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)

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) 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 important and urgent to question therelationship between evidence-based medicineand power shifts in health care systems.Although definitions of EBM are phrased as ascientific approach to medicine, EBM is anormative concept: it aims to improve medicineand health care. Both proponents and opponentsuse a normative concept. More particularly,they provide particular views on positions,responsibilities, possibilities, norms andrelationships between professionals, patientgroups, governments and other parties in healthcare and society. From this perspective, wewant to analyse the role of EBM in modernwestern (...) societies. By using citizenshiptheory, we will argue that the role of EBM isnot fixed but depends on the relation betweenstate and society. We will first analyse thefundamental change in western societies duringthe past decades, from modern to post-modernsocieties. Then, we will elaborate a fourfoldmodel of possible relationships between stateand society, and discuss the issue of how EBM mayfit in, by giving some examples of the practiceof EBM in different European countries. On thisbasis, we conclude to consider EBM as a publicforum where proponents and opponents of EBMdiscuss diverse and possibly conflicting waysof changing medicine, health care, and healthpolicy. This requires the incorporation of theperspective of citizens and their socialnetworks, professionals with practical andtacit knowledge, and diverse public views onwhat is regarded as `a good life'. Inasmuch asEBM is expected to be practically relevant, itought to be tied to rather than separated fromthe normative world of emancipated patients anddiverse health care practices. Proponents andopponents of EBM should be prepared to defendthe normative claims and power effects that areinherently tied to any presentation ofevidence. (shrink)

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)

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)

Evidence-based medicine has been rapidly and widely adopted because it claims to provide a method for determining the safety and efficacy of medical therapies and public health interventions more generally. However, as others have noted, EBM may be riven through with cultural bias, both in the generation of evidence and in its translation. We suggest that technological and scientific advances in medicine accentuate and entrench these cultural biases, to the extent that they may invalidate the (...) evidence we have about disease and its treatment. This creates a significant ethical, epistemological and ontological challenge for medicine. (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)

L’ Evidence-Based Medicine (EBM) est définie comme « l’utilisation consciencieuse et judicieuse des meilleures données actuelles de la recherche clinique dans la prise en charge personnalisée de chaque patient ». L’EBM met en œuvre des standards de qualité du plus haut niveau par le tri actif de toutes les études cliniques disponibles. D’un côté, elle remet en question le fondement des savoirs pratiques basé sur l’intuition, l’expérience clinique et le mécanisme des maladies. D’un autre, elle refuse l’autorité (...) des experts et leurs recommandations. Si l’intention de l’EBM d’améliorer la pratique clinique est louable, elle ne peut résoudre la question cruciale de l’expertise clinique. En se concentrant sur les études cliniques, l’EBM oublie que le savoir clinique nécessite de rassembler plusieurs formes de savoirs. Dès lors, il manque à l’EBM une connaissance tacite, non formalisable, qu’elle rejette pour son absence supposée d’objectivité. L’expertise clinique comme incorporation de gestes à la fois intellectuels et techniques nécessite un travail de synthèse entre les connaissances implicites et explicites afin de revenir à son but : le soin au patient dans sa particularité. (shrink)

As a recent special report in the Hastings Center Report demonstrates, many bioethicists are rethinking the way we regulate both biomedical research and clinical practice, as well as the sharp boundary that the field has assumed can and should exist between them. Such a rethinking is long overdue. There is surely a meaningful normative distinction between activities whose expected risk‐benefit profile is and is not “reasonable” for participants (to echo the language in the Common Rule—the core set of human research (...) guidelines found in many federal regulations). But neither the research‐practice distinction nor the criteria underlying it—the intention of the actor, whether the activity is “systematic,” and whether its results are “generalizable”—closely track good and bad outcomes for research participants and patients or justify either the bureaucratic, paternalistic licensing system that governs human subjects research or the comparatively lax governance of medical practice. The specious distinction between research and practice is especially ripe for dismantling in light of the embarrassing fact that evidence‐based medicine remains more aspiration than reality. (shrink)

