Volume 18 • Issue 2 • 1000258J Psychiatry Psychiatry, an open access journal

Research Article Open Access

Prowse, et al., J Psychiatry 2015, 18:2 http://dx.doi.org/10.4172/Psychiatry.1000258

Research Article Open Access

Journal of Psychiatry

*Corresponding author: Phuong-Tu Prowse, Menzies School of HealthResearch, Department of Psychiatry, Monash University, Melbourne, Australia,Tel: 08 89228196; E-mail: ppro4@student.monash.edu

Received February 10, 2015; Accepted February 27, 2015; Published March 05, 2015

Citation: Prowse PTD, Nagel T, Meadows GN, Enticott JC (2015) Treatment Fidelity Over the Last Decade in Psychosocial Clinical Trials Outcome Studies: A Systematic Review J Psychiatry 18: 258. doi:10.4172/Psychiatry.1000258

Copyright: © 2015 Prowse PD, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited

Treatment Fidelity Over the Last Decade in Psychosocial Clinical Trials Outcome Studies: A Systematic ReviewPhuong-Tu D Prowse1*, Tricia Nagel2, Graham N Meadows3 and Joanne C Enticott4

1Menzies School of Health Research, Department of Psychiatry, Monash University, Melbourne, Australia2Menzies School of Health Research and Charles Darwin University, PO Box 40196, Casuarina, NT 0811, Australia3Department of Psychiatry, Monash University, Melbourne, Australia4Department of Psychiatry, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Australia

AbstractBackground: Treatment fidelity tools are frequently used in clinical trials, promoting treatment consistency and

therefore validity of trial findings. However, treatment fidelity procedures have not been included within international clinical trial guidelines such as the Consolidated Standards of Reporting Trials (CONSORT 2010).

Aim: This study systematically reviews psychological clinical trials that incorporate Treatment Fidelity procedures and appraises their implementation using the Implementation of Treatment Integrity Procedures Scale (ITIPS).

Method: Using the PRISMA Checklist as a guide for systematic review, a comprehensive search of the Medline, PsychINFO, Ovid, Cochrane Library, Scopus, PUBMED databases for the period 2004 to 2014 resulted in retrieval of 3186 potential articles. Thirty-two studies meeting inclusion criteria were analysed against the ITIPS.

Results: Sixteen studies were assessed as ‘approaching adequacy’ in implementing Treatment Fidelity procedures as measured by the ITIPS scale, 8 studies were assessed as ‘adequate’ whilst a further 8 studies were deemed ‘inadequate’ against this assessment. Treatment Fidelity tools generally increased the intensity of the intervention or program within which they were used, resulting in improved levels of Treatment Fidelity.

Conclusion: Current evidence supporting the inclusion of Treatment Fidelity tools is limited since there have been relatively few published studies examining the effectiveness of Treatment Fidelity tools. Further research into the efficacy, feasibility and measurement of Treatment Fidelity in implementing treatments is recommended, in tandem with additions to the CONSORT Guidelines to better support the inclusion of Treatment Fidelity procedures within clinical trials.

Keywords: Treatment fidelity; Integrity; Adherence; Competence;Scales; Mental health research

Review Contributions to Existing Research• Assesses current evidence and identifies areas for future

research

• Highlights several key strengths of Treatment Fidelity inimprovingqualityassuranceandimplementationstrategiesforclinical trials

• Finds limited use of Treatment Fidelity procedures withincurrentclinicaltrials

• Provides evidence to support the inclusion of TreatmentFidelitytoolsintheCONSORTGuidelines.

IntroductionTreatment fidelity concepts

The last decade has witnessed rapid development in TreatmentFidelityresearchtailoredtoenhancetherapyimplementationincludingprogress in terms of fidelity definitions, strategies, and approachestomaintenance. Accurate assessment of the effectiveness of therapyrequires knowledge of the degree of Treatment Fidelity within theprogramunderevaluation.TreatmentFidelityhasbeenanimportanttopicinthepsychosocialresearchasitthushasimportantimplicationsforclinicalpractices.Itprovidesevidenceastowhetherthetreatmentbeing investigatedwas implemented inaccordance to recommendedprotocols. Without this evidence it is difficult to ascertain theeffectivenessofanygiventherapy.EarlyconceptualizationofTreatment

Fidelity,alsoreferredtoas ‘treatmentintegrity’or ‘treatmentpurity’,was described as treatment delivered as intended [1]. Subsequently,‘treatment differentiation’ gained favour amongst researchers as adescriptorofTreatmentFidelity; this referred towhetherornot thetreatmentimplementeddifferedfromitsintendedmanner[2-4].Lateragain,‘treatmentreceipt’emergedasaseparateelementofTreatmentFidelity. Defined as whether the client comprehended and used thetreatment skills taught during the sessions [5]. As the field evolved,‘treatmentenactment’wasidentifiedasaTreatmentFidelityelementthatevaluatedwhethertheclientappliedskills learnt intreatmenttotheirdailylife[6,7].Leichsenringandcolleagues[1],expandedfurtherdefining Treatment Fidelity as a means of exploring: (i) whether atreatmentdeliveredisrepresentativeofthetheoreticalconstructsandmechanismspresumedtounderpinitspurpose,(ii)theextenttowhichtreatmenteffectsarecausallyattributedtothetreatmentimplementedand(iii)whetherthesemethodsaregeneralizableintheclinicalsetting.

