Accounting for EBM: Notions of evidence in medicine

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Accounting for EBM: Notions of evidence in medicine

Helen Lambert�

Department of Social Medicine, University of Bristol, Canynge Hall, Whiteladies Road, Bristol BS8 2PY, UK

Available online 4 January 2006

Abstract

This paper takes as a focus of anthropological enquiry the set of techniques and practices for the appraisal and clinical

application of research evidence that has become known as evidence-based medicine (EBM) (or, more recently, evidence-

based health care). It first delineates and classifies the criticisms of EBM emerging from within the health professions. It

then charts the evolution of EBM in responding to these criticisms and uncovers its character as a pedagogical innovation

aimed at transforming clinical practice. It identifies EBM as an indeterminate and malleable range of techniques and

practices characterised not by particular kinds of methodological rigour, but by the pursuit of a new approach to medical

knowledge and authority. It situates this characterisation within a contemporaneous political and economic climate of

declining trust and growing accountability. This analysis provides a basis from which to consider the notions of evidence

implicit in EBM itself and also in the qualitative social sciences, including anthropology, which not only critique but also

contribute to these notions themselves. Finally, the paper considers possible future trajectories for EBM with regard to the

incorporation of cultural and structural dimensions of health and the inclusion of qualitative material in the evidence base.

r 2005 Elsevier Ltd. All rights reserved.

Keywords: Evidence; Evidence-based medicine; Anthropology; Narrative-based medicine; Methodology; Qualitative research

Introduction: A pedagogical and autobiographical

trajectory

My personal impetus for beginning to think andwrite about notions of evidence has been my dualinstitutional position in two academic departmentsof public health since 1991 as both observer of therise of evidence-based medicine and as participant,required (as is usual in multidisciplinary environ-ments) to defend and promote ethnographic andother qualitative approaches to research. Here, Igloss ‘evidence-based medicine’ (henceforth EBM)loosely as referring to the demand that clinicalpractice and, increasingly, all health policy and

e front matter r 2005 Elsevier Ltd. All rights reserved

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practice (and indeed other areas of social policy) bebased on systematically reviewed and criticallyappraised evidence of effectiveness. The packageof quantitative techniques and procedures currentlyknown as EBM is generally agreed to have beenfounded by a group of colleagues at McMasterUniversity in the mid-1980s. ‘Clinical epidemiology’(Sackett, Haynes, Guyatt, & Tugwell, 1985) was thefirst volume to announce the arrival of a newapproach to clinical medicine by showing thatepidemiology (until then a discipline associatedlargely with population health) could be applied toindividual patient care. For social scientists of aninterpretative bent who can (and often all tooreadily do) mock with great fluency the naı̈vepositivist tendencies of biomedical science, it issalutary to begin by recalling that well before 1985

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Table 1

Limitations of EBM identified in critical literature

1 Incommensurate nature of population evidence and

individual patient profiles

2 Bias towards individualised interventions

3 Exclusion of clinical skills from medical practice

4 Production of formulaic guidelines

5 Failure to consider patient views and narratives

6 Difficulties in disseminating & implementing evidence into

practice

H. Lambert / Social Science & Medicine 62 (2006) 2633–26452634

when that volume was first published, there weregood reasons for EBM’s proponents to attempt toshift medical practice towards a more ‘science-based’ approach. I refer to the increasing recogni-tion, probably from the 1960s onwards, within andoutside the profession that doctors are not infallibleand that many medical interventions have histori-cally been based on tradition or preference,unsupported by any evidence of benefit other thanthe conviction of the administering practitioner.

Critiques of EBM: A typology of alleged limitations

While what ‘EBM’ is continues to be negotiatedand broadened—a point central to the argument ofthis paper—the limitations rather than the benefitsof EBM have been the subject of fervent and oftenpolemical debate in the pages of many healthpractitioners’ journals. Many mainstream medicaljournals have published articles on the topic, whilethe Journal of Evaluation in Clinical Practice hasemerged as a major site for critique with an annualthematic issue on the EBM debate. I undertook asearch of medical and public health journals forletters, articles and commentaries written in Englishsince 1990 that comment (favourably or unfavour-ably) on EBM.1 All identified literature wasreviewed and those items that critiqued EBM inany fashion were categorised manually into the-matic groups, as discussed below; the next section ofthe paper discusses responses to these critiques fromEBM advocates. My review did not seek to becomprehensive, but rather to capture the range ofcritiques that have been made of EBM during itsascendancy and to identify responses to them. Thisreview—arguably less ‘systematic’ than the partially

1My search initially produced roughly 35 cited references

(limited to those sources available free online or at Bristol

University and restricted to relatively non-specialised medical

and health professional publications; thus commentaries on

aspects of EBM appearing in journals directed at, for example,

audiences of gerontologists or occupational health workers, were

accessed only where they could be traced from initial citations in

more mainstream sources.). I conducted further searches during

revision of this paper to verify the initially derived categories;

Web of Science (which provides citation counts), yielded 333

initial references on ‘EBM’ AND ‘crit*’ OR ‘limit*’, reduced to

51 references after title and abstract review. The Journal of

Evaluation in Clinical Practice yielded over 200 references on

these keywords. Abstract and where necessary content review

confirmed the veracity of my typology, but suggested a possible

nascent sixth category concerning ethics that is referred to in the

concluding section.

quantitative review methods recommended withinEBM, but nonetheless fairly rigorous—suggests thatcritical responses to EBM, from the first declara-tions of a ‘paradigm shift’ in medical practice(Evidence-Based Medicine Working Group, 1992)to date can broadly be categorised into thefollowing six groups (see Table 1).

