Who contextualises clinical epidemiological evidence?: A political analysis of the problem of evidence-based medicine in the layered Dutch healthcare system

Tilburg University

Who contextualises clinical epidemiological evidence?

Felder, M.; van de Bovenkamp, H.; Meerding, J.W.; de Bont, A.A.

Published in:

Health Policy

DOI:

10.1016/j.healthpol.2020.09.006

Publication date:

2021

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Publisher's PDF, also known as Version of record

Link to publication in Tilburg University Research Portal

Citation for published version (APA):

Felder, M., van de Bovenkamp, H., Meerding, J. W., & de Bont, A. A. (2021). Who contextualises clinical

epidemiological evidence? A political analysis of the problem of evidence-based medicine in the layered Dutch

healthcare system. Health Policy, 125, 34-40. https://doi.org/10.1016/j.healthpol.2020.09.006

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ContentslistsavailableatScienceDirect

Health

Policy

j ou rn a l h om ep a g e :w w w . e l s e v i e r . c o m / l o c a t e / h e a l t h p o l

Who

contextualises

clinical

epidemiological

evidence?

A

political

analysis

of

the

problem

of

evidence-based

medicine

in

the

layered

Dutch

healthcare

system

Martijn

Felder

_,

_Hester

_van

_de

_Bovenkamp

_,

_Willem

_Jan

_Meerding

_,

Antoinette

de

Bont

a_{ErasmusSchoolofHealthPolicy&Management,ErasmusUniversity,Rotterdam,theNetherlands}

b_{MeerdingAdvies,Gouda,theNetherlands}

a

r

t

i

c

l

e

i

n

f

o

Articlehistory:

Received17April2020

Receivedinrevisedform1September2020

Accepted20September2020 Keywords: Evidence-basedmedicine Institutionallayering Politics Healthcaredecision-making Qualitativeresearch

a

b

s

t

r

a

c

t

Wecriticallyexaminethediscussionontheroleofevidence-basedmedicine(EBM)inhealthcare gov-ernance.WetaketheinstitutionallylayeredDutchhealthcaresystemasourcasestudy.Here,different actorsareinvolvedintheregulation,provisionandfinancingofhealthcareservices.Overthelastdecades, theseactorshaverelatedtoEBMtoinformtheiractorspecificroles.Atthesametime,EBMhas increas-inglybeenproblematised.Tobetterunderstandthisproblematisation,weorganisedfocusgroupsand interviews.WenoticedthatparticularlyEBM’sreductionistepistemologyanditsuncriticaluseby ‘profes-sionalothers’areconsideredproblematic.However,ouranalysisalsorevealsthatsomethingelseseems tobeatstake.Infact,alltheactorsinvolvedunderwriteEBM’sreductionistepistemologyandemphasise thatevidenceshouldbecontextualised.Theyhoweverdosoindifferentwaysandwithdifferentcontexts inmind.Moreover,thewaysinwhichsomeactorscontextualiseevidencehasconsequencesfortheways inwhichotherscandothesame.WethereforeemphasisethatbehindEBM’sscientificproblematisation lurksapoliticalissue.Adisputeoverwhoshouldcontextualiseevidencehow,inalayeredhealthcare systemwithinterdependentactorsthatcatertobothindividualpatientsandthepublic.Weurge pub-licadministrationscholarsandpolicymakerstoopen-upthepoliticalconfrontationbetweenhealthcare actorsandtheirsometimesirreconcilable,yetevidence-informedperspectives.

©2020TheAuthor(s).PublishedbyElsevierB.V.ThisisanopenaccessarticleundertheCCBYlicense

(http://creativecommons.org/licenses/by/4.0/).

1. Introduction

In many countries, ‘evidence-based medicine’ (EBM) has become animportant principlein healthcare governance [1]. It emergedinthefieldofclinicalepidemiologyandgained promi-nenceamongstprofessionalsinthe1990’s[2].EBMaimedtoreduce unexplainedvariationintheprovisionofcare.Itadvocated treat-ment based onthe best epidemiological evidence available [1] and criticisedhealthcare decision-makingbasedonprofessional authority. It encouraged more standardised forms of decision-making,based onstatisticalevidence abouttheeffectiveness of interventions.EBMfurtheredrandomisedcontrolledtrials(RCT’s) asthegoldstandardofevidence[3].

ThestandardisingqualitiesofEBMareincreasingly problema-tised[4].Intheacademicliterature,EBMiscriticisedalongtwo

∗ Correspondingauthor.

E-mailaddress:felder@eshpm.eur.nl(M.Felder).

linesofargumentation.Firstly,authorscriticiseits epistemologi-calreductionistapproachandcomplexmethodology;emphasising thatEBMdraws predominantlyonstatisticaldata derivedfrom selectivepopulations,analysedinwaysthatonlymethodological expertsunderstand[5].Secondly,authorscriticiseitsusein–and beyond–thecounsellingroom.Theircritiqueisthatprofessionals, healthcare managers,policymakers,health insurersand regula-torsbasetheirtreatmentplans,policiesormonitoringinstruments onstatisticaldata,withoutconsideringthesituationofindividual patients[4,6].

Thequestioning of EBM’s scientific principlesand uncritical usehave becomeladenaffairs inhospitals, knowledgecentres, insurancecompanies and government offices.Actors defending evidence-basedhealthcaredecision-makingareclassifiedas ortho-doxpositivists([7][responses]).Actorsquestioningthedominant role of statistical evidence in healthcare decision-making are accused of quackery [7]. At conferences, the vices and virtues of EBM are celebrated and disqualified. Presenters are lauded

https://doi.org/10.1016/j.healthpol.2020.09.006

M.Felderetal. HealthPolicy125(2021)34–40

orhooted(personalobservations2017).TheEBMdiscussionhas becomeasiteofpluralism,conflictandstrive[8].

