensityofpain

theyfeelona10cmlineor11pointscale.Thisisnottheparticipantdoingthetestaswouldbethecasewhentheyhopor

jumporsquatinthedomainitem'painonactivityorloading'above.

Committee’scomments:

With60%disagreeand20%unsure,theredoesnotappeartobesufficientsubstanceforthisinacoredomain

set.

CommentsofAgreeresponders:

1.Obvious.

2.THisishowImeasurephysicalexamsigns

CommentsofDisagreeresponders:

3.Idontseethisbeing"universal"enoughtogoincoreset-whichspecialtestwouldidoforpatella/achillesfor

example.

4.No.Perhapsonlyrelevantifthe'stress'couldbequantified.

5.Notanimportantoutcomeforpatients.

6.notreliable

7.Pleaseseequestion13.

8.unlikleytoloadthetendonenough

9.Unreliableandtendonspecific

CommentsofUnsureresponders:

10.Ispartofclinicalexamination

11.Notsurehowthisdiffersfrompainonpalpation.

12.Thismightprovideareasonablyobjectivemeasureofelicitedpainforcomparisonbetweenindividuals?

13.Yes-Butnotsurewehavetheappropriateknowledgeorconsensusonwhatthebest"stress"testsareforthe

relevanttendons

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CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:8.

PercentAgree/Disagree/Unsure:11%/54%/36%

Domainasonsurvey:Sensory-modalityspecificpain

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedin8papers(7%).*The

amountofastimulus(suchaspressure,heat,cold)thatelicitspainismeasuredwithaninstrument(analgometer)forthis

domain.Soitisnotthelevelofpainthatisthefocusbuthowmuchstimuluselicitsthepain,andthestimulusisasensory

one.

Committee’scomments:

Commentsoftheunsurealignstronglywiththedisagreeresponseanddonotsupportsensorymodality

specificpainasacoredomain.

CommentsofAgreeresponders:

1.Anywaytoquantifypainiswelcome.Itshouldbenoted,however,thatpainonpalpationmaynotcorrespondto

painonuseofthelimb

2.Optionaldependingonequipmentavailableandexpertise

CommentsofDisagreeresponders:

3.Asperimaging/rom/strength/costanalysis-greatifyoucandobutnot"core"

4.Difficulttoadequatelyevaluate

5.Interestingexplorativemeasure,butnotaC-TOM.

6.Maybeusefulforresearchstudies,butnotacoredomainthatwouldbewidelyclinicallyapplicable.

7.Morearesearch/mechanismsapplicationforme.

8.Notcriticalandnotreportedenough.

9.Toovariable

CommentsofUnsureresponders:

10.AlthoughIthinkthisisaveryimportantmetric-Iamnotsureweareatthepointwhereweknowenough

aboutQuantitativesensorytestingintendoncomplaintstomakeitacoredomainset

11.howvalidarethesemeasurementsandwhatdotheyad?

12.importantinstudiesdirectedatthis,butforclinicalstudiesno,willbedonebadlyunlessgoodequipmentand

thisistooexpensiveformanyresearchers

13.Maybenotacoredomain,butveryusefulinfurtherinvestigationintothegreaterchallengeofpaingeneration

andmodulation.

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Page 11 of 34

CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:9.

PercentAgree/Disagree/Unsure:57%/21%/21%

Domainasonsurvey:Physicalfunction

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedin6papers(5%).*The

typesofmeasuresusedforthisdomainwere:distancejumped,heighthopped,numberofsingleheelraises.Thatis,how

muchofatasktheparticipant(patientorcontrol)waswillingtoperform.

Committee’scomments:

Thephysicalfunctiondomainalignsreasonablywellwiththeloadingtestsinthebaselinereporting

recommendationsurvey(61%agreethere).Someofthecommentsinhereneedtobeexploredatthe

meetingtoensurethatthereisadifferencebetween'function'and'disability'domains,aswellasphysical

activitypossibly.Otherwisethereappearstobesupportforthisasastandalonecoredomain.

CommentsofAgreeresponders:

1.asaloadrelatedcondition,tendinopathyoughtbedescribedintermsofthephysicalfunctionoftheindividual

2.Asabove,overlapswithfunction,disability.Mypreferencefromallofthesewouldbephysicalfunction.

3.definitelykey.

4.Especiallyforphysicallyactiveindividualsthereturnoffunction(toatleastreachingtheuninjuredside)isof

importanceforfullrecovery.

5.forstudiesinthemoreactivedefinitelyandagainmorespecificforsometendons,suchaswalkingdistancefor

glutmed

6.Thiscanbemeasuredalongsidethepainmeasurementsduringthesetaskssodoesnottakeadditionaltime.

7.YesPleaserefertoArthroscopy.1998Nov-Dec;14(8):840-3.Overusetendonconditions:timetochangea

confusingterminology.MaffulliN1,KhanKM,PudduG.

8.YesbutnotinadditiontoQ18

CommentsofDisagreeresponders:

9.combinewithabove?

10.Interestingexplorativeoutcomemeasure,butitisverydependedonpatient'smotivation.Asasportsphysician,

Iamnotusingitintheclinicalsetting.Soforme,thisisnotaC-TOM.

11.Isthatproventobereliableandrepeatableandsensitive?Idoubtit.

12.Whilesuchmeasuresareusefulforassessingimpairmentswithinanindividualwhichmightprovidesome

treatmentdirectioninclinicalpracticeforthatindividual,correlationwithoutcomesespimposingasinglemeasure

acrossagroupofindividualsasanindicatorofoutcomesislikelytobepoor.

CommentsofUnsureresponders:

13.Couldbeveryusefulbuthowtodefinewhichteststodoaccrosstheagerangesandabilityrangesuseein

practice.InAchillesImayhave65yroldgrandmawhocanthoponce-butneverneedsto-or20yearoldrunner

whocannail5hopsbutcantrun21kmatburningpace-sopassesthetestbutisstillrestricted.Soasaprinciple-

wouldbegreat-butmaybechallenginginpractice

14.Perhapsnotacoredomainastheapplicationwouldbecohort-specific.InAchillestendinopathyforexample,

normalisationofheightordistancehopcouldbeanimportantglobalparameterinahighfunctioninggroup,yetit

mustbeacknowledgedthiscouldnotbeapplieduniversally.

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CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:10.

PercentAgree/Disagree/Unsure:25%/57%/18%

Domainasonsurvey:Pain',withoutanyfurtherspecification

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedin36papers(30%).

*Theuniquefeatureofthisdomain(Pain)isthattheauthorsonlystatetheyreportedpainoftheparticipants.Thatis,

theydidnotspecifyifitwasunderloading(e.g.,activity,hoporwalk)orspecificcircumstances(e.g.,firststep)orina

particulartimeframeorataspecifictime(e.g.,morning).Sothisiteminthissurveyisaskingyoutoconsiderifpain

shouldbefurtherspecified,asinsomeoftheotheritemsinthissurvey.

Committee’scomments:

Commentsbyagreeresponderslookliketheydidnotunderstandthedomainandwouldlikelydisagreewith

thisdomain.Thecommentsfromtheunsurerespondersalsotendtomirrorthosefromthedisagree.The

approx60%disagreementplacesith'asthe3rdhighestdisagreementproportion.Givencommentshereand

responseratesforotherpainrelateditems,painneedstobespecifiedincontext(egwithloading).

CommentsofAgreeresponders:

1.asabove

2.IrecommendpainbeingadomainonitsownANDhavingspecificationslisted.

3.thisisthereasonpatientspresent.Itisacriticaldomain.

CommentsofDisagreeresponders:

4."Pain"provideslimitedinformationandcannotberegardedasacoredomainsetfortendinopathy.Theintensity

ofpainunderwhat"kind"ofloading,what"intensity"ofloading,and"time"

5.conditioninwhichpainoccursshouldbespecified

6.Inastimulus-responseparadigmbothelementsshouldbereportedforrigourandadeeperunderstanding.

Perhapspainatrestmaybeusefulthoughinsomeoftheupperlimbtendinopathieswheretheseaffectdaily

function.