Incommensurability of population evidence and

individual patient needs

First (1 in Table 1), there are the difficulties thatcan be characterised as arising out of the individual-population discrepancy. Many clinicians have ar-gued—and many epidemiologists and medicalstatisticians, their general support for the entrench-ment of EBM in clinical practice notwithstanding,have agreed (Davey-Smith & Egger, 1998)—thatevidence deriving from randomised controlled trialsand other studies of the effects of interventions inpopulations cannot straightforwardly be ‘readacross’ to the clinical management of individualpatients (Parker, 2002; Schattner & Fletcher, 2003;Sullivan & Macnaughton, 1996). Underlying thisdifficulty in translation is the notion that theseforms of knowledge are essentially incommensurate.

Bias towards individualised interventions

A further criticism (2 in Table 1) which derivesfrom this same issue but holds potentially proble-matic implications for public health rather thanclinical practice, concerns the constraining effectthat EBM may have on what types of interventionare considered legitimate. Briefly, this criticismalleges the following: that since what is most readilymeasurable through evidence-based approaches aredirect comparisons between simple treatments suchas a single drug against a placebo, assessments suchas the classical clinical trial are increasingly

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favoured. Meanwhile the growing requirement toprovide evidence of effectiveness before implement-ing interventions means that complex interventionsare by default less and less likely to be supportedover time. Hence behavioural, psychosocial, com-munity-based and multiple-component interven-tions lose out in favour of individual patient-basedtreatments (Dieppe, 1998; Tallon, Chard, & Dieppe,2000) and resultant public health policy-settingincreasingly focuses on individuals rather than ongroups (Davey-Smith, Ebrahim, & Frankel, 2002). Ireturn to the issue of the individualised focus ofEBM later in the paper.

Exclusion of clinical skills

A third set of critiques (3 in Table 1) focusdirectly on the putative exclusion from the conceptof EBM of what has been variously characterised asthe ‘diagnostic art’, ‘clinical expertise’ or ‘clinicaljudgement’—in other words, the experientiallyacquired craft skills of clinical practice. This groupof critiques focuses most squarely on the hoary ‘artvs. science’ debate (cf. Gordon, 1988) in thecharacterisation of clinical medicine. Some earlyresponses in this vein suggested that EBM is aspurious exercise in attempting to codify andregulate what is already intuitively or otherwise‘known’ and practised by clinicians and that,essentially, medicine has long been evidence based.Others have contended that EBM seeks to reduceclinicians to reading automata by stripping patientcare of clinical skills in favour of the strictapplication of scientific knowledge (Williams &Garner, 2002).

Production of formulaic guidelines

A subdivision of the above type of response thatis profuse and distinct enough to warrant separateidentification (as 4 in Table 1) relates specifically tothe formulation and application of formulaicprocedures (‘clinical guidelines’, ‘protocols’ or‘algorithms’) to guide clinical practice (Kassirer,1993). Critiques of this process (mostly from withinthe medical profession) have mainly focused on thepotential erosion of clinical autonomy representedby these formulae (for example Rappolt, 1997; butsee Denny, 1999). Attention has also been paid toimplicit assumptions about knowledge acquisitionthat underlie the production of such guidelines andthe consequent implications for physicians’ learn-

ing—and hence the quality of patient care (Berg,Horstman, Plass, & Van Heusden, 2000; Smith,Goodwin, Mort, & Pope, 2003). Others haveexamined the production of clinical guidelines andhave argued that they limit, rather than advance,patient choice (Rogers, 2002) or that, far fromensuring universal standardisation, in reality suchformulae are subject to processes of local adapta-tion (Timmermans & Berg, 1997).

Failure to consider patient views

Contributors to the group of critiques labelled 5in Table 1 are concerned with the ‘voice’ of thepatient; with patient autonomy and levels ofsatisfaction in the care patients receive. A promi-nent argument in these contributions is the putativedanger that EBM, in relying solely on a stricthierarchy of acceptable forms of evidence, prior-itises evidence of clinical effectiveness and cost-effectiveness and excludes subjective perceptions,including those of the potential or actual recipientsof care (Richards, 1997). Obviously this group ofcritiques overlaps partially with the third categorydescribed above in arguing, for example, for theimportance of patient narrative and subjectivejudgement in clinical practice (and hence thatclinical medicine is inherently interpretative)(Greenhalgh, 1999; Greenhalgh & Hurwitz, 1999).

Difficulties in translating evidence into practice

Chronologically, the final group of criticalresponses to EBM (6 in Table 1) has expanded asthose of the fifth category just described havegradually subsided under the weight of EBM’sgrowing orthodoxy. This final type of response,distinctively, is produced as often by proponents asby critics of EBM and does not seek to question thestatus or value of evidence production and collec-tion itself. Most contributions focus on the problemof introducing, disseminating, and implementingevidence (that is, research findings) in clinicalpractice (Maeseneer, Van Driel, Green, & VanWeel, 2003), though some have argued that EBM-oriented attempts to improve practice are based onan overly simplistic concept of behavioural change(Grol & Grimshaw, 2003; Haines & Donald, 1998;Wood, Ferlie, & Fitzgerald, 1998). This group ofcritiques includes systematic reviews of studies thatattempt to gather evidence regarding the implemen-tation of research evidence in practice. Finally, a

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Clinicalexpertise

Researchevidence

PatientPreferences

Fig. 1. Early model of the key elements for evidence-based

clinical decisions.

