While evidence-based medicine (EBM) is often accused on relying on a paradigm of 'absolute truth', it is in fact highly consistent with Karl Popper's criterion of demarcation through falsification. Even more relevant, the first three steps of the EBM process are closely patterned on Popper's evolutionary approach of objective knowledge: (1) recognition of a problem; (2) generation of solutions; and (3) selection of the best solution. This places the step 1 of the EBM process (building an answerable (...) question) in a pivotal position for the understanding of the whole process, and underscores a few aspects which are often overlooked in EBM courses. First in this step internal evidence (including personal expertise) must be appraised and integrated in the problem. Second, issues of applicability of the possible solution should be anticipated. Third, and possibly more important, the goal of the intervention should be set at this stage (typically by choosing the outcome in a PICO question). Depending whether or not goals depend on the goals of others, and whether they concern others' voluntary behaviour, goals may be classified as self-serving, moral, altruistic or moralistic. Thus, delicate ethical questions must be addressed at this stage, which means that patient preferences and values must be carefully sought, so that empathy, counselling and narrative medicine must be mastered to be able to formulate correctly an answerable question. The need to modify the current description of the EBM process to increase the recognition of implicit assumptions and increase the consistency of this model is discussed. (shrink)

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

This paper challenges the traditional assumption that descriptive and prescriptive sciences are essentially distinct by presenting a study on the implicit normativity of the production and presentation of biomedical scientific facts within evidence-based medicine. This interdisciplinary study serves as an illustration of the potential worth of the concept of implicit normativity for bioethics in general and for integrated empirical ethics research in particular. It demonstrates how both the production and presentation of scientific information in an evidence- (...) class='Hi'>based decision-support contain implicit presuppositions and values, which pre-structure the moral environment of the clinical process of decision-making. As a consequence, the evidence-based decision support did not only support the clinical decision-making process; it also transformed it in a morally significant way. This phenomenon undermines the assumption within much of the literature on patient autonomy that information disclosure is a conditional requirement before patient autonomy even starts; patient autonomy is already influenced during the production and presentation of information. These results imply an increased responsibility of those who produce and present evidence-based facts(i.e. scientists in general and physicians in particular). The insights of this study not only involve a different focus on both theory and practice of patient autonomy and informed consent, but they also call for a broader scope of morality than does traditional empirical research in bioethics. The concept of implicit normativity within integrated empirical ethics research calls for a strong cooperation between bioethicists and descriptive scientists, i.e., a cooperation that goes beyond the discipline-specific epistemic values and that takes place during all phases of the research process. (shrink)

There is quite some ethical controversy on Evidence-based Medicine (EbM) with regard to issues of physician autonomy as well as its allocative implications. Yet, there are some shortcomings in the current debate. First of all, some of the arguments brought up against EbM are similarly defaults of “classical medicine” as well, for instance its negligence of social aspects of medicine. Second, it is often maintained that EbM is just a tool to attain cost containment. (...) This argument is false in two regards for neither is there any idea of cutting costs in the roots of EbM nor does EbM once practiced necessarily lead to less costs as there can be underuse as well as overuse. Third, both opponents and proponents of EbM come up with the same arguments against each other. Both maintain that the other way of practicing medicine does not allow for physicians’ autonomy and free judgment. Therefore, we are going to search for the different presuppositions on which these “reproaches” rely. In this way we can demonstrate that both opponents and proponents rely on different notions of autonomy and free judgment in their argument. Finally, we hope to show that some of the ethical criticism may be raised against classical medicine as well and that allocation in terms of costs is not primarily an aim of EbM. (shrink)

“Evidence based medicine” is often seen as a scientific tool for quality improvement, even though its application requires the combination of scientific facts with value judgments and the costing of different treatments. How this is done depends on whether we approach the problem from the perspective of individual patients, doctors, or public health administrators. Evidence based medicine exerts a fundamental influence on certain key aspects of medical professionalism. Since, when clinical practice guidelines are created, (...) costs affect the content of EBM, EBM inevitably becomes a form of rationing and adopts a public health point of view. This challenges traditional professionalism in much the same way as managed care has done in the US. Here we chart some of these major philosophical issues and show why simple solutions cannot be found. The profession needs to pay more attention to different uses of EBM in order to preserve the good aspects of professionalism. (shrink)

Explores the ethical issues faced by GPs 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.

