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The University of Manchester Research
Increasing the Value of Orthodontic Research Through theUse of Dental Patient-Reported OutcomesDOI:10.1016/j.jebdp.2019.04.005
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Citation for published version (APA):Hua, F. (2019). Increasing the Value of Orthodontic Research Through the Use of Dental Patient-ReportedOutcomes. Journal of Evidence-Based Dental Practice. https://doi.org/10.1016/j.jebdp.2019.04.005
Published in:Journal of Evidence-Based Dental Practice
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Download date:16. Oct. 2020
Increasing the Value of Orthodontic Research Through the Use of Dental Patient-Reported Outcomes
FangHuaa,b
aCenterforEvidence-BasedStomatology&DepartmentofOrthodontics,Hubei-MOSTKLOS&
KLOBM,School&HospitalofStomatology,WuhanUniversity,Wuhan,ChinabDivisionofDentistry,SchoolofMedicalSciences,FacultyofBiology,MedicineandHealth,The
UniversityofManchester,ManchesterAcademicHealthScienceCentre,Manchester,UK
Correspondingauthor:
Fang Hua, School & Hospital of Stomatology, Wuhan University, 237 Luoyu Road, Wuhan
430079,China
E-mail:[email protected]
How to Cite:
Hua F. Increasing the Value of Orthodontic Research Through the Use of Dental
Patient-Reported Outcomes. Journal of Evidence-Based Dental Practice, 2019. doi:
10.1016/j.jebdp.2019.04.005 [Epub ahead of print].
doi: 10.1016/j.jebdp.2019.04.005
Please note that this is a post-print version (after peer-review) for the purpose of self-
archiving. Please download the final published version from the publisher’s website:
https://www.sciencedirect.com/science/article/pii/S1532338219300806
Abstract
Tenyearsago,ChalmersandGlaszioupointedoutinLancetthat85%ofallbiomedical
researchwasbeingavoidablywastedduetoimbalancedresearchquestion/outcome
selection,aswellaspoorstudydesign,executionandreporting.Accordingtofindings
ofrecent“researchonresearch”studies,ahighlevelofsuchkindofavoidablewaste
shouldalsoexistinorthodonticresearch.Thiswarrantseffortstoimproveeachstage
oftheresearchproductionandreportingprocess.
Nowadays,patients’psycho-socialfunctionisconsideredacoreelementoforalhealth.
Also, their treatment needs and preferences have formed a main component of
evidence-baseddentistry(EBD).Therefore,inordertoachieveshareddecision-making,
orthodontistsneedtohaveanadequateunderstandingofeachpatient’svaluesand
perceptions.
In this context, orthodontic research should be patient-centered so that the
knowledgeandperceptiongapsbetweencliniciansandpatientscanbereduced,and
research evidence that is suitable for patients to understand can be provided. In
addition, patient-centered outcomes that can reflect patients’ perceptions and
psycho-socialstatusshouldbewidelyused.
However, recent scoping reviewshaveshownthatduring thepastdecade,patient-
centeredoutcomesincludingthoseregardingadverseeffects,healthserviceresource
utilizationandqualityof lifehaveremainedunderrepresented inorthodontictrials.
Thus, the use of dental patient-reported outcomes (dPROs) and dental patient-
reportedoutcomemeasures(dPROMs)shouldbepromotedtofacilitatetheprovision
ofapatient-centeredevidencebase,reducetheavoidablewasterelatedtoresearch
question/outcomeselection,andtherebyincreasethevalueoforthodonticresearch.