H. Lambert / Social Science & Medicine 62 (2006) 2633–26452636

growing number of publications focus on the use ofevidence not in clinical practice but in health policyand health services delivery (Dobrow, Goel, &Upshur, 2004; Niessen, Grijseels, & Rutten, 2000).

Encompassing objections: The evolution of EBM

The previous section provided a brief orientationto major categories of criticism levelled at EBM. Aseach type of putative limitation has been identifiedin commentaries and papers, each has progressivelybeen accommodated within the parameters of EBMitself. My review of the literature suggests thatcriticism has characteristically been countered notby rejection, contestation or entrenchment, but byincorporation. This assimilationist response is fairlycharacteristic of the way in which biomedicine, asan institutionally dominant system, has dealt inmany country contexts with other (traditional,indigenous and alternative) medical traditions. Acurrent example is the growing trend to apply EBMprinciples to complementary and alternative medi-cal traditions (Haynes, 1999; Villanueva-Russell,2004; Wilson & Mills, 2002), facilitating theselective incorporation of appropriately validatedalternative traditions into biomedicine’s organisa-tional health care delivery system. The take-up ofevidence-based approaches by various traditions ofcomplementary medicine simultaneously bears tes-timony to its growing value as a legitimatingstrategy.

Section 1 illustrate incorporation as a character-istic reaction to criticism of EBM using a singleresponse to each identified category of limitation.Thus, regarding the incommensurability of indivi-dual and population-based forms of evidence (type1 limitation), the founders of EBM have argued thatthese forms of evidence were never meant to bealternatives. In the second edition to their textbookClinical Epidemiology Sackett et al. (1991) describetheir eponymous subject as the ‘science of the art ofmedicine’ (1991, p. xiv) and, noting the need tointegrate it with the other basic sciences, theycomment that, ‘were the approaches presented hereto constitute the sole scientific basis for clinicalaction, we would simply be substituting a newtyranny of unachievable methodologic rigor for theold tyranny of unteachable clinical art.’ (1991, pp.xiv–xv). This response nominally also addresses thetype of criticism categorised as 2 in Table 1, thatEBM biases the selection of interventions towardssimple individual treatments, though in practice its

assimilation has not been directly asserted. It is,however, dealt with indirectly by other members ofthe EBM Working Group in an attempt toencompass broader social structural dimensions ofhealth, considered in the final section of this paper.

Assimilationist response to the third type oflimitation, the supposed exclusion of clinical judge-ment and the interpretive art of medicine fromEBM, has been voiced extensively in publishededitorials and articles. It is most succinctly ex-pressed through the reformulation of a diagram thatwas published initially in editorials in both ACPJournal Club and EBM in 1996, with a text that alsoappeared in the British Medical Journal (Sackett,Haynes, Guyatt, & Tugwell, 1996). This venndiagram depicts three interlocking circles, termed‘Research evidence’, ‘Clinical expertise’, and ‘Pa-tient preferences’ (Fig. 1).

A revised version of the diagram (Fig. 2) waspublished in 2002 in ACP Journal Club and inabbreviated form 3 months later by the BMJ, withanother extended version in EBM the following year(Haynes, Devereaux, & Guyatt, 2003).

This version (Haynes, Devereaux, & Guyatt,2002) overlays the intersecting area between thesame three circles with a dotted ovoid entitled‘Clinical expertise’, while the circle previously giventhis name is renamed ‘Clinical state and circum-stances’ and the circle to the lower left is referen-tially expanded by tagging it ‘Patients’ preferencesand actions’. Thus the combination of interpretiveart and clinical experience is repositioned to acentral position in the representation of EBM,

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Clinical state and circumstances

Patients’preferencesand actions

Researchevidence

Clinicalexpertise

Fig. 2. Updated model for evidence-based clinical decisions.

H. Lambert / Social Science & Medicine 62 (2006) 2633–2645 2637

visually overlying all the other elements of the triad.This repositioning definitively accommodates thecomplaints of those professionals who consideredtheir medical judgement impugned by its initialdemotion to a third of the clinical process, occupy-ing equal status with ‘patients preferences’ and‘research evidence’. Tellingly however, in thisreformulation the sole element left untouched isthe circle named ‘Research evidence’, while theapparent restoration of clinical expertise to a centralposition is limited or, perhaps, even renderedoptional by the dashed rather than solid line usedto indicate its compass.

