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)

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)

Proponents of Evidence-based medicine (EBM) do not provide a clear role for basic science in therapeutic decision making. Of what they do say about basic science, most of it is negative. Basic science resides on the lower tiers of EBM's hierarchy of evidence. Therapeutic decisions, according to proponents of EBM, should be informed by evidence from randomised studies (and systematic reviews of randomised studies) rather than basic science. A framework of models explicates the links between the mechanisms of basic (...) science, experimental inquiry, and observed data. Relying on the framework of models I show that basic science often plays a role not only in specifying experiments, but also analysing and interpreting the data that is provided. Further, and contradicting what is implied in EBM's hierarchy of evidence, appeals to basic science are often required to apply clinical research to therapeutic questions. © 2010 Springer Science+Business Media B.V. (shrink)

Evidence based medicine 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)

Agent-based models (ABMs) are one of the main sources of evidence for decisions regarding mitigation and suppression measures against the spread of SARS-CoV-2. These models have not been previously included in the hierarchy of evidence put forth by the evidence-based medicine movement, which prioritizes those research methods that deliver results less susceptible to the risk of confounding. We point out the need to assess the quality of evidence delivered by ABMs and ask the question of what is the risk (...) that assumptions entertained in ABMs do not include all the key factors and make model predictions susceptible to the problem of confounding. (shrink)

What meaning does epidemiological evidence have for the individual? In evidence-based medicine, epidemiological evidence measures the patient’s risk of the outcome or the change in risk due to an intervention. The patient’s risk is commonly understood as an individual probability. The problem of understanding epidemiological evidence and risk thus becomes the challenge of interpreting individual patient probabilities. I argue that the patient’s risk is interpreted ontically, as a propensity. After exploring formidable problems with this interpretation in the medical context, (...) I propose an epistemic reinterpretation of individual patient probabilities as credences. On this view, epidemiological evidence informs medical uncertainty. (shrink)

Epidemiologists’ discussions on causation are not always very enlightening with regard to the notion of ‘cause’ in epidemiology. Epidemiologists rightly work from a science-based approach to causation in epidemiology, but largely disagree about the matter. Disagreement may be partly due to confusion of the question of useful concepts for causal inference in epidemiological practice with the question of the metaphysical presuppositions of causal concepts used in epidemiology. In other words, epidemiologists seem to confuse the practical results of epidemiological research at (...) the population level with the metaphysical views about the reality of disease causation at the individual level in their writings on causation. (shrink)

Epidemiologists’ discussions on causation are not always very enlightening with regard to the notion of ‘cause’ in epidemiology. Epidemiologists rightly work from a science-based approach to causation in epidemiology, but largely disagree about the matter. Disagreement may be partly due to confusion of the question of useful concepts for causal inference in epidemiological practice with the question of the metaphysical presuppositions of causal concepts used in epidemiology. In other words, epidemiologists seem to confuse the practical results of epidemiological research at (...) the population level with the metaphysical views about the reality of disease causation at the individual level in their writings on causation. (shrink)

Why is understanding causation so important in philosophy and the sciences? Should causation be defined in terms of probability? Whilst causation plays a major role in theories and concepts of medicine, little attempt has been made to connect causation and probability with medicine itself. Causality, Probability, and Medicine is one of the first books to apply philosophical reasoning about causality to important topics and debates in medicine. Donald Gillies provides a thorough introduction to and assessment of (...) competing theories of causality in philosophy, including action-related theories, causality and mechanisms, and causality and probability. Throughout the book he applies them to important discoveries and theories within medicine, such as germ theory; tuberculosis and cholera; smoking and heart disease; the first ever randomized controlled trial designed to test the treatment of tuberculosis; the growing area of philosophy of evidence-based medicine; and philosophy of epidemiology. This book will be of great interest to students and researchers in philosophy of science and philosophy of medicine, as well as those working in medicine, nursing and related health disciplines where a working knowledge of causality and probability is required. (shrink)

