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Medicine and evidence: knowledge and action in clinical practice

2007; Wiley; Volume: 13; Issue: 4 Linguagem: Inglês

10.1111/j.1365-2753.2007.00923.x

1365-2753

Andrew Miles, Michael Loughlin, Andreas Polychronis,

Healthcare cost, quality, practices

This issue of the Journal of Evaluation in Clinical Practice is the 10th Thematic Edition charting the evolution and development of the evidence-based healthcare debate [1–10]. Through it, we contribute a further and substantial set of scholarly articles to the international medical literature, with the aim of improving clinical and scientific understanding of the nature of evidence for clinical practice and how such evidence, properly defined, gathered and understood, can be directly employed as part of the working knowledge necessary for the making of sound clinical decisions by the 'good doctor', acting with and for his individual patient. The Journal has gained a pre-eminent international reputation for ensuring that the concepts and precepts of the EBM movement, given their extraordinary nature and profound implications for the exercise of effective clinical practice, remain subject to intensive intellectual and clinical inquiry. In having taken this approach over some 13 academic volumes of publication, the JECP has not only contributed substantially to the EBM debate, but has also actively shaped it, having had a major effect on its claims and direction. The journal's work in this context will move forward with increasing vigour through 2008 and beyond, with the aim of leading the international debate towards an intellectual resolution of the many illogicalities and inconsistencies of EBM which continue to remain clearly in evidence. In the editorial introduction to the previous thematic edition [10] we remarked upon the one-sided nature of the EBM 'debate' in mainstream medical literature, the predominance of 'pro-EBM' viewpoints and the increasingly marginalised nature of any criticism of EBM. We invited anyone who believed this debate to have now been 'settled' to write to us explaining the precise time and manner of its intellectual resolution. As yet we have received no reply, yet the ever-expanding EBM literature remains awash with references to the undoubted superiority of the EBM 'approach', 'paradigm', 'methodology', 'philosophy', 'system' and 'process' (all of these terms were used to characterise the nature or 'essence' of EBM in the same paper[109] by an EBM protagonist), with bald assertions to the effect that it is 'unquestionably the right approach to follow in medicine, wherever and whenever possible', 'the only way to view medicine in the near future'[109], the 'only game in town' and 'here to stay'[107], and assertions that 'anyone in medicine today who does not believe it is in the wrong business'[110]. Such claims are sometimes accompanied by those of a moral nature; for example, that it is 'blameworthy not to bend one's knee' at the 'altar' of EBM, because 'science and morality are linked'[111] and there are even references to 'evidence-based ethics', where moral principles are enunciated on the absolute requirement to use 'best evidence' as understood by exponents of EBM [112]. Where, we ask, outside of the pages of this journal, is the serious and penetrating interrogation of such claims? Where is the debate? Why do authors who attempt to articulate fundamental criticisms of EBM find it difficult to publish in mainstream medical media [78]? Amongst the rhetorical barrage, the perpetual references to the latest 'advances' in EBM thinking and practice, we find little or no attempt on the part of EBM enthusiasts to justify, or even to explain in any detail, its underlying assumptions: about the nature of science, rationality and evidence itself and how these key concepts may be put to work in the formulation of any defensible view about proper medical practice [10]. EBM has become the dominant ideology of medical discourse [10,108]. Its defenders, treating their own basic assumptions as far too obvious to require any clear explanation or defence, have come to regard any form of disagreement as evidence that the dissenter has not understood – hence their magisterial disdain of criticism and their typical refusal to engage in formal intellectual exchange, a posture which we have previously described as both unscientific and antiscientific [10]. When the failure to agree is automatically treated as symptomatic of both intellectual and moral corruption, the ground is prepared for dogmatism and intolerance, for the sort of 'education' that might reasonably be confused with indoctrination [108]. This has acted as a trigger for the development of more 'EBM training', more practice guidelines and the tools with which to measure 'compliance' with them, and still more applications to governments for the funding of activities, rather than to independent medical and scientific funding councils – an observation and its implications to which