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)

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 use of evidence in medicine is something we should continuously seek to improve. This book seeks to develop our understanding of evidence of mechanism in evaluating evidence in medicine, public health, and social care; and also offers tools to help implement improved assessment of evidence of mechanism in practice. In this way, the book offers a bridge between more theoretical and conceptual insights and worries about evidence of mechanism and practical means to (...) fit the results into evidence assessment procedures. (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)

The concept of evidence has gone unanalysed in much of the current debate between proponents and critics of evidence-based medicine. In this paper I will suggest that part of the controversy rests on an understanding of the word “evidence” that is too broad, and therefore contains the contradictions that allow both camps to defend their position and charge their adversaries. I will argue that reconciling the different meanings of the word ‘evidence’ in “evidence-based (...) class='Hi'>medicine” should help put EBM in its rightful place. (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)

Inference to the Best Explanation is usually employed in the Scientific Realism debates. As far as particular scientific theories are concerned, its most ready usage seems to be that of a theory of confirmation. There are however more uses of IBE, namely as an epistemological theory of testimony and as a means of categorising and justifying the sources of evidence. In this paper, I will present, develop and exemplify IBE as a theory of the quality of evidence - (...) taking examples from medicine and showing that IBE can thereby provide the epistemological underpinning and justify the criteria of grading quality of mechanistic evidence that have been recently provided in the Clarke et al. paper on how evidence of medical mechanisms is to be construed alongside population studies. (shrink)

Medical scientists employ ‘quality assessment tools’ (QATs) to measure the quality of evidence from clinical studies, especially randomized controlled trials (RCTs). These tools are designed to take into account various methodological details of clinical studies, including randomization, blinding, and other features of studies deemed relevant to minimizing bias and error. There are now dozens available. The various QATs on offer differ widely from each other, and second-order empirical studies show that QATs have low inter-rater reliability and low inter-tool reliability. (...) This is an instance of a more general problem I call the underdetermination of evidential significance. Disagreements about the strength of a particular piece of evidence can be due to different—but in principle equally good—weightings of the fine-grained methodological features which constitute QATs. (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)

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)

Evidence based medicine has had an increasing impact on primary care over the last few years. In the UK it has influenced the development of guidelines and quality standards for clinical practice and the allocation of resources for drug treatments and other interventions. It has informed the thinking around patient involvement in decision making with the concept of evidence based patient choice. There are, however, concerns among primary care clinicians that evidence based medicine is not (...) always relevant to primary care and that undue emphasis placed on it can lead to conflict with a clinician’s duty of care and respect for patient autonomy. In this paper we consider the impact of evidence based medicine on primary care, and the ethical implications of its increasing prominence for clinicians and managers in primary care. (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 (...) class='Hi'>evidence we have about disease and its treatment. This creates a significant ethical, epistemological and ontological challenge for medicine. (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.

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)

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-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)

Even though the evidence‐based medicine movement (EBM) labels mechanisms a low quality form of evidence, consideration of the mechanisms on which medicine relies, and the distinct roles that mechanisms might play in clinical practice, offers a number of insights into EBM itself. In this paper, I examine the connections between EBM and mechanisms from several angles. I diagnose what went wrong in two examples where mechanistic reasoning failed to generate accurate predictions for how a dysfunctional mechanism (...) would respond to intervention. I then use these examples to explain why we should expect this kind of mechanistic reasoning to fail in systematic ways, by situating these failures in terms of evolved complexity of the causal system(s) in question. I argue that there is still a different role in which mechanisms continue to figure as evidence in EBM: namely, in guiding the application of population‐level recommendations to individual patients. Thus, even though the evidence‐based movement rejects one role in which mechanistic reasoning serves as evidence, there are other evidentiary roles for mechanistic reasoning. This renders plausible the claims of some critics of evidencebased medicine who point to the ineliminable role of clinical experience. Clearly specifying the ways in which mechanisms and mechanistic reasoning can be involved in clinical practice frames the discussion about EBM and clinical experience in more fruitful terms. (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)

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)

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.