The subgroup of critiques concerned with theconstraining of professional autonomy and disre-gard of clinical skill via the imposition of standar-dised protocols and guidelines (type 4 in Table 1)was confronted by Sackett et al. in a widely citededitorial published in the BMJ (Sackett et al., 1996).This response characterises such formulaic ap-proaches as ‘cookbook medicine’ and continues,‘Because it requires a bottom up approach thatintegrates the best external evidence with individualclinical expertise and patients’ choice, [EBM] cannotresult in slavish, cookbook approaches, etc. Clin-icians who fear top down cookbooks will find theadvocates of evidence based medicine joining themat the barricades’ (1996, p. 71). Such a response ineffect counters the argument that EBM constrainsprofessional autonomy and disregards clinical skillby arguing that such criticism arises, like limitationtype 1, from an overly narrow misconstrual ofEBM. Like the response to 1, the statement citedhere can best be seen as an effective rhetorical

strategy that disarms the beleaguered ranks ofmedical professionals by a sturdy expression ofsolidarity. In reality, the establishment of clinicalprotocols to enforce ‘best practice’ is undoubtedlyone manifestation of EBM (take for example theestablishment of the UK’s National Institution ofClinical Excellence (NICE), one of whose three corestated activities is ‘Developing clinical guidelines’(NICE, 2004)).

A particularly strong focus in the past decade’songoing debate about EBM has been the patient’srole in clinical decision-making—my fifth categoryof limitation (Schattner & Fletcher, 2003). Againthis limitation is dealt with by encompassing it.Although ‘patient choice’ was included in theearliest EBM model, as described above (Fig. 1), awidely quoted definition of EBM taken from the1996 editorial cited above nowhere mentions patientpreference. EBM was there defined (in a widelyquoted phrase) as, ‘The conscientious, explicit, andjudicious use of current best evidence in makingdecisions about the care of individual patients’(Sackett et al., 1996, p. 71). The revised version ofthe EBM diagram (Fig. 2) however places greateremphasis than the original on the patient as activeagent in—rather than passive recipient of—evi-dence-based practice. More generally, ‘evidence-based patient choice’, which combines EBM andpatient centred care (Edwards & Elwyn, 2001;Hope, 2002) and emphasises the need to commu-nicate research evidence to patients to assist theirinformed decision-making, has become an impor-tant area of development in health care research andclinical practice.

Due to the inherently pro-EBM character of thesixth category in my typology, acknowledgement ofdissemination difficulties in the production and useof new medical evidence takes the form of treatingthis issue increasingly within the framework ofEBM itself. An example is a three-part series in thehigh-impact journal Lancet on ‘Research intoPractice’, the first paper of which is entitled ‘Frombest evidence to best practice: effective implementa-tion of change in patients’ care’ (Grol & Grimshaw,2003). A current concern in the promotion ofevidence-based practice is clinicians’ reading activ-ities, with new initiatives for disseminating the latest‘best evidence’ becoming the focus of particularlyactive research efforts (Mykhalovskiy, 2003). Ineffect, the rectitude of EBM is increasingly beingtaken as a given; criticisms have been assimilatedthrough corrections to the original formulation and

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emphasis is shifting to methods for facilitating itseffective practice.

Having demonstrated how EBM has evolved inresponse to different types of criticism, the nextsection turns to consider the foundations of EBM inclinical training. Situating EBM in medical histor-ical perspective helps to shed some light on itsremarkable ability to accommodate criticism andthe speed of its incorporation into normativeclinical practice.

Models of and models for medical practice: education

and revolution

The rise and rise of EBM in the UK, as elsewhere,can be seen perhaps most clearly in its gradualentrenchment within the medical curriculum (De-mar, Glasziou, & Mayer, 2004; Sinclair, 2004;Straus & Jones, 2004). A study of UK medicalschools in 2001 found that most include criticalappraisal in the curriculum and examinations forpostgraduate training (Alderson, Gliddon & Chal-mers, 2003), while a 1998 survey of the UK medicalRoyal Colleges (which licence clinicians to practiceat consultant level in their specialist areas) foundthat two-thirds examined skills in ‘EBM’ (Leung &Whitty, 2000). Medical students at Bristol, forexample, now have to complete EBM moduleswithin their public health training and EBM is a‘vertical theme’ throughout the undergraduatedegree. Trainees undergoing their hospital-basedresidency attend weekly meetings aimed at review-ing the evidence for selected clinical problems as ameans of developing literature searching and criticalappraisal skills. Far from being an incidentalindicator of EBM’s success, the pedagogical dimen-sion is central to the EBM initiative as conceived byits founders and I turn now to the meaning andimplications of this.

Berg (1995) provides a fascinating account ofpostwar biomedicine in the US, analysing the turnsby which clinical practice came to be redrawn as ascience (rather than, as previously, an art that drawson science in its practice). He demonstrates howparticular characterisations of medical practice (forexample, the physician as information-processingmachine) in turn inevitably lead to the ‘discovery’ ofconsequent failures (physicians’ information-pro-cessing abilities are then investigated and found tobe flawed). The successive developments in medicalpractice addressed by this history include compo-nents of what has now come to be known as EBM,

such as the use of guidelines or protocols (Berg etal., 2000).

What emerges with particular force from the linesof this argument is the way in which pedagogicalmodels developed for medical practice have repeat-edly been reframed as models of medical practice.When applied to practice those models are thenfound wanting. Effort then becomes focused onattempting to improve practice. To illustrate by wayof an example relevant to EBM, the ‘hypothetico-deductive method’, based on cognitive models ofproblem-solving, was originally introduced intomedicine for use in training medical students indiagnostic decision-making (Berg, 1995; Groen &Patel, 1985). It was subsequently reformulated as adescription of what clinicians actually do inpractice; and finally, it has been critiqued as aninaccurate representation of what clinicians actuallydo ‘‘do’’ (Greenhalgh, 1999).

