The philosophy of evidence-based medicine -- What is EBM? -- What is good evidence for a clinical decision? -- Ruling out plausible rival hypotheses and confounding factors : a method -- Resolving the paradox of effectiveness : when do observational studies offer the same degree of evidential support as randomized trials? -- Questioning double blinding as a universal methodological virtue of clinical trials : resolving the Philip's paradox -- Placebo controls : problematic and misleading baseline (...) measures of effectiveness -- Questioning the methodological superiority of "placebo" over "active" controlled trials -- Examining the paradox that traditional roles for mechanistic reasoning and expert -- Judgment have been up-ended by EBM -- A qualified defence of the EBM stance on mechanistic reasoning -- Knowledge that versus knowledge how : situating the EBM position on expert clinical judgment -- Moving EBM forward. (shrink)

Since its introduction just over two decades ago, evidence-based medicine (EBM) has come to dominate medical practice, teaching, and policy. There are a growing number of textbooks, journals, and websites dedicated to EBM research, teaching, and evidence dissemination. EBM was most recently defined as a method that integrates best research evidence with clinical expertise and patient values and circumstances in the treatment of patients. There have been debates throughout the early 21st century about what counts (...) as good research evidence between EBM proponents and philosophical critics and even within the EBM community itself. Similar controversy arises about the relative worth of patient values and clinical expertise (and how these can be integrated). EBM has also evolved in ways that have come under scrutiny. Specifically, policymakers have used EBM research methodology to increase the relative importance of clinical guidelines that some clinicians have argued are tyrannical. Philosophers have addressed all of these controversies, and with very few exceptions have been critical of EBM. In addition most philosophical attention has been on the epistemic role of Randomization and evidence hierarchies, with relatively little attention being paid to the role of Diagnosis, expertise, patient values, and Systematic Reviews within EBM. (shrink)

Increasing philosophical attention is being directed to the rapidly growing discipline of evidence-based medicine. Philosophical discussions of EBM, however, remain narrowly focused on randomization, mechanisms, and the sociology of EBM. Other aspects of EBM have been all but ignored, including the nature of clinical reasoning and the question of whether it can be standardized; the application of EBM principles to the logic, value, and ethics of diagnosis and prognosis; evidence synthesis ; and the nature and ethics (...) of placebo controls. Philosophical analysis in each of these areas has the potential to enhance the discussion of EBM methodology and practice. (shrink)

The idea that prescribing physicians should be guided by the most reliable scientific evidence seems obvious, but the actual methodology of evidence-based medicine was only introduced in the early 1990s by an international group of clinicians and researchers led by Gordon Guyatt. Since then it has provided a new paradigm for the scientific foundation of medicine and has influenced other disciplines outside of medicine, for example, evidence-based psychotherapy, science and government. The novel (...) concept of evidence-based medicine is based on hierarchies of evidence from opinions of respected authorities, mechanistic reasoning, and reports of expert committees at the bottom to... (shrink)

Evidence-based medicine has been the subject of much controversy within and outside the field of medicine, with its detractors characterizing it as reductionist and authoritarian, and its proponents rejecting such characterization as a caricature of the actual practice. At the heart of this controversy is a complex linguistic and social process that cannot be illuminated by appealing to the semantics of the modifier evidence-based. The complexity lies in the nature of evidence as a (...) basic concept that circulates in both expert and non-expert spheres of communication, supports different interpretations in different contexts, and is inherently open to contestation. We outline a new methodology that combines a social epistemological perspective with advanced methods of corpus linguistics and elements of conceptual history to investigate this and other basic concepts that underpin the practice and ethos of modern medicine. The potential of this methodology to offer new insights into controversies such as those surrounding EBM is demonstrated through a case study of the various meanings supported by evidence and based, as attested in a large electronic corpus of online material written by non-experts as well as a variety of experts in different fields, including medicine. (shrink)

Although evidence-based medicine (EBM) has gained prominence in current medical practice and research, it has also had to deal with a number of problems and inconsistencies. For example, how do clinicians reconcile discordant results of randomized trials or how do they apply results of randomized trials to individual patients? In an attempt to examine such problems in a structured way, this essay describes EBM within a philosophical framework of science. Using this approach, some of the problems and (...) challenges faced by EBM can be explained at a more fundamental level. As well, by employing a similar description of the competing alternative research tradition of clinical medicine, this essay not only highlights the philosophical differences between these two modes of medical practice, but suggests that they, in fact, play a de facto complementary role in current clinical medicine. (shrink)