7.Maydependonthepatientpopulation.MyresponsesaremainlybasedonthepopulationIworkwith,(elite)

athletes.Forthese,itisimportanttouseintrumentsthatclearlyseparaterest/nightpainwithpainduringandafter

activity(activity-rleatedpain).Otherwise,anathletewhocannottrainmayreportnopain,becauseheisnot

training...

8.Needsmoredetails

9.Needssomeformofclarification

10.Needstobeclearunderwhatcircumstance

11.Needstobespecified

12.notspecificenough,sourceofpoordiagnosis

13.Painifdescribedshouldbespecified

14.Painisthemainreasonwhypatientsconsult,yetifreportedwithoutcontextishasnovalueasyoucant

inpterpret/understandit

15.Painshouldbequalified

16.Painshouldberatedinaspecificcontext.

17.Seemstovaguetobevaluable.RestpainNOTafeatureofmosttendinopathyasuknow

18.Whenpainisasked,itshouldbespecifiedunderwhichconditionsthepainisoccurring,otherwisethismaybe

misleading.

19.Withoutspecificationitisuselessimo

CommentsofUnsureresponders:

20.Iamunsurehowtoanswerduetotheexplanation.YesIthinkpainquestionsneedfurtherexplanationsuchas

atrest,morningpainetc.ButstillnotsureifIshouldanswerthisquestionyesorno.

21.Painimportantonlyiflocatedinasoecifictendonandrelatedtoacertaintypeofloadingofthattendon.

22.Painseveritywithoutfurtherspecificationappearstobelessusefulthanspecifiedpain.Sometimeswherethis

canbedifficulthoweverisifthemostpainfultaskorsituationchangesovertime.So,worstpaincansometimesbe

usefultocapturethis.Painconstancy/frequencycanalsobeausefulmeasureofpain-%oftimeoverthelastweek

apatienthasexperiencedpain.

23.Wouldneedtobefurtherdefined.

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CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:11.

PercentAgree/Disagree/Unsure:57%/29%/14%

Domainasonsurvey:Sportparticipation

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedin3papers(2.5%).

*Thesortsofmeasuresusedherewere:thetimetoreturntosport,thelevelofsportachieved,andarangeofdifferent

scalesofparticipationinsport(e.g.,socialorelitelevel).

Committee’scomments:

Mostcommentsfromtheagreeresponders-buttheseseemtoreflecttheothersinthatitmightbetoo

restrictivefortendinopathygenerally.Giventheresponsestotheaggregate/removeitemsonthesurvey,it

wouldseemreasonablethatwediscusswherethisfits(eg,aspartofanotherdomain-likeparticipation?).

CommentsofAgreeresponders:

1.Aloadrelatedconditionoughttoencompassparticipation,includingsport.

2.activityratherthansport,returntotheirlevelofactivitycritical

3.Andnotjustparticipationlevel,butperformancerelatedtonormalperformancelevel.

4.Andnotonlysportparticipation/RTSyesornobutalsotheparticipationlevel(egOSTRCquestionnaire)

5.Appliestoasubset.Again,willdependontendonandscope.

6.Importantforpatientsandsomethingwealwaysaskashealthcareprovidersduringfollow-up.Myimpressionis

thatthistypeofoutcomemeasuredescriptioninliteratureisveryheterogeneous.Couldweprovideastandardfor

tendinopathyonthissubject?

7.itmaybeanoptionalquestionforthoseactivelyparticipateinsport

8.OfimportanceinathletesItshouldberecognised,though,thatmanysedentaryindividualssufferfrom

tendinopathy

9.PartofVISAofcourse-insportsmedicineIthinkitis:)

10.Thiscanreallyvarydependingontypeandsiteoftendinopathy.Meaningistheinjurymainlyasport/physical

activityrelatedinjurythenveryimportant.Istheinjurymoreworkrelatedthanlessimportant.

11.Yes-butneedstobedefined-BernconsensusonRTSinBJSMwouldseemgoodplacetostart.Justas"pain"is

uselessdomainwithoutspecifics-RTSdoesnothelpwithoutcontextandspecifics,

CommentsofDisagreeresponders:

12.Forsometendonproblems,thisisveryimportantbutnotsousefulforothersthataremoreprevalentinolder

peoplelessengagedinformalsport.Iftheaimistoachieveacoresetapplicableacrossalltendons,thenno.

13.Mostpatientspresentingarepasttheageofactivesports.

14.Noteveryoneparticipatesinsport

15.Unreliable

CommentsofUnsureresponders:

16.Againbestconsideredasupplementarydomain,astendinopathyisnotrestrictedtosportspeople.

17.Althoughthisisperhapsthemostsignificantactivityforalargeproportionoftendinopathypatients,thisseems

tooverlapwithpreviousquestionsonactivityanddisability?

Supplementary material Br J Sports Med

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Page 14 of 34

CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:12.

PercentAgree/Disagree/Unsure:57%/29%/14%

Domainasonsurvey:Medicationuse

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedin3papers(2.5%).

Committee’scomments:

Ratedatalmost60%,medicationuseisthe5thhighestrankedonagreementofalldomains.Theminimal

reportingofbaselinefeatureshasreturneda79%agreementthatthisshouldbereported.Thiswhen

consideredalonsidethecomments,allofwhicharebytheagreeresponders,itwouldseemthatthisdomain

iscore.

CommentsofAgreeresponders:

1.Corticosteroidsandfluoroquinolonesdoinfluencetheonsetandcourseoftendinopathy

2.dependsifitincludesthosethatareusedforthetendon,thinkinghereofthepolypilletcalsomaygive

indicationofsystemicconditionssuchasdiabetesthataffecttendon

3.Ithink'medicationuse'needstobespecifiedegtendoninjectionororalanti-inflammatorymedication.

4.Ithinkalco-medicationshouldbereported,asitisconsideredanimportantmeasurethatcaninfluenceprimary

outcome.

5.influencesothermeasures

6.Mayneedfurtherconsensus/agreementonwhatexactlywemeanbymedicationuse(i.e.Whatmedicationsare

relevantintendinopathyspecifically?)

7.Theusageofco-interventionsisalwaysimportanttorecord.

8.thiscanbeanextrainformation.Butnotsurewhetheritiscommonlyusedorseldomuseduetothechronicity

natureofthedisease

9.Thisiscriticalasitisafunctionofmedicalisationofwhatisessentiallyahealthrelatedissue-ieloading

associatedpainstate

10.Wouldbeimportanttoknow.

11.Yes-easytodo

CommentsofDisagreeresponders:

12.Doesnotlinktoseverity

CommentsofUnsureresponders:

nocomments

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Page 15 of 34

CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:13.

PercentAgree/Disagree/Unsure:25%/50%/25%

Domainasonsurvey:Participation

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:IThisdomainwasreportedin1paper,butithad4

scales(3%ofallscales).*Thiswasmeasuredbyaskingparticipants(patientsandcontrols)whattheirlevelofactivitywas

withfamilyandathome,recreation,runningorotherphysicalactivity,andsocialactivities,usinga10cmline(0cm=no

limitation,100cm=completelimitation).

Committee’scomments:

Commentsindicatingsomeuncertaintyaboutthisdomaingenerallyandoverall,suggestingitshouldbe

discussedinthemeeting.Itwouldseemthatsuchadiscussionwouldencompassthedomainsof

participation,physicalactivity,sportandworkrelatedparticipationasseparatedomains.

CommentsofAgreeresponders:

1.Aloadrelatedconditionoughttoencompassparticipation

CommentsofDisagreeresponders:

2.asabove

3.CantseehowthisisdifferentfromPhysicalactivity-howphysicallyactiveareyoucanbeusedforathletesand

nonathletesalike?

4.combinedwithqualityoflifeoffunctionscales?

5.Difficulttovalidate

6.Ithinksitishardtotranslatethisoutcomemeasuretopatients.

7.needsmorequantifiedinformation

8.willnotaddmuch

CommentsofUnsureresponders:

9.Overlapsgreatlywithotherqueries.

10.Participationinwhat?Thisneedstobebetterqualified

11.Wouldneedtobespecifiedandcontextrelatedtoaddmeaning

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CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:14.

