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PREVENTINGRECURRENTANKLE
SPRAINSTHEIMPLEMENTATIONEFFECTIVENESSOFTHE‘STRENGTHENYOUR
ANKLE’APP
MiriamvanReijen
2
ThestudiespresentedinthisPhDthesiswereconductedwithintheAmsterdam
CollaborationonHealth&SafetyinSportsandtheAmsterdamPublicHealthResearch
Institute,attheDepartmentofPublic&OccupationalHealthoftheAmsterdamUniversity
MedicalCenter,locationVUmc,theNetherlands.
TheworkpresentedinthisthesiswasfundedbytheDutchorganisationforhealth
researchanddevelopment(ZonMW),grantnumber525001003.
Englishtitle:Preventingrecurrentanklesprains:theimplementationeffectivenessofthe
‘strengthenyourankle’app.
Nederlandsetitel:Hetvoorkomenvanrecidiefenkelletsel:deeffectviteitvande‘Versterk
jeEnkel’app.
ISBN:978-94-6323-440-5
Coverpicture:BarbaraKerkhof.Reproducedwithpermissionofthecopyrightowner.
Coverdesign:EviannedeGroot
Printedby:Gildeprint–Enschede,theNetherlands
©2018MiriamvanReijen,theNetherlands
Allrightsreserved.Nopartofthisthesismaybereproducedortransmittedinanyformor
byanymeanswithoutpriorpermissionfromtheauthor,or,whenappropriate,the
publishersofthearticles.
3
VRIJEUNIVERSITEIT
PREVENTINGRECURRENTANKLESPRAINS
THEIMPLEMENTATIONEFFECTIVENESSOFTHE‘STRENGTHENYOUR
ANKLE’APP
ACADEMISCHPROEFSCHRIFT
terverkrijgingvandegraadDoctorofPhilosophy
aandeVrijeUniversiteitAmsterdam,
opgezagvanderectormagnificus
prof.dr.V.Subramaniam,
inhetopenbaarteverdedigen
tenoverstaanvandepromotiecommissie
vandeFaculteitderBewegingswetenschappen
opdinsdag15januari2018om11.45indeaulavandeuniversiteit,
DeBoelelaan1105
door
MiriamvanReijen
geborenteUtrecht
4
promotor:prof.dr.W.vanMechelen
copromotor:prof.dr.E.A.L.M.Verhagen
5
TABLEOFCONTENTS
CHAPTER1 Generalintroduction
7
CHAPTER2 Theimplementationeffectivenessofthe‘Strengthenyourankle’
smartphoneapplicationforthepreventionofanklesprains:designofa
randomizedcontrolledtrial�
13
CHAPTER3 CompliancewithSportInjuryPreventionInterventionsin
RandomisedControlledTrials:ASystematicReview
27
CHAPTER4 Increasingcompliancewithneuromusculartrainingtoprevent
anklespraininsport:doesthe‘Strengthenyourankle’mobileAppmakea
difference?Arandomisedcontrolledtrial
71
CHAPTER5 The"Strengthenyourankle"programtopreventrecurrent
injuries.Arandomizedcontrolledtrialaimedatlong-termeffectiveness.
87
CHAPTER6 Preventingrecurrentanklesprains:IstheuseofanAppmore
cost-effectivethanaprintedBooklet?ResultsofaRCT.
101
CHAPTER7 Evidencebasedanklesprainpreventioninyourpocket?Amixed
methods approach on user’s perspectives, opportunities and barriers of the
Strengthenyourankleapp.
117
CHAPTER8 GeneralDiscussion
135
SUMMARY
145
SAMENVATTING
148
DANKWOORD
151
OVERDEAUTEUR 153
6
7
CHAPTER1
Generalintroduction
one.
8
Aminorinjury?
Weexercise for the love of sport, for keeping fit, for losingweight or becauseweenjoy
spendingtimewithfriends.Whateverthereason,thereisnodiscussionthatregularexercise
benefits our health: both physically and mentally [1]. One could argue that the only
disadvantageofbeingphysicallyactiveistheriskofgettinginjured[2].Whileexerciseis
generallyadvocatedtocontributetooverallwell-being,itcomeswithahealthrisk,bothfor
theindividual,asforsocietyasawhole[2].Thatthisriskissubstantialisclearlyillustrated
bythefollowing:theDutchOBiNresearch(ongevallenenbeweginginNederland:accidents
and exercise in the Netherlands) calculated that the Netherlands has a population
participatinginsportofjustover12million.These12millionpeoplewereconfrontedwith
no less than 4.5 million injuries in 2013 only; 3.2 Million (69%) of those injuries was
classifiedasacute,and1.9millioninjuries(42%)wasmedicallytreated.Thebodypartsthat
aremostoftenaffectedbyaninjuryarethekneeandtheankle,withrespectively970.000
and680.000injuries.Thesinglemostcommoninjuryisananklesprain[3],whichmakesup
85%ofallankleinjuries(480.000).Apreviouscost-effectivenessstudy[4]hasshownthat,
disregardingtherequirementofmedicaltreatment,themeantotal(directandindirect)cost
of one ankle sprain amounts to approximately€360. This givesa rough estimate of the
annual(201C)sportsrelatedanklespraincostsintheNetherlandsof€183.6M.Inaddition
tosocietalcosts,thereisextensiveevidencethatthereisanuptotwofoldincreasedriskfor
anklere-injuryduringthefirst-yearpost-injury[5,6].Inabout50%ofallcasesrecurrences
mayresultindisability,canleadtochronicpainorinstabilityandmayrequireprolonged
medicalcare[5].Assuch,anklesprainsposeasignificantburdentotheindividualathlete
andtosociety.
Anefficacioussolutionathand
Previous research has shown that bothexternallyappliedankle supports (i.e. taping or
bracing), as well as neuromuscular training programs are successful in preventing
recurrentcasesofanklesprain,bothfromaneffectiveness,aswellasacost-effectiveness
perspective [7,8,9].While suchmeasures have not been linked to a primary preventive
effect,thesemeasurescanreducetheincreasedriskofrecurrentinjurytothesamelevelas
never injured athletes. Therefore, in most current treatment guidelines, secondary
preventive measures - preferably through continued neuromuscular training - are
recommendedafterrehabilitation.Notonlyhavethesesecondarypreventiveeffortsshown
to be efficacious, they are also associatedwith high short-term (i.e. 1 year) returns on
investment.Theneuromuscularprogramthatisthecentreofthisthesishasbeenlinkedto
a€100net returnforeachinterventionpackagehandedout[8].The ‘VersterkjeEnkel’
neuromuscular training program consists of six exercises taking all together eighteen
minutes,thatshouldbeperformedthreetimesaweekoveraneight-weekperiod.Withthe
useofadetailedscheduletheuserischallengedtoincreasethedifficultyoftheprogram
overtime.
9
Efficaciousbutwithouteffect
Althoughthisprogramhasbeenshowntobeeffectiveinreducingrecurrentanklesprains,
large-scalecommunityuptakeofthepreventivemeasureislaggingbehind.Thisisdespite
the high prevalence of ankle sprains, and despite an active stand by various Dutch
stakeholders–suchassportsfederations,generalpractitioners,physiotherapistsandthe
NationalOlympicCommittee-inimplementingtheneuromusculartrainingprogram.The
lackofwidespreaduptake,resultsinthefactthatanklesprainscontinuetomakeupalarge
percentageofallsportinjuries.TheDutchinjuryrates,registeredbytheDutchConsumer
SafetyInstituteVeiligheidNL[3],showedthatanklesprainrateshavebeenconsistentover
thepastyears.
Whiletheneuromuscularprogramhasbeenproven(cost-)effective[8,9]compliancewith
theprogramispoor[9].Infact,thepreventiveeffectinthesestudieswasachievedonlyin
a subsample of compliant participants showing significant population effects.However,
analysesweredonefromanintention-to-treatapproach,implyingthatthereismuchtogain
atbothanindividualasapopulationlevelbyincreasingcompliance.
Acontemporaryapproachtotheproblem?
Ithasbeen increasinglyacknowledged thatpreventive interventionsshouldnotonlybe
basedonevidence-basedmedicinebutshouldincludealsouser’sopinionsandbarriers[15,
16]. In this thesis, the study population varied from elite athletes aiming for top
performance to elderly peoplewhosemainaimwas tocontinue theiractivities of daily
livingwithoutdifficulties.Interventionsforsuchadiversepopulationshouldbesuitedfor
all those involved. In previous studies from this research group it was concluded that,
althoughtheprogramwaseffective,methodsofimplementationshouldbeimprovedtoend
upwithaninterventionwiththelowestbarrierspossibletoeverydayuse[2].
Inanattempt tobridge this so-called implementationgap,VeiligheidNL looked into the
possiblefeasibilityofnew(social)mediaininjuryprevention.Afreelyavailableinteractive
App(‘VersterkjeEnkel’;availableforiOSandAndroid)wasdevelopedthatcontains-next
to general advice on bracing and taping - the cost- effective neuromuscular training
programpreviouslydevelopedby this researchgroup. It isgenerallyassumed that such
interactive, online andmobilemethods of information transfer are theway forward in
preventionandimplementationefforts.However,thishasnotyetbeenformallyestablished
fortheuptakeofevidence-basedinjurypreventivemeasures.Whilenumerousmobileapps
areavailable,only fewcontainpreventionadvice that isactually supportedbyscientific
evidence[17].Furthermore,althoughuserreviewsarepositive-the‘VersterkjeEnkel’App
has not been evaluated against the well-studied ‘regular’ approach to advocate the
neuromuscular training program by making use of printed and DVD materials. If the
‘Versterk je Enkel’ App indeed does increase intervention uptake, thiswill provide the
necessaryvalidationtofurtherdevelopandenhancethispromisingroleofnewmediain
theimplementationofpreventivemeasuresandinterventions.
10
Theoutlineofthisthesis
Theaimofthisthesiswastoevaluatetheimplementationvalueofthe‘VersterkjeEnkel’
App as compared to the usual practice of providing injured athletes with ‘ordinary’
materials. The premise was that use of the ‘Versterk je Enkel’ App would increase
compliance to the prescribed programand, consequently, would decrease ankle sprain
recurrenceincidence.
Chapter2 contains the studydesign article thatwas publishedduring initiation of thecurrentstudy.
In chapter 3 one can find a review study inwhich themain features of 100 RCTs aredescribedthatdealwithsportinjuryprevention.Themaintopicofconcerned‘howsport
injurystudiesdealwiththeconceptofcompliance’.Itwasalsolookedathowcompliance
was defined, measured and reported and what effect compliance rates had on the
effectivenessofpreventiveinterventions.
Chapter4Thestudypresentedinthischapterevaluatedwhetherthe‘VersterkjeEnkel’applicationresultedininahighercompliancetothetotheembeddedprescribed8-week
exerciseprogram,andwhethertherewasadifferenceinprogrameffectivenessbetween
groupsofusersthathadusedtheprograminitsoriginalpaperform,versusaninteractive
appform.
Chapter5reportsthelong-termstudyresultsofa12-monthfollow-upduringwhichtheneuromuscular training program was no longer continued. During these 12 months,
recurrentinjuriesinthestudypopulationwereanalysedbymonthlyonlinequestionnaires.
Themainquestionofthischapterwasiftherewasadifferenceinanklesprainrecurrence
incidenceratesbetweenthegroupapplyingthe‘VersterkjeEnkel’Apporthegroupusing
writtenmaterials.
Inchapter6astudyisdescribedinwhichthecost-benefitoftheinterventionwasanalysed.Thischapterfocusedontwoquestions.Firstly,isthereadifferenceindirectandindirect
costsduringa12-monthfollow-up,betweengroupsapplyingthe ‘VersterkjeEnkel’App
and written materials? And secondly, is there a difference in ankle sprain residual
complaints(i.e.instability,feelingofgivingway,pain,andcontinuedsportsparticipation)
after a 12-month follow-up, between groups applying the ‘Versterk je Enkel’ App and
writtenmaterials?Thischaptergivesinsightinthecost-effectivenessoftheinterventionas
comparedtousualcare.
Chapter7presentsaqualitativeevaluationoftheneuromusculartrainingprogramwhichis based on semi-structured interviews and open questionnaires. By means of the
interviews and open questionnaires, the barriers and facilitators that affected program
compliancewereevaluated.Inaddition,thesubjectiveuserexperienceofthe‘Versterkje
Enkel’Appandthewrittenmaterialswasexamined.
Finally, in chapter 8 the general discussion presents an overview of themain results,discussesmethodologicalissuesandprovidessuggestionsforfutureresearch.
11
REFERENCES
1. WarburtonDER,NicolCW,BredinSSD.Healthbenefitsofphysicalactivity:the
evidence.CMAJ2006.14:174(6):801-809
2. VerhagenE,BollingC,FinchCF.Cautionthisdrugmaycauseseriousharm!Why
wemustreportadverseeffectsofphysicalactivitypromotion,BrJSportsMed2015
Jan;49(1):1-2
3. ConsumentenVeiligheid.Enkelblessuresdoorsport.Availableat:http://www.
veiligheid.nl/sportblessures/kennis/cijfers-over-sportblessures.VisitedOctober28,
2017.
4. VerhagenEALM,HupperetsMDW,FinchCF,etal.Theimpactofadherenceon
sportsinjurypreventioneffectestimatesinrandomisedcontrolledtrials:Lookingbeyond
theCONSORTstatement.JSciMedSport.2011;14(4):287–92.
5. VerhagenEALM,VanTulderM,VanderBeekAJ,etal.AnEconomicalEvaluation
ofaProprioceptiveBalanceBoardTrainingProgramforthePreventionofAnkleSprains
inVolleyball.BrJSportsMed2005:39(2);111-115.
6. BahrR,BahrIA.Incidenceofacutevolleyballinjuries:aprospectivecohortstudy
ofinjurymechanismsandriskfactors.ScandJMedSciSports1997;7:166-71.
7. VerhagenE,BayK.Optimisinganklesprainprevention:acriticalreviewand
practicalappraisaloftheliterature.BrJSportsMed.2010;44(15):1082–1088.
8. HupperetsM,VerhagenE,HeymansM,etal.Potentialsavingsofaprogramto
preventanklesprainrecurrence:economicevaluationofarandomizedcontrolledtrial.
AmJSportsMed2010;38(11):2194–2200.
9. HupperetsM,VerhagenE,VanMechelenW.Effectofunsupervisedhomebased
proprioceptivetrainingonrecurrencesofanklesprain:randomisedcontrolledtrial.BMJ
2009;339:b2684.
10. KluglM,ShrierI,McBainK,etal.Thepreventionofsportinjury:ananalysisof
12,000publishedmanuscripts.ClinJSportsMed.2010Nov;20(6):407–12.
11. McKayCD,VerhagenE.Complianceversusadherenceinsportinjuryprevention:
whydefinitionmatters.BrJSportsMed50:7:382-383
12. SteffenK,EmeryCA,RomitiM,etal.Highadherencetoaneuromuscularinjury
preventionprogramme(FIFA11+)improvesfunctionalbalanceandreducesinjuryriskin
Canadianyouthfemalefootballplayers:aclusterrandomisedtrial.BrJSportsMed.2013
Aug1;47(12):794–802.
13. SabatéE.AdherencetoLong-termTherapies.WorldHealthOrganization;2003.
12
14. SchulzKF,AltmanDG,MoherD.CONSORT2010statement:updatedguidelinesfor
reportingparallelgrouprandomisedtrials.BMCMed.2010;23(340):c332.
15. HansonD,AllegranteJP,SleetDA,FinchCF.Researchaloneisnotsufficientto
preventsportsinjury.SportsMed2014:48:682-684
16. GreenL.Fromresearchtobestpracticesinothersettingsandpopulations.AmJ
HealthBehav.2001.35:165-178
17. VanMechelenDM,VanMechelenW,VerhagenEALM.Sportsinjurypreventionin
yourpocket?!Preventionappsassessedagainsttheavailablescientificevidence:areview.
BrJSportsMed2014.48:878-882
13
CHAPTER2 Theimplementationeffectivenessofthe‘Strengthenyourankle’smartphoneapplication
forthepreventionofanklesprains:designofarandomizedcontrolledtrial�MiriamvanReijen
IngridVriend
VictorZuidema
WillemvanMechelen
EvertVerhagen
BMCMusculoskeletalDisorders2014Digitalobjectidentifier(doi):10.1186/1471-2474-15-2
two.
14
ABSTRACT
Anklesprainscontinuetoposeasignificantburdentotheindividualathlete,aswellasto
societyasawhole.However,despiteanklesprainsbeingthesinglemostcommonsports
injury and despite an active approach by various Dutch organisations in implementing
preventivemeasures,large-scalecommunityuptakeofthesepreventivemeasures,andthus
actualpreventionofanklesprains,islaggingwellbehind.
In an attempt to bridge this implementation gap, the Dutch Consumer Safety Institute
VeiligheidNL developed a freely available interactive App (‘Strengthen your ankle’
translatedinDutchas:‘Versterkjeenkel’;availableforiOSandAndroid)thatcontains-
next to general advice on bracing and taping - a proven cost-effective neuromuscular
program. The ‘Strengthen your ankle’ App has not been evaluated against the ‘regular’
preventionapproachinwhichtheneuromuscularprogramisadvocatedthroughwritten
material. Theaimof the current project is to evaluate the implementation value of the
‘Strengthenyourankle’Appascomparedtotheusualpracticeofprovidinginjuredathletes
withwrittenmaterials.Inaddition,asasecondaryoutcomemeasure,thecost-effectiveness
willbeassessedagainstusualpractice.
Theproposedstudywillbearandomisedcontrolledtrial.Afterstratificationformedical
caregiver, athletes will be randomised to two study groups. One group will receive a
standardizedeight-weekproprioceptive trainingprogram[10,11] thathasproven tobe
cost-effectivetopreventrecurrentankleinjuries,consistingofabalanceboard(machU/
MSGEuropeBVBA),andatraditionalinstructionalbooklet.Theothergroupwillreceivethe
same exercise program and balance board. However, for this group the instructional
bookletisexchangedbytheinteractive‘Strengthenyourankle’App.
Thistrialisthefirstrandomizedcontrolledtrialtostudytheimplementationeffectiveness
ofanAppforproprioceptivebalanceboardtrainingprogramincomparisontoatraditional
printedinstructionbooklet,withtherecurrenceofanklesprainsamongathletesasstudy
outcome.Resultsofthisstudycouldpossiblyleadtochangesinpracticalguidelinesonthe
treatment of ankle sprains and in the use ofmobile applications for injury prevention.
Resultswillbecomeavailablein2014.
Keywords:Mobilehealth,Anklesprains,Ankleinjury,Prevention,Neuromusculartraining
Trialregistration
TheNetherlandsNationalTrialRegisterNTR4027.TheNTRispartoftheWHOPrimary
Registries.
15
BACKGROUND
Anklesprainsarethemostcommonsportsandphysicalactivity(PA)relatedinjury[1-3].
Ithasbeenestimated thatapproximately25%ofall injuriesacrossall sportsareankle
injuries.Ofallankleinjuries85%involvethelateralankleligaments,i.e.acutelateralankle
sprains[3].IntheNetherlands,themostrecentcountofsportsinjuriesshowedthatthere
is an estimated absolute number of 3.7M acute sports injuries each year in a sporting
populationof11Mathletes [4].Ofall annual sports injuries,approximately530,000are
ankle sprains, of which almost 40 per cent requires (para)medical treatment [5]. Our
researchgrouphaspreviouslyshowninacost-effectivenessstudy[6]that,disregardingthe
requirementofmedicaltreatment,themeantotal(directandindirect)costofoneankle
sprainisapproximately€360.Thiswouldgivearoughestimateoftheannualsports-related
ankle sprain costs in the Netherlands of €190,800,000. In addition, there is extensive
evidencethatthereisanuptotwofold-increasedriskforanklere-injuryduringthefirst
yearpost-injury[6,7].Infiftypercentofallcasesrecurrencesmayresultindisabilityand
canleadtochronicpainorinstability,requiringprolongedmedicalcare[8].Assuch,ankle
sprainscontinuetoposeasignificantburdentotheindividualathlete,aswellastosociety
asawhole.
Researchhasshownthatbothexternallyappliedsupports(i.e.tapingorbracingof
theankle),aswellasneuromusculartrainingprogramsareverysuccessfulinpreventing
recurrent ankle sprains, both from effectiveness, as a cost-effectiveness perspective
[3,9,10].Whilesuchmeasureshavenotbeenclearlylinkedtoaprimarypreventiveeffect,
the increased risk of recurrent injury can be reduced to the same level as previously
uninjuredathletes.
Therefore, in all current ruling treatment guidelines secondary preventive
measures-preferablythroughcontinuedneuromusculartraining-arerecommendedafter
rehabilitation. These secondary preventive efforts regarding ankle sprains have been
associatedwithhighshort-termreturnsoninvestment.Theneuromuscularprogramthat
willbethecentreoftheproposedproject,hasbeenlinkedtoa€100netreturnforeach
interventionpackagedistributed[10].
However,despiteanklesprainsbeingthesinglemostcommonsportsinjuryand
despite an active approach by various Dutch organizations in implementing effective
preventive measures and interventions, large-scale community uptake of preventive
measures,andthusactualpreventionofanklesprains,islaggingwellbehind.Thischallenge
can be derived from the Dutch injury rates registered by the Dutch Consumer Safety
Institute VeiligheidNL [5], indicating that ankle sprain rates, treated at hospitals’
EmergencyDepartments, areconsistent over the past years. Inaddition, the previously
mentionedneuromusculartrainingprogram,thathasbeenproveneffective[8]andcost-
beneficial[6],hasbeenshowntohavepoorcompliance[12].Infact,thepreventiveeffect
informerstudieswasachievedinasubsampleofcompliantathletes,neverthelessshowing
significantpopulationeffects.Althoughanalyseshavebeendonefromanintention-to-treat
approach,thisshowsthereisalottogainatanindividualaswellasapopulationlevelby
increasingcompliancetothesesimpleandeffectivemeasuresthatarebeingadvocatedin
varioustreatmentguidelines.
16
Inanattempttobridgethisimplementationgap,VeiligheidNLlookedintothepossiblerole
ofnew(social)mediaandhasdevelopeda freelyavailable interactive ‘Strengthenyour
ankle’App;availableforiOSandAndroid)thatcontains-nexttogeneraladviceonbracing
andtaping-thecost-effectiveneuromuscularprogram,asevaluatedinaprevioustrial.This
Appprovidestheuserwithvideosandaninteractiveneuromuscularexerciseschedule.It
isageneralbeliefthatsuchinteractive,onlineandmobilemethodsofinformationtransfer
arethewayforwardinpreventionandimplementationefforts.However,thishasnotyet
beenformallyestablishedfortheuptakeofinjurypreventivemeasures,and-althoughuser
reviewsarepositive-the‘Strengthenyourankle’Apphasnotbeenevaluatedagainstthe
well-studied‘regular’approachtoadvocatetheneuromuscularprogramthroughwritten
materials. Furthermore, if the ‘Strengthen your ankle’ App indeed does increase
intervention uptake this will provide the necessary validation to further develop and
enhancethispromisingroleofnewmediaintheimplementationofpreventivemeasures
andinterventions.
OBJECTIVES
Theobjectiveofthisrandomisedcontrolledtrialistoevaluatetheimplementationvalueof
the ‘Strengthenyourankle’Appascomparedtotheusualcommonpracticeofproviding
injuredathleteswithwrittenmaterials.
Ourhypothesisisthattheuseofthe‘Strengthenyourankle’Appwillincreasecompliance
totheprescribedneuromusculartrainingprogramand,consequently,willdecreaseankle
sprainrecurrenceincidence.
Specificresearchquestionsthatwillbeansweredare:
• Whatisthecompliancetotheprescribed8-weekexerciseprogramviatheAppandviawrittenmaterial?
• Isthereadifferenceinprogramcomplianceratesbetweenthe‘Strengthenyourankle’Appandwrittenmaterials?
• Is there a difference in ankle sprain recurrence incidence rates during a 12-monthfollow-up, between groups applying the ‘Strengthen your ankle’ App and written
materials?
• Isthereadifferenceindirectandindirectcostsduringa12-monthfollow-up,betweengroupsapplyingthe‘Strengthenyourankle’Appandwrittenmaterials?
• Isthereadifferenceinanklesprainresidualcomplaints(i.e.instability,feelingofgivingway, pain, and continued sports participation) after a 12-month follow-up, between
groupsapplyingthe‘Strengthenyourankle’Appandwrittenmaterials?
• Whatis theparticipants’userexperienceof the ‘Strengthenyourankle’Appand thewrittenmaterials?
17
METHODS
Design
Theproposedstudywillbearandomisedcontrolledtrial.Thestudydesignandflowofthe
athletes are shown in Figure 1. The study design, procedures and informed consent
procedurewere approved by the Medical Ethics Committee (no. 2013/248) of the VU
UniversityMedicalCenterAmsterdam(VUmc),theNetherlands.Thetrialisregisteredin
theNetherlandsTrialRegistry(NTR4027).
Participants
Activeparticipants(athletes),between18and70yearsofage,whohavesustainedanankle
sprainwithinthepasttwomonths,areeligiblefor inclusion.Respondersareexcludedif
theyhavesufferedfromaninjurydifferentfromalateralanklespraininthesameankle
(e.g.fractureoftheankle)inthepreviousyear.Athletesshouldownamobilephonewith
eitherAndroidofiOS.Athleteswillberecruitedthroughparticipatingcaregivingpractices,
websitesfromnationalsportfederations,newsletters,anopeninvitationviatheInternet
andthroughthecommunicationchannelsofparticipatingsportassociations.
STUDYOUTLINE
Randomisationprocedure
Afterathleteshave finishedanklesprain treatmentbymeansofusual care, theywillbe
randomised to one of the two study groupswith stratification for initial treatment (i.e.
medicalornon-medical).Randomisationwilltakeplaceattheendoftreatment.Thiswill
minimise the risk of allocation bias. In addition, thiswill provide room to contact the
medicalcareprovider(s)involvedintheathletes’treatment.Medicalcareproviderswillbe
informedaboutthestudyinwhichtheathletepartakesandwillbeaskedtofollowtheir
usual treatment and/or rehabilitation program. Furthermore, they will be asked to
encourage the athlete to take up their allocated intervention program after treatment
and/orrehabilitationhasceased.
Athletesallocatedtothe ‘regular’ interventiongroupwillreceiveastandardized
eight-weekproprioceptivetrainingprogram,consistingofabalanceboard(machU/MSG
EuropeBVBA),andaninstructionalbooklet.Thisprogramhasbeenshowntobeeffective
inreducingrecurrenceinjuryriskinpreviousrandomizedcontrolledstudies[9,10].
Athletesallocatedtothe‘App’groupwillalsoreceiveabalanceboard(machU/MSG
EuropeBVBA),butthestandardizedeight-weekproprioceptivetrainingprogramwillbe
provided through an interactive smartphone application, which is freely available for
Android and iOS users. These two platforms are the most commonly used operating
systemsonsmartphones(ofallsmartphones79,3%runsonandroid,13,2%oniOS)(18).
Thereby,selectionbiasisconsideredminimal.Allathletesreceivethesamebalanceboard.
Boththeinstructionbookletandthe‘Strengthenyourankle’Appcontainthesametraining
programandsixbasicexercises(Figure2).
18
Figure1Studydesignandflowoftheathletes
19
Figure2Basicexercisesofthe‘Strengthenyourankle’proprioceptivetrainingprogram.
Baselinemeasurement
The online baseline questionnaire gathers information of each athlete on demographic
variables, physical characteristics, sports & injury history, use of preventive measures,
knowledge on injury prevention, severity of the current ankle sprain and subsequent
treatmentand/orrehabilitation.
Follow-upmeasurement
Afterthe8-weektrainingprogram,athleteswillreceiveanonlinefollow-upquestionnaire
to measure residual complaints of the initial ankle sprain and attitude towards the
prescribedexercises.Bothpainandfeelingofgivingwaywillbescoredonfive-pointLikert
scaleforaseriesofquestions.
20
Recurrent injuryincidenceandcostof injuryoutcomeswillbemeasuredoncea
monthforatotalperiodof12months.Thefollow-upmeasurementswillgatherinformation
foreachathleteonanklesprainssustainedduringtheprecedingmonth,includingdetails
andmechanismsofthissprainandabsencefromsportsduetotheanklesprainrecurrence
as ameasure of recurrence severity. Finally, these online follow-upquestionnaireswill
measureresidualcomplaintsoftheinitialanklesprain.Bothpainandfeelingofgivingway
willbescoredonfive-pointLikertscaleforaseriesofquestions,e.g.doyoufeelpainwhen
beingactive,doyoufeelpainwhengettingoutofbedinthemorning,doyoufeelyourankle
givingwaywhenwalkingacross the street, etc. At the last follow-upmeasurement (12
months)residualcomplaintsoftheinitialanklesprainwillbemeasuredagaininallathletes.
Compliance
Compliance (primary outcome)measurementswill commence after randomisation (i.e.
aftertreatmentandatthestartoftheallocatedintervention)andwilltakeplaceweeklyfor
thedurationoftheprogram(8weeks).Thesemeasurementswillgatherinformationfor
eachathleteonthenumberandsetsofexecutedexercises.Inaddition,onlinequestionswill
beaskedregardingtheclarityoftheinstructionsprovided,difficultyoftheexercisesand
recurrenceofananklesprain.
Costdiary
In order to evaluate the cost-effectiveness of the allocated interventions, athleteswho
sustainananklesprain recurrencewillbecontactedbyphone toobtaininformationon
costs associated with treatment. Based on this information direct and indirect costs
resulting from the sustained ankle sprain recurrence will be calculated for use in an
economic evaluation. The economic evaluation will be performed from a societal
perspective.
Cost-effectivenessevaluation
Costs of the allocated intervention will include costs that are directly related to the
implementation of the allocated intervention program. These costs include thewritten
information materials, the development and maintenance of the application, and the
balanceboards.Inadditiontothecostoftheinterventionitself,directhealthcarecostswill
beincluded,i.e.costsofcarebyageneralpractitioner,physiotherapist,massagetherapist,
alternative therapist, sports physician or medical specialist (e.g., orthopaedic surgeon,
generalsurgeon);hospitalcare,useofdrugs(e.g.acetaminophen,ibuprofen)andtheuseof
medicaldevices(e.g.,crutches,tape,braces).Thecostsofdrugswillbeestimatedonthe
basisofpricesrecommendedbytheRoyalDutchSocietyofPharmacy(19).Also,indirect
costsresultingfromalossofproductionduetoabsenteeismfrompaidorunpaidworkwill
beincluded.Indirectcostsforabsenteeismfrompaidworkarecalculatedusingthefriction
costapproachof4months,basedonthemeanageandsexspecific incomeoftheDutch
21
population.Indirectcostsforproductivitylossofunpaidwork,suchasstudyandhousehold
work,costsareestimatedatashadowpriceof€8.30anhour(20).
Samplesize
Samplesizecalculationsarebasedupontheprimaryoutcomemeasurecompliance,andare
baseduponpreviouslyestablishedcomplianceratestothesameprogramwhenadvocated
throughwrittenmaterials[12].Fullcomplianceratesinthewrittenmaterials’groupare
expected tobearound25%.Adoublingof this rate to at least50% is considered tobe
clinicallyrelevant.Baseduponabetaof0.90andanalphaof0.05atotalof158athletesis
requireddividedacrossbothstudygroups.Inourexperiencefrompreviouscomparable
studiesthedropoutrateduringa12monthsfollow-upisabout20%.Thiswouldmeanthat
asampleof190athletesisneededpergroup.
Recruitmentofstudypopulation
Physical therapy and physician practices will aid in the recruitment of athletes.
