Post on 17-Oct-2020
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Single-Case Experimentele designs Johan Vlaeyen en Bart Michiels EMDR congres 31 Maart 2017
1. Whatistransla-onalscience?2. Single-caseexperimentaldesigns3. Design&sta-s-calanalysis4. AnIllustra-on:fearreduc-oninchronicpain
Overview
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1. Whatistransla-onalscience?2. Single-caseexperimentaldesigns3. Design&sta-s-calanalysis4. AnIllustra-on:fearreduc-oninchronicpain
Overview
Thelab
Theclinic
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Thelab
Theclinic
Thelab
Theclinic
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Thelab
TheclinicExperiencewithasesmentsandtreatmentsforpa-ents
ExperiencewithExperimentalcontrol
Publica-ons
Thelab
Theclinic
TRANSLATION
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…effec-vetransla-onofnewknowledge,mechanisms,andtechniquesgeneratedbyadvancesinbasicscienceresearchintonewapproachesforpreven-on,diagnosis,andtreatmentofdisease.
JAMA 2008
…ensuringthatnewtreatmentsandresearchknowledgeactuallyreachthepa-entsorpopula-onsforwhomtheyareintendedandareimplementedcorrectly.
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Basicscience Clinicalapplica-on
Transla-onalresearch
Basicscience Clinicalefficacy Clinicaleffec-veness
Popula-onhealth
Transla-onalresearch
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ClinicalefficacyBasicscience
T2 T3
Clinicalefficacyresearch
T1
- Compara3veoutcomestudies- Cost-effec3veness
T2
-Implementa3onofinterven3ons- healthcaresystemredesign- Treatmentfortherightpa3entontheright3me
T3
Clinicaleffec-veness
Popula-onhealth
Transla-onalresearch
Basicscience
Transla-onalresearch
€
Clinicalefficacy Clinicaleffec-veness
Popula-onhealth
T1 T2T3
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1. Thebasisforpar-cipa-onshouldbetrustandreciprocity2. Objec-vesaremeasurable3. Gaincommitmentof“leadusers”4. Engagetheworkforce
Principlesforknowledgesharing:
Trustandreciprocity:ClinicalskillsMedicalinfrastructurePar-cipants(pa-ents)
Noveltreatmentmodali-esDiagnos-cmethodsEvalua-onmethods
Transla-onalResearch&Treatment
Theclinic
ThelabSYNERGY
Theclinical lab
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Prac33onerScien3st
Descien-st-prac--onerbridgeTransla-onalResearch&Treatment
HOW?
Transla-onalresearch&Treatment
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1. Whatistransla-onalscience?2. Single-caseexperimentaldesigns3. Design&sta-s-calanalysis4. AnIllustra-on:fearreduc-oninchronicpain
Overview
PaulBroca1824-1880
GustavFechner1801-1887JND
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WilhelmWundt1832-1920Introspec3onPercep3onandsensa3on
HermannEbbinghaus1850-1909Learning&Memory
IvanPavlov1849-1936PhysiologyLearning
BurrhusFrederickSkinnerOperantbehavior1904-1990
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SirRonaldAylmerFisher1890-1962
Nomothe3capproach:ComesfromtheGreekwordνόμος“nomos”meaning“law”.
Assump3ons:• varianceisresultofmeasurementerror• measuringmethodsdonotinfluencethemeasurementitself• repeatableobserva-ons
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Sample-wisegeneraliza3onofknowledge
Sample
Popula-on
Nomothe3capproach:
Tradi-onalOutcomeEvalua-on:Group-basedRCT
B:ControlA:Experimental B(N=50)
A(N=50)R
Randomiza-on
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Tradi-onalOutcomeEvalua-on:Group-basedRCT
Voordelen:Uitsprakenovergemiddeldeveranderingvangrotegroepen:
MogelijkinteressantvoorpolicymakersNadelen:Erkunnengeenuitsprakengedaanwordenoverindividuen:
Nietzointeressantvoorbehandelaarsenpa-ënten
IdiographicmethodComesfromtheGreekwordιδιος“idios”meaning“own”or“private”.
