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)

Clinical trials and other forms of evaluation of medical treatment are held to give an objective assessment of the 'clinical effectiveness' of the medical treatments under evaluation. This kind of evaluation is central to the evidence-based medicine movement, as it provides a basis for the rational selection of treatment. The ethical status of randomised clinical trials is widely agreed to depend crucially upon the state of equipoise regarding which of two (or more) treatments is more (or most) effective in (...) a defined population. However, the meaning and nature of 'clinical effectiveness' are unclear. in this paper, I discuss the proposals to define clinical effectiveness as a relational property and as an intrinsic property, and the way effectiveness may supervene upon more fundamental physical properties of treatments. I discuss whether effectiveness is a single property or a family of properties; the types of outcome which can be explained by effectiveness properties; and the relationship between 'objective' and 'preference' outcomes. This paper suggests that while it may be possible to put clinical effectiveness on a proper metaphysical footing, in practice the language of clinical effectiveness is more properly a topic of the human sciences than of the natural sciences. (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)

Attempts to formalize the diagnostic process are by no means a recent undertaking; what is new is the availability of an engine to process these formalizations. The digital computer has therefore been increasingly turned to in the expectation of developing systems which will assist or replace the physician in diagnosis. Such efforts involve a number of assumptions regarding the nature of the diagnostic process: e.g. where it begins, and where it ends. ‘Diagnosis’ appears to include a number of quite different (...) cognitive processes, some of which seem more subject to formalization than others. Underlying the difficulties inherent in these efforts at formalization, is the hierarchical structure of medical knowledge including that of diseases. (By ‘hierarchical structure’, I mean no more than that our descriptions of clinical objects necessarily refer to different levels of organization; atomic, molecular, cellular, physiological system, entire patient.) Since diagnosis is in part a form of classification, measures of similarity between the clinical findings of a particular patient and a potential disease, are needed. This is complicated by the fact that some diseases are described using the vocabularies of physics and chemistry, others with the vocabulary of psychology, and most, with terms taken from a number of different hierarchical levels. The differences between the descriptions made using these vocabularies will be seen to exert systematic (if not uniform) influences upon the diagnostic process. CiteULike Connotea Del.icio.us What's this? (shrink)

Evidence-based medicine (EBM) ranks different medical research methods on a hierarchy, at the top of which are randomized controlled trials (RCTs) and systematic reviews or meta-analyses of RCTs. Any study that does not randomly assign patients to a treatment or a control group is automatically placed at a lower level on the hierarchy. This article argues that what matters is whether the treatment and control groups are similar with respect to potential confounding factors, not whether they got that way through (...) randomization. Moreover, nonrandomized studies tend to have other characteristics that make them useful sources of evidence, in that they tend to last longer and to enroll more patients than do randomized trials. Replacing the sharp dichotomy between randomized and nonrandomized studies with a continuum from "clean" studies (which have high internal validity but whose results do not readily generalize to clinical practice) to pragmatic studies (which are designed to more closely reflect clinical practice) would also make a place for outcomes research and research using clinical databases, which are not included in the current hierarchy of evidence but which can provide important information about the safety and efficacy of treatments. (shrink)

Intuition in medical and moral reasoning -- Moral intuitionism -- The place of Aristotelian phronesis in clinical reasoning -- Aristotle's practical syllogism: accounting for the individual through a theory of action and cognition -- Individual and statistical physiognomy: the art and science of making the invisible visible -- Clinical intuition versus statistical reasoning -- Contingency and correlation: the significance of modeling clinical reasoning on statistics -- Abduction: the intuitive support of clinical induction -- Conclusion: medical ethics beyond ontology.

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)

In the first part of this paper, I will sketch the main features of traditional models of evidence, indicating idealizations in such models that I regard as doing more harm than good. I will then proceed to elaborate on an alternative model of evidence that is functionalist, complex, dynamic, and contextual, which I will call DYNAMIC EVIDENTIAL FUNCTIONALISM. I will demonstrate its application to an illuminating example of scientific inquiry, and defend it from some likely objections. In the second part, (...) I will use that alternative to solve a variety of classic and contemporary problems in the literature on scientific evidence having to do with the empirical basis of science and the use of evidence in public policy. (shrink)