PercentAgree/Disagree/Unsure:54%/32%/14%

Domainasonsurvey:Physicalactivity

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedinatleast5papers

(4%).*Thisisabouttheparticipant(patientorcontrol)ratingoverallphysicalactivityregardlessofpainorthe

tendinopathy.

Committee’scomments:

Physicalactivityisstronglysupportedasabaselinefeaturetobereportedinthatsurvey.Commentshereare

mainlyaboutitbeingcapturedinotherdomains-wewillneedtolookatthequestionsthatdealwith

aggregationanddeletiontotrytocometosomeagreementregardingcoredomainforphysicalactivity.

CommentsofAgreeresponders:

1.Aloadrelatedconditionoughttoencompassphysicalactivitycapacity

2.inviewoftherelationshipbetweentendinopathyandintensityofexercise/activitiy

3.partoftheoverallperspectiveoftheperson'sactivitylevel

4.Physicalactivityiskeybutcouldbeinferredfromotherdomains

5.Pleaserefertoquestionaboutsport

6.Theramificationsofnotbeingabletobephysicallyactiveareseriousformaintaininghealth.

7.work,sports,adl,hobby

CommentsofDisagreeresponders:

8.couldbecapturedinfunction

9.Doesn'tchangetreatmentoreval.

10.Ithinkwouldneedtobespecified-asRTSabove

11.Ifthisisdifferentfromsportsactivity,Iwouldsayno.

12.Therearesomanyfactorsthatcaninfluencegeneralphysicalactivity,sounlikelytobeusefulasacoredomain.

CommentsofUnsureresponders:

13.Lessstringentreportingelementthanthetendon-specifictools.

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CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:15.

PercentAgree/Disagree/Unsure:50%/29%/21%

Domainasonsurvey:Adverseeffects/events

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:hisdomainwasreportedin9papers(7%).

*Adverseeffects/eventsareanyeventthatoccurstotheparticipant(patientorcontrol)whileinthestudy(orbeing

followedclinically).Theyneednotberelatedtoatreatmentforthetendinopathyortothestudyinparticular,butjustany

eventthatisadversetothehealthoftheindividual.

Committee’scomments:

Thecommentsfromtheunsurerespondersalignwithsupportingadverseeventsasacoredomain,butwith

furtherqualification,possiblyinthemeasurementofthedomain.Veryfewcommentsofanysubstanceinthe

disagreeresponderslendssupporttothisobservation.

CommentsofAgreeresponders:

1.Beendonepoorlyinthepastbutveryimportanttohave!

2.Iwouldlikedocumentationoradverseeventspertainingtodropoutsordetailsonexacerbationofsymptomsetc

3.importantforallstudies

4.Importanttolookforpossibleissueswithtreatment

5.Theassociatedadversehealthissues,whetherrelatedtothetendonissueornot,shouldbepartoftheoverall

healthdomainsetofanymusculoskeletalcondition.

6.Thisisunderreported,butveryimportantwheninformingpatients.

7.Weneedtoknowwhatadverseeffectsagiventreatmentmayinduce

CommentsofDisagreeresponders:

8.Notimportant.

9.Notsurehowthisisrelevant

10.provocativeactivity/testsaremoreappropriatetorule-in

CommentsofUnsureresponders:

11.Ithinkitisausefulitemespeciallyintreatmenttrials,butIbelievethenatureoftheadverseeventneedstobe

specifiedinmoredetail.

12.Maybeeventspecific.Ifthisextendedtosayutilisationofcoach-ratedperformanceinaprofessional

sportspersonthiswouldbequiteuseful,althoughmaybenotacoredomain.

13.notinallstudiesIthinkonlyininterventionstudies

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CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:16.

PercentAgree/Disagree/Unsure:46%/29%/25%

Domainasonsurvey:Workparticipation

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedin2papers(2%).*This

domainrelatestothingslikehowlongtoreturntowork,thelevelofwork(howstrenuousfortheparticulartendon).

Committee’scomments:

Commentsaligningwiththeotherparticipationresponses.

CommentsofAgreeresponders:

1.Aloadrelatedconditionoughttoencompassparticipation,definitelywork(whichmightbesportinprofessional

sport)

2.Butdependsonthepatientpopulation.Insports,workequalsreturntosport.

3.forsometendonsmorethanothers,upperlimbespecially

4.Importantaspartofdisabilitythattendinopathyinduces

5.Importantforfunding.Andnotonlythisdichotomousoutcome,butalsolimitationsduringworkanddaysabsent

fromwork.

6.Importanttodeterminetheimpactonworkperformanceandviceversa,workloadontendonproblems

7.Sameanswerasabovetosports.Itdependsonsiteandcauseofinjury.Ifworkrelatedthenyesofgreat

importance.

8.Yes-easytodoandnotbeendonewellinpast

CommentsofDisagreeresponders:

9.Mosthavetoworkanyway.Lowreportingtoo.

10.Notnormallyrecordedandsoweknowlittleaboutthis

CommentsofUnsureresponders:

11.conditionspecific.becausetheinfluencewouldbedifferinsubjectswithelbowverseanklepainassociated

withtendinopathy

12.Deoendantontypeofworkandtendon.

13.Isthisrelevantforeverypatient-effectsoftendoncomplaintsonworkpracticesmaybeasmallsubsetforitto

beincludedasacoredomain.Enoughondisability/functiondatacapturedalreadyinpreviousstatements?

14.Maybesupplementary,onlyusefulinthosewholoadtheaffectedtendonintheirwork.

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CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:17.

PercentAgree/Disagree/Unsure:46%/32%/21%

Domainasonsurvey:Discontinuetreatment(dropout)

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thiswasnotextractedfromthereviewedreports

andisincludedhereforconsideration.

Committee’scomments:

Approximately50%agreementandcommentsindicateneedclarityonreasonsfordis-continuingtreatment.

CommentsofAgreeresponders:

1.Ithinksthisshouldbepartoftheevaluation.Itisstrikingthatthiswasnotdoneinprevioustrials.

2.Obbious.”

3.Partofanywellconductedstudy

4.persistentpainstates,liketendinopathyinmanyinstances,ismarkedbyafrustratingoffandon,trymany

treatments,cyclicalpattern-sotreatmentadherenceorlacktherofisafunctionofthecondition

5.Yes-canhavebigimpactoninterpretingresults-againlikeGROC-thisisreallyafollowupmeasureandcould

bespecifiedasbeingsuch-ratherthansomethingdoneatbaselineandagainatf/u

CommentsofDisagreeresponders:

6.Difficulttodefineeasily

7.No,therearemanyreasonswhypeoplemaydiscontinuetreatmentthathavenothingtodowiththeeffectof

theintervention.

CommentsofUnsureresponders:

8.Maybenotcorebutausefulsupplementaryquestionwhichmayempiricallyreflectabalanceoftreatment

burdenagainstefficacy.Reasonfordropoutwouldalsoneedtoberecordedasitmaybeinfluencedbynon-

treatmentrelatedissues.

9.notsurewhatthismeans,needscontext

10.Onlyininterventionstudies

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CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:18.

PercentAgree/Disagree/Unsure:43%/29%/29%

Domainasonsurvey:Structure

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedin36papers(30%),as

51differentmeasuresor42%ofalldomainsextracted.*Thetypesofoutcomemeasuresreportedwere:MRI,US(grey

scale,Doppler),andXray.

Committee’scomments:

Structurewasthe13thmostagreedanddisagreeddomainwiththe6thhighestproportionofunsure.The

latterreflectstheuncertaintyoftherelationshipbetweenstructuralchangeandsymptoms,asreflectedin

manycomments.Thenumberofcommentswasalmosttwiceasmanyfromtheagreeresponders(11)than

thedisagree(7)andunsure(6)-manyoftheseagreecommentsacknowledgetheissueswithmeasurement

ofstructureandthepresentingsignsandsymptomsofthepatientwithtendinopathy,butfeltitanimportant

healthdomain,sufficienttobeacoredomain.Thoseinthedisagreecounteredbymeansofhighlightingthe

disconnectbetweenstructureandclinicalpresentation.Thecommentsfromtheunsureresponderslargely

reflectthedisagreecomments.Thiswillbeadomaintodiscussatthemeeting-weneedtoconsiderthe

following:Agreethatitisacoredomain,butnothaveavalid(responsive,feasible)measure-thiswouldbe

basedonthetendonstructure(changesintendinopathy)arecoretotheconditionoftendinopathy.Onthe

otherhand,ifwedisagreethatitisacorehealthdomainoftendinopathy,itdoesnotmatterifthereexistsa

valid,responsiveandfeasiblemeasure.

