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Introduction

Introduction: Gift horse or Trojan horse? Social scienceperspectives on evidence-based health care

Over the past decade and a half since theinception of evidence-based medicine (EBM), evi-dence-based approaches have come to play anincreasingly important role in many national healthsystems, not only in guiding clinical practice butalso in shaping research agendas, formulating policyand allocating financial resources. In many healthcare settings, EBM—which began as ‘clinicalepidemiology’—has come to be equated with ‘bestpractice’ and is increasingly assuming a position ofsymbolic authority in clinical decision-making. Theseemingly incontestable principle that clinical prac-tice be based primarily on the best availableresearch evidence is now being applied across alldomains of health care delivery, from nursing,social work and midwifery to psychiatry and publichealth. EBM now encompasses not only practi-tioners’ efforts to garner pertinent research evidenceand apply it to the resolution of clinical problems,but also a broader panoply of associated activities inthe health sector, from the production of ‘evidence-based guidelines’, through ‘evidence-based decision-making’ about the use of new and old treatments, tothe promotion of ‘evidence-based patient choice’. Inkeeping with such usage, in this Special Issue ofSocial Science & Medicine we treat the acronym as abroad gloss for all evidence-based activities withinthe health sector.

In this introduction, we provide some back-ground to the contents of this Special Issue byoutlining briefly the key components and attendantassumptions of evidence-based approaches to healthcare, and summarise the main advantages andlimitations of this approach according to itschampions and detractors. We then offer a synopsisof each paper before reflecting on the intersectingthemes, topics and implications for social science

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understandings of EBM that emerge from thecollection as a whole. The Special Issue originatedin two conference panels convened independentlyby the present authors. In 2003, Elizabeth (Libby)Bogdan-Lovis and Elisa Gordon, together withKate Bent, convened a panel on, ‘Gift horse orTrojan horse?: Evidence-based Practice Transform-ing Medicine’ at the American AnthropologicalAssociation annual meetings, while Helen Lambertorganised a panel entitled, ‘Anthropology andMedical Science: Notions of Evidence’ for the2003 UK Association of Social Anthropologists’Decennial conference. This Special Issue includes aselection of the papers originally presented on thoseoccasions.

One key feature of EBM is that the ‘evidence’upon which evidence-based approaches in medicineand elsewhere in the health sector rely is essentiallyepidemiological and comes primarily in two char-acteristic forms: the systematic review and itsrefined subspecies, the meta-analysis. The CochraneCollaboration exemplifies international efforts togenerate evidence and provides something of amodel for other EBM researchers to work with.This endeavour relies on the voluntary collabora-tion of individuals to generate systematic reviews ofresearch studies that evaluate therapeutic effective-ness. Scholars engaged in generating systematicreviews assiduously attempt to collect and appraiseall relevant studies of a particular treatment,regardless of national origin or language of pub-lication, using a standardised ‘Hierarchy of Evi-dence’ that ranks ‘evidence’ according to thereliability and verifiability of the epidemiologicalresearch design used, from randomised controlledtrials at the top to physicians’ anecdotal reports andcase studies at the bottom. Systematic reviews thus

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seek to provide strict comparability across differentsets of research data by applying putatively uni-versal appraisal criteria to them. In a furtherrefinement, meta-analyses and meta-regression aimnot just to collate, compare and evaluate but also tosynthesise primary data across studies via specificstatistical operations that are designed to compen-sate for the small sample sizes of some studies andto identify bias introduced by selective publicationof positive findings and other potential systematicbiases. Meta-analyses are intended to harness thepotentially greater statistical power of larger num-bers through combining studies in order to arrive ata more reliable overall assessment of the trueeffectiveness of each therapeutic intervention. Afurther goal can be the detection of situations inwhich reliable evidence is currently not available, tostimulate further research in these areas.

EBM—in the broad sense described above—hasgrown rapidly in international prominence over thepast decade as a means of ensuring that health careprofessionals provide effective and efficient care andthat public health interventions are demonstrablyeffective before they are funded and implemented bygovernmental authorities. Governments worldwideare relying increasingly on EBM databases toestablish health policy, and international healthorganisations are making growing use of evidence-based approaches to formulate cross-national re-commendations for health policy and practice. Akey reason for the attractiveness of EBM to policymakers and practitioners is that the evaluativeprocess outlined by an evidence-based approachpermits a certain measure of transparency, allowingothers to critically examine the steps employed andthereby lending itself to accountability. Further, itholds out the promise of providing a reliable,objective means of informing decision-makingabout resource allocation, by determining whichtherapeutic interventions have been shown to bemost effective. Given such promise, most healthcare providers understandably tend to see EBM as a‘gift horse’ that offers obvious benefits and shouldnot be too closely or critically examined beforebeing accepted and put to work.

