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 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)

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 (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 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)

Clinicians and policy makers the world over are embracing evidence-based medicine. The promise of EBM is to use summaries of research evidence to determine which healthcare interventions are effective and which are not, so that patients may benefit from effective interventions and be protected from useless or harmful ones. EBM provides an ostensibly rational and objective means of deciding whether or not an intervention should be provided on the basis of its effectiveness, in theory leading to (...) fair and effective healthcare for all. In this paper I closely examine these claims from the perspective of healthcare for women, using relevant examples. I argue that the current processes of evidence-based medicine contain a number of biases against women. These biases occur in the production of the research that informs evidence-based medicine, in the methods used to analyse and synthesise the evidence, and in the application of EBM through the use of guidelines. Finally, the biomedical model of health that underpins most of the medical research used by EBM ignores the social and political context which contributes so much to the ill-health of women. (shrink)

In evidence-based medicine (EBM), methodology has become the central means of determining the quality of the evidence base. The “gold standard” method, the randomised, controlled trial (RCT), imbues medical research with an ethos of disinterestedness; yet, as this essay argues, the RCT is itself a rhetorically interested construct essential to medical-professional boundary work. Using the example of debates about methodology in EBM-oriented research on complementary and alternative medicine (CAM), practices not easily tested by RCTs, I (...) frame the problem of method as a fundamentally rhetorical problem, situated within a boundary drama, and deeply rooted in the discursive practices of science and medicine. The genre of the RCT report, for example, idealises the research process and can tilt the course of arguments about CAM, while the notion of efficacy can function as a rhetorically mobile boundary object that can redefine the very terms of debate. I suggest herein that arguments about method in CAM debates can productively be read, metonymically, as expressions of more general anxieties in medicine about knowledge and evidence, community values, and professional boundaries; as such, these debates can illuminate some of the rhetorical dimensions of EBM. (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)

BACKGROUND AND RATIONALE: Evidence based medicine is the present backbone of rational and objective, modern medical problem solving and is a meeting ground for quantitative and qualitative researchers alike as it culminates into applying the fruits of clinical research to the individual patient. A systematic enquiry into the evolving paradigms in EBM is a need of the hour. AIMS AND METHODS: A qualitative enquiry examining the impact of different methodologies in EBM and their role in generating (...) meaning interpretable at individual levels. RESULTS: Present day outcome based research deals less with patients as individuals than as populations. Evidence based medicine struggles to apply the fruits of population based research to individuals who are often not as predictable as linear quantitative research would like them to be. The present EBM literature neglects a lot of events it doesn't believe to be statistically significant and perhaps here is an area that needs to be improved on - it assumes that because associations are demonstrated between interventions and outcomes in RCTs/meta-analysis, these associations are linear and causal in the real world. While they may be demonstrated repeatedly in highly controlled environments, in the real 'uncontrolled' world of clinical practice with real people, their validity breaks down. CONCLUSIONS: One needs to make the EBM standard model patient-individual (a projection of collective patient event data) resemble the real human individual patient so that optimal EBM individual data that matches our query can be easily and quickly spotted from the dense jungle of information that has grown over the years. This hints at rethinking our entire research methodology and modifying it to suit the needs of the individual patient. (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.

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)

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)

As a way to make medical decisions, Evidence-Based Medicine (EBM) has failed. EBM's failure arises from not being founded on real-world decision-making. EBM aspires to a scientific standard for the best way to treat a disease and determine its cause, but it fails to recognise that the scientific method is inapplicable to medical and other real-world decision-making. EBM also wrongly assumes that evidence can be marshaled and applied according to an hierarchy that is determined in an (...) argument by authority to the method by which it has been obtained. If EBM had valid theoretical, practical or empirical foundations, there would be no hierarchy of evidence. In all real-world decision-making, evidence stands or falls on its inherent reliability. This has to be and can only be assessed on a case-by-case basis applying understanding and wisdom against the background of all available facts—the "factual matrix." EBM's failure is structural and was inevitable from its inception. EBM confuses the inherent reliability and probative value of evidence with the means by which it is obtained. -/- EBM is therefore an ad hoc construct and is not a valid basis for medical decision-making. This is further demonstrated by its exclusion of relevant scientific and probative real-world decision-making evidence and processes. It draws upon a narrow evidence base that is itself inherently unreliable. It fails to take adequate account of the nature of causation, the full range of evidence relevant to its determination, and differing approaches to determining cause and effect in real-world decision-making. EBM also makes a muddled attempt to emulate the scientific method and it does not acknowledge the role of experience, understanding and wisdom in making medical decisions. (shrink)

We motivate the possibility of using notions and methods derived from quantum physics, and more specifically from the research field known as ‘quantum cognition’, to optimally model different situations in the field of medicine, its decision-making processes and ensuing practices, particularly in relation to chronic and rare diseases. This also as a way to devise alternative approaches to the generally adopted double-blind gold standard.