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

Evidence-based medicine is a clinical decision-making framework which makes claims about what physicians ought to do. Though heralded as the cutting edge of medical science, evidence-based medicine is a value-laden normative theory which implicitly depends on substantive views regarding what is morally good or right. In this paper, I provide an ethical analysis of evidence-based medicine. I consider its normative underpinnings in three ethical theories: utilitarianism, Kantian deontology, and virtue (...) ethics. In the face of uncertainty, evidence-based medicine endorses expected utility theory using the best available evidence in order to avoid doing more harm than good. In accordance with the Kantian respect for individuals as ends in themselves, evidence-based medicine calls for integrating the values and preferences of the patient. De-emphasizing intuition, clinical expertise, and pathophysiologic rationale emphasizes the need for the intellectual virtues of curiosity, critical thinking, and courage. Evidence-based medicine is a successful clinical practice that can be morally justified by all three major ethical theories. Although its focus on maximizing good health outcomes and integrating respect for individual patients has been emphasized, the role of the intellectual virtues in evidence-based medicine remains highly under-explored. (shrink)

Evidence-based medicine is a clinical decision making framework which makes claims about what physicians ought to do. Though heralded as the cutting edge of medical science evidence-based medicine is a value laden normative theory which implicitly depends on substantive views regarding what is morally good or right. In this paper, I provide an ethical analysis of evidence-based medicine. I consider its normative underpinnings in three ethical theories: utilitarianism, Kantian deontology, (...) and virtue ethics. In the face of uncertainty, evidence-based medicine endorses expected utility theory using the best available evidence in order to avoid doing more harm than good. In accordance with the Kantian respect for individuals as ends in themselves, evidence-based medicine calls for integrating the values and preferences of the patient. De-emphasizing intuition, clinical expertise, and pathophysiologic rationale emphasizes the need for the intellectual virtues of curiosity, critical thinking, and courage. Evidence-based medicine is a successful clinical practice that can be morally justified by all three major ethical theories. Although its focus on maximizing good health outcomes and integrating respect for individual patients has been emphasized, the role of the intellectual virtues in evidence- based medicine remains highly under-explored. (shrink)

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

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

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)

Complementary and alternative medicine has become an important section of healthcare. Its high level of acceptance among the general population represents a challenge to healthcare professionals of all disciplines and raises a host of ethical issues. This article is an attempt to explore some of the more obvious or practical ethical aspects of complementary and alternative medicine.

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

The difficulties of undertaking good quality effectiveness research in palliative medicine are well documented. Much of the ethical literature in this area focuses on the vulnerability of the palliative care population. It is clear that a wider ethical approach will need to be used to justify research in the terminally ill. Some themes of ethical thought are underutilised in considering the ethics of palliative care research. Three arguments to justify the need for effectiveness research in palliative (...) care should be highlighted: there is evidence of an untapped altruism amongst the population of palliative care patients who would be keen to be involved in such research; traditional Aristotelean and Thomistic virtue ethics would point to the need to gain knowledge in and of itself, but especially in palliative medicine for the benefit of patients: virtue also accrues in the acquisition of a stock of research experience which in turn makes further research feasible; most compellingly, justice would dictate that palliative treatments are effective, that futile or useless treatments are avoided and that patients are not party to “n of 1” trials by default. The current state of the evidence base of effectiveness in palliative care leads us to the uncomfortable position where patients are in precisely the position of being unwitting participants in “n of 1” clinical trials by default, without their explicit consent. (shrink)