Participatingpracticeswillbe instructedon theaim,backgroundandproceduresof the
study.Athletestreatedforananklesprainatparticipatingpracticeswillbeinformedofthe
study by their caregiver. Athletes willing to participate, will then be contacted by the
researchteambyphoneafterwhichtheywillenrolinthestudy.
Athleteswill also be recruited through the Internet.Callswill be placed on the
websites of associations of sports with a relatively high ankle sprain rate (volleyball,
handball,basketball,korfball,soccerandathletics),websitesoforganisationsparticipating
in this studyandonsports-relatedwebsites (e.g.www.meetingpoint.nl,www.runinfo.nl,
www.volleybalforum.nl,etc.).Wherepossible,existingmailing listsof sportassociations
willbeusedtocontactpotentialathletesdirectly.Inaddition,electronicnewsletterswillbe
usedforactiverecruitmentofathletes.
Thesamerecruitmentstrategyasdescribedabovehasbeenemployedsuccessfully
intwopreviousstudiesonthesametopic[13,14].Inbothstudiesalargersampleofinjured
athleteswassuccessfullyincluded,476and352athletesrespectively.
Oneofthedrawbacksofthismethodofinclusionisthatwehavenocontrolover
thetreatmentthatisbeinggivenorhasbeengivenforthecurrentanklesprain.Although
rulingguidelinesareconsideredusualcare,thisdoesnotnecessarilymeanthatcaregivers
areactuallyfollowingtheseguidelinesbythebook.Inclusionofathletesthroughalimited
numberofcontrolled(para)medicalcaregiverswoulddecreasethisproblem.However,as
wehavelearnedinpreviousstudies,inclusionthroughsuchchannelsisproblematicand
almostalwaysresultsinlowerinclusionratesthanexpected.Evenso,intheproposedstudy
wearelookingforathletestreatedbyavarietyof(para)medicalcaregivers.Meaningthat
intheproposedstudyarelativelylargenumberofdifferentcaregiverswouldneedtobe
found, informedonthestudy,andcontrolledasto theirgiventreatment.Lookingatthe
required number of athletes we believe thiswould prove an undoable and unrealistic
22
undertaking. Moreover, the proposed study is on the effect of secondary preventive
measuresthatarebeingappliedaftertreatmentbythe(para)medicalcaregiver.Whenthe
caregiverwouldperforminclusion,thismeansthatrandomisationneedstotakeplaceat
thelevelofthecaregiver.Thisfurthercomplicatesthestudydesign.
Usualcareasemployedinthecurrentstudy
Forthecurrentstudy,usualcareisdefinedasanycaretheathletemightseekorreceive
afterananklesprain.Wealsodefineself-treatmenttobeusualcareinthecurrentstudy.
Nexttotreatmentbya(para)medicalprofessional60percentofanklesprains-mostly
minor-isself-treatedbytheathlete(5).Consequently,theseathletesdonotreceivethecare
asdescribedinthebelowmentionedrulingguidelines.
Incasetheathletedoesreceive(para)medicalcare,therearetworulingmedical
guidelines for the treatment of ankle sprains in the Netherlands, i.e. the Royal Dutch
PhysiotherapyAssociation (KNGF)guideline (16)and theDutchInstituteforHealthcare
Improvement (CBO) guideline (17). The KNGF guideline, which is the most commonly
employed, aims at optimal functional recovery of the ankle, returning to full sports
participation and preventing recurrent ankle injuries. Rehabilitation consists of three
phases:phase1whichaimstoreducepainandswelling,phase2inwhichloadisgradually
increasedandfunctionality isre-establishedandphase3inwhichnormalaveragedaily
living (ADL) tasks are performed. After full rehabilitation athletes are advised to use
secondarypreventivemeasures.Whereaseliteathletescouldhavetreatmentdurationof
uptotwelveweeks,sixweeksareconsideredsufficientforamateurathletes,accordingto
theKNGFguidelines(16).
Forthepurposeofthecurrentstudywedonotinterfereintheathletes’choiceof
caregiverandthecaregivers’compliancetotherulingguidelines.
Statisticalanalyses
Allanalyseswillbecarriedoutaccordingtotheintention-to-treatprinciple.
Complianceratesbetweengroupswillbecomparedbymeansofamultivariate
linear regression analysis using compliance as a continuous dependent variable. Cox-
regressionanalysiswillbeusedtocompareanklerecurrenceriskbetweentheintervention
andthecontrolgroup.Absencefromsportswillbecomparedbetweenthetwogroupsusing
aMann-Whitneytest,sinceabsencefromsportsduetoaninjuryisnotnormallydistributed.
Forallanalyses,variableswillbecheckedforconfoundingand/oreffect-modificationand
willbeadjustedforaccordingly.
Meandirect,meanindirectandtotalcostswillbeestimatedandcomparedbetween
thetwogroups,bothforthecostsperathleteintheinjuredpopulationandforthecostsper
athlete in the total population. Because costs will not be normally distributed, 95%
confidenceintervalsforthedifferencesinmeancostswillbeobtainedbybias-corrected
andacceleratedbootstrappingwith2000replications.Differencesincostsanddifferences
23
inanklesprainrecurrenceswillbeincludedinacost-effectivenessratio,whichestimates
theincrementalcoststopreventoneanklesprainrecurrence.Confidenceintervalsforthe
cost-effectiveness ratio will be calculated with bootstrapping, using the bias-corrected
percentilemethodwith5000replications.Uncertaintyof this ratiowillbeevaluatedby
presentingacost-effectivenessplaneandsensitivityanalyseswillbeperformedtocheck
therobustnessoftheresults.Anacceptabilitycurvewillalsobepresented.
Impactofresults
Theresultsofthisstudycanpossiblyleadtoachangeinthetreatmentofanklesprains.
Positiveresultscanofferextendedpossibilitiesforimplementationoftheinterventionin
usualcare.Positivestudyresultscanalsoleadtochangesinthepracticalguidelinesonthe
treatmentofanklesprains.Furthermore, if the ‘Strengthenyourankle’Appindeeddoes
increaseinterventionuptakethiswillprovidethenecessaryvalidationtofurtherdevelop
and enhance this promising role of new media in the implementation of preventive
measuresandinterventions.
Resultsofthisstudywillbecomeavailablein2014.
Competinginterests
Theauthorsdeclarenocompetinginterest.
Authors’contributions
EV(e.verhagen@vumc.nl)conceivedtheresearchidea.MVR(m.vanreijen@vumc.nl)and
EVhavewrittentheprotocol.MVRwillscreenandincludepatients,performdataanalysis
and be the main author of articles on the primary aim of the study. IV
(i.vriend@veiligheid.nl), WVM (w.vanmechelen@vumc.nl) and VZ (v.zuidema@vumc.nl)
contributed to ideas in theprotocol.All authorshavereadandcommentedon thedraft
versionandapprovedthefinalversionofthemanuscript.
ACKNOWLEDGEMENTS
This study was funded by the Netherlands organisation for health research and
development(ZonMW),grantnumber525001003.
24
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2. FernandezWG,YardEE,ComstockRD(2007)Epidemiologyoflowerextremity
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5. VerhagenEALM,VanTulderM,VanderBeekAJ,etal.(2005)AnEconomical
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8. SanderE.(1980)Ligamentousinjuriestotheankle.AmFamPhys22:132-8.
9. VerhagenEALM,BayK(2010).Optimisinganklesprainprevention:acriticalreview
andpracticalappraisaloftheliterature.BrJSportsMed.44(15):1082–1088.
10. HupperetsM,VerhagenEALM,HeymansM,etal.(2010)Potentialsavingsofa
programtopreventanklesprainrecurrence:economicevaluationofarandomized
controlledtrial.AmJSportsMed38(11):2194–2200.
11. HupperetsM,VerhagenEALM,VanMechelenW(2009)Effectofunsupervisedhome
basedproprioceptivetrainingonrecurrencesofanklesprain:randomisedcontrolledtrial.
BMJJul9;339:b2684.
12. VerhagenEALM,HupperetsM,FinchC,MechelenWV(2011)Theimpactof
adherenceonsportsinjurypreventioneffectestimatesinrandomisedcontrolledtrials:
lookingbeyondtheCONSORTstatement.JSciMedSportJul.;14(4):287–92.
13. JanssenK,MechelenWV,VerhagenEALM(2011).Anklesbackinrandomized
controlledtrial(ABrCt):bracesversusneuromuscularexercisesforthesecondary
preventionofanklesprains.Designofarandomisedcontrolledtrial.BMCMusculoskelet
Disord.12:210.
25
14. HupperetsM,VerhagenEALM,MechelenWV(2008)The2BFitstudy:isan
unsupervisedproprioceptivebalanceboardtrainingprogram,giveninadditiontousual
care,effectiveinpreventinganklesprainrecurrences?Designofarandomizedcontrolled
trial.BMCMusculoskeletDisord.9:71.
15. DeBieRA,HendriksHJM,LenssenAF,vanMoorselSR,OprausKWF,Remkes
WFA,SwinkelsRAHM(1998)KNGFRichtlijn:Acuutenkelletsel.NederlandsTijdschrift
voorFysiotherapie108(supplement)
16. Consensusdiagnostiekenbehandelingvanhetacuteenkelletsel,CBO1999
17. PressreleaseIDC:Applecedesmarketshareinsmartphoneoperatingsystem
marketasAndroidsurgesandWindowsphonegains,accordingtoIDC.August7,2013.
Availableat:http://www.idc.com/getdoc.jsp?containerId=prUS24257413.VisitedAugust
12,2013
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specialist,exclusiefpsychiaters.Bijlagebijtariefbeschikkingnummer5600-1900-97.
Utrecht:CTG,1996.
19. OostenbrinkJB,BouwmansCAM,KoopmanschapMA,RuttenFF.Handleidingvoor
kostenonderzoek.Methodenenstandaardkostprijzenvooreconomischeevaluatiesinde
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26
27
CHAPTER3 CompliancewithSportInjuryPreventionInterventionsinRandomisedControlledTrials:
ASystematicReview
MiriamvanReijen
IngridVriend
WillemvanMechelen
CarolineFinch
EvertVerhagen
SportsMedicine2016Digitalobjectidentifier(doi):doi:10.1007/s40279-016-0470-8
three.
28
ABSTRACT
INTRODUCTION: Sport injury prevention studies vary in theway compliance with aninterventionisdefined,measuredandadjustedfor.
OBJECTIVE:To assess the extent bywhich sport injury preventionRCTs have defined,measuredandadjustedresultsforcompliancewithaninjurypreventionintervention.
METHODS:AnelectronicsearchwasperformedinMEDLINE,PubMed,theCochraneCenterof Controlled Trials, CINAHL, PEDro and SPORTDiscus. English RCTs, quasi-RCTs and
cluster-RCTwere considered eligible. Trials that involved physically active individuals,
examinedtheeffectsofaninterventionaimedatthepreventionofsportorphysicalactivity
relatedinjurieswereincluded.
RESULTS:Atotalof110studieswereincluded.Ofallstudies,71.6%mentionedcomplianceorarelatedterm,68.8%provideddetailsoncompliancemeasurement,and51.4%provided
compliancedata.Only19.3%analysedtheeffectofcomplianceratesonstudyoutcomes.
Whilestudiesusedheterogeneousmethods,pooledeffectscouldnotbepresented.
CONCLUSIONS: Studies that account for compliance demonstrated that compliancesignificantaffectsstudyoutcomes.Thewaycomplianceisdealtwithinpreventionsstudies
issubjecttoalargedegreeofheterogeneity.Validandreliabletoolstomeasureandreport
complianceareneededandshouldbematchedtoauniformdefinitionofcompliance.
KEYPOINTS:• Compliancetoinjurypreventioninterventionscansignificantlyaffectstudyoutcomes• Thereisconsiderableheterogeneityinthewaythatsportsinjurypreventionstudieshavemeasured,definedandreportedcompliance.Moreuniformityisneededinfuturestudiestobetterprogresssportsinjuryprevention.
29
INTRODUCTION
It iswidely recognized thatparticipation in regular sportsandphysicalactivityhas the
potentialtoimprovehealth[1].However,involvementinsuchactivitiesalsoentailsarisk
ofsustaininganinjury.Serioussportinjuriesthattakeaconsiderabletimetohealcanforce
thoseinvolvednotonlytowithdrawfromtheactivity,butalsotoseekmedicalcare,invest
in medication and assisting materials – such as tape, braces, crutches. They can even
preventsomeonefromcontinuingworkorstudyactivities.Asaresult,injuriesleadnotonly
toanindividualburden,butalsotosubstantialsocietaldirectandindirectcost[2].
Numerousstudieshavebeenperformedtoevaluatetheefficacyofinterventionstoprevent
sportinjuriesortoreducetheriskofrecurrentinjury[3].Althoughavarietyofefficacious
preventiveinterventionshavebeenproposed,implementationoftheseinterventionsfaces
thechallengeofpersuadingparticipantstofollowinstructionsasprescribed.Establishing
theeffectiveness ofany injury prevention intervention, requires knowledgeaboutwhat
percentage of the targeted population exactly complied with the prescribed protocol.
Especially in an intention-to-treat approach, insights into the compliance to the
interventionprovidesvaluable,andarguably,necessaryinformationtojudgetheefficacyof
anintervention[4].
When one incorrectly assumes that the entire study population has compliedwith the
intervention protocol, the preventive effect of any intervention can be either over- or
underestimated. Unfortunately, many different definitions of compliance have been
reported in the sports medicine literature [3]. Both the constructs of compliance and
adherencehavebeenusedinterchangeablytodescribethecompleteandcorrectfollowing
ofaprescribedintervention.Nonetheless,thetwotermsarenotsynonymous.Compliance
refers to participant obedience in a study where a clinician/researcher prescribes the
intervention,withlittletonorightofconsultationonbehalfoftheparticipant.Itcanthus
bedefinedas“theathletes’correctfollowingoftheprescribedintervention”.[4]Adherence
implicatesamorecollaborativeenvironmentinwhichaclinician/researcherandastudy
participant cooperate to develop an intervention that fits with the participants’
opportunitiesandrestraints[5,6].Research,ideallyperformedinamoreorlesscontrolled
setting,thereforeimplicitlyfocusesoncompliance,ratherthanonadherence.
In addition to using correct definitions, the operationalization of compliance requires
attention. A comprehensive assessment of study resultswill only be possible if there is
thoroughinsightintothewaycompliancehasbeendefined,measuredandadjustedfor.If
thereisno,orincomplete,informationavailableontheextenttowhichparticipantshave
compliedwiththeintervention,itwillremainunclearastowhethertheinterventionhas
beentrulyefficaciousornot.Therefore,itisimportantthatresearchers,whoaimtopresent
studiesofhighqualitywithalowriskofbias,acknowledgetheimportanceofcompliance,
andmeasureandreportuponcomplianceanditseffectsonstudyoutcomes.
Anumberofstudyreportingguidelines,suchastheSTROBEstatementandtheCONSORT
statement,recognizetheimportanceofcomplianceandincludespecificitemsonthetopic
intheirguidelines[7-9].
The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)
30
statement addresses cohort, case-control and cross-sectional studies: CONsolidatedStandardsOfReportingTrials(CONSORT)–specificallyaddressesthequalityofreportsofrandomizedcontrolledtrials(RCTs).
Until 2010, the CONSORT statement advocated the use of iIntention-tTo-tTreat (ITT)
analysisforrandomizedcontrolledtrials.Intention-to-treatanalysisdoesnotincludethe
measurementofcompliancebutassumesfulladherencetotheprescribedintervention[4].
However, asmentioned in the CONSORT statement, strict ITT analysis ‘is often hard to
achievefortwomainreasons:missingoutcomesforsomeparticipantsandnon-adherence
totheprotocol.Therefore,since2010,theCONSORTStatementhasreplacedthemention
ofITTbytherequirementof‘moreinformationonretainingparticipantsintheiroriginal
assignedgroups’[7].AsanalternativetoanITTanalysis,ithasbeensuggestedthatper-
protocol-analysis (PPA)– sometimesreferred toas ‘modified intention-to-treat’- canbe
used[4].Inthisapproach,theanalysisisperformedonlyonthoseparticipantswhohave
fullycompliedwiththeprogram.APPAcanprovideameasurementofefficacyinthat it
gives the result of a prescribedprogram that is implementedexactly as the researcher
originally has developed it. It is currently unclear towhat extent RCTs on sport injury
preventionhaveincludedtheguidelinesprovidedbytheCONSORTStatementandtowhat
extentcompliancemeasureshavebeenaddressed.Thissystematicreviewthereforeaims
toassess theextent towhichsport injurypreventionRCTshavedefined,measuredand
adjustedtheirresultsforcompliancewiththetrialledintervention/s.
METHODS
Researchquestions
This review answers the following questions to provide a detailed analysis on how
compliancehasbeenreportedinsportinjurypreventionstudies:
1) Howandhowoftenwascompliancedefined?
2) Whendefined,howwascompliancemeasured?
3) Whendefinedandmeasured,howwastheoutcomeadjustedforcomplianceintheanalysis?
Electronicsearches
Sevenelectronicdatabasesweresystematicallysearchedforpeer-reviewedpublicationson
sport injury prevention interventions: PubMed (to October 2014), MEDLINE (1966 to
October 2014), SPORTDiscus (1949 toOctober 2014), the CochraneCentral Register of
Controlled Trials (to October 2014), CINAHL – Cumulative Index toNursing and Allied
HealthLiterature(1982toOctober2014),PEDro–ThePhysiotherapyEvidenceDatabase
(toOctober2014)andWebofScience(toOctober2014).Astandardizedsearchstrategy,
31
basedonawordstring,includingrelevantsportsinjurytermsandstudydesigns,wasused.
Thefollowingkeywords,andvariouscombinationsofthosewords,wereusedinthesearch:
sport injury/ies, athletic injury/ies, prevention, preventive, preventi*, randomiz/s/ed,
randomiz/s/edcontrolledtrial.Referencelistsandrelatedcitationsofincludedstudiesand
relevantsystematicreviewswerealsohandsearchedforapplicablepublications.
Inclusioncriteria
OnlyRCTs,quasi-RCTsandcluster-RCTwereconsideredeligibleforinclusion.Thereason
for including only (cluster and/or quasi)RCTs is that these studies maximize internal
validitywhichcanbeseenasaprerequisiteforexternalvalidity.Trialswereincludedthat
involvedphysicallyactiveindividualsofeithersexandofallages.Tobeselected,studies
hadtoexaminetheeffectsofaninterventionaimedatthepreventionofsportorphysical
activityrelatedinjuries.Theprimaryoutcomeofthestudieshadtobeameasureofsports
or physicalactivity related injury (i.e. injury rate, time to first injury, or the number of
injuredindividuals).OnlyEnglishlanguagepublicationswereconsidered.
Exclusioncriteria
Studiesthatdidnotassesspreventionofsportsinjury,thatwerenotaRCT,quasi-RCTor
cluster-RCT or did not involve a physically active population were excluded from this
review.
Definitions
Compliance in this reviewwasdefinedas ”theathletes’ correct followingofaprescribedintervention”[4].Itisacknowledgedthatanumberoftermshavebeenusedinthescientificliterature, referring to comparable constructs. As such, for the purpose of this current
review,we considered all text referrals to participants’ following of an intervention as
compliance. Other examples of phrases equivalent to compliance commonly used in
publicationsare‘use’,‘cooperation’and‘adoption’[4].Inthisreview,allstudiesincluded
werescrutinizedthoroughlytoidentifythespecificform/phraseusedbytheauthors.This
ensuredthatallaccountsofcompliancewereincluded.
Methodologicalquality
Potentiallyeligiblestudieswereinitiallyscreenedbytitleandabstractbytheprimary
author.Wheneligibilitywasunclear,full-textarticleswereretrieved.Inordertoassess
themethodologicalqualityandriskofbias,allincludedstudieswereassessedbasedon10
outof12criteriaasrecommendedbyFurlanetal.[10].Theseincludedthemethodof
randomization,concealedallocation,blindingofparticipants,blindingofcareproviders,
blindingofoutcomeassessors,dropoutrate,analysisaccordingtoallocatedgroup,
baselinesimilarityofthegroups,complianceandtimingofoutcomeassessment.Thiswas
donetoassessifthereweredifferencesintheriskofbiasbetweenstudiesthatdidanddid
32
notreportcompliance.Itispossiblethatstudiesthatdidnotreportcompliance,alsofailed
toreportotherimportantmethodologicalanddesignproperties.Twocriteriawere
omittedfromFurlanetal.[10]:thereportingwithoutselectiveoutcomeandavoidanceof
co-interventionsasthesecriteriawherenotconsideredasdistinctiveforriskofbias
betweentheincludedstudies.
Eachcriterionwasscoredas‘yes’,‘unclear’or‘no’.Furlanetal.[10]definedstudieswith
morethansixpoints(yes=1point)ashaving‘lowriskofbias’.Astwocriteriawereomitted,
theoriginalscoringwasadjusted.Hence,morethanfivepointswasconsideredasthecut-
offfor‘lowriskofbias’.
Tofamiliarizetheauthorswiththeriskofbiasassessment,threereviewers(MvR,IVand
EV) scored ten studies that were randomly selected from all studies. Examining the
disagreement in the assessment of these 10 studies allowed the reviewers to identify
possible incongruities in scoring. Thereafter, the total number of studies (n=110) was
randomly divided in two equal size sets (n=55) and two reviewers (MvR and IV) both
independentlyassessedriskofbiasforoneset.Forthecodingreliabilityassessment,from
eachofthesets,19studieswererandomlyselected.Bothreviewersscoredthese38studies.
Itwasagreedthatiftheagreement(kappa)scoreforthese38studieswas>0.9,agreement
wasacceptableandtherewasnoneedforthereviewerstoscoreallstudiesseparately.Out
ofthe380itemsthatwerescoredtwice,therewasagreementon370items.Thisresulted
inanagreement(kappa)scoreof0.95.Basedonthishighlevelofagreement,itwasthus
decided that the remainder of themanuscripts did not needed to be assessed by both
reviewers.
Dataextraction
Onereviewer(MvR)scrutinizedtheincludedstudiesforalltermsreferringtocompliance.
Thereafter, for thestudies thatmentionedcompliance,detailsabout thedefinitions, the
methodsofcompliancemeasurementsand thecorrespondingoutcomeswereextracted.
Finally,allstudieswereexaminedforadjustmentofthemainoutcomeintheiranalysesby
compliancerates.
RESULTS
Searchresults
Thesearchstrategyinitiallyyielded1,902studies,ofwhich,atotalof289full-textarticles
wereretainedafterinitialscreeningforeligibility.Atotalof180studieswerethenexcluded
(Figure1),resultingin109studiesincludedinthisreview.Primaryreasonsforexclusion
werethatstudiesdidnotinvolveanRCTordidnotuseinjuryasanoutcomemeasure.For
five studies, full-text articles could not be retrieved [11-15]. Electronic Supplementary
Material Appendix S1 provides an overviewof the studies included in the final review.
Figure2describestheincludedstudiesintermsoftheirmentioningof,measurementof
and/oradjustmentforcompliance.
33
Fig.1:Literaturesearchflowchart
34
Fig.2:Annualtrendsincompliancereporting
Riskofbiasscores
The109includedstudiesscoredanaverageof4.1±1.8yesratings(outof10),2.8±1.3no
ratingsand3.3±1.8unknown(DK’s)ontheriskofbiasassessmentinstrument.Itcanthus
beconcludedthatingeneral,theincludedstudiesdemonstratedafairlyhigh‘riskofbias’.
The21studiesthatexplicitlyadjustedforcomplianceratesintheirstudyoutcomes–and
hencehadprovidedmostdetailsoncomplianceintheirreport-scoredanaverageof4.7±
1.6ontheriskofbiasassessment,comparedtoaveragescoresof3.9±1.8forthe88studies
that did not account for compliance. This suggests that the studies that accounted for
compliancehadaslightlyhighermethodologicalqualitythandidthosestudieswithoutsuch
adjustment. Electronic Supplementary Material Appendix S1, section I provides an
overviewoftheriskofbiasscoreofeachoftheincludedstudies.
10
23
6
11
21
33
24
Total number of studiesCompliance mentionedCompliance definedCompliance measuredCompliance adjusted for in analyses
Num
ber
of st
udie
s
0
5
10
15
20
25
30
35
Year of publication1970 - 1975 1976 - 1980 1981 - 1985 1986 - 1990 1991 - 1995 1996 - 2000 2001 - 2005 2006 - 2010 2011 - 2014
35
Compliance
Termsusedforcompliance
Ofallstudies,78(71.6%)mentionedcomplianceorarelatedterm.Mostcommonwasthe
use of the term ‘compliance’ (n=57, 52.3%). Other terms used were ‘use’ (n=8) and
‘adherence’(n=6)‘attendance’(n=2),‘cooperation’(n=1)and‘participation’(n=1).Some
studies usedmultiple terms by switching between ‘compliance’ and ‘adherence’ (n=2),
‘compliance’and‘exposure’(n=1)or‘compliance’and‘internaldrop-out’(n=1).Electronic
SupplementaryMaterialAppendixS1,sectionIIprovidesanoverviewofthetermsusedin
theincludedstudies.
Measurementsofcompliance
The majority of the 78 studies that mentioned compliance, 75 (68.8% of all studies
included) provided details on how they measured compliance. Compliance rates were
recorded through a diversity of methods. Studies that concerned supervised exercises
derivedcompliancerates fromawrittenoronline reportbya supervisor,e.g.a trainer,
coachordesignatedteammember(n=15):[16-30].Home-basedorindividualexercises
studiesmadeuseofawrittenoronlineself-report(n=12):[31-42].Instudiesrelatingto
theuseofprotectiveequipment(orthoses,wristprotectorsetc.)orsupplements,thisuse
was recorded by either the participant (n=4: [43-46]or a supervisor (n=5): [47-51]. In
fifteenstudies [47,52-65] thewearing/usageofprotectiveequipmentwasonlychecked
visually.Inthreestudies[52,54,62],alackofcompliancewithwearing/usageofmaterial
resultedinprohibitiontoparticipate;thesestudiesthereforesuggested100%compliance
forpeoplewhoremainedinthestudy.Forexample,theparticipantswhoweredesignated
towearahelmetduringfootballwerevisuallycheckedbeforetheyenteredthefield;non-
compliancewearingthehelmetresultedintheprohibitiontoplay[52].
In twenty-four studies, researchers verified the reported compliance rates bymultiple
methods.These includedcombiningself-reportwith thereportofa supervisor [66-70],
combiningareportofasupervisorwithrandomvisits[5,71-78],combiningareportofa
supervisorwithphonecallsandvisits[79-81],combiningself-reportwithrandomvisits
[82],combiningareportofasupervisorwithphonecallsandemails[83]orcombiningself-
reportwithphonecalls[71].
Thirty-onestudiesincludedinthisreviewwereconductedinamilitarysetting.Althoughit
mightbeexpectedthatamilitarysettingwouldmakeiteasiertoreportoncompliance–
withmanysupervisedactivitiesandahighlycompliantenvironment–thesestudiesdidnot
providemoredetailsoncompliancethanotherstudies.Slightlylessthanhalfofthemilitary
studies(n=14)provideddetailsoncompliancemeasurements.In8ofthese14studies,it
wasreportedthattheparticipantswerevisuallycheckedorsupervisedwhilecarryingout
theintervention.Twoofthoseeightstudiesprovidednofurtherdetailsoncompliancerates
[53,54], two studiesexcludedparticipants from theanalysiswhen they did not comply
[55,61] and the other four studies reported compliance rates between 57% and 100%
[47,56,57,60]. Electronic Supplementary Material Appendix S1, section III provides an
overviewofwaysinwhichstudieshavereportedcompliancerates.
36
Compliancedataandadjustmentsforcompliancerates
Ofthe75studiesthatprovidedinformationoncompliancemeasurement,only56studies
(51.4%ofall includedstudies)providedcompliancedata.Thesedatawerepresentedin
heterogeneous ways. Nine studies [5,16,67,71,74,79,81,84,85]created subclasses of
participants in which high, intermediate and low rates of compliance were defined.
However, the (arbitrary) cut-off percentage that was considered for high versus low
compliancevariedconsiderablybetweenstudies.
Forexample,inacluster-RCTontheFIFA11+injurypreventionprogram,low,middleand
highcomplianceweredefinedrespectivelyasperforming<24.7%,24.8-48.1%or>48.2%
ofallexercises[84].Thisresultedinthecategorizationof18%teamsinthelowcompliance
category,41%teamswithinthemoderatecompliancecategoryand41%teamsinthehigh
category. In another neuromuscular training intervention cluster-RCT, high compliance
wasdefinedascarryingoutthree(outof3)sessionsinafirstintensiveinterventionperiod,
twosessionsinthesecondinterventionperiodandonesessioninthethird/maintenance
period[16].Inthisstudy,36%oftheteamswereconsideredashighlycompliant,43%of
theteamsasirregularlycompliantand21%oftheteamsashavinginterruptedcompliance.
Otherstudieschoose to report compliance foreachplayer [5,73,75,79,81,84,86], for the
teamasawhole[17,19,20,72,74,75,78,79,81,87],oraseasonalcompliancerate[20,79].In
addition, some studies combined compliance rates of the intervention and the control
group, which were presented as one overall compliance rate [21,22,57,70,82,88,89].
ElectronicSupplementaryMaterialAppendixS1, section IVprovidesanoverviewof the
studiesthatreportedcompliancedata.
Inaddition toprovidingcompliancerates,amere21studies[5,16,17,20,31,32,43,58,67,
71,74,76,77,79,83-85,88,90,91], (19.3% of all included studies) analysed the effect of
differentcomplianceratesonstudyoutcomes.Asthestudiesusedheterogeneousmethods
to report theseanalyses, it is impossible toprovideapooledeffectof compliancerates.
Therefore,Table1presentsthedetailsoftheeffectofmeasuredcomplianceratesontheir
studyoutcomeinthese21studies.
Study Intervention Population(nintervention/ncontrol;%male)
Reportedcompliancerate(%)ingroupsbeingcompared
Analysisoftheeffectofcomplianceonstudyoutcome
Cobbetal.
[43]2007
Oral
contraceptives
Youngdistancerunners
(69/81,0%)
74.5%wereseenascompliant.Compliance
wasdefinedasusingmorethan6monthsof
oralcontraceptives.
Compliantwomenweresignificantlyprotectedagainst
fractures(by77%),thoughthisestimatewas
weakenedwhenweexcludedfracturesthatoccurred
earlyinthetrial(58%reductioninrisk,P=0.20).The
researchersdomentionthatthisfindingcouldhave
beentheresultofchanceorbiasasitwasfoundthat
womenwhoswitchedfromthecontrolgrouptooral
contraceptiveusewerelesslikelytohaveahistoryof
stressfracturesbeforejoiningthestudy.
Emeryetal.
[71]2005
Home-based
balancetraining
PEstudents
(66/61,50%)
Noreportofspecificcompliancerates Effectofcomplianceonstaticbutnotdynamicbalance.
Compliancewithbalancetrainingsessionshadaneffect
onthechangeinstaticbalance:theobservedchange
amongstudentsintheinterventiongroupwho
reportedfewerthan18sessionsover6weekswas
holdingtheirbalancefor6.1seconds(95%CI–8.4to
20.7),ascomparedwith25.8seconds(95%CI16.4to
35.1)amongthosewhoreported18ormoresessions.
Compliancedidnothaveasignificanteffectonchange
indynamicbalance.
