The authoritarian standpoint in medicine has been under challenge by various groups and researchers since the 1980s. The challenges have been ethical, political and medical, with patient movements at the forefront. Over the past decade, however, a deep challenge has been posed by evidence-based medicine (EBM), which has challenged the entire strategy of medical treatment from the point of view of a self-critical, anti-authoritarian and hereby also (it has been claimed) a more democratic medical practice. Previously, the (...) challenges arose out of the patient rights perspective. EBM, by contrast, was taken to challenge the way doctors consider their medical practice as a whole. The present paper puts this claim of democratization into a historical context. Two dimensions of the democratization hypothesis are discussed and it is argued that they are insufficient to capture the substantial changes going on in the intersection between medical practice, biomedical science and citizens. (shrink)

The question what scientific progress means for a particular domain such as medicine seems importantly different from the question what scientific progress is in general. While the latter question received ample treatment in the philosophical literature, the former question is hardly discussed. I argue that it is nonetheless important to think about this question in view of the methodological choices we make. I raise specific questions that should be tackled regarding scientific progress in the medical sciences and demonstrate their (...) importance by means of an analysis of what evidence-based medicine (EBM) has, and has not, to offer in terms of progress. I show how critically thinking about EBM from the point of view of progress can help us in putting EBM and its favoured methodologies in the right perspective. My conclusion will be that blindly favouring certain methods because of their immediately tangible short-term benefits implies that we parry the important question of how best to advance progress in the long run. This leads us to losing sight of our general goals in doing research in the medical sciences. (shrink)

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)

Evidence-based medicine has been the subject of much controversy within and outside the field of medicine, with its detractors characterizing it as reductionist and authoritarian, and its proponents rejecting such characterization as a caricature of the actual practice. At the heart of this controversy is a complex linguistic and social process that cannot be illuminated by appealing to the semantics of the modifier evidence-based. The complexity lies in the nature of evidence as a basic concept that circulates in both expert (...) and non-expert spheres of communication, supports different interpretations in different contexts, and is inherently open to contestation. We outline a new methodology that combines a social epistemological perspective with advanced methods of corpus linguistics and elements of conceptual history to investigate this and other basic concepts that underpin the practice and ethos of modern medicine. The potential of this methodology to offer new insights into controversies such as those surrounding EBM is demonstrated through a case study of the various meanings supported by evidence and based, as attested in a large electronic corpus of online material written by non-experts as well as a variety of experts in different fields, including medicine. (shrink)

The institutional review board at the University of Nebraska Medical Center has a policy on contraceptive use in research that aims to balance the protection of potential fetuses from potential harm resulting from drug exposure in research against respect for the autonomy of women research participants. The policy draws on the U.S. Food and Drug Administration’s Use-in-Pregnancy categories in an innovative way. These categories are meant to help prevent the exposure of fetuses to harmful drugs when (...) used for therapy by pregnant women. The UNMC IRB policy applies the FDA categories as a guideline for mandating contraceptive use among research participants. Clinical trials of drugs in the different FDA categories require different levels of contraceptive protection under the UNMC IRB policy. Though we agree with the insight that contraceptive requirements in research could helpfully be guided by the current and future FDA Use-in-Pregnancy guidelines, we argue that in several places, the UNMC IRB policy unjustifiably prioritizes the protection of potential fetuses from potential harm at the expense of respecting the autonomy and well-being of women research participants. In response to the deficiencies we identify in the UNMC IRB policy, we formulate an alternative, ideal policy on contraceptive use in research. (shrink)

Evidence-based medicine frequently uses statistical hypothesis testing. In this paradigm, data can only disconfirm a research hypothesis’ competitors: One tests the negation of a statistical hypothesis that is supposed to correspond to the research hypothesis. In practice, these hypotheses are often misaligned. For instance, directional research hypotheses are often paired with non-directional statistical hypotheses. Prima facie, one cannot gain proper evidence for one’s research hypothesis employing a misaligned statistical hypothesis. This paper sheds lights on the nature (...) of and the reasons for such misalignments and it provides a thorough analysis of whether they pose a threat to evidence-based medicine. The upshots are that the misalignments are often hidden for clinicians and that although some cases of misalignments can be partially counterbalanced, the overall threat is non-negligible. The counterbalances either lead to methodological inadequacy, loss of statistical power, or involve a lack of information that could be crucial for decision making. This result casts doubt on various findings of medical studies in addition to issues associated with under-powered studies or the replication crisis. (shrink)