Journ

al of Psychiatry

Citation:Prowse PTD, Nagel T, Meadows GN, Enticott JC (2015) Treatment Fidelity Over the Last Decade in Psychosocial Clinical Trials Outcome Studies: A Systematic Review. J Psychiatry 18: 258. doi:10.4172/Psychiatry.1000258

Volume 18 • Issue 2 • 1000258J Psychiatry Psychiatry, an open access journal

Page 2 of 8

Fidelity tools

The introduction of treatment manuals allowed interventionsunder empirical investigation to be operationalised to best supporttherapy delivery in line with designed treatment structures [8,9].ManualisationenabledaninterventiontobemonitoredforTreatmentFidelitylevelsaccordingtotheresearchprotocols[4,7].Intheareaofpsychologyandtherapyimplementations,anumberofresearchershavedescribedmanualsasareliableandcosteffectivemechanismtosupportTreatmentFidelity tomaximize targetedoutcomes[10-13].However,severalresearchersarguemutualizedtreatmentsdonotensureeffectivedeliveryofthetreatment[14-18].Thishelpstoexplaintheintroductionof adherence and competence scales to enhance the assessment andmeasurementofTreatmentFidelity.

Thevalueofmeasuringadherenceandcompetence todeterminethequalityofTreatmentFidelity isa fundamentalconsideration[19-21]. Adherence is expressed as the delivery of a key component ortechnique of the treatment [9]. In contrast, competence measuresassesstheskillsoraccuracywithwhichthetreatmentisimplemented[22,23].QuantitativeandqualitativeresearchmethodsarepivotaltoolsfortheinvestigationofthesecomplexTreatmentFidelityphenomena[24-27].DespiteadvancesinthefieldofTreatmentFidelity,studiesoftreatmentadherenceandcompetencecontinuetorevealinconsistenciesbetweentreatmentandoutcome[28].PerepletchikovaandKazdin[29]suggested that adequateTreatment Fidelitymeasures are essential inresearch settings to explain such inconsistencies. Treatment Fidelityprocedurescanassistinexplorationofassociationsbetweenoutcomesandfeaturesoftheintervention,orthetherapist.

Treatment fidelity in randomised clinical trials

Randomised controlled trials (RCT) are a rigorous meansof describing and determining the existence of cause and effectrelationships between treatment and outcome, and assessing thecost-effectiveness of a treatment. When clinical trials are designed,delivered,analysedand interpreted,generalisationandattributionoffindingsarepossible.However,publishedclinicaltrialscanyieldbiasedresults, lack methodological rigour, and may provide incompletereporting,thuslimitingtheopportunityforreplicationofstudies[30].In1998,theseknownlimitationswereacatalystforthedevelopmentoftheConsolidatedStandardsofReportingTrials(CONSORT),whichweresubsequentlyupdatedin2001and2010[31,32].TheCONSORTweredevelopedtohelpimprovethequalityofclinicaltrialsintermsofaccuracy,clarity,transparency,researchdesignandfindings[31,33].

Members of theNational Institute ofHealth (NIH) BehaviouralChange Consortium (BCC) offered a comprehensive TreatmentFidelity Framework that included a five-part theoretical model forTreatment Fidelity in clinical trials [34]. The model suggested thefollowingfactorsbeconsideredwhendesigningatrial;(i)studydesign;(ii) training: specific competencies required for successful deliveryof the intervention for training design; (iii) delivery: processes thatmonitorandmaintainqualityofdelivery; (iv) receipt:processes thatensure thatparticipantsunderstand the informationprovided in theintervention; and (v) enactment: processes tomonitor and improvetheabilityofparticipantstoperformtreatment-relatedcognitiveandbehaviouralstrategiesintheirdailylives[34,35].

Measuring and assessing Treatment Fidelity provides a methodto document deviations within and from an intended model andenhancesinternalandexternalvalidity,andreliabilityofbehaviouralresearchinterventions[5,36-38].WhilsttheassessmentofTreatment

Fidelityisimportant,itcanalsoberesource-intensive[39].Ithasthepotential to add an enhanced dimension to clinical trial implementation [40,41].Perepletchokovaandcolleagues[23]emphasisedthatfidelityprocedures and measures are central to the delivery of successfulclinicaltrials.TheyhighlightedfourkeyareasofTreatmentFidelityinclinicaltrialsthatincluded:establishmentoffidelity(e.g.specificationofprotocol,structuredtrainingoftherapistsandcontinuedmonitoringof therapist’s adherence to the prescribed procedures); assessmentoffidelity (e.g. assessedviadirectobservations in areasof treatmentadherence, therapist competence and treatment differentiation),evaluation of fidelity (e.g. use of adherence and competence scales)andreportingoffidelity(e.g.overallintegrityoftreatmenttheextentto which all components were correctly implemented according tothemanual, andcomponent integrity- consistently implementingalltreatmentcomponentacrosssessions).Thismeasurewasreferredtoasthe ImplementationofTreatment IntegrityProceduresScale (ITIPS)andwasdesignedtoevaluatetheextentclinicaltrialsaddressedthesefourdefinedareas[23].