As Sackett et al. make clear in the preface to thesecond edition of their textbook on clinical epide-miology, while the initial impetus to develop EBMemerged from their own career experiences, it wasthrough involvement in developing a new structurefor medical education (at McMaster University)that they found the opportunity to formulate anddisseminate the concept. In a 1992 paper that is lessoften referenced than some of the group’s later,more programmatic writings on EBM, they maketheir intentions perfectly explicit. The second sub-heading of their paper is, ‘A paradigm shift’ andafter summarising Kuhn’s characterisation of thesame they continue, ‘Medical practice is changingand the change, which involves using the medicalliterature more effectively in guiding medicalpractice, is profound enough that it can appro-priately be called a paradigm shift.’ (Evidence-Based Medicine Working Group, 1992). Thissection goes on to describe ‘methodological ad-vances’—use of RCTs to assess drug efficacy, meta-analysis, articles on how to do literature searches,textbooks on clinical epidemiology, evidence dis-semination vehicles such as ACP Journal Club andso on—before stating, ‘We call this new paradigm‘‘EBM’’ ’. They go on to describe the building of aresidency program that aims to inculcate EBM andemphasise in some detail how a key feature of the‘new paradigm’ is that much lower value is placedon authority than in the older paradigm for medicaleducation.

The authors close the paper with the admirablyfrank admission that there is little or no evidence


that ‘EBM’ actually improves outcomes for pa-tients. The apparent hubris of proposing a parti-cular educational model while characterising it as aparadigm shift in professional practice nonethelessappears to have been justified. The approachdeveloped at McMaster’s had its initial impact inschools of medicine and public health in the guise ofa radical pedagogical model described as ‘problem-based learning’ (an attractive potential solution forthose grappling with the problem of an ever-expanding medical curriculum). Just over a decadelater, EBM has spread to become if not standardpractice, at least a widely entrenched notion inclinical medicine across North America and Europe.Although it remains a contested one, EBM hasalready become accepted institutionally as a modelfor practice. One measure of this is the fact that—like the earlier representations of medical practiceexamined by Berg—concerns are now focusing lesson whether EBM is desirable in itself than onbarriers to its successful implementation (see mydiscussion of type 6 critiques above). Proposing amodel for practice for pedagogical purposes, whichthen comes to represent a model of ideal practice towhich actual practice must be made to conform, is awell-established trajectory in the history of biome-dical ideas.

‘EBM’ is, moreover, an umbrella term thatencompasses a whole gamut of practices, techni-ques, attitudes and innovations in biomedicalscience and clinical practice—outcome measure-ment, the development of algorithms to guidepatient care, clinical trial requirements for licensingnew drugs, the notion of continuing medicaleducation or ‘lifelong learning’, software develop-ment for diagnostic decision-making, electronicjournals, Medline and the innovation of the WorldWide Web. Those who coined the term were, in thisstrict sense, correct to claim it as a paradigm shift—one that was already happening but that was readyto be named and harnessed to a specific set ofpedagogical objectives at that historical moment.This judicious rebranding had other positive effectsfor the promotion of its component approaches, for(unlike ‘outcome measurement’ or the use ofcomputers by the bedside), who could possibly beagainst evidence (Carr-Hill, 1995; Dieppe, 1998)?While we now associate EBM with features such ascritical appraisal, literature searching, and a focuson efficiency and effectiveness in diagnostic deci-sions and clinical prescribing, at the core of EBM’searly formulation was a concern to downgrade the

ultimate authority of the clinical expert in favour ofimpersonal scientific research evidence (Hampton,2002, 1983; Norman, 1999). The branding as‘evidence-based’ of an essentially social politicalstrategy to unseat professors of medicine as solearbiters of good practice (Evidence-Based MedicineWorking Group, 1992) rather effectively neutralisedat the outset resistance from those occupyingtraditional positions of authority in the medicalworld. It simultaneously opened a pathway for therelatively young and—to conventional biomedicalwisdom—relatively disrespectful fields of epidemiol-ogy and public health, to move into a more centralposition in biomedical education and practice. This‘disrespect’ is evident in some of the more light-hearted critiques of EBM that have appeared, suchas ‘Seven alternatives to EBM’ (Isaacs & Fitzgerald,1999), and ‘EBM: Unmasking the ugly truth’(CRAP Writing Group, 2002), an extended spoofwhich portrays EBM as a fully fledged religious cult.

EBM, then, is an indeterminate and malleablerange of techniques and practices unified not—as itsproponents and critics alike have tended toassume—by particular kinds of methodologicalrigour, but by the pursuit of a new approach tomedical knowledge and authority. This accounts forthe remarkable flexibility in accommodating criti-cism identified earlier in this paper. The ‘catch-all’character of the very term ‘EBM’ and the ultimateaim of this medical educational strategy, as justdescribed, also help to explain the assimilationistcharacter of EBM’s responses to criticism asdescribed in the first sections of this paper. EBMis able to absorb criticisms alleging disparate kindsof shortcomings in its parameters, premises ormethods simply by modifying these, since EBM isa rolling programme the precise components andboundaries of which are entirely secondary to itscentral aims. Before turning to consider theimplications of my analysis for what is held toconstitute ‘evidence’ within EBM, I briefly situatethe nature of EBM as characterised so far within abroader societal context.