We live in an age alleged devoted to evidence-based medicine. Evidence-based medicine, however, depends on reliable data and if the data are largely, if not completely, manipulated by the manufacturer of pharmaceuticals, then the data are not reliable. Evidence-based medicine is an illusion. This book raises and attempts to answer the following questions: What are the ways in which the profit motive of industry undermines the integrity of science? How is science (...) protected from corporate malfeasance in a capitalist economy? Our particular focus is the relationship between the pharmaceutical industry and medicine. We argue that medicine desperately needs to re-evaluate its relationship with the pharmaceutical industry and re-affirm the ideal of evidence-based medicine. In our view, Karl Popper’s philosophy of science, Falsificationism and Critical Rationalism, provides a rigorous conception of science required to preserve the integrity of the scientific basis of medicine against the commercial influences. (shrink)

The editors of the symposium hope it will provide a balanced appraisal of evidence based medicine.This symposium is devoted to evidence based medicine and the ethical issues it raises. Since Sir Archie Cochrane’s seminal Nuffield Provincial Hospitals Trust lectures in 1972 and their publication as the Rock Carling monograph for that year, Effectiveness and Efficiency: Random Reflections on Health Services, the idea that medical interventions and health services should be evaluated and selected on the (...) basis of the most reliable evidence available for their effectiveness and cost effectiveness has become very widely accepted.1,2 This widespread acceptance has not been complete, and it sometimes seems that there are as many critics of EBM as advocates. Whereas the importance of randomised trial evidence, critical appraisal, meta-analysis, and systematic review …. (shrink)

Significant contributions to debates in the philosophy of evidence-based medicine (EBM) have come from a variety of different philosophical quarters, yet mainstream discourse in the field has been largely devoid of contributions from scholars working in the pragmatist tradition. This is a particularly conspicuous omission, given pragmatism’s commitment to the melioristic view that philosophy both can, and should, be about the business of concretely bettering the human estate. Two exceptions to this oversight come from Brian (...) Walsh and Maya Goldenberg. Unfortunately, in both cases, the misapplication of pragmatist thinking leads to the mistaken view that EBM is committed to some form of pernicious objectivism. This article aims to revise these pragmatist critiques in order to bring them more consistently in line with pragmatist values and commitments. Doing so shows that EBM is defensible on pragmatist grounds against objectivist attacks. (shrink)

The evidence-based medicine (EBM) movement is touted as a new paradigm in medical education and practice, a description that carries with it an enthusiasm for science that has not been seen since logical positivism flourished (circa 1920–1950). At the same time, the term ‘‘evidence-based medicine’’ has a ring of obviousness to it, as few physicians, one suspects, would claim that they do not attempt to base their clinical decision-making on available evidence. However, the (...) apparent obviousness of EBM can and should be challenged on the grounds of how ‘evidence’ has been problematised in the philosophy of science. EBM enthusiasm, it follows, ought to be tempered. The post-positivist, feminist, and phenomenological philosophies of science that are examined in this paper contest the seemingly unproblematic nature of evidence that underlies EBM by emphasizing different features of the social nature of science. The appeal to the authority of evidence that characterizes evidence-based practices does not increase objectivity but rather obscures the subjective elements that inescapably enter all forms of human inquiry. The seeming common sense of EBM only occurs because of its assumed removal from the social context of medical practice. In the current age where the institutional power of medicine is suspect, a model that represents biomedicine as politically disinterested or merely scientific should give pause. (shrink)

Proponents of evidence-based medicine have argued convincingly for applying this scientific method to medicine. However, the current methodological framework of the EBM movement has recently been called into question, especially in epidemiology and the philosophy of science. The debate has focused on whether the methodology of randomized controlled trials provides the best evidence available. This paper attempts to shift the focus of the debate by arguing that clinical reasoning involves a patchwork of evidential approaches (...) and that the emphasis on evidence hierarchies of methodology fails to lend credence to the common practice of corroboration in medicine. I argue that the strength of evidence lies in the evidence itself, and not the methodology used to obtain that evidence. Ultimately, when it comes to evaluating the effectiveness of medical interventions, it is the evidence obtained from the methodology rather than the methodology that should establish the strength of the evidence. (shrink)