we will return later in this article. Yet despite the energy and enthusiasm of EBM advocates and the support of their work by politicians and their advisers, EBM has achieved nothing like the degree of automatic acceptance by practising clinicians that it set out to achieve. It is usually reported that most clinicians will confirm their interest in and acceptance of some of its principles if specifically asked for their opinion, though in an environment where it is tacitly understood what a 'reasonable' practitioner should say, the significance of this observation requires some interpretation. Indeed, real measures of 'commitment' to EBM, such as a working knowledge of EBM terminology, the use of practice guidelines and frequent consultations of the Cochrane database, illustrate a very different picture of clinicians' judgements and practices. While some researchers (including authors whose contributions we are happy to include in this journal [43,49,50,54–60]) might be inclined to see the work of research as identifying and (in some cases) considering ways to solve this 'problem' for the implementation of EBM, it is surely appropriate, in the interests of open debate about a matter of profound import for the future of medical practice, to raise also the more fundamental, philosophical question of how we characterise 'the problem' here. It is at least possible to argue that the real problem is the attempted imposition of a set of dogmas and practices upon a working population, in the absence of any demonstration of its benefits, the truth of its key claims nor even a detailed and consistent exposition of their meaning. Medical epistemology – the systematic study of medical knowledge to discover its nature, basis and the conditions, possibilities and limitations of its application in practice – is hardly a new area of enquiry. (Consider ancient ruminations on the extent to which medicine is a science and an art – questions that are still the topic of journal papers today.) Nor can its central questions plausibly be claimed to have been given a decisive answer. For EBM to be meaningfully described as a 'paradigm' (let alone the 'dominant' paradigm in medicine) it would need to have developed a detailed theoretical structure with explanatory power and substantial empirical corroboration. This is elementary philosophy of science, and while it could be supported with reference to Kuhn [95], it strikes us as barely requiring a reference, any more than the claim that humans have hearts requires an established medical source. Some fifteen years after its inception, EBM remains a practice bereft of a clear theoretical foundation, in a state of constant flux with regard to its definitions of itself and not infrequently revising old methodologies in favour of new ones. Its adherents freely and frequently admit that it is unable to provide any proof, in accordance with its own evidentiary systems, that EBM produces superior clinical outcomes over what is typically and disparagingly described by the EBM community as 'traditional' Medicine [25,107,109,111]. It continues to insist that it cannot be used to contain healthcare costs and limit the care of individuals, even as governments and healthcare systems are increasingly convinced of (indeed, impressed by) its ability to do so. Its advocates now admit that EBM does have limitations, but they have refrained from a proper listing of them, let alone a systematic addressing of the same. Fifteen years is not a long time in intellectual history. It is easy for researchers to become so engulfed by whatever is 'current' in their field that they lose a sense of their place in history and the contingency of academic fashions, which are as often dictated by economic and social factors as by experiment, analysis and sound rational argument [108]. Far from having been settled, we contend that the most pressing, intellectually demanding and practically challenging questions of medical epistemology remain open. This is why we welcome not only contributions from within the EBM camp [43,49,50,60], but also from those whose concern is not to see how well EBM is being implemented but to question, in a variety of different and sometimes incompatible ways, whether it can and should be implemented at all. If this position seems radical or eccentric to some then they need to examine their own expectations about the nature and scope of proper academic debate: for how can it be eccentric to promote open and rigorous debate of unresolved and fundamental questions that promise to shape our conceptions of medical knowledge and practice in future? Is this not the raison d'etre of any serious academic journal? In the pages to follow we therefore present a sustained examination and discussion of alternative positions in medical epistemology [24,41,48] and the philosophy of medicine [30–35] that question the fundamental assumptions of EBM, as well as discussions of critical thinking and its relationship both to EBM and to good practice in general [45,46]. The debate must continue. It must be wide-ranging and not delimited by commercial interests, political constraints or ideology [10]. The Journal of Evaluation in Clinical Practice is gratified to assist its progress by contributing in the current Thematic Issue, some 36 papers on the subject of EBM for international study, assimilation and use. The 9th Thematic Edition featured an important piece by Tonelli outlining a thesis on methods, alternative to EBM, for the integration of evidence into clinical practice [11], upon which the Journal commissioned twelve commentaries from a wide variety of intellectual sources [12–23]. In direct response to his commentators Tonelli contributes the first article of this edition, which sets out to develop his earlier casuistic model of clinical decision making by advancing a refinement of his argument with reference to the content of those substantive analyses [24]. While Tonelli finds himself in agreement with much of what his commentators advance, he is unable to cede certain core precepts which he continues to regard as fundamental to his casuistic model. He acknowledges the point made by Geanellos and Wilson, that the complexity and inherent inequity in the relationship between patients and clinicians means that it is impossible neatly to categorize into goals and values all of the important factors and characteristics of a particular patient seeking care [22]. Tonelli nevertheless remains convinced that his casuistic model is able to embrace the complexity of individuals and of human relationships with much greater ease than EBM approaches, which attempt to convert these features into quantifiable patient 'utilities'[25]. We agree with Tonelli that a careful examination of his model does in fact illustrate its basic capacity to 'unpack and expand' the elements which relate to patient values and preferences, to allow for these and other complexities of the individual patient to be properly considered. As he points out, the protagonists of EBM have developed no such tool to date which has, or purports to, replace the skills of the compassionate and inquisitive clinician in best understanding the needs and personal context of the individual patient. Such 'personal context' must of its nature encompass the social setting in which the clinical encounter takes place. Responding to Malterud's observations [20], Tonelli is clear that in his view the casuistic model can and does accommodate this central factor – and far more so than current EBM-inspired models. He goes on to provide an explanation, in overview, of precisely how this can be achieved. The most consistent and recurring criticism within the set of twelve commentaries [12–23] related not to the completeness of the topics, but rather to whether potential warrants under each topic constituted 'evidence' or not. The contention here was expressed in both epistemic and pragmatic terms. It derived from Tonelli's demarcation between, on the one hand, the empirical results from clinical research and systematic formulation of clinical experience (which he describes as 'evidence') and on the other hand warrants relating to principles of physiology, patient goals and values – or the system in which clinical care is provided (which he describes as 'non-evidentiary'). In acknowledging the immediately controversial nature of this 'division', Tonelli explains the basis of his distinction as having been made specifically in order to 'draw a bright line between EBM and its alternatives, highlighting the self-referential focus on a narrowly defined understanding of evidence within the EBM community'. It is as part of this same strategy that Tonelli asserts as 'non-evidentiary' the status of other (and legitimate) forms of medical knowledge such as pathophysiological principles – as an attempt to counter their incorporation into the EBM model, where they would immediately be subjugated to the 'tyranny of data'. A similar concern leads Tonelli to caution against the suggestion put forward by Tanenbaum [16], that evidence can be generated from within any of the five topics by conducting relevant empirical research: for example, on patients' goals and preferences in order to synthesize knowledge with a degree of generalizability sufficient to allow it to be considered for clinical decisions. This, Tonelli fears, may re-inforce, rather than counter, the erroneous notions of the EBM model which continue to insist on the fundamental primacy of empirical evidence. Indeed, notwithstanding such an approach, there would still remain the other 'non-evidentiary' factors: the goals and values of the given particular, individual patient, and the unsystematic experience of the particular, individual clinician. By allowing EBM to claim that some empirical evidence available to aid clinical decision making is derived from each of the topic areas, one risks a further devaluation of the remaining and much more personal aspects of the potential warrants. Tonelli has related concerns in assimilating