Next SectionEvidence based medicine is rightly at the core of current medicine. If patients and society put trust in medical professional competency, and on the basis of that competency delegate all kinds of responsibilities to the medical profession, medical professionals had better make sure their competency is state of the art medical science. What goes for the ethics of clinical trials goes for the ethics of medicine as a whole: anything that is scientifically doubtful is, other (...) things being equal, ethically unacceptable. This particularly applies to so called orphaned fields of medicine, those areas where medical research is weak and diverse, where financial incentives are lacking, and where the evidence regarding the aetiology and treatment of disease is much less clear than in laboratory and hospital based medicine. Examples of such orphaned fields are physiotherapy, psychotherapy, medical psychology, and occupational health, which investigate complex syndromes such as RSI, whiplash, chronic low back pain, and chronic fatigue syndrome. It appears that the primary ethical problem in this context is the lack of attention to the orphaned fields. Although we agree that this issue deserves more attention as a matter of potential injustice, we want to argue that, in order to do justice to the interplay of heterogeneous factors that is so typical of the orphaned fields, other ethical models than justice are required. We propose the coordination model as a window through which to view the important ethical issues which relate to the communication and interaction of scientists, health care workers, and patients. (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)

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)

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)

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)

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.

Poor quality medical care is sometimes attributed to physicians’ unwillingness to act on evidence about what works best. Evidence-based performance standards (EBPSs) are one response to this problem, and they are increasingly employed by health care regulators and payers. Evidence in this instance is judged according to the precepts of evidence-based medicine (EBM); it is probabilistic, and the randomized controlled trial (RCT) is the gold standard. This means that EBPSs suffer all the infirmities of EBM generally—well rehearsed problems with (...) the external validity of research findings as well as the inferential leap from study results in the aggregate to individual patient care. These theoretical weaknesses promise to have a practical impact on the care of patients. To avoid this, EBPSs should be understood as guidelines indicative of average effectiveness rather than standards to be applied in every case. (shrink)

The use of platelet rich plasma as a novel treatment is discussed in the context of a qualitative research study comprising 38 interviews with sports medicine practitioners and other stakeholders working within the English Premier League during the 2013–16 seasons. Analysis of the data produced several overarching themes: conservatism versus experimentalism in medical attitudes; therapy perspectives divergence; conflicting versions of appropriate evidence; subcultures; community beliefs/practices; and negotiation of medical decision-making. The contested evidence base for the efficacy of (...) PRP is presented in the context of a broader professional shift towards evidence based medicine within sports medicine. Many of the participants while accepting this shift are still committed to casuistic practices where clinical judgment is flexible and does not recognize a context-free hierarchy of evidentiary standards to ethically justifiable practice. We also discuss a tendency in the data collected to consider the use of deceptive, placebo-like, practices among the clinician participants that challenge dominant understandings of informed consent in medical ethics. We conclude that the complex relation between evidence and ethics requires greater critical scrutiny for this emerging specialism within the medical community. (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)

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)

Thirty years after the rise of the evidence-based medicine (EBM) movement, formal training in philosophy remains poorly represented among medical students and their educators. In this paper, I argue that EBM’s reception in this context has resulted in a privileging of empiricism over rationalism in clinical reasoning with unintended consequences for medical practice. After a limited review of the history of medical epistemology, I argue that a solution to this problem can be found in the method of (...) the 2nd-century Roman physician Galen, who brought empiricism and rationalism together in a synthesis anticipating the scientific method. Next, I review several of the problems that have been identified as resulting from a staunch commitment to empiricism in medical practice. Finally, I conclude that greater epistemological awareness in the medical community would precipitate a Galenic shift toward a more epistemically balanced, scientific approach to clinical research. (shrink)

As a recent special report in the Hastings Center Report demonstrates, many bioethicists are rethinking the way we regulate both biomedical research and clinical practice, as well as the sharp boundary that the field has assumed can and should exist between them. Such a rethinking is long overdue. There is surely a meaningful normative distinction between activities whose expected risk‐benefit profile is and is not “reasonable” for participants (to echo the language in the Common Rule—the core set of human (...) research guidelines found in many federal regulations). But neither the research‐practice distinction nor the criteria underlying it—the intention of the actor, whether the activity is “systematic,” and whether its results are “generalizable”—closely track good and bad outcomes for research participants and patients or justify either the bureaucratic, paternalistic licensing system that governs human subjects research or the comparatively lax governance of medical practice. The specious distinction between research and practice is especially ripe for dismantling in light of the embarrassing fact that evidence‐based medicine remains more aspiration than reality. (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)