Treatment fidelity and CONSORT

AtpresentmanyelementsofTreatmentFidelityareabsentfromtherevisedCONSORTstatementsandexplanations[42].PerscheandPage[25]highlightedthatthoughtheCONSORTGuidelinesareregularlyused in clinical trials, they are deficient in the area of supportingthe attainment of high levels of Treatment Fidelity, potentiallydetracting from the effectiveness of the delivered intervention.IdentifieddeficienciesoftheCONSORTGuidelinesinclude:inabilityto capture the provision of clinician professional development andthe inability to record the attainmentof clinically significant results.Moreover,theguidelinesareineffectiveintermsofassessingtreatmentdelivery, treatment receipt and treatment enactment [34,43]. Theidentifiedweaknesseswithin thepresentCONSORTguidelineshavedirect implicationsforclientcare,as theattainmentofhigh levelsofTreatmentFidelity isoftencritical forprogramgoalsandreplicationacrossmultiplesites[44].

TheinclusionofTreatmentFidelitytoolscanassistwithadequatetestingofaproposedhypothesis,andcanenhancestatisticalpowerformeasuresof internalvalidity,Fromthepointofviewoftranslationalresearch, it enhances the ability to replicate the treatment in otherstudies, promptly disseminate the treatment, and potentially tomaximisesuccessfulpatient/clientoutcomes[45,46].Incontrast,alackof attention toTreatmentFidelity implementationmay lead topoorstandardisationwithinandacrosstreatmentsinclinicaltrialsandwillcontributetoaninflatederrorvariance,decreasedstatisticalpowerandincreasedlikelihoodofaTypeIIError[47,48].

AimThis systematic review aims to identify how Treatment Fidelity

hasbeenimplementedinclinicaltrialstohelpcontributetoimprovedunderstandingofcurrenttrends.

The review appraises psychosocial clinical trials that specificallyinvestigate Treatment Fidelity over the last decade. It uses theImplementationofTreatmentIntegrityProceduresScale(ITIPS)[23]tocriticallyappraiseandsynthesizeevidenceintermsof:

1. Use of Treatment Fidelity procedures within clinical trials ofpsychologicalinterventions

2. Alignmentof clinical trialTreatmentFidelityprocedureswiththeImplementationofTreatmentIntegrityProceduresScale.

Citation:Prowse PTD, Nagel T, Meadows GN, Enticott JC (2015) Treatment Fidelity Over the Last Decade in Psychosocial Clinical Trials Outcome Studies: A Systematic Review. J Psychiatry 18: 258. doi:10.4172/Psychiatry.1000258

Volume 18 • Issue 2 • 1000258J Psychiatry Psychiatry, an open access journal

Page 3 of 8

MethodTypes of studies

OnlyrandomisedcontroltrialspublishedinEnglishbetween2004and2014wereincluded.Whenatrialdidnotreportrandomisationbutwasdescribedas“double-blind”andthedemographicsdetailsofeachgroupweresimilar,thetrialwasdeemedtoberandomised.Theauthorsexcludedquasi-randomisedstudies,butstudiesthatemployed“clusterrandomisation”(suchasrandomisationbyclinicianorpractice)wereincluded.

Search strategy

Priortocommencingthesystematicreview,apreliminarysearchof the Database of Abstracts of Reviews of Effects (DARE), andthe Cochrane Database of Systematic Reviews (CDSR) confirmedno similar systematic reviews had been published. The followingelectroniclibrarydatabaseswereinvestigatedbytworesearchassessorsusingthePRISMA(2009)ModelofSystematicReview:TheCochraneCentral Register of Controlled Trials on the Cochrane Library(January2004-January2014);PubMed (January2004-January2014);Ovid Medline (January 2004-January 2014); PsychINFO (January2004-January 2014); CINAHL Plus (January 2004-January 2014);Scopus(January2004-January2014).Searchtermsincludedtreatmentfidelity, integrity, intervention integrity, adherence, competence, andimplement,scale,assessment,andmonitorandoutcomemeasure.

Twoassessors(ClinicalPsychologistTedGrahamandfirstauthor-PP)independentlyscreenedtitlesandabstractsbasedontheresearchquestions, study design, specified population, intervention, andoutcome(s). Each individual articlewas assessed using the inclusioncriteriaofrandomisedcontroltrials,mentalhealthtreatments,Englishand full text articles.Theexclusioncriteria consistedofpoorqualityresults, non-randomised control trial, not peer reviewed, meta-analysis/systematic reviews, trials not explicitly assessing TreatmentFidelity, letters, opinions, inadequate considerations of confounders,development of scale articles, tools used not validated/reliable andqualitativestudies.Thereferencelistsofincludedstudiesandreviewsweresearchedtohelpidentifyfurtherrelevantstudies.Iftheassessorsagreed an assessed trial did not supply sufficient pre-requisite data,that study was omitted from the review. Publications were viewedindividually and any double reporting recorded. Figure 1 shows theresultsofdifferentsearchengines[49].

Data extraction

Thetwoassessorsindependentlyextracteddatafromtheselected32articlesusingtheITIPS.Tomaintaindataintegritythisinformationwascross-checkedbyeachassessor.Intheeventconsensuscouldnotbe reached pertaining to the rating of itemswithin the scale, TriciaNagel (TN-second author) assisted inmaking a final determination.Decisions requiring clarification or data extraction challenges weredocumentedforfuturediscussion.