Engebretsen
etal.[31]
2008
Exerciseprogram Soccerplayers
(315/193,100%)
Compliancewasdefinedascompleting
morethan30sessions:29.2%forknee
exercises,21.1%forhamstringand19.4%
forgroinexercises
Nodifferencewasdetectedintheriskofkneeinjury
betweenplayersinthehighriskinterventiongroup
whowerecompliantwiththekneeprogram(0.2[95%
CI,–0.2to0.7]injuriesper1000hours)andthehigh
riskplayersinthehighriskcontrolgroup(0.5[95%CI,
0.2-0.9]injuriesper1000hours;RR=0.46;95%CI,
0.1-3.7).Inthesameway,nodifferencewasobserved
intheincidenceofhamstring(RR=0.94;95%CI,0.3-
3.2)andgroininjuries(RR=1.6;95%CI,0.5-5.6)
betweenplayersinthehighinterventiongroupwho
werecompliantwiththerespectivetrainingprograms
andthehighcontrolgroup.
Gabbeetal.
[90]2006
Eccentric
hamstring
exercises
AmateurAustralian
Footballplayers
(114/106,100%)
46.8%participatedinmorethan2sessions Significantdifferenceduetocompliance.Whenonly
controlandinterventiongroupplayerswho
participatedinatleastthefirsttwosessionswere
analyzed,atrendtowardsaprotectiveeffectforthe
interventiongroupwasnoticed(RR0.3,95%CI:0.1,
1.4;p=0.098).Only4%ofthecompliantgroupsustainedaninjurycomparedto13.2%inthecontrol
group(nop-valuespecified).
Hagglundet
al.[74]
2013
Neuromuscular
trainingprogram
Soccerplayers
(2471/2085,0%)
79%teamcompliance.Teamcompliance
wasdefinedascompletingasupervised
neuromusculartraining.
Teamswiththehighestlevelofcompliance(89%)had
88%lowerriskofre-injuryratecomparedtocontrol
andlowcompliance(63%)teams.Lowandcontrol
werenotsignificantlydifferent.
Hupperets
etal.[32]
2009
Proprioceptive
training
Athleteswithanankle
sprain(256/266,52.4%)
Fullycompliant:23%,partiallycompliant
29%,non-compliant35%,unknown13%.A
definitionofcompliancewasnotprovided.
Althoughasignificantreductioninriskofinjurywas
foundinallgroups,theresearcherssuggestthata
highercompliancemighthaveresultedinfewer
recurrentinjuries.
Kianietal.
[20]2010
Exerciseprogram
+education
Soccerplayers
(777/729,0%)
6%ofplayerswere50%compliant,75%
were75%compliantand18%were100%
compliant.Adefinitionofcompliancewas
notprovided.
Includingonlycompliantteams:therewasanon-
significantdifferentrateratiointheinterventiongroup
comparedwithcontrolsforallinjuries(0.17(95%CI,
0.02-0.75))andfornoncontactinjury0.11(0.95%CI,
0.02-0.77).
1Inthisstudyparticipantswereassignedtothreedifferentstudygroups:thecontrolgroup,thestandardheadgeargroupandthemodifiedheadgeargroup.
Larsenetal.
[68]2002
Custommade
shoeorthoses
Conscripts
(77/69,99.3%)
88.3%overall(controlandintervention).A
definitionofcompliancewasnotprovided.
ITTanalysisgaveanRRof0.7(0.5-1.1)andPPA
analysisanRRof0.3(0.1-0.7)
Longoetal.
[83]2012
FIFA11+warm-
up
Basketballplayers
(80/41,100%)
100%compliance.Adefinitionof
compliancewasnotprovided.
Intheinterventiongroup,IID'swerelowerthanthose
inthecontrolgroupforoverallinjuries(0.95vs2.16;P=.0004),traininginjuries(0.14vs0.76;P=.007),lowerextremityinjuries(0.68vs1.4;P=.022),acuteinjuries(0.61vs1.91;P=.0001),andsevereinjuries(0vs0.51;P=.004).Theinterventiongroupalsohadlowerinjuryratesfortrunk(0.07vs0.51;P=.013),leg(0vs0.38;P=.007),andhipandgroin(0vs0.25;P=.023)comparedwiththecontrolgroup.Differencesin
matchinjuries,kneeinjuries,ankleinjuries,and
overuseinjuriesbetween2groupswerenotsignificant.
Macholdet
al.[58]
2002
Wristprotectors Students
(342/379,60%)
96.5%Adefinitionofcompliancewasnot
provided.
Theriskofseverewristinjurydecreasedbyafactor
0.13usingtheprotector.
McIntoshet
al.2009
[76]
Paddedheadgear Rugbyplayers
(1493/1128/1474/100%)1
Standard:48.9%,modified:40.1%.
Compliancewasdefinedaswearing
headgear.
Headinjuryandconcussionratesbasedonheadgear-
wearingcompliancewerenotsignificantlydifferent.
Myklebust
etal.[17]
2007
Neuromuscular
training
Handballplayers
(850/942,0%)
1stseason26%&42%elite,2ndseason29%
&50%elite,youth87%.Compliancewas
definedasconductingaminimumof15ACL
injurypreventionsessionsduringthe5-7
weekperiodwithmorethan75%ofthe
athletesparticipating.
Therewasdownwardtrendinthenumberofinjuries
duringthestudyperiod,ascomplianceseemedto
improve.Duetoacrossovereffectof22%,bothteams,
showedasignificantlowerrateofinjuries.
Pasanenet
al.[16]
2008
Neuromuscular
training
Floorballplayers
(256/201,0%)
74%Highcompliancewasdefinedas
carryingoutatleastthreetrainingsaweek
duringthefirstintensiveperiod,atleast
twiceaweekduringthesecondintensive
period,andatleastonceaweekduringthe
maintenanceweeks.
Interventionteamswithhighcompliancetothe
neuromusculartraininghadalowerriskofinjurythan
thecontrolgroup:theincidencerateratiobetweenthe
highcompliancegroupandcontrolgroupfornon-
contactleginjurywas0.19(95%confidenceinterval
0.06to0.64,P=0.007),fornon-contactankleligament
injury0.19(0.05to0.82,P=0.026),andfornon-contact
kneeligamentinjury0.32(0.04to2.59,P=0.284).
Ronninget
al.[91]
2001
Wristprotectors Snowboarders
(2515/2514,64.2%)
99.5%Adefinitionofcompliancewasnot
provided.
Inthebracedgroup,8wristinjuries(3fracturesand5
sprains)wererecorded,comparedwith29wrist
injuries(2fracturesand27sprains)recordedinthe
controlgroup.Consideringalltypesofinjuries,atotal
of33injuriesoccurredinthebracedgroupand51in
thecontrolgroup.Thisisasignificantdifferencein
favorofthebracedgroup(chi-squaretest:x2=3.9,
p=0.05).
Sodermanet
al.[67]
2000
Balanceboard
training
Soccerplayers
(62/78,0%)
70%.Complianceisdefinedasperforming
morethan70sessions.
Intheinterventiongroup,nosignificantdifferencewas
foundinthenumberoftraumaticinjuriesorinjured
playersbetweenthosewhowerecompliant(n=27)and
thosewhowerenon-compliant(n=35)subgroups.
Soligardet
al.[79]
2008
FIFA11+warm-
up
Footballplayers
(1055/1220,0%)
77%(team)and57.9%(player),high
compliance(33-95sessions),intermediate
compliance(15-32sessions),low
compliance(0-14sessions)
Theriskofinjurywas35%lowerinintervention
playersinthethirdwiththehighestcompliance2.6
(2.0.to3.2)injuries/1000playerhours,comparedwith
playersintheintermediatethird4.0(3.0to5.0)
injuries/1000playerhours(rateratio0.65,0.44to
0.94,P=0.02).The32%reductioninriskofinjury
comparedwiththethirdwiththelowestcompliance
(3.7(2.2to5.3)injuries/1000playerhoursdidnot
reachsignificance(rateratio0.68,0.41to1.12,
P=0.13).
Soligardet
al.[81]
2010
FIFA11+warm-
up
Footballplayers
(1055/1220,0%)
77%(team)and57.9%(player),high
compliance(33-95sessions),intermediate
compliance(15-32sessions),low
compliance(0-14sessions)
Theriskofinjurywas35%lowerinintervention
playersinthethirdwiththehighestcompliance2.6
(2.0to3.2)injuries/1000playerhours,comparedwith
playersintheintermediatethird4.0(3.0to5.0)
injuries/1000playerhours(rateratio0.65,0.44to
0.94,P=0.02).The32%reductioninriskofinjury
comparedwiththethirdwiththelowestcompliance
(3.7(2.2to5.3)injuries/1000playerhoursdidnot
reachsignificance(rateratio0.68,0.41to1.12,
P=0.13).Furthermore,theriskofanacuteinjurywas
39%(p=0.008)lowerforplayersinthetertilewiththe
highestcompliancecomparedwithplayersinthe
intermediatetertile,whereasa35%reductionofinjury
riskcomparedwiththetertilewiththelowest
compliancewasnotstatisticallysignificant(p=0.09).
Steffenetal.
[80]2008
FIFA11+warm-
up
Footballplayers
(1091/1001,0%)
52%,compliant>20sessions,non-
compliance>20sessions
Inasub-groupanalysistodeterminewhether
compliancewiththeinterventionprogramcouldhave
influencedtheriskforinjuriesthroughoutthestudy
period,itwasshownthattherewasnodifferenceinthe
injuryincidenceofoverallandacuteinjuriesbetween
thecompliantgroupandthenon-compliantgroup.
Steffenetal.
[84]2013
FIFA11+warm-
up
Footballplayers Intervention1:High,medium,low
compliance:52%,23%,25%.Intervention
2:High,medium,lowcompliance:41%,
41%,18%.Teamcompliancewasdefinedas
Theunadjustedoverallinjuryrateforplayers
categorizedintothehighcompliancegroupwas57%
lowerthantheinjuryrateofplayersinthelow
adherencegroup(IRR=0.43,95%CI0.19to1.00).
2Inthisstudyparticipantswereassignedtothreedifferentstudygroups:anunsupervisedgroup,agroupwhoreceivedcoach-ledworkshopsandagroupwhoreceived
coach-ledworkshopsandon-fieldsupervision.
(129/121/135,0%)2 the11+theproportionofallpossible
sessionswherethe11+wasdelivered,the
numberofteam11+sessions/weekandthe
meannumberofteam11+
exercises/session.
However,adjustingforthecluster,agegroup,levelof
playandinjuryhistory,thisbetween-groupdifference
ininjuryriskwasnotstatisticallysignificant(IRR=0.44,
95%CI0.18to1.06).Nootherdose-response
relationshipbetweenhighandlowadherencetothe
11+andinjuryriskcouldbeidentified.
Steffenetal.
[85]2013
FIFA11+warm-
up
Footballplayers
(68/78/80,0%)2
Intervention1:High,medium,low
compliance:37%,23%,8%.Intervention2:
High,medium,lowcompliance:29%,26%,
23%.Teamcompliancewasdefinedasthe
11+theproportionofallpossiblesessions
wherethe11+wasdelivered,thenumberof
team11+sessions/weekandthemean
numberofteam11+exercises/session.
Nosignificantdifferencesintriplejumpperformance
oroverallriskinjury.Effectofhighadherenceon
sustaininginjuryIRR=0.28(0.1-0.79)
Waldenet
al.[77]
2012
Neuromuscular
training
Footballplayers
(2479/2080,0%)
Compliancedefinedas>1sessionperweek:
52.5%
Anadjustedsubgroupanalysisofcompliantplayers
(1303playersin112interventiongroupclubs,1967
playersin106controlgroupclubs)showeda
statisticallysignificant83%ratereductioninanterior
cruciateligamentinjury(rateratio0.17,0.05to0.57,
P=0.004),aswellassignificantreductionsfor
secondaryoutcomesintheinterventiongroup
comparedwiththecontrolgroup(severekneeinjury
rateratio0.18,0.07to0.45,P<0.001;anyacuteknee
injuryrateratio0.53,0.30to0.94,P=0.03).Analysesof
non-contactanteriorcruciateligamentinjuriesshowed
areductioninratesfavouringtheinterventiongroup.
Thereductionwasstatisticallysignificantonlyforthe
Table1:Studiesthatanalyzetheeffectofcomplianceratesonstudyoutcome
PE=Physicaleducation,RR=RelativeRisk,ITT=Intention-to-treat=PPA=Per-protocol-analysis-treat,IRR=Incidencerateratio,IID=Injuryincidencedensity.
adjustedsubgroupanalysisofcompliers(intention-to-
treatanalysisrateratio0.40,0.13to1.18,P=0.10;
adjustedsubgroupanalysisrateratio0.26,0.07to0.99,
P=0.049).
44
DISCUSSION
Alackofauniformdefinitionofcompliance
Inthestudiespresentedinthisreview,variousmethodswereemployedtodefinemeasureand analyse the effect of compliance. Themost important finding is that, although themajority of studies mention the concept of compliance, there is a large degree ofheterogeneityinthemannerinwhichstudiesdealwiththisconcept.Somestudiesmerelymention compliance in either the introduction or discussionwithout providing furtherdetailsoncomplianceassessmentandcompliancedata.AscanbeseenfromFigure2therearemorestudiesthatprovidecompliancedatathantherearestudiesthatgiveanexplicitdefinitionofcomplianceoroneoftherelatedconstructs.Inotherwords,whilstmanyreportcompliance,amajoritydonotdefinethistermorexplicitlystatehowtheyoperationalizedit.Themajorityofthestudiesreportminimaldetailson:(1)thedefinitionofcompliance,2)how compliance was measured, 3) the frequency bywhich compliance was measured(everyday,week,month),and4)howcomplianceaffectedstudyoutcomes.From1970onwards,therewasaclearincreaseinthenumberofsportinjurypreventionRCTstudies.However,inthelastfewyears(2011-2014)thistrendhasnotcontinuedandthe number of injury prevention RCTs has actually decreased. It is likely that afternumerous efficacy studies, research now focuses on implementation of preventionmeasuresinnon-RCTstudies.Asthesenon-RCTstudiesarenotthetopicofthisreview,theywillnotappearinFigure2.Theimportanceofcompliancereporting
Inordertoevaluatestudyoutcomesinthecontextinwhichtheyareexamined,itisessentialthat studies report the percentage of participantswhohaveactually compliedwith theprescribed intervention. Compliance to an intervention significantly influences theoutcomes of intervention studies, which is clearly illustrated by a number of studiesincludedinthisreview[5,32,71,74,90].Forexample,inthestudybySteffenetal.[5]thatassessed compliance rates to a neuromuscular injury prevention programme, high,intermediateandlowcompliancegroupsweredefined.Theauthor’sPPAfoundthatonlythehighcompliantgroupbenefitedsignificantlyfromtheintervention.
InthestudybyEmery[71]evaluatinghome-basedbalancetraining,participantswhohadconductedmorethan18sessions(outoftherecommended42sessions)in6weekshadachieved a significant improvement in static balance skills. Participants with lowercomplianceratesdidnot improve their staticbalanceskills.Gabbeetal. [90]evaluatedeccentrichamstringexercisesinamateurfootballplayers,ofwhichonly4%ofthosewhowerecompliantwiththeinterventionsustainedaninjury.Playerswhowerenotcomplianttotheinterventionshowednoreducedinjuryriskwhencomparedtothecontrolgroup.Hagglundetal.[74]reportedsimilaroutcomes,showingthatonlyinteamswithhighestcompliancetoaneuromusculartrainingprogramasignificantreductionininjuryrateswasfound.Finally,thestudyofHupperetsetal.[32]suggestedthatahighercompliancewouldhaveresultedinfewerinjuries.Inthatstudy,only23%ofparticipantswerefullycompliant.Inasecondaryanalysisinasubsequentpaper,itwasindeedshownthatthesmallgroupof
45
participantswithhighcompliancewasresponsibleforthepositiveeffectoftheexerciseprogramonrecurrentinjuryrisk[92].
Informationontherateofcomplianceanditseffectonstudyoutcomescanbeshapedintoaclearmessageforthetargetgroupsinvolved;theyshouldbeinformedaboutthenumberoftrainingsessionstheyshouldatleastparticipateintoreducetheirriskofsustaininganinjury.Providinginformationoncomplianceratesandtheeffectofthosedifferentratesonstudyoutcomesmightincreasethepracticalusabilityofstudyresultsforthetargetgroup.
AcknowledgmentoftheCONSORTStatement
The CONSORT statement argues that, in order to evaluate both efficacy (with theassumption of full compliance and no recognition of implementation barriers) andeffectiveness(thereallifeadoptionofanintervention),researchersshouldanalysestudyresultsusingITT,PPAandagradedcompliancemeasure[7].Thelatterreferstotheextenttowhichparticipantshavecompliedwiththeprogramandwhateffectthishashadontheoutcome.
Inadditiontothediversitybywhichcomplianceisdefined,measuredandadjustedforintheanalysis,thestudiesincludedinthisreviewshowalargedegreeofheterogeneityintheuseofITT,PPAorgradedcompliance.
Thirty-sevenstudieshaveusedoneormoreoftherecommendedanalyses.Twenty-eightstudies[16,17,27,29,32,34,37-40,42,44,50,52,71,72,75-82,84,93-95]usedITTanalysis,oneused PPA [19] and eight studies [31,43,47,58,88,90,96,97] used both analyses (seeElectronicSupplementaryMaterialAppendixS1). It isclearthat,althoughtheCONSORTstatementclearlyacknowledgestheimportanceofcomplianceandhence,providesastepforwardinimprovingthequalityofinterventionstudies,thereisstillalackofuniformity.Whatisneededisauniformwayinwhichcomplianceisdealtwith.
Furtherresearch
Further research needs toconfirmwhichmeasures provide themost valid and reliableassessment of compliance. Although various methods have been used to measurecompliance (e.g. the use of written, vocal or online self-reports, supervision and/orunscheduledvisits),eachmethodhasitsownlimitations.Participantscanincorrectlyrecalltheir activities or provide socially desirable reports on self-reported measures ofcompliance. In addition, a uniform definition of compliance and a categorization ofcomplianceratesmightincreasethepossibilityofcomparingtheeffectivenessofdifferentinjurypreventionprograms.ThemainweaknessofthecurrentstudyisthatitonlyincludedRCTs.ItwouldbeofinteresttoconductasimilarreviewthatincludesbothRCTsandless-controlledstudiestoidentifyadherencetosportinjuryinterventionstudiesinwhichthesettingislesscontrolled.
46
CONCLUSION
Injurypreventionstudiesvarysignificantlyinthewaytheydefine,measureandadjustforcompliance.Whilethemajorityofthesestudiesmentiontheconceptofcompliance,onlyonefifthofthestudiesgaveamoredetailedaccountofhowcomplianceratesinfluencetheirstudyresults.Thestudiesthatdidaccountforcompliance,demonstratethatthelevelofcompliance can have a significant effect on study outcomes. Valid and reliable tools tomeasureandreportcomplianceneedtobedeveloped,matchedtoauniformdefinitionofcompliance.Althoughcurrentguidelinesforreportingofstudieshaveincreasedawarenessoftheneedforcompliancemeasurements,thewaythesemeasurementsareexecutedandreportedstilldealswithalargedegreeofheterogeneity.
COMPLIANCEWITHETHICALSTANDARDS
FundingThis study was funded by the Netherlands Organisation for health research anddevelopment(ZonMW),grantnumber525001003.ConflictsofInterestMiriamvanReijen,IngridVriend,WillemvanMechelen,CarolineFinchandEvertVerhagendeclarethattheyhavenoconflictsofinterestrelevanttothecontentofthisreview.
47
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ElectronicSupplementaryMaterialAppendixS1:INCLUDEDSTUDIES
SectionISection
IISectionIII
SectionIV
Authors[reference]
Year
InterventionFurlanScore
Iscompliancementioned?
Whatisthetermused?
Iscompliancemeasured?
Howiscompliancemeasured?*
Arecompliance
ratesprovided?
Arecompliance
ratesadjustedfor?
Krausetal.
[52]1970 Useofahelmet 4 YES Use YES
Visualcheckby
supervisorYES NO
Ekstrandetal.
[24]1983
Prophylactic
exercisesanduseof
ankletape
1 YES Attendance YES Reportbysupervisor NO NO
Milgrometal.
[59]1985
Useoforthotic
insoles1 YES Use YES
Visualcheckby
supervisorYES NO
Smithetal.
[98]1985
Useoforthotic
insoles1 NO NO NO NO
Gardneretal.
[99]1988
Useoforthotic
insoles3 YES Compliance NO NO NO
Schwellnuset
al.[100]1990
Useofneoprene
insoles4 YES Compliance YES
Visualchecksbyresearchers&self-report.Military
study
YES NO
Sitleretal.
[60]1990 Useofakneebrace 3 YES Compliance YES
Visualcheckby
researchers.Military
study
YES NO
Milgrometal.
[53]1992 Useofmodifiedshoes 2 YES Use YES
Visualcheckby
supervisors.Military
study
NO NO
Schwellnus
andJordaan
[48]
1992Useofcalcium
supplements4 YES Compliance YES
Reportby
supervisor.Military
study
NO NO
Barrettetal.
[61]1993
Useofdesignated
shoes6 YES Use YES
Visualcheckby
supervisorYES NO
VanMechelen
etal.[33]1993
Warm-up,cool-down
andstretching
exercises
2 YES Compliance YES Self-report YES NO
Sitleretal.
[62]1994 Useofananklebrace 2 YES Compliance YES
Visualcheckby
researchers.Military
study
YES NO
Surveetal.
[25]1994 Useofankleorthoses 1 YES Compliance YES Reportbysupervisor NO NO
Caraffaetal.
[101]1996
Proprioceptive
training2 YES Cooperation NO NO NO
Bengaletal.
[102]1997 Useofakneebrace 2 NO NO NO NO
Jorgensenet
al.[103]1998 Educationalvideo 3 NO NO NO NO
Popeetal.
[104]1998 Stretchingexercises 5 NO NO NO NO
Buchmanet
al.[105]1999
Useofarginine
supplements3 NO NO NO NO
Finestoneet
al.[54]1999
Useofadesignated
shoe4 YES Compliance YES
Visualcheckbysupervisors.Militarystudy
NO NO
Holmeetal.
[106]1999
Rehabilitation
exercises3 NO NO NO NO
Wedderkopp
etal.[107]1999
Ankledisctraining
andwarm-up
exercises
1 NO NO NO NO
Heidtet
al.[108]2000
Preconditioning
program3 NO NO NO NO
Popeetal.
[93]2000 Stretchingexercises 4 YES Attendance YES
Visualcheckbysupervisorsand
visitsbyresearchers.Militarystudy
NO NO
Sodermanet
al.[67]2000
Balanceboard
training1 YES
Compliance
andinternal
dropout
YES
Self-reportandreportbysupervisors
YES YES
Ronningetal.
[91]2001
Useofawrist
protector4 NO NO NO YES
Larsenetal.
[88]2002 Useofshoeorthoses 7 YES Compliance YES Unknown YES YES
Larsenetal.
[68]2002
Strengthening
exercises6 YES Compliance YES
Self-reportandvisualcheckbyresearchers
NO NO
Macholdetal.
[58]2002
Useofanwrist
protector6 YES Compliance YES
Visualcheckby
supervisorsYES YES
Torkkietal.
[109]2002
Useofdesignated
shoes5 YES Adherence YES Self-report YES NO
Asklinetal.
[110]2003
Preconditioning
exercises3 NO NO NO NO
Knapiketal.
[56]2003
Physicalreadiness
training3 NO YES
Visualcheckby
supervisors.Military
study
YES NO
Pernaetal.
[111]2003 Stresstherapy 5 NO NO NO NO
Wedderkopp
etal.[34]2003 Ankledisctraining 1 YES Compliance YES Self-report NO NO
Finestoneet
al.[112]2004 Useoffootorthoses 5 YES Use YES
Visualcheckby
supervisors.Military
study
YES NO
Koltetal.
[113]2004 Stresstherapy 2 NO NO NO NO
Milgrometal.
[47]2004
Useofrisedronate
supplement4 YES Compliance YES
Visualcheckby
supervisors.Military
study
YES NO
Sherryand
Best[35]2004
Rehabilitation
exercises1 YES Compliance YES Self-report YES NO
Stasinopoulos
[114]2004
Proprioceptive
exercisesand
externalsupport
2 YES Compliance NO NO NO
vanTiggelen
etal.[115]2004 Useofabrace 2 NO NO NO NO
Verhagenetal.
[26]2004
Balanceboard
training4 YES Compliance YES Reportbysupervisor NO NO
Arnasonetal.
[116]2005 Educationalvideo 3 NO NO NO NO
Barbicetal.
[72]2005 Useofamouthguard 4 YES Compliance YES
Reportbysupervisorand
visitsbyresearchers
YES NO
Emeryetal.
[71]2005
Balanceboard
training5 YES Compliance YES
Self-reportandphonecallsbyresearchers
NO YES
Finchetal.
[63]2005 Useofamouthguard 3 YES Compliance YES
Visualcheckby
supervisorsNO NO
Milgrometal.
[96]2005 Useoffootorthoses 2 YES Compliance YES
Visualcheckbysupervisorsand
visitsbyresearchers.Militarystudy
NO NO
Olsenetal.
[117]2005 Warm-upexercises 7 YES Compliance YES Reportbysupervisor YES NO
Gabbeetal.
[90]2006
Preconditioning
exercises4 YES Compliance YES Reportbysupervisor YES YES
Mcguineand
Keene[28]2006 Balancetraining 5 YES Compliance YES Reportbysupervisor NO NO
Mickeletal.
[64]2006
Useofabraceand
tape4 YES Compliance YES
Visualcheckby
supervisorNO NO
Withnalletal.
[94]2006 Useofinsoles 5 NO NO NO NO
Cobbetal.
[43]2007 Useofcontraceptives 5 YES Compliance YES Self-report YES YES
Emeryetal.
[69]2007 Balancetraining 6 YES Compliance YES
Self-reportandreportby
supervisors.YES NO
Hagglundet
al.[29]2007
Rehabilitation
exercises5 YES Compliance YES Reportbysupervisor YES NO
Kekkonenet
al.[44]2007 Useofprobiotics 7 YES Adherence YES Self-report YES NO
Mohammadi
[118]2007
Proprioceptive&
strengthexercises
plususeoforthoses
2 YES Compliance NO NO NO
Myklebustet
al.[17]2007 Balancetraining 3 YES Compliance YES Reportbysupervisor YES YES
Nohetal.[36] 2007Autogenicand
relaxationtraining3 YES Adherence YES Self-report YES NO
Brushojetal.
[87]2008
Strength,flexibility
andcoordination
exercises
6 YES Compliance YES Reportbysupervisor YES NO
Buistetal.
[37]2008 Gradedtraining 5 YES Compliance YES Self-report YES NO
Cumpsetal.
[38]2008 Preventiveexercises 4 YES Compliance YES Self-report YES NO
Engebretsen
etal.[31]2008 Targetexercises 2 YES Compliance YES Self-report YES YES
Fredbergetal.
[21]2008
Prophylacticand
stretchingexercises1 YES Compliance YES Reportbysupervisor YES NO
Gilchristetal.
[19]2008 Warm-upexercises 4 YES Compliance YES Reportbysupervisor YES NO
Lappeetal.
[97]2008
Useofcalciumand
vitaminD
supplements
6 YES Use YES
Visualcheckandinterviewbyresearchers.Militarystudy
NO NO
Pasanenetal.
[16]2008
Neuromuscular
training6 YES
Compliance
andadherenceYES Reportbysupervisor YES YES
Soligardetal.
[79]2008 Warm-upexercises 5 YES Compliance YES
Reportbysupervisor;phonecallsandvisitsbyresearchers
YES YES
Steffenetal.
[85]2008
Warm-upexercises
(FIFA11+)5 YES Compliance YES
Reportbysupervisor;phonecallsandvisitsbyresearchers
YES YES
Holmichetal.
[73]2009 Preventiveexercises 4 YES Participation YES
Reportbysupervisorand
visitsbyresearchers
NO NO
Hupperetset
al.[32]2009
Proprioceptive
exercises5 YES Compliance YES Self-report YES YES
Knapiketal.
[55]2009
Useofdesignated
shoes3 NO YES
Visualcheckby
supervisors.Military
study
YES NO
McIntoshetal.
[76]2009
Useofpadded
headgear4 YES Compliance YES
Reportbysupervisorsand
YES YES
visitsbyresearchers
Childsetal.
[132]2010
Corestabilisation
exercises5 NO NO NO NO
Collardetal.
[119]2010 Preventiveexercises 4 NO NO NO NO
Eilsetal.
[120]2010
Proprioceptive
exercises4 NO NO NO NO
Emeryand
Meeuwisse
[66]
2010Neuromuscular
training3 YES Adherence YES
Self-reportandreportbysupervisors
YES NO
Jamtveldtet
al.[39]2010 Stretchingexercises 5 YES Compliance YES Self-report YES NO
Kianietal.
[20]2010
Motorskillexercises
+education5 YES
Compliance
andadherenceYES Reportbysupervisor YES YES
Knapiketal.
[121]2010
Useofcustomized
shoes5 NO NO NO NO
Soligardetal.
[81]2010 Warm-upexercises 5 YES Compliance YES
Reportbysupervisor;phonecallsandvisitsbyresearchers
YES YES
Belloetal.
[122]2011
Stabilization
exercises2 NO NO NO NO
Coppacketal.
[22]2011 Preventiveexercises 7 YES Compliance YES Reportbysupervisor YES NO
Franklyn-
Milleretal.
[123]
2011 Useofshoeorthoses 5 NO NO NO NO
Georgeetal.
[65]2011
Stabilization
exercises6 YES Compliance YES
Visualcheckby
researchers.Military
study
NO NO
Gomesetal.
[124]2011
VitaminCandE
supplements6 NO NO NO NO
Kinchingtonet
al.[49]2011
Useofdesignated
footwear4 YES Compliance YES Reportbysupervisor YES NO
Labellaetal.
[70]2011
Neuromuscular
training5 YES Compliance YES
Self-reportandreportbysupervisors
YES NO
Mattilaetal.
[82]2011 Useoffootorthoses 9 YES Compliance YES
Self-reportandvisualcheckbyresearchers
YES NO
Mcguineetal.
[50]2011 Useofananklebrace 5 YES Compliance YES Reportbysupervisor NO NO
Parkkarietal.
[40]2011
Neuromuscular
training7 YES Compliance YES Self-report YES NO
Petersenetal.
[30]2011 Eccentrictraining 7 YES Compliance YES Reportbysupervisor YES NO
Ryanetal.
[45]2011
Useofdesignated
shoes2 YES Use YES Self-report NO NO
Shihetal.
[125]2011 Useoffootorthoses 5 NO NO NO NO
Beijsterveldt
etal.[78]2012
Preventivetraining
(FIFA11+)3 YES Compliance YES
Reportbysupervisorsand
visitsbyresearchers
YES NO
Bredeweget
al.[95]2012
Preconditioning
program4 YES
Compliance,
adherenceand
exposure
YES Self-report YES NO
Hidesetal.
[126]2012
Motorcontrol
training4 NO NO NO NO
Longoetal.
[83]2012
Preventivetraining
(FIFA11+)7 YES Compliance YES
Reportbysupervisor;phonecallsandemailsby
researchers
YES YES
Mcguineetal.
[51]2012 Useofanklebrace 4 YES Compliance YES Reportbysupervisor NO NO
Waldenetal.
[77]2012 Warm-upexercises 6 YES Compliance YES
Reportbysupervisorsand
visitsbyresearchers.
YES YES
Cusimanoet
al.[127]2013
Educationalvideo
andbrochure6 NO NO NO NO
Hagglundet
al.[74]2013
Neuromuscular
training2 YES Compliance YES
Reportbysupervisorsand
visitsbyresearchers
YES YES
Kristetal.
[75]2013
Preventivetraining
(FIFA11+)5 YES Compliance YES
Reportbysupervisorsand
visitsbyresearchers
YES NO
Steffenetal.