AvoidableWasteinOrthodonticResearch
Justtenyearsago,ChalmersandGlasziou1pointedoutinLancetthatamajorityofall
biomedicalresearchwasbeingavoidablywastedduetoimbalancedresearchquestion
/outcomeselection,inadequatestudydesignandexecution,non-publication,lackof
accessibility,andpoorreporting.Asover50%ofstudiesfailedtotakeadequatesteps
toreducebiases(e.g.inadequateallocationconcealment),2over50%ofstudieswere
never published in full,3 andmore than50%of planned studyoutcomeswerenot
reported,4theyestimatedthattheproportionofsuchwastewasgreaterthan85%.1
Thereafter, the Lancet launched theREWARD (REduce researchWasteAndReward
Diligence)campaignandpublishedaseriesoffivereviewsregarding“increasingvalue
and reducing waste”, each covering one stage in the production and reporting of
biomedicalresearch(Figure).5,6
Inorthodontics,recent“researchonresearch”studieshavefoundthatabout70%of
randomizedcontrolledtrials(RCTs)didnothaveadequateallocationconcealment,750%
ofstudieswereneverfullypublished,8andmorethan80%ofRCTsdidnotadequately
reporttheirpre-specifiedprimaryoutcomemeasures.9Basedonthesefindingsand
thecalculationmethodusedbyChalmersandGlasziou,1theestimatedproportionof
avoidablewasteinorthodonticresearchwouldbeevenhigherthan85%.Thislooks
appalling,butstillithasnottakenintoaccountthefactthatover60%oforthodontic
RCTswerefocusedonoutcomesthatwereirrelevanttopatients,10andthatmorethan
30%oforthodonticpaperswerenotfreelyavailableonlineforcliniciansandpatients
(Figure).11
Undoubtedly,suchahighlevelofavoidablewastewarrantseffortstoimproveallfive
stagesoftheproductionandreportingoforthodonticresearch.Thisarticlewilldiscuss
potentialmeasurestotakeforthefirststageand,morespecifically,thesignificanceof
patient-centered research and dental patient-reported outcomes (dPROs) for
orthodontics.
Patients’PerceptionsandtheDefinitionofOralHealth
Recognition of the importance of patients’ perception can be traced back to the
additionof“socialwell-being”intotheWHOdefinitionofhealthin1940s,whichled
to a paradigm shift in the model of health from biomedical to biopsychosocial.12
Thereafter,similarmodificationsweremadetothedefinitionoforalhealth.In1993,
Dolan definedoral health (for older populations) as “a comfortable and functional
dentitionwhich allows individuals to continue in their desired social role”.13More
recently,theFDIWorldDentalFederationdevelopedanewdefinitionfororalhealth:
“Oralhealthismultifacetedandincludestheabilitytospeak,smile,smell,taste,
touch,chew,swallow,andconveyarangeofemotionsthroughfacialexpressions
with confidence and without pain, discomfort, and disease of the craniofacial
complex.”14
Inaddition,theFDIWorldDentalFederationemphasizedthatoralhealth“reflectsthe
physiological,socialandpsychologicalattributesthatareessentialtothequalityoflife
(QoL),” and “is influenced by the person’s changing experiences, perceptions,
expectations, and ability to adapt to circumstances.”14 These definitions have all
importantlyindicatedthatthegoalsofdentalhealthcareshouldincludenotonlythe
treatmentofpatients’diseases/conditions,butalsotheimprovement/restoration
oftheirphysiologicalandpsycho-socialfunctions.Toachievethese,itisessentialthat
dentalprofessionalsincludingorthodontistshaveanadequateunderstandingoftheir
patients’perceptionsandexpectations,bothatanindividuallevelandapopulation
level.