Associated with this rapid uptake and the keeninterest in EBM among those in the healthprofessions has been the development of a vastliterature on evidence-based medicine and practice.This literature, however, generally reflects theefforts and perspectives of those working fromwithin the field—representing best those who

champion its merits from the standpoint of epide-miology and those who critique it from thestandpoint of clinical medicine. Relatively fewcommentators have taken a social science, and evenfewer an anthropological approach, to analyzingsome of the tacit assumptions underlying EBMtheory and practice (but for social scientific work onEBM, primarily from a sociological viewpoint, seeArmstrong, 2002; Denny, 1999; Mykhalovskiy,2003; Mykhalovskiy & Weir, 2004; Pope, 2003;Rappolt, 1997; Sinclair, 2004; Timmermans & Berg,1997; Traynor, 2000, and contributors to a SpecialIssue of Health (Vol.7, No. 3, 2003) and eightannual thematic editions of the Journal of Evalua-

tion in Clinical Practice devoted to EBM). Yet,examining the substance and processes of this ill-defined but highly influential approach to healthcare, uncovering the social, political and ideologicalcurrents that affect the development, delimitation,use and implementation of EBM, and exploring theconsequences for health care providers, users andresearchers in the health sciences, merits criticalattention. For EBM constitutes a profound chal-lenge to the ways in which established health careprofessions, such as clinical biomedicine, impartknowledge to new members and maintain profes-sional autonomy.

The EBM approach challenges earlier conven-tional medical wisdom that clinical expertise isanchored in sound, objective science. EBM suppor-ters emphasise the fact that, historically, objectiveevidence of effective outcomes has often beensecondary to apprenticeship, precedent, intuition,expert opinion, and custom in guiding medicalpractice. EBM, by contrast, is a practice that placesthe highest value on secondary ‘evidence’ drawnfrom epidemiological research. More specifically,EBM privileges randomised controlled trials(RCTs) and, due to its reliance primarily oncritically appraised systematic literature reviewsand secondary meta-analyses of trials data, thisparticular research design has become paradigmaticfor medical knowledge production. The resultingevaluative information can be used to guideindividual clinical judgements, establish clinicalpractice guidelines and evaluate practice. Mean-while, the information technologies (such as web-based information databases and search engines)that make EBM possible allow clinical practiceto be monitored and overseen at multiple levelsof authority. Health care purchasers, includinggovernments, health care trusts, insurers and

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consumers, can potentially hold care providersaccountable for their clinical decisions. Accord-ingly, this approach fosters greater attentiveness toand thus oversight and control of the clinical, socialand structural factors contributing to poor or goodhealth outcomes.

In effect, EBM has considerable potential toimprove health outcomes efficiently—the ‘gift horse’to health care systems of our title. In other respects,however, EBM brings with it possibilities forintroducing—in the covert manner of a ‘Trojanhorse’—various undesirable features into healthcare systems, and we now delineate these. First,the potential loss of professional autonomy ensuingfrom the adoption of evidence-based approachesand the associated displacement of individualclinical judgement from the heart of clinical practicehas given rise to particular disquiet among healthprofessionals. Secondly, implementing population-based treatment guidelines has given rise to ethicaland clinical concerns as to whether individualpatients will receive the best care for their particularneeds. Furthermore, EBM may act as a manage-rially useful brake on public provision of health careinterventions, as well as a means of standardisingthe effectiveness and, to some extent, the quality ofwhat is provided. Purchasing authorities can controlcosts by limiting the availability of interventionsaccording to the extent to which ‘evidence’ (definedin clinical epidemiological terms) is available tosupport the provision of particular interventions forspecific patient populations. Evidence-based ap-proaches are increasingly used to justify resourceallocations including reductions in expenditure, andto control professionals’ prescribing practice, ratherthan to support patient choice. In the US, managedcare organisations are devising EBM guidelines inorder to contain costs, the assumption being thatclinicians who follow guidelines will neither over-treat nor undertreat.