With the ascent of modern epidemiology in the Twentieth Century came a new standard model of prediction in public health and clinical medicine. In this article, we describe the structure of the model. The standard model uses epidemiological measures-most commonly, risk measures-to predict outcomes (prognosis) and effect sizes (treatment) in a patient population that can then be transformed into probabilities for individual patients. In the first step, a risk measure in a study population is generalized or extrapolated to a (...) target population. In the second step, the risk measure is particularized or transformed to yield probabilistic information relevant to a patient from the target population. Hence, we call the approach the Risk Generalization-Particularization (Risk GP) Model. There are serious problems at both stages, especially with the extent to which the required assumptions will hold and the extent to which we have evidence for the assumptions. Given that there are other models of prediction that use different assumptions, we should not inflexibly commit ourselves to one standard model. Instead, model pluralism should be standard in medical prediction. (shrink)

Society has historically not taken a benign view of genetic disease. The laws permitting sterilization of the mentally re tarded~ and those proscribing consanguineous marriages are but two examples. Indeed as far back as the 5th-10th centuries, B.C.E., consanguineous unions were outlawed (Leviticus XVIII, 6). Case law has traditionally tended toward the conservative. It is reactive rather than directive, exerting its influence only after an individual or group has sustained injury and brought suit. In contrast, state legislatures have not been (...) inhibited in enacting statutes. Many of their products can be characterized as hasty, unnecessary, ill-conceived, and based on the heart rather than the head. Moreover the lack of expert consultation sought has also been remarkable. One state legislature, for example, has advocated immunization for sickle cell anemia! Many others have enacted laws for the screening of inborn errors of metabolism, e.g., phenylketon uria, but have poorly defined the lines of responsibility to secure compliance. A spate of specific disease-related bills has emerged in the u.S. Congress, each seeking recognition and appropriations. Sickle cell anemia, hemophilia, Cooley's anemia and Tay-Sachs disease have been among the front-runners for support. Finally, in 1975, Congress has begun to examine an omnibus bill concerning all forms of genetic disease. The bill, termed the National Genetic Diseases Act is, however, still far from being enacted. (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)

According to the Russo-Williamson Thesis, causal claims in the health sciences need to be supported by both difference-making and mechanistic evidence. In this article, we attempt to determine whether Evidence-based Medicine can be improved through the consideration of mechanistic evidence. We discuss the practical composition and function of each RWT evidence type and propose that exposure-outcome evidence provides associations that can be explained through a hypothesis of causation, while mechanistic evidence provides finer-grained associations and knowledge of entities that ultimately (...) explains a causal hypothesis. We suggest that mechanistic evidence holds untapped potential to add value to the assessment of evidence quality in EBM and propose initial recommendations for the integration of mechanistic and exposure-outcome evidence to improve EBM by robustly leveraging available evidence in support of good medical decisions. (shrink)

Clinical research must be understood to be the foundation of scientific medicine of the clinical type. But the essence of scientific clinical medicine remains a matter of profound confusion, even in clinical academia, and so does the essence of clinical research. The confusion now revolves, principally, around ‘clinical epidemiology’. We address clinical research in the meaning of quintessentially ‘applied’ clinical research, which we take to be the foundation of the scientific knowledge base of clinical medicine, of gnosis (...) (dia‐, etio‐, pro‐) in it. More specifically, we address the essence, priorities, and status quo of this research – and argue that the requisite theory of this is not a matter of ‘clinical epidemiology’ but of theory of clinical research endogenous to clinical (rather than epidemiological) academia. (shrink)

SummaryThis article analyses the viewpoints of doctors, patients and the state of the phenomenon of unconventional methods of treatment/alternative medicine in Slovenia. The doctors’ viewpoints are taken from the official documents of the Medical Chamber of Slovenia and the Slovene Medical Association. The patients’ viewpoints are established on the basis of public opinion and epidemiological research, carried out in 1994 and 1996 on two representative samples of the Slovene population from the Celje area. The estimation of the attitude of (...) the state is based on legislation and other regulations connected with alternative medicine. The findings of our analysis show a strongly negative attitude of doctors to any form of alternative medicine. In contrast, as many as half the patients express a favourable opinion on alternative methods of treatment, and more than a third of them actually make use of them. From existing laws it is evident that the state in general does not deal with alternative medicine, except for possibilities in such cases when a doctor or some other healthcare professional uses alternative methods of treatment. Alternative medicine is, from the point of view of social medicine, a phenomenon that should be followed, analysed and controlled. Dangerous as well as protective factors which accompany the exceution of alternative methods should be recognised so as to be able to inform the public of the results in a timely and accurate manner. Because of the need for the legal and healthcare security of Slovene citizens, the state should regulate existing unconventional treatments. (shrink)