Although evidence-based medicine (EBM) has gained prominence in current medical practice and research, it has also had to deal with a number of problems and inconsistencies. For example, how do clinicians reconcile discordant results of randomized trials or how do they apply results of randomized trials to individual patients? In an attempt to examine such problems in a structured way, this essay describes EBM within a philosophical framework of science. Using this approach, some of the problems and challenges (...) faced by EBM can be explained at a more fundamental level. As well, by employing a similar description of the competing alternative research tradition of clinical medicine, this essay not only highlights the philosophical differences between these two modes of medical practice, but suggests that they, in fact, play a de facto complementary role in current clinical medicine. (shrink)

Aim: The aim of this paper is to present the development and evaluation of an art psychotherapy brief treatment method for complex depression for patients referred to mental health services.Background: Art Psychotherapy literature describes a range of processes of relational change through the use of arts focused and relationship focused interventions. Complex depression has a prevalence of 3% of the population in the West and it is recorded that in 2016 only 28% of that population were receiving psychological treatment. This (...) study was developed to test the hypothesis of whether an accessible and acceptable approach to the treatment of complex depression could be developed in relation to existing evidence-based practice within mental health services.Method: The United Kingdom Medical Research Council phased guidance for complex intervention development was used to develop the intervention. The process included producing a literature overview, systematic description of clinical practice, including a logic model and a clinical protocol. The art psychotherapy protocol described an arts-based dynamic interpersonal therapy approach, offered 1:1 over 24 sessions. Further to this the intervention was tested for referrer acceptability. The intervention is in the early stages of evaluation, using changes to the patient's depression and anxiety measured pre- and post-treatment with a follow-up measure at 3 months following completion of treatment.Results: Phase I of the study provided a good basis for developing a logic model and protocol. The authors found that there was good clinical consensus about the use of a structured clinical art psychotherapy method and the literature overview was used to support specific examples of good practice. The verification of clinical coherence was represented by a logic model and clinical protocol for delivering the intervention. The acceptability study demonstrated very high levels of acceptability for referrers reporting that ADIT was acceptable for patients with complex/major depression, that they were likely to refer to ADIT in the future that the use of arts was likely to improve accessibility the use of arts was likely to improve outcomes and that offering ADIT was an effective use of mental health resources.Discussion: Phase I of this intervention development study demonstrated theoretical and practice coherence resulting in a clinical protocol and logic model. Whilst Phase II of this study showed promising results, Phase II would need to be sufficiently scaled up to a full trial to further test the intervention and protocol. (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)

In recent years, the government, advocacy organizations, the press, and the public have pressured universities, academic medical centers, and physicianinvestigators to do more to ensure that their financial interests and relationships do not conflict with their duties to conduct high-quality research and protect the safety and welfare of clinical trial participants. A number of factors underlie the increased focus. First, private sector funding of clinical research has grown both in absolute terms and as a proportion of overall (...) funding. In 2008, the pharmaceutical, medical device, and biotechnology industries’ domestic research and development expenditures constituted approximately 60.9% of funding for biomedical research in the United States; the next largest funder, the National Institutes of Health, funded 27.9%. Private industry spent $58.6 billion on research in 2007, up from $40 billion in 2003, an increase of 25% after adjusting for inflation. (shrink)

Tieu, Matthew The main results of the reports published on the efficacy and achievements of the Medically Supervised Injecting Centre in Kings Cross over the last decade of its operations are discussed. The reports do not provide any substantive evidence that the MSIC has achieved its objectives.

