Evidence-based medicine (EBM) calls for medical practitioners to “integrate” our best available evidence into clinical practice. A significant amount of the literature on EBM takes this integration to be unproblematic, focusing on questions like how to interpret evidence and engage with patient values, rather than critically looking at how these features of EBM can be implemented together. Other authors have also commented on this gap in the literature, for example, identifying the lack of clarity about how patient preferences and evidence (...) from trials is supposed to be integrated in practice. In this paper, I look at this issue from an epistemological perspective, (looking at how different types of knowledge in EBM can be used to make sounds judgements). In particular, I introduce an epistemological issue for this integration problem, which I call the epistemic integration problem. This is essentially the problem of how we can use information that is both general (eg, about a population sample) and descriptive (eg, about what expected outcomes are) to reach clinical judgements that are individualized (applying to a particular patient) and normative (about what is best for their health). (shrink)

Since its inception in the early 1990s, evidence-based medicine (EBM) has become the dominant epistemic framework for Western medical practice. However, in light of powerful criticisms against EBM, alternatives such as casuistic medicine have been gaining support in both the medical and philosophical community. In the absence of empirical evidence in support of the claim that EBM improves patient outcomes, and in light of considerations that it is unlikely that such evidence will be forthcoming, another standard is needed to assess (...) EBM against its alternatives. In this paper, I propose a set of criteria for this purpose based on Helen Longino's criteria for assessing the objectivity of a knowledge productive community. I then apply these criteria to assess EBM against a casuistic framework for medical knowledge. I argue that EBM's strict adherence to a hierarchical organization of knowledge can reasonably be expected to block it from fulfilling a high level of objectivity. A casuistic framework, on the other hand, because it emphasizes critical evaluation in conjunction with the flexibility of a case-based approach, could be expected to better facilitate a more optimal epistemic community. (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)

We raise a problem of applicability of RCTs to validate nuclear diagnostic imaging tests. In spite of the wide application of PET and other similar techniques that use radiopharmaceuticals for diagnostic purposes, RCT-based evidence on their validity is sparse. We claim that this is due to a general conceptual problem that we call Prevalence of Treatment, which arises in connection with designing RCTs for testing any diagnostic procedure in the present context of medical research, and is particularly apparent in this (...) case. We also identify three practical reasons why RCTs do not qualify as the best option for PET validation, which have to do with specific characteristics of nuclear diagnostic imaging, and of radiopharmaceuticals. The paper is meant to contribute both to the philosophical discussion on the EBM hierarchy of evidence, and on the specific debate on radiopharmaceuticals in nuclear medicine. (shrink)

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

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)

Evidential Pluralism maintains that in order to establish a causal claim one normally needs to establish the existence of an appropriate conditional correlation and the existence of an appropriate mechanism complex, so when assessing a causal claim one ought to consider both association studies and mechanistic studies. Hitherto, Evidential Pluralism has been applied to medicine, leading to the EBM+ programme, which recommends that evidence-based medicine should systematically evaluate mechanistic studies alongside clinical studies. This paper argues that Evidential Pluralism can also (...) be fruitfully applied to the social sciences. In particular, Evidential Pluralism provides (i) a new approach to evidence-based policy; (ii) an account of the evidential relationships in more theoretical research; and (iii) new philosophical motivation for mixed methods research. The application of Evidential Pluralism to the social sciences is also defended against two objections. (shrink)

Over the past several decades, we devoted much energy to generating, reviewing and summarizing evidence. We have given far less attention to the issue of how to thoughtfully apply the evidence once we have it. That’s fine if all we care about is that our clinical decisions are evidence-based, but not so good if we also want them to be well-reasoned. Let us not forget that evidence based medicine (EBM) grew out of an interest in making medicine ‘rational’, with the (...) idea that rational clinical evaluations should be evidence-based. I agree with the uncontroversial statement that the best decision is supported, at least in part, by the best available evidence. Rationality, however, is constituted by reasoning, not evidence. Complete arguments are necessary for rational evaluations, arguments that begin with general evidence and end in a conclusion about a particular patient. In order to traverse these inferential gaps, medicine must address the issue of how to establish, as an intermediate premise, what the evidence has to say about the efficacy of an intervention for particular patients in a particular practice setting. (shrink)