In public health research, tracking folk racial categories (in disease risk, etc.) is a double-edged tool. On the one hand, tracking folk racial categories is dangerous because it reinforces a problematic but fairly common belief in biological race essentialism. On the other hand, ignoring racial categories also runs the risk of ignoring very real biological phenomena in which marginalized communities, likely in virtue of their marginalization, are sicker and in need of improved resources. Much of the conversation among epidemiologists and (...) philosophers of medicine concerning the issue of tracking folk racial categories in public health research springs forth from largely black/white binarized health inequities. While health inequities between black and white Americans are certainly a very important topic, I am interested in investigating the complications to this conversation about the potential harms of tracking folk racial categories in public health research generated by the consideration of Indigenous identities in the US—groups whose health inequities are typically tracked based on the folk racial category of “Native American” or “American Indian,” but whose unique identity categories and community membership problematize the current spectrum of approaches to tracking folk racial categories in epidemiologic research. This paper will draw on scholarship by and about Indigenous people in the US context to address an undertheorized facet of the conversations concerning the potential harms of tracking folk racial categories in public health research, including the potential undermining of American Indian sovereignty and Indigenous epistemologies. I will end on some methodological considerations inspired by the inclusion of Indigenous identities in the US in the conversation about tracking folk racial categories in epidemiologic research. (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)

Philosophy of medicine encompasses a broad range of methodological approaches and theoretical perspectives—from the uses of statistical reasoning and probability theory in epidemiology and evidence-based medicine to questions about how to recognize the uniqueness of individual patients in medical humanities, person-centered care, and values-based practice; and from debates about causal ontology to questions of how to cultivate epistemic and moral virtue in practice. Apart from being different ways of thinking about medical practices, do these different philosophical approaches have (...) anything in common? Are they committed to incompatible assumptions about the nature of science and its relationship to experience, value, and the art of medicine, or are different approaches nonetheless complementary? The chapter examines the questions these different approaches and perspectives raise and considers why so many theorists of medicine seek to find a “base” or “center” for medicine—as though there is, or should be, some general conceptual thread linking the things we call “usual clinical practice” in the real world. It further considers whether there are alternative approaches to the philosophy of medicine, which do not embody this philosophical assumption; and it suggests that a key tool for evaluating approaches must be their ability to contribute something of genuine value to clinical medicine. (shrink)

Philosophy of medicine encompasses a broad range of methodological approaches and theoretical perspectives—from the uses of statistical reasoning and probability theory in epidemiology and evidence-based medicine to questions about how to recognize the uniqueness of individual patients in medical humanities, person-centered care, and values-based practice; and from debates about causal ontology to questions of how to cultivate epistemic and moral virtue in practice. Apart from being different ways of thinking about medical practices, do these different philosophical approaches have (...) anything in common? Are they committed to incompatible assumptions about the nature of science and its relationship to experience, value, and the art of medicine, or are different approaches nonetheless complementary? The chapter examines the questions these different approaches and perspectives raise and considers why so many theorists of medicine seek to find a “base” or “center” for medicine—as though there is, or should be, some general conceptual thread linking the things we call “usual clinical practice” in the real world. It further considers whether there are alternative approaches to the philosophy of medicine, which do not embody this philosophical assumption; and it suggests that a key tool for evaluating approaches must be their ability to contribute something of genuine value to clinical medicine. (shrink)