Evidence-based medicine (EBM) has long deemphasized mechanistic reasoning and pathophysiological rationale in assessing the effectiveness of interventions. The EBM+ movement has challenged this stance, arguing that evidence of mechanisms and comparative studies should both be seen as necessary and complementary. Advocates of EBM+ provide a combination of theoretical arguments and examples of mechanistic reasoning in medical research. However, EBM+ proponents have not provided recent examples of how downplaying mechanistic reasoning resulted in worse medical results than would (...) have occurred otherwise. Such examples are necessary to make the case that EBM+ responds to a problem in clinical practice that urgently demands a solution. In light of this, we examine the failed rollout of efavirenz as a first-line HIV treatment in Zimbabwe as evidence of the importance of mechanistic reasoning in improving clinical practice and public health policy decisions. We suggest that this case is analogous to examples commonly given to support EBM. (shrink)

It has often been emphasised that psychiatry is still an ‘expertise’ and has not yet reached the status of a science. Science calls for systematic, conceptual thinking which can be communicated to others. Only in so far as psychopathology does this can it claim to be regarded as a science. What in psychiatry is just expertise and art can never be accurately formulated and can at best be mutually sensed by another colleague. It is therefore hardly a matter for textbooks (...) and we should not expect to find it there. This quotation indicates that Jaspers was immersed in a major debate in nineteenth century philosophy of science: the Methodenstreit. His dismissive comments about the ‘art’ of psychiatry set the .. (shrink)

Proponents of evidence-based medicine (EBM) provide the “hierarchy of evidence” as a criterion for judging the reliability of therapeutic decisions. EBM's hierarchy places randomized interventional studies (and systematic reviews of such studies) higher in the hierarchy than observational studies, unsystematic clinical experience, and basic science. Recent philosophical work has questioned whether EBM's special emphasis on evidence from randomized interventional studies can be justified. Following the critical literature, and in particular the work of John Worrall, I (...) agree that many of the arguments put forward by advocates of EBM do not justify the ambitious claims that are often made on behalf of randomization. However, in contrast to the recent philosophical work, I argue that a justification for EBM's hierarchy of evidence can be provided. The hierarchy should be viewed as a hierarchy of comparative internal validity. Although this justification is defensible, the claims that EBM's hierarchy substantiates when viewed in this way are considerably more circumscribed than some claims found in the EBM literature. (shrink)

Evidence-based medicine (EBM) puts forward a hierarchy of evidence for informing therapeutic decisions. An unambiguous interpretation of how to apply EBM's hierarchy has not been provided in the clinical literature. However, as much as an interpretation is provided proponents suggest a categorical interpretation. The categorical interpretation holds that all the results of randomised trials always trump evidence from lower down the hierarchy when it comes to informing therapeutic decisions. Most of the critical replies to EBM (...) react to this interpretation. While proponents of EBM can avoid some of the problems raised by critics by suitably limited the claims made on behalf of the hierarchy, further problems arise. If EBM is to inform therapeutic decisions then a considerably more restricted, and context dependent interpretation of EBM's hierarchy is needed. (shrink)

Evidence-Based Medicine (EBM) developed from the work of clinical epidemiologists at McMaster University and Oxford University in the 1970s and 1980s and self-consciously presented itself as a "new paradigm" called "evidence-based medicine" in the early 1990s. The techniques of the randomized controlled trial, systematic review and meta-analysis have produced an extensive and powerful body of research. They have also generated a critical literature that raises general concerns about its methods. This paper is a systematic (...) review of the critical literature. It finds the description of EBM as a Kuhnian paradigm helpful and worth taking further. Three kinds of criticism are evaluated in detail: criticisms of procedural aspects of EBM (especially from Cartwright, Worrall and Howick), data showing the greater than expected fallibility of EBM (Ioaanidis and others), and concerns that EBM is incomplete as a philosophy of science (Ashcroft and others). The paper recommends a more instrumental or pragmatic approach to EBM, in which any ranking of evidence is done by reference to the actual, rather than the theoretically expected, reliability of results. Emphasis on EBM has eclipsed other necessary research methods in medicine. With the recent emphasis on translational medicine, we are seeing a restoration of the recognition that clinical research requires an engagement with basic theory (e.g. physiological, genetic, biochemical) and a range of empirical techniques such as bedside observation, laboratory and animal studies. EBM works best when used in this context. (shrink)

Evidence-based medicine and medical professionalism are two prominent notions in current medical debates. However, proponents of professionalism fear a restriction in doctors’ freedom to make their best decisions for individual patients caused by the influence of EBM and highly standardised decision procedures. The challenge which EBM allegedly poses to physicians’ discretion forms the starting point for an analysis of the relationship between professionalism, as an inherent value system of medical practice, and EBM, as an approach to optimise (...) the decision-making for individual patients. The analysis starts with a brief conceptual clarification of the ambiguous term “professionalism”. It then focuses on three key aspects of medical professionalism which may come into conflict with the basic tenets of EBM. The potential tensions between professional autonomy and clinical practice guidelines, individualised care and standardisation, and esoteric authority and public accountability are analysed and a suggestion for reconcilement regarding each point is made. The article closes with a summary on how a better reflection on medical professionalism may help towards a fuller understanding of EBM and vice versa. (shrink)