Increasing philosophical attention is being directed to the rapidly growing discipline of evidence-based medicine. Philosophical discussions of EBM, however, remain narrowly focused on randomization, mechanisms, and the sociology of EBM. Other aspects of EBM have been all but ignored, including the nature of clinical reasoning and the question of whether it can be standardized; the application of EBM principles to the logic, value, and ethics of diagnosis and prognosis; evidence synthesis ; and the nature and ethics (...) of placebo controls. Philosophical analysis in each of these areas has the potential to enhance the discussion of EBM methodology and practice. (shrink)

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

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)

All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process: (...) designing the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms. This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested. (shrink)

The editors of the symposium hope it will provide a balanced appraisal of evidence based medicine.This symposium is devoted to evidence based medicine and the ethical issues it raises. Since Sir Archie Cochrane’s seminal Nuffield Provincial Hospitals Trust lectures in 1972 and their publication as the Rock Carling monograph for that year, Effectiveness and Efficiency: Random Reflections on Health Services, the idea that medical interventions and health services should be evaluated and selected on (...) the basis of the most reliable evidence available for their effectiveness and cost effectiveness has become very widely accepted.1,2 This widespread acceptance has not been complete, and it sometimes seems that there are as many critics of EBM as advocates. Whereas the importance of randomised trial evidence, critical appraisal, meta-analysis, and systematic review …. (shrink)

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

This is an account of the evolution of ideas and the confluence of support and vision that has eventuated in the founding of the Journal of Empirical Research on Human Research Ethics (JERHRE). Many factors have contributed to the creation of this rather atypical academic journal, including a scientific and administrative culture that finally saw the need for it, modern electronic technology, individuals across the world who were committed to somehow finding common ground between researchers and those charged with (...) class='Hi'>ethical oversight of research, a network of helpful colleagues, and a university whose administration gave moral support to the endeavor in a time of fiscal austerity. Perhaps equally important were the decisions to make JERHRE a nonprofit undertaking, to emphasize the implications of empirical research for specific best practices, to serve the educational needs of those concerned with human research, and to seek to stimulate the interest of students in gaining an evidence-based understanding of the research contexts in which they decide to work. This article explores the ‘chemistry’ that has made it possible to develop a somewhat unorthodox journal and set of related activities. (shrink)

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

In this paper, the author argues that the requirement to conduct randomised clinical trials to inform policy in cases where one wants to identify a cheaper alternative to known effective but expensive interventions raises an important ethical issue. This situation will eventually arise whenever there are resource constraints, and a policy decision has been made not to fund an intervention on cost effectiveness grounds. It has been thought that this is an issue only in extremely resource poor settings. This (...) paper gives an example from the United Kingdom illustrating that this is also a problem faced by richer countries. (shrink)

In this paper, the results of a pilot interview study with 19 subjects participating in an EEG-based non-invasive brain–computer interface (BCI) research study on stroke rehabilitation and assistive technology and of a survey among 17 BCI professionals are presented and discussed in the light of ethical, legal, and social issues in research with human subjects. Most of the users were content with study participation and felt well informed. Negative aspects reported include the long and cumbersome preparation procedure, discomfort (...) with the cap and the wet electrodes, problems concerning BCI control, and strains during the training sessions. In addition, some users reflected on issues concerning system security. When asked for morally problematic issues in this field of non-invasive BCI research, the BCI professionals stressed the need for correct information transfer, the obligation to avoid unrealistic expectations in study participants, the selection of study participants, benefits and strains of participation, BCI illiteracy, the possibility of detrimental brain modifications induced by BCI use, and problems that may arise at the end of the trials. Furthermore, privacy issues were raised. Based on the results obtained, psychosocial and ethical aspects of EEG-based non-invasive BCI research are discussed and possible implications for future research addressed. (shrink)