How can philosophy of science be of more practical use? One thing we can do is provide practicable advice about how to determine when one empirical claim is relevant to the truth of another; i.e., about evidential relevance. This matters especially for evidence-based policy, where advice is thin—and misleading—about how to tell what counts as evidence for policy effectiveness. This paper argues that good efficacy results (as in randomized controlled trials), which are all the rage now, are only a very (...) small part of the story. To tell what facts are relevant for judging policy effectiveness, we need to construct causal scenarios about will happen when the policy is implemented. (shrink)

The more popular complementary and alternative medicine (CAM) has become, the more often it is demanded that the integration of CAM should be limited to those approaches that are scientifically proven to be effective. This paper argues that this demand is ethically and philosophically questionable. The clinical legitimacy being gained by CAM and its increasing informal integration should instead caution against upholding the biomedical framework and evidence-based medicine as conditions of acceptance. Patients’ positive experiences with CAM deserve a truly scientific (...) exploration of non-biomedical conceptualizations of health and illness. It is also problematic to request scientific evidence when there is proven resistance against CAM in research institutions, under-funding and a lack of suitable research methodologies. This is even more so, when much conventional medicine is not practiced with the same level of evidence as demanded from CAM. (shrink)

In this paper, I offer one example of conceptual change. Specifically, I contend that the discovery that viruses could cause cancer represents an excellent example of branch jumping, one of Thagard’s nine forms of conceptual change. Prior to about 1960, cancer was generally regarded as a degenerative, chronic, non-infectious disease. Cancer causation was therefore usually held to be a gradual process of accumulating cellular damage, caused by relatively non-specific component causes, acting over long periods of time. Viral infections, on the (...) other hand, were generally understood to be acute processes, whereby single, specific and necessary causal agents acted alone to produce disease. However, during the 1960s and 1970s, a number of cancers were discovered to have an infectious aetiology. Of particular note were two—Burkitt’s lymphoma and cervical cancer—which I will discuss in detail later in this piece. Together, these discoveries led, in the short term, to a tentative aetiological reclassification of some types of cancer as infectious diseases and, in the longer term, to a full-blown reclassification of cancer as an aetiological disease branch in its own right. This process of reclassification forms the empirical basis for my concluding remarks on the influence of classification upon causation in medicine. Through this, I aim to demonstrate that conceptual change, far from being a purely abstract concern of the philosopher of science, is of substantial import to scientific practitioners. (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)

Evidence-based policy is gaining support in many areas of government and in public affairs more generally. In this paper we outline what evidence—based policy is then discuss its strengths and weaknesses. In particular, we argue that it faces a serious challenge to provide a plausible account of evidence. This account needs to be at least in the spirit of the hierarchy of evidence subscribed to by evidence-based medicine (from which evidence—based policy derives its name and inspiration). Yet evidence-based policy’s hierarchy (...) needs to be tailored to the kinds of evidence relevant and available to the policy arena. The evidence required for policy decisions does not easily lend itself to randomised controlled trials (the "gold standard" in evidence-based medicine), nor, for that matter, being listed in a single all—purpose hierarchy. (shrink)

Because physicians use scientific inference for the generalizations of individual observations and the application of general knowledge to particular situations, the Bayesian probability solution to the problem of induction has been proposed and frequently utilized. Several problems with the Bayesian approach are introduced and discussed. These include: subjectivity, the favoring of a weak hypothesis, the problem of the false hypothesis, the old evidence/new theory problem and the observation that physicians are not currently Bayesians. To the complaint that the prior probability (...) is subjective, Bayesians reply that there will be ultimate convergence, but the rebuttal to this is that there will not be uniform convergence. Secondly, since the Bayesian scheme favors a weak hypothesis, theories turn out to be a gratuitous risk. The problem with the false hypothesis comes out in the denominator of the theorem, revealing that a factor which is not a theory at all is being considered in the reasoning. On the old evidence/new theory problem old evidence cannot confirm a new theory so that the posterior probability will equal the prior probability. Finally, empiric studies have shown that current physicians are not Bayesians. But on consideration of Bayesian inference as a system of inference, it can be reasoned that physicians should be Bayesians. However, the problem of physicians' and patients' own subjectivity continue to plague this system of medical decision making. (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)

Medical criteria rooted in evidence-based medicine are often seen as a value-neutral ‘trump card’ which puts paid to any further debate about setting priorities for treatment. On this argument, doctors should stop providing treatment at the point when it becomes medically futile, and that is also the threshold at which the health purchaser should stop purchasing. This paper offers three kinds of ethical criteria as a counterweight to analysis based solely on medical criteria. The first set of arguments concerns futility, (...) probability and utility; the second, justice and fairness; the third, consent and competence. The argument is illustrated by two recent case studies about futility and priority-setting: the US example of ‘Baby Ryan’ and the UK case of ‘Child B’. (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.