Measurement used for data management

The PRISMA (2009) Checklist for Systematic Review [31] is astructured way to summarise literature reviews, which was furthercomplementedby the inclusionof theImplementationofTreatmentProceduresScale(ITIPS).TheITIPSwasdesignedbyPerepletchikovaandcolleagues [23] topromoteacommon language tobestpositionresearchers tounderstand,measureanddefineTreatmentFidelity. Itprovidesa frameworktosystematicallyevaluateandcodeTreatment

Fidelityinclinicaltrials[23,50].TheITIPSconsistsof22-itemscoveringdomains of establishment (use of treatment manuals), assessment(treatment adherence, therapist competence, evaluation (therapistreactivity(e.g.therapistperformancealteredduetoawarenessofbeingobserved)andreporting(professionaldevelopmentof therapistsandratersofTreatmentFidelityinoutcomesstudies).Eachofthe22-itemshas a potential rating scale of four points. Total scores range from22 to 88. Higher scores indicate more adequate implementation ofTreatmentFidelityprocedures(e.g.,“Trainingstrategiesoftherapists,”where1:nottrained,2:authorsmentionedthattherapistsweretrainedbutnootherinformationwasprovided,3:usedindirectstrategies,and4:useddirectstrategies).Theestablishingtreatmentfidelitydomain(6items) refers tohowresearchers conceptualizefidelity (e.g., in termsofadherenceand/orcompetence),aswellastheextenttowhichtheyprovideadetailedtreatmentmanualtotherapists,trainandsupervisethem.Theassessing treatmentfidelitydomain(7 items)refers to theassessmentoftreatmentfidelityviadirect,indirect,orhybridstrategies;measurementoftherapisttreatmentadherenceaswellascompetence;andemploymentoffidelitymeasureswithgoodpsychometricproperties(i.e., validity and reliability). The evaluating treatment integritydomain(5 items)refers toproceduressuchasensuringtheaccuracyof the representationof theobtainedfidelitydata, trainingof raters,assessinginter-raterreliability,andcontrollingformeasurereactivity.Thereportingtreatmentfidelitydomain(4items)referstoproceduressuch as reporting numerical data; reporting overall, component andsessionfidelity; and reporting the implementationof variousfidelityprocedures.Therapisttreatmentadherenceandtherapistcompetenceaspects of fidelity (6 items each) encompass how the terms weredefined,assessed,evaluated,andreported[23].Toreducetheriskof

Database search identified 3186 records

667 records excluded, not in English format

2519 records screened

Additional studies identified through reference lists and expert suggestions (n=70). Treatment manuals were only included if there was an adherence scale.

406 full text article considered for inclusion

256 records excluded due to 1. No or unclear definition of Treatment Fidelity 2. No measurement or adherence scale 3. Not RCT4. No inclusion of fidelity measurement scale (even if treatment manual included) 5. No usable data

150 full text articles reviewed for quality 92 records excluded

1. Author non response to inquiry for insufficient or incomplete data 2. Not validated Questionnaire/Scale 58 Treatment Fidelity studies

26 Excluded records due to: 1. Not focused on psychosocial treatments 2. Fewer than 10 participants3. and/or lack of useable data

2183 records excluded, not focussed on Treatment Fidelity or RCT

Inc

lude

Elig

ibili

ty

Scr

eeni

ng

I

dent

ifica

tion

32 Treatment Fidelity studies with RCT treatments with adherence/and or competence scales

Figure 1: Clinical trials vetting process employed using The PRISMA Systematic Review flow diagram.

Citation:Prowse PTD, Nagel T, Meadows GN, Enticott JC (2015) Treatment Fidelity Over the Last Decade in Psychosocial Clinical Trials Outcome Studies: A Systematic Review. J Psychiatry 18: 258. doi:10.4172/Psychiatry.1000258

Volume 18 • Issue 2 • 1000258J Psychiatry Psychiatry, an open access journal

Page 4 of 8

biasassociatedinover-estimatingtheeffectsassessorsratedthearticlesindependently,prior toassigning ITIPS scores.Assessor scoreswereaveragedandrecordedonanExcelSpreadsheetforanalysis.

Treatment Fidelity procedures were categorised as determinedbytheITIPSguidelines:adequate(AD);approachingadequate(AA);andinadequate(IA).Foreachitemascoreof1or2wasassumedtoreflect inadequate implementation of integrity procedures as theclinicaltrialshowedeithernoevidenceortalkedonlyinbroadtermsof Treatment Fidelity; a score of 3 indicated that implementationapproachedadequacyastheclinicaltrialhadprovidedsomedatathatmeasuredTreatmentFidelity ; and a score of 4 designated adequateimplementationoffidelityproceduresastheclinicaltrialhadprovideddetailed data thatmeasured Treatment Fidelity. Because there were22itemsontheITIPS,studieswereclassifiedasimplementingfidelityprocedures(a)inadequatelyifthestudy’stotalscorerangedbetween22and44;(b)inamannerapproachingadequacyifthetotalscorerangedbetween45and66;and(c)adequatelyifthetotalscoreexceeded66.This strategywas also utilized for evaluation of the adequacy of theTreatmentFidelityproceduresforthefourdomainsandthetwoaspectsoffidelity.StatisticalanalysiswasconductedusingSPSSforWindows.

ResultsFigure1 illustrates theflowof information through thedifferent

phasesofthesystematicreviewandmapsoutthenumberofrecordsidentified,included,andreasonsforexclusions.Thirtytwostudiesmetallselectioncriteriaforinclusion.3224recordswereexcludeddueto:non-RCTdesign,treatmentfocusnotpsychosocial,lackofappropriatefidelity measures or treatment fidelity definition, fewer than 10participants,and/orlackofuseabledata.