Wearguethatapoliticalanalysisofthediscussiongenerates insights that cannot be capturedby biomedical or professional approaches.InformedbyMouffe[8]andBacchi[9],we conceptu-alisecontemporaryhealthcaresystemsashighlypolitical.Onthe onehand,suchsystemsconsistofdifferentregulatoryframeworks (from professionalself-regulationtoregulatedmarkets[10,11]). Ontheotherhand,suchsystemsharbourapluralityofactors[12]. Theseactorscan(re)shapeandlegitimiseactors-specificrolesand positionsbyrelatingtodifferentregulatoryframeworksand sci-entific truth claims at differenttimes and for differentreasons [13–15].Problematisingregulatoryframeworksandscientifictruth claimscanthereforegohandinhandwithattemptstoimprove spe-cificrolesandpositions,possiblyatthecostofothers[16].Astriking example is theestablishmentof adivision between‘us’critical interpretersofevidenceversus‘them’naïveusersofevidence[8] andthequestionwhohasmorelegitimacytomakehealthcare deci-sions[13].Inthislight,itisimportanttolookbeyondtheproblem itselfandstudystrategicrelationsthathavegoneintoaproblem’s making[9].

Informedbytheabove,weexamine:a)howEBMinformsthe identities,rolesandpositionsofdifferentactorsinlayered health-caresystems;andb)theperceivedproblemsthatemergefromsuch differenceswhenitcomestohealthcaredecision-making.Wedo sobyansweringthefollowingresearchquestion:

Howandby whomhastheroleofEBMinhealthcare decision-makingbeenproblematisedandwhyisthatthecase?

TheNetherlandshasbecomeanexemplarycasetorevealthe complex relations in which EBM has become constituted as a problem that needsto besolved. Here, healthcare governance, traditionallycontrolledbyprofessionalauthority,hasbeen sup-plementedwithaplethoraofmarketandstate-basedregulatory arrangements[10].Indoingso,theDutchcaseresonateswiththe healthcaresystemsinmanyWesterncountries[1,17].

Ourpoliticalanalysisrevealsthatbehindtheepistemologically andprofessionallyframeddiscussionunfoldsadisputeoverwhois able–andshouldbeallowed–tointerpretandcontextualise clin-icalepidemiologicalevidenceindecision-makingthatdoesright toindividualpatientsandupholdsthequality,safetyand afford-abilityofacollectivehealthcaresystem.ThefutureofEBMshould thereforenot justbeanepidemiological orprofessionalproject. Instead,weurgepolicymakersandscholarsofpublic administra-tiontotaketheEBMdiscussionseriouslyandtostartfocusingon thelayeredhealthcaresystemsinwhichevidence-informed deci-sionsarebeingmade.

2. EBMinthelayeredDutchhealthcaresystem

AsinmanyWesterncountries,thedominantpositionofDutch healthcareprofessionalshasbeencalledintoquestion[18].EBM playedanimportantroleinthisprocessasitscrutinisedhealthcare decision-making basedonprofessionalauthorityandstimulated decision-making based on the best evidence available [2]. The earlyadvocatesofEBMhoweverstillintendedforevidence-based decision-makingtobeaprofessionalaffair;describingitasa pro-cessofcriticalappraisal[4].Criticalappraisalherereferredtothe useof:(a)clinicalepidemiologicalevidence,(b)clinicalexperience and(c)patients’needsandwishes,duringshareddecision-making withpatientsinthecounsellingroom[2].

However,Dutchhealthcaregovernancewaschangingbeyond theconvincesofprofessionalself-regulation.Asnewgovernance principles suchas‘accountability’, ‘efficiency’and ‘affordability’ became important frames of reference [1], so too were new

regulatoryarrangementsintroducedontopofprofessional self-regulation. A Dutch example is the introduction of the Health InsuranceActin2006[19].Thisactaimedtoreducecostsandraise thequalityofhealthcarethroughtheintroductionofmarket mech-anisms.Itdecreedthatprofessionalsshouldstartcompetingonthe qualityandpriceofhealthcareservices.Concurrently,it strength-enedthepositionofhealthinsurers.Theyshouldstartnegotiating withprovidersabouttheprice,volumeandqualityofhealthcare provided.

Meanwhile,theDutchhealthcaresystemwasnotentirelyleftto thewhimsofthemarket.Inaddition,severalsemi-governmental organisationswerechargedwithsafeguardingaccesstocareand minimumquality [10]. The DutchHealthcare Institutewas, for instance,chargedwithstimulatingandoverseeing the develop-ment of qualityinstruments and with advisingthe Minister of Healthonwhichcareshouldbeincludedin andexcludedfrom the‘basichealthcareagreement’. Thisagreementrecognisesthe minimumcaretobecoveredbyhealthinsurers;therebymaking suchcareaccessiblefor(obligatoryinsured)Dutchcitizens. More-over,theDutchHealthcareInspectoratecontinuedtoinspecton thequalityandsafetyofcareprovided.

Byintroducing market mechanismsbeside professional self-regulationandstate-basedregulation,alayeredhealthcaresystem emerged[10].Aneffectofsuchlayeringisthathealthcare decision-makinghasbecomefragmented[11].Itpromptedaproliferationof ‘professionalothers’involvedinhealthcaredecision-making[12]. Examplesarehealthinsurers,policymakers,knowledgeinstitutes andinspectorates.EachoftheseactorshasadoptedEBMinthe waysinwhichtheyshapetheirrolesandlegitimiserole-specific decisions[9,13,14].But,aswewillalsoshowinofourempirical section,thiswideuptakeofEBMhasnotbroughtcoherenceinthe governanceofcare(Fig.1).