“Evidence” in the form of data collected and analysis thereof is fundamental to medicine, health and science. In this paper, we discuss the “evidence-based” aspect of evidence-based medicine in terms of statistical inference, acknowledging that this latter field of statistical inference often also goes by various near-synonymous names—such as inductive inference (amongst philosophers), econometrics (amongst economists), machine learning (amongst computer scientists) and, in more recent times, data mining (in some circles). Three central issues to this discussion of “evidence-based” are (i) (...) whether or not the statistical analysis can and/or should be objective and/or whether or not (subjective) prior knowledge can and/or should be incorporated, (ii) whether or not the analysis should be invariant to the framing of the problem (e.g. does it matter whether we analyse the ratio of proportions of morbidity to non-morbidity rather than simply the proportion of morbidity?), and (iii) whether or not, as we get more and more data, our analysis should be able to converge arbitrarily closely to the process which is generating our observed data. For many problems of data analysis, it would appear that desiderata (ii) and (iii) above require us to invoke at least some form of subjective (Bayesian) prior knowledge. This sits uncomfortably with the understandable but perhaps impossible desire of many medical publications that at least all the statistical hypothesis testing has to be classical non-Bayesian—i.e. it is not permitted to use any (subjective) prior knowledge. (shrink)

General Practice and Ethics explores the ethical issues faced by general physicans in their everyday practice, addressing two central themes: the uncertainty of outcomes and effectiveness in general practice and the changing pattern of general practitioners' responsibilities.

Values-Based Medicine (VBM) is the theory and practice of clinical decision-making for situations in which legitimately different values are in play. VBM is thus to values what Evidence-Based Medicine (EBM) is to facts. The theoretical basis of VBM is a branch of analytic philosophy called philosophical value theory. As a set of practical tools, VBM has been developed to meet the challenges of value diversity as they arise particularly in psychiatry. These challenges are illustrated in this paper by a case (...) study of the differential diagnosis between delusion and religious experience. In a traditional model of scientific medicine, such challenges would be expected to become less pressing with advances in medical science. Philosophical value theory suggests, to the contrary, that scientific progress, through opening up an ever-wider range of choices, will increasingly bring the full range and diversity of human values into play not just in psychiatry but in all areas of medicine. The future, then, for medicine, is an integrated model in which VBM and EBM are equal partners in a genuinely human discipline. (shrink)

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

Medical discourse currently manages two broad visionary movements: "evidence-based medicine," the effort to make clinical medicine more responsive to the medical research, and "patient-centered care," the platform for a more humane health-care encounter. There have been strong calls to synthesize the two as "evidence-based patient-centred care" (Lacy and Backer 2008; see also Borgmeyer 2005; Baumann, Lewis, and Gutterman 2007; Krahn and Naglie 2008), yet many question the compatibility of the two competing programs.This might sound to some like a new version (...) of an old story. Despite the fact that evidence-based medicine and patient-centered care are relatively new programs, the story of their oppositional .. (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)

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)

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)

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 (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. 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)

The Evidence-Based Medicine (EBM) movement is an ideological force in health research and health policy which asks for allegiance to two types of methodological doctrine. The first is the highly quotable motherhood statement: for example, that we should make conscientious, explicit and judicious use of current best evidence (paraphrasing Sackett). The second type of doctrine, vastly more specific and in practice more important, is the detailed methodology of design and analysis of experiments. This type of detailed methodological doctrine tends to (...) be simplified by commentators but followed to the letter by practitioners. A number of interestingly dumb claims have become entrenched in prominent versions of these more specific methodological doctrines. I look at just a couple of example claims, namely: Any randomised controlled trial (RCT) gives us better evidence than any other study. Confidence intervals are always useful summaries of at least part of the evidence an experiment gives us about a hypothesis. To offer a positive doctrine which might move us past the current conflict of micro-theories of evidence, I propose a mild methodological pluralism: in any local context in which none of a variety of scientific methodologies is clearly and uncontentiously right, researchers should not be discouraged from using any methodology for which they can provide a good argument. (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)