We motivate the possibility of using notions and methods derived from quantum physics, and more specifically from the research field known as ‘quantum cognition’, to optimally model different situations in the field of medicine, its decision-making processes and ensuing practices, particularly in relation to chronic and rare diseases. This also as a way to devise alternative approaches to the generally adopted double-blind gold standard.

This paper explores some of the important parallels between recent reforms to legal rules for the admissibility of scientific and expert evidence, exemplified by the US Supreme Court's decision in Daubert v Merrell Dow Pharmaceuticals, Inc. in 1993, and similar calls for reforms to medical practice, that emerged around the same time as part of the Evidence-Based Medicine (EBM) movement. Similarities between the “movements” can be observed in that both emerged from a historical context where the (...) quality of medicine and legal approaches to science were being subjected to growing criticism, and in the ways that proponents of both movements have used appeals to “folk epistemologies” of science to help legitimate their reform aspirations. The term folk epistemology is used to describe the weaving together of formal and informal images of scientific method with normative and pragmatic concerns such as eradicating “junk science”, and promoting medical best practice. Perhaps unsurprisingly, given the unfocused breadth of these aspirations the implications of these “reforms” for medical and legal practice have not been straightforward, although they do represent an important new set of rhetorical resources to critique and or legitimate expertise in medical and legal domains. Discussion closes, by noting the growth of calls for these movements to reciprocate in areas where law and medicine intersect, such as medical negligence litigation. (shrink)

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)

Evidence based medicine has much to offer, but a great deal remains to be done to create a better understanding of what it can and cannot do.The term EBM , as we use it nowadays, was introduced in 1992 by the same group of people who, years before, founded the discipline called “Clinical epidemiology” .1 CE stemmed essentially from the idea of adapting and expanding epidemiological methods to medical and health care decision making; CE was in (...) fact defined as “ the discipline dealing with the study of the occurrence of medical decisions in relation to their determinants”.1CE has been very successful in illustrating new ways of teaching medicine and training health professionals, and has positioned itself around the notion that “critical appraisal skills” are yet another set of essential abilities which—in addition to the interpersonal, diagnostic, and prognostic skills—a good doctor should master. An important by product of CE was documentation which showed that much of the available evidence on diagnosis, prognosis, and treatment of diseases was of poor methodological quality and quite often of dubious transferability to everyday clinical practice.This led to a strong call for improving the scientific basis of clinical practice, which was seen as too often dominated by practices of unproven effectiveness. This was the background for the 1992 Journal of the American Medical Association article that first used the term “evidence based medicine”.2In essence, proponents of EBM said that “all medical action of diagnosis, prognosis, and therapy should rely on solid quantitative evidence based on the best of …. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Do People Defy Generalizations?Examining the Case Against Evidence-Based Medicine in PsychiatryGloria Ayob (bio)KeywordsPhilosophy, psychiatry, action, contentEvidence-based medicine (EBM) in psychiatry presupposes that it is possible to track the causal efficacy of treatments for psychopathological conditions using scientific methods. One central aim of EBM is to ascertain the causally efficacious component of the treatment of a given condition. This is done by collecting data (...) from randomized control trials, where this data are of groups rather than of individuals (Bolton, 2008).EBM is felt by many to have significant limitations when applied in the field of psychiatric medicine, and these limitations are thought to arise owing to a particular fact about psychiatry, namely that the subject of psychiatry is the human person. For brevity, I will refer to this broad claim as the Unsuitability Intuition (UI), which can be stated as follows:The UI is the intuition that EBM is somehow unsuitable for dealing with people.The aims of this paper are twofold. First, I try to pinpoint the source(s) of anxiety about EBM, and therein to clarify the exact sense(s) in which EBM might be said to be unsuitable or problematic. Second, I evaluate the validity of these concerns, focusing on two broad interrelated questions: (1) Is it actually something about human persons that creates trouble for EBM in psychiatry, and if so, what is the nature of this trouble?; and (2) What assumptions about EBM are made such that EBM is problematic in light of the fact that the subject of psychiatry is the human person?As an empirical point, EBM in psychiatry is applied to two methods of treatment: psychotropic drugs, and more recently, cognitive–behavioral therapies. Each of these throws up slightly different issues in light of the two questions just identified. To accommodate relevant differences, I structure this paper as follows. Bearing in mind that the overall aim of the paper is to scrutinize the intuition that EBM is somehow unsuitable for dealing with people, I begin by exploring one common suggestion as to what underpins this intuition: The problem we are confronted with, in applying EBM to people, is the problem of applying generalizations to particular instances (Wifstad 2008). To anticipate, I argue that this worry concerns a problem that, in fact, applies to the scientific method in general. That is, it is not a [End Page 167] problem arising specifically from the fact that the subject of psychiatry is the human person. So if this is the worry about EBM, then as it stands, it does not satisfactorily explain the intuition that EBM is somehow unsuitable for dealing with people.Against this, the UI theorist might defend his intuition by attempting to specify the reasons why persons, unlike physical material, present a special challenge to the scientific method presupposed by EBM. One way of doing this is to point out that the determinants of human behavior cannot be captured by generalizations (and in particular, by causal generalizations). There are two ways of worrying about EBM here: On the first, the problem of EBM in psychiatry is a pragmatic worry that arises in view of the complexity of the determinants of human behavior and the limited capacity for observation. If this is the worry, though, it can be overcome to a greater or lesser extent within psychiatric practice. The second worry consists in the thought that humans pose a constitutive problem for EBM in psychiatry. However, I argue that this worry turns out to rest on assumptions about human behavior that are not unproblematic in themselves. Thus, UI is underpinned either by a pragmatic worry that can be overcome to some extent, or else it is underpinned by certain assumptions that are problematic, if not altogether wrong. This means that UI cannot be founded on a constitutive point about persons—at least, it does not seem to be, if it arises from a concern about applying generalizations to individual human beings.But there is a very different type of worry that might underpin UI, one that does not issue from considerations about the relation between the general and the particular. UI theorists could be worried about specific... (shrink)