Evidence-Based Medicine (EBM) is defined as the conscious, and judicious use of current best evidence in making decisions about the care of individual patients. The greater the level of evidence the greater the grade of recommendation. This pioneering explicit concept of EBM is embedded in a particular view of medical practice namely the singular nature of the patient-physician relation and the commitment of the latter towards a specific goal: the treatment and the well being of (...) his or her client. Nevertheless, in many European countries as well as the United States, this integration of the best evidence from systematic research with clinical expertise and patient values appears to be re-interpreted in light of the scarcity of healthcare resources. The purpose of this paper is double. First, to claim that from an ethical perspective EBM should be a guideline to clinical practice; and second, that in specific circumstances EBM might be a useful tool in macro-allocation of healthcare resources. Methodologically the author follows Norman Daniels' theory of democratic accountability to justify this assumption. That is, choices in healthcare must be accountable by democratic procedures. This perspective of distributive justice is responsible for the scope and limits of healthcare services. It follows that particular entitlements to healthcare — namely expensive innovative treatments and medicines —may be fairly restricted as long as this decision is socially and democratically accountable and imposed by financial restrictions of the system. In conclusion, the implementation of EBM, as long as it limits the access to drugs and treatments of unproven scientific results is in accordance with this perspective. The use of EBM is regarded as an instrument to facilitate the access of all citizens to a reasonable level of healthcare and to promote the efficiency of the system. (shrink)

Proponents of Evidence-based medicine (EBM) do not provide a clear role for basic science in therapeutic decision making. Of what they do say about basic science, most of it is negative. Basic science resides on the lower tiers of EBM's hierarchy of evidence. Therapeutic decisions, according to proponents of EBM, should be informed by evidence from randomised studies (and systematic reviews of randomised studies) rather than basic science. A framework of models explicates the links between (...) the mechanisms of basic science, experimental inquiry, and observed data. Relying on the framework of models I show that basic science often plays a role not only in specifying experiments, but also analysing and interpreting the data that is provided. Further, and contradicting what is implied in EBM's hierarchy of evidence, appeals to basic science are often required to apply clinical research to therapeutic questions. © 2010 Springer Science+Business Media B.V. (shrink)

Obviously medicine should be evidence-based. The issues lie in the details: what exactly counts as evidence? Do certain kinds of evidence carry more weight than others? (And if so why?) And how exactly should medicine be based on evidence? When it comes to these details, the evidence-based medicine (EBM) movement has got itself into a mess – or so it will be argued. In order to start to resolve this (...) mess, we need to go 'back to basics'; and that means turning to the philosophy of science. The theory of evidence, or rather the logic of the interrelations between theory and evidence, has always been central to the philosophy of science – sometimes under the alias of the 'theory of confirmation'. When taken together with a little philosophical commonsense, this logic can help us move towards a position on evidence in medicine that is more sophisticated and defensible than anything that EBM has been able so far to supply. (shrink)

Thomas, Bracken, and Timimi (2012) make an important contribution in critiquing the extent to which the profession of psychiatry can be so bureaucratic that patients are treated as problems to be solved in an ‘efficient’ assembly line fashion rather than as individual persons. The trouble with bureaucracies is that they promote a cold and impersonal accounting approach in which critical reflection on purposes is circumvented by decision-making algorithms (Zachar and Bartlett 2009). Psychotherapy treatment manuals definitely satisfy the bureaucratic instinct, and (...) the fifteen-minute medication management session even more so (Harris 2011). Ideally, evidence-based medicine (EBM) should be used to promote the goals of .. (shrink)

Evidence-Based Medicine is a relatively new movement that seeks to put clinical med- icine on a firmer scientific footing. I take it as uncontroversial that medical practice should be based on best evidence-the interesting questions concern the details. This paper tries to move towards a coherent and unified account of best evidence in medicine, by exploring in particular the EBM position on RCTs (randomized controlled trials).

Evidence-Based Medicine is a relatively new movement that seeks to put clinical medicine on a firmer scientific footing. I take it as uncontroversial that medical practice should be based on best evidence—the interesting questions concern the details. This paper tries to move towards a coherent and unified account of best evidence in medicine, by exploring in particular the EBM position on RCTs.