CommentsofAgreeresponders:

1.asidentifiedinourresearchandreviewseghttps://bmjopensem.bmj.com/content/3/1/e000279.info

https://www.ncbi.nlm.nih.gov/pubmed/26666736https://onlinelibrary.wiley.com/doi/full/10.1002/jcu.22318

2.Functiondeterminesstructureandstructureinfluencesfunction.Thereseemsnotastrongrelationshipbetween

tendonstructure,painandfunction.Sameasforlowbackpain.X-ray,MRIdoesn'tassociatewithpainor

dysfunctioninthosewithlowbackpain.However,imagingcanfurtherconfirmclinical/physicaldiagnosis.

3.Iagreeitshouldbeacoredomainandconsensusregardingthetypesofoutcomemeasuresisneeded.However,

acknowledgementthatfeasibility/fundingetcmayprecludemeasuresof'structure'beingreportedinallfuture

studiesmaybeworthwhile.

4.Ithinkitiscriticaltolookatstructureinadditiontosymptomsanddisability,sinceweneedtounderstandmore

abouttherelationshipbetweenstructuralchangesandsymptoms.Bylookingatstructurewemayalsoidentify

subgroupsofdifferenttendinopathyphenotypesaswellasstratifypatientsforspecifictreatmentsinregardsto

subgroupsofprognosis.

5.Inpatientswithsymptoms,structurerelatestosymptoms.Inadditionmanytreatmentsareaimedatimproving

structure,andstructurerelatestofunction.

6.IssuesaretendonspecificHowtohandlepoorcorrelationbetweenstructureandsymptomsSomemodalities

egultrasoundareinvestigatordependent

7.MyyesisbecauseIbelieveweneedmuchmoreresearchtounderstandtherelationshipbetweenstructurand

function/symptoms.Butstructuredoesnotneedtobecore,assuch.

8.Structureimportant-butdifficulttoaccuratelyvisualize.UTCisasfarasIknowtheonlyobjectiveevsluationof

structure.

9.Structurereferringtoanatomicregionaffected?YES.

10.THeissueofstructuralchangesisimportant,butnotofessentialimportance.Somepatientsmayhavepainand

disabilitywithoutevident(orwithminimallyevident)changes.Clinicalsymptomsandtheclinicalpictureshould

guideinthediagnosisandmanagement

11.Toughoneandwillbeasourceofdebate.Theproblemwithexcludingitisthatfolkswillarguethatthetendon

conditionmayhavebeensomethingelse,e.g,inferiorpolepatellararticularcartilagedamageratherthanpatellar

tendinopathy.Ifyouincludeimagingaspartofthecoreyoustillhavethechoiceofincluding'normalimaging'in

astudycohort.(earlytendinopathy).goodluckwiththisone!

CommentsofDisagreeresponders:

12.Duetothemismatchbetweenpain&functionandimaging,Idon'tbelievestructureshouldbeapartofthe

'coredomainset'.Itmaystillbeofinterestwithinaresearchenvironmentandisanimportantriskfactorforthe

developmentofpainfultendinopathy,butusuallyhaspoorcorrelationwithoutcomes.

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CoreDomainSetforTendinopathy:SurveyData

13.notalotofevidencethatthischangeswithinterventionand/orpain

14.Notasanoutcomemeasureasnotshowntocorrelatewithpatientstatus

15.Poorrelationshipwithpain,prognosis,andlimitedevidencethatitchangeswithloading.

16.Thereisalreadyevidencethatthisisnotrelatedtoseverityofsymptoms.Notinpresentstateduringexam,nor

inthefuture.Itmightbeaninterestingoutcomemeasureinsomecases,butnotaC-TOM.

17.Thereseemstobenorelationandactualpatientcontactisneeded

18.Thislimitsthepossibilityofstudiestocomplywiththeminumumsetcriteriaasitmakesreasearchmore

expensive.Iseearoleforimagingstudiesbutwouldnotconisderthosethathavenotusedimagingtohavefailed

orbelessuseful.

CommentsofUnsureresponders:

19.Depends.Notsurewhatyouaregettingat,apartfromusingimaging(US)todescribegradeandphysiology.

20.Giventhedisconnectbetweenstructureandpain,Iamnotsurethisshouldbeincludedinacoredomainsetfor

tendinopathy

21.Incontemporarythinkingappearsless/unrelatedtopatientoutcomes.GoodanalogiestoOA.....howeverin

thatfieldjointchangesarestilltrackedandpublished.Perhapsusefultounderstandsomesubsetsofthecondition

butnotacoredomain.

22.Itdependsonwhatthedomainsetislookingat.Ifitisessentiallyaclinicaltoolthen,giventhatthereislittle

relationshipbetweenstructureandfunction/painthenstructureisnottooimportant.Structurealsoappearsto

changelittle,atleastintheshorttomediumterm.Ifitismoreofascientificassessment,oryouwanttolink

structuretotendonseveritythenthereismoremeritinthis.

23.Nodoubtthetendonstructureisanintegralpartofthecondition,butnotsureifitshouldbeadomain-

becauseadomainwillneedtobemeasuredinclinicaltrials-reliably,validly,discriminativelyandfeasibly.

24.painandfunctionnotrelatedtostructureontheotherhanditisanobjectiveoutcomemeasure

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CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:19.

PercentAgree/Disagree/Unsure:32%/43%/25%

Domainasonsurvey:Painover24hours

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedin23papers(19%).

*Themeasuresusedhereincludeaskingtheparticipant(patientsorcontrols)toratetheirpainoveraspecifiedtime

frame(s)(e.g.,lastweek,last24hours,inthemorning,atnight)ona10cmline(VisualAnalogueScale)oroutof10

(NumericalRatingScale).

Committee’scomments:

Generalsensefromthecommentswasthattimeframeismuchlessimportantthantheloadingactivity

(whichwasthemostagreedupondomainofallherein).Someexpressionsthatatimeframeoverwhichthe

painisratedwasinsomecomments,butverymuchintheminority(andusuallyasasecondary

consideration)comparedtoloading/activity.Thereweresomecommentselsewhereforstartuppaininthe

morning-shouldweconsiderthatispartofthe24hourpainpicture?

CommentsofAgreeresponders:

1.akeyresponseforthosewithtendonpain

2.Dependsonthepatientpopulation.MyresponsesaremainlybasedonthepopulationIworkwith,(elite)

athletes.Forthese,itisimportanttouseintrumentsthatclearlyseparaterest/nightpainwithpainduringandafter

activity(activity-rleatedpain).Otherwise,anathletewhocannottrainmayreportnopain,becauseheisnot

training...

3.Describingpainpatternovera24hourperiodinconjunctionwithanappropriatepainscaleisanimportant

featureoftendinopathy

4.Iagreethisisimportantbutveryhardtoassessinpractice.Patientsmaybedoingactivitiesthataggravatedaily,

ortheymaynothaveanaccurateunderstandingofthe24hourresponse.Thismaybelesstrueforsomesports

andtendinopathies,forexamplepatellartendinopathyamongjumpers.Oftentheyhaveabetterunderstandingof

the24hourresponse.

5.ifnot24hoursthenoveradeterminedperiodoftime

CommentsofDisagreeresponders:

6.Dependsonwhatpatienthasdoneinthattimeframe

7.Ithinkitisimportanttobeawarethatpainintendinopathycanfluctuateovertime.Myimpressionisthatthere

isnotsomuchchangein24hours,soIdon'tthinkthisisuseful.However,Ithinkthatweshouldagreeonacertain

timeframewhenweassesssubjectiveoutcomemeasures(e.g.meanpainduringADLactivitiesduringthepast

week).