Assump3ons:• everyobserva-onisunique• measuringmethodscaninfluencethemeasurementitself• goalis:“dasverstehen”(understand)
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Popula-on
A
B
C
D
Event-wiseindividualiza3onofknowledgeIdiographicapproach:
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Single-CaseExperimentalDesigns:PersonalizedN=1RCT
R R
Transla-onalResearch&TreatmentSmallisbeau3ful:
Replicatedsingle-caseexperiments
Asingle-caseexperimentisanexperimentinwhichoneunitisobservedrepeatedlyduringacertainperiodof-meunderdifferentlevelsofat
leastonemanipulatedvariable
Onghena&Edgington,2005
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1. Whatistransla-onalscience?2. Single-caseexperimentaldesigns3. Design&sta-s-calanalysis4. AnIllustra-on:fearreduc-oninchronicpain
Overview
1. ReliableandvalidmeasurementSensi4vetochangebutrobustagainstrepeatedadministra4on
2. Randomiza3onSta4s4calcontroloverunknownconfoundingvariablesrelatedto4me,par4cipants,se@ngetc….
Prerequisites
3.Randomiza3onTestDataarepermutedintoallsortsofdifferentorders,andtheteststa4s4coneachpermuta4on.Thedistribu4onprovidesthep-value
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Conduc-ngSingle-CaseResearch
1. Researchques3on2. Designofsingle-caseexperimentanddata
collec-on3. Visualanalysisofdata4. Sta-s-calanalysisofdataandeffectsize
es-ma-on5. Formulateconclusions
Researchques-on
• Deviseresearchques-on&hypothesesDependentandindependentvariables
• ChoosemeasurementinstrumentsReliabilityValidity
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DeJonghetal.,2002
Researchques-on‘DoesEMDRreducefearofdentaltreatmentinpa-entswithdentalphobia?’Design:Replicatedsingle-caseABAphasedesignacross4par-cipantsInterven-on:EMDRtreatmentOutcomemeasures:
DAS(Corah,1969)DCQ(DeJongetal.,1995)SCL-90-R(Deroga-s,1977)
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Conduc-ngSingle-CaseResearch
1. Researchques-on2. Designofsingle-caseexperimentanddata
collec3on3. Visualanalysisofdata4. Sta-s-calanalysisofdataandeffectsize
es-ma-on5. Formulateconclusions
Designofsingle-caseexperimentThingstodetermine:
Ø TypeofdesignØ LengthØ Specialrequirements(e.g.,minimumphaselength)Ø Randomiza-onØ Teststa-s-c?
Designchoices~researchques4on
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Designofsingle-caseexperimentPhasedesigns Example:ABphasedesign
Designofsingle-caseexperimentAlterna4ondesigns
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Designofsingle-caseexperimentReplica4ondesignsExample:mul-ple-baselineacrosspar-cipantsdesign
Conduc-ngSingle-CaseResearch
1. Researchques-on2. Designofsingle-caseexperimentanddata
collec-on3. Visualanalysisofdata4. Sta-s-calanalysisofdataandeffectsize
es-ma-on5. Formulateconclusions
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VisualanalysisofdataThingstoconsider(Kratochwilletal.,2010):
• Meanleveldifferences• Trend• Variability• Immedicacyoftheeffect• Thepropor-onofoverlap• ‘Consistencyofthedata’
⇒ Weak/medium/strongevidencefortreatmenteffect?
0 10 20 30 40
02
46
810
Measurement Times
Scor
es
A B
VisualanalysisofdataMeans
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0 10 20 30 40
02
46
810
Measurement Times
Scor
es
A B
Trended range
Visualanalysisofdata
Visualanalysisofdata
Advantages:• Easyandflexiblemethod• Holis-cassessment
Disadvantages• Pronetosubjec-vity• Interrateragreementissues• Difficultforsmalleffects
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1. Researchques-on2. Designofsingle-caseexperimentanddata
collec-on3. Visualanalysisofdata4. Sta3s3calanalysisofdataandeffectsize
es3ma3on5. Formulateconclusions
Conduc-ngSingle-CaseResearch
Sta-s-calanalysisofdata:randomiza-ontests
Whysta3s3calanalysis?!
• Cf.disadvantagesofvisualanalysis• Detec-onofsmallbutsystema-ceffects• Corrobora-onofresultsfromvisualanalysis
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Sta-s-calanalysisofdata:randomiza-ontests
WhatisaRandomiza3ontest?
Asta4s4caltestthatrandomizesthedataacrosstreatmentcondi4onstodetermine
thesta4s4calsignificanceofatreatmenteffect.
Sta-s-calanalysisofdata:randomiza-ontests
Characteris-csofsingle-casedata:• Smallsamples• Unknowndistribu-ons• Serialdependence• Parametricassump-onsoyenviolated!