The increased demand for evidence-based medicine has proven much more challenging for psychiatry to accept than for medicine in general. Among the concerns is a perception that EBM does not respond appropriately to the character and complexity of psychiatric disorders and treatments, that the concept of ‘evidence’ is too narrowly construed, and that it may encourage a false sense of competence. It has also been claimed that EBM may encourage a kind of ‘cookbook medicine,’ (...) leaving out tacit knowledge and the empathic and caring aspects of the psychiatrist– patient relationship. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Evidence-Based Medicine and EvaluativismTim Thornton (bio)KeywordsPhilosophy, psychiatry, values, causalThe rise of evidence-based medicine (EBM) in psychiatry has brought, in its train, a concentration on the validity of psychiatric taxonomy to augment the previous focus on reliability (in the medical sense of inter-subject agreement). This is not surprising. If EBM is to be a trustworthy guide to future events, such as patient recovery, it (...) must be based on projectible predicates (Goodman 1983). Not all the predicates that apparently fit past observations would produce true predictions for the future. Furthermore, there is reason to think that employing projectible predicates goes a long way to satisfy the (widespread if contested) aim of being based on a nomological science (Papineau 1986). Thus, the successful implementation of EBM within psychiatry requires the successful articulation of a valid psychiatric taxonomy.This connection helps to explain why fears about the application of EBM to psychiatry often turn on fears about the application of the criteriological model of diagnosis to individuals. In her commentary in this issue, Gloria Ayob has examined some of the arguments concerning the application of EBM to individuals. In this brief commentary, I examine a different potential source of disquiet focused on the underlying nature of psychiatric taxonomy.Dimensions for Psychiatric TaxonomyIn their recent paper, Peter Zachar and Kenneth Kendler suggest a number of different dimensions according to which rival conceptions of psychiatric taxonomy can be mapped. These include (1) causalism–descriptivism, (2) essentialism– nominalism, (3) objectivism–evaluativism, (4) internalism–externalism, (5) entities–agents, and (6) categories–continua (2007, 557). At the heart of the objectivism-evaluativism dimension is the question:Is deciding whether or not something is a psychiatric disorder a simple factual matterY (objectivism), or does it inevitably involve a value-laden judgment (evaluativism)?(Zachar and Kendler 2007, 558)Objectivists argue that the concept of disorder is a simple or plain factual matter by contrast with an evaluation. The apparently evaluative connotations of disorder, they argue, can either be reduced to, or explained away in, more basic terms, which are not themselves essentially evaluative. Thus, for example, the attempt to explain disorder in statistical terms is a form of objectivism. The more plausible attempt to explain disorder through the idea of a biological or proper function is also usually presented as a form of objectivism. (The most famous proponent of a biological approach, however, Jerome Wakefield, adds to an objectivist-aspiring core an explicit value in the form of harm [End Page 175] [Wakefield 1999].) Whether or not it can be successful as a form of objectivism, in addition to whether an analysis in biological terms is possible, depends on whether the account of function can fully discharge any initial evaluative or normative assumptions.There seems to be good evidence that current psychiatric taxonomy, at least, contains values. John Sadler, for example, makes a powerful case for this in his substantial work Values and Psychiatric Diagnosis (2005). Sadler, furthermore, addresses in some detail a further set of questions concerning the kinds and nature of the values involved. I outline just one further question about the nature of values involved.Zachar and Kendler contrast the presence of values with objectivism. Objectivity has at least two relevant senses reflecting contrasts with two senses of subjectivity. It—objectivity—might mean requiring no special subject for the conception and framing of relevant judgments. (This mirrors primary, by contrast with secondary qualities, and Williams' idea of an absolute conception [Williams 1978]). Or, it might mean disciplining and providing a contrast between correctness and incorrectness, or truth and falsity, for the relevant judgments. This contrasts with subjective whimsy.Although it seems relatively straight forward that the conception and framing of value judgments requires that subjects have a particular kind of mind, that still leaves open the other issue. Are value judgments disciplined by anything or does the "truth" of a value judgment collapse back into its being sincerely made?Evaluativism in Psychiatric Taxonomy and EBMThis question relates to the application of EBM to psychiatry in this way. On a disciplined account, psychiatric taxonomy can aim to get right the mixture or, better, the compound of simple facts and values... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Evidence-Based Medicine and EvaluativismTim Thornton (bio)KeywordsPhilosophy, psychiatry, values, causalThe rise of evidence-based medicine (EBM) in psychiatry has brought, in its train, a concentration on the validity of psychiatric taxonomy to augment the previous focus on reliability (in the medical sense of inter-subject agreement). This is not surprising. If EBM is to be a trustworthy guide to future events, such as patient recovery, it (...) must be based on projectible predicates (Goodman 1983). Not all the predicates that apparently fit past observations would produce true predictions for the future. Furthermore, there is reason to think that employing projectible predicates goes a long way to satisfy the (widespread if contested) aim of being based on a nomological science (Papineau 1986). Thus, the successful implementation of EBM within psychiatry requires the successful articulation of a valid psychiatric taxonomy.This connection helps to explain why fears about the application of EBM to psychiatry often turn on fears about the application of the criteriological model of diagnosis to individuals. In her commentary in this issue, Gloria Ayob has examined some of the arguments concerning the application of EBM to individuals. In this brief commentary, I examine a different potential source of disquiet focused on the underlying nature of psychiatric taxonomy.Dimensions for Psychiatric TaxonomyIn their recent paper, Peter Zachar and Kenneth Kendler suggest a number of different dimensions according to which rival conceptions of psychiatric taxonomy can be mapped. These include (1) causalism–descriptivism, (2) essentialism– nominalism, (3) objectivism–evaluativism, (4) internalism–externalism, (5) entities–agents, and (6) categories–continua (2007, 557). At the heart of the objectivism-evaluativism dimension is the question:Is deciding whether or not something is a psychiatric disorder a simple factual matterY (objectivism), or does it inevitably involve a value-laden judgment (evaluativism)?(Zachar and Kendler 2007, 558)Objectivists argue that the concept of disorder is a simple or plain factual matter by contrast with an evaluation. The apparently evaluative connotations of disorder, they argue, can either be reduced to, or explained away in, more basic terms, which are not themselves essentially evaluative. Thus, for example, the attempt to explain disorder in statistical terms is a form of objectivism. The more plausible attempt to explain disorder through the idea of a biological or proper function is also usually presented as a form of objectivism. (The most famous proponent of a biological approach, however, Jerome Wakefield, adds to an objectivist-aspiring core an explicit value in the form of harm [End Page 175] [Wakefield 1999].) Whether or not it can be successful as a form of objectivism, in addition to whether an analysis in biological terms is possible, depends on whether the account of function can fully discharge any initial evaluative or normative assumptions.There seems to be good evidence that current psychiatric taxonomy, at least, contains values. John Sadler, for example, makes a powerful case for this in his substantial work Values and Psychiatric Diagnosis (2005). Sadler, furthermore, addresses in some detail a further set of questions concerning the kinds and nature of the values involved. I outline just one further question about the nature of values involved.Zachar and Kendler contrast the presence of values with objectivism. Objectivity has at least two relevant senses reflecting contrasts with two senses of subjectivity. It—objectivity—might mean requiring no special subject for the conception and framing of relevant judgments. (This mirrors primary, by contrast with secondary qualities, and Williams' idea of an absolute conception [Williams 1978]). Or, it might mean disciplining and providing a contrast between correctness and incorrectness, or truth and falsity, for the relevant judgments. This contrasts with subjective whimsy.Although it seems relatively straight forward that the conception and framing of value judgments requires that subjects have a particular kind of mind, that still leaves open the other issue. Are value judgments disciplined by anything or does the "truth" of a value judgment collapse back into its being sincerely made?Evaluativism in Psychiatric Taxonomy and EBMThis question relates to the application of EBM to psychiatry in this way. On a disciplined account, psychiatric taxonomy can aim to get right the mixture or, better, the compound of simple facts and values... (shrink)