Although we theorize that nurses ‘make a difference’ to patient outcomes and speculate that this happens because nurses ‘care’, there is so far little evidence to support this nebulous claim. Efforts to promote care as the defining characteristic of nursing, and an ‘ethic of care’ as the ethical basis of nursing, have sparked debate within the discipline. This debate has resulted in a polarization that has effectively stalled productive discourse on the issues. Moreover, the focus on care has (...) been at the expense of understanding the true nature of the relationship between caring and the broader base of ethical knowledge that underpins nursing and that must underpin nursing if it is a viable practice profession. This paper used the framework of philosophical argument to explore the moral and ethical foundations of nursing from the perspective of personal and public morals, and responsive nurse–patient relationships as the reflection of ethical nursing knowledge. The foundation of ethical nursing knowledge is the personal moral sense that resides within the individual and that nurses hold in common with others. Personal moral knowledge is transformed into disciplinary ethical knowledge specific to nursing through disciplinary consensus. Responsive relationships are conceptualized in the nursing literature as founded on three essential elements: respect, trust, and mutuality. These three elements are grounded in ethical nursing knowledge; therefore responsive nurse–patient relationships reflect both personal moral knowledge and disciplinary ethical knowledge. By facilitating the articulation of ethical nursing knowledge in practice, responsive relationships connect theory, ethical knowledge, and clinical outcomes. (shrink)

ABSTRACT:Novel biotechnologies produce new person-related biological entities, such as cell lines, organoids, and synthetic organisms, that tend to disrupt existing concepts, taxonomies, modes of evidence production, as well as moral norms and values. This raises the question of how we can manage these new person-related biological entities. This article identifies and analyzes key conceptual, ontological, epistemological, and ethical aspects of such entities in order to suggest how to make, manage, and regulate them. It argues that in order (...) to avoid conceptual vagueness and taxonomic confusion, it is important to clarify how person-related biological entities relate to existing concepts and to make new concepts where necessary. Ontologically, we need to determine the thing- and person-likeness of such entities. Epistemically, we must provide measures to verify the characteristics of person-related biological entities and to provide high-quality knowledge of their implications (outcomes). And ethically, we must clarify the moral status, rights, and responsibility for and of the entities, and how they will change our norms and values. Addressing these issues up front may improve our making and managing of person-related biological entities. (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)

As health care embraces the tenets of evidence-based medicine it is important to ask questions about how evidence is produced and interpreted. This essay explores normative dimensions of evidence production, particularly around issues of setting the tolerable level of uncertainty of results. Four specific aspects are explored: what health care providers know about statistics, why alpha levels have been set at 0.05, the role of randomization in the generation of sufficient grounds of belief, and the (...) role of observational studies. The essay concludes with recommendations to acknowledge the value permeation of outcome measures and suggests that attention to reasoning and argument analysis can augment traditional evidence-based approaches in providing a robust critical approach to medical knowledge. (shrink)

A long-debated question in the philosophy of health, and contingent disciplines, is the extent to which wise clinical practice (“clinical wisdom”) is, or could be, compatible with empirically validated medicine (“evidence-based medicine”—EBM). Here we respond to Baum-Baicker and Sisti, who not only suggest that these two types of knowledge are divided due to their differing sources, but also that EBM can sometimes even hurt wise clinical practice. We argue that the distinction between EBM and clinical wisdom (...) is poorly defined, unsupported by the methodology employed, and ultimately incorrect; crucial differences exist, we argue, not in the source of a particular piece of clinical knowledge, but in its dependability. In light of this subtle but fundamental revision, we explain how clinical wisdom and EBM are—by necessity—complementary, rather than in conflict. We elaborate on how recognizing this relationship can have far-reaching implications for the domains of clinical practice, medical education, and health policy. (shrink)