3. Materialsandmethods

OurinquirystemsfromadiscussionintheNetherlandsabout evidence-baseddecision-making.Infact,thefirstandthirdauthor participated asresearchersin a Dutchadvisoryboard (deRaad voordeVolksgezondheidandSamenleving[RVenS])thatsought tobetterunderstandtheimplicationsofthisdiscussionforDutch healthcaregovernance[20]. Datagatheredfor thepolicyadvice isreusedinthispaper.Althoughtheproblemspresentedbelow reflectthepolicyadvice,wehaveplacedmoreemphasisona polit-icalanalysisofEBM’sproblematisation[9].

Togain insight into theDutchdiscussion, theRVenS organ-isedtwofocusgroupsinNovemberandDecember2016.Thefirst includedavarietyofexperts(N=7);medicalsociologists,amedical historyscholarandamedicalphilosopher,studyingand publish-ingonEBM.Thesecondincludedhealthcarepractitionersfromthe field(N=5);amedicalspecialist,ageneralpractitioner,ageriatric practitioner,amedicalresearcherandajuniormedicalspecialist. Togaincomplementaryinsight,theRVenSorganisedinterviewsin thespringof2017.Intervieweeswereapsychiatrist(N=1); gynae-cologists(N=2);midwife(N=1);respondentsfromtheDutch HealthcareInspectorate(N=2);aknowledgeinstitute(N=5);and ahealthcareinsurer(N=2).

Withoursamplingapproach,weaimedtogaininsightintothe differentwaysinwhichEBMwasproblematisedand/ordefended andwhyitwasproblematisedordefendedassuch.Informedby Bacchi[9], we therefore approached respondentsthat were: a) activelyinvolvedinthediscussion;andb)representeddifferent kindsofactorsinDutchhealthcaregovernance.Importantly,our aimwasnottoworktowardsa representativesampleofoneof theseactorgroupsspecifically(e.g.aspecificgroupofmedical spe-cialists),ortheDutchhealthcaresystemasawhole(withallthe

Fig.1. ArepresentationofthelayeredDutchhealthcaresystemandtheroleofevidencetherein.

differentactorgroupsincluded).Instead,ouraimwastoidentify thoseactors–andtheirinterrelations–throughwhichEBMhad becomeconstitutedasa problemthatneededtobesolved.We reflect onthelimitationsofthisapproachattheendofour dis-cussion.

Focusgroupsandinterviewsweresemi-structuredaroundtwo questions:I)howdoesEBMcontributetohealthcareprovision? andII)whichproblemsorchallengesdorespondentsencounter? Focusgroupsandallbutoneoftheinterviewswereaudiotaped and transcribed verbatim.Whereaudiotapingwasnotpossible, fieldnotesweremadeandfurtherelaboratedafterwards.Individual contributionswereanonymised.

Forthispaper,werevisitedthetranscripts.Wecodedpassages ofwhatEBMis(andwhatnot),whatitsproblemsare(andwhat not)andhowitshouldbeusedbywho(andwhonot).We member-checkedouranalysisontwoseparateoccasionsinthespringof 2017.Wepresentedourpreliminaryinterpretationonaconference onevidence-basedguidelinedevelopmentandduringthepublic releaseofthepolicyadvice[20].Commentswereusedtofine-tune ouranalysis.

4. Results:theproblemsofEBMintheDutchgovernanceof care

This empirical section is divided into three parts. First, we presenthowEBMinformstheactionsofactorsinDutch health-caregovernance.Thereafter,wepresenthowandbywhomEBM

hasbecomeproblematised.Lastly,weconsiderhowthese prob-lematisationsmirrordecision-makingdynamicsbetweenactorsin thelayeredDutchhealthcaresystem.

Part1:theuseofEBMbydifferentactors

EachoftheactorsintroducedinFig.1usesEBMinandontheir ownterms.Inthecomingfoursubsections,wedescribehow. 4.1. Evidenceinthecounsellingroom

The professionals we interviewed described themselves as interpreterswhomakecontextdependentdecisionsabout individ-ualtreatmentplans.Suchtreatmentplansareinformedbyclinical epidemiologicalevidence,buttheycannotbereducedtosuch evi-dence.In fact, the interviewed professionals stressedthat they shouldbeabletotranslateevidencetothehealthproblemof indi-vidualpatients.

‘The whole ideaisthat you explorethe problemof the patient inthecontextofthepatient,thenlookintowhatthe [evidence-informed]guidelinessayaboutwhatwedo–onaverage–with suchaproblemandafterthatmakeadecisiontogetherwiththe patient.’(Geriatricpractitioner,focusgroup,2016)

M.Felderetal. HealthPolicy125(2021)34–40

evidence-informedprofessionalguidelines.Inthenextparagraph, weexplainwhythisisanimportantdifference.

4.2. Evidenceinguidelinedevelopment

Althoughprofessionalsfrequentlyrefertoprofessional guide-lineswhentalkingaboutevidence,suchguidelinesaremorethana representationofclinicalepidemiologicalevidence.Infact,notonly inthecounsellingroom,butalsointhedevelopmentofguidelines, suchevidenceisweightednexttoclinicalexperienceandpatients’ needsandwishes.

‘Guidelinesaresupportedbyevidence,buttheyalsoincludea trans-lationoftheinternationalevidencetotheDutchcontext,theextent oftheproblemhere,itsspecificorganisationofcare,thepatient perspective.Onlyafterthatdowepresentconsiderationsand rec-ommendations.’(Gynaecologist,interview,2017)

Althoughtherelativeweightofthepatientperspectiveremains animportantpointfordiscussion[21],theabovementionedquote illustrateshowprofessionalguidelinesclaimtobemorethanasum oftheepidemiologicalevidenceonatopic.Infact,whatemergesis asituationinwhichevidenceiscontextualisedontwolevelswithin aprofessionalcontext:inthedevelopmentofguidelinesandinthe counsellingroom.