Evidence-BasedMedicineandEvidence-BasedDentistry
A common criticismof evidence-basedmedicine (EBM)has been that EBMmeans
“cookbook medicine” and decision-making based on evidence alone, without
necessarydeliberationandreasoning.15However,asexpertsinEBM16andevidence-
based orthodontics (EBO) 17 have pointed out, such an argument is merely a
misunderstandingofwhatEBMis.Ineffect,theneedtoconsidereachpatient’svalues
hasbeenaggressivelypromotedsincetheveryearlyyearsofEBM.16
In1996,Sacketandcolleaguesalreadystatedthat:
“EBMistheconscientious,explicit,andjudicioususeofcurrentbestevidencein
makingdecisionsaboutthecareofindividualpatients.ThepracticeofEBMmeans
integrating individual clinical expertisewith the best available external clinical
evidence from systematic research. … Increased expertise is reflected inmany
ways, but especially inmore effective and efficient diagnosis and in themore
thoughtful identification and compassionate use of individual patients’
predicaments, rights, and preferences in making clinical decisions about their
care.”18
Monthslater,theywentontoproposeasimplemodelforevidence-baseddecision-
making,withclinicians’expertise,patients’preferencesandresearchevidencebeing
thethreemaincomponentsofthismodel.19In1999,thesecomponentswereadopted
bytheAmericanDentalAssociation(ADA)foritsofficialdefinitionofevidence-based
dentistry(EBD):
“EBDisanapproachtooralhealthcarethatrequiresthejudiciousintegrationof
systematic assessments of clinically relevant scientific evidence, relating to the
patient’s oral and medical condition and history, with the dentist’s clinical
expertiseandthepatient’streatmentneedsandpreferences.”20,21
Theemphasis thatEBMandEBDplaceonpatients is inaccordancewithacultural
change inmedicine over the past decades: the increasing importance of patients’
autonomyandconsent,aswellastheassociateddemandforshareddecision-making
(SDM)andpatient-centeredcare.16,22
SharedDecision-MakinginOrthodonticPractice
AccordingtoGatellarietal,23SDMisadecision-makingprocessinwhichcliniciansand
patientsareequalpartnersandarerequiredtoexchangeinformationandpreferences
in order to negotiate a mutually acceptable treatment decision. In the case of
orthodontics,thisapproachisparticularlyimportantformanyreasons.Someofthe
mainonesareasfollows.
First, as malocclusion is not a disease but a variation from the societal norm,24
orthodontictreatmentisoftenelective.25Plus,orthodontictreatmentisnotwithout
risks / adverse effects (e.g. root resorption, enamel demineralization).26 The SDM
approachcanfacilitatethoroughexchangeofexpectations,preferencesandpossible
treatment outcomes between orthodontists and patients, and thereby help them
determinewhetherorthodontictreatmentisabletoachievetheintendedeffect,and
whetherthepotentialgainoutweighrisksandcosts.
Second,orthodonticpatientsusuallyexpecttoimprovetheirdentofacialappearance
through orthodontic treatment.27 However, the patients’ perception of esthetics is
oftendifferent from thatof orthodontists. For instance, patients seem tobemore
tolerant / less sensitive than orthodontists towards gummy smile,28 midline
discrepancies,29andwhitespotlesions.30Inlightofsuchdiscrepancies,orthodontists
shouldusetheSDMapproachtoobtainanadequateunderstandingofthepatient’s
expectationandtreatmentneed.Apersonalizedtreatmentgoalthatisacceptableto
bothpartiescouldthenbesetandachieved.
Inaddition,likeinotherdentalspecialties,foreachorthodonticproblemthereusually
exist multiple therapies / techniques that can be considered.31 Examples include
differenttypesofappliances(e.g.conventionalbrackets,self-ligatingbrackets,clear
aligners),methodstorelievecrowding(e.g.toothextraction,interproximalreduction,
total arch distalization), and methods to reinforce anchorage (e.g. miniscrews,
transpalatalarch,headgear).However,sincemanysystematicreviewsinorthodontics
failedtoperformmeaningfulmeta-analyses(mostlyduetolowquantityandquality
of eligible studies, as well as the use of heterogeneous outcome measures),
orthodontistsareoftenfacedwithindefiniteorconflictingevidencewhencomparing
theavailable therapies/ techniques.32 In thiskindofsituations,SDMisparticularly
needed so that clinician’s expertise and patients’ values / preferences can bewell
integratedandleadtothemostsuitableclinicaldecision.33
Patient-CenteredResearchandPatient-CenteredOutcomes
Theultimategoalofallmedicalresearchistoimproveourknowledgeunderpinning
thepreventionandtreatmentofillness.34InthecontextofEBD,dentalstudiesshould
bedesigned,executedandreportedproperly,sothattheirfindingsarerelevant,valid
and usable, facilitating the achievement and development of patient-centered,
evidence-baseddentalpractice.Towards thisend, the researchquestionsofdental
studiesshouldberelevanttopatients,theoutcomesthattheyuseshouldbeableto
reflectpatients’valuesandperceptions.35
In2013,TsichlakiandO’Brien10carriedoutascopingreviewtoanalyzetheoutcomes
usedinorthodonticRCTsduring2008-2012.Theyfoundthat63%ofthesetrialswere
focusedonassessingmorphologicchangesofmalocclusion;whereaspatient-centered
outcomesincludingthoseregardingadverseeffects,healthserviceresourceutilization
andQoLwereonlymeasuredin32%,32%and9%oftheincludedtrials,respectively.