Accountability and the moral loading of EBM

debates

It is beyond the scope of this paper to consider indetail the broader institutional and social environ-mental structures and historical circumstanceswithin which EBM has been formulated andpropagated. However, lest it appear that I am


suggesting that EBM’s current institutionalisationwithin several national health systems can beaccounted for solely in medical historical terms, itis important briefly to indicate the political andeconomic dimensions of the EBM critiques dis-cussed above. Clearly, EBM exemplifies, within theparticular domain of clinical medicine, the kind of‘audit culture’ (Shore & Wright, 1999; Strathern,2000) that has become characteristic of all Statemonitored public sector institutions as public trustin authority declines and the perceived need fortransparency and accountability increases (a phe-nomenon discussed by Power, 1997; see Charlton,1998). The identification of EBM as a pedagogicalturn in medical education by no means precludesthe possibility of explaining its initial formulation orsubsequent success in broader structural terms. Onthe contrary, the particular concerns of EBM’sfounders with the unwarranted reliance placed onpersonal experience and status in the constructionof medical authority is entirely consistent with itshistorical positioning as a modernist project. Otherobservers of EBM have argued that EBM actuallyconstitutes a retrenchment of, rather than an assaulton, clinical medical autonomy via its relocationfrom individual doctor to collective professionalbody (Armstrong, 2002; Denny, 1999).

Participants in debates about EBM within theprofessions rarely invoke concerns about the declineof trust in medical authority (in contrast to thesocial scientific analyses just cited) but they dofrequently allude to the economic implications andpolitical uses of evidence-based practice in order tojustify their positions. Many of the moral andpolitical issues associated with EBM are played outin this area, technically outside the explicit para-meters of EBM itself—that is, they concern thepossible uses to which EBM technologies such asmeta-analyses and systematic reviews can be put.Thus, evidence-based approaches have been criti-cised for providing healthcare management andorganisations with ammunition to cut costs ongrounds of insufficient evidence for certain healthinterventions; in the words of EBM’s own founders,that EBM is ‘perpetrated by the arrogant to servecost cutters and suppress clinical freedom’ (Sackettet al., 1996; also see Mykhalovskiy & Weir, 2004, onthe ‘political economy approach’). EBM proponentssuggest, conversely, that resistance to EBM amongclinicians on the grounds of preserving clinicalautonomy is potentially harmful to patients sincethese clinicians are primarily concerned to protect

their own reputations and profits. In these argu-ments both sides claim to represent the greater goodand the higher moral ground (see also Traynor,2000, who compares the writing style of ‘evidencebased movements’ to evangelical religious dis-course).

What counts as evidence in EBM?

My original intention in examining critiques ofEBM and responses to them was to explore under-lying notions of what actually constitutes ‘evidence’within EBM, beyond the definitions provided byexponents. The quantitative, essentially epidemio-logical definition of evidence used in EBM was mostoften identified as problematically restrictive incritiques classified as type 5 in Table 1—failure toconsider patient views. For although in evidence-based clinical practice the starting point for select-ing what population-based evidence is relevant isalways the individual patient (or ‘case’), patientnarratives are not themselves usually regarded as‘evidence’ within EBM. The apparent exclusion of‘patients voices’ especially in the form of ‘narra-tive’—a term often overextended in health carecircles to refer to interview-derived qualitativematerial on patients views or experiences ingeneral—has therefore been a particular focus ofcriticism. Alliances have developed between clin-icians, especially psychiatrists, and sociologists,social anthropologists, narrative specialists andother social scientists in opposition to the dom-inance of epidemiology in making up the ‘evidencebase’. Recent meetings on Medicine and Narrativein the UK convened by reputable bodies such as theDrugs and Therapeutics Bulletin and the BritishMedical Association have featured sometimes fer-vent denunciations of EBM as dehumanising andcalls for an explicitly resistant stance to EBM’sincursions in favour of the putatively gentler, morepatient-centred practice of ‘Narrative-Based Medi-cine’ (NBM).

Though some have argued that ‘narrative’ and‘evidence-based’ approaches to clinical practiceneed not be opposed, since EBM is itself inherentlyinterpretative and should incorporate ‘NBM’(Greenhalgh, 1999), the predominant attitude of‘NBM’ advocates toward EBM appears to beadversarial. Opposing EBM and NBM, however,necessarily implies accepting an epidemiologicaldefinition of ‘evidence’ as relating exclusively tothe findings of studies that appear in the Cochrane


Collaboration’s hierarchy of research designs; ifnarrative is ‘not-EBM’ it is not evidence. Thisposition relegates what patients say and how theirhealth carers respond to the murky realms ofinchoate experience (see also Littlewood, 2003, pp257–258) on how the, ‘‘narrative alone’’ emphasis inmedical anthropology’ implies that we have lostconviction in sociocultural realities and ‘must cedethese truth claims to our patients’ subjectivity’).More generally, this kind of difficulty implies that itis the methods used to collect ‘evidence’, rather thanthe nature of the evidence per se, that define whetheror not data are potentially applicable to evidence-based practice. Narrative is simply one form of non-quantitative material that could, in an alternative orexpanded representation, be construed as ‘evidence’.