Now in its fourth edition, Rational Diagnosis and Treatment: Evidence-Based Clinical Decision-Making is a unique book to look at evidence-based medicine and the difficulty of applying evidence from group studies to individual patients._ The book analyses the successive stages of the decision process and deals with topics such as the examination of the patient,_the reliability of clinical data, the logic of diagnosis, the fallacies of uncontrolled therapeutic experience and the need for randomised clinical trials and meta-analyses. It is the main (...) theme of the book that, whenever possible, clinical decisions must be based on the evidence from clinical research, but the authors also explain the pitfalls of such research and the problems involved in applying evidence from groups of patients to the individual patient._ For this new edition, the sections on placebo and meta-analysis and on alternative medicine have been thoroughly updated, and there is more focus on insufficient reporting of harms of interventions. The sections on different research designs describe advantages and limitations, and the increased medicalisation and the effects of cancer screening on health people are noted. A section on academic freedom when clinicians collaborate with industry and ghost authors is added._ This essential reference work integrates the science and statistical approach of evidence-based medicine with the art and humanism of medical practice; distinguishing between data, sets of data, knowledge and wisdom, and their application. Such an intellectually challenging book is ideal for both medical students and doctors who require theoretical and practical clinical skills to help ensure that they apply theory in practice. (shrink)

Subjective probabilities play a significant role in the assessment of evidence: in other words, our background knowledge, or pre-trial beliefs, cannot be set aside when new evidence is being evaluated. Focusing on homeopathy, this paper investigates the nature of pre-trial beliefs in clinical trials. It asks whether pre-trial beliefs of the sort normally held only by those who are sympathetic to homeopathy can legitimately be disregarded in those trials. The paper addresses several surprisingly unsuccessful attempts to provide a satisfactory justification (...) for ignoring the pre-trial beliefs of the homeopathic community. The ensuing diagnosis of the difficulties here emphasizes that the reason the arguments for choosing the pre-trial beliefs of the conventional community seem insufficient is not the arguments per se. It is rather that there is no cogent argument for choosing the conventional stance which would at the same time rationally persuade a member of the homeopathic community. The paper concludes that, once we understand that this is the predicament, there is no genuine reason to doubt the reasoning that leads us to reject the pre-trial beliefs of the homeopathic community. (shrink)

The evidence-based medicine movement advocates basing all medical decisions on certain types of quantitative research data and has stimulated protracted controversy and debate since its inception. Evidence-based medicine presupposes an inaccurate and deficient view of medical knowledge. Michael Polanyi’s theory of tacit knowledge both explains this deficiency and suggests remedies for it. Polanyi shows how all explicit human knowledge depends on a wealth of tacit knowledge which accrues from experience and is essential for problem solving. Edmund Pellegrino’s classic treatment of (...) clinical judgment is examined, and a Polanyian critique of this position demonstrates that tacit knowledge is necessary for understanding how clinical judgment and medical decisions involve persons. An adequate medical epistemology requires much more qualitative research relevant to the clinical encounter and medical decision making than is currently being done. This research is necessary for preventing an uncritical application of evidence-based medicine by health care managers that erodes good clinical practice. Polanyi’s epistemology shows the need for this work and provides the structural core for building an adequate and robust medical epistemology that moves beyond evidence-based medicine. (shrink)

Physicians, nurses, and other clinicians readily acknowledge being troubled by encounters with patients who trigger moral judgments. For decades social scientists have noted that moral judgment of patients is pervasive, occurring not only in egregious and criminal cases but also in everyday situations in which appraisals of patients' social worth and culpability are routine. There is scant literature, however, on the actual prevalence and dynamics of moral judgment in healthcare. The indirect evidence available suggests that moral appraisals function via a (...) complex calculus that reflects variation in patient characteristics, clinician characteristics, task, and organizational factors. The full impact of moral judgment on healthcare relationships, patient outcomes, and clinicians' own well-being is yet unknown. The paucity of attention to moral judgment, despite its significance for patient-centered care, communication, empathy, professionalism, healthcare education, stereotyping, and outcome disparities, represents a blind spot that merits explanation and repair. New methodologies in social psychology and neuroscience have yielded models for how moral judgment operates in healthcare and how research in this area should proceed. Clinicians, educators, and researchers would do well to recognize both the legitimate and illegitimate moral appraisals that are apt to occur in healthcare settings. (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) has now been part of the dominant medical paradigm for 15 years, and has been frequently debated and progressively modified. One question about EBM that has not yet been considered systematically, and is now particularly timely, is the question of the novelty, or otherwise, of the principles and practices of EBM. We argue that answering this question, and the related question of whether EBM-type principles and practices are unique to medicine, sheds new light on EBM and has (...) practical implications for those involved in all EBM. This is because one's answer to the question (whether explicit or implicit) affects the amount and type of funding and attention received by EBM, the extent to which EBM, and the generation, judgment and use of evidence more generally, can be appropriated by certain groups and questioned by others, and the extent to which truly unique socio-political developments in evidence, and in medicine more generally, are recognized and harnessed. (shrink)