[84]2013
Preventivetraining
(FIFA11+)2 YES Adherence YES
Reportbysupervisorsand
visitsbyresearchers
YES YES
Steffenetal.
[5]2013
Preventivetraining
(FIFA11+)6 YES Adherence YES
Reportbysupervisorsand
visitsbyresearchers
YES YES
Asklingetal.
[128]2014
Rehabilitation
exercises4 NO NO NO NO
Drobnicetal.
[129]2014 Useofcurcumin 8 NO NO NO NO
Janssenetal.
[42]2014
Neuromuscular
traininganduseofan
anklebrace
3 YES Compliance YES Self-report YES NO
Sebelienetal.
[130]2014
Strengthening
exercises5 NO NO NO NO
Sharmaetal.
[131]2014
Gaitretrainingand
flexibilityexercises4 NO NO NO NO
Theisenetal.
[46]2014 Useofmidsole 6 YES Use YES Self-report YES NO
71
CHAPTER4 Increasingcompliancewithneuromusculartrainingtopreventanklespraininsport:doesthe‘Strengthenyourankle’mobileAppmakeadifference?Arandomisedcontrolledtrial.
MiriamvanReijenIngridVriendVictorZuidemaWillemvanMechelenEvertVerhagenBritishJournalSportsMedicine2016Digitalobjectidentifier(doi):10.1136/bjsports-2015-095290
four.
72
ABSTRACT
BackgroundE-healthhasthepotentialtofacilitateimplementationofeffectivemeasurestopreventsportsinjuries.
Aim:Weevaluatedwhetheraninteractivemobileapplicationcontainingaproveneffectiveexerciseprogrammetopreventrecurrentanklesprains,resultedinhighercomplianceascomparedtoregularwrittenexercisematerials.
Methods220athletesparticipatedinthisrandomisedcontrolledtrialwithafollow-upofeight-weeks; 110 athletes received a booklet explaining an eight-week neuromusculairtrainingprogram;110athletesthesameprograminaninteractivemobileApp(‘Strengthenyourankle’).Theprimaryoutcomewascompliancewiththeexerciseprogram.Secondaryoutcomemeasurewastheincidencedensityofself-reportedrecurrentanklesprains.
ResultsThemeancompliancetotheexerciseschemewas73.3%(95%CI:67.7-78.1)intheAppgroup,comparedto76.7%(95%CI:71.9-82.3)intheBookletgroup.Nosignificantdifference in compliance was found between groups. The incidence densities of self-reportedtime-lossrecurrenceswerenotsignificantlydifferentbetweenbothgroups(HR3.07;95%CI0.62-15.20).
Summary:Thisstudyshowsthatthemethodof implementingtheexercisesbyusinganApporaBookletdoesnotleadtodifferentcompliancerates.
Newfindings:TheuseofamobileApporaBookletleadtosimilarcomplianceandinjuryratesintheshortterm.
Trialregistration
TheNetherlandsNationalTrialRegisterNTR4027.TheNTRispartoftheWHOPrimaryRegistries.
73
BACKGROUND
Ankleinjuriesarethesecondmostcommonsportsrelatedinjuriesandanklesprainisthemostcommontypeofankleinjury.Anklesprainmayaccountforasmuchas80%ofallankleinjuries.Theincidenceofankleinjuryandanklesprainisespeciallyhighinpopularsportsasrugby,(indoor)soccer,triathlon,handball,volleyballandbasketball[1].Bothexternallyappliedsupports (i.e. tapingorbracingof theankle), aswellasneuromuscular trainingprogramspreventrecurrentanklesprainsandarecost-effectiveness[2,3,5].
Despite these cost-effective interventions, large-scale community uptake of thesemeasures,andthusactualpreventionofanklesprains,islagging[4,5].Thecost-effectiveneuromuscular training program [3,6] has suffered from poor compliance [4] and itspreventive effect was achieved solely among a subsample of compliant athletes [5].Althoughanalyseshavebeenperformedusinganintention-to-treatapproach,thereisstillalotofeffectivenesstogainbyincreasingcompliancewithpreventivemeasures.
E-health has potential to bridge this so-called implementation gap [7]. The companyVeiligheidNL developed an interactive mobile application: 'Strengthen your ankle'('Versterk je enkel', free for iOS and Android) that contains the cost-effectiveneuromusculartrainingprogram.Althoughmobileappsareplentifulandhavethecachetoftechnologicaladvancement,thevalueofthisapproachforinjurypreventionhasnotbeenevaluated formally [8].Consequently,weevaluatedwhether the ‘Strengthenyourankle’Appresultedinhighercompliancewiththeneuromusculartrainingprogramascomparedtotheregularwrittenexercisematerials.
METHODS
Design
Thisstudywasarandomisedcontrolledtrial.Adetaileddescriptionofthestudyprotocolhas been published elsewhere [9]. The study design, procedures and informed consentprocedure were approved by the Medical Ethics Committee (2013/248) of the VUUniversityMedicalCenterAmsterdam(VUmc)theNetherlands.Thetrial isregisteredintheNetherlandsTrialRegistry(NTR4027).
Participants
ParticipantswererecruitedfromOctober2013toApril2014throughphysiotherapyandsportphysicianpractices,nationalsportfederations’websites,digitalnewslettersandanopeninvitationviasocialmedia,theInternetandwrittenmedia.Activesportsparticipants(athletes)between18and70yearsofagewhohadsustainedananklesprainwithinthepast twomonths,andwhohadaccess toamobile phone (eitherAndroid or iOS),wereeligibleforinclusion.Respondentswereexcludediftheyhadsustainedaninjuryotherthanalateralanklespraininthesameankleintheprecedingyear(e.g.,fractureoftheankle).Beforeinclusion,themainauthorcontactedallpotentialparticipantsbyphonetoconfirmstudyeligibility.TherecruitmentofparticipantsisshowninFigure1.
74
Figure1|Flowchartofparticipantrecruitmentandfollow-up
SampleSize
Samplesizecalculationswerebasedupontheprimaryoutcomemeasurecomplianceandoriginated from previously established compliance rates to the same program whenadvocated throughwrittenmaterials [4].Full compliancerates in thewrittenmaterials’group were expected to be around 25%. A doubling of this rate to at least 50% wasconsideredtobeclinicallyrelevant.Baseduponabetaof0.90andanalphaof0.05,atotalof158athleteswererequireddividedacrossbothstudygroups.Assumingadropoutrateof20%,asampleof190participantswascalculated.
Randomisationprocedure
Afterparticipantshadfinishedanklespraintreatmentbymeansofusualcare,andafterthebaseline questionnaire and the informed consent were received, participants wererandomly assigned to one of two study groups. The control group received theneuromuscular training program on paper (Booklet group) and the intervention group
75
receivedtheneuromusculartrainingprogramthroughtheApp(Appgroup).Participantswereallocatedtothestudygroupsthrougharandomnumbergenerator.
Interventions
Allparticipantsreceivedtheneuromusculartrainingbalanceboard(machU/MSGEuropeBVBA).BoththeBookletandtheAppcontainedthesameneuromusculartrainingprogram.TheAppcanbedownloadedforfreefromboththeAppStore(http://apple,co/1EcHyFP)and theGooglePlaystore (http://bit,ly/1AHuZkB).Whereas theAppprovided theuserwithinstructionalvideosandverbalinstructions,theBookletincludedonlypicturesoftheexercises thatneeded tobeperformed.Theembeddedneuromuscular trainingprogramconsistedofsixdifferentexercisestobeperformedduringthreesessionsaweek,withamaximumdurationof30minutespersession,foraperiodof8weeks.Exercisesgraduallyincreasedindifficultyandloadduringthecourseofeightweeks.Thisprogramhasbeenshowntobecost-effectiveinreducingrecurrentanklesprain[6].Afulldescriptionoftheprogramhasbeenpublishedelsewhere[4].Figure2showstheexercises,andTable1givestheschemethatparticipantswererequiredtofollow.
A:One-leggedkneeflexionVariations:1. Onanevensurface2. Onanevensurface,eyesshut3. Onabalanceboard
B:ToestandVariations:1. Withhandhold2. Withouthandhold
C:One-leggedstanceVariations:1. Onanevensurface2. Onanevensurface,eyesshut3. Onabalanceboard
D:Runner’sposeVariations:1. Onanevensurface2. Onanevensurface,eyesshut3. Onabalanceboard
E:Cross-leggedswayVariations:1. Withhandhold2. Withouthandhold3. Withouthandhold;eyesshut4. Onabalanceboard
F:ToewalkVariations:1. Walking2. Jumping
Figure2|Theexercisesoftheneuromusculartrainingprogram
76
Table1|Exerciseschemeofthe8-weekneuromusculartrainingprogram
Training(threetimesaweekforaperiodof8weeks;increaseddifficultylevel1to4)
Exercise
Week1 Week2 Week3 Week4 Week5 Week6 Week7 Week8
1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3
A 1 1 1 1 1 1 1 1 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3
B 1 1 1 1 1 1 1 1 1 1 1 1 2 2 2 2 2 2 2 2 2 2 2 2
C 1 1 1 1 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3
D 1 1 1 1 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3
E 1 1 1 1 1 1 2 2 2 2 2 2 3 3 3 3 4 4 4 4 4 4 4 4
F 1 1 1 1 1 1 1 1 1 1 1 1 2 2 2 2 2 2 2 2 2 2 2 2
Baselinemeasurement
An online baseline questionnaire collected information from each participant ondemographicvariables,physicalcharacteristics,sportsandinjuryhistory,useofpreventivemeasures, severity and received treatment and/or rehabilitation of the current anklesprain.
Outcomemeasures
Theprimaryoutcomemeasurewascompliancetotheexerciseschemeprescribedintheneuromusculairtrainingprogram.Compliancewasdefinedastheparticipant’sfollowingofthe prescribed intervention, i.e. the scheme of exercises (Table 1) [10]. Compliancemeasurements commenced after the start of the allocated intervention and took placeweeklyforthedurationoftheprogram(eightweeks).Participantsreceivedarequestbyemailtocompleteanonlinecompliancequestionnaire.Afterthreedaysareminderwassentin case of non-response. These weekly measurements gathered information for eachparticipantonthenumberofexecutedexercisespersessionandthenumberofexecutedsessionsperweek.Fromthisinformation,weeklycompliancerateswerecalculatedasthepercentageofprescribedexercisesconducted,bymultiplyingthepercentageperexercisewiththenumberoftimestheseexerciseswereperformedperweek.Previousresearchhasshownthat,inorderfortheneuromuscularprogramtobeeffective,participantshavetobehighlycompliantwiththeexercisescheme10.Inthisstudy,acompliancerateofover75%wasconsideredadequate.
77
Exposureandinjuryregistration
Secondaryoutcomemeasurewas the incidencedensityof self-reportedrecurrentanklesprains.Injuryincidencedensitywasdefinedasthenumberofrecurrentanklesprainsper1,000 hours of sports exposure. During the eight weeks follow-up, in addition to thequestions regarding compliance, participants were asked weekly about their hours ofsportsexposureandwhether theyhadsustainedananklesprain in thepreviousweek.Ankle sprain recurrencewas defined as a self-reported inversionmoment of the sameankle. Both an episode of giving-was, aswell as a grade 1, 2 or 3 ankle sprainswereregistered.Self-reportedrecurrentanklesprainswerefurthercategorizedtoseveritybylooking at recurrences that had led to time-loss, defined as the discontinuity of (sport)activityand/ormissing(partof)thenextplanned(sports)activityduetotherecurrence[4].Thistime-losscategorizationisinlinewiththeaccepteddefinitionofananklesprain[11].
Statisticalanalyses
MeanbaselinedifferencesbetweentheAppandtheBookletgroupweredeterminedusingan independent samples t-test for continuous data (age, weight, height, exposure) andFisher’s exact test (withMonte Carlo 95% confidence interval simulation due to smallnumberofsamples)forcategoricaldata(levelofsport,severityofanklesprain,gender).Baselinemeasurementswerebasedonthetotalnumberofparticipants(n=220)thatwereallocatedtoeitheroneoftheinterventions.
Whilecompliancewasnotnormallydistributed,weeklyandoverallcompliancemeansandcorresponding 95%CIwere obtained throughbiascorrected accelerated bootstrappingwith1,000bootstrapsamples.Meanweeklyandoverallcompliancerateswerecomparedbetweengroupsbymeansofanon-parametricMann-WhitneyUtest.Cox regression analyses compared risk of self-reported and time loss recurrent anklesprainsbetweenthegroups.Analyseswerecheckedforconfoundingbybaselinevariables,butnonewerefound.Genderwasfoundtobeaneffectmodifier;consequently,analysesweredoneseparatelyforbothmalesandfemales.Allanalyseswereconductedaccordingtotheintention-to-treatprincipleanddifferenceswereconsideredsignificantwithasignificancelevelof.05.
RESULTS
Recruitment
Between October 2013 and April 2014, a total of 220 participantswere recruited andrandomized to one of the two groups (Figure 1). After randomization, a number ofparticipantsindicatedthattheynolongerwishedtoparticipateinthestudyduetotimerestraintsor lackofmotivation.Fortheremainderofthestudyperiod,theircomplianceratesweresetto0%.Asmallnumberofparticipantshadtoleavethestudyduetoanon-ankle injury (n=4) or due to personal reasons (n=4). The compliance rates of these
78
participantswereonlyincludedfortheweekstheyparticipatedinthestudy.Atbaseline,bothgroupswerecomparableregardingallvariablesmeasured(Table2).
Table2Baselinecharacteristicsofthestudypopulation.Numbersarepresentedaspercentageofthepopulation(%)orasthemeanwithcorrespondingstandarddeviation(mean±SD).
Combined App Booklet
Participants(n) 220 110 110
Numberoffemales(%) 50.0% 50.0% 50.0%
Age(years) 37.9±13.4 37.6±13.1 38.1±13.7
Weight(kg) 73.3±12.8 73.0±13.0 73.7±12.6
Height(cm) 177.3±9.1 177.0±8.9 177.7±9.4
Levelofsport(%)
Competitive.international
Competitive.national
Competitive.regional
Recreational.organised
Recreational.unorganised
8,2
29,1
69,1
50,9
42,7
1,8
17,3
36,4
22,7
21,8
6,4
11,8
32,7
28,2
20,9
Severityofinclusionsprain(%)
Grade1
Grade2
Grade3
Unknown
84,6
58,2
16,4
40,9
42,7
30,9
9,1
17,3
41,8
27,3
7,3
23,6
Compliance
Overthecomplete8weeks,themeancompliancetotheexerciseschemewas73.3%(95%CI:67.7-78.1)intheAppgroupascomparedto76.7%(95%CI:71.9-82.3)intheBookletgroup(Table3).Nosignificantdifferenceinmeanoverallcompliancewasfoundbetweengroups, nor for males or females. In both groups 82 out of 110 participants (74.5%)complied tomore than75%of the program. Compliance gradually declined over the 8weeksinbothgroups(Figure3).
79
Table3|Meanweeklyandoverallcomplianceandcorresponding95%CIinbothstudygroups.
Overall Male Female
App Booklet App Booklet App Booklet
Week190.2%
(84.4-94.9)91.3%
(86.8-95.3)
91.5%(84.0-98.2)
90.7%(83.9-95.8)
89.0%(82.3-95.2)
91.9%(85.3-97.1)
Week278.3%
(70.9-84.8)82.3%
(75.2-88.4)
80.6%(71.4-90.3)
82.0%(72.5-90.9)
76.0%(65.2-85.1)
82.5%(72.8-90.9)
Week376.8%
(69.7-83.5)78.9%
(72.0-84.6)
76.7%(67.1-85.5)
79.2%(70.1-87.3)
76.9%(67.7-85.8)
78.7%(69.2-86.4)
Week472.7%
(65.2-79.7)75.5%
(67.8-82.6)
70.6%(61.0-80.3)
70.5%(59.3-81.4)
75.0%(64.9-84.9)
80.0%(70.4-88.0)
Week567.1%
(58.9-74.2)75.3%
(67.2-82.8)
68.5%(57.9-78.6)
71.2%(58.7-82.2)
65.6%(54.5-75.6)
78.6%(69.3-88.3)
Week670.2%
(61.7-77.8)67.9%
(60.4–75.7)
70.7%(60.1-81.3)
59.2%(46.1-70.1)
69.6%(58.1-79.9)
74.9%(64.9-84.5)
Week763.3%
(54.2-71.9)70.5%
(62.8-77.9)
58.2%(45.7-70.3)
64.9%(51.0-77.2)
68.8%(56.1-80.3)
75.1(64.3-85.0)
Week864.1%
(55.7-72.5)66.2%
(57.7-74.6)
61.6%(50.3-73.9)
57.4%(42.3-71.3)
66.8%(53.6-79.2)
73.0%(61.0-83.2)
Overall73.3%
(68.0-78.5)76.7%
(71.7-81.9)
71.8%(63.9-78.6)
75.2%(67.2-81.6)
74.8%(67.1-82.0)
78.2%(70.5-84.9)
80
Figure3 |Meanweeklycomplianceratesandcorresponding95%CIofbothgroupsacross the8weeksofthe
neuromusculartrainingprogram.
Exposureandrecurrentinjury
Intotal,participantstookpartin2,429hoursofsportintheAppgroupand2,547hoursofsportintheBookletgroupduringtheeight-weekprogram.Intheeightweeksoftheexerciseprogram 93 self-reported recurrent ankle sprains were reported, resulting in injuryincidencedensitiesofrespectively25.3self-reportedrecurrencesper1,000hours(95%CI:18.0-32.7)intheAppgroup,and25.6self-reportedrecurrencesper1,000hours(95%CI:18.3-32.9)intheBookletgroup(Table4).Theinjuryincidencedensitiesoftime-lossanklesprainswererespectively0.82time-lossrecurrencesper1,000hours(95%CI:-0.3-2.0)intheAppgroup,and2.36 time-loss recurrencesper1,000hours (95%CI:0.5-4.2) in theBookletgroup.Nosignificantdifferencesininjuryincidencedensitiesbetweengroupswerefoundforeitherself-reportedortimelossrecurrentinjuries.
Genderactedasaneffectmodifierintherelationshipbetweengroupallocationandinjuryrecurrenceoutcome.Nosignificantdifferenceswerefoundbetweengenders.
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Table4Injuryincidencedensity(IID)ofself-reportedandtimelossanklesprainrecurrences(95%CI)per
1,000hofsportsparticipation,aswellastheHazardRatio(95%CI)derivedfromCoxregressionanalyses.
Recurrentanklesprain App Booklet
Overall n IID n IID HR
Self-reported 46 25.3
(18.0-32.7)
47 25.6
(18.3-32.9)
1.04
(0.69–1.56)
Timeloss 2 0.82
(-0.3-2.0)
6 2.36
(0.5-4.2)
3.07
(0.62–15.20)
Male
Self-reported 21 17.0
(9.7–24.2)
11 10.8
(4.4–17.1)
0.64
(0.31–1.34)
Timeloss 1 0.7
(-0.7–2.0)
3 2.7
(-0.4–5.8)
3.95
(0.41–38.02)
Female
Self-reported 25 43.3
(26.3–60.3)
36 44.2
(29.8–58.7)
1.10
(0.66–1.85)
Timeloss 1 1.0
(-1.0–3.1)
3 2.1
(-0.3–4.5)
2.65
(0.27–25.14)
DISCUSSION
Wefoundthatthemethodofimplementingthe‘StrengthenyourAnkle’exercisescheme,byusinganApporaBooklet,didnot lead tosignificantdifferentmeanoverall compliancerates. Also, the percentage of participants thatwere highly compliantwas not differentbetweengroups.Inbothgroups74.5%ofparticipantscompliedwiththeneuromusculartrainingprogram.
Comparisonwithpreviousstudies
Thecurrent study is the first tocomparecompliancerates toapreventive interventionprogramundertheinfluenceofdifferentimplementationmethods.Twopreviousstudieshavetestedtheeffectivenessofthesameneuromusculartrainingprogramusingwritten
82
materials,andbothstudiesreportedcompliancerates[4,5].Thepercentageofparticipantswhowere fully compliant during the twomonths of the programwas as low as 23%4.Janssenetal.[5]describedfullcomplianceof45%.Inthecurrentstudy,thepercentageofparticipantsthatwerehighlycompliantwas65%,Janssenetal.[15]arguedthatatthetimeof their study the neuromuscular training program was more widely accepted in theNetherlandsthansomeyearsbefore,explainingthehighercomplianceratesintheirstudy.It is possible that the neuromuscular training program at the time of our study hasincreased acceptance in practice even further. In addition, the previous studies used aprinted-paperwithasimplelay-out.BoththeBookletandtheAppusedinthecurrentstudywereupdatesofthematerialsthathavebeenusedinthepreviousstudies.WespeculatethattheBookletandtheAppemployedinourstudymayhavehadamoreattractiveformatthatresultedinincreasedcompliancerates.
Effectoninjuries
Injury incidence densities of self-reported recurrences between theApp group and theBookletgroupwerenotsignificantlydifferent.Intwopreviousstudiesthatevaluatedthesameneuromusculartrainingprogram,reductionsininjuryriskwereobservedundertheinfluenceoftheprogram[4,5].Janssenetal.[5]reportedanoverallinjuryincidencedensityof2.51recurrentanklesprainsper1,000hofsport(95%CI:1.51-3.42)inthegroupthatfollowedtheprogram.Hupperetsetal.[4]foundananklespraininjuryincidencedensityof1.86 per 1,000h of sport (95% CI: 1.28-2.75). These injury incidence densities areconsiderablylowerthanfoundinourstudy.Amaindifferencebetweenthepreviousstudiesand the current study is that an inversionmoment (giving-way)wasalso counted as arecurrent event in the current study. Hence this may explain the disparity in injuryincidencedensitiesbetweenourstudyandpreviouslyreportedinjuryincidencedensities.Comparingonlytheinjuryincidencedensitiesofrecurrentinjuriesthatledtotime-loss,theresultsofHupperetsetal.[4](0.65per1,000hofsport;95%CI:0.38-0.92),andJanssenetal.[5](0.95per1,000hofsport;95%CI:0.39-1.51)aremorecomparabletoourfindings.
WenoteatrendforAppuserstohavereportedalowerrateofrecurrentanklesprainwithtimeloss.However,duetothelownumberofrecurrentinjuriesthatwerereportedandtherelativeshorttimespanoffollow-up,welackedstatisticalpowertocommentonthisresult.OnecouldspeculatethattheAppmaypromotebetterqualityexecutionoftheexercises.WheretheBookletcontainedprintedinstructionsandimagesonhowtoproperlyexecutetheexercises,theAppcontainedvideosandverbalinstructionsonthecorrectexecutionoftheexercises.Thismayhavehelpedparticipantstocorrectlyexecutetheexercises. Inarecent study among athleteswhowere ‘compliant’ with an exercise scheme, only 67%performedtheexercisesasdescribed[12].Incorrectexecutionofexercisesmaydiminishthepreventiveeffectofanexercise.Ourdataprovidethebasistostudythisquestionwithappropriatepower.
83
Methodologicalconsiderations
Onecouldarguethatinpracticepatients,whoarenotinvolvedinastudy,mighthavelowercomplianceratesthatthosewereporthere.Participantswhovolunteeredtoparticipateinthestudymayalreadybeinherentlymoremotivatedtoperformtheexercises.Additionally,the weekly questionnaires used in the study allowed for a weekly reminder and thecompliancewiththeexerciseswasassessedthroughself-report.Theobligationtoreportmissedexercisesmayhaveincreasedself-reportedcompliancerates.Thisshouldbetakenintoaccountwheninterpretingthereportedcompliancerates.
84
Summary
ThecurrentstudyshowedthatthemethodofimplementingtheexercisesthroughanApporaBookletdoesnotleadtodifferentcompliancerates.Bothmethodsresultedinaround75%oftheparticipantsperforminganadequatenumberofexercises.
Competinginterests
The authors declare no competing interest. VeilgheidNL has provided themobile App.However,thisAppisavailableforfree.
Contributors
EV (e.verhagen@vumc.nl) conceived the research idea, MVR (m.vanreijen@vumc.nl,@miriamvanreijen) and EV havewritten the protocol,MVR has screened and includedpatients,performeddataanalysesandisthemainauthor.IV(i.vriend@veiligheid.nl),WVM(w.vanmechelen@vumc.nl)andVZ(v.zuidema@veiligheid.nl)contributedtoideasintheprotocol.Allauthorshavereadandcommentedonthedraftversionandapprovedthefinalversionofthemanuscript.
Acknowledgements
Wewouldliketothankthefollowingpartnersfortheircollaborationandrecruitmentofstudyparticipants: RoyalDutch Society for Physical Therapy (KNGF),Dutch Society forPhysicalTherapyinSports (NVFS),DutchCollegeofGeneralPractitioners (NHG),DutchSports Medicine Society (VSG), Dutch Olympic Committee (NOC*NSF), Zilveren KruisAchmea(ZKA),andDisporta.
Patientconsent
Obtained
Ethicsapproval
The studywas approvedby themedical ethics committee of theVUUniversityMedicalCenter,Amsterdam,TheNetherlands(protocolnumber2013/248).
Funding
This study was funded by the Netherlands Organisation for Health Research andDevelopment (ZonMw) grant number 525001003, Balance boards were provided byDisportaandbookletswereprovidedbyVeiligheidNL.
85
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2. VerhagenEALM,BayK,Optimizinganklesprainprevention:acriticalreviewandpracticalappraisaloftheliterature,BritishJournalofSportsMedicine2010;44:1082–1088
3. HupperetsMDW,VerhagenEALM,HeymansMW,etal,Potentialsavingsofaprogramtopreventanklesprainrecurrence:economicevaluationofarandomizedcontrolledtrial,TheAmericanJournalofSportsMedicine2010;38:2194–200
4. HupperetsMDW,VerhagenEALM,vanMechelenW,Effectofunsupervisedhomebasedproprioceptivetrainingonrecurrencesofanklesprain:randomisedcontrolledtrial,BMJ2009;339:b2684–4
5. JanssenKW,vanMechelenW,VerhagenEALM,Bracingsuperiortoneuromusculartrainingforthepreventionofself-reportedrecurrentanklesprains:athree-armrandomisedcontrolledtrial,BritishJournalofSportsMedicine2014;48:1235–9
6. VerhagenEALM,vanTulderM,vanderBeekAJ,etal,Aneconomicevaluationofaproprioceptivebalanceboardtrainingprogrammeforthepreventionofanklesprainsinvolleyball,BritishJournalofSportsMedicine2005;39:111–5
7. VerhagenE,BollingC,Protectingthehealthofthe@hlete:howonlinetechnologymayaidourcommongoaltopreventinjuryandillnessinsport,BritishJournalofSportsMedicineChangetoBrJSportsMed2015Sep;49(18):1174-8
8. VriendI,CoehoornI,VerhagenE,ImplementationofanApp-basedneuromusculartrainingprogrammetopreventanklesprains:aprocessevaluationusingtheRE-AIMFramework,BrJSportsMed.2015Apr;49(7):484-8.PublishedOnlineFirst:27January2014,doi:10,1136/bjsports-2013-092896
9. VanReijenM,VriendII,ZuidemaV,etal,Theimplementationeffectivenessofthe"Strengthenyourankle"smartphoneapplicationforthepreventionofanklesprains:designofarandomizedcontrolledtrial,BMCMusculoskeletDisord2014;15:1–8
10. VerhagenEALM,HupperetsMDW,FinchCF,etal,Theimpactofadherenceonsportsinjurypreventioneffectestimatesinrandomisedcontrolledtrials:LookingbeyondtheCONSORTstatement,JournalofScienceandMedicineinSport2011;14:287–292
11. GribblePA,DelahuntE,BleakleyC,CaulfieldB,DochertyCL,FourchetF,FongD,HertelJ,HillerC,KaminskiTW,McKeonPO,RefshaugeKM,vanderWeesP,VicenzinoB,WikstromEA.Selectioncriteriaforpatientswithchronicankleinstabilityincontrolledresearch:apositionstatementoftheInternationalAnkleConsortium.JournalofOrthopaedicinSportsandPhysicalTherapy2013Aug;43:8:585-91.
12. Fortington,LV,DonaldsonA,LathleanT,YoungWB,GabbeBJ,LloydD,FinchCF.When
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“justdoingit”isnotenough:Assessingthefidelityofplayerperformanceofaninjurypreventionexerciseprogram,Journalofscienceandmedicineinsport/SportsMedicineAustralia,2015:05:1–6
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CHAPTER5 The"Strengthenyourankle"programtopreventrecurrentinjuries.Arandomizedcontrolledtrialaimedatlong-termeffectiveness.
MiriamvanReijenIngridVriendVictorZuidemaWillemvanMechelenEvertVerhagen.JournalofScienceandMedicineinSport2017Digitalobjectidentifier(doi):10.1016/j.jsams.2016.12.001
five.
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ABSTRACT
ObjectivesRecurrentanklesprainscanbereducedbyaneuromusculartrainingprogram(NMT). Theway NMT is deliveredmay influence the incidence of long term recurrentinjuries,residualpainanddisability.
DesignThisRCTwithafollow-upoftwelvemonths,evaluatedwhethertheimplementationmethodofaproveneffectiveNMTprogramdeliveredbyamobileapplicationorawritteninstruction booklet, resulted in differences in injury incidence rates, functional ankledisability/pain in the long term, assuming equal compliance – as in shown in previousresearch-withtheeight-weekintervention.
Methods220 athleteswith a history of ankle sprainwere recruited for this RCT. 110athleteswereofferedthefreelyavailable“StrengthenyourankleApp”andtheother110received a printed Booklet. Primary outcome measure was incidence density of anklesprains. Secondary outcome measureswere residual pain/disability and the individualcumulativenumberofanklesprainsduringfollow-up.Results The incidence densities of self-reported ankle sprain recurrences were notsignificantly different between both groups (HR 1.06; 95% CI 0.76-1.49).Median FADIscoresincreasedequallyovertimeinbothgroups,indicatingalowerrateoflimitationandpain inbothgroupsat follow-up.NeitherFADIscoresnorcumulative recurrentinjuriesweresignificantlydifferentbetweengroups.ConclusionThisstudyshowedthattheimplementationmethodofaNMTprogrambyusinganApporaBookletdidneitherleadtodifferentinjuryincidenceratesinthelongtermnordiditinfluenceresidualfunctionaldisability/pain.Assumingequalcomplianceduringtheeight-weekintervention,bothmethodsshowsimilareffectivenessintwelve-monthfollow-up.
TrialregistrationTheNetherlandsNationalTrialRegisterNTR4027.TheNTRispartoftheWHOPrimaryRegistries.