In2017,Tsichlakiandcolleagues36updatedtheabove-mentionedscopingreview,as
the first stage of developing a core outcome set (i.e. an agreed, minimum set of
outcomestobemeasuredandreported)fororthodontictrials.37Atotalof54different
outcomescovering14outcomedomainswereidentified,withhalfoftheoutcomes
assessedbymultipleoutcomemeasures (range:2 to6).Althoughpatient-reported
painwasthemostfrequentlyusedoutcome(18%),theauthorsfoundthatmostofthe
outcomeswere still focusedon the assessment ofmorphologic changes,withQoL
measuredbyonly4(2%)oftheincludedtrials.
These data have shown a problem with the current selection of outcomes in
orthodontic studies.AspointedoutbyO’Brien,38 although those clinician-centered
outcomesthatorthodonticresearcherstraditionallymeasure(e.g.changesinoverjet
ortheANBangle)canbeeasilycollectedfromstudycasts,radiographs,patientrecords
andclinicalexaminations,theycanneitherreflectpatients’perceptionsandvalues,
nor demonstrate how well an intervention can improve the patient’s oral health.
Studiesthatonlyassessclinician-centeredoutcomesmaybeignoringormissingthe
acceptabilityofeachintervention,i.e.thebenefitsanddrawbacksofanintervention
fromthepatient’sperspective.
InanarticlepublishedinTheNewEnglandJournalofMedicine,Porter39proposeda
three-tiered hierarchy of outcome measures that can cover health circumstances
relevanttopatients,includingthehealthstatusachievedorretained(tier1),process
ofrecovery(tier2),andsustainabilityofhealth(tier3).Heemphasizedthatthevalue
ofhealthcareshouldalwaysbedefinedaroundpatients,andtheonlywaytomeasure
this value accurately is to track patient outcomes and costs longitudinally, with a
follow-uplongenoughtoencompasstheultimateresultsofcare.
Furthermore,inordertoachieveandimproveSDM,weneedmorepatient-centered
researchthatcanreducethegapinknowledgeandperceptionsbetweencliniciansand
patients, providing research evidence that is suitable for patients to understand.31
PromotingtheuseofdPROsinorthodonticresearchcouldbeonestepfurthertowards
theprovisionofsuchapatient-centeredevidencebase.25
Dental Patient-Reported Outcomes and Dental Patient-ReportedOutcomeMeasures
dPROs,atermrecentlycoinedbyJohn,40aredefinedas“anyreportofthestatusofa
patient’s oral health condition that comes directly from the patient, without
interpretationof thepatient’s responsebyaclinicianoranyoneelse.” Just likeoral
healthisacomponentofgeneralhealth,dPROsareasubsetofallpatient-reported
outcomes(PROs).dPROscancapturetheimpactofconditionsorinterventionsonoral
health,whiledentalpatient-reportedoutcomemeasures(dPROMs)areusedtoassess
thisimpactandexpressitnumerically.40
Inarecentsystematicreview,Johnandcolleagues41analyzedtheexistingmulti-item,
genericdPROMsforadultdentalpatients.Basedon20eligiblequestionnaires(e.g.the
OralHealthImpactProfile),theyidentified53dPROMs,whichrepresentallcurrently
availablemulti-iteminstrumentsforassessingtheperceivedoralhealthofpatients.A
total of 36 unique dPROswere assessed by these dPROMs, including 35 narrower
dPROs (e.g. functional limitations, physical pain, psychological discomfort) and 1
broader dPRO – the oral health-related quality of life (OHRQoL). Also, the authors
found that those 35 narrower dPROs can be categorized into four groups: Oral
Function, Orofacial Appearance, Orofacial Pain, and Psychosocial Impact. This is in
accordancewiththefourdimensionsofOHRQoL,42,43indicatingthatthesedPROshave
coveredallmajorconcernsofdentalpatientswiththeiroralhealth.41
In an earlier article of this series, Reissmann 44 introduced several additional
advantages of dPROMs over disease-oriented outcome measures for research: 1)
better reliability and the resultant smaller required sample size; 2) flexible
administrationandeasydatacollection;3) lowerworkloadandhigherefficiency;4)
providinginformationabouttheentirepatient;and5)easyinterpretationandsample
sizecalculation(whentheminimalimportantdifferenceisavailable).