There exists a vast literature on evidence-based practice (EBP) in education. The debate branches out in several directions, for example, what EBP entails for the nature of educational practice, what it entails for the teaching profession, what counts as use and abuse of evidence, and what educational research could or should contribute to a what works kind of practice. In this essay Tone Kvernbekk focuses on the fate of the concept of evidence in the debate, observing that the concept seems, (...) by and large, to be missing from the debate. She argues that educational debates about EBP stand to gain in nuance and depth from employing philosophical insights about evidence. Kvernbekk develops this claim by discussing different conceptions of evidence and by inquiring into three aspects of the evidentiary relation: the meaning of “based,” underdetermination, and the relativization of evidence. (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)

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. (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 is a thesis about reasoning: it champions a certain way of thinking about practice, one based not on the particular, not on thecontext-specific, but on broad statistical concerns. It emphasises “the increasing realisation of the power of probabilistic reasoning” to establish “a new epidemiologic standard”. So the claims of the “EBMers” imply a whole position in medical epistemology. But authors seem unwilling to give a detailed exposition, let alone defence of this position to critics. Hence the accusations (...) of arrogance. (shrink)

Individualized care and equality of care remain two imperatives for formulating any scientifically and morally informed public health policy. Yet both continue to be elusive goals, even in the age of genomics, proteomics, and evidence-based medicine. Nonetheless, with the rapid growth and improvement of human biotechnologies, the need to individualize therapies while allocating medical care equally may result partly from our biological constitution. Human beings are all unique, and their biological differences significantly influence variability in disease causation and therapeutic response (...) to treatments. However, because humans have equal moral worth, there is no ethically justifiable reason to establish an a .. (shrink)

We argue that a responsible analysis of today's evidence-based risk assessments and risk debates in biology demands a critical or metascientific scrutiny of the uncertainties, assumptions, and threats of error along the manifold steps in risk analysis. Without an accompanying methodological critique, neither sensitivity to social and ethical values, nor conceptual clarification alone, suffices. In this view, restricting the invitation for philosophical involvement to those wearing a "bioethicist" label precludes the vitally important role philosophers of science may be able to (...) play as bioevidentialists. The goal of this paper is to give a brief and partial sketch of how a metascientific scrutiny of risk evidence might work. (shrink)

There is near universal recognition that human participant protection is both morally and practically essential for all forms of research involving humans. Yet most of the discourse around human participant protection has focussed on norms—rules, regulations and governance arrangements—rather than on the actual effectiveness of these norms in achieving their ends—protecting participants from undue risk and ensuring respectful treatment as well as advancing the generation of useful knowledge. In recent years there has been increasing advocacy for evidence-based human participant protection (...) that would be grounded on the careful investigation of the effects of research on human participants. We offer an analysis of evidence-based protection and then focus on Canadian examples of research on evidence-based protection. We consider the prospects for such research being put into practice in Canada. Finally we connect our remarks to the theme of “the changing landscape of human participant protection.”. (shrink)

American medicine has long sought to control the standard of care that physicians are expected to provide to their patients. One effort to insulate the standard of care from external interference, called a “safe harbors” approach, would enable physicians to avoid liability for malpractice if they adhered to medical practice guidelines. The idea is to eliminate the “battle of experts” and reduce defensive medicine by requiring judges and juries to accept guidelines as conclusive evidence of the standard of care. Yet (...) current efforts to improve the guideline development process, including the use of evidence-based guidelines, are unlikely to be able to overcome the shortcomings that led a similar safe harbors initiative to fail in the early 1990s. Moreover, there is no adequate justification for conferring this degree of self-regulatory power on the medical profession. (shrink)