8.incidenceofpainnormallyassociatedwithloadingbutnottime

9.Itdoesnotchangemanagement

10.Mypreferencewouldbeworstpainoverlastweektocaptureactivitiesthatarenotperformedonadailybasis.

11.Seemyanswersabove.

12.Smallnumberofpapersreporting;it'snothowpatientsperceiveorreportpain.Italsodoesn'taffecthowwe

treatthisproblem.

13.Toorestrictive

14.Withoutspecifyingwhattheydidinlast24hoursdoesnotreallyhelpmeinterpret

CommentsofUnsureresponders:

15.Onlywhenconnectedtoactivity/loading

16.Specificationofthecircumstances(restvsactivity)whenpainisoccurringmaybenecessary.

17.Thismeasureofitselfdoesassumevarietyandmagnitudeareconstantsinsubjects.Lessrigorousthanother

measuresabove.Notcorebutmaybeuseful

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CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:20.

PercentAgree/Disagree/Unsure:29%/39%/32%

Domainasonsurvey:Clinicalexaminationfindings

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedin28papers(/122;

23%).*Thisdomaincoversmeasuresthatreportasinglenumber/scoreforacombinationofclinicaltests(e.g.,combine

thetestresultsofrangeofmotion,strength,palpationintoonescore).Someexamplesofthesemeasures/scoresare:

UniversityofCalifornia-LosAngeles(UCLA);Constantscore;Liverpoolelbowscore.

Committee’scomments:

Thecommentslargelyconcerncombininganumberofclinicaltestsintoonescore.Thepercentagreement

wasalmostsimilaracrossallresponseoptions(agree,disagree,unsure:30,40,30%),butthecommentsare

largelyalignedwithdisagree.

CommentsofAgreeresponders:

1.asabove

2.butnotsurewhichhavetobereportedindifferentconditions

3.Itwillbedifficult,butshouldbeincluded.

4.PleaserefertoArthroscopy.1998Nov-Dec;14(8):840-3.Overusetendonconditions:timetochangeaconfusing

terminology.MaffulliN1,KhanKM,PudduG.

5.Yes,butonlyspecifictendontelatedtests.

CommentsofDisagreeresponders:

6.Anytimeyoutakedataandcombineyoulooseinformation.

7.Clinicalscoresofthisnaturearenotwellenoughworkedoutforalloftherequiredcommontendonissues

8.Clinicianmeasuresareatbestsurrogate.

9.Iwouldratherhavespecificclinicalfindingsreportedseperatley-onceyoumakeacompositescoreitgets

hardertointerpretfindingsandknowwhatthepatientslookedlikeonexamination

10.Manymaynotchangeaftertreatment/improvementofsymptomse.g.palpationtendernessisaverygood

exampleofthis.

11.Notspecificenoughwhencombinedintoonescore,interobserverreliabilityisoftenlow

CommentsofUnsureresponders:

12.Dependsonwhichtendon

13.dependswhattheseare,manyclinicaltestsspecifiedabovewillnotbevalidfortendonpain

14.Eachtendinopathyisindividualinpresentation.Here,painfreeshoulderROMforexampleisausefulreflection

ofchangeinstatus,whereasinlowerlimbtendonsthisisalessusefulmeasure.Anyamalgamationofclinical

findingsisonlyasgoodastherigourofeachportion.Thatsaid,asinglescoreisusefulinportrayingoverallstatus.

15.Ithinktheadditionofanumberofreliableclinicaltestsforeachspecifictendinopathylocationcanbevaluable.

ButIamnotsurewhetherthesecombinationtestsshouldbeaC-TOM.

16.Notsurewhetheranaggregatescoreisveryuseful.Iamassumingthatwhenthecombinedscoreisavailable,

thereshouldalsobeinformationontheindividualclinicaltests,whichmaybemoreinformative.

17.theuseofcompositemaybe"condition"specific.Tendinopathyintheupperlimb(rangeofmotionandmuscle

functionarenormallyaffected)mayhavedifferentdomainfromthelowerlimb(moreassociatedwithimpact

loading,lessassociatedwithphysicalfindingssuchrangeofmotion/musclestrength).

18.Theremaybeahugevariationinthenumberofclinicalteststhatmaybeusedtocreatethiscompositescore.I

amnotsureweareaatastageyetwerewehaveareliableanddefinedsetof"tests"thatcouldthebeusedto

createareliablecompositescore.

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CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:21.

PercentAgree/Disagree/Unsure:29%/39%/32%

Domainasonsurvey:Economicimpact:costs

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedin4papers(3%).*This

isusuallymeasuredfrommedical/healthrecords,questionnaires,diaries,orinterviews.

Committee’scomments:

30/40/30%spreadacrossagree/disagree/unsureindicatesthisisundecidedasputinthesurvey.Butlookingatthe

commentsthedisagreehasfewestcomments(3/14)andtheseholdanelementoffeasibilityintheirwording(nice

tohavebutnotdevaluestudy,societalnotindividual,difficulttoanalyse).Theothercommentsintheunsureare

alsoalongtheselines.Therearecommentselsewhereintheadditionofdomainsitemforexamplethatindicate

healthcareutilisationandcostsshouldbeincluded,andothercommentsthatindicateissueswithmeasuringit.If

weforthisstageoftheprocessignorethemeasure,thenthequestionbecomesisthecostsoftendinopathy

(individualandsocietal)adomainthatoughtbeinthecoreset.

CommentsofAgreeresponders:

1.Costeffectivenessisanecessityinthepresenthealthcareenvironment

2.Especiallywhendataaretobeusedincosteffectivenessanalysesorhealthtechnologyassessment.

3.Importanttonote

4.inoursocietyonewaywemeasureimpact/valueisthrougheconomicimpacts(directandindirectcosts,lost

timeatwork,etc)

5.thisneedsmoreattentiontogettpontheagenda

CommentsofDisagreeresponders:

6.Againhereitsa"nicetohave"likestrength/ROM/Imaging-drivesupthecostofresearchandnothavingit

doenstde-valueastudy

7.AtasocietallevelthenMSKinjurycanhaveamajorburdenonmortalityrisk-butforanindividualdifficultto

include

8.Itisdifficulttoanalyzecostforthisinjuryduetotheslowinsidiousonsetandsincethepatientoftencanbe

activeduringtreatment.Surgeryisalsonotamaintreatment.

CommentsofUnsureresponders:

9.asecondarymeasureformoststudies,butincreasinglyimportantasmorepeopletrowmoneyatuseless

interventions

10.Couldbeusefulincertaincohortsegprofessionalsportspersonsortradespeople.Notsureifitshouldbeacore

domainbutagainusefulinappreciatingimpactoftendinopathyincertaincohorts.

11.Notsurethisisfeasibleasacoredomainset

12.Onlyinsomestudies.

13.Thisisimportantforfunding,butIamnotsurewhetheritshouldbeaC-TOM

14.Wontthatbeinsensitive?

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CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:22.

PercentAgree/Disagree/Unsure:36%/29%/36%

Domainasonsurvey:Psychologicalimpact

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedin3papers(2.5%),

accountingfor5%ofalldomainsextracted.*Thetypesofoutcomemeasureswere:paincatastrophizingscale,painself-

efficacy,anxietyanddepressionscales.

Committee’scomments:

Basedonthecomments,whicharelargelyaboutthemeasureratherthantheconstruct,itwouldseemthat

combinedtheagreeanddisagreewouldmeetthe70%target.Thereisacommenttoconsiderifthisdomain

shouldbesplitfurtherintosmallerdomains-butnosuggestionofwhattheymightbe.

CommentsofAgreeresponders:

1.Iwouldarguethatwedonotcurrentlyhaveappropriatetendonspecificoutcomemetricstoquantifythis-have

FABQetcbeenvalidatedinatendonpopulation?

2.Painisusuallyamainpresentingfeature,andnotuncommonlypersistently,whichisassociatedwithvarious

levelsofpsychologicaldistress.