4.3. Evidenceinregulatingqualityandsafety

Nexttoprofessionals,otheractorsuseprofessionalguidelines toinformtheiractions.Forinstance,theDutchHealthcare Inspec-torateusesthedevelopedguidelinesto:(a)prospectivelyinfluence healthcareprocesses;and(b)toretrospectivelyassessthesafety andqualityofcareprovided(Inspector,interview,2017).

AccordingtotheInspectorate,thecontentofcareisstillinthe handsofprofessionalorganisationsthroughtheirkeyrolein guide-linedevelopment.TheInspectorate,in turn,superviseswhether professionals liveup tothestandardsthat professionalssetfor themselvesintheseguidelines.Inthewordsofaninspector (inter-view,2017):

‘Thereisnoevidencethatdrivingontherightsideissaferthan drivingontheleftside.Nevertheless,thereisenoughevidencethat supportstheideathatadecisionneedstobemadetoeitherdrive ontheleftorontherightsideoftheroad.’

TheInspectorateacknowledgestheweighingofevidenceonthe levelofguidelinedevelopment.Atthesametimeandincontrast tothefirstsubsection,theInspectorate’sapproachcompromises thecriticalappraisalofsuchguidelinesinthecounsellingroom.To bespecifichere,theInspectoratesupportstheprofessional’sclaim thatclinicalepidemiologicalevidenceneedstobecontextualised. TheInspectoratehoweveralsoemphasisesthatsuch contextuali-sationshouldbedoneuniformlyandonanaggregatelevel;thatof theprofessionalorganisation.

4.4. Evidenceinpolicymaking

AlsotheDutchHealthcareInstituteusesclinicalepidemiological evidenceandprofessionalguidelines.Theydosotoprovidepolicy advicetotheMinistryofHealthaboutwhichtreatmentsshould be(preliminary)includedinthe‘basichealthcareagreement’.This agreementdictateswhichcareistobeconsideredstandardinsured careand needstobecoveredbyhealthinsurers. TheInstitute’s objectiveistoincludecarethatisproveneffectiveandaffordable inordertoprotectahealthcaresystemthatiscollectivelyfinanced [22].

TheInstitutedevelopedasystematicassessmentframeworkto supportthemintheirtask[22].Relativeeffectivenessisthekey

principleinthisframework.Thismeansatreatmentneedstobe animprovement,thisimprovementneedstobesignificant,andit shouldexertitselfinprofessionalpractice[22].Itisherethat pro-fessionalandpatientperspectivesareconsidered,specificallythere wereevidenceisinconsistentorwherethereisbroadconsensus aboutvalueoftreatment[22].

Infollowingthesesteps,theDutchHealthcareInstitute explic-itlyrelatestheiractionstotheprinciplesofEBM.

‘WeusetheprinciplesofEBMinourassessment.Althoughitwas developedtoaidprofessionalstomakeclinicaldecisionsfor individ-ualpatients,itsprincipleshavefoundamuchbroaderapplication. Itisalsousedinthedevelopmentofprofessionalguidelinesand policiesregardingpublichealth.Inthesecases,itisnolongerabout decision-makinginrelationtoindividualpatients,butratherabout adviceanddecisionsonthelevelofthepopulation.’([22]:6) The Institute uses EBM’s methodological design on how to gather and grade evidence [3], but explicitly departs from [2] emphasisonweighingsuchevidenceinthecontextofindividual patients.Instead,theyweighsuchevidenceinthecontextofthe Dutchpopulation.Althoughprofessionalinsightsandthepatient perspective areconsidered, theInstitutemakes evidence-based assessmentsindependentfromtheprofessionalorganisations. 4.5. Concludingremarksforpart1

Allactorspresentedabovelegitimisetheirrolesanddecisionsby relatingtoclinicalepidemiologicalevidence.Eachofthem further-morestressestheimportanceofcontextualisingevidence.Theydo soondifferentlevelsandinlinewiththeirperceivedroles. Individ-ualprofessionalscontextualiseevidenceinthecounsellingroom inrelationtoindividualpatients;professionalorganisations(and theDutchHealthcareInspectorate)dosoonthelevelofguidelines developmentinrelationtopatientgroups;andtheDutch Health-careInstitutedoes soin policymakingin relationtotheDutch population.

Part2:EBM’sproblematisation

Inthissubsection,wepresentthemainproblemsidentifiedin theDutchEBMdiscussion.Weemphasiseattheonsetthatit is mainlyprofessionalswhovoiceproblems.Below,wediscussthese inturn.

4.6. Thebiddableuseofguidelines

Aproblemfrequentlyvoiced byprofessionals is aboutother professionals.It addressesthewayinwhich evidence-informed guidelinesareusedinthecounsellingroom:

‘Guidelinesshouldprovide supportinthecounsellingroom,but oftentheyareusedaskeystones.Youreceiveapatientwith hyper-tensionandchecktheguidelinefortreatment.Asecondquestion couldthenbe“whoisactuallysittinginfrontofme?”Butoften, doctorsdon’tdothat.’(Internist,interview,2016)

Theseprofessionalsstresstheimportanceofweighingclinical epidemiologicalevidencenexttoclinicalexperienceandpatients’ needsand wishes, butconcludethatthere isa lackofit inthe counsellingroom.ThisisalongstandingproblematisationofEBM, frequentlyaddressedintheliteratureaswell[23].

Importantly,thosethataddressthisproblemrelatesuch uncrit-icaluseofguidelinestoforcesexternaltoindividualprofessionals andtheiractionsinthecounsellingroom.Ajuniormedical special-isttriestodescribethecauseofthisproblem:

‘Itisakindofdefensivemedicine;becauseotherscanhardly ques-tionyouractionswhenyoufollowedtheguidelines.’(focusgroup, 2016)

Thisprofessionalarticulatesuncertaintyamongstprofessionals. Aformofuncertaintythatconstrainsthemtocriticallyinterpret– andwherenecessarydivertfrom–guidelinesindecision-making withandforindividualpatients.