OralHealth-RelatedQualityofLifeandOrthodonticResearch
Asmentionedabove,OHRQoLisamajordPRO,andeachOHRQoLinstrumentcanbe
seenasadPROMoracombinationofseveraldPROMs(dependingonthenumberof
dimensions the instrument contains).41 During the past twenty years, orthodontic
researchershavecarriedoutmanyepidemiologicalstudiesregardingOHRQoL.45Based
onthese,recentsystematicreviewshaveconcludedthatmalocclusionhasasignificant
(thoughsmall)negativeimpactontheOHRQoLofchildren(mainlyintheemotional
and socialwell-being dimensions),46-48 and that orthodontic treatment can lead to
moderate but significant improvement in OHRQoL.49, 50 Despite the low quality
evidence underlying these reviews (mainly due to inadequate study design and
substantial heterogeneity), they have demonstrated the capability of OHRQoL to
reflectorthodontictreatmentneedandthebenefitsoforthodonticinterventionsto
patients. Unfortunately, so far very few clinical studies in orthodontics have used
OHRQoL as their primary or secondary outcome, especially those RCTs.10, 36
Nevertheless,anopportunitytosolvethisproblemmayariseinthenearfuture,once
the core outcome set for orthodontic research (which includes OHRQoL related
dPROMs)iscompletedandavailable.37
Inaddition,anotherrelevantissueisthelargenumberofOHRQoLinstrumentsthat
havebeenusedinorthodonticresearch.Forinstance,amongstudieswithregardto
the association between malocclusion and OHRQoL, at least eight different
instrumentshavebeenused.47Suchalackofstandardizationbringsdifficultiestothe
interpretationandsynthesesofdifferentstudies,andisthereforeunhelpfulforSDM
and patient-centered care (even though dPROMs have been used). Again, a core
outcomesetmaybethekeytothisissueifitincludesonlyoneOHRQoLinstrument
for each possible situation (e.g. different age groups). Such an instrumentmay be
selected /modified fromtheexisting toolsbasedon their scopeandpsychometric
properties,43, 44 or be developed specifically for the context of malocclusion /
orthodonticsbasedonperceptionsofthetargetpopulation.51,52
Summary
Patients’psycho-socialfunctionisacoreelementoforalhealth;theirtreatmentneeds
andpreferencesformamaincomponentofEBD.However,recentstudieshaveshown
thatmostoftheoutcomesmeasuredinorthodontictrialsarefocusedonassessing
morphologic changes, whereas patient-centered outcomes have remained
underrepresented.Inlightofthis,theuseofdPROsanddPROMsshouldbepromoted
tofacilitatetheprovisionofapatient-centeredevidencebase,reducetheavoidable
waste related to research question / outcome selection, and thereby increase the
valueoforthodonticresearch.
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Acknowledgements
FHissupportedbytheChinaPostdoctoralScienceFoundation(No.2018M630884).
FigureLegend
Figure.ThefivestagesofresearchwasteproposedbyChalmersandcolleagues1,5,6
andrelevantfindingsfrom“researchonresearch”studiesinorthodontics(in
italics).7-11