Finally, not all diseases and clinical interventionshave been or can be studied by an RCT. The unevenavailability of such research ‘evidence’ can give riseto bias within biomedical policy and rationingdecisions by favouring those types of clinicalinterventions for which the best RCT data exist.By their design, complex and population-basedinterventions (such as nutritional supplements forpre-school children from low-income families) areless likely to be substantiated by evidence fromclinical trials than simple, individual treatments(such as a new drug).

Hence, the enhancement of accountability andtransparency in health care decision-making that isapparently produced by the adoption of evidence-based approaches may be offset by the introductionof systemic bias that favours the production ofcertain types of research data. This difficultybecomes even more acute when a requirement toproduce ‘evidence’, defined in clinical epidemiolo-gical terms, is applied to other medical systems andmedical traditions—alternative, complementary ortraditional—which are based on rather differentknowledge paradigms and understandings of evi-dence. Patients’ views of ‘what works’, moreover,often differ from those of researchers and practi-tioners, and particular tensions arise in attemptingto combine, or balance, evidence-based approachesto health care with the views and preferences ofpatients receiving health care. EBM thereby raisesquestions about what constitutes clinical knowledgeregarding therapeutic efficacy; whether such knowl-edge can derive from data that are perceived to be‘subjective’ or ‘inter-subjective’ as well as from thoseregarded as ‘objective’; and how evidence is defined,and by whom.

This Special Issue addresses the phenomenon ofEBM (variously identifiable as a movement, apractice, a paradigm, a methodology, an innovationand a regulatory system) from a social scienceperspective, in order to provide new insights intowhat has become a dominant approach in con-temporary health policy and clinical practice.Between them, the papers in this issue investigatemany of the component constructs, processes andprocedures that comprise EBM and practice. Theseinclude the development of evidence-based guide-lines; the use (and non-use) of such guidelines inclinical practice; the production of research evidencefor new and existing health care interventions; therelationships between the production of evidence,and the diffusion and adoption of medical innova-tions; the formulation of related health policy andsupporting legislation; the measurement and inter-pretation of therapeutic effectiveness; and the verydefinition of ‘evidence’ itself.

The first two papers examine notions of evidencewithin EBM from, respectively, philosophical andanthropological perspectives. Maya Goldenbergdraws on recent currents in the philosophy ofscience to demonstrate that EBM’s construct of‘evidence’ draws on positivist philosophy withoutbenefit of more recent phenomenological andfeminist critiques that, together with social studies

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of science and technology, have effectively decon-structed the notion of classical scientific enquiry aspolitically disinterested and objective [ref. to articlein this issue]. She argues that the notion of EBM isappealing precisely because the evidence it promotesas the basis for decision-making is represented asvalue-free ‘fact’ rather than as the product ofcomplex interpretation. A positivist approach, farfrom being fully objective, simply obscures thealways-present subjective elements of scientificenquiry. Goldenberg’s paper also points to theinability of EBM approaches that rely on theestablished ‘hierarchy of evidence’ to providepatient-centred care, since this epidemiologicallybased hierarchy does not incorporate subjectivedimensions of ill health.

Her consideration of the potential for an ‘inte-grated’ model of evidence and the need for areconfiguration of biomedicine’s goals is taken upmore fully in Helen Lambert’s paper, whichanalyses the debates about and criticisms of EBMemanating from within the health professions inorder to uncover its mutable character [ref. to articlein this issue]. Tracing the recent historical trajectoryof medical education to reveal EBM’s foundationsas a pedagogical innovation, Lambert situates thedowngrading of medical authority and clinicalexpertise that characterises EBM as part of abroader trend towards accountability in publicservices. Many ‘internal’ critics of EBM as well asother contributors to this Special Issue have arguedthat the current formulation of ‘evidence’ withinEBM is too narrow. Lambert points out how EBMproponents respond to such arguments by adap-tively incorporating these critiques into the verystructure of EBM, thereby rendering EBM an evenmore powerful tool for legitimisation of clinicalpractice. She also considers the constraining effectsthat EBM’s evidentiary requirements have had oncontributory disciplines to the health sciences suchas anthropology. Her paper assesses the positiveand negative implications of recent attempts toincorporate into the evidence base more qualitativeassessments of ill-health and well-being so as to takeinto account social and cultural influences onhealth.