4.7. Weighingevidenceontherightlevel

Wepreviouslyobservedthatprofessionalorganisations consid-eredtheirguidelinesasuniformagreementsamongstprofessionals about how totreat patients. Guidelines are therefore informed byclinicalepidemiologicalevidence,clinicalexperienceandthe patientperspective.Guidelinesarethusmuchmorethan represen-tationsofclinicalepidemiologicalevidencealone.Yetitisexactly thisweighingofevidenceonthelevelofguidelinedevelopment thatisproblematisedbyprofessionalsweinterviewed.

‘Whensomethingisproveneffective,thenthereisnoproblemin presentingthatinguidelines[andconsideringthatauniform agree-ment].Theproblemhoweveristhatmanythingsinguidelinesare basedonconsensusorauthority.Inthosecases,Ifeelitisharderto divertfromtheguideline.’(Gynaecologist,interview,2016) There where the guideline is based on consensus – or a weightedinterpretationofevidence–professionalorganisations havealreadyincludedthepatientperspectiveandclinical experi-enceonanaggregatelevel.Inthecounsellingroom,professionals subsequentlyfeelthattheyareexpectedtofollowtheweighted advice.Divertingfromtheguidelinesthennolongermeans divert-ingfromtheclinicalepidemiologicalevidence.Instead,itmeans divertingfromtheagreementsthatprofessionalorganisations,in collaborationwithotheractors,havemadeasaprofessional col-lectiveforindividualprofessionals.

Theprofessionalsweinterviewedthusfeelthatweighingand contextualisingisimportant,butproblematisethelevelonwhich that is done. These professionals criticise the emergent trend in which professional organisations translate evidence, clinical experienceand thepatientperspectiveintogeneralagreements presentedinguidelines(previoussubsection).Theseprofessionals arguethatguidelinescannevercapturethecomplexityoftreating individualpatients.Theyproduceafalsesenseofcollective pro-fessionalcontroloverhealthcaredecision-makingandimpedethe roleofindividualprofessionals;whichistoweighevidence,next toclinicalexperienceandpatients’needsandwishes,withpatients andinthecounsellingroom.

4.8. Theprofessionalother

Thefactthat‘professionalothers’useprofessionalguidelines to inform their actor-specific actions further complicates the situation.Suchuseisproblematisedbybothprofessionalsand rep-resentativesofprofessionalorganisationsthatengageinguideline development.

‘WhatIfindproblematicisthatmanyhealthcareactorssee guide-linesas“thisisthe waythingsneedtobedoneandwhenyou don’tdoitlikethatitiswrong”.TheInspectorateforinstancetalks aboutnorms.Inthatphrasingalreadyliesaverydifferentmeaning attachedtoguidelines.’(Representativeofaknowledgeinstitute, interview,2016)

‘Theproblemisthatinsurersuseinsightsderivedfromaveragesof populationstomeasurethequalityofcaredeliveredtoindividual patients.’(Internist,focusgroup,2016)

Inabovementionedquotes,aprecarioustensionisarticulated between:(a)thewayinwhichprofessionalstranslateprofessional guidelinestothecontextofindividualpatients;and(b)thewayin whichinsurersandinspectoratesusesuchguidelinestodetermine

whetherthecarethathasbeenprovidedtoindividualpatientsisin linewiththeuniformagreementsmade.Formostinterviewed pro-fessionals,itisherethatprofessionalguidelines,usefulfortinkering inthetreatmentforandwithindividualpatients,consolidateinto rigidnorms.

4.9. Concludingremarkspart2

In the discussion on EBM, a distinction is drawn between the (ideal typical) patient-centred individual professional and the(problemtypical)standardisation-centredprofessionalother. Whetherthisprofessionalotherisahealthinsurer,health inspec-torate,orprofessionalorganisationdoesnotreallymatter.What matterstothosethatproblematiseEBMisthatclinical epidemio-logicalevidenceisreductionistandneedstobecontextualised.At thesametime,thecounsellingroomisfurtheredasthesitewhere suchcontextualisationshouldtakeplace.Inthenextsection,we discusswhythislineofreasoningneedsscrutiny.

Part3:whodecidesbasedonwhat?

Itisimportanttounderlinethatotheractorsinvolvedinthe governanceofcaredonotdisagreewithhealthcareprofessionals thatclinicalepidemiologicalevidenceneedstobeinterpretedand contextualised.Infact,mostactorsinvolvedseemtointerpretand contextualisesuchevidencethemselves,albeitinandontheirown terms(firstempiricalsubsection).Theissuesraisedabovetherefore donotseemtobeaboutwhetherclinicalepidemiologicalevidence shouldbeinterpretedand contextualised,butrather aboutwho shouldinterpretandcontextualisesuchevidenceandhow.

FormostprofessionalsthatengageintheEBMdiscussion,the questionwhoshouldinterpretclinicalepidemiologicalevidenceis easilyanswered:

‘Healthinsurersshouldnotbeabletosay:“thereisnoevidence for thissowedonotpay”. Wesitinthe counsellingroomnot them...Insurersshouldnotdetermine,onlypay.’(Gynecologist, interview,2017)

IntheNetherlands,aftertheintroductionoftheHealth Insur-ance Act in 2006, health insurers are formally given the role to represent their insured (patients) in negotiations with pro-fessionalsaboutthepriceandqualityof care.However,neither professionals nor insurersact as independent negotiators. Pro-fessionalsaredeemedbyinspectoratestolive-uptotheuniform agreements presented in guidelines developed by professional organisations.Insurersareobligedtoinsurecareincludedinthe ‘basichealthcare agreement’.Inthis context,evidence-informed healthcare decisionsare nolongerunder controlof either pro-fessionals, insurers, patients or the state. Instead healthcare decision-makinghasbecomefragmentedanddynamic,influencing –andbeinginfluencedby–actorsindifferentspheres[10].