Establishing treatment fidelity

Themajorityofstudies(71.9%)reporteduseofatreatmentmanualto support the therapistas shown inTable1.However,more thanaquarter(28.1%)ofstudiesmadenoreferencetotheuseofatreatmentmanual.Of the 23 studieswhich used amanual, 14 studies (43.5%)referredtotheuseofaspecificmanual,ninestudies(28.1%)mentionedthegeneraluseofamanualwithinthetreatmentprocess.

Assessment of adherence and competence procedures of the treatment

Table1alsoshowsthatmoststudies(90.6%,n=29)approachedorachievedadequacyintermsofuseoftreatmentadherenceprocedures.Competence measures were less frequently employed. More thanhalf of the studies (56.2%, n=18) approached or achieved adequacyof therapist implementing competence procedures while 14 studies(43.8%)didnotrefertotheuseoftherapistcompetenceprocedures.

Evaluating treatment fidelity

Clinician adherence and competence: Of the 32 studies thatassessed Treatment Fidelity, most reported conceptualisation ofTreatmentFidelitydata.Data includedcompetence raters, employedmethodologyandkeypropertiesofthetreatment.Whilethemajorityof these studies defined Treatment Fidelity specifically in terms ofadherence and/or competence (59.4%, n=19), one third of studiesappraisedTreatmentFidelityinonlygeneralterms(34%,n=11),(Table2). Amajority of studies (71.9%, n=23) assessed Treatment Fidelityusingadherenceand/orcompetenceconcepts,andhalfofthestudies(50%,n=16)usedspecificadherenceorcompetencetoolstomeasureTreatmentFidelity.

Ontheotherhand,morethanaquarterofthestudies(28%,n=9)onlyassessedTreatmentFidelityindirectlyorfailedtoprovidedetailoftheassessmentofTreatmentFidelity(28.2%,n=9).Mostofthese(sixstudies) referred toTreatmentFidelity indirectlywith the remainingthreestudiesnotreportingtheuseofanyfidelitytools.Explainingandassessing(observationaldata)adherenceandcompetencecaninvolvedirect, indirectorhybridstrategies.Directobservationsaregenerallyconducted by trained staff present in the treatment setting, viewingsessions throughone-waymirrororviamonitorsand/orvideotapes.Indirect methods include self-report, rating scales, interviews andpermanent products (eg. written homework assignments or datacollectionsheets)oftreatmentimplementation.

Rating adherence and competence:EvaluatingTreatmentFidelitythroughtheuseofadherenceandcompetencescalesrequirestheuseof raters who assess and score treatment delivered by clinicians orresearchers.Halfofthe32studies(n=16)didnotreportanytrainingof raters, (Table 3). In a third of the studies (31.3%, n=10) trainingprovidedtoraterswasindirectornotspecifictothetreatment.Overtwo thirds of the studies (68.7%, n=22)measured adherence and/orcompetence.

A third of studies (31.3%, n=10) relied on indirectmeasures toassess fidelity. Reactivity to Treatment Fidelity (clinicians alteringtheir performance or behaviours due to the awareness that theyare beingobserved)was controlledwithin 21 studies (65.6%)with afurther11studies(34.4%)controllingforreactivityindirectly.Thatis,observationswereconductedatrandomisedtimeswithoutpriornoticebeingprovidedtoclinicians.

Reporting treatment fidelity:Nine studiesprovided informativedatarelatedtotherapistadherence,eightofwhichprovidednumericaldatarelatedtomeasurementofTreatmentFidelityusingcompetencescales, (Table4).Of the remaining23 studiesusingadherence scalesmost (71.9%)didnotprovidedetailed informativedataof treatmentadherence levels although they assessed treatment adherence andprovidednumericaldata.Ofthe24whichdidnotprovideinformation

Therapist treatment adherence procedures Therapist competence procedures Use of the manualVariable

(ITIPS range)IA

(6-12)AA

(13-18)AD

(19-24)IA

(6-12)AA

(13-18)AD

(19-24)Manual not mentioned

Manual only mentioned

Manual is general

Manual is specific

Overall (N) 3 17 12 14 9 9 9 14 4 5Overall (%) 9.4% 53.1% 37.5% 43.8% 28.1% 28.1% 28.1% 43.8% 12.5% 15.6%Mean Score 12 15.4 21 7.6 15.3 21.8

SD 0 1.8 1.7 1.5 1.9 1.9Median 12 15.0 20.5 7 16 22Min-Max 12-12 13-18 19-24 6-11 13-18 19-24

Table 1: Implementation of therapist treatment adherence and therapist competence procedures and use of the manual Note: IA=inadequate; AA=approaching adequacy; AD=adequate. Total studies N=32.

Citation:Prowse PTD, Nagel T, Meadows GN, Enticott JC (2015) Treatment Fidelity Over the Last Decade in Psychosocial Clinical Trials Outcome Studies: A Systematic Review. J Psychiatry 18: 258. doi:10.4172/Psychiatry.1000258

Volume 18 • Issue 2 • 1000258J Psychiatry Psychiatry, an open access journal

Page 5 of 8

aboutcompetencescales12studies(37.5%)providednodatarelatedtocompetencelevels.Theremaining12studies(37.5%)providedsomenumericaldata,howeveritwasnotsufficienttoallowdeterminationofcompetencelevels.

Implementation of treatment fidelity procedures across the four domains of the ITIPS:Table5showstheadequacylevelsacrossthefourdomainsofestablishing,assessing,evaluating,andreportingfidelity.