Background: There is a lack of empirical data on lay attitudes toward different sorts of deception in medicine. However, lay attitudes toward deception should be taken into account when we consider whether deception is ever permissible in a medical context. The objective of this study was to examine lay attitudes of U.S. citizens toward different sorts of deception across different medical contexts. Methods: A one-time online survey was administered to U.S. users of the Amazon “Mechanical Turk” website. Participants were (...) asked to answer questions regarding a series of vignettes depicting different sorts of deception in medical care, as well as a question regarding their general attitudes toward truth-telling. Results: Of the 200 respondents, the majority found the use of placebos in different contexts to be acceptable following partial disclosure but found it to be unacceptable if it involved outright lying. Also, 55.5% of respondents supported the use of sham surgery in clinical research, although 55% claimed that it would be unacceptable to deceive patients in this research, even if this would improve the quality of the data from the study. Respondents supported fully informing patients about distressing medical information in different contexts, especially when the patient is suffering from a chronic condition. In addition, 42.5% of respondents believed that it is worse to deceive someone by providing the person with false information than it is to do so by giving the person true information that is likely to lead them to form a false belief, without telling them other important information that shows it to be false. However, 41.5% believed that the two methods of deception were morally equivalent. Conclusions: Respondents believed that some forms of deception were acceptable in some circumstances. While the majority of our respondents opposed outright lying in medical contexts, they were prepared to support partial disclosure and the use of placebos when it is in the patient's interests or when it is what the person would want. These results support the position that physicians should be allowed a greater degree of authority to make a professional judgment about whether deception might be morally warranted by the circumstances, provided that it doesn't involve outright lying. (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 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)

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)

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)

The clinical decision is supposed to be based on evidence. In fact, what counts as evidence is far from being established. Some definition of "proof" is needed to distinguish between scientific medicine and charlatanism. My thesis is that unfortunately a clear-cut boundary between evidence and lack of evidence cannot be found, for several reasons that I summarise in the paper. Evidence in medicine very often has fuzzy boundaries, and dichotomising fuzziness and uncertainty can (...) have serious consequences. Physicians and patients should accept the irreducible fuzziness of many of the concepts they use when dealing with health and disease. (shrink)

Uncertainty is the name of the game in philosopher Kenneth W Goodman’s attempt to apply ethics to evidence based medicine . Indeed, the book is as much about epistemology, or the study of how we learn and know about the world, as it is about ethics. Goodman’s desire is to understand what constitutes proof, or evidence, that a particular treatment is better than others. One of the ethical connections is that a failure to use such treatments is (...) blameworthy.EBM is a concept that is getting a great deal of attention these days. At least two factors drive this …. (shrink)

In this article we explore the role evidence ought to play in complementary and alternative medicine. First, we consider the claim that evidence in the form of randomized controlled trials cannot be obtained for CAMs. Second, we consider various claims to the effect that there are ways of obtaining evidence that do not make use of RCTs. We argue that there is no good reason why CAM should be exempted from the general requirement that treatments undergo (...) evaluation by RCT. Third, we consider two implications for health care policy. First, many activities in conventional medicine have never been rigorously evaluated and are widely in use nonetheless. We argue that this fails to provide a reason for exempting CAM from a demand for evidence. Second, CAM use may be compared to a choice of lifestyle, and this has a significant impact on which requirements of evidence can reasonably be imposed. (shrink)

Evidence-based medicine has always required integration of patient values with ‘best’ clinical evidence. It is widely recognized that scientific practices and discoveries, including those of EBM, are value-laden. But to date, the science of EBM has focused primarily on methods for reducing bias in the evidence, while the role of values in the different aspects of the EBM process has been almost completely ignored.

“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)

In this thesis, I give a metascientific account of causality in medicine. I begin with two historical cases of causal discovery. These are the discovery of the causation of Burkitt’s lymphoma by the Epstein-Barr virus, and of the various viral causes suggested for cervical cancer. These historical cases then support a philosophical discussion of causality in medicine. This begins with an introduction to the Russo- Williamson thesis (RWT), and discussion of a range of counter-arguments against it. Despite these, (...) I argue that the RWT is historically workable, given a small number of modifications. I then expand Russo and Williamson’s account. I first develop their suggestion that causal relationships in medicine require some kind of evidence of mechanism. I begin with a number of accounts of mechanisms and produce a range of consensus features of them. I then develop this consensus position by reference to the two historical case studies with an eye to their operational competence. In particular, I suggest that it is mechanistic models and their representations which we are concerned with in medicine, rather than the mechanism as it exists in the world. -/- I then employ these mechanistic models to give an account of the sorts of evidence used in formulating and evaluating causal claims. Again, I use the two human viral oncogenesis cases to give this account. I characterise and distinguish evidence of mechanism from evidence of difference-making, and relate this to mechanistic models. I then suggest the relationship between types of evidence presents us with a means of tackling the reference-class problem. This sets the scene for the final chapter. Here, I suggest the manner in which these two different classes of evidence become integrated is also reflected in the way that developing research programmes change as their associated causal claims develop. (shrink)