The question what scientific progress means for a particular domain such as medicine seems importantly different from the question what scientific progress is in general. While the latter question received ample treatment in the philosophical literature, the former question is hardly discussed. I argue that it is nonetheless important to think about this question in view of the methodological choices we make. I raise specific questions that should be tackled regarding scientific progress in the medical sciences and demonstrate their (...) importance by means of an analysis of what evidence-based medicine (EBM) has, and has not, to offer in terms of progress. I show how critically thinking about EBM from the point of view of progress can help us in putting EBM and its favoured methodologies in the right perspective. My conclusion will be that blindly favouring certain methods because of their immediately tangible short-term benefits implies that we parry the important question of how best to advance progress in the long run. This leads us to losing sight of our general goals in doing research in the medical sciences. (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)

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)

Contesting that a debate on evidence-based health care has taken place, this article charts three paths to the future: continuing avoidance of debate by proponents of evidence-based medicine (EBM); conflict, which the EBM movement courts and critics have espoused, and dialogue. The last portal allows for integration, which would end the disagreement between EBM and its critics and make a debate unnecessary. In search of integration, I sketch a bridge whose construction requires not compromise but (...) a win- win approach. The bridge is a medicine of meaning (MOM). Consolidating multiple pillars of evidence to unify questions that are not necessarily the same for protagonists and critics of EBM, a MOM contends that the purpose or meaning of medicine is always healing and helping, and each party finds meaning in medicine by contributing to this common purpose in its own distinctive way. (shrink)

In this paper we set out to examine thearguments for and against the claim thatEvidence-Based Medicine (EBM) will improve thequality of care. In particular, we examine thefollowing issues.

The basis for ‘sound’ medical opinion has moved from clinical opinion to evidence based research. This article will comment on the basis on which evidence in clinical medicine is collected and, indeed, what actually constitutes evidence. It is suggested that the definition of guidelines arising from evidence-based medicine may lead to false conclusion and, as noted by Sir Douglas Black, whilst ‘guidelines can of course be helpful in clear-cut situations; [but] these are (...) the minority in actual practice’. (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)

Evidence-based psychiatry (EBP) has arisen through the application of evidence-based medicine (EBM) to psychiatry. However, there may be aspects of psychiatric disorders and treatments that do not conform well to the assumptions of EBM. This paper reviews the ongoing debate about evidence-based psychiatry and investigates the applicability, to psychiatry, of two basic methodological features of EBM: prognostic homogeneity of clinical trial groups and quantification of trial outcomes. This paper argues that EBM may not (...) be the best way to pursue psychiatric knowledge given the particular features of psychiatric disorders and their treatments. As a result, psychiatry may have to develop its own standards for rigour and validity. This paper concludes that EBM has had a powerful influence on how psychiatry investigates and understands mental disorders. Psychiatry could influence EBM in return, reshaping it in ways that are more clinically useful and congruent with patients’ needs. (shrink)

Evidence-based medicine is seen not only as an important means to improve the quality of medical care, but also as an instrument to control costs. In view of the scarcity of health care resources, decisions on the allocation of care will have to be made more explicitly and should be made more transparent.

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)

Evidence-based medicine was developed to ensure that health-care decisions are based on the best available research evidence. Making this evidence available to patients is supposed to increase their autonomy by putting them in a position to make better-informed choices. In this paper, I draw on work in feminist bioethics to critique EBM’s approach to involving patients in decision making, in which patients are asked merely to select their preferences among various possible treatment outcomes but (...) are not encouraged to actively contend with the effects of illness on their lives as a whole. (shrink)

While evidence-based medicine (EBM) is often accused on relying on a paradigm of 'absolute truth', it is in fact highly consistent with Karl Popper's criterion of demarcation through falsification. Even more relevant, the first three steps of the EBM process are closely patterned on Popper's evolutionary approach of objective knowledge: (1) recognition of a problem; (2) generation of solutions; and (3) selection of the best solution. This places the step 1 of the EBM process (building an answerable (...) question) in a pivotal position for the understanding of the whole process, and underscores a few aspects which are often overlooked in EBM courses. First in this step internal evidence (including personal expertise) must be appraised and integrated in the problem. Second, issues of applicability of the possible solution should be anticipated. Third, and possibly more important, the goal of the intervention should be set at this stage (typically by choosing the outcome in a PICO question). Depending whether or not goals depend on the goals of others, and whether they concern others' voluntary behaviour, goals may be classified as self-serving, moral, altruistic or moralistic. Thus, delicate ethical questions must be addressed at this stage, which means that patient preferences and values must be carefully sought, so that empathy, counselling and narrative medicine must be mastered to be able to formulate correctly an answerable question. The need to modify the current description of the EBM process to increase the recognition of implicit assumptions and increase the consistency of this model is discussed. (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)