Evidence-based medicine’s (EBM) quantitative methodologies reflect medical science’s long-standing mistrust of the imprecision and subjectivity of ordinary descriptive language. However, EBM’s attempts to replace subjectivity with precise empirical methods are problematic when clinicians must negotiate between scientific medicine and patients’ experience. This problem is evident in the case of bibliotherapy (patient reading as treatment modality), a practice widespread despite its reliance on anecdotal evidence. While EBM purports to replace such flawed practice with reliable (...) class='Hi'>evidence-based methods, this essay argues that its aversion to subjective language prevents EBM from effectively evaluating bibliotherapy or making it amenable to clinical and research governance. (shrink)

Background The increase in empirical methods of research in bioethics over the last two decades is typically perceived as a welcomed broadening of the discipline, with increased integration of social and life scientists into the field and ethics consultants into the clinical setting, however it also represents a loss of confidence in the typical normative and analytic methods of bioethics. Discussion The recent incipiency of "Evidence-Based Ethics" attests to this phenomenon and should be rejected as a (...) solution to the current ambivalence toward the normative resolution of moral problems in a pluralistic society. While "evidence-based" is typically read in medicine and other life and social sciences as the empirically-adequate standard of reasonable practice and a means for increasing certainty, I propose that the evidence-based movement in fact gains consensus by displacing normative discourse with aggregate or statistically-derived empirical evidence as the "bottom line". Therefore, along with wavering on the fact/value distinction, evidence-based ethics threatens bioethics' normative mandate. The appeal of the evidence-based approach is that it offers a means of negotiating the demands of moral pluralism. Rather than appealing to explicit values that are likely not shared by all, "the evidence" is proposed to adjudicate between competing claims. Quantified measures are notably more "neutral" and democratic than liberal markers like "species normal functioning". Yet the positivist notion that claims stand or fall in light of the evidence is untenable; furthermore, the legacy of positivism entails the quieting of empirically non-verifiable considerations like moral claims and judgments. As a result, evidence-based ethics proposes to operate with the implicit normativity that accompanies the production and presentation of all biomedical and scientific facts unchecked. Summary The "empirical turn" in bioethics signals a need for reconsideration of the methods used for moral evaluation and resolution, however the options should not include obscuring normative content by seemingly neutral technical measure. (shrink)