During the COVID-19 epidemic, the name of the 19th-century English physician John Snow (1813-1858) has cropped up to a surprising extent, notably in connection with the severe cholera epidemic of 1854 in the district of Golden Square, London. It is repeatedly stated that Snow brought this epidemic of waterborne disease to an end by removing the handle of the Broad Street pump. It is also widely known that this story is a myth. Nonetheless, the Broad Street pump story as told (...) by Snow's close friend Benjamin Ward Richardson remains embedded, partly, it is argued, because of its appeal to areas of the cultural consciousness. In America, Snow and his work on the epidemiology of cholera, including the Broad Street pump story, achieved a serious status which has endured, in one form or another, to the present day. In contrast to Britain, the heroic age of public health in America coincided with the optimism of the bacteriological revolution and higher hopes for medical science. However, this rapidly changing environment exacerbated differences of opinion as to what the small and emergent specialty of epidemiology should look like, what its project was, and where it should be based. Different versions of Snow's persona came to represent basic and often conflicting conceptions of epidemiology and the status (or lack of it) of its practitioners. For many, consciously or otherwise, the removal of the Broad Street pump handle remained an individualistic triumph, a single human intervention which resembled modern medicine in providing a “cure.”. (shrink)

BackgroundThe conduct of research is critical to advancing human health. However, there are issues of ethical concern specific to the design and conduct of research in conflict settings. Conflict-affected countries often lack strong platform to support technical guidance and monitoring of research ethics, which may lead to the use of divergent ethical standards some of which are poorly elaborated and loosely enforced. Despite the growing concern about ethical issues in research, there is a dearth of information about ethical compliance in (...) conflict areas. Valid and ethically informed decision-making is a premier pact with research participants in settling possible ethical issues before commencing the research, which is ensured by gaining informed consent from prospective participants of the research.AimsThis research aimed to explore compliance with research ethics and consent validity in community-based epidemiological research conducted previously.MethodsResearch participants were recruited in the western part of Ethiopia in three districts subjected to conflicts. A community-based cross-sectional study design was utilized, and 338 residents were enrolled as study participants. All participants had previously been enrolled as research participants in epidemiological studies. Data was collected using a questionnaire that was pilot-tested before the commencement of the main data collection. The questionnaire focused on participants’ experiences of the informed consent process followed when they were recruited for an epidemiological study and covered themes such as essential information provided, level of comprehension, and voluntarism of consent.ResultsOver half of the study participants, 176 (52%), were not provided with essential information before consenting. And 135 (40%) of them did not comprehend the information provided to them. One hundred and ninety (56%) participants freely and voluntarily agreed to partake in one of these epidemiological studies, with over a quarter (97; 28.7%) of them reporting they were subjected to undue influence. Written consent was obtained from only 32 (9.4%) of the participants. (shrink)

This article analyses the viewpoints of doctors, patients and the state of the phenomenon of unconventional methods of treatment/alternative medicine in Slovenia. The doctors’ viewpoints are taken from the official documents of the Medical Chamber of Slovenia and the Slovene Medical Association. The patients’ viewpoints are established on the basis of public opinion and epidemiological research, carried out in 1994 and 1996 on two representative samples of the Slovene population from the Celje area. The estimation of the attitude of (...) the state is based on legislation and other regulations connected with alternative medicine. The findings of our analysis show a strongly negative attitude of doctors to any form of alternative medicine. In contrast, as many as half the patients express a favourable opinion on alternative methods of treatment, and more than a third of them actually make use of them. From existing laws it is evident that the state in general does not deal with alternative medicine, except for possibilities in such cases when a doctor or some other healthcare professional uses alternative (non-verified) methods of treatment. Alternative medicine is, from the point of view of social medicine, a phenomenon that should be followed, analysed and controlled. Dangerous as well as protective factors which accompany the exceution of alternative methods should be recognised so as to be able to inform the public of the results in a timely and accurate manner. Because of the need for the legal and healthcare security of Slovene citizens, the state should regulate existing unconventional treatments. (shrink)