3.Somesortofscreeningforpsychologicalimpact/factorsmayhelpprovideearlyindicationoftreatment

requirementsforanindividual.Painself-efficacycanbeusefulinprovidinganindicationofeffectofinterventions

suchaseducationandfunctionalretraining,improvingapatientsconfidenceintheirabilitytoengagein

activity/recreation/normallifestyle.Thismaybeanimportantmechanismbywhichourinterventionsprovide

effect.Highlevelsofanxiety,depressionandcatastrophisingarenotascommoninthosewithanisolated

tendon,butwhentheyarepresenttheymaypresentasignificantimpedimenttorecovery.Soearlyscreeningfor

thesecouldbeusefultodirectmostappropriatetreatment,butasanoutcomemeasureforthemajorityofthose

withtendonrelatedproblems,changesinthesemeasuresovertimeareunlikelytobeastrongindicatorof

recovery.

4.Thisdimensionhasbeensparselystudied.Personally,Ibelievethatpersonalitytraitsmakeadifferencein

treatmentandimpact.Iamnotapsychologist,though,andappropriatequestionnairesneedtobetestedinthis

respect.

5.Yes!Seemstobeanimportantfactorbutisnotgivenenoughattentioninstudiessofar.

CommentsofDisagreeresponders:

6.Difficulttodefine-butcouldbeassessede.g.viaEQ5D

7.Interestingasexplorativeoutcomemeasure,butnotaC-TOM

8.Notreportedandnotimportant.

CommentsofUnsureresponders:

9.DoesthisdifferfromQOL?Ifso-ithinkweshouldhavethisaswell-givesholisticviewofimpact

10.Evsluationonlyinsomestudies.

11.Idoubtit-notsensitivenorspecific

12.Mybenotacoredomain,butaveryusefulsupplementarydomain,whereongoinglimitationhasmoregeneral

effectsonpatientwellbeing.

13.specificstudiesonthisimportantbutnotacoredomainformoststudies

14.Wouldthisperhapsprovideameansofcontrollingforcopingfactorsinotherdomains?

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CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:23.

PercentAgree/Disagree/Unsure:39%/43%/18%

Domainasonsurvey:Palpation(painortenderness)

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedin11papers(9%).

*Theclinicianpressesonthetendonwithathumborfingerandelicitspain(ornotincontrols)andtheparticipant

(patientorcontrol)reportsthispainortendernessinavarietyofways(e.g.,ona10cmline,outofa11pointratingscale

(0to10),bespokenominal/ordinalscales,orinsomecasesnotstatedinthepaper).

Committee’scomments:

Eventhoughagreeanddisagreewereselectedaboutthesameproportions(40%each),thecomments

affirmingpalpationarelargelyaboutclinicalexaminationandinthemainmostcommentsdonotsupport

palpationasacoredomain.

CommentsofAgreeresponders:

1.Istillplaceclinicalvalueonpalpationandfindituseful-itsquick,universallyaccessibleandeasytounderstand

forpatientsandclinicians.Amhoweverhappytobevoteddownhere-iknowithasdrawbackstoo-standardising

pressuresetc

2.Itisimportant,butitshouldbeagainbetterqualified.Algometryshouldbeemployed

3.Itisveryhardtostandardize,sothismeasurehasalotoflimitations.Itis,however,oneofthemaindiagnostic

criteriafortendinopathyandmosthealthcareprovidersuseitintheclinicalsetting.Fromthatperspective,itis

importanttoknowmoreaboutitsclinicalvalue.

4.Painonpalpationisoneoftheclinicaltestsindefiningtendon-relatedproblem.

5.Thisispartofthediagnosisbutnotactuallysurehowthatwoulddifferentiatefromcoredomain.

6.VeryimportantforatleastAchilles.Alsotolocalusewherepainislocated-superficial,deep,medialorlateral

side.

CommentsofDisagreeresponders:

7.forthetendonsofmyareaofinterestitisnotpossibletoaccuratelyidentifythestructuretherelationship

betweenpalpationandpainremainsuncertain

8.Hardlyeveruseful,asidefromrulingoutatendonissueinthediagnosticprocess.

9.Itisdifficulttopalpatemanytendonse.g.supraspinatus

10.Notdiagnosticoragoodoutcomemeasure,infactleadsmostpeopleastray

11.Palpationisoftenmostusefulasanegativepredictorofthepresenceofpainfultendinopathybutisnotagood

indicatorofoutcome.Tendernessonpalpationoftenremainsinthepresenceofsubstantialimprovementsin

outcome/function.

12.Palpationpainchangesappearpoorlycorrelatedtofunctionaloutcomes

13.Toopronetoerrors

CommentsofUnsureresponders:

14.Asainclusioncriteriaorasanoutcomemeasure?

15.Dependsontendon.Overall,no

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CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:24.

PercentAgree/Disagree/Unsure:36%/39%/25%

Domainasonsurvey:Strength

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Thisdomainwasreportedin19papers(16%).

*Strengthbeingmeasuredbyaninstrumentsuchas:adynamometersorforcetransducers.

Committee’scomments:

Onbalancethecommentsindicatethatstrengthmightnotbeacoredomain,withmanycommentsinthe

agreerespondersnotfavouringitascore-whichwouldlikelyindicatethat70%wouldbereachedonfurther

discussion.

CommentsofAgreeresponders:

1.asabove

2.Basedprimarilyonaneliteathletepopulation,whereobjectivemeasuresoffunctionareimportantoutcomesof

treatment.

3.Notasaninnercoredomain.Asanouterdomain.

4.Oftenaperceivedissue;functionimpactedbydecreasedstrength

5.Strengthchangesarelesscommonlyinvestigatedinmuchoftheliteratureasperhapsoverthedecadesthere

hasbeentoomuchfocusonthetendoninisolation.Morerecentpapershaveidentifiedstrengthchangesthat

appeartohavesomerelationtooveralloutcome,yetmoreworkisrequiredinthearea.

6.tendonsjoinmuscletobone-andstrengthtestingisofthemuscle-acriticalimpairmenttocapture

7.Thisisimportant,sincetheinjuryisanoverloadinginjuryandtreatmentisoftenaimedatimprovingstrength

8.Yesbecausestrengthisfundamentaltofunctionandmanyofourrehabilitationtechniques

CommentsofDisagreeresponders:

9.Alimbcanbestrongandstillnotfunction.Whileitisaninterestingvariabletoknow,strengthinandbyitself

doesnotcarrymuchclinicalrelevance

10.Feasibilityandreproducibilityissues

11.Idontthinkstrengthnecessarilyneedstobeevaluated.Painverymuchaffectsstrength,andIhaveseenthat

efterlocalanestesiathestrengthvaluesarecompletelydifferentandnotseldomnormal.

12.IseestrengthasIseeimaging-itsanicetohave-butnotamusthavedomain.Forthesamereasons-Ithink

youcanhaveawellsetupandusefulstudywithoutstrengthmeasures.

13.Interestingexplorativeoutcomemeasure,butnotaC-TOM.

14.Needforspecificmeasurementapparatus

15.notthecore-willruleouttoomanyinvestigators

16.Strengthseemstobeapoorindicatorofoutcomeandfunctioninapainfulpopulation.

CommentsofUnsureresponders:

17.iftheseswererelevantandstandardisedpossibly,buthardtodoacrossstudiesandcouldbetooexpensiveto

doforsomeinvestigators

18.Noneedundertheinclusion/exclusionpart.ButcanberegardedasoneoftheoutcomemeasuresHowever,it

shouldincludemuscleinthekineticchain.e.g.forpatellar/achillestendinopathy,musclestrengthofthehip

shouldbeincludedaswell;supraspinatus/ECRL/ECRBtendinopathy,musclestrengthofthescapularmuscleshould

beincluded.

19.Notsureiagreewiththetermstrengthasthishasvariousinterpretations-iwouldfavourfunction.AlthoughI

thinkfunctionisanimportantcoredomainsetIamnotsureweareinapositionthatweappropriateknowledgeof

whatthecorrectfunctionaltestsare.

20.Thisoverlapswiththequestiononclinicalexamination.Iamtoounfamiliarwiththistopictojudgethe

differencesinstrengthassessmentswithandwithoutinstruments.