BackgroundThe increase in empirical methods of research in bioethics over the last two decades is typically perceived as a welcomed broadening of the discipline, with increased integration of social and life scientists into the field and ethics consultants into the clinical setting, however it also represents a loss of confidence in the typical normative and analytic methods of bioethics.DiscussionThe recent incipiency of "Evidence-Based Ethics" attests to this phenomenon and should be rejected as a solution to the (...) current ambivalence toward the normative resolution of moral problems in a pluralistic society. While "evidence-based" is typically read in medicine and other life and social sciences as the empirically-adequate standard of reasonable practice and a means for increasing certainty, I propose that the evidence-based movement in fact gains consensus by displacing normative discourse with aggregate or statistically-derived empirical evidence as the "bottom line". Therefore, along with wavering on the fact/value distinction, evidence-based ethics threatens bioethics' normative mandate. The appeal of the evidence-based approach is that it offers a means of negotiating the demands of moral pluralism. Rather than appealing to explicit values that are likely not shared by all, "the evidence" is proposed to adjudicate between competing claims. Quantified measures are notably more "neutral" and democratic than liberal markers like "species normal functioning". Yet the positivist notion that claims stand or fall in light of the evidence is untenable; furthermore, the legacy of positivism entails the quieting of empirically non-verifiable (or at least non-falsifiable) considerations like moral claims and judgments. As a result, evidence-based ethics proposes to operate with the implicit normativity that accompanies the production and presentation of all biomedical and scientific facts unchecked.SummaryThe "empirical turn" in bioethics signals a need for reconsideration of the methods used for moral evaluation and resolution, however the options should not include obscuring normative content by seemingly neutral technical measure. (shrink)

Evidence based medicine (EBM) is under critical debate, and person centered healthcare (PCH) has been proposed as an improvement. But is PCH offered as a supplement or as a replacement of EBM? Prima facie PCH only concerns the practice of medicine, while the contended features of EBM also include methods and medical model. I here argue that there are good philosophical reasons to see PCH as a radical alternative to the existing medical paradigm of EBM, (...) since the two seem committed to conflicting ontologies. This paper aims to make explicit some of the most fundamental assumptions that motivate EBM and PCH, respectively, in order to show that the choice between them ultimately comes down to ontological preference. While EBM has a solid foundation in positivism, or what I here call Humeanism, PCH is more consistent with causal dispositionalism. I conclude that if there is a paradigmatic revolution on the way in medicine, it is first of all one of ontology. (shrink)

BackgroundThe concept of evidence-based medicine has strongly influenced the appraisal and application of empirical information in health care decision-making. One principal characteristic of this concept is the distinction between "evidence" in the sense of high-quality empirical information on the one hand and rather low-quality empirical information on the other hand. In the last 5 to 10 years an increasing number of articles published in international journals have made use of the term "evidence-based ethics", making (...) a systematic analysis and explication of the term and its applicability in ethics important.DiscussionIn this article four descriptive and two normative characteristics of the general concept "evidence-based" are presented and explained systematically. These characteristics are to then serve as a framework for assessing the methodological and practical challenges of evidence-based ethics as a developing methodology. The superiority of evidence in contrast to other empirical information has several normative implications such as the legitimization of decisions in medicine and ethics. This implicit normativity poses ethical concerns if there is no formal consent on which sort of empirical information deserves the label "evidence" and which does not. In empirical ethics, which relies primarily on interview research and other methods from the social sciences, we still lack gold standards for assessing the quality of study designs and appraising their findings.ConclusionThe use of the term "evidence-based ethics" should be discouraged, unless there is enough consensus on how to differentiate between high- and low-quality information produced by empirical ethics. In the meantime, whenever empirical information plays a role, the process of ethical decision-making should make use of systematic reviews of empirical studies that involve a critical appraisal and comparative discussion of data. (shrink)