Thiscreatesdirecttensionsbetweenactorsinvolvedabouthow tointerpret and contextualiseclinicalepidemiological evidence andabouttheconsequencesofsuchinterpretations.

M.Felderetal. HealthPolicy125(2021)34–40

In abovementioned example, the DutchHealthcare Institute relates toEBM’s evidencehierarchy in order tomake a binary decisionthatcountsforallDutchcitizens;theexclusionofa treat-mentfromthebasichealthcareagreementduetolimitedandlow gradedevidence[24]. Ofkey concernisthatthis interpretation ofevidencebytheInstitutediffersfrom–yetdoeshave conse-quencesfor –theevidence-informedactionsofprofessionalsin thecounsellingroom.Theseprofessionals wanttointerpretthe evidencethatdoesexistinthecontextofanindividualpatient. However,this becomesimpossiblebecausethebasichealthcare agreementprescribeswhatinsurersshouldconsiderinsuredcare. Professionals,inturn,canhardlyrecommendtreatmentsthatare notcoveredbyhealthinsurers.IntheDutchgovernanceofcare,the evidence-informeddecisionsofsomeactorscanthusexcludethe evidence-informedactionsofotheractors.

Itisinresponsetotheabovethatmanyprofessionals problema-tise EBM’sreductionist epistemologyand stresstheimportance ofcontextualisingclinicalepidemiologicalevidence.However,we would like topoint out that theproblem withEBM in above-mentionedexampleisnotnecessarilyalackofcontextualisation. Rather,theproblemisthatinterdependentactorsinterpretand contextualiseclinicalepidemiological evidencein verydifferent ways.Professionalsinterpretsuchevidenceinthecontextofthe situation of an individual patient; the Dutch Healthcare Insti-tute interpretssuchevidenceinthecontextofpolicymakingon theleveloftheDutchpopulation.Importantly,whenclinical epi-demiologicalevidenceiscontextualisedontheleveloftheDutch population,suchcontextualisationisnotnecessarilyaremedyto EBM’s reductionism.After all,in thelatter case, reductions are placed in thecontext of otherreductions(e.g. ‘general consen-sus’or‘thepatientperspective’).Aswepointedoutpreviously,this notonlyhappensonthelevelofpolicymaking,butalsoin guide-linedevelopmentandinnegotiationsbetweenhealthinsurersand healthcareproviders.

5. Discussion

Inthispaper,weformulatedthefollowingresearchquestion: How and by whom has the role of EBM in healthcare decision-makingbeenproblematisedandwhyisthatthecase?Wetookthe Netherlandsasourcasestudy.WeobservedthatEBMinformsthe practicesofavarietyofactors,operatingondifferentlevels(Fig.1). Wefurthermoreobservedthateachoftheseactorsunderlinesthe importance ofcontextualisingclinicalepidemiological evidence. Theycontextualisesuchevidencewithintheirownorganisations (fromthecounsellingroomtopolicyoffices),accordingtospecific methodologies(fromcriticalappraisaltosystematicassessments) andinrelationtoactorspecificobjectivesandresponsibilities(from craftingindividualtreatmentplanstoproposingnationalpolicies). Wehoweveralsoobservedthatinalayeredhealthcaresystem,the contextualisationofevidencebyoneactorcanlimitthewaysin which otheractorsareabletocontextualisesuchevidence.We arguethisisanimportantreasonwhyEBMhasbeen problema-tisedinDutchhealthcaregovernanceandwhyadivisionemerged betweenan‘usprofessionalsandcriticalinterpretersofevidence’ versus‘themprofessionalothersandnaïveusersofevidence’[8].In thislight,theDutchEBMdiscussionnotonlyconcernsthevalueof clinicalepidemiologicalevidence,butalsoconcernswhoshouldbe consideredalegitimateactortomakeevidence-informed health-caredecisions[13].

Basedontheabovementionedobservations,wechallengesome dominantclaimsmadeintheDutchEBMdiscussion,aswellasin theinternationalmedicalliterature.Emphasisisoftenplacedonthe factsthat:a)clinicalepidemiologicalevidenceisreductionist[25];

b)thatsuchevidenceshouldthereforealwaysbecontextualised [6];andc)thatthisnolongerhappensbecauseprofessionalothers haveadoptedEBM uncriticallyandplace constrainson individ-ualprofessionalstocontextualisesuchevidenceinthecounselling room[4].Themainissuewewanttoaddressinthislineof reason-inghastodowithstepc.Aswerevealed,clinicalepidemiological evidenceisinterpretedandcontextualisedondifferentlevels,by differentactorsandinthecontextofagreatmanythings; rang-ing frompatients’ individual needsand wishes, to quality and safety, healthcare expenditures and the protection of a collec-tivelyfinancedhealthcaresystem.ClassifyingEBMasareductionist approachmightthusbeepistemologicallysoundandcallingfor contextualisationmightbealogicalresponse.However,suchcalls forcontextualisingarenotenoughtoresolvethecurrenttensions thathaveemergedaroundevidence-informeddecision-making.In fact,mostactorsagreethatEBMisareductionistapproachandthat clinicalepidemiologicalevidenceneedstobecontextualised;but theyalldosoinandontheirownterms.Thecontextualisationof EBMisthereforenotabsent.Rather,itisallovertheplace.