One serious limitation of evidence-based ap-proaches as they are currently formulated is raisedwith particular clarity by the subsequent twopapers, which address the question of ‘‘evidence’’and the implications of EBM from the viewpoint ofother medical traditions. By considering the ques-

tion ‘evidence of what?’ from a vantage pointexternal to biomedicine, both highlight the issue oftherapeutic effectiveness and its measurement as acentral interrogative of evidence-based approaches.Christine Barry’s paper discusses integration ofcomplementary and alternative medicine (CAM)into the UK’s National Health Service (NHS),suggesting that the call for adequate evidence ofeffectiveness to justify or support the incorporationof CAM into a State-funded health system is, atleast in part, political [ref. to article in this issue].Primary Care Trusts and other representatives ofthe biomedical establishment demand evidence as agate-keeping strategy intended to protect profes-sional territory and status from alternative practi-tioners. Alternative practitioners, commensurately,desire evidence of effectiveness that is acceptable tothe health policy community in order to bolstertheir case for State funding of alternative therapies.There are clear resonances, in NHS fundholders’requirements for evidence to justify expenditure,with Gordon’s observation that the more costly theproposed intervention, the stronger the evidencethat US legislators require [ref. to article in thisissue]. Barry’s paper goes on to consider directly thefundamental question of what, in these debates,counts as evidence. The evidence required fromCAM practitioners to validate their therapiesamong NHS policy makers and practitioners mustbe of a kind that conforms to EBM paradigms(namely, quantitative, amenable to statistical ana-lysis and comparison and ideally derived fromrandomised controlled clinical trials). CAM practi-tioners and many of their patients, however,commonly take other types of data, such asindividual embodied sensations, transformations inidentity, inter-subjectively produced observations,and shifts in micro-social environment, to beevidence of therapeutic effectiveness.

Of course, construing embodied experiences orpersonal observations as evidence is not confined toadherents of alternative medicine and, according toBarry, anthropologists; the experiences of users ofbiomedicine also frequently differ from biomedicalcriteria of efficacy. This difference between ‘evi-dence’ as construed from within the EBM para-digm—the necessarily quantifiable measurement oftherapeutic efficacy through standardised and con-trolled comparisons—and that of users is theprimary source of the tension between EBM and‘patient-centred’ approaches to which several papersin this Special Issue refer. As Barry notes, the kinds

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of experiential changes that many alternativepractitioners and their patients take as evidence ofwhat ‘works’ are not even measured within clinicaltrial research, which tends to confine relevant datafrom patients to quantifiable (and strictly compar-able) indicators of relief from physical symptoms.

Harish Naraindas’s case study of a singleAyurvedic practitioner and her patients offersanother perspective on the question of therapeuticefficacy [ref. to article in this issue]. His paperprovides further evidence of the lack of fit betweenbiomedical measurements which count as the onlylegitimate evidence of effectiveness in EBM, andpatients’ and alternative practitioners’ understand-ings of what works. Moreover, the comparisonbetween the scenario described by Barry for CAMin a UK setting and the Ayurvedic practicedescribed by Naraindas in southern India isparticularly illuminating. Naraindas’s practitionerhas chosen to adhere unflinchingly to a puristversion of Ayurveda rather than to offer the moreeclectic type of clinical practice embracing biome-dical principles that is favoured by many contem-porary college-trained Ayurvedic practitioners. Thisvaidya’s well-educated, socially elite patients derivetheir conceptual orientation to the body and healthfrom a conventional biomedical perspective, suchthat they are accustomed to having the sort ofevidence of effectiveness that is provided bybiomedical tests. Rather than content themselveswith the experiential evidence supplied by their ownsubjective perceptions of improvement or treat astruly authoritative the Ayurvedic medical knowl-edge held by their practitioner, they continue torefer—at least conceptually—to scientific evidencefor proof of the therapy’s effectiveness. Naraindasargues that these patients have been unable toundergo the ‘fundamental cognitive shift’ to em-brace the alternative medical paradigm (and itsnotions of evidence and knowledge) that Barryconsiders to occur among more committed patientsof homeopathy in England. Moreover, while Barryasserts that the patients least able to accept thedifferent underlying therapeutic principles of ho-meopathy were the ones who failed to benefit muchfrom it, several of Naraindas’s patient informantsstruggled to reconcile their own subjective experi-ence of benefit (relief from illness) with the lack ofany objective evidence that their treatment had‘really’ worked (remittance of disease).