Evidence‐based practice (EBP) first appeared on the healthcare horizon just over a decade ago. In 2003 its presence has intensified and extended beyond its initial relation to medicine embracing as it does now, nursing and the allied health disciplines. In this paper, I contend that its appearance and subsequent growth and development are the effects of potent ‘regimes of truth’, four of which bear the names: positivism, empiricism, pragmatism and economic rationalism. My aim is to show how (...) EBP generates the controversy it does because its nature and methods are inextricably interwoven with the way it has become politicised and professionalised. This exegesis is an attempt to outline how the combined effects of the four forms of rationality mentioned above allow for both the methods and objectives of EBP to be constructed as they are, while at the same moment producing the particular effects of knowledge and power in terms of who sells and who buys the idea of EBP in the culture of contemporary healthcare. (shrink)

We claim that if a complete philosophy of evidence-based practice is intended, then attention to the nature of causation in health science is necessary. We identify how health science currently conceptualises causation by the way it prioritises some research methods over others. We then show how the current understanding of what causation is serves to constrain scientific progress. An alternative account of causation is offered. This is one of dispositionalism. We claim that by understanding causation from a (...) dispositionalist stance, many of the processes within an evidence-based practice framework are better accounted for. Further, some of the problems associated with the health research, e.g. external validity of causal findings, dissolve. (shrink)

Rationale, aims and objectives : Evidence-based medicine (EBM) claims to be based on 'evidence', rather than 'intuition'. However, EBM's fundamental distinction between quantitative 'evidence' and qualitative 'intuition' is not self-evident. The meaning of 'evidence' is unclear and no studies of quality exist to demonstrate the superiority of EBM in health care settings. This paper argues that, despite itself, EBM holds out only the illusion of conclusive scientific rigour for clinical decision making, and that (...) EBM ultimately is unable to fulfil its own structural criteria for 'evidence'. Methods : Our deconstructive analysis of EBM draws on the work of the French philosopher, Jacques Derrida. Deconstruction works in the name of justice to lay bare, to expose what has been hidden from view. In plain language, we deconstruct EBM's paradigm of 'evidence', the randomized controlled trial (RCT), to demonstrate that there cannot be incontrovertible evidence for EBM as such. We argue that EBM therefore 'auto-deconstructs' its own paradigm, and that medical practitioners, policymakers and patients alike ought to be aware of this failure within EBM itself. Results : EBM's strict distinction between admissible evidence (based on RCTs) and other supposedly inadmissible evidence is not itself based on evidence, but rather, on intuition. In other words, according to EBM's own logic, there can be no 'evidentiary' basis for its distinction between admissible and inadmissible evidence. Ultimately, to uphold this fundamental distinction, EBM must seek recourse in (bio)political ideology and an epistemology akin to faith. (shrink)

Objective: To examine the role of explainability in machine learning for healthcare (MLHC), and its necessity and significance with respect to effective and ethical MLHC application. Study Design and Setting: This commentary engages with the growing and dynamic corpus of literature on the use of MLHC and artificial intelligence (AI) in medicine, which provide the context for a focused narrative review of arguments presented in favour of and opposition to explainability in MLHC. Results: We find that concerns regarding explainability (...) are not limited to MLHC, but rather extend to numerous well-validated treatment interventions as well as to human clinical judgment itself. We examine the role of evidence-based medicine in evaluating unexplainable treatments and technologies, and highlight the analogy between the concept of explainability in MLHC and the related concept of mechanistic reasoning in evidence-based medicine. Conclusion: Ultimately, we conclude that the value of explainability in MLHC is not intrinsic, but is instead instrumental to achieving greater imperatives such as performance and trust. We caution against the uncompromising pursuit of explainability, and advocate instead for the development of robust empirical methods to successfully evaluate increasingly inexplicable algorithmic systems. (shrink)