I) Establishment: Less than half (40.6%, n=13) of the studiesestablishedproceduresforascertainingTreatmentFidelityandnearlya quarter (21.9, n=7) of the studies approached adequacy in thisdomain.However,morethanonethirdofstudies(37.5%,n=12)didnotestablishadequateTreatmentFidelityprocedures.

II)Assessment:IntermsofassessingTreatmentFidelityaboutonethirdof studies (31.3%,n=10) approachedadequacy, a further thirdofstudiesimplementedadequateprocedures(34.4%,n=11),whiletheremainingthirdofstudies(34.3%,n=11)scoredwithintheinadequaterangeontheITIPSscale.

III) Evaluation:Overahalfofstudies(53.1%,n=17)approachedadequacyintermsofmethodsofevaluationofTreatmentFidelity,withmarkedly fewer (18.8%, n=6) achieving scores indicating adequateimplementation. More than a quarter of the studies (28.1%, n=9)achievedscoreswhichindicatedinadequateevaluationprocedures.

IV) Reporting: Approximately a third of studies approachedadequacy (31.3%,n=10) in termsof reportingofTreatmentFidelity

Establishing Assessing Evaluating ReportingVariable(ITIPS range)

IA(6-12)

AA(13-18)

AD(19-24)

IA(7-14)

AA(15-20)

AD(21-28)

IA(5-10)

AA(11-15)

AD(16-20)

IA(4-8)

AA(9-12)

AD(13-16)

Overall (N) 12 13 7 11 10 11 9 17 6 7 15 10Overall (%) 37.5% 40.6% 21.9% 34.4% 31.3% 34.4% 28.1% 53.1% 18.8% 21.9% 46.9% 31.3%

Mean Score 10.8 15.2 21.0 12.1 16.7 24.1 8.9 12.9 17.5 7.3 10.7 14.5

SD 1.5 1.7 1.3 1.5 1.2 2.3 0.8 1.4 1.4 0.5 1.0 1.1Median 11.5 15.0 22.0 12.0 16.5 24.0 9.0 13.0 17.5 7 11 14.5

Min-Max 8-12 13-18 19-22 10-14 15-19 21-28 8-10 11-15 16-19 7-8 9-12 13-16

Note: IA=inadequate; AA=approaching adequacy; AD=adequate. Total studies N=32. Table 5: Adequacy levels across the four domains of establishing, assessing, evaluating, and reporting fidelity.

No Indirect Adherence or competence

Adherence and competence No Indirect Adherence or

Competence Adherence and Competence

% 6.3 34.4 37.5 21.9 9.4 18.8 50.0 21.9

N 2 11 12 7 3 6 16 7

Table 2: Treatment Fidelity in terms of treatment adherence and therapist competence.

Training raters Assessment inter-rater reliability Control for measure reactivity

Yes No Indirect Yes (adherence or competence)

Yes(both adherence and competence No Indirect Yes No Indirect

% 18.7 50.0 31.3 53.1 15.6 0 31.3 65.6 0 34.4N 6 16 10 17 5 0 10 21 0 11

Table 3: Measuring Treatment Fidelity.

proceduresandfindingswithevenmore(46.9%;n=15)demonstratingadequate reporting. However, seven studies (21.9%) did not reportTreatmentFidelityproceduresadequately.

Total levels of treatment fidelity implemented:Overalloneachof the 22 items, a scoreof 1or 2was assumed to reflect inadequateimplementation of integrity procedures; a score of 3 indicated thatimplementation approached adequacy; and a score of 4 reflectedadequateimplementationofintegrityprocedures.Theoverallscoreofeachclinicaltrialwascalculatedusingacombinationofthepercentageoftreatmentsimplementingintegrityprocedureswith(a)inadequatelyif the study’s total score rangedbetween22and44; (b) inamannerapproaching adequacy if the total score ranged between 45 and 66;and (c) adequately if the total score exceeded 66.The percentage oftreatments implementing integrity procedures within each range ofscoreswascalculatedandshowninTable6.

Ofthe32clinicalstudieswithinthissystematicreview,aquarterof the studies (25%, n=8) did not adequately implement TreatmentFidelity. Three quarters of the reviewed studies either approachedadequacy(50%,n=16)orwereadequate(25%,n=8)inimplementingTreatmentFidelityprocedures.

DiscussionWhilstsolidadvances inTreatmentFidelityresearchcontinueto

bemade,severalopportunitiestostrengthenthisapproachareyettobe realised.This review assessed 32 clinical trials ofwhichonlyfiftypercentadequatelyaddressedTreatmentFidelity.

Adherence CompetenceNo Not informative Informative No Not informative Informative

% 0 71.9 28.1 37.5 37.5 25.0N 0 23 9 12 12 8

Table 4: Provision of numerical data of treatment adherence and competence in clinical trials.t

Citation:Prowse PTD, Nagel T, Meadows GN, Enticott JC (2015) Treatment Fidelity Over the Last Decade in Psychosocial Clinical Trials Outcome Studies: A Systematic Review. J Psychiatry 18: 258. doi:10.4172/Psychiatry.1000258

Volume 18 • Issue 2 • 1000258J Psychiatry Psychiatry, an open access journal

Page 6 of 8

Use of Treatment Fidelity Procedures within Clinical Trials of Psychological Interventions

ThisreviewfoundgapsacrossallfourdomainsoftheITIPSscale,with12 studies attaining inadequate scores for establishment, 11 forassessment,nineforevaluation,andsevenforreportingofTreatmentFidelity. Overall, a third of the selected articles showed inadequateimplementationofTreatmentFidelity.Insomecases,thepoorratingmay reflect insufficient reporting rather than a lack of procedures,whileinothercasestheestablishment,measurement,orevaluationofTreatmentFidelitymayhavebeeninadequate.