OurinquiryintoEBM’sproblematisationhasthreeimportant limitations.Firstly,by focussingontheuseof clinical epidemi-ological evidencein healthcare decision-making, we ignorethe processinwhichsuchevidenceisproduced.Differentscholarshave howevercriticallydiscussedhowaplethoraofactorsparticipate inand influencethis process(e.g.pharmacistsand professional experts [26,27]). The clinical epidemiological evidence used in healthcare decision-making shouldtherefore not beconsidered absolute,objectiveorneutral(beforethepoliticsofcontextualising [28]).Secondly,theactorsthatfeatureinthispaperdonot repre-senthomogenousgroups.Amongsthealthcareprofessionals–and withinthehealthcareorganisationsdiscussed–deliberationsexist aboutthewaysinwhichevidenceshouldbeinterpreted[29].Inthe EBMdiscussion,however,suchnuancesareoftenbackgrounded whilstmoreclear-cutdivisionsbetween‘us’criticalinterpreters versus‘them’naïveusersareforegrounded(seealsoparttwoof ourresultssection).Thirdly,webaseouranalysisonrespondents that activelyengaged in theEBM discussion. Therefore, not all actorsthatuseEBMinhealthcaredecision-makingareincluded. ExamplesmissingaretheDutchMinistryofHealthandindividual patients.Wechosetofocusonthosethatengagedinthe discus-sionbecauseitallowedustoidentifythestrategicrelationspart andparcelofEBM’sproblematisation[9].Nevertheless,we recog-nisethatnotparticipatinginthediscussioncouldalsobeastrategic choice.Forinstance,followingtheprinciplesofmarketregulation andrecognisingthecomplexityoftheproblem,theMinistrycould haveavoidedgettinginvolved,leavingthediscussionuptothose thatengagewithoneanotheronthisregulatedhealthcaremarket. Importantexamplesareprofessionals,healthinsurersandthose semi-governmentalorganisationsoverseeingtheirconduct(Fig.1). Itisinterestingtoconsidersuchstrategiesofnon-engagementin futurestudiesintothepoliticsbehindEBM’sproblematisation.

Comparative analyses are another interesting direction to furtherexploreEBM’sproblematisationandapoliticsof contextu-alisingclinicalepidemiologicalevidence.ManyWesternhealthcare systems consist of layered regulatory frameworks [10] and a plethoraofinterdependentactorsthatrelatetosuchframeworks aswellasEBM[12].Inmostofthesesystems,EBMhasbeen prob-lematised[1,4,17].Inthislight,itisimportanttoassesswhetherand howapoliticsofcontextualisingexistsinthesesystemsandthe consequencesthishasforactor-relationsandevidence-informed decision-making.Suchinsightsareimportant,weargue,because theywilldeepenourunderstandingofsystemspecificrelations thathavefuelledarathersystemnon-specific(readinternational) EBMdiscussion.

6. Conclusions

EBMisparticularlyproblematisedinamedicalandscientific register.However,wearguethatthediscussionisactuallyfuelled by:I)tensionsbetweenindividualandpublicneeds;II)the layer-ingofinstitutionalarrangementsthathavebeenintroducedtodeal withsuchtensions;andIII)thedifferencesbetweenactorsandtheir idiosyncraticrolesandpositionspresumedandlegitimisedbysuch layeredarrangementsaswellasclinicalepidemiologicalevidence [10,11].ThismakestheEBMdiscussionnotjustaprofessionalaffair, butratheraquestionofgovernance.Wethereforeurge policymak-ersandpublicadministrationscholarstotaketheEBMdiscussion seriouslyandtostartscrutinisingthelayeringofhealthcare sys-temsandthewaysinwhichsuchlayersshapeevidence-informed healthcaredecision-making.Wefurthermoreurgehealthcare pro-fessionals totakethe EBM discussionbeyondtheircounselling roomsandopen-uptoabroaderdiscussionabouttheroleofclinical epidemiologicalevidenceinlayeredhealthcaresystems[1,17].

DeclarationofCompetingInterest

Thisworkwasfinanciallysupportedbythe‘Verenigingvan Art-senAutomobilisten’(VvAA),amemberorganisationandinsurerfor healthcareprofessionalsintheNetherlands.Thedatausedinthis paperhasbeengatheredduringthedevelopmentofapolicyadvice bythe‘RaadvoordeVolksgezondheidenSamenleving(RVenS).See further,materialsandmethodssection.

Acknowledgements

WethankourcolleaguesthatattendedtheESHPMHealthCare Governancemeeting(29January2018)fortheirconstructive feed-back.SpecialthanksgotoRobertBorst,whowaswillingtoactasa discussant.

References

[1]BerwickDM.Era3formedicineandhealthcare.JAMA2016;315:1329–30,

http://dx.doi.org/10.1001/jama.2016.1509.

[2]SackettDL,RosenbergWM,GrayJM,HaynesRB,RichardsonWS.Evidence

basedmedicine:whatitisandwhatitisn’t.BMJ1996;312:71–2,http://dx.

doi.org/10.1136/bmj.312.7023.71.

[3]TimmermansS,BergM.Thegoldstandard.Thechallengeofevidence. Philadelphia:TempleUniversityPress;2003.

[4]GreenhalghT,HowickJ,MaskreyN.Evidencebasedmedicine:amovementin

crisis?BMJ2014;348:1–7,http://dx.doi.org/10.1136/bmj.g3725.

[5]BerlinJA,GolubRM.Meta-analysisasevidence:buildingabetterpyramid.

JAMA2014;312:603–5,http://dx.doi.org/10.1001/jama.2014.8167.

[6]HargravesI,KunnemanM,BritoJP,MontoriVM.Caringwithevidencebased

medicine.BMJ2016;353:1–2,http://dx.doi.org/10.1136/bmj.i3530.

[7]MolBW,EversH,MedischContact06-07-2017Erismaareenwerkelijkheid: RVenS-rapporttorntaanhetgelijkvanevidencebasedmedicine;2017.