RATIONALE: The concept of evidence-based medicine is important in providing efficient health care. The process uses research findings as the basis for clinical decision making. Evidence-based practice helps optimize current health care and enables the practitioners to be suitably accountable for the interventions they provide. Little work has been undertaken to examine how allied health professionals change their clinical practice in light of the latest evidence. The use of opinion leaders to disseminate new (...) class='Hi'>evidence around the management of low back pain into practice has been proposed. AIMS: The aim of this study was to investigate if physiotherapists' clinical management of patients with low back pain would change following an evidence-based education package, which utilized local opinion leaders and delivered the best evidence. METHOD: Thirty musculoskeletal physiotherapists from a Community Trust in North Staffordshire were cluster randomized by location of work, to two groups. The intervention group received an evidence-based programme on the management of low back pain, including advice regarding increasing activity levels and return to normal activity and challenging patients' fears and beliefs about their pain. The control group received a standard in-service training package on the management of common knee pathologies. The physiotherapists' clinical management of patients with low back pain was measured prior to training and 6 months post training. Outcome measures were based on physiotherapists completing 'discharge summary' questionnaires, which included information relating to the use and importance of therapies for treating their low back pain patients. RESULTS: There were few significant differences in treatment options between the intervention and control groups post training. Whilst there was some indication that physiotherapists were already utilizing aspects of psychosocial management for patients with low back pain, there was little change in what physiotherapists perceived to be important to patient recovery and actual clinical practice following the intervention. CONCLUSIONS: Psychosocial factors have been identified as an important factor in the recovery of patients with low back pain. This project incorporated the latest evidence on the management of low back pain and utilized the theory of opinion leaders to disseminate this evidence into clinical practice. Whilst there were some limitations in the overall size of the study, the results help to give an insight into the challenges faced by the health care system and researchers alike to ensure quality evidence is actually utilized by practitioners for the benefits of patient care. (shrink)

Gupta effectively probes the methodological and ethical presuppostions of Evidence Based Medicine, and its more contestable application to psychiatry. She concludes with an endorsement of a very modest reformulation of it as one guide to practice among many.

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)

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.

Fulford has argued that (1) the medical concepts illness, disease and dysfunction are inescapably evaluative terms, (2) illness is conceptually prior to disease, and (3) a model conforming to (2) has greater explanatory power and practical utility than the conventional value-free medical model. This ‘reverse’ model employs Hare's distinction between description and evaluation, and the sliding relationship between descriptive and evaluative meaning. Fulford's derivative ‘Values Based Medicine’ (VBM) readjusts the imbalance between the predominance of facts over values in (...) medicine. VBM allegedly responds to the increased choices made available by, inter alia, the progress of medical science itself. VBM attributes appropriate status to evaluative meaning, where strong consensus about descriptive meaning is lacking. According to Fulford, quasi-legal bioethics, while it can be retained as a kind of deliberative framework, is outcome-based and pursues ‘the right answer’, while VBM approximates a democratic, process-oriented method for dealing with diverse values, in partnership with necessary contributions from evidence-based medicine (EBM). I support the non-cognitivist underpinnings of VBM, and its emphasis on the importance of values in medicine. But VBM overstates the complexity and diversity of values, misrepresents EBM and VBM as responses to scientific and evaluative complexity, and mistakenly depicts ‘quasi-legal bioethics’ as a space of settled descriptive meaning. Bioethical reasoning can expose strategies that attempt to reduce authentic values to scientific facts, illustrating that VBM provides no advantage over bioethics in delineating the connections between facts and values in medicine. (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)

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 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 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)

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)

Fifty years ago, in 1961, Feinstein published his first path-breaking articles leading to his seminal work Clinical Judgement and to the establishment of clinical epidemiology. Feinstein had an Aristotelian approach to scientific method: methods must be adapted to the material examined. Feinstein died 10 years ago and few years before his death he concluded that efforts to promote a person-oriented medicine had failed. He criticised medicine for not having recognized that only persons can suitably observe, evaluate and (...) rate their own health status. Feinstein’s position was—as in Clinical Judgement—methodological. He didn’t espouse ethical principles. He pointed to methodological deficiencies in clinical epidemiology and evidence-based medicine. In this article we’ll provide a framework for understanding and justifying Feinstein’s call for a person-oriented medicine which recognizes patients as co-actors in clinical reasoning. It’s argued that craftsmanship and practical wisdom are integrated in clinical judgement and reasoning and that clinical reasoning is not only about means to achieve the end, health. We do also reason and deliberate about ends. The ‘defining end’ of medicine (health) has continuously been negotiated and so been the object of deliberation. For centuries among professionals, in recent years among professionals and patients. These negotiations and deliberations lead to ongoing specifications of health as a ‘guiding end’, i.e. an end guiding clinical reasoning about what to do in particular situations. Feinstein’s self-critical account to clinical epidemiology at the end of his professional career reflects the fact that patients during the last 30–40 years (i.e. in the period after the publication of Clinical Judgement) widely have been recognized as persons with rights to autonomy. Feinstein’s lesson is, however, that espousing and recognizing ethical ideals is not enough. A change of clinical practice and its methods is necessary. His critique also implies that clinical epidemiology and evidence-based medicine as practiced haven’t provided such a turn. (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 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)