Treatment Fidelity in psychosocial research is implemented inaccordancewiththeoreticalandproceduralmodelsofadherenceandcompetencemeasurements.Asmallnumberofstudiesaddressedboththeuseofadherenceandcompetencemeasuresandtheirassessment.However,more valuewasplacedon the assessmentof adherence toTreatment Fidelity than on therapist’s competence levels. Goenseand colleagues [49] identified a similar trend in their review. TheconceptofadherencewithinTreatmentFidelitymaybebettersuitedtoquantitativemeasurement.Adherencemeasuresassesshowfrequentlyand to what degree the therapist ensures treatment “purity” [50].In contrast, it is difficult to provide a quantitative measurement oftherapistcompetenceinimplementingthetreatmentwithoutrelyingheavilyupontheclinicaljudgementandexpertiseofselectedassessors.

Alignment of Clinical Trial Treatment Fidelity Procedures with the Implementation of Treatment Integrity Procedures Scale (ITIPS)

Across the four domains ofTreatment Fidelity in the ITIPS,wefoundthatmethodsforestablishingandassessingfidelityscoredbelowfiftypercentonaverage,whilsttheevaluatingandreportingofresultsapproachedaverageinanumberofstudies.Onlysevenstudies(21.9%)had adequately established procedures for ascertaining TreatmentFidelity. Typically, a manual was provided for the therapist whenimplementing the treatment. However, it is noteworthy that onlyfive studies reported providing therapists with a specific treatmentmanual.Additionally,notallstudiesprovidedtherapistswithtrainingand/orsupervisionrelatedtouseof themanualandimplementationof treatment. One explanation could be that the therapy was wellknownandthatguidelinesandtrainingwerealreadybroadlyavailable.Forexample,severalstudies involvedtheuseof thewidelypracticedtreatmentofCognitiveBehaviouralTherapy.

Incontrast,itwouldbeexpectedthatnewtherapiesandemerginginterventionswouldplacegreaterrelianceontheprovisionofaspecificmanual.Itshouldbenotedthatwhilstacliniciancanbeveryskilledin delivering a treatment, they may not necessarily be adhering topertinenttechniquescontainedwithinaprescribedmanual.Interms

ofassessment,inmoststudiesindirectmethodsoffidelityassessmentweremorecommonlyused than specificadherenceandcompetencescales.Akeylimitationofsuchindirectmethodsisthelackofcapacityinmeasuringthequalityofthedeliveredinterventionortreatment[50].

The fourthandfinaldomain, reporting, scoredpoorlyoverall. Itappeared the reporting of Treatment Fidelity was influenced by thelack of establishment and implementation of rigorous assessmentprocedures across several studies. This rendered interpretationof fidelity data difficult. Clinician adherence was generally moreadequatelyreported thancliniciancompetencewithvery fewstudiesreportingbothadherenceandcompetencemeasures.Numerousstudiesweredeficientinreportingcriticaldetailsoftheirevaluation,suchasinter-rater reliability. Moreover, when reporting Treatment Fidelitydata,manystudiesprovidedlittledetailoftheirfidelitymeasurementfindings.Apossibleexplanationmaybeauthorsattachedmoreweightto treatment outcomes than to the importance of assessing andreporting Treatment Fidelity. Nevertheless the failure to implementTreatment Fidelity strategies limits the available conclusions to bedrawnfromthestudyandtheoverallgeneralizabilityofthefindings.

The findings of this systematic review suggested a need forguidelinestobetterdetailthekeyTreatmentFidelityofestablishment,evaluation, assessment and reporting. The clinical trials in thisreview had implemented and reported according to the CONSORTGuidelines[31];however,thequalityoffidelityprocesseswasgenerallyinadequate with a majority of studies insufficiently reporting boththerapist adherence and competence measurements. Whilst it isrecognised that conceptualisingandevaluatingTreatmentFidelity iscriticalinunderstandingthevalidityofresearchresults,clinicaltrialscanstillachievethis ‘goldstandard’withoutevidenceofhighqualityTreatment Fidelity procedures. Perrepletchikova and colleagues [23]argued that Treatment Fidelity needs to be elevated in prominenceand tobeviewedas fundamental forempirical research.Our reviewsupports this argument. This review highlights an opportunity forstrengthened program implementation through adopting enhancedprocedures for future clinical trials to maximise outcomes, a viewshared by Perepletchivova and colleagues [23] who stated that,“guidelinesofempiricaltestingofpsychologicaltreatmentrequirere-evaluation” (p838).Thisreviewprovides furtherevidence insupportofthisrecommendation.Moreover,changesarerecommendedtotheGuidelinesforreportingofclinicaltrialsforpsychologicalresearchtobettercommunicateproceduresforestablishingassessing,evaluating,andreportingoffidelity.Areviewof theCONSORTguidelines [32]wouldprovideanopportunityforamendmentstoestablishproceduresfor ascertaining Treatment Fidelity across each of the four ITIPSdomains.Whilst theguidelinesprovidea solid startingpoint for thereporting of clinical trials, they remain vague in terms of reportingon Treatment Fidelity. Borrelli and colleagues [34] suggested theaddition of a fidelity framework to best support treatment design,therapisttraining,treatmentdelivery,treatmentreceiptandtreatmentenactment.