The nosological status of the putative clinical entity of compensation neurosis and the relationship of chronic pain complaints to compensation are explored. It is concluded that, using the traditional criteria of diagnostic validity, there is no support for the view that a specific type of psychiatric disorder related to compensation or litigation can be demonstrated. Although it has been generally considered that chronic pain complaints reflect an underlying disease state, recent evidence has shown that in the medico-legal setting the nature (...) of the compensation system and the level of available benefits have a marked influence on both the rate of chronic pain complaints and the duration of pain related work incapacity. (shrink)

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)

In this article, I argue that distinguishing ‘evolutionary’ from ‘Darwinian’ medicine will help us assess the variety of roles that evolutionary explanations can play in a number of medical contexts. Because the boundaries of evolutionary and Darwinian medicine overlap to some extent, however, they are best described as distinct ‘research traditions’ rather than as competing paradigms. But while evolu- tionary medicine does not stand out as a new scientific field of its own, Darwinian medicine is united by a number of (...) distinctive theoretical and methodological claims. For example, evolutionary medicine and Darwinian medicine can be distinguished with respect to the styles of evolutionary explanations they employ. While the former primarily involves ‘forward looking’ explanations, the latter depends mostly on ‘backward looking’ explanations. A forward looking explanation tries to predict the effects of ongoing evolutionary processes on human health and disease in contem- porary environments (e.g., hospitals). In contrast, a backward looking explanation typically applies evolutionary principles from the vantage point of humans’ distant biological past in order to assess present states of health and disease. Both approaches, however, are concerned with the prevention and control of human diseases. In con- clusion, I raise some concerns about the claim that ‘nothing in medicine makes sense except in the light of evolution’. (shrink)

Evidence-based approaches to policy-making are growing in popularity. A generally embraced view is that with the appropriate evidence at hand, decision and policy making will be optimal, legitimate and publicly accountable. In practice, however, evidence-based policy making is constrained by a variety of problems of evidence. Some of these problems will be explored in this article, in the context of the debates on evidence from which they originate. It is argued that the source of much disagreement might be a failure (...) to addressing crucial philosophical assumptions that inform, often silently, these debates. Three controversial questions will be raised which appear central to some of the challenges faced by evidence-based policy making: firstly, how do certain types of facts candidate themselves as evidence; secondly, how do we decide what evidence we have, and how much of it; and thirdly, can we combine evidence. In addressing these questions it will be shown how a philosophically informed debate might prove instrumental in clarifying and settling practical difficulties. (shrink)

This article is a rebuttal to Kevin Smith's ‘Against Homeopathy,’ which was posted on 14 February 2011.1 It contends that his argument rests entirely on the assumption that homeopathic remedies are nothing but placebos. His argumentation is good, but his assumption is false. Evidence is presented to show that the Law of Similars is plausible and that ultradilute remedies do indeed have biological activity.

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 purpose of this exploratory and descriptive study was to examine old-age dementia in the Hmong community of Milwaukee, Wisconsin. Formal and informal Hmong leaders were interviewed to determine the prevalence of dementia in the Hmong community and how it is perceived and experienced. Interviews revealed few cases of dementia among the Hmong. Dementia was perceived as a natural part of the life cycle, rather than as a devastating disease that robs individuals of their autonomy. Treatment is not sought for (...) dementia. Some of the common manifestations of dementia, such as wandering and combativeness, were rare or non-existent in the Hmong community. Individuals with dementia are cared for in their sons' homes. Nursing home placement in advanced dementia was only acceptable if sanctioned by the entire extended family. Further research on the Hmong perception of and experience with dementia needs to be conducted in other Hmong communities to validate the generalizability of these results. (shrink)

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)

The convergence of complementary and alternative medicine (CAM) and evidence-based medicine (EBM) is a prominent feature of healthcare in western countries, but it is currently undertheorised, and its implications have been insufficiently considered. Two models of convergence are described – the totally integrated evidence-based model (TI) and the multicultural-pluralistic model (MP). Both models are being incorporated into general medical practice. Against the background of the reasons for the increasing utilisation of CAM by the public and by general practitioners, TI-convergence is (...) supported and MP-convergence is rejected. MP-convergence is epistemologically and clinically incoherent, and it cannot be regulated. It is also inconsistent with developments in the legal determination of the standard of care for both diagnosis/treatment and disclosure. These claims concerning MP-convergence are justified by the fact that science is not a member of the group of perspectives or world-views which postmodernism treats as equally valid, and this is especially important for healthcare. (shrink)

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