In current mental health care psychiatric conditions are defined as compilations of symptoms. These symptom-based disease categories have been severely criticised as contingent and boundless, facilitating the rise to epidemic proportions of such conditions as depression. In this article we look beyond symptoms and stress the role of epidemiology in explaining the current situation. By analysing the parallel development of cardiovascular disease and depression management in Finland, we argue, firstly, that current mental health care shares with the medicine of (...) chronic somatic conditions an attachment to risk factor epidemiology, which accentuates risk and prevention in disease management. However, secondly, due to the symptom-based definitions of psychiatric conditions, depression management cannot differentiate properly between symptoms, signs and risk factors such as, for example, cardiovascular medicine, but treats symptoms as signs or risk factors in contexts of treatment and prevention. Consequently, minor at-risk conditions have become difficult to separate from proper cases of depression. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Women and Health Research:A Report from the Institute of MedicineAnna C. Mastroianni (bio), Ruth Faden (bio), and Daniel Federman (bio)In recent years, claims have been made by segments of the research community and by women's health advocacy groups that clinical research practices and policies have not benefitted women's health to the same extent as men's health. Central to these claims has been an assertion that women have been inadequately (...) represented as subjects of clinical studies and that as a result neither health conditions unique to women—e.g., menopause—nor women's manifestations of health problems affecting both sexes—e.g., heart disease—have been investigated sufficiently.The scientific community, including federal agencies that sponsor and regulate clinical studies, is increasingly responsive to these claims and is taking steps to raise the level of women's participation in clinical studies. Controversy and concern have surrounded these actions, however. Two of the claims that have been made are: (1) that women are more difficult to study than men because of their cyclical hormonal changes; and (2) that conducting gender-specific subgroup analyses would increase the size of study populations, raise the cost of studies, and thereby reduce the number of studies that could be performed with the limited resources available. In addition, controversy over the inclusion of women of childbearing potential and pregnant women has been particularly salient. Concerns have been expressed about avoiding potential harm to existing or potential fetuses and about the possible legal and financial ramifications of such harm. A further concern involves the perceived difficulties in enrolling women in studies and retaining them for the duration of the studies.Against this backdrop, the Office of Research on Women's Health at the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) in October 1992 to establish the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. The Committee's charge was to: (1) consider the ethical and legal implications of including women, particularly pregnant women and women of childbearing potential, in clinical studies; (2) examine known instances of litigation regarding injuries to research subjects [End Page 55] and describe existing legal liabilities and protections; and (3) provide practical advice on these issues for consideration by NIH, institutional review boards (IRBs), and clinical investigators.The 16 Committee members came from diverse backgrounds: bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences.1 Chaired by two of the authors of this article, Ruth Faden and Daniel Federman, and coordinated by the third, IOM Study Director Anna Mastroianni, the Committee met five times over a fourteen-month period, convened a one-and-one-half day invitational workshop, and commissioned several background papers. The Committee's deliberations were complicated by the announcement of new federal policies late in its term. Specifically, the Food and Drug Administration (FDA) issued guidelines (FDA 1993) to replace its 1977 guidelines, which prohibited the inclusion of women of childbearing potential in early phases of most clinical drug trials. In addition, Congress passed the NIH Revitalization Act of 1993 (P.L. 103-43), which contains provisions mandating the inclusion of women and racial and ethnic minorities in NIH-sponsored clinical research. In February 1994, the IOM Committee publicly issued its final report and recommendations, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, publishing the workshop presentations and commissioned papers in a separate volume.Deliberations of the CommitteeA number of issues arose at the outset as the Committee considered its charge. A few members initially believed that verification of the underrepresentation of women relative to men in clinical studies as a whole was a prerequisite to providing policy recommendations. Others believed that such an examination would be an important contribution to the knowledge base, but that it was not necessary for addressing the Committee's charge. As summarized in the Committee's report, the Committee's research indicated that firm conclusions about the relative underrepresentation of women could not be drawn from the available data because of the lack of systematic information... (shrink)

This paper discusses the legal implications of setting up two new biobanks in Belgium. The first is hospital-based and will archive tissue from patients with haematologic cancer, whereas the second is linked to a general practice based morbidity registry and will involve storage of blood samples. To date, Belgium has no specific legislation that regulates storage of human tissue and related databases. Several issues concerning the protection of individuals with regard to the processing of personal medical data are discussed from (...) the existing privacy legislation. We will address the principle of consent (broad versus specific) and the type of data recorded (anonymous, encoded and identifiable) for both biobanks. (shrink)

The genome between socially constructed racial groups is 99.5%–99.9% identical; the 0.1%–0.5% variation between any two unrelated individuals is greatest between individuals in the same racial grou...