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INTRODUCTION
Despite on-going societal and scientific attention, sports injuries continue to pose asubstantial health care problem. Although exercise is generally seen as contributing tooverallhealth,themanifestationofasportorphysicalactivityrelatedinjurycausesharmbothfromapersonalaswellasasocietalviewpoint[1].Theankleisthesecondmostinjuredbodypartacrossallsportsandactivities,withananklesprainbeingthemostcommonankleinjury[2].IntheNetherlandsalone,in2013,onapopulationof17million480,000peoplesufferedfromananklesprainduetosports[3].Previous studies have shown the effectiveness of neuromuscular training programs [4].Suchprogramsrequireindividualstocompleteamulti-weekexerciseprogramthatshouldbe carried out multiple times a week. Although the effectiveness of such preventiveprogramshasbeenshownincontrolledstudies,themajorityofindividualsinvolvedwereneitherablenorwillingtocomplywiththeprescribedprogram.Performingonlypartofsuchpreventiveexerciseprogramshasbeenshowntobeineffectiveinreducingtheriskofan(recurrent)anklesprain[5,6]. Inrecognitionofthemajorproblemthatanklesprainscontinue to pose for those involved in physical activities and sports, it is, therefore, ofimportancethatavailableprogramsareenhancedinsuchawaythatcompliancewiththeexerciseschemeisincreased.Inordertoincreasecompliance,itiscrucialthatthemethodofimplementationisseenasattractiveandhaslowbarriersofusetotheonesinvolved.Thechoiceofimplementationmethodmay influence both compliance and,more importantly, the recurrence of sportinjuries. A previous study has shown that during the actual course of an interventionprogram,therewasnodifferenceincompliancewhenaprintedinstructionBookletwasused when compared with a mobile application, and that during the course of theintervention program the number of recurrent injuries did not differ between bothimplementationmethods[7].However,differenceinpreventiveeffectivenessmaybeseenoveralongerfollow-upperiod,i.e.duringafollow-upperiodbeyondtheactualinterventionprogram.Consequently,theaimofthecurrentstudywastoinvestigatewhetherdeliveringaproveneffectiveneuromusculartrainingprogramthroughaBookletoranAppresultsindifferences in recurrent ankle sprain incidence over a 12-month follow-up, under thecondition of equal effectiveness and equal compliance/adherence across deliverancemethods during the actual 8 weeks intervention program. A secondary aim was toinvestigatedifferencesinpainandfunctionaloutcomesduringdailyactivitiesoverthe12monthsoffollow-up.Theanswertothesequestionsisofimportancetofurtherdevelopthemethods of delivery of the neuromuscular training program in particular and injurypreventioningeneral,whicharebotheffectiveandattractiveforthoseinvolved.
METHODS
Thisstudywasarandomisedcontrolledtrial.Adetaileddescriptionofthestudyprotocolhasbeenpublishedpreviously[8].TheMedicalEthicsCommittee(2013/248)oftheVUUniversityMedicalCenterAmsterdam(VUmc)theNetherlandsapprovedthestudydesignandinformedconsentprocedureforthisstudy.ThetrialisregisteredintheNetherlandsTrialRegistry(NTR4027).FromOctober2013 toApril2014physiotherapyandsportphysicianpractices,nationalsportfederations’websites,digitalnewslettersandsocialmediawereusedtorecruitactive
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sportsparticipants(athletes)between18and70years.Tobeincludedinthestudyathleteshadtohaveincurredaself-reportedanklesprainwithintwomonthsbeforeinclusionintothestudyandhadtohaveaccesstoamobilesmartphone(eitherAndroidoriOS).Whenrespondentshadsufferedadifferentinjuryinthesameankleintheprecedingyear(e.g.,fracture of the ankle) they were considered non-eligible. The first author assessed allreportedanklesprainsfromtheparticipantsorallytoconfirminclusioneligibility.TheflowofparticipantsisshowninFigure1.
Figure1|Flowchartofparticipantrecruitmentandfollow-up
Previoustothecurrentstudyon thelong-termeffects,astudywascarriedoutwiththesamestudysampleontheshort-termeffects.Theprimaryoutcomemeasureofthisshort-term studywas compliance to the 8-week training programme. Therefore, sample sizecalculationswerebasedupontheexpectedcomplianceratesandgroundedonpreviouslyreportedcomplianceratestothesameprogram[11].Fullcomplianceratesinthecontrolgroup(Booklet)wereexpectedtobearound25%.Adoublingofthisratetoatleast50%inthe intervention group (i.e., the App group; see below)was considered to be clinically
91
relevant.Baseduponabetaof0.90andanalphaof0.05,atotalof158athleteswasrequired,divided across both study groups. Assuming a dropout rate of 20%, a sample of 190participantswascalculated.Afterparticipantshadfinishedusualcarefortheiranklespraintreatment,andhadreturnedtheinformedconsentandbaselinequestionnaire,theywererandomlyassignedtooneoftwostudygroups;i.e.anAppgroupandawritten(print)materialsonlygroup(i.e.‘Bookletgroup). Participants were allocated to the study groups through a random numbergenerator.TheAppgroupwas instructed touse the"StrengthenyourAnkle” (inDutch:“VersterkjeEnkel”)Appontheirmobilephone,whichcouldbedownloadedforfreefromeithertheAppStore[9]ortheGooglePlaystore[10].TheBookletgroupreceivedaBookletwiththesameNMTprogramonpaper.Allparticipantsreceivedthesamebalanceboard(machU/MSGEuropeBVBA).BoththeBooklet and the App contained the same NMT program that consisted of six differentexercises to be performed during three sessions a week, for a period of eight weeks.Difficulty and load of the exerciseswere prescribed to increase every week. The NMTprogramhasbeenshowntobecost-effectiveinreducingrecurrentanklespraininprevioustrials [5,12]. The App provided the participant with an interactive exercise schedule,possibility for reminders,written instructions, and narrated video instructions on eachexercise.TheBookletusedpicturesandwritteninstructionstoexplaintheexercises.Duringtheeightweeksoftheintervention,weeklyquestionnairesweresenttoallparticipants.After theeightweeks thesequestionnairesweresentmonthly fora further tenmonths.Duringtheseten-monthfollow-upparticipantswerenolongerrequiredtofollowtheNMTprogram.Thesemonthlyquestionnairesincludedquestionsonrecurrentinjuries,exposuretosportactivitiesand,painandlimitationsasaresultoftheinitialand/orrecurrentanklesprain.ThestudyshowednodifferencesincompliancewiththeinterventionbetweentheApp-groupandtheBooklet-groupduringtheeightweeksoftheinterventionprogramme
[7].Anonlinebaselinequestionnairewasusedtocollectparticipants’informationonphysicalcharacteristics, injuryand sports history, use of preventivemeasures (tape, brace), andseverity,receivedtreatmentandrehabilitationoftheinclusionanklesprain.Theprimaryoutcomemeasureofthecurrentstudywasincidencedensityofanklesprainsasmeasuredbyself-reportduring the twelve-month follow-up. Injury incidencedensity(IID)was defined as the number of recurrent ankle sprains per 1,000 hours of sportsexposure.Duringthetwelve-monthfollow-up,participantswereaskedmonthlythroughonlinequestionnairesabouttheirhoursofsportsexposureandwhethertheyhadsustainedan ankle sprain in the previousmonth. Ankle sprain recurrencewas defined as a self-reportedinversionmomentofthesameankle,bywhichbothameremomentofinversion(givingway)aswellasclinicalanklesprainswereincluded.Self-reportedrecurrentanklesprainswerecategorizedbyseveritybylookingatrecurrencesthathadledtotime-lossorcosts.Timelosswasdefinedasthediscontinuityof(sport)activityand/ormissing(partof)thenextplanned(sports)activityduetotherecurrentanklesprain[11].Sprainsthatresultedineitherdirectorindirectcostswerecategorizedassprainsleadingtocosts.ThesemethodshavebeenusedpreviouslyintwocomparablestudieslookingattheeffectivenessoftheNMTprogramtopreventrecurrentanklesprain[6,12].SecondaryoutcomemeasurewastheFunctionalDisabilityAnkleIndex(FADI,Martin1999)[12].Thisindexhasbeenvalidatedpreviouslyandhasbeenusedtodescribepainatthe
92
ankleanddifficultyduringdailyactivities[14,15].TheFADIconsistsof26itemsscoredonafive-pointLikertscale.TheFADIwasincludedinthemonthlyquestionnaires.Theindexscorewasrecordedasapercentage.Afullscoreof104pointsresultedina100%score.ThehighertheFADI,thelowertherateof limitationandpainasaresultoftheanklesprain.Twenty-twoitemsquestionedlimitationsondailyactivities.Subjectsratedtheactivityasno difficulty at all (4 points), slight difficulty (3 points),moderate difficulty (2 points),extremedifficulty(1point),unabletodo(0points).Notapplicable(N/A)wasscoredwhentheactivitywaslimitedbysomethingotherthantheanklesprain.IfN/Awasscored,thisitemwasnot included in thefinal score.Forpainrelated itemsscoreswere:nopain (4points), mild pain (3 points), moderate pain (2 points), extreme pain (1 point) andunbearablepain(0points).Anothersecondaryoutcomemeasurewasthecumulativenumberofanklesprainsand/orinversions during the twelve months of follow-up from baseline, per participant. Thissecondary outcome measurewas calculated by adding all recurrent injuries thatweresustainedduringthetwelvemonthsoffollow-up.MeanbaselinedifferencesbetweentheAppandtheBookletgroupweredeterminedusingan independent samples t-test for continuous data (age, body weight, body height,exposure)andFisher’sexacttest(withMonteCarlo95%confidenceintervalsimulationduetosmallnumberofsamples)forcategoricaldata(levelofsport,severityofanklesprain,gender).Baselinemeasurementswerebasedonthetotalnumberofparticipants(n=220)thatwereallocatedtoeitheroneoftheinterventions.Coxregressionanalysescomparedriskofself-reported,timelossandcostrecurrentanklesprainsbetweenthegroups.Nosignificantdifferencebetweentheincidenceofrecurrentinjurieswas found. Injury incidence analyseswere checked for confounders and effectmodifiers.During the firsteightweeksof thestudy,allparticipantswerequestionedontheircompliancewiththeexerciseprogram.Performingatleast75%ofallexerciseswasregardedasbeingcompliantwiththeexerciseprogram[6].Noconfounderswerefound.Asgenderwasfoundtobeaneffectmodifierintheshortterm,separateresultswerepresentedformenandwomen[7].AMann-WhitneyUtestwasusedtocalculatethedifferencesbetweenmonthlyFADIscoresandcumulativeinjuryrecurrencesbetweenbothgroups.Allanalyseswereconductedaccordingtotheintention-to-treatprincipleanddifferenceswereconsideredsignificantwithasignificancelevelof0.05.
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RESULTS
Atotalof220athleteswasrecruitedduringtherecruitmentperiodOctober2013toApril2014.Atbaseline,bothgroupswerecomparableregardingallvariablesmeasured(Table1).
Table1Baselinecharacteristicsofthestudypopulation.Numbersarepresentedaspercentageofthepopulation
(%),themedianwithcorrespondingrangeorasthemeanwithcorrespondingstandarddeviation(mean±SD)
Combined App Booklet Pvalue
Participants(n) 220 110 110
Numberofmales(nand%) 110(50.0) 55(50.0) 55(50.0) 1.000
Age(yrs) 37.9±13.4 37.6±13.1 38.1±13.7 0.741
Weeklysportsexposure(hoursand
range)
3.0
(0-19.5)
3.0
(0-15.0)
3.0
(0-19.5)
0.791
Levelofsport(nand%)
Competitive,international
Competitive,national
Competitive,regional
Recreational,organised
Recreational,unorganised
9(4,1)
32(14,5)
76(34.5)
56(25.5)
47(42.7)
2(1.8)
19(17.3)
40(36.4)
25(22.7)
24(21.2)
7(6.3)
13(11.8)
36(32.7)
31(28.2)
23(20.9)
0.311
Contactsport(nand%) 136(61.8) 68(61.8) 68(61.8) 1.000
Severity of inclusion sprain (n and
%)
Grade1
Grade2
Grade3
Unknown
91(41.3)
64(28.9)
18(8.0)
48(21.8)
47(42.7)
34(30.9)
10(9.1)
19(17.3)
44(40.0)
30(27.3)
8(6.9)
29(26.4)
0.666
Medicallytreated(nand%) 134(61.0) 67(61.0) 65(59.0) 0.783
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Atotalof20,046hoursofsportsparticipationwasregisteredduringthe12-monthfollow-up.IntheAppgroupthetotalexposurewas9,397hours,whereasintheBookletgrouptotalexposurewas10,648hours.During12monthsfollow-up,therewere139recurrentankleinjuries:70intheAppgroupand69intheBookletgroup.Thirty-twoinjuriesledtocostsand38injuriestotimeloss.Table2showstheinjuryincidencedensitiesofallrecurrentinjuries,thoseleadingtotimelossandthoseresultingincosts.ViaCoxregressionanalysisnodifferencesininjuryincidencedensitywerefoundbetweengroups(p<0.05).
Table2Injuryincidencedensity(IID)ofself-reported,timeloss,andanklesprainrecurrencesleadingtocosts
(95%CI)per1,000hofsportsparticipation,aswellastheHazardRatio(95%CI)derivedfromCoxregression
analyses.
App Booklet
Overall n IID n IID HR
Self-reported 7015.59
(11.94-19.24)69
15.84(12.10-19.58)
1.06(0.76–1.49)
Timeloss 131.50
(0.69-2.32)25
2.71(1.65-3.77)
0.55(0.82–1.09)
Costs
16
1.96
(1.00-2.92)
16
1.85
(0.95-2.76)
1.13
(0.56–2.27)
Male 55 55 110
Self-reported 349.88
(6.56-13.20)27
8.74(5.00-12.48)
1.12(0.68-1.87)
Timeloss 81.49
(0.46-2.52)11
3.65(1.49-5.81)
0.51(0.20-1.29)
Costs 91.76
(0.61-2.9)6
1.99(0.40-3.58)
1.17(0.41-3.30)
Female 55 55 110
Self-reported 3634.25
(23.06-45.44)42
20.99(14.57-27.42)
1.09(0.70-1.72)
Timeloss 51.52
(0.19–2.85)14
2.49(1.19-3.80)
0.51(0.18-1.44)
Costs 72.30
(0.60-4.00)10
1.61(0.61-2.61)
1.04(0.39-2.77)
95
MedianFADIscoresincreasedovertimefrom92.9(62.0-100.0)atbaselineto100(57.6-100.0)at12months’follow-upintheAppgroupandfrom93.8(57.1-100.0)atbaselineto100(78.9-100.0)at12months’follow-upintheBookletgroup,respectively.Innoneofthefollow-upmonthsFADIscoresweresignificantlydifferentbetweengroups.Fromthe3rdmonth onwards, after the training programme had been completed, participantsexperiencedlittlepainandordisabilityfromtheirankleinjury.Duringthefinalmonthsofthefollow-up,painanddisabilityscoresdid,onaverage,notincrease.A total of 58 participants reportedmore than one self-reported recurrent ankle injuryduringthefollowup.TwelveparticipantsintheAppgroupand20intheBookletgroupsuffered from two ankle sprains in the 12-months follow-up; another 4 (App) and 9(Booklet)participantsrecurredthreeanklesprains,4(App)and2(Booklet)participantsdealtwith four recurrentanklesprains,and inbothgroups3participants recurred fiverecurrentanklesprains.Finally,oneparticipantintheAppgrouphadhadsixself-reportedanklesprainswithin the twelvemonths.A totalof11participants suffered two injuriesleadingtocosts;6intheAppgroupandfiveintheBookletgroup.Afurther7participantsdealtwithtwoinjuriesleadingtotimeloss,3intheAppgroupand4intheBookletgroup.Thedifferenceintotalnumberofinjuriesleadingtotimelossbetweenbothgroupsreachedsignificance(p<0.04),withnosignificantdifferencebetweenbothtotalnumberofrecurrentinjuries(p>0.58)andtotalnumberofinjuriesleadingtocosts(p<0.98).
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DISCUSSIONThe persistent existence of sport-related injuries has provided researchers and healthprofessionalswithacontinuingchallengetodevelopandimproveeffectiveinterventions
[3]. To stimulate injured athletes to comply with such interventions, the programsimplementedshouldbeattractivewithlowbarrierstouse[1].Inthepresent-daysociety,wheremobileandtabletusageisrising,E-healthisthoughttoprovidenewopportunitiestoincreasecompliancetoeffectiveinterventionprograms.Mobileapplicationsallowfornewfeatures,suchasverbalinstructions,video’sshowingthecorrectexecutionofexercisesandacalendarfunctiontoreminduserstodotheexercisesasadvised.Asourpreviousstudyhasshown,anAppdidnot lead tobettercompliance,comparedtothetraditionalwayofdeliveringaninterventionviaprintedmaterialintheshapeofaBooklet.However,thepreviousstudydidnotaddresseffectsoninjuryincidenceoveratwelve-monthperiod,asthisstudydid.Thisstudyshowed,duringthefollow-upoftwelvemonths,neitherasignificantdifferenceininjuryincidencedensitybetweenthetwogroupsnoradifferenceininjuriesleadingtocostsortimeloss.Inaddition,theFADIscoresincreasedequallyinbothgroupsduringfollow-upandreachedaceilingeffectafterthreemonths.Hereafter,painanddisabilityscoresdidnotincreaseduringtheremainderofthefollow-up. The cumulative number of recurrent injuries did not show a significantdifferencebetweentheAppandtheBookletgroup.Theseresultsdonot,byanymeans,showthattheuseofE-healthisofnouseinsportinjuryprevention.Itdoesshowthattheuseofmobileapplicationsisaseffectiveastheuseofmoretraditionalprintedinstructions.Bothmethodsofimplementationhavereceivedanupdateaftercompletingourstudy.Thisupdateaimstoincreasetheattractivenessandusabilityandthismayleadtoevenbettercompliance/adherencerates,thuspotentiallyleadingtoevenbetteroutcomes.Itispromisingthatthecomplianceinourstudywiththeinterventionshowedanincrease,ascomparedtopreviousstudieslookingatthesameneuromusculartrainingprogrambutwithanolder,simplerversionofthebooklet[5,12].Inthesestudies,compliancewiththeprogramwaslowerduringtheeightweeksofexercises–respectively23%[5]and45%oftheathleteshadhighcompliancewiththeintervention–ascomparedto65%inthestudyusingthenewmaterial[12].Withrespecttorecurrentankleinjuries,theprevioustwostudiesreportedaninjuryincidencedensityof1.86per1000hofsport;95%1.37-2.34and2.51per1000hofsport;95%1.59-3.42[5,12].Althoughtheseinjurydensitiesarevastlowerthantheonesreportedinthecurrentstudy(15.59per1000hofsport;95%11.94-19.24)fortheAppgroupand(15.58per1000hofsport;95%12.10-19.58)intheBookletgroup,thisshouldbeinterpretedasadifferenceduetoadifferenceininjury definition as the current study also included ‘givingway’ as a component of thedefinition of recurrent ankle injury. Additionally, more than half of the recurrent self-reportedinjuries(46/70intheAppgroupand47/69intheBookletgroup)inthecurrentstudyoccurredduringthefirsttwomonthsofthestudy,inwhichtheparticipantswerestillfollowingtheexerciseprogram.Thelesserhalfofallinjurieswasspreadovertheten-monthfollow-upperiod.Itisunknownhowthedistributionofrecurrentinjuriesdevelopedovertimeintheothertwostudies.Itwouldbeofgreatinteresttoseeifthesimultaneousandcombineduseofbothmethodscanfurtherincreasecomplianceandhencecontributetoeffectivesportinjuryprevention.Whenbothmethodsofimplementationcanbeusedsimultaneously,athletesinvolvedhavea diversity of means to use. This allows athletes to choose the method that is most
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convenient at a certain moment in time and/or that is in line with their personalpreferences.The results from this study can be seen as an important contribution to the scientificcommunity.WhereforthemajorityofavailableAppstheAppcontentisnotevidence-based,the“StrengthenyourAnkle”Appusesaproveneffectiveintervention[5,16].In the twelve months of follow-up, athletes were contacted monthly to assess theirrecurrent injuries and FADI scores. In the questionnaires used, they were also askedwhethertheyhadcontinuedusingtheAppand/ortheBooklet.Itispossiblethatbeingpartofthisstudyprotocolhasinfluencedtheiruseoftheintervention.Therefore,inareal-lifesituation,withoutthestimulusofthisresearch,athletesmightbelesslikelytocontinuetheexercisesandasaresultdevelopmorerecurrentinjuries.
CONCLUSION
Thisstudyshowedthatthemethodof implementingtheexercisesbyusinganApporaBookletdidnotleadtodifferentinjuryincidenceratesinthelongtermnordiditinfluenceresidual functionaldisabilityorpain.Assumingequal complianceduring theeight-weekintervention – as is shown in previous research - both methods showed similareffectivenessinatwelve-monthfollow-up.Thisindicatesthatbothmethodscanbeusedinterchangeablytoreducetheriskofrecurrentanklesprains.
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PRACTICALIMPLICATIONS
• Aproveneffectiveneuromusculartrainingprogrammecanbedeliveredbothinamobileapplicationasinaprintedinstructionbooklet.
• Both methods of implementation can be used interchangeably to reducerecurrentanklesprainsinthelongterm.
• Number of recurrent ankle injuries, residual pain/disability and cumulativenumber of recurrent ankle sprains are similar with both implementationmethods.
ACKNOWLEDGEMENTS
Wewouldliketothankthefollowingpartnersfortheircollaborationandrecruitmentofstudyparticipants: RoyalDutch Society for Physical Therapy (KNGF),Dutch Society forPhysicalTherapyinSports (NVFS),DutchCollegeofGeneralPractitioners (NHG),DutchSports Medicine Society (VSG), Dutch Olympic Committee (NOC*NSF), Zilveren KruisAchmea(ZKA),andDisporta.
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4. VerhagenEALM,BayK,Optimizinganklesprainprevention:acriticalreviewandpracticalappraisaloftheliterature,BrJSportsMed2010;44:1082–1088
5. HupperetsMDW,VerhagenEALM,vanMechelenW,Effectofunsupervisedhomebasedproprioceptivetrainingonrecurrencesofanklesprain:randomisedcontrolledtrial,BMJ2009;339:b2684
6. VerhagenEA,HupperetsMD,FinchCF,etal.Theimpactofadherenceonsportsinjurypreventioneffectestimatesinrandomisedcontrolledtrials:lookingbeyondtheCONSORTstatement.JSciMedSport2011;14:287–2892.
7. VanReijenM,VriendI,ZuidemaV,etal.Increasingcompliancewithneuromusculartrainingtopreventanklespraininsport:doesthe‘Strengthenyourankle’mobileAppmakeadifference?Arandomisedcontrolledtrial.BrJSportsMed.doi:10.1136/bjsports-2015-095290
8. VanReijenM,VriendI,ZuidemaV,etal,Theimplementationeffectivenessofthe"Strengthenyourankle"smartphoneapplicationforthepreventionofanklesprains:designofarandomizedcontrolledtrial,BMCMusculoskeletDisord2014;15:1–8
9. “VersterkjeenkelApp”Appstore:https://itunes.apple.com/nl/app/versterk-je-enkel/id456001033?mt=8Lastvisited:24-11-2015
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12. JanssenKW,vanMechelenW,VerhagenEALM,Bracingsuperiortoneuromusculartrainingforthepreventionofself-reportedrecurrentanklesprains:athree-armrandomisedcontrolledtrial,BrJSportsMed2014;48:1235–1239
13. MartinRL,IrrgangJ,BurdettRG,DevelopmentoftheFootandAnkleDisabilityIndex
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(FADI)[abstract]JOrthopSportsPhysTher.1999;29:A32–A33.
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15. HaleSA,HertelJ.ReliabilityandsensitivityoftheFootandAnkleDisabilityIndexinsubjectswithchronicankleinstability.JAthlTrain2005,40(1):35-40.
16. VanMechelenDM,vanMechelenW,VerhagenEA.Sportsinjurypreventioninyourpocket?Preventionappsassessedagainsttheavailablescientificevidence:areview.BrJSportsMed.2014.Jun;48:11:878-882
17. BoudreauxED,WaringME,HayesRBetal.Evaluatingandselectingmobilehealthapps:strategiesforhealthcareprovidersandhealthcareorganizations.TranslBehavMed.2014.Dec:4:4:363-371
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CHAPTER6 Preventingrecurrentanklesprains:IstheuseofanAppmorecost-effectivethanaprintedBooklet?ResultsofaRCT.MiriamvanReijenIngridVriendWillemvanMechelenEvertVerhagenScandinavianJournalofMedicineandScienceinSports2017Digitalobjectidentifier(doi):10.1111/sms.12915
six.
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ABSTRACT
ObjectivesRecurrentanklesprainscanbereducedbyfollowinganeuromusculartraining(NMT)programviaaprintedBookletoramobileapplication.Regardingthehighincidenceofanklesprains,cost-effectiveness regarding implementationcanhavea largeeffectontotalsocietalcosts.Design In this economic analysiswe evaluatedwhether themethod of implementing aproveneffectiveNMTprogrambyusinganApporaBookletresultedindifferencesininjuryincidenceratesleadingtocostsandhencetodifferencesincost-effectiveness.Methods220athleteswithapreviousanklesprainwererecruited for this randomisedcontrolled trial with a follow-up of twelvemonths. Half of the athletes used the freelyavailable‘Strengthenyourankle’AppandtheotherhalfreceivedaprintedBooklet.Afterthe eight-week program athleteswere questioned monthly on their recurrent injuries.Primaryoutcomemeasureswereincidencedensityofankleinjuryandincrementalcosteffectivenessratio(ICER).ResultsDuring follow-up31athletes suffered froma recurrentanklesprain that led tocosts resulting in a Hazard Ratio of 1.13 (95% CI: 0.56-2.27). The incremental cost-effectivenessratio(ICER)oftheAppgroupincomparisonwiththeBookletgroupwas€-361.52. TheCE plane shows that therewas neither a difference in effects nor in costsbetweenbothinterventionmethods.DiscussionThisstudyshowedthatthemethodofimplementingtheNMTprogrambyusinganAppora Booklet led to similar cost effectiveness ratios and the same occurrence of recurrentinjuries leadingtocosts.BoththeAppandtheBookletcanbeusedtopreventrecurrentankleinjuries,showingnodifferencesin(cost-)effectivenessat12months’follow-up.
Trialregistration
TheNetherlandsNationalTrialRegisterNTR4027.TheNTRispartoftheWHOPrimaryRegistries.
Contributors
EV(e.verhagen@vumc.nl)conceivedtheresearchidea,MVR(m.vanreijen@vumc.nl,@miriamvanreijen) and EV havewritten the protocol,MVR has screened and includedpatients,performeddataanalysesandisthemainauthor.IV(i.vriend@vumc.nl)andWVM(w.vanmechelen@vumc.nl)contributedtoideasintheprotocol.Allauthorshavereadandcommentedonthedraftversionandapprovedthefinalversionofthemanuscript.
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INTRODUCTION
Thereisnodiscussionwhetherphysicalactivityandexercisecanbenefittheindividual.Theright sort and amount of physical activity and exercise can increase an individual’slongevity,reducetheriskofnumerousdiseasesandallowforfeelingsofjoy,friendshipandrelaxation [1-4]. There is no doubt that these individually experienced benefits alsoinfluence thewellbeing of society as awhole [5]. However, exercise does bring aboutburden and related costs to the individual aswell as society in the formof sports andexerciserelatedinjuries[6].In2013intheNetherlandsalone,atotalof4.5millionsportandexerciserelatedinjuriesoccurredonanactivepopulationof12million.Twofifthofthoseinjuries(1.9million)requiredmedicaltreatment.Itwascalculatedthatthisresultedinatotalcostof€520million[7].Anklesprainsarethemostcommonsportsandexerciserelatedinjury.Inadditiontothedirectburdenofsuchinjuries,thereisanincreasedriskofincurringrecurrentanklesprainandtheriskofchronicresidualpain[8-11].Boththehighincidenceofanklesprain,thehighriskofrecurrence,aswellastheresultingsocietalcostsjustifypreventiveefforts.Toaddressthepreventionofrecurrentankleinjuriesnumerousinterventionshavebeendeveloped. Examples of interventions are predominantly focused on using supportivematerial(e.g.tapeandbrace)andorthestrengtheningoftheanklebyexercises[12,13].Aninterventionthathasbeenshownrepeatedlytoreducerecurrentankleinjuryrisktothelevelofsomeonewhohasneversprainedhis’/herankleisaneight-weekneuromusculartraining program [14]. This program has been shaped in the ‘Strengthen your Ankle’training program and has been implemented in The Netherlands both via a printedinstructionalBookletaswellasviaamobileapplication.Previousstudieshaveshownthatbothmethodsofimplementingthisneuromusculartrainingprogramareequallyeffectivein enabling compliance with the program, as in reducing the number of self-reportedrecurrentinjuries[15,16].Althoughequallyeffectiveontheseoutcomes,cost-effectivenessmay still differ. As bothmethods require substantial development and implementationcosts,itisimportanttoevaluatewhetherthecostsandtheassociatedpreventiveeffectoftheAppandtheBooklet justifytheirwidespreaduse.Anumberofstudieshavealreadyaddressed the importance of cost-effectiveness and allow for comparisons of differentmethods. As a result, accurate analyses have been developed that determine the cost-effectivenessofthecurrentintervention[14,17].Thepresentstudyfollowsthelineofthesestudies and evaluates the cost-effectiveness of the Booklet and the App in preventingrecurrentanklesprainsovera12monthfollowup.
METHODS
This study, evaluating cost effectiveness of two methods used to implement theneuromuscular ‘Strengthen your Ankle’ program was part of a larger randomizedcontrolledtrialofwhichthedesignhasbeenpublishedbefore[18].Briefly,activesportsparticipants(athletes)whohadincurredaself-reportedanklesprainwithinthepasttwomonthswererandomizedtooneoftwostudygroupsviaarandomnumbergenerator.TheMedicalEthicsCommittee (2013/248)of theVUUniversityMedicalCenter,Amsterdam
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(VUmc)theNetherlands,hadapprovedthestudydesignandinformedconsentprocedureforthisstudy.ThetrialisregisteredintheNetherlandsTrialRegistry(NTR4027).InclusionwasheldbetweenOctober2013andApril2014viaphysiotherapyandsportsphysician practices, national sport federations’ websites, digital newsletters and openinvitationvia socialmedia, the Internetandwrittenmedia.Tobe included in thestudyactivesportsparticipants(between18and70years)hadtohavesustainedananklesprainwithinthepasttwomonthsandhadtohaveaccesstoamobilesmartphone(eitherAndroidoriOS).Whenrespondentshadsufferedanotherinjuryinthesameankleintheprecedingyear (e.g., fracture of the ankle) theywere considered non-eligible. All reported anklesprainswereassessedbyphonebythemainauthortoconfirminclusioneligibility.Theflowofparticipantscanbefoundelsewhere[18].Samplesizewasbasedoncompliancetotheeight-weektrainingprogram,whichwasthemainoutcomeoftheprimaryshort-term(i.e.duringthe8weeksofthetrial)effectivenessstudy[15].Itwasexpectedthat25%oftheparticipantswouldbefullycompliantwiththetrainingprogram.Adoublingof this complianceratewasconsideredclinically relevant.Baseduponabetaof0.90andanalphaof0.05,atotalof158athleteswasrequired,i.e.74pergroup.Previouscomparablestudieshaveshownadropoutrateduringa12months’follow-upofabout20%[14].Thismeansthatasampleof190participantswasrequiredatbaseline,i.e.95pergroup.ThestudywasapprovedbythemedicalethicscommitteeoftheVUUniversityMedicalCentre,Amsterdam,TheNetherlands(protocolnumber2013/248)andpatientconsentwasobtained.Participantsinbothgroupsreceivedthesamebalanceboard(machU,MSGEuropeBVBA)and the same neuromuscular training (NMT) program,which consisted of six differentexercisestobeperformedduringthreesessionsaweek,foraperiodofeightweeks.Theprinted instruction Booklet showed pictures of the exercises, an eight-week trainingscheduleandwritteninstructions.TheAppprovidedtheparticipantswithbothwritten,visualandverbalinstructionsandincludedacalendarfunction.TheAppgroupwasinstructedtousethe‘StrengthenyourAnkle’Appontheirmobilephone,whichcouldbedownloadedfor free fromeither theAppStoreor theGooglePlayStore[19,20].TheBookletgroupreceivedaBookletwiththesameNMTprogram,butonpaper.Bothgroupswerequestionedweekly–withonlinequestionnaires-ontheircompliancewiththeprogram,aswellasanyincurredrecurrentankleinjuriesduringthe8weeksoftheneuromuscular training program. Thereafter participants were questioned monthly onincurredrecurrentankleinjuries,foratotalfollow-upoftenmonths.Whenanathletesufferedfromarecurrentinjury,acostdiaryhadtobecompletedweeklyuntilfullrecovery.Thiscostdiaryregisteredallabsencefromstudy,schooland(un)paidwork,aswellashealthcareutilization,and thepurchaseofmedicalequipmentsuchasbraces,tapeormedication.Thismethodhasbeenusedinpreviousstudiestodeterminecost-effectivenessofthesameNMTprogramme[14,17].Ankle sprain recurrencewas defined as a self-reported inversionmoment of the sameankle,bywhichbothameremomentof inversionaswellasclinicalanklesprainswereincluded. Self-reported recurrent ankle sprainswere further categorized to severity bylooking at recurrences that led to time-loss or costs. Time loss was defined as thediscontinuityof(sport)activityand/ormissing(partof)thenextplanned(sports)activityduetotherecurrentanklesprain[21].Sprainsthatresultedineitherdirectorindirectcostswerecategorizedassprainsleadingtocosts.Thismethodhasbeenusedpreviouslyintwo
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comparablestudieslookingattheeffectivenessoftheNMTprogramtopreventrecurrentanklesprain[14,17]Atbaselineaquestionnairewassendtoallparticipantstoquestionphysicalcharacteristics,injuryandsportshistory,useofpreventivemeasures(tape,brace),andseverity,receivedtreatmentandrehabilitationoftheinclusionanklesprain.Costs related to the use of the ‘Strengthen your ankle’ App and theprinted instructionBooklet includedtheusefortheincludedmaterialcosts(thebalanceboard)andforthedevelopmentoftheApporBooklet,thetimespentconductingtheprogram(patienttimecosts),aswellasthecoststhatwereincurredduetoarecurrentanklesprain(indirectanddirecthealthcarecosts)during the twelvemonthsof follow-up.Table1shows thecostcategoriesthatwereusedinthisstudy.