Gupta's thinking [21] and, with all of the commentaries having been considered, his firm view is that there are real risks in abandoning a defence of the 'non-evidentiary'. As Tonelli points out, defining all potential warrants for clinical decision making in the casuistic model as 'evidence' allows not only the continued rejection of the authentically personal and individual, but it also strengthens ongoing efforts to structure hierarchies of evidence that demote and devalue evidence derived from anything other than rigorously conducted, journal-published, clinical research. It seems certain that within such hierarchical structures, evidence from sources other than such studies is acknowledged as of value or use only when evidence given higher standing remains unavailable. Tonelli recognises that while advancing a claim to a broader view of evidence has the advantage of gaining the casuistic and other such models of clinical decision making an 'acceptability' and 'prominence' now (both in terms of medical education and also health policy), a sacrifice of the 'non-evidentiary', though possibly representing a pragmatic concession, would be intellectually unwise. Tonelli is equally concerned to clarify that the casuistic model does not necessarily conflate evidence with decision making, a concern that Djulbegovic had expressed [12]. Rather, he makes clear that the casuistic model (variously applied in different specialties) explicitly recognises that evidence, even when understood in its broader sense, is never determinative [26]. Thus, the casuistic understanding of clinical decision making necessarily recognises that just as the process of arriving at the assessment of the truth of an inference is frought with uncertainty [27], every casuistic decision can only probabilistically represent the 'right' course of action. We agree with Tonelli that there is an essential relationship (though clearly a difference) between advancing a thesis on the philosophical basis of medicine and the making of a clinical decision and in taking the approach to the EBM debate that he has done, Tonelli has contributed much to illustrate the inherent weaknesses of EBM and to illuminate ways forward. Tonelli's particular focus on epistemic underpinnings and decision making at the bedside should not therefore be viewed as reductionist in itself but, in our view, represents necessary concentration on those areas of intellectual inquiry and clinical understanding that have typically and woefully been absent from EBM debates [10]. Our own sense is that while Tonelli's article has stimulated vigorous and highly valuable debate [11–24,26,28,29], the debate on what exactly constitutes evidence for clinical decision making remains far from intellectual resolution and that a great deal more academic and clinical exchange will be necessary before any meaningful consensus can be synthesized to act as a platform on which a deeper understanding of 'sound' clinical decision making can proceed. The casuistic model advanced by Tonelli should in our own view be actively built upon with the aim of stimulating further philosophical and clinical inquiry. Tonelli himself notes, as will the astute reader, that there is now a pressing need to 'unpack' the topics and to develop a more detailed understanding of the relationship between knowledge, warrants and decisions. Suggestions of how this work might commence have already been advanced in thoughtful commentaries by Upshur [18] and Buetow [23]. For his part, the Editor has already consulted on Tonelli's current work [24] with each of his previous commentators, two of whom contribute further suggestions in the present issue [28,29]. For our part, we wholeheartedly agree with Tonelli that the 'importance and use of argument and analogy in clinical decision making requires further examination and defence'. While this is most certainly a demanding task under the repressive, anti-intellectual conditions for debate that the protagonists of EBM have created [10], it is not only worthwhile, but as Tonelli recognises, essential in working towards the optimal practice of clinical medicine. We now move to the next major article in the current Thematic Edition [30] and its associated commissioned commentaries [31–34]. Like Tonelli's article, the piece by Murray and his colleagues [30] has been synthesized in response to major commentary on an earlier publication [35]. The authors had constructed that article by drawing in part on the philosophical writings of Deleuze, Guattari and Foucault to illustrate that the evidence-based movement in the health sciences is 'outrageously exclusionary and dangerously normative with regards to scientific knowledge'. From this position, they were able to assert that the evidence-based movement in health sciences constituted a 'good example of microfascism at play in the contemporary scientific arena' and identified the Cochrane Collaboration as having created a hierarchy of evidence and thought, now endorsed by a plethora of