Kerry et al. criticize our discussion of causal knowledge in evidence-based medicine (EBM) and our assessment of the relevance of their dispositionalist ontology for EBM. Three issues need to be addressed in response: (1) problems concerning transfer of causal knowledge across heterogeneous contexts; (2) how predictions about the effects of individual treatments based on population-level evidence from RCTs are fallible; and (3) the relevance of ontological theories like dispositionalism for EBM.

Because few would object to evidence-based medicine’s (EBM) principal task of basing medical decisionmaking on the most judicious and up-to-date evidence, the debate over this prolific movement may seem puzzling. Who, one may ask, could be against evidence (Carr-Hill, 2006)? Yet this question belies the sophistication of the evidence-based movement. This chapter presents the evidence-based approach as a socio-medical phenomenon and seeks to explain and negotiate the points of disagreement between supporters (...) and detractors. This is done by casting EBM as more than the simple application of research findings to clinical care and improved health outcomes, but rather an umbrella term that harnesses a specific set of pedagogical objectives (some rather radical) under a name that makes it difficult to argue against. (shrink)

BackgroundExpertise has been a contentious concept in Evidence-Based Medicine. Especially in the early days of the movement, expertise was taken to be exactly what EBM was rebelling against—the authoritarian pronouncements about “best” interventions dutifully learned in medical schools, sometimes with dire consequences. Since then, some proponents of EBM have tried various ways of reincorporating the idea of expertise into EBM, with mixed results. However, questions remain. Is expertise evidence? If not, what is it good for, if (...) anything?MethodsIn this article, I describe and analyze the three historical models of expertise integration in EBM and discuss the difficulties in putting each into practice. I also examine accounts of expertise from disciplines outside of medicine, including philosophy, sociology, psychology, and science and technology studies to see if these accounts can strengthen and clarify what EBM has to say about expertise.ResultsOf the accounts of expertise discussed here, the Collins and Evans account can do most to clarify the concept of expertise in EBM.ConclusionsWith some additional clarification from EBM proper, theoretical resources from other disciplines might augment the current EBM account of expertise. (shrink)

A long-debated question in the philosophy of health, and contingent disciplines, is the extent to which wise clinical practice (“clinical wisdom”) is, or could be, compatible with empirically validated medicine (“evidence-based medicine”—EBM). Here we respond to Baum-Baicker and Sisti, who not only suggest that these two types of knowledge are divided due to their differing sources, but also that EBM can sometimes even hurt wise clinical practice. We argue that the distinction between EBM and clinical (...) wisdom is poorly defined, unsupported by the methodology employed, and ultimately incorrect; crucial differences exist, we argue, not in the source of a particular piece of clinical knowledge, but in its dependability. In light of this subtle but fundamental revision, we explain how clinical wisdom and EBM are—by necessity—complementary, rather than in conflict. We elaborate on how recognizing this relationship can have far-reaching implications for the domains of clinical practice, medical education, and health policy. (shrink)

Evidence-Based Medicine (EBM) and Personalized Medicine (PM) share a common goal: reducing the gap between the results of biomedical research and their clinical application. PM is, however, often presented as a “new paradigm” for medicine, just as EBM was in the 1990s. It covers a wide variety of projects but the core idea that generally unites them is the ambition of better taking account of individual specificities than did EBM with its statistical and population-centred approach. (...) In this article, I concentrate on PM in cancerology, the essence of which is to target treatments based on the molecular profile of the patient. This targeting is made possible by gaining better knowledge about the molecular mechanisms of cancers. The classification of patients as a function of their molecular profile entails the creation of patient sub-groups. This creates a problem for the traditional evaluation of therapeutic treatment promoted by EBM, in particular the use of randomized trials using sizeable cohorts. But a better understanding of the mechanisms and the greater precision of treatments could reduce the need for these trials. Does PM thus represent the revenge of a physio-pathological and mechanistic culture in clinical research against the statistical and empirical one of EBM? My objective is to show how current practices of PM leads to epistemological changes in our estimation of what count as relevant types of information and proof in medicine, in particular in the field of therapeutic evaluation. I defend the idea that PM, far from obviating the need for statistical approaches and the search for correlations, ultimately poses new challenges for EBM. PM drives EBM to strengthen the articulation and the integration of statistical and mechanistic data with a view to providing a better service for each patient. (shrink)

It is surely obvious that medicine, like any other rational activity, must be based on evidence. The interest is in the details: how exactly are the general principles of the logic of evidence to be applied in medicine? Focussing on the development, and current claims of the ‘Evidence-Based Medicine’ movement, this article raises a number of difficulties with the rationales that have been supplied in particular for the ‘evidence hierarchy’ and for (...) the very special role within that hierarchy of randomized controlled trials (and meta-analyses of the results of randomized controlled trials). The point is not at all to question the application of a scientific approach to evidence in medicine, but, on the contrary, to indicate a number of areas where philosophers of science can contribute to a proper implementation of exactly that scientific-evidential approach. (shrink)

Thirty years after the rise of the evidence-based medicine (EBM) movement, formal training in philosophy remains poorly represented among medical students and their educators. In this paper, I argue that EBM’s reception in this context has resulted in a privileging of empiricism over rationalism in clinical reasoning with unintended consequences for medical practice. After a limited review of the history of medical epistemology, I argue that a solution to this problem can be found in the method (...) of the 2nd-century Roman physician Galen, who brought empiricism and rationalism together in a synthesis anticipating the scientific method. Next, I review several of the problems that have been identified as resulting from a staunch commitment to empiricism in medical practice. Finally, I conclude that greater epistemological awareness in the medical community would precipitate a Galenic shift toward a more epistemically balanced, scientific approach to clinical research. (shrink)