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Table1|Costsappliedintheeconomicanalysis
CostoftheAppgroup(perathlete)
Balanceboard €14.00
CostperdownloadedApp €1.61
Patienttime(maximum) €168.00
CostoftheBookletgroup(perathlete)
Balanceboard €14.00
CostperprintedBooklet €0.26
Patienttime(maximum) €168.00
Directhealthcarecosts
Generalpractitioner(20minpervisit)a
€33.00
Generalpractitioner(telephoneconsult)a
€17.00
Physicaltherapist(30minpervisit)a
€33.00
Medicalspecialist(pervisit)a
€52.00
Indirecthealthcarecosts
Absenteeismfrompaidwork-men(perday)a
€37.90
Absenteeismfrompaidwork-women(perday)a
€31.60
Absenteeismfromunpaidwork(perhour)a
€14.00
a:PriceaccordingtoDutchguidelines[22]
The development costs of the App were calculated by Veiligheid.NL and included therecordingofinstructionalvideos,thecostsofdesign,thecostsforpublicationinboththeGooglePlayStoreandtheAppStoreandtestingofboththeiPhoneandAndroidversionsofthe app. Development costs were then divided by the total number of downloads asregistered inDecember 2013 (n=39,350),when follow-up of this study had ended. Thedevelopmentofthebooklet includedthecostsfordevelopment,printing,transportationandstorageofthebooklets.Thesetotalcostsaredividedbythetotalnumberofprintedbooklets(n=112,500)bytheendof2013.Patienttimewasconsideredasunpaidwork,estimatedatashadowpriceof€14,00perhour[22].Timespentonthetrainingprogramcouldbedeterminedveryaccurately,asallparticipantskeptadetailedrecordofwhichexercisestheyperformedeachweekduringthe
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eight-weekofthetrainingprogram.Fromthisitcouldbedeductedhowmuchpatienttimewasactuallyinvolved.Withfullcompliance,thecompleteprogramrequires3x30minutesofpatienttimeperweek.Associatedhealthcarecosts, standardprices forhealthcareutilizationand thecostsofmedicationandmedicalequipmentwerebasedonthepricesasrecommendedbytheRoyalDutchSocietyofPharmacy[22].Finally,costsforabsenteeismfromschool,studyand/or(un)paidworkwereincluded.Unpaidworkwasestimatedatashadowpriceof€14,00perhour,paidworkwasdeterminedbyusingthefrictionmethod.Thismethodassumesthatallworkisreplaceableandthatassociatedsocietalcostsareonlymadeduringthetimeittakes to find replacement [17]. It is recommended that the average period to findreplacement,andthustherecommendedfrictionperiod, is85days[22].Allpriceswerestandardizedtotheyear2015.Fromtheonlinequestionnaires,theinjuryincidencedensity(IID)andcorresponding95%confidenceinterval(95%CI)wascalculatedasthenumberofrecurrentanklesprainsper1,000hoursofexposure[17,23].From30ofthe31participants(97%)thathadsustainedarecurrentinjuryduringfollow-upperiod,acostdiarywasretrieved.Oneparticipantfailedtosendinformationonpossiblecoststhatweremadeaftertherecurrentinjury,althoughtheystatedtohavemadecosts.TheparticipantfromwhichdatawasmissingwasfromtheBookletgroup.Giventhelimitedamountofmissingdata,imputationtechniqueswerenotused.Tocalculate95%CIsaroundmeancosts,costdifferencesandmeanpatienttimeandpatienttime differences, nonparametric bootstrapping was used with 1,000 replications. Coxregression analyses compared risk of self-reported, time loss and cost recurrent anklesprainsbetweenbothgroups.
In addition, the Incremental Cost-Effectiveness Ratio (ICER) was calculated, using theBookletgroupasthereferencegroup[24].TheICERrepresentstheincrementalcostsofthetrainingprogramusingtheApptopreventoneanklesprainrecurrence,incomparisontotheprogramfollowedusingtheBooklet.TheICERcanbecalculatedas:(Cb-Ca)/(Eb-Ea)=DC/DE,inwhichCb=meancostsintheBookletgroup,Ca=meancostsintheAppgroup,Eb=meaneffectsintheBookletgroupandEa=meaneffectsintheAppgroup.TheuncertaintythatresultsfromthisICERwasplottedinacost-effectivenessplane,usingnonparametricbootstrapping with 1,000 replications. All analyses were conducted according to theintention-to-treatprincipleanddifferenceswereconsideredsignificantwithasignificancelevelof.05.
RESULTS
Atotalof220athleteswasrecruitedduringtherecruitmentperiodOctober2013toApril2014. At baseline, both groups had no significant differences regarding all variablesmeasured.Table2showsthebaselinecharacteristicsofthestudypopulation.
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Table2Baselinecharacteristicsofthestudypopulation.Numbersarepresentedaspercentageofthepopulation
(%),themedianwithcorrespondingrangeorasthemeanwithcorrespondingstandarddeviation(mean±SD).
Combined App Booklet
Participants(n) 220 110 110
Numberofmales(%) 110(50.0%) 55(50.0%) 55(50.0%)
Age(years) 37.9±13.4 37.6±13.1 38.1±13.7
Weeklysportsexposureatinclusion
(hours)
3.0
(0-19.5)
3.0
(0-15.0)
3.0
(0-19.5)
Contactsport(%) 61.8% 61.8% 61.8%
Severityofinclusionsprain
Grade1
Grade2
Grade3
Unknown
41.3%
28.9%
8.0%
21.8%
42.7%
30.9%
9.1%
17.3%
40.0%
27.0%
6.9%
26.1%
Medicallytreated(%) 61.0% 61.0% 61.0%
Duringthetwelve-monthfollow-upperiod,therewere139self-reportedrecurrentinjuries.Oftheseinjuries,38ledtotimeloss(13intheAppgroupand25inthebookletgroup),and31ledtocosts(16intheAppgroupand15intheBookletgroup).Table3showstheIIDofallrecurrentinjuriesduringthetwelvemonthsoffollowup,injuriesleadingtotimelossandinjuriesleadingtocosts.
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Table3InjuryIncidenceDensities(IID)andaccompanyingHazardRatiosofallself-reportedrecurrentinjuries,
injuriesleadingtotimelossandinjuriesleadingtocosts.
App
(n=110)
Booklet
(n=110)HazardRatio
Recurrentinjuries(IID)
15.59
(95%CI:11.94-
19.24)
15.84
(95%CI:12.10-
19.58)
0.94
(95%CI:0.76-1.49)
Recurrentinjuriesleadingtotimeloss
0.82
(95%CI:−0.30-
2.00)
2.36
(95%CI:0.50-
4.20)
0.55
(95%CI:0.28-1.09)
Recurrentinjuriesleadingtocosts
1.96
(95%CI:1.00-2.92)
1.85
(95%CI:0.95-2.76)
1.13
(95%CI:0.56-2.27)
Median±interquartilerangeofoveralltimespentontheexerciseprogramwas600±307minutes.IntheAppgroupthemeanoveralltimespentontheexerciseprogramwas547±278 minutes and in the Booklet group 547 ± 278 minutes. The overall time was notsignificantlydifferentbetweenbothgroups.Thetotalcostperathletewascalculatedasthesumofpatienttime,directhealthcarecostsandindirecthealthcarecosts(Table4).Therewasanoverallnon-significantcostdifferenceof€0.65perathletebetweentheAppandBookletgroup, in favourof theApp.Therewasa totalnon-significantcostdifferenceof€7.91 (95%CI€-77.95 - €85.69) per injured athlete between theApp and theBookletgroup,infavouroftheBooklet.
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Table4MeanandtotalCosts(€)perathleteandperinjuredathleteduring1-yearfollow-up.Valuesareexpressed
asmean(95%confidenceinterval).CostdifferencesarecalculatedwiththeAppgroupasthereference.
Theincrementalcost-effectivenessratio(ICER)oftheAppgroupincomparisonwiththeBookletgroupwas€-361.52,basedonadifferenceinthemeancost€-3.29andadifferenceinthemeaneffectsof1%.Thismeansthatpreventionof1anklesprainrecurrenceintheAppgroupisassociatedwith€361.52costsavingsperpreventedrecurrentanklesprain.
App Booklet Meandifference
Costsperathlete(€) n=110 n=110
Interventionmaterials €15.61 €14.26 €1.35
Patienttimecosts€123.07
(€113.29-€131.14)
€128.68
(€118.33-€138.12)
€-5.61
(€-5.15-€7.58)
Materialforrecovery
(i.e.brace,tape)
€5.41
(€1.41-€10.33)
€2.19
(€0.43-€4.31)
€3.22
(€-1.49-€8.13)
Directhealthcarecosts€11.93
(€3.67-€23.63)
€6.66
(€1.77-€12.36)
€5.27
(€-5.76-€17.43)
Indirecthealthcarecosts
(productivityloss)
€15.18
(€1.13-€38.45)
€23.04
(€0.76-€60.01)
€-7.86
(€-56.45-€27.67)
Total€171.20
(€147.15-€204.35)
€173.29
(€148.20-€212.44)
€-2.09
(€-51.32-€48.74)
Costsperinjuredathlete(€) n=70 n=69
Interventionmaterials €15.61 €14.26 €1.35
Patienttimecosts€134.78
(€125.12-€143.92)
€128.20
(€117.43-€139.00)
€6.58
(€-7.75-€20.26)
Materialforrecovery
(i.e.brace,tape)
€8.51
(€2.33-€16.05)
€3.51
(€0.80-€7.29)
€5.00
(€-2.09-€12.62)
Directhealthcarecosts€18.74
(€6.33-€36.66)
€10.68
(€2.66-€20.79)
€8.06
(€-9.98-€27.83)
Indirecthealthcarecosts
(productivityloss)
€23.86
(€1.36-€61.37)
€36.94
(€1.44-€94.59)
€-13.08
(€-95.65-€48.00)
Total€201.50
(€163.91-€257.34)
€193.59
(€154.43-€252.70)
€7.91
(€-77.95-€85.69)
111
Figure1showsthecost-effectiveness(CE)planefordifferencesintherecurrenceofanklesprainsduringthetwelvemonthsoffollow-upfortheBookletgroupversustheAppgroup.Therewasneitheradifferenceineffectsnorincostsbetweenbothinterventionmethods,as for theBookletgrouponly38%was in thedominantsoutheastquadrant (indicatingmoreeffect)and30%wasinthesouthwestquadrant(indicatinghighercosts).
Figure1Cost-effectivenessplanepresentingcost-effectpairsestimatedbyusingbootstrapping(1,000samples)
for the difference in ankle sprain recurrence risk between the App group and the Booklet group. Each dot
representsofonebootstrappedcost-effectpairthedifferenceincostsandeffectsoftheAppgroupcomparedto
the Booklet group. The outcomes of the samples are spread over the four quadrants, with only 38% of the
bootstrappedcost-effectpairsinthesouth-east‘dominant’quadrant.
In a sensitivity analysis, we calculated the ICER when the patient time costs weredisregardedfromtheanalysis.TheICERoftheBookletgroupincomparisonwiththeAppgroup,theincrementalcost-effectivenessratio(ICER)was€755.31,basedonadifferenceinthemeancostof€6,87andadifferenceinmeaneffectsof1%.Thismeansthat,whenpatient time is not taken into account, prevention of 1 ankle sprain recurrence in theBooklet group is associated with €755.31 cost savings per prevented recurrent anklesprain.Figure2showstheCEplanefordifferencesintherecurrenceofanklesprainsduringthetwelvemonthsoffollow-upfortheBookletgroupversustheAppgroup.
112
Figure2Cost-effectiveness planeafter theexclusionofpatient time, presentingcost-effectpairsestimatedby
usingbootstrapping(1,000samples)forthedifferenceinanklesprainrecurrenceriskbetweentheAppgroupand
theBookletgroup.Eachdotrepresentsofonebootstrappedcost-effectpairthedifferenceincostsandeffectsof
theAppgroupcomparedtotheBookletgroup.Theoutcomesofthesamplesarespreadoverthefourquadrants,
withonly12%ofthebootstrappedcost-effectpairsinthesouth-east‘dominant’quadrant.
DISCUSSION
Cost-effectiveness studies in sports injury preventionare rare. So far, only a handful ofstudieshasperformedsuchananalysis[14,17,25-28].The2014studybyJanssenwasthecompared two different treatment: the practice of using a brace in combination withneuromusculartrainingwascomparedtoNMTandbracingalone.Comparedtothecurrentstudy, using the same NMT programme, the patient time costs for the NMT group asreportedbyJanssenetal.2014wereconsiderablylowerduetoalowercompliancerate.Whereasonly45%ofthepatientsinthe2014studywereseenashighlycompliant,morethan70%of thepatients in thecurrent study reachedhighcompliance (i.e.performingmorethantwothirdsofallprescribedexercises).TheuseofeithertheBookletortheAppseems to bemore accepted in the sports community and the updated versions of bothmethodsarelikelymoreattractive.Thedifferenceincomplianceandhencepatienttimecostsbetween thisand the2014studyis reflected in thedifferent totalcostperathlete(€171.52inthecurrentversus€135.26forNMTgroupinthe2014study).Costsforthecombinationgroup(€163.60)weresimilarduetohighinterventioncosts(brace).TheinterventionmaterialcostsoftheAppwerebasedontheknowledgethattheAppwasdownloaded a total of 39,350 times at the time of analyses. This number is increasingsteadily,asmorepeopleareawareoftheexistenceandeffectivenessoftheApp.Andthus,with time, the intervention costs associated with the App will decrease. The costs forprintingtheBookletwillremainthesame,withnoinfluenceofthenumberprinted.The
113
AppismorethantwiceasexpensiveastheBooklet,anditisnotlikelythatbothmethodswillhave thesamepriceperunit in the future.TheApphas tobedownloadedanother204,026 times to have the same price per unit as the printed Booklet. However, as adownloadedAppcanbeupdated,newprintsarenecessaryassoonasanupdatedBookletwillbeavailable.Anothermethodological consideration is that athlete compliance has steadily increasedover the last few years.NMT is nowwidely accepted as an effectivemethod to reducerecurrentanklesprains.ItislikelythatanumberofathleteshavealreadyperformedsomesortofNMTbeforeparticipatinginthisstudy.Thismightarguablereducetheinitialriskofdevelopinga(recurrent)anklesprain.
PERSPECTIVE
Thisstudyevaluatedthecost-effectivenessofaninterventiontopreventtherecurrenceofanklesprainsdeliveredthroughanAppversusthesameinterventiondeliveredthroughaBooklet.Asisshowninpreviousresearch[15,16]theuseofeithertheApportheBookletshowsimilaroutcomes,bothintheshortandinthelongrun.Notonlydidbothmethodsresultincomparablecomplianceratesduringtheeightweeksofthetrainingprogramme,bothmethods also led to comparable ankle sprain recurrence rates on the short (eightweeks)aswell as long term (one-year). Adding the results from this cost-effectivenessstudy, inwhich it was found that the costs associated with both intervention deliverymethodswerenot-significantlydifferent,itcanbearguedthatboththeAppandtheBookletcan be used successfully, andwith the same cost efficiency, to reduce recurrent anklesprains. The NMT program, in both methods of implementation, has the potential torigorouslyreducethecurrentlyhightotalsocietalcostsofanklespraintreatment.
Competinginterests
The authors declare no competing interest. VeiligheidNL has provided themobile App.However,thisAppisavailableforfree.
ACKNOWLEDGEMENTS
Wewouldliketothankthefollowingpartnersfortheircollaborationandrecruitmentofstudyparticipants: RoyalDutch Society for Physical Therapy (KNGF),Dutch Society forPhysicalTherapyinSports (NVFS),DutchCollegeofGeneralPractitioners (NHG),DutchSports Medicine Society (VSG), Dutch Olympic Committee (NOC*NSF), Zilveren KruisAchmea(ZKA),andDisporta.
114
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CHAPTER7 Evidencebasedanklesprainpreventioninyourpocket?Amixedmethodsapproachonuser’sperspectives,opportunitiesandbarriersoftheStrengthenyourankleapp.MiriamvanReijenIngridVriendMarianneAsschemanWillemvanMechelen
EvertVerhagenJMIRRehabilitationandAssistiveTechnologies2018Digitalobjectidentifier(doi):10.2196/rehab.8638
seven.
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ABSTRACT
IntroductionThe "Strengthen your ankle” neuromuscular training (NMT)programhasbeenthoroughlystudiedinthepast8years.ThisprocessevaluationispartofaRCTthatexaminedboththeshortandlong-termeffectivenessofthisparticularprogram.Althoughitwasshownpreviouslythattheprogram–bothavailableinaprintedBookletandamobileApp-isabletoeffectivelyreducethenumberofrecurrentanklesprains,fromtheshortandlong-termstudiesitwasconcludedthatparticipants’compliancewiththeprogramisanongoingchallenge.
ObjectiveThisprocessevaluationexploredparticipants’opinionsregardingbothmethodsof delivery, using the RE-AIM (Reach Effectiveness Adaptation ImplementationMaintenance) Framework to be able to identify barriers and challenges to programcompliance.WhileReach,EffectivenessandAdaptationwheresubjectofpreviousstudy,thispaperfocussesontheImplementationandMaintenancephase.
Methods Semi-structured interviews and online questionnaires were analysed usingqualitative content analysis. Fisher’s exact, χ2 and t-tests assessed differences inquantitative survey responses among groups. Interviews were assessed by thematicanalysiswhichidentifiedkeythemes.
ResultsWhilsttherewasnosignificantdifferenceinperceivedsimplicity,usefulnessandliking of the exercise during the eight weeks of the NMT program, semi-structuredinterviews showed that 14/16 participants agreed that an Appwould be of additionalbenefitoveraBooklet.Aftertwelvemonths’follow-up,whenaskedhowtheyevaluatedtheoveralluseoftheApportheBooklet,usersoftheAppgaveameanscoreof(mean±sd)7.7±0.99versusameanscoreof7.1±1.23fortheusersoftheBooklet.Thisdifferenceinmeanscorewassignificant(p=0.006).
ConclusionsAlthoughboththeAppandtheBookletshowhighusersatisfaction,usersoftheAppweresignificantlymoresatisfied.Semi-structuredquestionnairesalloweduserstoaddress issues theywould like to improve in future updates. Including a possibility forfeedbackandpostponementofexercises,anexplanationoftheuseofspecificexercisesandpossiblymusiccanfurtherimprovethecontentmentoftheprogramandhencemightleadtoincreasedcompliance.
Trialregistration
TheNetherlandsNationalTrialRegisterNTR4027.TheNTRispartoftheWHOPrimaryRegistries.
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INTRODUCTION
Injuries,duetoparticipationinsportsandphysicalactivities,areprevalent.Internationally,anklesprainsareoneofthemostcommonmusculoskeletalinjuries[1].Inparticular,indoorandcourtsportshaveshownhighincidencesofanklesprainswithupto7injuriesper1000hours of participation [2]. Generally considered a “minor” injury, ankle sprains pose asignificantriskforlong-termsecondarycomplaintslikeinstabilityandchronicpain[3].Forthe prevention of acute lateral ankle sprains, numerous effective strategies have beendevelopedandevaluatedfortheircost-effectiveness[2].
One of themanyavailable interventions that hasbeenshown to beeffective inreducing the risk of recurrent ankle sprains, as well as protecting against secondarycomplaints, is neuromuscular training (NMT) [3-5].Multiple variations of such trainingprograms have been evaluated [6-8], including the “Strengthen Your Ankle” program(NMT).The“StrengthenYourAnkle”programconsistsof6exercisesthatareperformed3timesaweek,over8weeks.Multipletrialshaveindicatedthatthisprogramcanbeeffectivein reducing the injury incidence density [9,10] as well as being cost-effective [10,11].Despitetheprovenvalueoftheprograminpreventingrecurrentinjuryrisk,compliancewiththisandotherNMTprogramsisanongoingchallenge[3].SufficientcompliancewithNMTprogramsisessentialforsuccessfulpreventionofanklesprains[12].Consequently,afreemobileAppwasdevelopedasanovelandattractivemeansofprovidingathleteswiththe “Strengthen Your Ankle” program [13]. Details of the App have been describedelsewhere[3].Arecenttrial(NTR4027)showedthattheAppneitherincreasedcompliancenor decreased recurrence of ankle sprains compared with a standard programadministeredviaapaperBooklet[3,4,13].
Aswithotherpreventiveinterventions, the translationof theevidenceonanklesprainpreventionthroughNMTtothereal-worldcontextofsportsremainsachallenge,bywhicheffectiveanklesprainpreventioninthecommunityis lagging[14].ThesuccessofintroducinganyinterventionstrategyinapracticalcontextcanbeevaluatedusingtheRE-AIMframework[15].RE-AIMisaconceptualframeworkthatwasoriginallyusedtodevelopandevaluatehealthcareprograms.Thegoalof theRE-AIM framework is to “encourageprogramplanners,evaluators,readersofjournalarticles,funders,andpolicymakerstopaymoreattentiontoessentialprogramelements,includingexternalvalidity,thatcanimprovethesustainableadoptionand implementationofeffective,generalizable,evidence-basedinterventions”[16].
Althoughdevelopedforuseinhealthcaresettings,theRE-AIMframeworkhasbeenpreviously used to evaluate the success of introducing strategies for sports injurypreventionwithinapracticalsportscontext[17,18].Consequently,usingthecomponentsoftheRE-AIMframework,thisstudydescribedtheuserexperienceofthe“StrengthenYourAnkle”Appandbooklet tounderstandwhycompliancewaschallengedduringprogramimplementation.
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METHODS
DesignandParticipants The full details of the “Strengthen Your Ankle” study have been described elsewhere[3,4,13].Inbrief,220sportsparticipantswhoexperiencedananklesprainduringthepast2monthswereincludedinthisRCT.ParticipantswererandomlyassignedtoeithertheAppor Booklet intervention group and were instructed to follow the embedded 8-week“Strengthen Your Ankle”NMT prevention program using either the App or the printedBooklet.OutcomeMeasures TheRE-AIMframeworkdescribesfivedimensionstoevaluatethepracticalfeasibilityofanintervention: “Reach,” “Effectiveness,” “Adoption,” “Implementation,” and “Maintenance”[16]. The dimensions “Reach” and “Adoption” are out of scope when describing thefeasibilityofaninterventionwithinacontrolledtrial.Assuch,forthisstudy,wefocusedonthedimensions“Effectiveness,”“Implementation,”and“Maintenance.” Effectiveness The“Effectiveness”dimensiondescribestheclinicalimpactofthestudiedintervention.Theshort-andlong-termeffectivenessoftheAppcomparedwiththeBookletforpreventinganklesprainrecurrenceswereassessedinaRCT.Thefullmethodsandresultsofthistrialhave been published elsewhere [3,4,13]. In order to put the outcomes of the“Implementation”and“Maintenance”dimensionsincontext,wewillbrieflysummarizethe“Effectiveness”outcomes. Implementation Implementationconcernstheparticipants’useoftheinterventionstrategies.Inthisstudy,wequantifieduseascompliancewiththe8-weekNMTprogramineachofthestudygroups,measuredasapercentageof the totalprogramcompleted. Inaddition, theparticipants’attitudesandperceptionstowardthedeliveryoftheNMTprogramswereassessed.
During the8weeksof theNMTprogram,participants receivedaweeklyonlinequestionnaire.Thequestionnaireregisteredwhatpercentageoftheprogramwasexecutedduringtheweek,theamountofdifficultythatwasexperiencedwhileconductingeachoftheexercises, and the reason for a possible lack of compliance. For each of the 6 differentexercises, participants indicatedwhat percentage of the exercises they performed eachweek.Additionally,usinga5-pointLikertscale,participantswereaskedhowtheyperceivedtheexercises.Whenparticipantsfailedtocompletethequestionnaire,remindersweresentbyemail.Thedetailsonthequestionnairehavebeenpublishedpreviously[3].
Afterthe8-weektrainingperiod,amoreextensiveevaluationquestionnairewascompleted,includingclosedandfree-textquestionsonthesubjectively-experiencedvalue
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of the NMT program delivery mode, a subjective evaluation of the program, and theperceiveddisadvantagesandadvantagesoftheallocatedinterventiondeliverymode.Tomeasuresatisfaction,allremainingparticipants(75intheAppgroupand88intheBookletgroup)wereasked to givea 0-10 score for theApp orBooklet.An unpaired t testwasperformedtoexaminethedifferenceinscoresbetweenthetwogroups.Maintenance“Maintenance”describesthelong-termeffectivenessoftheinterventionstrategies.Forthisstudy, thisdimensionwasdefinedas thepercentageofparticipants still conducting theNMTprogramcombinedwiththeadvantagestheparticipantsperceivedrelatedtotheApporpaperBookletuseforinterventiondelivery.
After 12 months, semistructured interviews were conducted with individualparticipantstoassesstheperceivedadvantagesofusingtheAppoverthepaperBooklet.Allstudy participants were asked if they were willing to participate in a semistructuredinterview concerning the NMT program; 27% (32/119) of the remaining participants,evenly divided over the two study groups, responded positively. The interviews werestructured using a preselected topic list on the individual experiences with the NMTprogrameitherthroughtheBookletorApp.Allinterviewswereconductedandtranscribedby one researcher (MA). Interviewswere conducted via telephoneuntil saturationwasreached,thatis,wheninterviewsdidnotleadtonewthemesorinformation,withinbothstudy groups, resulting in 16 semistructured interviews with 8 randomly selectedparticipantsintheBookletgroupand8randomlyselectedparticipantsintheAppgroup.MultimediaAppendix1showsthequestionguideforthesemistructuredinterviews,aimedatprocessevaluation,afterfinishingthe12-monthintervention.DataAnalysesDuetodropoutduringfollow-up(n=57after8weeksandafurthern=44after12months),samplesizesdifferedbetweenquestionnaires.Thereasonsfordropoutwereunknown.Theparticipants’ answers on the 5-point Likert scales regarding attitudes and perceptionstoward theprogram,as registeredduring the8-weekprogram,wereaveraged foreachparticipant over the available follow-up moments. Independent sample t tests withassumedequalvarianceswereconducted toassess fordifferencesin theaverageLikertresponsesbetween the twostudygroups.Thesignificance levelwasevaluatedatP=.05.SPSS(version22.0)andwasusedforallstatisticalanalyses.
All semistructured interviewswereaudiorecordedandtranscribedverbatim. Intranscriptions,anypersonalinformationorinformationthatwasdeducibletoanindividualwas anonymized. Verbatim-transcribed interviews were thematically analyzed andfragmentedonthebasisoftopicalsimilarityusingAtlas.ti[19].Open,inductivecodingwasusedlinebylineonthetranscriptsoftheinterviewsandthesecodeswereconvergedintosubthemes[20].Peerdebriefingwasusedasanexternalchecktotheresearchprocess.Thismethodofanalysiswasusedaftereachinterviewandendedwhennonewcodesaroseandsaturationwasreached[19].Thefinalstepintheanalysisprocesswastosubmergethesubthemestoalimitednumberofmainthemes[19].
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RESULTS
Effectiveness Previousstudiesthatlookedattheeffectivenessofthe“StrengthenYourAnkle”programprovidedfurtherdetailsonthe(cost)-effectivenessoftheprogramintheshortandlongterm[3,4].Inshort,duringthe8weeksoftheNMT,therewere93self-reportedrecurrentanklesprains,whichresultedininjuryincidencedensitiesof25.3per1000hoursofsport(95%CI18.0to32.7)intheAppgroupand25.6per1000hoursofsport(95%CI18.3to32.9)intheBookletgroup.Therewasnosignificantdifferenceintheincidencedensitiesofself-reportedrecurrences(HR[hazardratio]3.07;95%CI0.62to15.20)[1].
Duringthe12-monthfollow-up,therewere139recurrentankleinjuries,resultingininjuryincidencedensitiesof15.59per1000hoursofsport(95%CI11.94to19.24)intheAppgroupand15.84(95%12.10to19.58)intheBookletgroup.Overthelongterm,thisdifferenceininjurydensitywasnotsignificant(HR1.06;0.76to1.49)[4].ImplementationThefirststudyinthislargerresearchprojectlookedatcomplianceduringthe8weeksoftheNMTintervention.Itwasshownthattheaveragecompliancetotheexerciseschemewas73.3%(95%CI67.7%to78.1%)intheAppgroupand76.7%(95%CI71.9to82.3%)intheBookletgroup.Nosignificantdifferenceincompliancewasfoundbetweenthegroups[3].
Theweeklyquestionnaires(Table1)showedthatparticipantsinboththeAppandBooklet groups gave comparable scores with regard to simplicity, usefulness, andsubjective evaluation of the exercises. Table 1 shows the averaged responses of theparticipantsoverthe8weeks.
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Table1.Participants’attitudesandperceptionstowardtheallocateddeliveryoftheNMTprogramduringthe8-
weekinterventionperiod.
Participants’opinions Methodof
delivery
Average
(SDa)Meandifferenceb
(95%CI)Pvalue
Theexercisesaresimple.
1. App 3.79(0.86) 0.03(−0.19to0.25) .79
Booklet 3.76(0.78)
DuetothevariationinexercisesIstaymotivated.
2. App 2.25(0.82) −0.16(−0.36to0.05) .13
Booklet 2.41(0.71)
Ifinditeasytoexecutetheexerciseswithouthelp.
3. App 3.72(0.85) 0.05(−0.16to0.26) .65
Booklet 3.67(0.75)
Theexercisesgivemeasenseofsecurity.
4. App 3.30(0.94) −0.01(−0.25to0.23) .96
Booklet 3.30(0.87)
Theexercisesarepainful.
App 3.94(0.68) −0.04(−0.22to0.14) .64
Booklet 3.98(0.67)
Theexercisesdon’tfitwithmyregularschedule.5. App 3.42(0.87) 0.09(−0.14to0.32) .47
Booklet 3.33(0.88)
Ihavetoolittletimetodotheexercises.