[8]MouffeC.Onthepolitical.London:Routledge;2005.

[9]BacchiC.Whystudyproblematizations?Makingpoliticsvisible.OpenJournal

ofPoliticalScience2012;2:1–8,http://dx.doi.org/10.4236/ojps.2012.21001.

[10]vandeBovenkampHM,DeMulM,QuartzJG,Weggelaar-JansenJWM,Marie

A,BalR.Institutionallayeringingoverninghealthcarequality.Public

Administration2014;92:208–23,http://dx.doi.org/10.1111/padm.12052.

[11]FelderM,vandeBovenkampHM,MaaijenMM,deBontAA.Togetheralone:

organizingintegrated,patient-centeredprimarycareinthelayered

institutionalcontextofDutchhealthcaregovernance.JournalofProfessions

andOrganization2018;5(2):88–105,http://dx.doi.org/10.1093/jpo/joy006.

[12]LascoumesP,LeGalèsP.Introduction:understandingpublicpolicythrough

itsinstruments-fromthenatureofinstrumentstothesociologyofpublic

policyinstrumentation.Governance2007;20(1):1–21,http://dx.doi.org/10.

1111/j.1468-0491.2007.00342.x.

[13]DeaconR.Theoryaspractice:Foucault’sconceptofproblematization.Telos 2000;2000:127–42.

[14]FlynnTR.Sartre,Foucault,andhistoricalreason,volumetwo:a

poststructuralistmappingofhistory.Chicago:UniversityofChicagoPress; 2005.

[15]HalffmanW.Boundariesofregulatoryscience.Amsterdam:Universiteitvan Amsterdam;2003.

[16]VoßJP,FreemanR,editors.Knowinggovernance:theepistemicconstruction ofpoliticalorder.Basingstoke:PalgraveMacmillan;2016.

[17]ToveyD,ChurchillR,BeroL.Evidencebasedmedicine:lookingforwardand

buildingonwhatwehavelearnt.BMJ2014;349:1,http://dx.doi.org/10.1136/

bmj.g4508.

[18]FreidsonE.Theprofessionsandtheirprospects.ThousandOaks:Sage;1973.

[19]HeldermanJK,SchutFT,vanderGrintenTE,vandeVenWP.Market-oriented

healthcarereformsandpolicylearningintheNetherlands.JournalofHealth

Politics,PolicyandLaw2005;30:189–210,http://dx.doi.org/10.1215/

03616878-30-1-2-189.

[20]RVenS,RVenSTheHagueNoevidencewithoutcontext:abouttheillusionof

evidence-basedpracticeinhealthcare;2017.Retrievedfrom:https://www.

raadrvs.nl/documenten/publicaties/2017/06/19/zonder-context-geen-bewijs.

[21]vandeBovenkampHM,Zuiderent-JerakT.Anempiricalstudyofpatient

participationinguidelinedevelopment:exploringthepotentialfor

articulatingpatientknowledgeinevidence-basedepistemicsettings.Health

Expectations2015;18:942–55,http://dx.doi.org/10.1111/hex.12067.

[22]TheDutchHealthcareInstitute.Beoordelingstandvandewetenschapen

praktijk:definitieveactueleversie2015.Diemen:ZorginstituutNederland;

2015.Retrievedfrom:https://www.zorginstituutnederland.nl/publicaties/

rapport/2015/01/15/beoordeling-stand-van-de-wetenschap-en-praktijk.

[23]McCartneyM,TreadwellJ,MaskreyN,LehmanR.Makingevidencebased

medicineworkforindividualpatients.BMJ2016;353:1–6,http://dx.doi.org/

10.1136/bmj.i2452.

[24]GuyattG,OxmanAD,AklEA,KunzR,VistG,BrozekJ,etal.GRADEguidelines:

1.Introduction-GRADEevidenceprofilesandsummaryoffindingstables.

JournalofClinicalEpidemiology2011;64:383–94,http://dx.doi.org/10.1016/j.

jclinepi.2010.04.026.

[25]BoltT,HuismanF.Evidence-basedmedicineincrisis?Eenhistorisch commentaaropeenactueeldebat.TijdschriftvoorGezondheidszorgen Ethiek2015;25:102–7.

[26]KeatingP,CambrosioA.Who’smindingthedata?Datamonitoring

committeesinclinicalcancertrials.SociologyofHealth&Illness

2009;31(3):325–42,http://dx.doi.org/10.1111/j.1467-9566.2008.01136.x.

[27]BothwellLE,GreeneJA,PodolskySH,JonesDS.Assessingthegoldstandard– lessonsfromthehistoryofRCTs.NewEnglandJournalofMedicine 2016;374(22):2175–81.

[28]BalR.Evidence-basedpolicyalsreflexievepraktijk.Watkunnenwelerenvan evidence-basedmedicine?TijdschriftvoorGezondheidszorgenEthiek 2015;25(4):108–13.

[29]Kleinhout-VliekT,deBontA,BoerB.Thebarenecessities?Arealistreviewof

necessityargumentationsusedinhealthcarecoveragedecisions.Health

Policy2017;121(7):731–44,http://dx.doi.org/10.1016/j.healthpol.2017.04.

011.

MartijnFelderisAssistantProfessor;hefocussesonchangingrolesofprofessionals

andpatientsinthecontextofinstitutionalchange.

HestervandeBovenkampisAssociateProfessor;shefocussesonpatientandcitizen

participationandrepresentationinhealthcaredecision-making.

WillemJanMeerdingisSeniorAdvisor;hefocussesonpolicymakinginthefields

ofhealthcareandsocialwork.

AntoinettedeBontisProfessorinSociologyofInnovationinHealthcare;she

focussesontheinterdependenciesbetweenpeopleandtechnologiesinthecontext