academic organisations, which actively excludes certain forms of research from scientific and clinical inquiry. Labelling the evidence-based healthcare movement vividly as a 'regime of truth', Holmes and his colleagues [35] insisted that scholars have not only a scientific duty, but also an ethical obligation, to deconstruct such regimes of power. The authors designed their intervention as a 'productive misapplication' of sorts [35] and they achieved what many critics before them had failed to achieve, in provoking a swift response from the 'EBM community'. Indeed, their argument that a theoretical discussion on truth, power and political fascism had the potential to provide a valuable insight into the impact and influence of the evidence-based healthcare movement met with an extraordinary level of reaction within both the popular as well as the scientific press. Unfortunately, the greater part of this discourse was characterised more by vacuity than insight. Following an invitation from the Editor of the JECP to develop their thinking in the light of such responses, Murray, Holmes, Perron and Rail [30] return in this Thematic Issue to the debate on inappropriate power structures in the health sciences. Have we arrived at an impasse in the health sciences? Has the regime of 'evidence' coupled with corporate models of accountability and best practices led to an inexorable decline in innovation, scholarship and actual health care? Would it be fair to speak of a methodological fundamentalism, a totalising ideology from which there is no escape? These are the pivotal questions with which the authors open the article No exit? Intellectual integrity under the regime of 'evidence' and 'best-practices'[30]. Their use of the question 'No exit?' alludes to Jean-Paul Sartre's play of this name and to his discussions of mauvaise foi or 'bad faith'. Murray and colleagues argue that clinicians and researchers who adopt evidence-based practices in line with officially sanctioned dogma but in the striking absence of a persuasive intellectual rationale, act in 'bad faith', denying their status as autonomous thinkers and agents with the associated responsibility such a status entails. Autonomous thinking and practice require 'critique'– systematic reflection upon the conditions of knowledge and truth. By eschewing critique in this sense, the faithful devotee of EBM fails to think or act authentically and with intellectual integrity, foresaking scientific rigour and honest inquiry for the simple gratifications of ideology, greed, routinisation and efficiency. As such he acts on the basis of 'a peculiar type of evidence – non persuasive evidence'. Although at some level he knows the truth, he instead chooses to turn from it and to adopt a posture of defence, often from a moralistic vantage, remaining deliberately impervious to persuasive evidence in order to remain faithful to his worldview. The authors position themselves against those who have, by initial hubris and later stealth, achieved control of the terms by which the public understands 'integrity' and 'truth'. For Loughlin [31], the first of four commentators invited to review Murray et al.'s article, the response of the EBM community to their work [30,35] proves their point more effectively than the arguments advanced in their papers (not that he is critical of the latter). Noting that all practice embodies theoretical assumptions of some sort, he argues that a refusal to engage in learned argument on the theoretical foundation of one's practice represents nothing more than the intellectually arbitrary stipulation that one's own assumptions are to be accepted without argument. In considering the nature and scale of the responses to Murray et al.'s previous work [35], Loughlin is concerned not only with the 'shameless stupidity' of those responses but also with the sheer cynicism of those who generated them. Loughlin identifies Goldacre [36] as a particularly luminous example of a commentator who is able not only to combine audacity with outrage, but who in a very real way succeeds in manufacturing a sense of having been personally offended by the article in question. Such moralistic posturing acts as a defence mechanism to protect cherished assumptions from rational scrutiny and indeed to enable adherents to appropriate the 'moral high ground', as well as the language of 'reason' and 'science' as the exclusive property of their own favoured approaches. Loughlin brings out the Orwellian nature of this manoeuvre and identifies a significant implication. If Goldacre and others really are engaged in posturing then their primary offence, at least according to the Sartrean perspective adopted by Murray et al. is not primarily intellectual, but rather it is moral. Far from there being a moral requirement to 'bend a knee' at the EBM altar, to do so is to violate one's primary duty as an autonomous being. So we seem to have here the basis for an alternative to the emerging 'evidence-based ethics'. We might label this move the