App 3.29(0.99) −0.09(−0.35to0.17) .49
Booklet 3.38(0.97)
Ithinktheexercisestakealongtime.
App 2.00(0.58) −0.15(−0.32to−0.01) .07
Booklet 2.16(0.67)
Theexercisesmakemetired.
App 3.87(0.75) −0.02(−0.21to0.17) .84
Booklet 3.89(0.66)
Iforgettoexecutetheexercises.
App 2.34(0.68) −0.06(−0.24to0.11) .49
Booklet 2.41(0.64)
Theexercisesarenotusefultopreventarecurrentinjury.
App 3.42(0.88) 0.12(−0.11to0.35) .32
Booklet 3.31(0.84)
Theexerciseswon’thelpme.
App 2.66(0.77) 0.07(−0.13to0.26) .50
Booklet 2.59(0.71)
aScorespresentaverages(SD)of5-pointLikertscales(1=stronglyagree;5=stronglydisagree).
bDifferencesinscoresbetweengroupswereanalyzedbyindependentttestswithequalvariancesassumed.
Afterthe8-weekinterventionperiod,35participantsusingtheAppand22participantsusingtheBookletdiscontinuedthestudyforunknownreasons.Theremaining75usersoftheAppfoundthismethodofNMTprogramdeliverymoreuserfriendly,easier,funtouse,
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andlessannoyingandthoughtthatthevideosweremorehelpfulthantheBooklet(Table2). The latter question should be interpretedwith caution because online videoswereavailablefortheBookletusers(n=88),butmanyoftheparticipantsstatedthattheywerenot aware of this possibility. Therefore, the answers of 53 of the Booklet users were“neutral”whenaskediftheonlinevideoswereofhelp;thiswasincomparisonwith5%(4/75)intheAppgroup.Someparticipantsfailedtoanswerallthequestions,thenumberofmissingresponsescanbefoundinTable2.AdditionalquestionsspecificallyrelatedtopossibleimprovementsintheApp,andnottheBooklet,(MultimediaAppendix2)indicatedthatparticipantsdesiredfeedbackaftertheexercises(44/75,59%)andwantedtheabilitytopostponeatrainingsession(41/75,55%).Overall,attestshowedthattheusersoftheAppweresignificantlymoresatisfiedwiththeApp(score1outof10with10referringtothehighestscore,mean±SD)comparedwithBookletusers;7.7(SD0.99)versus7.1(SD1.23)P=.006.
Table2.Thesubjectively-experiencedvalueoftheNMTprogramandperceiveddisadvantagesandadvantages
oftheallocatedinterventiondeliverymodeassesseddirectlyafterthe8-weekintervention.
Participants’opinions Method
of
delivery
Average
(SDa)Meandifferenceb
(95%CI)Pvalue
Theinterventionisuserfriendly.
App 1.85(0.98) −0.43(−0.75to−0.11) .009
Booklet 2.28(1.10)
Theinterventioniseasytouse.
App 1.84(0.92) −0.40(−0.69to−0.11) .008
Booklet 2.24(0.97)
Theinterventionlooksattractive.
App 2.12(0.90) −0.06(−0.35to0.23) .68
Booklet 2.18(0.97
Navigationoftheinterventionisclear.
App 2.13(0.95) −0.29(−0.59to0.01) .06
Booklet 2.42(1.01)
Theinterventiongivesenoughinformation.
App 2.19(0.95) −0.29(−0.59to0.01) .06
Booklet 2.48(0.97)
Iwouldadviseotherstousetheintervention. App 2.08(1.03) −0.29(−0.62to0.03) .07
Booklet 2.38(1.04)
Itisannoyingtousetheintervention.
App 4.09(1.09) 0.47(0.12to0.81) .008
Booklet 3.63(1.13)
Ihaveusedtheinterventionwithpleasure.
App 2.25(0.95) −0.18(−0.48to0.12) .23
Booklet 2.44(0.97)
Thevideoshelpedme(onlinefortheBooklet).
App 1.96(1.07) −0.99(−1.31to−0.68) <.001
Booklet 2.95(0.96)
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Thewritteninstructionshelpedme.
App 2.08(0.98) −0.07(−0.35to0.21) .64
Booklet 2.15(0.84)
Theschedulehelpedme.
App 2.12(1.10) 0.08(−0.23to0.38) .62
Booklet 2.05(0.87)
Theinterventionisboring.
App 3.48(1.03) −0.05(−0.36to0.26) .73
Booklet 3.53(0.97)
Theinterventionmakesiteasiertodotheexercises.
App 2.09(0.94) −0.36(−0.65to−0.07) .02
Booklet 2.45(0.95)
Theinterventionmakesitfuntodotheexercises.
App 2.68(0.94) −0.37(−0.66to−0.08) .01
Booklet 3.06(0.93)
Theinterventionisinformative.
App 2.20(0.74) −0.14(−0.39to0.11) 0.26
Booklet 2.34(0.84)
Theinterventionistrustworthy.
App 2.23(0.84) −0.17(−0.42to0.09) 0.13
Booklet 2.40(0.870)
Theexplanationoftheexercisesisclear.
App 2.26(1.07) −0.22(−0.52to0.10) 0.17
Booklet 2.47(0.91)
aScorespresentaverages(SD)of5-pointLikertscales(1=stronglyagree;5=stronglydisagree).
bDifferencesinscoresbetweengroupswereanalyzedthroughindependentttestswithequalvariancesassumed.
Maintenance Attheendofthe12-monthfollow-upperiod,anadditional44participantsdiscontinuedthestudy.Theseparticipantswereaskediftheywerestilldoing(partofthe)NMTprogram.Only23%(28/122)ofallparticipantsstillinthestudyrespondedaffirmatively.Wedidnotaskwhatamountoftheprogramtheywerestilldoing.
Twomain themesarose from the semistructured interviews that related to thedesign of the App and possible additional benefits of the App. Fourteen out of 16participants stated that an App would provide an additional benefit compared with aBooklet.ThemainreasonsgivenwerethatmostoftheparticipantsalwayshadtheirmobilephoneswiththemandthattheAppprovidedvisualsupportandhadareminderfunction.ThetwoparticipantswhodidnotfeelthattheAppofferedanybenefitfoundtheexercisestooeasy,whichmadetheAppredundant.
Errorsinnavigationandexplanation,thelackoffeedbackandmusic,andlackofexplanationofthepurposeoftheexerciseswerethemaindisadvantagesexperiencedbytheAppusers.ThegreatestperceiveddisadvantagesoftheBookletwerethebigsizewhenfolded out, small font, lack of robustness, and errors in explanation. Table 3 shows theindividual responsesduring thesemistructured interviews to illustrate theflavorof theoriginaldataanddemonstratetheprevalenceofthethemes,assuggestedbyKing[21].
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Table3.Individualresponsesfromsemistructuredinterviews.
Respondent Addedbenefit
oftheapp?
Reasongiven Pros(+)andsuggestionsfor
improvement(−)fortheapp
App
R1 Yes Youalwayshaveyour
phonewithyou
Youforgetthebooklet
+Easytouse
+Agendafunction
+Videoswithinstructions
R2 No Theexercisesaresoeasy,
youdon’tneedanapp
+Videoswithinstructions
+Tickoffdoneexercises
- R3 Yes Youalwayshaveyour
phonewithyou
Seeingtheapponmyphone
remindsyoutodothe
exercises
+Tickoffdoneexercises
−Showwhyyouneedtodoan
exercise
R4 Yes Theappgivesvisual
support
+Easytouse
+Videoswithinstructions
R5 Yes Youalwayshaveyour
phonewithyou
+Easytouse
R6 Yes Theappissmallerandthus
easiertouse
+Easiernavigation
R7 Yes Theappgivesvisual
support
Seeingtheapponmyphone
motivatesyoutodothe
exercises
+Videoswithinstructions
+Countingdownthenumberof
exercises
R8 Yes Youalwayshaveyour
phonewithyou
+Videoswithinstructions
+Tickoffdoneexercises
Booklet
R9 Yes Youalwayshaveyour
phonewithyou
−Showwhyyouneedtodoan
exercise.
+Remindertodotheexercises.
R10 No Theexercisesaresoeasy,
youdon’tneedanapp
−Stopwatchfunction
- R11 Yes Theappgivesvisual
support
−Showwhyyouneedtodoan
exercise
R12 Yes Youalwayshaveyour
phonewithyou
+Remindertodotheexercise
−Possibilitytopostponeexercises
R13 Yes Theappgivesvisual
support
+Videoswithinstructions
R14 Yes Youalwayshaveyour
phonewithyou
Seeingtheapponmyphone
wouldremindyoutodothe
exercises
−Directtranslationoftheapptoa
booklet
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R15 Yes Youalwayshaveyour
phonewithyou
−Morevariationintheexercises
R16 Yes Anagendafunctionwould
beeasy
−Directtranslationoftheapptoa
booklet
DISCUSSION
PrincipalFindings Previous studies [3,4] have shown that using an App or a Bookletwith a special NMTprogramtoprevent recurrentanklesprainshas resulted incomparableinjurydensitiesduring both short- (8 weeks) and long-term (12 months) follow-ups and comparablecompliancerateswiththeprogram.Duringtheexecutionoftheprogramduringthefirst8weeks,theAppandBookletweregivencomparablescoresforsimplicity,usefulness,andlikingoftheexercises.Afterthe12-monthfollow-up,theusersoftheAppweresignificantlymoresatisfiedwiththeAppcomparedwiththeusersoftheBooklet.TheusersoftheAppevaluatedtheAppasmorepatientfriendly,easiertouse,andlessannoyingandthoughtthat the videoswere helpful.With the help of semistructured interviews, 14 out of 16participantsagreedthatanAppwouldbeofadditionalbenefitoveraBooklet,mainlydueto use of instructional videos, phone portability, and the agenda function. FurthersuggestionsforimprovingtheAppthatwerementionedbyvariousparticipantsweretheabilitytopostponeexercisesandtheprovisionofexercisefeedback.
Interventionsforpreventingsportinjuriesrequirehighparticipantcompliance[3]Therefore,waystoincreasecomplianceareafocusofmanyinterventionstudies[3].The“StrengthenYourAnkle”programwasdevelopedin2009.Sincethen,theprogramhasbeenstudied intensively [3,4,9-11,22]. It was shown that (1) the program was effective inreducingrecurrentanklesprainsforthosewithhighcompliance[10],(2)theuseofeithertheApporaBookletproducednonsignificantdifferences in injurydensities inboth theshort and long term [3,4], and (3) both methods had comparable cost-effectiveness ofimplementation[23].
Overtheyears,compliancewiththe“StrengthenYourAnkle”programinRCTshassteadily increased from 23% [9] to 45% [10] and 75% [3], likely as a result of annualupdates, increased acknowledgment of the usefulness of the program by the targetpopulation,andimprovementsintheprogramcontent.However,thereachofthetargetpopulationstillrequiressubstantialattention.In2011,theannualnumberofdownloadsofthe“StrengthenYourAnkle”Appreached25,781,whichcorrespondstoalowpercentage(25,781/911,576,2.6%)ofpotentialusers[18].SomestudieshavelookedattheuseofAppsininjurypreventionoverthelastdecade.WhatcanbeconcludedfromthosestudiesisthatnumerousApps seek to prevent (re)injury.However, the scientific evidence supportingtheseApp-basedprogramsisnonexistentorscarce[22,24].Arecentreviewfoundthatoutof18appsconcernedwithpreventingsportsandphysicalactivity-relatedinjuries,onlyfourincludedevidenceregardingefficacy[22].InadditiontotheAppthat isthefocusofthisstudy,oneofthosefourappsdealtwithankleinjurypreventionusingNMT.NoinformationisavailableontheuseorcomplianceoftheotherApp[22].
ThisstudyaimedtoexploreuserexperienceswiththeNMTprogram,aswellaswiththeAppandBookletasdeliverymethods,bymeansofsemistructuredinterviews.The
128
informationgatheredcanbeusedtofurtherimprovethemethodsofdeliveryand,thus,increasefuturereachandcompliance.TheinterviewsandquestionnairesshowedthattheAppandBookletcanbesuccessfullyusedtopreventrecurrentanklesprainsandthatbothshow high user satisfaction. Future updates may include options for feedback orpostponement ofexercises, anexplanation of the use of specificexercises,andpossiblymusic;theseadditionscouldfurtherimproveuserperceptionsoftheprogramandhenceincreasecompliance.
A limitation of this study,and that of previous studieson the “StrengthenYourAnkle” program, is the mismatch between compliance and adherence. Although bothconstructshavebeenusedinterchangeably,theyarenotsynonymous.Adherencereferstoa situationwhereaclinicianor researcherdevelopsa program incooperationwith theparticipant. The participant attempts to follow the program as best as possible, takingpersonalpreferencesandconstraints intoconsideration.Adherencecanbeseenaswhathappens in real-life conditionswhen individualswith an ankle sprain try to follow theprogram; compliance is studied in clinical settings. The extent towhich the participantobeystheprograminstructionsismeasuredbycompliancerates[12,24].Research,ideallyperformedinamoreorlesscontrolledsetting,implicitlyfocusesoncompliance,ratherthanon adherence. However, the “Strengthen Your Ankle” program is meant to increaseadherenceforallindividualsatriskforananklesprain,notonlyforthosewhoparticipateinthestudiesinvolved.ThisstudyhastriedtoexplorethebarriersandopportunitiesthatparticipantsexperiencedwhileusingthetrainingprogramviaanApporBookletwithinacontrolledstudysetting.However,becausetheinterviewswereheldafterfollow-up,thatis,months after the participants had finished the 8weeks of the training program,weexpectedtogaininsightastoprogramperformanceinreal-lifesituations.
A further limitation of this study is the possibility of selection bias for thesemistructuredinterviews.Itispossiblethatonlythoseparticipantsthatcarriedastrongnegativeorpositiveviewoftheprogramagreedtoparticipatebecausetheinvitationfortheinterviewswasmadeonlyafterterminationofthe12-monthfollow-up.Additionally,the(single) interviewer did not structure the interviews and continued to question theparticipants when needed. This may have affected the validity of the data analyses.However, it is recognized that this characteristic is inherent to the flexible nature ofthematicanalysisanddoesnotthreatenthedepthofanalysis[5].ConclusionsWith the use of semistructured interviews and online questionnaires, wewere able toevaluate users’ opinions on both the App and Booklet. The users of the App weresignificantlymoresatisfiedwiththeAppalthoughtherewasnosignificantdifferenceintheperceivedsimplicity,usefulness,andlikingoftheexerciseduringthe8weeksoftheNMTprogram. In the interviews, users acknowledged the need for improvements. Futureupdatesshouldtaketheusers’suggestionsintoaccountbecauseadherencewiththeNMTprogramremainsanongoingchallenge.
ACKNOWLEDGEMENTS
This study was funded by the Netherlands Organisation for Health Research andDevelopment (ZonMw) grant number 525001003, Balance boards were provided byDisportaandBookletswereprovidedbyVeiligheidNL.
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We would like to thank the following partners for their collaboration andrecruitmentofstudyparticipants:RoyalDutchSocietyforPhysicalTherapy(KNGF),DutchSociety for Physical Therapy in Sports (NVFS), Dutch College of General Practitioners(NHG), Dutch Sports Medicine Society (VSG), Dutch Olympic Committee (NOC*NSF),ZilverenKruisAchmea(ZKA),andDisporta.ConflictsofInterestNonedeclared.
Abbreviations
ESSM: exercisescienceandsportsmedicineHR:hazardratioNMT:neuromusculartrainingRCT: randomizedcontrolledtrialZKA: ZilverenKruisAchmea
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5. VerhagenEALM,BayK.Optimizinganklesprainprevention:a critical reviewandpractical appraisal of the literature, British Journal of Sports Medicine2010;44:1082–1088
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MultimediaAppendix1:Questionguidefortheprocessevaluationusingsemi-structuredinterviewsafter
finishingthe12months’interventionperiod.
QuestionguidefortheApp
ItistruethatyouhaveusedtheApptofollowtheStrengthenyourankletrainingprogram?
Didyouexecutethe8weeksofthetrainingprogramasinstructed?
Ifno,whatwasthereasonfornotfollowingthetrainingprogramasinstructed?
Howmuchofthetrainingprogramdidyoufollow?
Doyoustillfollowthetrainingprogramnow?
Canyouelaborateonhowyouhaveexperienced:
- Theusability
- Theprovidedinformation
- Thedesign
HowdidtheappcontributetotheStrengthenyourankleprogram?
IftheAppwouldbeupdated,whatwouldyouliketoimprove?
Currentlytherearemanymedicalapplicationsavailable.Wouldyouonlyusetheseappswhenamedical
professionaladviceyoutodoso?
WouldyouadviceotherstousetheApptofollowtheStrengthenyourankletrainingprogram?
ArethereanyremarksyouwanttomakeconcerningtheApportheprogram?
QuestionguidefortheBooklet
ItistruethatyouhaveusedthebooklettofollowtheStrengthenyourankletrainingprogram?
Didyouexecutethe8weeksofthetrainingprogramasinstructed?
Ifno,whatwasthereasonfornotfollowingthetrainingprogramasinstructed?
Howmuchofthetrainingprogramdidyoufollow?
Doyoustillfollowthetrainingprogramnow?
Canyouelaborateonhowyouhaveexperienced:
- Theusability
- Theprovidedinformation
- Thedesign
YoumightbeawareofthefactthatthereisalsoamobileAppavailablewiththeStrengthenyourankle
program.Doyouthinktheappwouldcontributetothetrainingprogram?
Andifyes,how?
Howwouldyoulikeamobileapplicationtobedeveloped?Whatfeatureswouldyouprefer?
Currentlytherearemanymedicalapplicationsavailable.Wouldyouonlyusetheseappswhenamedical
professionaladviceyoutodoso?
WouldyouadviceotherstousetheStrengthenyourankletrainingprogram?
ArethereanyremarksyouwanttomakeconcerningthepossibilityofanApportheprogram?
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Multimedia Appendix 2: Responses to process evaluation of the neuromuscular training program after the
interventionperiod
Whatarethethreegreatest
benefitsoftheApp?
Whatarethethree
greatestdisadvantages
oftheApp?
Verbatimexamples
Visualaspects Video’sandsounds
Easytonavigate
Looksgood
Errorsinnavigation
Needtohavephoneat
hand
Nopossibilityto
postpone
“Thevideo’shelpmeto
dotheexercises
becausetheyshowme
howIshoulddothem.”
Informational
aspects
Schedule
Informationonbrace/tape
Writteninformation
Errorsinexplanation
Lackofexplanationof
purposeofexercise
“Theapphelpedme
withinformationonthe
exercises.”
Motivational
aspects
Thereminderfunction
Telephoneisalwaysathand
Lessboringtodotheexercises
Lackoffeedback
Notimerfunction
Nomusic
“Iwouldlovetoget
feedbackonwhyI
shoulddoaparticular
exerciseandwhat
exactlyI’mtraining.”
Whatarethethreegreatest
benefitsoftheBooklet
Whatarethethree
greatestdisadvantages
oftheBooklet?
Visualaspects Compact
Looksgood
Strongmaterial
Nopossibilitytoturn
pages
Bigwhenfoldedout
Smallletters
Lackofvideo’s
Notrobust
Noteasytounfold
“IfIknewhowthe
exerciseslooklikeona
videothismighthelp
metodothem
correctly.”
Informational
aspects
Schedule
Figures
Tothepoint
Informationonbrace/tape
Tooshortin
information
Difficultschedule
Errorsinexplanation
“Theschedulewasvery
clearandshowedme
whatIshoulddoat
whatmoment.”
Motivational
aspects
Easytocarry Lackoffeedback “Iwouldliketoseea
pictureofwhatmuscles
I’mtrainingandget
feedbackonhowIdo
theexercises.”
135
CHAPTER8Generaldiscussion
eight.
136
Theaimofthisthesiswastoevaluatethevalueofthe‘VersterkjeEnkel’Appascomparedto the usual practice of providing injuredathleteswith advisory printedmaterials. Thepremisewas that use of the ‘Versterk je Enkel’ Appwould increase compliance to theprescribedevidence-basedpreventiveprogramand,consequently,woulddecreaseanklesprain recurrence incidence. The findings from this study ultimately advance thedevelopmentofapracticalevidence-basedguidelineon‘howtoeffectivelyreducetheriskofanklesprainrecurrences’.Ideally,thisguidelineshoulddealwithtwoissues.First,theguideline should be evidence-based and feasible in a real-life situation. Second, theinterventionshouldbecost-effectiveforsocietyandshouldbeimplementableata largescale.Inordertodevelopsuchaguideline,thisthesisaddressedandansweredthefollowingquestions.
Howdoescomplianceaffectstudyresultsinsportsinjurystudies?
Studiesthathavebeendonepreviouslyonthe‘VersterkjeEnkel’neuromusculartrainingprogramprovideduswithclearfuturerecommendations.Itwasshownthattheprogramhad the potential to significantly reduce the risk of recurrent ankle sprains. However,ensuring compliancewith the program turned out to be a considerate and continuingchallenge. Inorder to findouthowcompliance isdealtwithinsports injurypreventionstudiesthisthesis,therefore,describesinchapter3asystematicreviewontheuseandrecognitionofcomplianceandadherenceinsport injurypreventiontrials. Itwasclearlydemonstrated that assuming that the entire study population had complied with theprescribed intervention could lead to erroneous conclusions. To further complicatematters, many different definitions of compliance have been reported in the sportsmedicineliterature[1].Also,althoughcomplianceandadherencearenotsynonymous[2,3],these constructs are being used interchangeably to describe the complete and correctfollowing of a prescribed intervention. Compliance refers to participant obedience in astudywhereaclinicianorresearcherprescribestheintervention,withlittletonorightofconsultationonbehalfoftheparticipant;compliancecanthusbedefinedas“theathletes’correct and complete following of a prescribed intervention” [2]. Adherence implies acollaborativeenvironmentinwhichaclinicianorresearcherandastudyparticipantworktogether to develop an intervention thatalignswith the participants’ opportunities andbarriers[4,5].Research,ideallyperformedinamoreorlesscontrolledsettingsuchasthecurrentstudy,thereforeimplicitlyfocusesoncompliance,ratherthanonadherence.Inthisreviewitwasfurtherconcludedthatinjurypreventionstudiesvarysignificantlyinthewaytheydefine,measureandadjustforcompliance.Whilethemajorityofincludedstudiesdomention the concept of compliance, only one-fifth of the studies gave amore detailedaccountofhowcomplianceratesinfluencedtheirstudyresults.Thestudiesthatdidaccountforcompliancedemonstratedthatthelevelofcompliancecouldhaveasignificanteffectonstudyoutcomes.Acknowledgingtheimportanceofcompliance,weensuredtoclearlydefine,measureandreportthisconceptandshowedhowcomplianceaffectedoutcomemeasures.
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DoestheuseofanAppincreasecompliancetotheprogram?
Intheshort-termeffectivenessstudy(chapter4)thisthesisexaminedwhethertheuseofthemobile ‘VersterkjeEnkel’Appincreasedcompliancetotheinterventionprogram,incomparisontoaprintedBooklet.Participantswereaskedweeklyabouttheircompliancewiththe‘VersterkjeEnkel’programandabouttherecurrenceofself-reportedankleinjury.This thesis shows that themethodof implementing the ‘Versterk jeEnkel’program, i.e.usinganAppversusaBooklet,didnotleadtosignificantdifferentmeanoverallcompliancerates. Additionally, the percentage of participants thatwas highly compliant – i.e. thosefollowingatleast70%oftheprogram,thearbitrarythresholdnecessaryfortheprogramtobeefficacious-wasnotdifferentbetweengroups.Inbothgroups,74.5%ofparticipantscompliedwiththeneuromusculartrainingprogrammeduringthe8weeksinwhichtheyparticipated in the study. The short-term study thus showed that compliance was notinfluencedbytheimplementationmethod.
BettereffectivenessoftheNMTprogramwhendeliveredbyApp?
Chapter5describedtheresultsaftercompletionoftheNMTprogram,at10monthsfollow-up.Participantswereaskedtocompleteanonlinequestionnaireattheendofeachmonthtoregisteranyrecurrentanklesprainandresidualfunctionaldisabilityorpain.InthisstudyitwasshownthattheimplementationmethodoftheNMTprogrambyeitheranApporaBookletdidneitherleadtodifferentinjuryincidenceratesat10monthsfollow-up,nortodifferences in residual functional disability or pain. From the above findings one canconcludethatwhentheparticipantiscompliantwiththeprogram,bothmethodsshowedsimilareffectivenessinreducingtheriskofrecurrentanklesprains,onboththeshortandthelongterm.
IstheNMTprogrammorecost-effectivewhendeliveredthroughanApp?
Considering that both theApp and theBooklet resulted in similar short and long-termeffectivenessandcompliance,thethesis’nextquestiondealtwithcost-effectiveness.Thecost-effectivenessstudyinchapter6thisthesisaddressedtwoquestions.Firstly,isthereadifference in direct and indirect costs during a 10-month follow-up, between groupsapplying the ‘Versterk je Enkel’ App and written materials? And secondly, is there adifferenceinanklesprainresidualcomplaints(i.e.instability,feelingofgivingway,pain,andcontinuedsportsparticipation)aftera12-monthfollow-up,betweengroupsapplyingthe ‘Versterk je Enkel’ App and written materials? Primary outcome measures of theanalysesweretheincidencedensityofankleinjuryandtheincrementalcost-effectivenessratio (ICER). It was shown that over the 10-month of follow-up, there was neither adifferenceineffects,norincostsbetweenbothinterventionmethods.Thisstudyshowed,assuch,thatthemethodofimplementingtheNMTprogramusinganApporaBookletcanbeusedtopreventrecurrentankleinjuries,showingnodifferencesin(cost-)effectivenessat12-monthfollow-up.
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Whatarethebarriersandfacilitatorsthataffectedprogramandhowcanthe‘VersterkjeEnkel’programbeimproved?From the five studies presented in this thesis one could conclude that in terms ofeffectiveness, theeffectoncompliance,and thecost-effectiveness,both theAppand theBookletcanbeusedtoreducetheriskofrecurrentankleinjury.Thisthesis’finalinquirywastofindouthowparticipantsevaluatedtheuseofbothmethodsofdelivery.InChapter7 this thesis presented a qualitative evaluation of the neuromuscular training programbasedonsemi-structuredinterviewsandopenquestionnaires.Multiple,individualbarriersand facilitators of the final userswere identified via a process evaluation. The RE-AIMframeworkwasusedtogetinsightintheadoptionandimplementationoftheprogram.Thisframeworkisseenasa‘reportingtemplate’toencouragesportsresearcherstodocumenttheir research inway thatenablespractitioners,policymakersandcommunities tousethemeffectively’ [6].Thestudydescribed inchapter7employed in-depth interviews toanalyseparticipants’valuationoftheNMTprogramwhileeitherusinganApporaprintedBooklet. The study looked at their challenges to comply with the NMT program andquestioned their opinion on possible improvements for the intervention and mode ofdelivery. There was no difference in perceived simplicity, usefulness and liking of theexercise between the program delivered through the App or the Booklet. After twelvemonths’ follow-up,usersof theAppweresignificantlymoresatisfiedwith theApp thanusersof theBookletwith theBooklet:7.7±0.99versus7.1±1.23 (P= .005).Participantsprovided us also with ideas on how the App could be improved to live up to theirexpectationsandhowtheseimprovementscouldhelpthemtoincreasetheircompliancewiththeprogram.Theinstructionalvideos,theagendafunctionandthesimplicityoftheAppwerefunctionsthatwerehighlyappreciated.Asexamplesoffurtherimprovements,afunction to postpone a training sessionwasmentioned, aswell as functions to providemusicandfeedbackonexercisesexecuted.
METHODOLOGICALCONSIDERATIONS
Eachofthechapterspresentmethodicalconsiderationsthatareuniquefortheindividualquestionsaddressed.Nonetheless,someconsiderationsareunderlyingthenatureofsportsinjuryresearchandarepresentedbelow.One of the most important limitations of our study was the regular contact with theparticipants.Our study involved220 athletes fromdifferent levels anddifferent sports.During follow-upwe regularly contacted the participants viaemail, and incase of non-responsebyphone.Thisinitialweekly(first8weeks)andlatermonthlycontactmostlikelyaffected the study results. Although it is unknown how compliance was influenced byparticipationinthisstudy,onecouldarguethattheregularcontactincreasedcompliancewith the program, as compared to a real-life situation where the participants are notrequiredtoreporthowmuchoftheprogramtheyexecuted.Inotherwords,contactingtheparticipantsmayhavecompromisedexternalvalidity.Asourmethodprovided theonlypossibilitytomeasurecompliancewiththeprogramwediddecidetodoso.Afurtherlimitationofthestudywasthehighrateofdrop-outduringthestudyprocess.During the first 12 months of follow-up, 35 participants (15.9%) dropped-out. Theirreasonsfordrop-outwerelackoftimeormotivationtocontinuetheprogram,orlackof
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time or motivation to continue the study (and replying to the weekly and monthlyquestionnaires).Itisnotknowniftheparticipantswhohaddropped-outdidordidnotfindthattheyhadbenefittedfromtheprogramandhadorhadnotenduredre-injury.Therefore,itisunknownifcompleteabsenceofdrop-outwouldhaveledtoadecreaseorincreaseofthe number of injuries. The high number of drop-outs, does showagain that, althoughparticipantswereregularlycontacted,motivationtocomplywiththeprogramremainsacomplexissue.Uniqueforthisstudyistheaccuratecalculationofcomplianceratesinthefirst8weeksoftheintervention.Theonlineweeklyquestionnairesallowedustodeterminewhatpartoftheprogramwascompletedbytheparticipantsandwhichexerciseswhereexecutedornot.Thisallowedforarobustevaluationofcomplianceratesfortheentiredurationofthe8-weekinterventionprogram.Furthermore,thesemi-structuredinterviewsprovideduswithdetailedanalysesoftheparticipants’evaluationoftheprogramaftertheyhadexperiencedthe use of it. This implies thatwe can, and should, not only include those involved indevelopinganintervention,butalsousingthefindingsforfutureupdates.A furtherstrengthof thecurrent studywas thecollaborationof important stakeholdersrightfromtheonsetofthisproject.Bydoingsotheprojectaimedtoreducethetimelagfromintroducingfindingsfromresearchtochangingguidelines,policiesandpractices[7].Witheverystepoftheprocess,nationalsportfederations,theNationalOlympicCommittee,Dutch health care insurance companies and federations for general practitioners andphysiotherapists were involved and enthusiastic to discuss our advice and findings.Additionally, this allowed us to relate our scientificmethods and findings to a real-lifesetting.Afterfinalisationofthisproject,thiscollaborationwillallowfortherealisationofanupdatedguidelineforthepreventionofrecurrentanklesprains.Viaourstakeholders,whoareinvolvedinthewritingofthisguideline,ourknowledgecanbetransferredtothosewhomaybenefitfromtheprogram.
FUTUREDIRECTIONS
Whatcanbeimprovedinfutureresearch?InvolvingstakeholdersTofurtherdevelopandimprovetheimplementationofthe‘VersterkjeEnkel’programitisimportantthattheend-usersareinvolvedfromaveryearlystartofprogramdevelopmentandthatathletesandstakeholdersidentifyeachother’spossibilitiesandbarriers.Assumingthattheresultsfromcontrolledtrialscanbeeasilytranslatedtoareal-lifesituationwouldneglecttheinfluenceofthemultipledeterminantsthatinfluencetheathletes’behavioursinvolved[6],ofteninanon-linearfashion.AsastutelyadvisedbyHanson[6]itisimportantnotonlytoensurecorrecttranslationfromresearchevidenceintopractice,butalsotoallowfora“bettertranslationofevidencefrompracticeintoresearch”,suchthatfutureresearchisbasedonamultidirectionalconversationinvolvingscientists,stakeholdersandathletes.Andalthoughtheremightbeaneedforthecontinuedexistenceoftraditionalpaper-basedformsof interventionmaterials,digitaltoolscanbeusednotonlytodeliverthespecificprogram,butalsotocollectdatafromtheathletethatcanbeusedtofurtherimprovetheinterventionprogram[8],suchthatallparticipantsarepartofeachdevelopmentphaseofanintervention.