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)

Suffering, defined as a state of undergoing pain, distress or hardship, is a multidimensional concept; it can entail physical, psychological and spiritual distress that prompts the sufferer to seek medical attention. As a construct originating from and unique to each patient, no patient’s suffering is equal to another’s or completely reducible to any generalizable frame of understanding. As it happens in a common medical encounter, the suffering patient requires an anamnesis provided by attentive and comprehensive listening to both the said (...) and unsaid parts of his or her discourse interpreted through the hermeneutical skills of the physician. Suffering can then be decoded into a complex construct, which can guide the formulation of a strategy to help patient coping by attempting to find meaning in it. To help this search for meaning, one may employ philosophic therapy, bibliotherapy and counseling, among other approaches. Suffering-based medicine (SBM) thus circumvents the limitations of the reductionistic Allopathic medical frame of understanding of disease. Such an attitude should be a common goal for all scientific medicine practitioners, as it complements and does not conflict with any of its therapeutic modalities. Furthermore, medical education should include humanistic disciplines to empower physicians to better understand their patients’ experience of suffering. (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)

Evidence-Based Medicine is a relatively new movement that seeks to put clinical medicine on a firmer scientific footing. I take it as uncontroversial that medical practice should be based on best evidence—the interesting questions concern the details. This paper tries to move towards a coherent and unified account of best evidence in medicine, by exploring in particular the EBM position on RCTs.

This book about philosophy of medicine bestows a bottom-up and not a top-down approach. It starts from clinical medicine and epidemiology, analyzing their interrelations with philosophical instruments. The book criticizes the constant search for generalities and the essentialism that too often characterizes this discipline, which results in philosophers of medicine dialoguing with each other without direct contact with medical science. In the light of Ludwig Wittgenstein's philosophy, this book proposes an approach to the philosophy of medicine (...) based on the quorum of language, what Wittgenstein calls family resemblances. In this way the author establishes a philosophy of medicine that is closely related to the medical clinic and to public health and as such avoids armchair philosophy. “Don’t think, but look", wrote Wittgenstein. (shrink)

Evidence-based medicine (EBM) has long deemphasized mechanistic reasoning and pathophysiological rationale in assessing the effectiveness of interventions. The EBM+ movement has challenged this stance, arguing that evidence of mechanisms and comparative studies should both be seen as necessary and complementary. Advocates of EBM+ provide a combination of theoretical arguments and examples of mechanistic reasoning in medical research. However, EBM+ proponents have not provided recent examples of how downplaying mechanistic reasoning resulted in worse medical results than would have occurred otherwise. (...) Such examples are necessary to make the case that EBM+ responds to a problem in clinical practice that urgently demands a solution. In light of this, we examine the failed rollout of efavirenz as a first-line HIV treatment in Zimbabwe as evidence of the importance of mechanistic reasoning in improving clinical practice and public health policy decisions. We suggest that this case is analogous to examples commonly given to support EBM. (shrink)

Evidence-based medicine (EBM) 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.

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)

Biometrics has done damage with levels of R or p or Student’s t. The damage widened with Ronald A. Fisher’s victory in the 1920s and 1930s in devising mechanical methods of “testing,” against methods of common sense and scientific impact, “oomph.” The scale along which one would measure oomph is particularly clear in biomedical sciences: life or death. Cardiovascular epidemiology, to take one example, combines with gusto the “fallacy of the transposed conditional” and what we call the “sizeless stare” of (...) statistical significance. Some medical editors have battled against the 5% philosophy, as did, for example, Kenneth Rothman, the founder of Epidemiology. And decades ago a sensible few in education, ecology, and sociology initiated a “significance test controversy.” But, grantors, journal referees, and tenure committees in the statistical sciences had faith that probability spaces can substitute for scientific judgment. A finding of p <.05 is deemed to be “better” for variable X than p <.11 for variable Y. It is not. It depends on the oomph of X and Y—the effect size, size judged in the light of how much it matters for scientific or clinical purposes. In 1995 a Cancer Trialists’ Collaborative Group, for example, came to a rare consensus on effect size: 10 different studies had agreed that a certain drug for treating prostate cancer can increase patient survival by 12%. An 11th study published in the New England Journal in 1998 dismissed the drug. The dismissal was based on a t-test, not on what William Gosset had called, against Ronald A. Fisher’s machinery, “real” error. (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)