replacement of an ethics of compliance with an ethics of authentic practice. The difference between the two is that, at present, no-one has offered any valid arguments for the former, while there is a lengthy philosophical history to defences of the latter. If Loughlin is correct in advancing such an hypothesis, then Goldacre does indeed function well as an example of what Murray and associates [30] discuss in terms of the Sartrean idea of 'bad faith'. Importantly, the nature of the exchange that has taken place provides a riposte to those who claim that the ideas of philosophers like Sartre provide us with no insight into 'real life' questions. For Loughlin, we cannot 'do without' the concept of 'bad faith' if we are to understand the EBM movement. Readers will see that Loughlin [31] has thrown down the gauntlet, issuing in these pages a challenge to Goldacre and other such EBM apologists. Here, he invites them carefully to study the arguments laid out by Murray and colleagues [30,35] and others [10] and to ruminate as to why these colleagues, who qualify for the label 'rational beings', can nevertheless fail to agree completely with EBM's assumptions about the meaning of 'evidence' in medicine and 'rationality' in scientific practice. Consider, Loughlin invites them, the possibility that someone could disagree with you without thereby qualifying as either stupid or insane. Do an old fashioned exercise in analysis, to try to identify the structure of the arguments that you reject, explain the premises, the conclusions and the relationship between them and then say specifically which part of the argument is wrong and why. This is, indeed, 'undergraduate stuff', but it has rarely characterized the nature of the response by the advocates of EBM to their critics; indeed, typically, there is no response at all. What seems likely, however, is that Goldacre will fail to take up this challenge. Will this, then, come to count as 'evidence' in support of Murray and associates' thesis that Goldacre, and those who can be compared with him, are guilty of 'bad faith'? Will that prove that their approach to argument is indeed fascistic in precisely the sense explained in the paper by Holmes and colleagues [35]? In the second commentary which follows, Couto [32], while agreeing that EBM has long been denounced as a 'set of crooked theories and principles', is unable to agree with Murray et al. [30] that a decline in healthcare innovation can be ascribed to EBM –yet. Couto agrees that EBM persuades on the basis of faith rather than on persuasive evidence and is thus able to conclude with Murray et al. that the proponents of EBM act in bad faith. As he has elegantly shown in the Journal, Couto is clear that while scientific paradigms in the Kuhnian sense are essential in the process of scientific development, they can also constrain and limit our vision of the World [37]. In order to push back the limits of our knowledge, it is incontrovertible that we must first possess a theoretical foundation. As Couto [32] points out, EBM, as a praxis that is disconnected from theory, cannot therefore provide such a foundation and he agrees with Foucalt that 'theory does not express, translate or serve to apply practice: it is practice'[38,39]. It is this, then, which illustrates the defective basis of EBM: formulated as a practice first, it cannot now be translated into theory; it is therefore transvestite because it is dressed up as something which it clearly is not, and a non-theory because its assumptions are absurd [37]. For reasons such as these, Couto believes that EBM has taken Medicine and the healthcare sciences in general, to a preparadigmatic phase. EBM indeed has the potential to impose upon us a state of intellectual minority and a system of tutelage and slavery from which an exit can be difficult to find. As to whether this potential 'dark grip of power' can be accurately described as fascist or microfascist he is not sure, but he is clear that it is a very authoritarian threat. EBM misrepresents evidence, disregards theory, and limits the development of knowledge. In concluding, Couto [32] re-iterates his view that EBM denies reality and reason and has replaced them with fantasy and emotionalism – a quixotic endeavour whose protagonists typically ignore rational argument in order to avoid any debates that would jeopardize their ideologies. Writing in the third commentary on Murray et al.'s paper, Miettinen and Miettinen [33] express their concern that rather than deconstructing the conceptual basis of EBM, Murray and his colleagues may actually have strengthened it. These commentators are convinced that a defective argument against EBM has been sythesized which in turn has dealt a minor blow against the cause of scientific medicine. Miettinen and Miettinen [33] contend that Murray and colleagues [30], in arguing against authority in favour of the self-empowerment and self-direction of practitioners, 'undermine the necessary authority' of a knowledge-generating scientific co