Patient self-management programs have become increasingly popular and are now also receiving official endorsements. This paper analyses two possible types of positive justifications for promoting patient self-management: evidence-based and patient-centred justifications. It is argued that evidence-based justifications, although important politically are deficient and that the primary justification for patient self-management must be a patient-centred justification focusing on the patient’s privileged access to his or her own lived body.

This thesis examines philosophical controversies surrounding the evaluation of medical treatments, with a focus on the evidential roles of randomised trials and mechanisms in Evidence-Based Medicine. Current 'best practice' usually involves excluding non-randomised trial evidence from systematic reviews in cases where randomised trials are available for inclusion in the reviews. The first paper challenges this practice and evaluates whether adding of evidence from non-randomised trials might improve the quality and precision of some systematic reviews. The (...) second paper compares the alleged methodological benefits of randomised trials over observational studies for investigating treatment benefits. It suggests that claims about the superiority of well-conducted randomised controlled trials over well-conducted observational studies are justified, especially when results from the two methods are contradictory. The third paper argues that postulating the unpredictability paradox in systematic reviews when no detectable empirical differences can be found requires further justification. The fourth paper examines the problem of absence causation in the context of explaining causal mechanisms and argues that a recent solution is incomplete and requires further justification. Solving the problem by describing absences as causes of 'mechanism failure' fails to take into account the effects of absences that lead to vacillating levels of mechanism functionality. The fifth paper criticises literature that has emphasised functioning versus 'broken' or 'non-functioning' mechanisms emphasising that many diseases result from increased or decreased mechanism function, rather than complete loss of function. Mechanistic explanations must account for differences in the effectiveness of performed functions, yet current philosophical mechanistic explanations do not achieve this. The last paper argues that the standard of evidence embodied in the ICE theory of technological function is too permissive for evaluating whether the proposed functions of medical technologies have been adequately assessed and correctly ascribed. It argues that high-quality evidence from clinical studies is necessary to justify functional ascriptions to health care technologies. (shrink)

Causal claims in biomedical contexts are ubiquitous albeit they are not always made explicit. This paper addresses the question of what causal claims mean in the context of disease. It is argued that in medical contexts causality ought to be interpreted according to the epistemic theory. The epistemic theory offers an alternative to traditional accounts that cash out causation either in terms of “difference-making” relations or in terms of mechanisms. According to the epistemic approach, causal claims tell us about which (...) inferences (e.g., diagnoses and prognoses) are appropriate, rather than about the presence of some physical causal relation analogous to distance or gravitational attraction. It is shown that the epistemic theory has important consequences for medical practice, in particular with regard to evidence-based causal assessment. (shrink)

This paper discusses the outstanding problem of replicability of empirical data in the context of recent work on meta-analysis, especially within the field of evidence-based medicine. Specifically, it deals with the methodological issue of how to determine the degrees of heterogeneity between different collected studies. After critically reviewing the standard measures used to quantify meta-analytical heterogeneity, we argue that they should be revised in such a way to take into account the statistical power of the individual studies. (...) We thus propose some new measures of heterogeneity. Subsequently, we apply them to re-assess concrete case-studies from clinical research, thereby showing explicitly how the relevant values of heterogeneity diverge from those obtained with the original measures. (shrink)

The relationship between evidence-based medicine (EBM) and clinical judgement is the subject of conceptual and practical dispute. For example, EBM and clinical guidelines are seen to increasingly dominate medical decision-making at the expense of other, human elements, and to threaten the art of medicine. Clinical wisdom always remains open to question. We want to know why particular beliefs are held, and the epistemological status of claims based in wisdom or experience. The paper critically appraises a (...) number of claims and distinctions, and attempts to clarify the connections between EBM, clinical experience and judgement, and the objective and evaluative categories of medicine. I conclude that to demystify clinical wisdom is not to devalue it. EBM ought not be conceived as needing to be limited or balanced by clinical wisdom, since if its language is translatable into terms comprehensible and applicable to individuals, it helps constitute clinical wisdom. Failure to appreciate this constitutive relation will help perpetuate medical paternalism and delay the adoption of properly evidence-based practice, which would be both unethical and unwise. (shrink)