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DealingwithcomplianceFromourreviewstudyitbecameclearthatvalidandreliabletoolstomeasureandreportcomplianceareneededandshouldbematched toauniformdefinitionofcompliance.Anumberofstudy-reportingguidelines,suchastheSTROBE(StrengtheningtheReportingofObservational Studies in Epidemiology) statement and the CONSORT (CONsolidatedStandards Of Reporting Trials) statement, recognise the importance of compliance andincludespecificitemsonthetopicintheirguideline[9,10,11].TheCONSORTstatementspecificallyaddressesthequalityofreportsofrandomisedcontrolledtrials(RCTs).Until2010,theCONSORTstatementadvocatedtheuseofITTanalysisforRCTs.ITTanalysisdoesnotincludethemeasurementofcompliancebutassumesnon-adherencetotheprescribedintervention[2].However,asmentionedintheCONSORTstatement,strictITTanalysisisoftenhardtoachievefortwomainreasons:missingoutcomesforsomeparticipantsandnon-adherencetotheprotocol.Therefore,since2010,theCONSORTstatementhasreplacedthementionofITTbytherequirementof‘‘moreinformationonretainingparticipantsintheir original assigned groups’’ [9]. As an alternative to an ITT analysis, it has beensuggestedthatper-protocol-analysis(PPA)—sometimesreferredtoas‘modifiedITT’—canbeused[2].Inthisapproach,theanalysisisperformedonlyonthoseparticipantswhohavefullycompliedwiththeprogramme.APPAcanprovideameasureofefficacyinthatitgivesthe result of a prescribed programme that is implemented exactly as the researcheroriginallydevelopedit,assumingthatnon-complianceisnotduetotheinterventionitself.The CONSORT statement argues that, in order to evaluate both efficacy (with theassumption of full compliance and no recognition of implementation barriers) andeffective-ness(thereal-lifeadoptionofanintervention),researchersshouldanalysestudyresultsusingITT,PPAandagradedcompliancemeasure[9].Thelatterreferstotheextenttowhichparticipantshavecompliedwiththeprogrammeandwhateffectthishashadontheoutcome.Whataretheimplicationsforpractice?Whileexaminingtheprogressofthe‘VersterkjeEnkel’programoverthelastdecade,itisclearthattheprogramanditsimplementationhaveevolved.Inthefirststudies,compliancewiththeprogramwasconsiderablylowerthaninthecurrentstudy.InthefirststudythatexaminedtheeffectivenessofthesameNMTprogrammeusingwrittenmaterialsonly,ratesofparticipantswhoshowedhighcompliancewereaslowas23%[12].Fouryearslater,inacomparablestudyfullcompliancewiththeprogramincreasedto45%[13].Inthecurrentstudy,thepercentageofparticipantsthatwashighlycompliantwas65%.ItwasarguedthatwithtimetheneuromusculartrainingprogrammehadbecomemorewidelyacceptedintheNetherlands.Thismightexplaintheincreaseincompliancerates.Withafurtherincreaseinthenumberofdownloadsandcampaignstosupportthe‘VersterkjeEnkel’programitispossible that theneuromuscular trainingprogrammewill show increasedacceptance inpracticeevenfurther.Inaddition,thepreviousstudiesusedaprintedpaperversion,withasimplelayout.BoththeBookletandtheAppusedinthecurrentstudywereupdatesofthematerialsthathavebeenusedinthepreviousstudies.WehypothesizethattheBookletandthe App used in our study may have had a more attractive format, which resulted inincreasedcompliancerates.However,althoughcomplianceinthecurrentstudyshowedasignificant increase compared to previous studies on the same program, to effectively
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reduce the persistent existence of sports injuries, we should continue to look forinterventionswiththelowestbarrierstouse.Ourprocessevaluationprovideduswithclearinstructionsonhowtofurtherimprovebothmethodsofimplementationsuchthattheyliveuptousers’expectationsandfurtherenhancecompliancewiththeprogram.Itisimportantthatfutureupdatestaketheserecommendationsintoaccount.Withthecollaborationofthestakeholdersinvolvedinthisresearchprocesswehopetohaveadecisiveimpactonthefutureguidelines.Allowco-existenceofinnovativeandtraditionalmethodsInthepastdecenniaavastnumberofmobileappshaveenteredthesportinjurypreventionarena.Theincreaseduseofmobilephonesinallareasofmodernlifemighthaveledtotheassumptionthatappscan,andshould,beexclusivelyusedaseffectivemethodstodeliverinjurypreventioninterventionstothoseinvolved.However,withtheuseofthein-depth-interviews,thehelpofthestakeholdersandourthoroughanalysisofcomplianceand(cost-)effectivenesswe learned from this study that there is no such thing as THE (injured)athletewithsetdeterminantsofbehaviour.Eachofthe220participantshaditsownstoryonhowthefirstanklesprainarose,ifandhowitwastreatedandhowtheindividualwentaboutpreventing(ornot)re-injury.Duringboththeshortandthelongterm,eachoftheparticipants had to find the time, the motivation and the resources to do so. Somesucceeded, somedidnotandsomeonly toa certainextent. Itbecameclear thatnotallparticipantspreferredtheuseofthemobileapp.This ledustoconcludethattraditionalmethods of delivery should not be forgotten and if possible, should co-existwithmoreinnovative,-mobile-options.Withmultipleoptions,thediversityinindividuallimitationsandbarrierscan be acknowledged. Or, as clearly stated byGreen and cited by others:“Wheredidthe(sportinjuryresearch)fieldgettheideathatevidenceofanintervention’sefficacyfromcarefullycontrolledtrialscouldbegeneralizedas ‘bestpractice’ forwidelyvariedpopulationsandsituations”[6.14,15]?
OVERALLCONCLUSIONS
Wefoundthatthemethodofimplementingdidneitherleadtodifferentratesofcompliancenortodifferencesin(cost-)effectiveness.Bothintheshortandlongterm,ratesofre-currentanklesprainweresimilarwhenusing theApp or theBooklet, andcompliancewith theprogramdidnotdifferbetweenbothmethodsduringthe8weeksoftheintervention.Ouradvicefortheindividualathleteandthestakeholdersinvolvedwouldthereforebetousethemethod that ispreferredby theathlete.This canbe theApp, theBookletorevenacombinationofboth,suchthattheathletecanchoosethemethodofimplementationthatismosteasilyaccessibleatacertainmomentoftime.Ourmainmessageisthattheprogramiseffectivebutshouldbeexecuted.
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3. McKayCD,VerhagenE.'Compliance'versus“adherence”insportinjuryprevention:whydefinitionmatters.BrJSportsMed2016;50:382–3.doi:10.1136/bjsports-2015-095192
4. SteffenK,EmeryCA,RomitiM,etal.Highadherencetoaneuromuscularinjurypreventionprogramme(FIFA11?)improvesfunctionalbalanceandreducesinjuryriskinCanadianyouth female football players: a cluster randomised trial. Br J Sports Med.2013;47(12):794–802.
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6. HansonD, Allegrante JP, SleetDA, FinchCF,Researchalone is not sufficient to preventsportsinjuryBrJSportsMed.2014Apr;48(8):682–684.
7. Bekker S, Paliadelis P, FinchCF. The translation of sports injury prevention and safetypromotion knowledge: insights from key intermediary organisations. Health Res PolicySyst.2017:15:25doi:1o.1186/s12961-017-0189-5
8. Finch CF, Barh R, Drezner JA, Dvorak J, Engebretsen L, Hewett T, Junge A, Khan KM,MacAuleyD,MathesonGO,McCroryP,VerhagenE.Towardsthereductionof injuryandillnessinathletes:definingourresearchpriorities10.1136/bjsports-2016-097042
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SUMMARY
Whileexerciseisgenerallyadvocatedtocontributetooverallwell-being,itcomeswithahealthrisk,bothfortheindividual,asforsocietyasawhole.Thebodypartsthataremostoften affected by an injury are the knee and the ankle, with respectively 970.000 and680.000 injuries in the Netherlands alone. The singlemost common injury is an anklesprain,whichmakes up85%of all ankle injuries. In addition to societal costs, there isextensiveevidencethatthereisanuptotwofoldincreasedriskforanklere-injuryduringthefirst-yearpost-injury.Inabout50%ofallcasesrecurrencesmayresultindisability,canleadtochronicpainorinstabilityandmayrequireprolongedmedicalcare.Assuch,anklesprainsposeasignificantburdentotheindividualathleteandtosociety.Previous research has shown that bothexternallyappliedankle supports (i.e. taping orbracing), as well as neuromuscular training programs are successful in preventingrecurrentcasesofanklesprain,bothfromaneffectiveness,aswellasacost-effectivenessperspective.Thesemeasurescanreducetheincreasedriskofrecurrentinjurytothesamelevelasneverinjuredathletes.However,althoughtheneuromuscularprogramhasbeenproven(cost-)effectivecompliancewiththeprogramispoor.Theaimofthisthesisistoevaluatetheimplementationvalueofthe‘VersterkjeEnkel’Appascomparedtotheusualpracticeofprovidinginjuredathleteswith‘ordinary’materials.Thepremiseisthatuseofthe ‘VersterkjeEnkel’Appwouldincreasecompliancetotheprescribedprogramand,consequently,woulddecreaseanklesprainrecurrenceincidence.Chapter2–ThefoundationforallincludedpublicationsinthisthesisChapter2 describes the studydesign of the ‘Verstek je Enkel’ research line that is thefoundationforthisthesis.Itexplainsindetailhowtheparticipantshavebeenrecruitedandhowtheflowofathleterecruitmentwasexecuted.Chapter2alsoprovidesdetailsonthe‘Versterk je Enkel’ programwith visual examples of the included exercises and gradedschedule.Chapter3-DelvingintotheconceptofcomplianceAnimportantpartofthisthesisdealswiththeconceptofcompliance.Chapter3showstheresultsofextendedreviewonsportinjuryinterventionstudies.Itshowshowcomplianceisdefined,measuredanddealtwithin100RCT’s.Itwasshownthatassuminganentirestudypopulationcomplieswiththeprescribedinterventioncouldleadtoerroneousconclusions.To further complicate matters, many different definitions of compliance are used andalthoughcomplianceandadherencearenotsynonymous,theseconstructsarebeingusedinterchangeably to describe the complete and correct following of a prescribedintervention.Whilethemajorityofincludedstudiesinthereview,domentiontheconceptofcompliance,onlyone-fifthofthestudiesgaveamoredetailedaccountofhowcompliancerates influenced their study results. The studies that did account for compliancedemonstratedthatthelevelofcompliancecouldhaveasignificanteffectonstudyoutcomes.
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Chapter4-Shorttermresultsfromthe‘VersterkjeEnkel’programme
Chapter4presentstheresultsfromtheshort-termstudy.ItcomparedthecomplianceratesoftheinterventionprogramfromAppuserswiththoseusingaprintedBooklet.Participantswereaskedweeklyabouttheircompliancewiththe‘VersterkjeEnkel’programandaboutthe recurrence of self-reported ankle injury. It was shown that using an App versus aBooklet,didnot leadtosignificantdifferentmeanoverallcompliancerates.Additionally,thepercentageofparticipantsthatwashighlycompliant–i.e.thosefollowingatleast70%oftheprogram,thearbitrarythresholdnecessaryfortheprogramtobeefficacious-wasnot different between groups. Themean compliance to theexercise schemewas 73.3%(95% CI: 67.7-78.1) in the App group, compared to 76.7% (95% CI: 71.9-82.3) in theBookletgroup.Additionally,theincidencedensitiesofself-reportedtime-lossrecurrenceswerenotsignificantlydifferentbetweenbothgroups(HR3.07;95%CI0.62-15.20).
Chapter5–Longtermeffectiveness–a12-monthfollow-upAftertheinterventionprogramthatlastedfor8weeks,participantswerefollowed-upforanother10months.Theywereaskedtocompleteonlinequestionnairemonthlytoexaminere-injuryandtoregisteranyresidualfunctionaldisabilityorpain.Afterthetotaltimeframeof12months,therewerenodifferencesininjuryincidencerates(HR1.06;95%CI0.76-1.49)nordifferencesinresidualfunctionaldisabilityorpain.Itwasconcludedthatwhentheparticipantiscompliantwiththeprogram,bothmethodsshowedsimilareffectivenessinreducingtheriskofrecurrentanklesprains,onboththeshortandthelongterm.Chapter6–Whichprogramismorecost-effective?PrimaryoutcomemeasuresofChapter6weretheincidencedensityofankleinjuryandtheincrementalcost-effectivenessratio(ICER)during12monthsfollow-up.Duringfollow-up31athletessufferedfromarecurrentanklesprainthatledtocostsresultinginaHazardRatioof1.13(95%CI:0.56-2.27).Theincrementalcost-effectivenessratio(ICER)oftheAppgroup in comparisonwith theBooklet groupwas€-361.52. TheCEplane presented inchapter6showsthattherewasneitheradifferenceineffectsnorincostsbetweenbothinterventionmethods.Chapter7–AthoroughexaminationofuserexperiencesTo evaluate the ‘Versterk je Enkel’NMTprogramweused theRE-AIM frameworkas areportingtemplate.Welookedattheimplementationandmaintenancephasetoidentifythebarriersandfacilitatorsasexperiencedbythefinalusers.Semi-structuredandonlinequestionnaires showed that therewas no significant difference in perceived simplicity,usefulnessandlikingoftheexerciseduringtheeightweeksoftheNMTprogram.14/16participantsfromtheinterviewsagreedthatanAppwouldbeofadditionalbenefitoveraBooklet.Aftertwelvemonths’follow-up,whenaskedhowtheyevaluatedtheoveralluseoftheApportheBooklet,usersoftheAppgaveameanscoreof(mean±sd)7.7±0.99versus
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ameanscoreof7.1±1.23fortheusersoftheBooklet.Thisdifferenceinmeanscorewassignificant(p=0.006).
CONCLUSION
Wefoundthatthemethodofimplementingthe‘VersterkjeEnkel’NMTprogramdidneitherleadtodifferentratesofcompliancenortodifferencesin(cost-)effectiveness.Bothintheshortandlongterm,ratesofre-currentanklesprainweresimilarwhenusingtheApportheBooklet,andcompliancewiththeprogramdidnotdifferbetweenbothmethodsduringthe8weeksoftheintervention.Thesemi-structuredinterviewsandourthoroughanalysisofcomplianceand(cost-)effectivenessshowedusthatthereisnosuchthingasTHE(injured)athletewithsetdeterminantsofbehaviour.Eachofthe220participantshaditsownstoryonhowthefirstanklesprainarose,ifandhowitwastreatedandhowtheindividualwentaboutpreventing(ornot)re-injury.Duringboththeshortandthelongterm,eachoftheparticipantshadtofindthetime,themotivationandtheresourcestodoso.Somesucceeded,somedidnotandsomeonlytoacertainextent.Itbecameclearthatnotallparticipantspreferredtheuseofthemobileapp.Thisledustoconcludethattraditionalmethodsofdeliveryshouldnotbeforgottenand ifpossible, shouldco-existwithmore innovative, -mobile-options.Withmultipleoptions,thediversityinindividuallimitationsandbarrierscanbeacknowledged.Ouradvicefortheindividualathleteandstakeholdersinvolvedwouldthereforebetousethemethod that ispreferredby theathlete.This canbe theApp, theBookletorevenacombinationofboth,suchthattheathletecanchoosethemethodofimplementationthatismosteasilyaccessibleatacertainmomentoftime.Ourmainmessageisthattheprogramiseffectivebutshouldbeexecuted.
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SAMENVATTING
Hoewelbewegingensportbijkandragenaaneengoedegezondheidbrengthetookhetrisicovanblessuresmetzichmee.Blessureskunnen leiden totaanzienlijkekostenvoorzowelhetindividualsvoordegemeenschapalsgeheel.Delichaamsdelendiehetvaakstgeblesseerdrakenzijndeknieendeenkelmetjaarlijksrespectievelijk970.000en680.000blessuresinNederland.85%vandeblessuresbetrefteenverstuikingvandeenkel.Hetishiermee de meest voorkomende blessure. Naast de maatschappelijke kosten van dezeblessures,brengteeneenmaligeenkelverstuikingookeentweevoudigrisicoopherletselmetzichmeevoordegetroffeneinheteerstejaarnahetletsel.Inongeveer50%vandegevallenleidtherletseltotchronischepijn,instabiliteitofvanlangdurigeinvaliditeit.Hetmoge duidelijk zijn dat enkelletsel voor zowel de maatschappij als het individu groteproblemenmetzichmeekanbrengen.Eerder heeft onderzoek aangetoonddat hulpmiddelen (zoals tape ofeen brace) en eenneuromusculair trainingsprogramma(hetVersterk jeEnkeloefenprogramma)succesvolzijn in het voorkomen van herletsel. Dit betreft zowel het aantal herletsel als dekosteneffectiviteit van deze interventies. Personen die deze hulpmiddelen gebruikenkunnen hun risico op herletsel reduceren tot hetzelfde level als personen die nooitgeblesseerd zijn geweest. Het probleem is echter dat de therapietrouw van dezeinterventieszeerlaagis.Hetdoelvandezethesisisomdeimplementatievande‘VerstekjeEnkel’Apptevergelijkenmethetzelfdeprogrammamaardanindevormvaneengeprintboekje.Deuitkomstenvandethesiskunnenzoeenbijdragenleverenaandehuidigerichtlijnenvoorhetverminderenvanrecidiefenkelletsel.Hoofdstuk2–HetfundamentvanhetonderzoekHoofdstuk2ishetgepubliceerdeonderzoeksontwerpzoalsgepresenteerdaanhetbeginvandezeonderzoekslijn.Hetbevateengedetailleerde(visuele)uitlegvanhetprogrammaendemanierwaaropdedeelnemerszijngerekruteerd.Wemaaktenbijhetwervenvandedeelnemersuitvoeriggebruikvandekanalenvanonzeconsortiumpartners.Hoofdstuk3–TherapietrouwnaderbekekenEen belangrijk deel van deze thesis gaat over het concept therapietrouw (compliance).Hoofdstuk 3 laat de resultaten zien van een review naar therapietrouw ininterventiestudiesmetbetrekkingtotsportblessurepreventie.Hethoofdstuklaatzienhoeditconceptinmeerdan100RCT’swordtgedefinieerd,berekendengeanalyseerd.Indereviewkwamnaarvorendatdeaannamedatalledeelnemersvolledigtherapietrouwzijn,kan leiden tot onjuiste conclusies aangaande de effectiviteit van de interventie. In deonderzochtestudieswordenbovendientalvanverschillendedefinitiesvoorhetconceptgehanteerd enwordt het concept ‘adherence’ veelal onjuist gebruikt als synoniemvoortherapietrouw(compliance).Hoewelhetmerendeelvandestudieswelaandachtbesteedtaanhetconcept,geeftslechtseenvijfdedeelaanhoezetherapietrouwberekenenenhoedit invloed heeft op de studieresultaten. De studies die wel nadrukkelijk kijken naartherapietrouwlatenziendathetconceptgroteinvloedheeftopdeuiteindelijkeconclusies.
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Hoofdstuk4–DeeffectiviteitvanhetoefenprogrammaopdekortetermijnHoofdstuk4laatderesultatenzienvandestudienaardeachtwekenwaarindedeelnemershet‘VersterkjeEnkel’oefenprogrammavolgen.Indithoofdstuktonenwehetverschilintherapietrouw en zelf-gerapporteerd, recidief enkelletsel gedurende deze periode. Dedeelnemerswerdgevraagdwekelijkseenonlinevragenlijstintevullen.Welietenziendater geen significant verschil bestaat tussen therapietrouw wanneer het boekje wordtgebruiktinvergelijkingmetdemobieleApp.Ookhetverschilindeelnemersdattenminste70%vanhetprogrammauitvoerden-dearbitrairedrempeldienodigisomhetprogrammaeffectief te laten zijn – was niet verschillend tussen beide groepen. De gemiddeldetherapietrouwwas73.3%(95%CI:67.7-78.1)indeAppgroep,vergelekenmet76.7%(95%CI:71.9-82.3)indegroepdiehetboekjegebruikte.Tenslottebleekookhetvoorkomenvanrecidiefenkelletseldatleiddetottijdverliesnietverschillend(HR3.07;95%CI0.62-15.20).Hoofdstuk5-DeeffectiviteitvanhetoefenprogrammaopdelangetermijnNa het ‘Versterk je Enkel’ oefenprogramma werden de deelnemers nog 10 maandengevolgd.Indezeperiodewerdhengevraagdelkemaandeenvragenlijstintevullen.Hierinwerdgevraagdofersprakewasvanrecidiefenkelletseleninhoeverrededeelnemerslasthaddenvanrestklachten.Nadetotaleperiodevantwaalfmaandenbleekergeenverschilinhetaantalherletsels (HR1.06:95%CI0.76-1.49)ofdematewaarinsprakewasvanrestklachten.Weconcludeerdendatwanneereendeelnemervoldoendetherapietrouwisaangaande het programma, het gebruik van zowel het boekje als de App het risico openkelblessures aanzienlijk kan verkleinen. Dit geldt voor zowel de korte als de langetermijn.Hoofdstuk6–Welkprogrammalaateengroterekosteneffectiviteitzien?Deprimaireuitkomstmatenvanhoofdstuk6warenhetaantalherletselsper1000urensportendeincrementalcost-effectivenessratio(ICER)gedurendede12maandenwaarindedeelnemerswerdengevolgd.Tijdensdeopvolgingkregen31atletentemakenmetherletselwaarbij er sprake was van gemaakte kosten. Dit resulteerde in een relatief risico opherletselvan1.13(95%CI:0.56-2.27).DeICERvandeAppgroepinvergelijkingmetdegroepdiehetboekjegebruiktewas-€361,52.Hetkosten-effectiviteitsvlak,gepresenteerdinhoofdstuk6,laatziendatergeenverschilineffectiviteitofinkostenbestaattussenbeideinterventiemethodes.Hoofdstuk7–Watvondendegebruikersvandeinterventie?Met behulp van het RE-AIM kader trachtenwe te bepalenwat de deelnemers aan hetonderzoek van de interventie vonden.We kekenmet name naar de implementatie- enbehoudsfase om de barrières en bevorderende factoren in kaart te brengen zoals diewerden ervarendoor de gebruikers. Semigestructureerde en online vragenlijsten lietenzien dat er geen verschil bestond in ervaren gebruiksgemak, nut en plezier van deoefeningengedurendedeachtwekendathetprogrammaduurde.Veertienvandezestiendeelnemers die werden geïnterviewd zagen een toegevoegde waarde van de App tenopzichtevanhetboekje.Natwaalfmaanden,wanneerhengevraagdwerdnaardetotale
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evaluatie van hun gebruikte interventiemethode, gaven de gebruikers van de App eengemiddelde(±SD)scorevan7.7±0.99invergelijkingmeteen7.1±1.23metdegebruikersvanhetboekje.Hetverschilisscoreissignificant(p=0.006).
CONCLUSIE
Wekunnenconcluderendatdemethodewaarophet‘VersterkjeEnkel’oefenprogrammawordt geïmplementeerd niet leidt tot een verschil in therapietrouw of in(kosten)effectiviteit.Ditgeldtvoorzoweldeduurvanhetprogrammazelf(8weken)alstijdenseenlangereperiodevan12maanden.Zowelopdekortealsdelangetermijnlatenbeidemethodenevenveelrecidieveenkelletselszien.Desemigestructureerdeinterviewsendeanalysesvantherapietrouwenkosteneffectiviteitduiden erop dat er niet gesproken kan worden over DE (geblesseerde) atleet metvastomlijndegedragsdeterminanten.Elkvande220betrokkendeelnemerskwammetzijneigen verhaal over hoe zijn blessure is ontstaan, hoe dezewerd behandeld en hoe hetindividuzichzelfinstaatachtteherletseltevoorkomen.Zoweltijdensdekortealsdelangetermijn moesten alle deelnemers de tijd, motivatie en middelen vinden om hetoefenprogramma te volgen. Sommigen slaagden hierin, anderen niet en weer enkelenslechtsinbeperktemate.HetwerdonsduidelijkdatnietalledeelnemersautomatischeenvoorkeurtoondenvoorhetgebruikvandeApp.Hetgeprinteboekjebleekvoorsommigeatleten voorkeur te hebben. Traditionele implementatiemethoden hebben dusbestaansrechtnaastdenieuwe,innovatievemobielemogelijkheden.Doorhetbestaanvankeuze-optieswordenookdeindividuelevoorkeurenmogelijkhedenvandebetrokkenenerkend.Onsadviesvoorpersonenmetenkelletselenbetrokkenpartnersisdaterruimtemoetzijnvoorpersoonlijkevoorkeuren.DitkanzijnhetgebruikvandeApp,gebruikvanhetboekjeofeencombinatievanbeide.Opdiemanierkandeatleetzelfkiezenwelkemethodevanimplementatie,opwelkmomentdevoorkeurgeniet.Onzebelangrijksteboodschapisdathetprogrammaeffectiefis,maarweluitgevoerdmoetworden.
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DANKWOORDMijnpromotiecombinerenmetmijneigenbedrijfenmijnsportambitieswassoms,netzoalsvoor de deelnemers aan dit onderzoek, balanceren. Prioriteiten stellen, traditionelekantooruren afschaffen en werkplekken inrichten op elke – exotische – locatie warenslechtsdeeenvoudigstemaatregelendienodigwarenomalledrietekunnenblijvendoen.Maarbelangrijkerwasdesteun,deflexibiliteitendeaanmoedigingendieikhiervoorkreegvanzowelEvertalsvanWillem.Alleendoorhunvertrouwen,begripenondersteuning–ookbuitenkantooruren–ishetmegeluktomdezepromotietoteengoedeindetebrengen.Nuallehordeszijngenomenishetgeweldigomditproefschrifttemogenbesluitenmeteenaantalmensendiedaarbijonmisbaarzijngeweest.Hetmooistewatelkvandemensendieikhierwilbenoemenmeheeftmeekunnengeveniseenstukjepersoonlijkeontwikkelingdatikmeeneemvoorderestvanmijnleven.Evert,tijdensmijnsollicitatiegesprekkwamenwevrijsneltesprekenoverhardlopen.Eenpassiedieweallebeidelenenwaarinweelkaarbegrepen.Datbegriphebiktijdenshethelepromotietraject steeds gevoeld. Nooit leek het je te veelmoeite omme te helpen, ookwanneer ik weer eens in het buitenland verbleef. Je hebt me geleerd om steeds mijnschouderserondertezettenenpositiefteblijven.Sterkinhoudelijkzijnéneengoede‘baas’ismaarweinigmensengegeven.Jijbenteenvandieweinigen.Willem,ondanksjedrukkewerkschemavoeldeikmebij jounooitonderzoekernummerzoveel. Je had oog voor mijn beperkingen, mijn andere activiteiten en toonde oprechtbelangstellingvoorallesbuitenhetwerkom.Debloemendie jemestuurdenahetWKdedenmemeerdanjewaarschijnlijkhebtgeweten.Promoverenonderjouwgezagiseeneerdieikvoltrotsdraag.Vanjouhebikgeleerdomaltijdoogtehoudenvoorwatiemandandersbezighoudt.Arno,Nelly,Jeffry,Ton,Abida,Cecillia,Victor,Casper,Lieke,Guus,MarcelenHan,zonderjulliehulpwashetnooitgeluktalledeelnemersterekruteren.Julliehebbenmegeleerdhoehetisomeenschakeltezijntussenbedrijfsleven,wetenschapenpubliekefunctieswaarbijiedersbelanggehoordwordt.Ikvondhetbijzonderomtemerkenhoebereidjulliewarenom dit onderzoek te verbeteren en ruimte te geven in het landschap van sport enblessurepreventie.Ingrid,bedanktvoorjouwtomelozeinzetommeetedenken,meetekijkenenallekleinefoutenoptesporeninmijnartikelen.Ikkenniemanddiezonauwgezetennauwkeurigtewerkgaat.Jehebtmegeleerdomdetijdtenemenomalledetailstecontroleren.Alsjijmijnartikelhadgelezenwasikpasvolvertrouwendathetgeenfoutenmeerbevatte.Ikhoopdatweelkaarnogvaakgaantegenkomen.Ineenprofessionelesettingofinhetzwembad.Marianne,bedanktvoorjebijdrageaandekwalitatieveanalyse.Hetwasmooiomtezienhoejehetonderzoekindookenvolenthousiasmeaandeslagging.Inge,somshebikhetideedatjij24/7werkt.Bedanktvoorallehonderdeneendingendiejevoormehebtgedaanalsikweereensergenstegenaanliep.Enalleanderehonderddieiknieteensdoorhebgehad.
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Beste ledenvande leescommisie;Prof.Dr.A.J. vanderBeek,Dr.G.J.deBruijn,Prof.Dr.G.M.M.J.Kerkhoffs,Prof.Dr.R.J.W.G.Ostelo,Prof.R.Meeusen,Dr.Ir.G.J.M.Tuijthof,bedanktvoordetijdenaandachtdiejulliehebbengewijdaanhetlezenvanmijnproefschriftenhetplaatsnemenindeoppositie.Lievepapa,mamaenMaaike,julliehebbenevengeduldmoetenhebben.Gelukkighebbenjulliedatmeerdanik.Datikuiteindelijkzoupromoverenwasnatuurlijkeengegeven.Alheb ikmaar een klein beetje van het doorzettingsvermogen van papa en de oneindigeleergierigheid van mama geërfd, dan was het een gegeven dat ik uiteindelijk zoupromoveren.Maaike,watjijklaarspeeltalsmama,enzus,daarvaltelkepromotiebijinhetniet.LieveJohn,Fernand,Ann,omaentanteMaaike,julliehebbenevengeduldmoetenhebben.Maarjulliewerdenhetnooitmoeteblijvenvragenhoehetgingmetmijnpromotie.Ikbentrotsdatikjulliefamiliemagnoemen.LieveChris,vanjouleeriknogelkedag.Ikkenniemanddiezoveelcompassieheeftenzoonbaatzuchtig is. Door jou was er alle ruimte om drie functies te combineren entegelijkertijdderusttehebbenommetjoutegenietenvanalleswatwedeafgelopenvijfjaarsamenhebbengedaanEnliefste,vanafnuishetdr.Duifje.
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OVERDEAUTEURMiriam van Reijen (1983) studeerde Ontwikkelingseconomie in Wageningen enBewegingswetenschappenaandeVrijeUniversiteitinAmsterdam.Nahaarstudieverlegdeze haar focus naar de atletiek (marathon, PB 2h41), duatlon en triatlon met als besteprestatieseengoudenmedaillebijhetNKduatlon(2017)eneenzilverenplakophetWKduatlon (2017). Naast haar sport heeft van Reijen haar eigen bedrijf, waarmee zepresentatiesverzorgtovervoeding,hardlopenentraining.In2013,terwijlMiriamtraindeinKenia,schreefzehetHardloperskookboek,gevolgddoordeel2in2016.Echter,hetdoenvan onderzoek bleef aan haar trekken en in 2013 keerde ze terug naar de VU om tepromoveren.Miriamwoont,traintenwerktinAmsterdammethaarvriendChris.
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