Public policymakers and institutional decision-makers routinely face questions about whether interventions “work”: does universal basic income improve people’s welfare and stimulate entrepreneurial activity? Do gated alleyways reduce burglaries or merely shift the crime burden to neighbouring communities? What is the most cost-effective way to improve students’ reading abilities? These are empirical questions that seem best answered by looking at the world, rather than trusting speculations about what will be effective. Evidence-based policy (EBP) is a movement that concretizes this intuition. It (...) maintains that policy should be based on evidence of “what works.” Not any evidence will do, however. Following on the heels of its intellectual progenitor, evidence-based medicine (EBM), EBP insists on the use of high-quality evidence produced in accordance with rigorous methodological standards. Though intuitively compelling, EBP has attracted significant criticism from methodologists, political scientists, and philosophers. This chapter provides a critical overview of EBP through a philosophical lens, reviewing and discussing some of the most pressing challenges that EBP faces and outlining some proposals for improving it. I first provide a brief overview of EBP and distinguish a broader and narrower understanding of it. I then review existing lines of criticism of EBP, two of which are considered in detail. The first elaborates how EBP struggles with extrapolation, that is, the use of evidence from study populations to make inferences about the effects of policies on novel target populations. The second maintains that EBP’s methodological tenets are deeply entwined with moral and political values, which can threaten EBP’s promise to promote objectivity in policymaking. Finally, I make some proposals for how EBP could be improved going forward. (shrink)

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

Because “evidence” is at issue in evidence-based medicine (EBM), the critical responses to the movement have taken up themes from post-positivist philosophy of science to demonstrate the untenability of the objectivist account of evidence. While these post-positivist critiques seem largely correct, I propose that when they focus their analyses on what counts as evidence, the critics miss important and desirable pragmatic features of the evidence-based approach. This article redirects critical attention toward EBM’s rigid hierarchy of evidence as the culprit of (...) its objectionable epistemic practices. It reframes the EBM discourse in light of a distinction between objectivist and pragmatic epistemology, which allows for a more nuanced analysis of EBM than previously offered: one that is not either/or in its evaluation of the decision-making technology as either iconoclastic or creedal. -/- . (shrink)

Philosophers of science have insisted that evidence of underlying mechanisms is required to support claims about the effects of medical interventions. Yet evidence about mechanisms does not feature on dominant evidence-based medicine “hierarchies.” After arguing that only inferences from mechanisms (“mechanistic reasoning”)—not mechanisms themselves—count as evidence, I argue for a middle ground. Mechanistic reasoning is not required to establish causation when we have high-quality controlled studies; moreover, mechanistic reasoning is more problematic than has been assumed. Yet where the problems can (...) be overcome, mechanistic reasoning can and should be used as evidence. (shrink)

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

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)

The emphasis on evidence based medicine (EBM) has placed increased focus on finding timely answers to clinical questions in presence of patients. Using a combination of natural language processing for the generation of clinical excerpts and information theoretic distance based clustering, we evaluated multiple approaches for the efficient presentation of context-sensitive EBM excerpts.

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)

We live in an age of evidence-based healthcare, where the concept of evidence has been avidly and often uncritically embraced as a symbol of legitimacy, truth, and justice. By letting the evidence dictate healthcare decision making from the bedside to the policy level, the normative claims that inform decision making appear to be negotiated fairly—without subjectivity, prejudice, or bias. Thus, the term ‘‘evidence-based’’ is typically read in the health sciences as the empirically adequate standard of reasonable practice and a means (...) for increasing certainty. Supporters believe that evidence-based medicine (EBM) can introduce rational order to the deliberative processes of healthcare decision making. It is perhaps puzzling, then, to come across critical perspectives (typically arising from the humanities and the more theory-driven social sciences) raising concerns about a seeming technogovernance being introduced by this deferral to the evidence where power interests can be obfuscated by way of technical resolve. The critics holding this minority view argue that technological solutions to problems of knowledge and practice cannot replace medicine’s normative content. Against EBM’s democratic leanings toward transparency and accountability, medical criteria alone cannot decide valueladen ethically charged decisions. This paper attempts to explain and evaluate this important debate in the philosophy of medicine, focusing specifically on the dispute over 'evidence-based women's health'. (shrink)