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CoreDomainSetforTendinopathy:SurveyData

Thefollowingitemswereaboutdeleting,aggregating,addingorsplittingthedomainspreviously

presentedaboveinthesurvey:providedheretohelpwithdecisionsoneachdomainatthemeeting.

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CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:.

PercentAgree/Disagree/Unsure:36%/43%/21%

Domainasonsurvey:Adddomains?

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Arethereanyotherdomainsthatyouconsider

importantenoughtobeincludedinacoredomainsetfortendinopathy?

Committee’scomments:

Somenewdomainstoconsiderare:(i)co-morbidities(otherconditions,otherareasofpain),(ii)Family

history,(iii)somedomainthatcoverspersistency-previoustendinopathy,andtreatments,(iv)painconstancy

asopposedtointensity,(v)bothersomeness/impactofinterferenceofpain,(vi)durationofsymptoms.Many

oftheothersuggestionsarealreadyincludedinthedomains.Forexamplehealthcareconsumptioniscovered

undereconcostsandmedicationuse;andpatientsatisfactionissimilartopatientstatusasagenericoverall

domain,asopposedtoameasureofthatdomain.Thenthefollowingaredirectlyincluded:participation

(sportslevel,performance,sportsspecific),imaging/structure,andstartuppaininmorning(ie,24hourpain).

CommentsofAgreeresponders:

1.healthcareconsumptionbeforethestartofatrialandduringthetrial(othertreatments/visitstohealthcare

providers).Thiscouldalsobeimportantintermsofeconomicanalysisandfinallyforfundingpurposes-patient

satisfaction(excellent/good/moderate/poor)isnotexplicitlymentioned.Whileithassomedisadvantagesas

outcomemeasure,itishelpfulforpatientinformationbeforestartingatreatment.-thereisnoinformation

regardingtherecommendedtimepointswhenC-TOMsshouldbetaken,butitiscertainlyimportanttodiscussthis

aswell

2.Asmentionedabove,inthesportssetting,ourpastmeasureshavebeencrude(professional/amateurlevel,

divisionlevel,etc.).Ibelieveweneedtotrytomeasure/gradeperformancelevel(comparedtonormal

performance,teammateperformance,etc).

3.FamilyhistoryPrevioustreatments

4.familyhistoryoftendonconditionsandothersystemicconditions

5.Lengthoftimeofsymptoms.Thedataonself-limitedvspersistentnatureoftendinopathyiscontroversial.It

wouldbeimportanttogatherthesedata.

6.longtermimpactrecurrencelevelofparticipationconfidenceforshortmediumandlongtermparticipation

7.OnequestionIaskiswhatdoesyourtendonpainstopyoudoing.Thisisnotnecessarilylinkedtosportbutadds

tomyassessmentclinically

8.Painconstancy/frequency-thepaindomainsmentionedalreadyappearedtobeprimarilyrelatedtoseverityor

intensityofpain.Inclinicalpracticepatientsmaynotethatalthoughthepainseverityissimilar,theremayhave

beenasubstantialreductionintheamountoftimetheirpainispresent.Ibelievethisisausefulpaindomain.

9.Paininotherbodilyareas,eitherindividualareas(egneck)orsumofareas.Bothersomeness/impactor

interferenceofpainDurationofsymptoms

10.startuppainonrisinginmorning(likert)nightpain

CommentsofDisagreeresponders:

(nocomments)

CommentsofUnsureresponders:

11.Asanimager,Iamwonderingwhetheranyfeaturesrelatingtotendinopathyfromimaging(USorMRI)maybe

usefultoaddIFavailable.

12.Ialludedtotheutilisationinspecificcohortsofindependentlyratedsportsperformance,whichwouldalsobea

usefulsupplementaryratinginprofessionalsportonly.

13.Nonethatcurrentlycometomind-itwouldbegoodtostartwithaforementioneddomainsandworkfrom

there

14.sports-specificandtendon-specificmayneedtobeconsiderinacoredomainsetfortendinopathy.

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CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:.

PercentAgree/Disagree/Unsure:21%/43%/36%

Domainasonsurvey:Removedomains?

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:ArethereanydomainsthatyouconsiderareNOT

importantenoughtobeincludedinacoredomainsetfortendinopathy?Thatis,theyshouldberemovedfromthislistof

domains.

Committee’scomments:

Domainssuggestedforremoval:1discontinuetreatemtn/dropout,2sensorymodalitytests(x2),3palpation

(x3),4painwithclinicalappliedstress(x2),4structure/imaging(x4),5painwithoutcontextspecified(x2),6

clinexaminationfindingsasacombinedscore,7pover24hourperiod,8strength,9ROM(x2),10Function,

11physicalfunction,12Psychologicalimpact,13participationlife,

CommentsofAgreeresponders:

1.asanswered!

2.DiscontinuetreatmentSensorymodalitytestsPalpationPainwithclinicianappliedstressStructure

3.Imaging-againgiventhetheinconsistentrelationshipbetweenstructureandpainIamnotsurewecanjustifyas

acoredomainset.AlsoifacoredomainsetdoesthatmeanallHCP'smusttraininimagingmodalitiestoinclude

thisdomain?

4.StructurePainwithoutcontextspecifiedClinicianexaminationfindingsasacombinedscorePainovera24hour

periodStrength(muscle)RangeofmotionSensorymodalitytestsFunctionPhysicalFunctionPsychological

impactParticipation(life)

5.Thedomainsthatarenotcontextspecificormainlyinvolvearatingbytheclinician(i.e,Painwithoutcontext

specified,Clinicianexaminationfindingsasacombinedscore,RangeofmotionPalpation,Painwithclinician

appliedstress)

CommentsofDisagreeresponders:

6.Possiblypalpationbecausenotallcanbepalpatedeasily

7.Theyareworthyofconsideration.Answersaboverewhichwouldseemmostimportant.

CommentsofUnsureresponders:

8.Fromapracticalpointofviewitwouldbeimportanttokeepanyquestionnairemanageable/limited

9.Importantheretoalsoconsiderbothcoreandsupplementarydomains.Iconsiderpalpation,imaging(generally)

andthelessspecificactivitydomainscandidatesforremoval.

10.seerepsonsein1stsection

11.somecouldbecombinedegtheactivityones

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CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:.

PercentAgree/Disagree/Unsure:46%/7%/46%

Domainasonsurvey:Aggregateanydomains

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Shouldanyofthedomainslistedabovebe

aggregated(combinedintooneorfewerdomains)beforebeingincludedinacoredomainsetfortendinopathy?

Committee’scomments:

Somediscussionaroundwhatthedomainsmean(ratherthanthemeasures)intermsoftheconditionappears

necessaryasthereisconflationbetweenthetwoapparenthere.Forexamplepainanddisability,arethey

actuallyonedomainortwo?Function,disability,participationalsoappeartobeinneedofsome

considerationhere,asisdisability,QoLandpsychological.Perhapsbestconsideredforeachdomainasthey

areindividuallyconsidered.

CommentsofAgreeresponders:

1.AggregrationintothenextgroupsHistoryActivity&LoadPainFunctionClinicalexaminationImaging

Impact(Disability,psycholol,QOL,costs)

2.cantrememberexactlywhattheywerecalledsomeoftheclinicalexaminationandclinicalstresstestsseemto

overlap

3.Disability,function,physicalfunctionParticipation,work/sportparticipation,physicalactivity

4.Palpationandpainwithstress.Painquestionscouldbecombined.

5.Quiteafew.Disability,QoL,psychologicaleffect-couldbecoveredbyEQ5Dforexample

6.ROMcombinedintoclinicalexamination.

7.Severalofthepainandactivitydomainsarehighlyoverlappingandcouldperhapsbeaggregated.

8.Someofphysicalactivity&participationdomainsmaybeaggregatedandpossiblyloading/stresstestrelated

statementsalso

9.SportsparticipationandphysicalactivityFunctionshouldincludework,strength

10.Thereshouldbeonefunctionalcapacitydomainthatencompasses(a)function,and(b)physicalfunction.How

thisismeasuredisanothermatter,butthereshouldbeadomainforfunction,whichisdifferenttodisability-there

shouldbeadistinctionbetweenfunctionanddisability.Functionbeingabilityandcapacity.Thereshouldbe

considerationforoneparticipationdomainthatencompasses(a)'generallife'participation(life),(b)sport

participation,and(c)workparticipation.Thereasonbeingthatmeasuresthatcapturethis'participation'domainto

bevalid,discriminatingandfeasiblewillneedtocapturetheoverallparticipationrelevantfortheindividual,

regardless(orencompassing)iftheyareeliteathletes,non-athleticworkersorotherwise.These(functionand

participation)oughttobedifferenttophysicalactivitylevel.