While these four papers analyse, from verydifferent angles, how ‘evidence’ and its main

referent (therapeutically produced improvement inhealth status) are conceptualised within evidence-based (bio)medicine and the effects that an expecta-tion to conform to these constructs has on differentmedical traditions, the fifth paper in this SpecialIssue shows the effect this model of evidence haswhen applied to a core EBM activity. A key elementin the translation of research ‘evidence’ into‘evidence-based’ clinical practice is the constructionof accessible clinical, or practice, guidelines (proto-cols, algorithms) for use by clinicians or otherrelevant health care providers; the next two papersin this Issue investigate the construction andutilisation of such guidelines, respectively. GailLandsman’s paper provides an insider’s account ofthe process of formulating ‘evidence-based’ clinicalpractice guidelines for physical therapy provisionfor disabled children in New York State [ref. toarticle in this issue]. Her case study points out howadherence to the conventional hierarchy of evidencein the preliminary search for relevant evidence ofeffectiveness led other forms of potentially relevantknowledge and information in this field—includingmothers’ and professional carers’ intimate observa-tions of individual children—to be excluded fromthe available evidence base. This selectivity deprivedthose constructing the guidelines of potentiallyhighly relevant evidence and forced them intoundue reliance on a combination of the limitedRCT data that were available and ‘panel consen-sus’—the very kind of expert opinion that EBM wasoriginally developed to circumvent.

Elizabeth Bogdan-Lovis and Aron Sousa con-sider a different scenario associated with guidelines,in which the problem is not lack of sufficientevidence or of inappropriate constraints on whatcounts as evidence but rather of insufficient utilisa-tion of the ample evidence available to legitimisepractice [ref. to article in this issue]. Their paperreports research into US Certified Nurse-Midwives’understanding and utilisation of evidence-basedprotocols in their work. Although available inter-national evidence from research supports a mid-wifery model of care as having better outcomes thana medical (obstetrician-supported, technology-in-tensive) model, the paper shows how midwives inUS hospital settings rely relatively little on thisevidence to defend and support their practice. Thisapparent paradox is explained by reference toseveral features of the broader structural andcultural context in which these midwives prac-tice. US health care financing arrangements and

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consumer preference alike both favour technologi-cal intervention and there are no incentives foradhering to (low-tech, non-interventionist) evi-dence-based practice in birth management, whileexisting hierarchies of authority that give greaterpower to physicians than to midwives limit thediffusion of EBM in this sphere. The paperillustrates with particular clarity how the availabil-ity of evidence does not, in reality, guarantee bestpractice but remains subordinate to the relativeauthority of the user of such evidence within localpower hierarchies.

Continuing this theme, Raymond De Vries andTrudo Lemmens put flesh on the bones of Gold-enberg’s assertion [ref. to article in this issue] thatthe putative objectivity of EBM masks (alwaysunavoidable) social and political influence, by wayof two case studies that demonstrate the influencesof social structural arrangements and culturalcontext on medical research [ref. to article in thisissue]. Using the example of industry-fundedpharmaceutical research, they show just howextensively commercial interest has come to shapethe evidence produced through clinical trials,through influence at every stage from the selectionof what research to conduct through to whichresults get published and publicised. In turn, theysuggest, the use of trial results as marketing toolsdiminishes public trust in the integrity and auton-omy of medical science. Their second case studyshows how data-gathering and the evaluation andpublication of evidence are similarly shaped bydominant cultural assumptions, in this case thegeneral public view of midwife-led childbirth in theNetherlands as safe and effective, versus high-technology hospital-based obstetric culture thatviews home birth as needlessly risky. Reflectingalso on publication bias, they conclude that main-stream obstetric science follows mainstream obste-tric practice, with studies being generated tosubstantiate whichever view of birth (generallynormal and rarely requiring intervention, or gen-erally risky and requiring technological monitoringand intervention) prevails in everyday practice. Thestartling assertion that science follows practiceinverts the core assumption of EBM, namely thatscientific research should and does lead practice andis neatly substantiated by Bogdan-Lovis and Sou-sas’ demonstration [ref. to article in this issue] thatin the US context—where obstetrics dominateswithin an interventionist-favouring culture ofbirth—the strong evidence base available to support

midwife-led, low-technology birth remains largelyignored and ineffective in shaping practice.