“Democratization” has recently become a popular trope in Western public discourses on medicine, where it refers to patient participation in the gathering and distribution of health-related data using various digital technologies, in order to improve healthcare technically and socially. We critically analyze the usage of the term from the perspective of the “politics of buzzwords.” Our claim is that the phrase works primarily to publicly justify the dramatic increase in the application of information and data technologies in healthcare and (...) therefore fosters the corresponding industry. As a buzzword, “democratizing healthcare” is characterized by vagueness, which is why it receives meaning only through a word collective—a group of words that provide it with a context and are often used together with it. We examine key terms associated with “democratization” in the healthcare discourse—participation, empowerment, and personalized medicine—and show that the buzzword receives rhetorical power through the ambiguous reference to these concepts. As a consequence, the idea of “democracy” becomes diluted into meaning merely “access to,” and “healthcare” is reduced to the notion of a preventive, nonacute, monitored form of medical care. (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)

According to current hierarchies of evidence for EBM, evidence of correlation is always more important than evidence of mechanisms when evaluating and establishing causal claims. We argue that evidence of mechanisms needs to be treated alongside evidence of correlation. This is for three reasons. First, correlation is always a fallible indicator of causation, subject in particular to the problem of confounding; evidence of mechanisms can in some cases be more important than evidence of (...) correlation when assessing a causal claim. Second, evidence of mechanisms is often required in order to obtain evidence of correlation. Third, evidence of mechanisms is often required in order to generalise and apply causal claims. While the EBM movement has been enormously successful in making explicit and critically examining one aspect of our evidential practice, i.e., evidence of correlation, we wish to extend this line of work to make explicit and critically examine a second aspect of our evidential practices: evidence of mechanisms. (shrink)

Despite its phenomenal success since its inception in the early nineteen-nineties, the evidence-based medicine movement has not succeeded in shaking off an epistemological critique derived from the experiential or tacit dimensions of clinical reasoning about particular individuals. This critique claims that the evidence-based medicine model does not take account of tacit knowing as developed by the philosopher Michael Polanyi. However, the epistemology of evidence-based medicine is premised on the elimination of the tacit dimension from (...) clinical judgment. This is demonstrated through analyzing the dichotomy between clinical and statistical intuition in evidence-based medicine’s epistemology of clinical reasoning. I argue that clinical epidemiology presents a more nuanced epistemological model for the application of statistical epidemiology to the clinical context. Polanyi’s theory of tacit knowing is compatible with the model of clinical reasoning associated with clinical epidemiology, but not evidence-based medicine. (shrink)

Evidence based medicine has been a topic of considerable controversy in medical and health care circles over its short lifetime, because of the claims made by its exponents about the criteria used to assess the evidence for or against the effectiveness of medical interventions. The central epistemological debates underpinning the debates about evidence based medicine are reviewed by this paper, and some areas are suggested where further work remains to be done. In particular, further work (...) is needed on the theory of evidence and inference; causation and correlation; clinical judgment and collective knowledge; the structure of medical theory; and the nature of clinical effectiveness. (shrink)

This article examines the implicit promises of fairness in evidence based medicine , namely to avoid discrimination through objective processes, and to distribute effective treatments fairly. The relationship between EBM and vulnerable groups is examined. Several aspects of EBM are explored: the way evidence is created , and the way evidence is applied in clinical care and health policy. This analysis suggests that EBM turns our attention away from social and cultural factors that influence health and (...) focuses on a narrow biomedical and individualistic model of health. Those with the greatest burden of ill health are left disenfranchised, as there is little research that is relevant to them, there is poor access to treatments, and attention is diverted away from activities that might have a much greater impact on their health. (shrink)