11.Whereapplicable,Ifavorcombiningpainfunctionandsportsparticipation(asinVISAscores)

CommentsofDisagreeresponders:

(nocomments)

CommentsofUnsureresponders:

12.Aggregatinglessspecificdomainsachieveslittle(garbagein-garbageout!)Thatsaid,ifsomeofthemore

rigorousinstrumentscanbecombinedforaglobaleffectIwouldsupportthis,howeverbecauseofthesignificantly

differentcohortsencountered,(tendonaffected,activitylevel)applyingthisuniversallymaybechallenging.

13.IthinkthisistheperfecttopicformeetingThingsthatcometomindwouldbeQOL-psychologyParticipation-

sportsVariouspainmeasures

14.needsdiscussion

15.tendinopathyisthe"failure"onmultiplefactorsthatmaybetendon-specific,sport-specificandgender-specific.

Iamnotsurewhetherwecanfindaggregateddomains

Supplementary material Br J Sports Med

doi: 10.1136/bjsports-2019-100894–451.:444 54 2020;Br J Sports Med, et al. Vicenzino B

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CoreDomainSetforTendinopathy:SurveyData

Orderofagreeordisagree:.

PercentAgree/Disagree/Unsure:14%/43%/43%

Domainasonsurvey:Splittingdomains

ThedomainaslistedonthesurveyandEXAMPLEmeasuresforcontext:Shouldanyofthedomainslistedabovebefurther

splitupordividedintotwoormoredomainsbeforebeingincludedinacoredomainsetfortendinopathy?

Committee’scomments:

Commentsfromtheagreeresponderstoconsiderare(i)splittinguppsychologicaljustaspainhasbeen,and

(ii)strength,endurance,powerfordifferentfunctionsofmuscle.

CommentsofAgreeresponders:

1.Aspainissplitupintoseveraldomains,thedomainpsychologicalimpactcanalsobesplitup

2.Iconsiderstrengthandendurancebothmeasureofmuscle.Idonotthinkheel-risetestshouldbeconsidereda

functionthesamewayasjumpingetc.

3.Thedemandonatendonissport/activity-specific.Itmaybeworthinconsidersplittingthedomainaccordingto

differentsportgroup.e.g.jumping/landingsport(volleyballandbasketball);lungingsport(badminton/fencing)for

thelowerlimb.throwingsports(cricket,volleyball);racketsports(badminton,tennis);crawlingsports(swimming)

fortheupperlimb.Thedomainscanbedesignedinvolvingthekineticchainaccordingtosport-specific

requirement

CommentsofDisagreeresponders:

4.Enoughalready

5.Ifeeltheyareprettyspecificnow

CommentsofUnsureresponders:

6.ditto,toohardtoconsiderbasedonthesurveytodate

7.I'mnotquitesurewhatanexampleofthismightbe.Painonloadinganddisability/functionwouldhavea

numberoftendon-specifictasksassub-questions,butIwouldn'tconsidertheseseparatedomains.

8.Thereisacaseattimesforminingthetendonspecificinstrumentsforeffectofanintervention.ieinVISAX,

sportparticipationdidnotchangeover6-12weeksbutotherparametersdid...

Supplementary material Br J Sports Med

doi: 10.1136/bjsports-2019-100894–451.:444 54 2020;Br J Sports Med, et al. Vicenzino B

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CoreDomainSetforTendinopathy:SurveyData

Patientsurvey:

InBrisbaneandMelbourne(Australia),219patientparticipantsonthedatabaselistsofthreeresearch

centerswereaskedtocompletetheDomainssurvey(i.e.,emailedwiththelinktotheDomains

survey).56participants(26%)wenttothelinkand32(57%)thenprovidedconsenttocompletethe

survey.Onlythedomainssurveywassenttotheseparticipants.Theresponsesofthepatientsis

summarizedinTable3,andtheircharacteristicsareinTable3a.

ThegreencodinginTable3highlighttheitemsreaching70%agreement.Notethatthereareno

disagreementsreachingthe70%threshold.

Thesedataareprovidedforclinicianstoconsiderwhenreviewingthecliniciandataandinpreparation

fortheconsensusmeetinginGroningen.

Table3:Summarystatisticsofpatient*responsestotheDomainsSurvey(n=56)

Item Domain Responses(rate%) AgreeN(%) DisagreeN(%) UnsureN(%)

4 PainonActivityorloading* 32(57%) 31(97%) 0(0%) 1(3%)

11 Strength 32(57%) 29(91%) 0(0%) 3(9%)

10 QoL 32(57%) 29(91%) 1(3%) 2(6%)

5 Patientperceptionofcondition

status

32(57%) 29(91%) 2(6%) 1(3%)

18 Function 31(55%) 27(87%) 2(6%) 2(6%)

12 ROM^ 32(57%) 27(84%) 2(6%) 3(9%)

24 Physicalactivity 32(57%) 25(81%) 3(10%) 3(10%)

20 Psychologicalimpact 32(57%) 24(77%) 6(19%) 1(3%)

8 Clinicalexamfindings 32(57%) 24(75%) 4(13%) 4(13%)

21 Sportparticipation 32(57%) 23(74%) 5(16%) 3(10%)

22 Medicationuse 32(57%) 23(74%) 4(13%) 4(3%)

3 Disability* 32(57%) 22(69%) 3(9%) 7(22%)

9 Painover24hours 32(57%) 22(69%) 7(22%) 3(9%)

13 Palpation 32(57%) 21(68%) 5(16%) 5(16%)

19 Physicalfunction 32(57%) 21(68%) 5(16%) 5(16%)

23 Workparticipation 32(57%) 20(65%) 6(19%) 5(16%)

25 Participation 32(57%) 20(65%) 8(26%) 3(10%)

7 Painwithoutfurtherspecification 32(57%) 20(63%) 8(25%) 4(13%)

14 Painelicitedwithclinician

appliedstresstest

32(57%) 19(61%) 3(10%) 9(29%)

26 Discontinuetreatment 32(57%) 19(61%) 5(16%) 7(23%)

15 Adverseeffects/events 32(57%) 18(58%) 6(19%) 7(23%)

16 Economicimpact:costs 32(57%) 17(55%) 7(23%) 7(23%)

17 Sensorymodalityspecificpain 32(57%) 13(42%) 7(23%) 11(35%)

6 Structure 32(57%) 11(34%) 4(13%) 17(53%)

*Theseitemsreached70%agreementinthecliniciansurvey(i.e.,cliniciansindicatedthesetobeacoredomain

^Thisitemreached70%disagreementinthecliniciansurvey(i.e.,cliniciansdidnotthinkitacoredomain)

Supplementary material Br J Sports Med

doi: 10.1136/bjsports-2019-100894–451.:444 54 2020;Br J Sports Med, et al. Vicenzino B

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CoreDomainSetforTendinopathy:SurveyData

Table3a:Patientparticipantcharacteristicsofthecompletingthesurvey.

Characteristic N(%)

SexFemale(%) 24(77%)

Role:

Clinician 1(3%)

NeitherCliniciannorResearcher/Scientist 28(90%)

Other 2(6%)

Casespermonth:

0(Iamapatient) 29(94%)

Atleast4 1(3%)

Between11and15 1(3%)

Highestacademicqualification:

UndergraduateDiploma/Certificate 5(16%)

Bachelor 14(45%)

Master 4(13%)

PhD 5(16%)

Other 3(10%)

Currentlyhavetendonproblem: 26(84%)

Pasthistoryoftendonproblem: 21(68%)

Supplementary material Br J Sports Med

doi: 10.1136/bjsports-2019-100894–451.:444 54 2020;Br J Sports Med, et al. Vicenzino B