The benefits of revising the CONSORT Guidelines include:establishing a structured Treatment Fidelity focus, increased usageof treatment manuals, enhanced consistency of clinician treatmentimplementation, and greater statistical power achieved through amorestandardisedmeasurementmethod.ThisreviewsuggeststhebestsuitedtoolstodeliverhighlevelsofTreatmentFidelitywereadherencescales,competencescalesandspecificmanuals.Thesetoolsprovideaconstantreferencepointtobettersupportconsistencyinthedeliveryofaprogramacrossmultiplesitesbydifferentclinicians.

Note: IA=inadequate; AA=approaching adequacy; AD=adequate. Total studies N=32.

Table 6: Adequacy levels of the total implementation of Treatment Fidelity procedures in 32 clinical trials studies.t.

Total Treatment FidelityVariable (ITIPS range) IA (22-44) AA (45-66) AD (67-88)

Overall (N) 8 16 8Overall (%) 25 50 25Mean score 38.75 54.81 76.75

SD 2.49 5.59 4.83Median 38.50 54.00 73.50Min-Max 35-42 47-64 70-83

Citation:Prowse PTD, Nagel T, Meadows GN, Enticott JC (2015) Treatment Fidelity Over the Last Decade in Psychosocial Clinical Trials Outcome Studies: A Systematic Review. J Psychiatry 18: 258. doi:10.4172/Psychiatry.1000258

Volume 18 • Issue 2 • 1000258J Psychiatry Psychiatry, an open access journal

Page 7 of 8

The ITIPS domains of establishment, evaluating, assessing, andreporting Treatment Fidelity supported the goals of this systematicreview. However, some minor refinement may prove beneficial forfuture research studies. The intentional broadness of the domainsmakesitdifficulttoeffectivelydrilldowntospecificelementsofinterest.Forexample,itisnotpossibletoreadilycapturethespecificTreatmentFidelitytoolsusedorprofessionaldevelopmentopportunitiesprovidedtoclinicians.Accordingly, theoptionto includeadditionalquestionswithindomainsmayhelpovercomethisidentifiedlimitation.

Limitations

Therearefivemainlimitationstothisstudy.Firstly,theassessorswere not blind to the authors of the selected clinical trials allowingfor the potential of observer bias. Secondly, inclusion and exclusioncriteriamayhavebeentoorestrictivewithspecificsearchtermshavingunintentionallyexcludedvalidclinicaltrials.Thirdly,thesmallnumberofclinicaltrialsincludedaffectsthegeneralisabilityofthecurrentstudy.Perhapshavinga longer time frameand includingstudiespublishedpriorto2004mayhaveledtoabetterunderstandingoftheevolvingnatureofTreatmentFidelity.

Fourthly,expanding thereviewparameters fromclinical trials toinclude systematic reviews and meta-analyses may have provided amoreheterogeneousfieldforcomparison.Finally,TreatmentFidelitywasidentifiedasnotcommonlybeingthespecificfocusoftheclinicaltrials, and these studies were often undertaken by a core group ofauthors. For example,Hogue contributed to three separate includedtrials. This makes it problematic to generalise findings given thepotentialforbiaslinkedwiththisresearchgroup.

Conclusion and future directions

Mentalhealthprofessionalsworkingwithinthefieldsofpsychologyandpsychiatryseekevidence-basedtreatmentstounderpintheirdayto day clinicalwork.High qualityTreatment Fidelitywithin clinicaltrials provides robust evidence for effectiveness of a given therapy.This systematic review, however, found under-usage of fidelitymeasures within clinical trials, contributing to limited quality ofTreatmentFidelity,andconsequentlimitedevidenceforeffectivenessof therapy.Thereviewalso found that thosestudies,which includedmulti-method approaches to Treatment Fidelity using adherenceand competence measures and treatment manuals, achieved higherratings of Treatment Fidelity quality. This provides clear directionfor futureresearch,suggestingthat inclusionofsuchprocedureswillpromoteimprovedTreatmentFidelity.WhilethedevelopmentoftheCONSORTGuidelineshascontributedtoimprovedqualityofclinicaltrialsandhencestrengthenedtheevidencebaseforspecifictherapies,these protocols do not presently provide detailed recommendationsrelatedtoTreatmentFidelityprocedures.ThusonemeansofimprovingqualityofTreatmentFidelityinclinicaltrialswouldbetheinclusionofsuchdetailedguidance.

ThisreviewevaluatedTreatmentFidelityqualityinfourproceduraldomains; establishment, evaluation, assessment, and reporting.Integrating procedureswithin these domains in future clinical trialswillprovidedata,whichpromotesgreaterunderstandingoftreatmentimplementationandstrengthenedevidencefortreatmenteffectiveness.Reaching agreement on coremeasures and fidelity tools to supportimproved levels of Treatment Fidelity in psychosocial research willpromotequalityofTreatmentFidelity,andconsistencyacrossmental

health disciplines, allowing future research to provide more robustevidenceinsupportofbetterclientoutcomes.

Acknowledgment

This project would have not been possible without the assistance of Ted Graham (Clinical Psychologist and Research Assistant) and Anne Young (Librarian, Monash University Melbourne).

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Citation: Prowse PTD, Nagel T, Meadows GN, Enticott JC (2015) Treatment Fidelity Over the Last Decade in Psychosocial Clinical Trials Outcome Studies: A Systematic Review J Psychiatry 18: 258. doi:10.4172/Psychiatry.1000258