If Bogdan-Lovis and Sousas’ paper illustrates thenon-use of available evidence in guiding practice,Elisa Gordon’s contribution demonstrates how evenwhat is required as evidence may be politicallydetermined [ref. to article in this issue]. Gordonexamines the (non-) uses of evidence in policy-making, through a case study of the politics aroundpending US legislation to provide Federal insurancecoverage for daily, rather than the current thrice-weekly, haemodialysis for patients with end-stagerenal disease. The paper shows how judgements asto what constitutes ‘good enough’ evidence tounderpin a policy decision vary according to thepolitical and economic positions of decision makersand that in general, the more expensive theimplications of a new treatment, the more sub-stantial the ‘evidence’ required for it to gainlegislative approval. Gordon’s paper also points tothe ethical dilemmas embedded in evidence-basedpolicy-making. Introducing a new treatment thathas not been sufficiently tested is potentially riskyand hence unethical. However, some advocatesargue that introducing such a treatment withoutwaiting for RCT results to come in, given a body ofinternationally generated observational evidence ofbenefit, enhances patient choice and is thereforeethically appropriate.

This second group of papers, then, offers apowerful critique of current assumptions withinEBM circles, namely that the underlying principlebehind EBM is well accepted but that more work onthe packaging and dissemination of clinicallyrelevant evidence is needed to render it readilyusable by practitioners. If these authors’ observa-tions are correct, then the barriers to implementingand adopting evidence-based practice are far moresubstantial than a practitioner’s lack of time orinclination to read medical journals, or inadequatetraining in critical appraisal skills. While EBM haspresented itself as a challenge to practice-basedconventional medical authority, our contributorssuggest some areas in which systemic bias in the wayevidence-based research operates is likely to tendtowards conservatism. Thus, the papers by Lands-man and Gordon indicate that the bar tends to beset higher for evidence requirements of novelapproaches to treatment than for established ones,producing a structural bias towards the latter,particularly where evidence is lacking. De Vriesand Lemmens, and Bogdan-Lovis and Sousa point

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to the possibility that practice guidelines andevidence-based recommendations are likely to havean impact on clinical practice only where a contextfor implementation is already relatively socio-politically favourable. Moreover, these contributorsshow how contexts shape not only which evidencecomes to be selected from an existing evidence baseto inform policy and practice, but also the veryproduction of evidence through primary research.Their material suggests that institutional researchagendas (as expressed for example in calls fromfunding agencies or drug companies’ investmentstrategies) are themselves partially determined byprevailing socio-political environments, so that thekinds of evidence produced are in turn more likelyto be broadly commensurate with existing practicethan to indicate entirely new directions.

While these papers demonstrate how social,cultural and political milieux influence both theselective utilisation of existing evidence for guidingclinical practice and the production of researchevidence itself, other contributors point to theselective framing of what counts as evidencethrough EBM procedures. Goldenberg’s analysisnotes that the selection of theory to investigate aphenomenon is inevitably related to a scholar’s ownbiases. As Landsman, Barry and Naraindas show,inclusion into EBM frameworks of only thosestudies that are based on conventionally acceptedand institutionally sanctioned theories—i.e., biome-dical ones—limits the potential impact of evidencebased on alternative theories of appropriate treat-ment. Landsman’s article highlights, for instance,how parents of disabled children hold goals oftherapy that are driven by a theory of humandevelopment which cannot readily be studiedthrough a trial design and for which ‘evidence’ is,in the conventional EBM sense, therefore lacking.Barry and Naraindas similarly found that the goalsof alternative medical traditions delineate certaintypes of outcome and kinds of evidence ofeffectiveness that do not always coincide with abiomedical definition of acceptable evidence. Botharticles reveal how new and non-conventionaltreatments may aim to produce outcomes that arevalued by patients but that currently either are notor cannot be investigated through biomedical studydesigns. Research findings produced using otherdesigns are excluded as evidence of effectivetherapies in EBM reviews.