The issue of what counts as evidence within aquantitative paradigm that accepts the randomisedcontrolled trial as the ‘gold standard’ is of particularrelevance for qualitative social scientists in generaland medical (social) anthropologists in particular.For paradoxically, over the same period that EBMhas grown into a dominant movement, medicalscience and public health have increasingly acceptedqualitative research approaches as legitimate stra-tegies for the acquisition of useful knowledge.Although interpretative understandings producedby qualitative work in health circles are valued,qualitative researchers in health are commonlyforced to argue for the legitimacy of their ap-proaches within the confines of an ‘evidence-based’framework. As qualitative and multidisciplinaryapproaches in medical, health services and publichealth research have become established, the drivetowards evidence-based practice has led to increas-ing weight being placed on the rigour and verifia-bility of the methods used rather than on thefindings themselves (cf. Eakin & Mykhalovskiy,2003). The emphasis on method is based onassumptions that are erroneous when applied toqualitative health research in general, tending toresult in superficial studies lacking in originality orinsight (Lambert & McKevitt, 2002; Williams,2001).

Moreover, the standardisation of qualitativeresearch method is being achieved in a matterstrikingly similar to the forms of standardisationthat EBM has brought to bear on clinical practice(described above as 4, the production of formulaicguidelines). In recent years there has been ananalogous proliferation of guidelines for conduct-ing, analysing, reporting on and appraising quali-

tative research (Giacomini & Cook, 2000a, b;Greenhalgh & Taylor, 1997; Mays & Pope, 1996)directed at health professional audiences and at theproducers of such research. Adherence to guidelinesincreases the likelihood of having work published inmedical and health care journals, despite the strongconstraints that requirements to demonstrate theuse of particular methodological approaches placeon research and, especially, on data analysispractices (Chapple & Rogers, 1998; Lambert &McKevitt, 2002). The publication of guides tocritical appraisal intended for health professionalsincrease the pressure to conform to a highlyspecified methodology for qualitative research,although these sometimes contain misleading orincorrect recommendations for evaluating the qual-ity of published studies (Barbour, 2001; Chapple &Rogers, 1998). This is problematic for manyvarieties of qualitative research style, includingethnography, solo (rather than team-based) re-search, and the use of data analysis techniques thatdo not include recommended methods such asdouble coding or grounded theory.

Considering qualitative ‘evidence’: The example of

anthropology

Ethnographic and other forms of anthropologicalresearch, for example, can plainly produceevidence just as much as the next RCT. Theproblem lies, rather, in the standards and criteriataken as authoritative in assessing the admissibilityand veracity of such evidence. In medical educationand practice, EBM reasonably requires the provi-sion of tools for appraising and interpretingevidence and these are currently formulated accord-ing to epidemiological criteria. In consequence itwould seem essential for social scientists engagedin health research to explicate the integrity andvalidity of their own approaches by elucidat-ing what constitutes ‘evidence’ in their own dis-ciplines. Notions of evidence remain implicit andunexamined in disciplines such as anthropology,however, although everyday disciplinary practices—evaluating a monograph, examining a PhD thesisor refereeing a paper based on ethnographicfieldwork—must of necessity draw on suchnotions. Applied anthropologists who work withother professions and disciplines are more usedto explicating and defending their disciplinarypractices than academic anthropologists whosecolleagues and audiences are primarily fellow


anthropologists. Nevertheless anthropology is soheterogeneous (or ‘eclectic’, Rapport & Overing,2000) methodologically that systematic evaluationof anthropological research findings based on themethods used is, as indicated in the previoussection, highly problematic. Anthropologicalknowledge is generally agreed to be experiential,context-specific, intersubjective and reflexive, andanthropologists are not comfortable, disciplinarilyspeaking, with providing any kind of mundaneaccount of how they agree on what they know.Clearly however, evidence is about making certainclaims as much as it is about representations; failureto consider seriously what the generic nature ofanthropological evidence might be forestalls en-gagement with the notions of science and truth thatunderpin evidentiary thinking in the health profes-sions and disciplines. This failure prevents anthro-pology from making such claims, even while itsdisciplinary practices and insights are in increasingdemand within fields in which such ‘evidence’ isvalued—albeit judged by the terms of the dominantdiscipline (hence the demands for methodologicalsystematisation described in the previous section).The time may now be right, however, to re-engagewith basic epistemological questions regarding thevalidity of anthropological knowledge claims andthe plausibility of ethnographic accounts see (Des-cola, 2005; Wilson, 2004), laying the grounds for anexamination of what counts as evidence in anthro-pology.

Future trajectories for EBM: Structural influences

and contextual dimensions

The main reason for taking seriously whetheranthropological and other qualitative material can,by its nature, be admitted into evidence withinhealth research, is to correct, or contest, thecomposition of the current evidence base. Whatstrikes many social scientists as obviously lacking indescriptions of research evidence as representedwithin EBM (for example Fig. 2), is a place for—oreven acknowledgement of—social structural influ-ences and social, cultural, political and economicdimensions, despite their critically important role indetermining health status and outcomes. This maybe especially the case with respect to decision-making regarding public health and health serviceinterventions, since here the informal sociologicaland cultural contextual information that manyclinicians hold about their individual patients when

practising EBM in clinical settings is not available.This is another aspect of the limitation described atthe beginning of this paper (denoted as 2 in Table 1)as the individualist bias inherent in EBM para-meters for evidence that affects information-gather-ing on such interventions.