⇒ RTshavemorevaliditythant-testsorANOVAsforthistypeofdata
WhyuseaRandomiza3ontest?
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Illustra-on• Design:ABdesign(A:baseline;Btreatment)• Observa3ons:8repeatedmeasurements• Limita3on:minimum2observa-onsperphase
→5possibleassignments:
AABBBBBB => AAABBBBB AAAABBBB AAAAABBB AAAAAABB
Illustra-on• Design:ABdesign(A:baseline;Btreatment)• Observa3ons:8repeatedmeasurements• Limita3on:minimum2observa-onsperphase
→5possibleassignments:Observa-ons:65320132 mean(A)–mean(B)
AABBBBBB 3.67 => AAABBBBB 3.07 AAAABBBB 2.50 AAAAABBB 1.20 AAAAAABB 0.33
p-value:2/5=0.4
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Effectsizecalcula-onProblem:p-valuedoesnotgiveinforma3onaboutthesizeoftheeffectSolu3on:calculateeffectsizes(ESs)Effectsizemeasure:quan-fiesthesizeofthetreatmenteffectinasinglenumber:
Standardizedmeandifferences,nonoverlapmeasures,...
EffectSizesprovidemoreinforma-onabouttreatmentefficacythanp-valuealone.Example:theNonoverlapofallPairs(NAP)…
NonoverlapofAllPairs(NAP)• Measureofeffectsize• Ordinalmeasure• Probabilis-cinterpreta-on• Chancelevel:50%• 0%(minimum)-100%(maximum)
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Soyware• Soywarepackagesforvisualandsta-s-cal
analysisofsingle-casedataavailableinR,afreesta-s-calprogram.o RCommanderpoint-and-clickpackageo Future:Web-basedShinyapplica-ons
1. Researchques-on2. Designofsingle-caseexperimentanddata
collec-on3. Visualanalysisofdata4. Sta-s-calanalysisofdataandeffectsize
es-ma-on5. Formulateconclusions
Conduc-ngSingle-CaseResearch
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FormulateconclusionsBaseconclusionsoninforma-onfrom:• Visualanalysis• Sta-s-calanalysis
Effectsizes&confidenceintervals• Feedbackfrompar-cipant(s)=>Sta-s-calsignificance≠clinicalsignificance=>Usemul-pleinforma-onsourcestocorroborateconclusions
ReferencesDeJongh,A.,VandenOord,H.J.M.,&TenBroeke,E.(2002).Efficacyofeyemovementdesensi-za-onandreprocessinginthetreatmentofspecificphobias:Foursingle-casestudiesondentalphobia.JournalofClinicalPsychology,58(12),1489–1503.Onghena,P.&Edgington(2005).Customiza-onofPainTreatments,ClinicalJournalofPain,21(1),56–68.
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1. Whatistransla-onalscience?2. Single-caseexperimentaldesigns3. Design&sta-s-calanalysis4. AnIllustra-on:fearreduc-oninchronicpain
Overview
Basicscience
T2 T3
Transla-onalresearch
Clinicalefficacy Clinicaleffec-veness
Popula-onhealth
T1 T2T3
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Basicscience
Transla-onalresearch
Clinicalefficacy Clinicaleffec-veness
Popula-onhealth
Fromthelabtotheclinic
T1
Exposure
a. Se�ngfunc-onalgoals
b. Educateaboutparadoxofsafetyseekingbehaviors
c. Hierarchy
d. Modeling
e. Challengeexpectancieswithbehavioralexperiments
Vlaeyen et al., CJP 2002
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h�p://www.psychology.unimaas.nl/phoda-sev/
FearHierarchy
Leeuwetal..JPain2007;8(11):840-849.
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RSIPa-ent#5
012345678910
CAT FOP FOM PAIN
-
+
BAS:19days GEXP:8sessionsin29days FU:7days
VAS
DeJongetal.PAIN2012
PAIN
Fear of Movement
DataAnalysis:Illustra-oninRData:‘pain’and‘fearofmovement’ofpa-ent5Steps:• Visualanalysis
• Meanleveldifferences• Trend• Variability• Immedicacyoftheeffect• Thepropor-onofoverlap• ‘Consistencyofthedata’
• Sta-s-calanalysis• p-value• Effectsize(NAP)
• Conclusion
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ComplexRegionalPainsyndrome
0123456789
10
A B C Dfear pain push the baby buggy lift a child
DeJongetalPain,2007
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Bedanktvoorjullieaandacht!!