The international differences in health carepractice and policy highlighted by this collection

of papers provide further illustration of the culturaland structural shaping of how data are interpretedas evidence according to context and the currentlimits to EBM as a universal, transparent endea-vour. De Vries and Lemmens, Bogdan-Lovis andSousa demonstrate the differential emphasis placedon midwifery in The Netherlands versus the USA(and other developed countries), despite the readyavailability of evidence for midwifery as the mosteffective approach to childbirth and the purporteduse of EBM approaches in US hospitals. Gordondescribes how daily haemodialysis is routinelyprovided in Canada and some European countriesbased on plentiful observational data, while the USrequires additional RCT data before supporting it.The contributions of Barry and Naraindas point upthe profound differences in the receptions accordedto non-biomedical therapies in the historicallydistinctive settings of England and India, bothcountries in which biomedicine is now institution-ally and socially dominant and other (alternative orindigenous) therapies are State-funded to a lesserextent.

Several other themes recur through this collectionof papers: dissatisfaction with the disregard of‘observational data’—if we take this to includeindividual observations of patient cases by qualita-tive researchers, practitioners, and lay persons suchas family members—in the EBM paradigm (Lands-man, Gordon, Lambert); the ethical dilemmasinherent in combining or balancing evidence-basedapproaches with patient preferences (Bogdan-Lovisand Sousa for clinical practice; Gordon for policy-making); the misleading and potentially distortingnature of the RCT (De Vries and Lemmons, whopropose that paradoxically, the very requirement toconduct randomised controlled trials has become auseful source of commercial leverage for pharma-ceutical companies; Gordon, in whose case studythe pending results of an RCT provide an excuse fordelaying legislation that might incur greater short-term costs; Barry; and Goldenberg); and of course,the definition and substance of ‘evidence’ itself(Lambert, Goldenberg, De Vries and Lemmens).

In sum, the articles in this Special Issue present anovel analytic perspective on EBM by considering theorigins, nature, application, uses and consequences ofevidence-based approaches in contemporary healthcare. Collectively they demonstrate how the notion of‘evidence’ is socio-culturally constructed and how thevariable power and authority of different stake-holders (patients, midwives, qualitative researchers,

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obstetricians, nephrologists, policy makers, parentsand so forth) affect their roles in the production anddetermination of the parameters for what counts asevidence. In asking fundamental questions about theassumptions lying behind EBM—evidence of what,and according to whom?—the contributions to thisSpecial Issue illustrate how what counts as evidence isa matter of legitimation as well as methodology. Theydemonstrate in a variety of ways how reliance onestablished EBM definitions of evidence in guidelinedevelopment and clinical practice may very well havemerit, but it can also potentially be reductionist,resulting in apparently robust recommendationsbased on knowledge that is actually partial andincomplete and that excludes the qualitative knowl-edge produced by much social science scholarship.While appearing to displace the socially exclusive,status-based authoritative knowledge of biomedicalclinicians with a more universally accessible, unbiasedmethodology for appraising all forms of therapy,EBM may instead entrench biomedical power due tothe evidentiary criteria that it employs. Thus, while itprovides a potentially invaluable means of ensuringtherapeutic effectiveness and clinical accountability,as many papers in this Special Issue reveal, EBM canreadily be used as a tool for political and sociallegitimisation of professional standing and treatmentpractices. Ultimately, the contributions that followshed light on the need to balance the potentiallydemocratising effects of adopting an evidence-basedapproach with critical attention to the exclusionarypotential of EBM, as currently formulated, indelineating what types and sources of data count aslegitimate forms of evidence.

Acknowledgements

We thank Henry Barry and George Davey Smithfor their readings of an earlier draft of this paperand the participants and discussants at the 2003conference panels, from which this Special Issuederives, for their helpful contributions.

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Helen LambertDepartment of Social Medicine, University of Bristol,

Canynge Hall, Whiteladies Road,

Bristol BS8 2PY, UK

E-mail address: h.lambert@bristol.ac.uk

Elisa J. GordonNeiswanger Institute for Bioethics and Health Policy,

Rm. 280, Stritch School of Medicine, Bldg. 120,

Loyola University Chicago, 2160 South First Avenue,

Maywood, IL 60153, USA

E-mail address: egordo1@Lumc.edu

Elizabeth A. Bogdan-LovisCenter for Ethics and Humanities in the Life

Sciences, C 221 E. Fee Hall, Michigan State

University, East Lansing, MI 48824, USA

E-mail address: bogdanlo@msu.edu