“Evidence based medicine” is often seen as a scientific tool for quality improvement, even though its application requires the combination of scientific facts with value judgments and the costing of different treatments. How this is done depends on whether we approach the problem from the perspective of individual patients, doctors, or public health administrators. Evidence based medicine exerts a fundamental influence on certain key aspects of medical professionalism. Since, when clinical practice guidelines are created, (...) costs affect the content of EBM, EBM inevitably becomes a form of rationing and adopts a public health point of view. This challenges traditional professionalism in much the same way as managed care has done in the US. Here we chart some of these major philosophical issues and show why simple solutions cannot be found. The profession needs to pay more attention to different uses of EBM in order to preserve the good aspects of professionalism. (shrink)

This article tries to present a broad view on the values and ethicalissues that are at stake in efforts to rationalize health policy on thebasis of economic evaluations (like cost-effectiveness analysis) andrandomly controlled clinical trials. Though such a rationalization isgenerally seen as an objective and `value free' process, moral valuesoften play a hidden role, not only in the production of `evidence', butalso in the way this evidence is used in policy making. For example, thedefinition of effectiveness of medical (...) treatment or health care serviceis heavily dependent on dominant individual or social views about thegoals of the particular treatment or service. There is also a concernthat a reliance on EBM in health policy will occur at the expense ofwidely shared social values like equity and solidarity. Moreover, thereis a concern that when economic considerations and rational proceduresbecome more influential, various `outside' groups third parties likeinsurance companies and policy makers will get a stronger influence onmedical practice which may lead to a change in the patient-providerrelationship. The authors conclude that social values and patientpreference should be explicitly addressed when health policy making isbased on economic and other scientific evidence. (shrink)

This paper challenges the traditional assumption that descriptive and prescriptive sciences are essentially distinct by presenting a study on the implicit normativity of the production and presentation of biomedical scientific facts within evidence-based medicine. This interdisciplinary study serves as an illustration of the potential worth of the concept of implicit normativity for bioethics in general and for integrated empirical ethics research in particular. It demonstrates how both the production and presentation of scientific information in an evidence- (...) class='Hi'>based decision-support contain implicit presuppositions and values, which pre-structure the moral environment of the clinical process of decision-making. As a consequence, the evidence-based decision support did not only support the clinical decision-making process; it also transformed it in a morally significant way. This phenomenon undermines the assumption within much of the literature on patient autonomy that information disclosure is a conditional requirement before patient autonomy even starts; patient autonomy is already influenced during the production and presentation of information. These results imply an increased responsibility of those who produce and present evidence-based facts(i.e. scientists in general and physicians in particular). The insights of this study not only involve a different focus on both theory and practice of patient autonomy and informed consent, but they also call for a broader scope of morality than does traditional empirical research in bioethics. The concept of implicit normativity within integrated empirical ethics research calls for a strong cooperation between bioethicists and descriptive scientists, i.e., a cooperation that goes beyond the discipline-specific epistemic values and that takes place during all phases of the research process. (shrink)

While much excitement has been generated surrounding evidence-based medicine, internal documents from the pharmaceutical industry suggest that the publicly available evidence base may not accurately represent the underlying data regarding its products. The industry and its associated medical communication firms state that publications in the medical literature primarily serve marketing interests. Suppression and spinning of negative data and ghostwriting have emerged as tools to help manage medical journal publications to best suit product sales, while disease mongering (...) and market segmentation of physicians are also used to efficiently maximize profits. We propose that while evidence-based medicine is a noble ideal, marketing-based medicine is the current reality. (shrink)