Evidence-Based Medicine (EBM) is defined as the conscious, and judicious use of current best evidence in making decisions about the care of individual patients. The greater the level of evidence the greater the grade of recommendation. This pioneering explicit concept of EBM is embedded in a particular view of medical practice namely the singular nature of the patient-physician relation and the commitment of the latter towards a specific goal: the treatment and the well being of (...) his or her client. Nevertheless, in many European countries as well as the United States, this integration of the best evidence from systematic research with clinical expertise and patient values appears to be re-interpreted in light of the scarcity of healthcare resources. The purpose of this paper is double. First, to claim that from an ethical perspective EBM should be a guideline to clinical practice; and second, that in specific circumstances EBM might be a useful tool in macro-allocation of healthcare resources. Methodologically the author follows Norman Daniels' theory of democratic accountability to justify this assumption. That is, choices in healthcare must be accountable by democratic procedures. This perspective of distributive justice is responsible for the scope and limits of healthcare services. It follows that particular entitlements to healthcare — namely expensive innovative treatments and medicines —may be fairly restricted as long as this decision is socially and democratically accountable and imposed by financial restrictions of the system. In conclusion, the implementation of EBM, as long as it limits the access to drugs and treatments of unproven scientific results is in accordance with this perspective. The use of EBM is regarded as an instrument to facilitate the access of all citizens to a reasonable level of healthcare and to promote the efficiency of the system. (shrink)

Evidence-based psychiatry (EBP) has arisen through the application of evidence-based medicine (EBM) to psychiatry. However, there may be aspects of psychiatric disorders and treatments that do not conform well to the assumptions of EBM. This paper reviews the ongoing debate about evidence-based psychiatry and investigates the applicability, to psychiatry, of two basic methodological features of EBM: prognostic homogeneity of clinical trial groups and quantification of trial outcomes. This paper argues that EBM may not (...) be the best way to pursue psychiatric knowledge given the particular features of psychiatric disorders and their treatments. As a result, psychiatry may have to develop its own standards for rigour and validity. This paper concludes that EBM has had a powerful influence on how psychiatry investigates and understands mental disorders. Psychiatry could influence EBM in return, reshaping it in ways that are more clinically useful and congruent with patients’ needs. (shrink)

Evidence-Based Medicine (EBM) developed from the work of clinical epidemiologists at McMaster University and Oxford University in the 1970s and 1980s and self-consciously presented itself as a "new paradigm" called "evidence-based medicine" in the early 1990s. The techniques of the randomized controlled trial, systematic review and meta-analysis have produced an extensive and powerful body of research. They have also generated a critical literature that raises general concerns about its methods. This paper is a systematic (...) review of the critical literature. It finds the description of EBM as a Kuhnian paradigm helpful and worth taking further. Three kinds of criticism are evaluated in detail: criticisms of procedural aspects of EBM (especially from Cartwright, Worrall and Howick), data showing the greater than expected fallibility of EBM (Ioaanidis and others), and concerns that EBM is incomplete as a philosophy of science (Ashcroft and others). The paper recommends a more instrumental or pragmatic approach to EBM, in which any ranking of evidence is done by reference to the actual, rather than the theoretically expected, reliability of results. Emphasis on EBM has eclipsed other necessary research methods in medicine. With the recent emphasis on translational medicine, we are seeing a restoration of the recognition that clinical research requires an engagement with basic theory (e.g. physiological, genetic, biochemical) and a range of empirical techniques such as bedside observation, laboratory and animal studies. EBM works best when used in this context. (shrink)

I am grateful to Drs. Richard Bukata and Jerome Hoffman and the staff of Primary Care Medicals for retrieving and analyzing some of the references used in this paper.

Decisions in healthcare are made against the background of cultural and philosophical definitions of disease, sickness and illness. These concepts or definitions affect both health policy and research , as well as individual encounters between patients and physicians . It is therefore necessary for evidence-based medicine to consider whether any of the definitions underlying research prior to the hierarchisation of knowledge are indeed compatible with its own epistemological principles.

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

The increased demand for evidence-based medicine has proven much more challenging for psychiatry to accept than for medicine in general. Among the concerns is a perception that EBM does not respond appropriately to the character and complexity of psychiatric disorders and treatments, that the concept of ‘evidence’ is too narrowly construed, and that it may encourage a false sense of competence. It has also been claimed that EBM may encourage a kind of ‘cookbook medicine,’ (...) leaving out tacit knowledge and the empathic and caring aspects of the psychiatrist– patient relationship. (shrink)

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

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