Consistent with my portrayal of EBM as flexibleand assimilationist in responding to critiques thatidentify limitations to its approach, some intriguingpreemptive gestures have already been made to-wards the future possibility of incorporating socialand institutional dimensions into EBM. A recenteditorial from the McMaster group (Haynes et al.,2003) notes that the ‘new’ model (Fig. 2) does havelimitations, ‘For example, we have not included theimportant roles that society and health careorganisations play in providing and limiting re-sources for health services. Rather our focus haspurposely been on the decisions made by patientsand their immediate healthcare providers, leaving

the bigger picture for another discussion.’ (2003, p.38, my emphasis).

If my analysis of the encompassing strategies ofEBM, seen as a ‘social movement’ (Pope, 2003), iscorrect, incorporation or at least attempts toincorporate less tangible forms of evidence thanthat of trials results is inevitable. Implicit bound-aries for defining evidence have not, as yet, beenredrawn, nor have practices substantively altered.Recent initiatives suggest movement in this direc-tion however, including the establishment of aCochrane Collaboration working group on qualita-tive research and several studies examining methodsfor synthesising qualitative evidence (Campbellet al., 2003; Dixon-Woods, Agarwal, Young, Jones,& Sutton, 2004; Dixon-Woods, Fitzpatrick, &Roberts, 2001).

Many others in addition to those directlyinvolved in these initiatives see such redefinition asdesirable (e.g. Barbour, 2000; Green & Britten,1998; Rycroft-Malone, et al 2004; Upshur, Van-DenKerkhof, & Goel, 2001), with qualitativemethods helping ‘to broaden the scope of evidencebased medicine’ (Green & Britten, 1998). Similarly,many advocates of narrative-based medicine andevidence-based patient choice argue that patients’narratives, or doctors’ accounts of patients’ experi-ences, are forms of evidence that should be includedin decision-making. It is one thing, however, toargue that ‘in the debate about evidence basedmedicine, it is vital to reiterate that good ‘‘evidence’’goes further than the results of meta-analysis of


randomised controlled trials’ (Green & Britten,1998, p. 1231) and another to promote incorpora-tion of non-statistical research findings into EBM.Given the methodological barriers to identifying,appraising and synthesising relevant qualitativematerial and the underlying epistemic distinctionsbetween, for example, anthropological and epide-miologic knowledges, it is difficult to envisage areformulation of ‘evidence’ that would be bothacceptable and truly satisfactory to either profes-sional activity.

Alternatively, Berkwitz has proposed trainingphysicians in what he terms a ‘social model ofcriticism’ (to contrast with EBM’s use of ‘criticalappraisal’, which refers to the evaluation of researchpapers in purely methodologic terms) that wouldenhance their ability to recognise the social andcultural forces shaping research activities, theselection of evidence and the resulting decisionsand policies (Berkwits, 1998). A third alternative toredrawing EBM’s boundaries to accommodatesocial structural and cultural dimensions of medicalpractice through the incorporation and synthesis ofnon-quantitative material is instead to segregatethese dimensions (as argued for the case of mentalhealth nursing by Geanellos, 2004). It would bepossible to confine EBM as a set of techniques andpractices squarely to the deployment of statisticalmeasurements of outcome derived from populationresearch; and to insist on the framing of suchrigorously bounded formulations by social andcultural research evidence, in order to assess theveracity and relevance of these formulations in realworld contexts. This scenario could be the mostattractive to those researchers and clinical practi-tioners who recognise the need to ensure quality andveracity by adhering to disciplinarily variant stan-dards of research integrity.

My analysis of EBM’s short but consistenthistory of incorporation and self-modification toencompass alleged limitations, however, indicatesthat this may be the least likely trajectory for EBMto take. Recent discussions of the ethical dimensionsof EBM (reflecting the growing emphasis onbioethics generally) in the medical literature, bothsuggest an emergent sixth category of EBM critiqueand response, and provide additional support formy analysis of EBM’s evolutionary orientation astending toward assimilation rather than retrench-ment. Whatever its future course, as EBM becomesinstitutionalised in health care it must inevitablyaffect the research work, methodological orienta-

tion and publishing practices of all disciplines alliedor applied to medicine. This paper has consideredthe cases of qualitative research and of anthropol-ogy to exemplify possible limitations and transfor-mations in EBM’s further evolution, but myaccount is also salient for other cognate disciplines,such as the basic sciences (Lemon & Dunnett, 2005).Whether EBM’s remarkable assimilationist tenden-cies are capable of encompassing research findingsemerging from investigative activities rooted infundamentally divergent epistemologies, remainsto be seen.

Acknowledgements

I am grateful to participants in the 2003 Amer-ican Anthropological Association panel on Evi-dence-Based Practice that provided the initialimpetus for this paper and particularly to mydiscussants, Robert Hahn and Deborah Gordon. Ialso thank Libby Bogdan-Lovis, George DaveySmith, Elisa Gordon and the Social Science andMedicine manuscript reviewers for their usefulcomments on an earlier draft of this paper.

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Accounting for EBM: Notions of evidence in medicine

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