Over the last few decades, there has been a push towards evidence-based medicine, with the medical fraternity recognising and embracing the improved outcomes brought about by this approach. Central to this is the ability of healthcare professionals across all levels to be able to understand and undertake scientifically sound efforts to gather and learn from this evidence. This can be on a local level, for example departmental audits, or on a national or international level, as is the case with (...) large randomised controlled trials. Unfortunately, although academic medicine topics such as research and teaching are often discussed and taught at medical schools - many of which are at the forefront of international research efforts - medical students and junior doctors rarely get the chance to participate in any real-world studies, or indeed critique any practice changing studies in a meaningful way for themselves. The situation in regard to teaching is similar. Peer to peer teaching opportunities may be limited to self-arranged sessions with little to no guidance or formal training in how to do this key task, which will be crucial for the rest of one's career. This is despite these activities being recognised as essential by undergraduate and post-graduate educators. In fact, they are a key part of selection for postgraduate employment. Candidates that demonstrate awareness of and proficiency with research and other academic activities such as teaching are highly sought after. However, many candidates, particularly those who don't take time out of their undergraduate programmes or pursue a higher degree, tend not to have had the exposure and opportunities to engage with these academic activities as students and junior healthcare professionals. Many will have never undertaken any formal research or teaching during this time. Furthermore, we have found that many students with an interest in medical research don't have the skills and experience required to get started, and may lack mentors and senior colleagues with the time, interest or experience to help them. (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 (EBM) has thus far failed to adequately account for the appropriate incorporation of other potential warrants for medical decision making into clinical practice. In particular, EBM has struggled with the value and integration of other kinds of medical knowledge, such as those derived from clinical experience or based on pathophysiologic rationale. The general priority given to empirical evidence derived from clinical research in all EBM approaches is not epistemically tenable. A casuistic alternative to EBM approaches (...) recognizes that five distinct topics, 1) empirical evidence, 2) experiential evidence, 3) pathophysiologic rationale, 4) patient goals and values, and 5) system features are potentially relevant to any clinical decision. No single topic has a general priority over any other and the relative importance of a topic will depend upon the circumstances of the particular case. The skilled clinician must weigh these potentially conflicting evidentiary and non-evidentiary warrants for action, employing both practical and theoretical reasoning, in order to arrive at the best choice for an individual patient. (shrink)

The basis for ‘sound’ medical opinion has moved from clinical opinion to evidence based research. This article will comment on the basis on which evidence in clinical medicine is collected and, indeed, what actually constitutes evidence. It is suggested that the definition of guidelines arising from evidence-based medicine may lead to false conclusion and, as noted by Sir Douglas Black, whilst ‘guidelines can of course be helpful in clear-cut situations; [but] these are the minority in actual practice’.

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

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

The main varieties of scientific misconduct are fabrication, falsification, misquoting and plagiarism. Considering the "improvement" of fraudulent skills, scientists, editors, and authorities must jointly combat the misconduct. Also, it is important that whistleblowers must be protected from revenge. The response to scientific misconduct requires national and international bodies to provide leadership and guidelines. Whistleblowers need a safe, confidential place to report misconduct. The quality of research and hidden conflicts of interest should be taken into account deciding which studies are (...) to be included into reviews. Forged publications and speculative theories have been used for promotion of drugs, dietary supplements and treatments without proven effectiveness. Marketing of placebos in the guise of evidence-based medications seems to be on the increase. Patients can be misinformed not only by the advertising but also by publications supposed to be scientific. Furthermore, it has become usual practice to disregard published criticism in spite of personal communications and debates at conferences. Some scientists seem to make use of critical comments without citing them, or just continue publications ignoring the criticism. The same scientists continue working sometimes in cooperation with renowned researchers; and it is possible that some later articles are more reliable than earlier ones. However, it is insufficient to hope that reliable publications would be shortly confirmed while forgeries would fall into oblivion. Fake papers are misleading for research and practice, cost time and money. Wrong concepts are persisting and reappearing, which may result in useless experimentation and application of invasive methods without sufficient indications. An international cooperation of bona fide scientists, editors and authorities is needed to eradicate the scientific misconduct and fraude in medicine. The book contains an overview of misconduct in medical research and practice mainly from the former Soviet Union. Ample documentary evidence is provided as illustrations. (shrink)

Institutional Review Board decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants inhaled hexamethonium, a (...) chemical ganglionic blocker that was not FDA-approved for use as specified in the experimental protocol. Risks of inhaling hexamethonium, including lung damage, had been reported in the 1950s and ‘60s. An investigation conducted after Roche's death determined that the study's principal investigator had failed to adequately search the medical literature; the protocol submitted for IRB review cited articles indexed in online literature databases that went back only as far as the 1970s. (shrink)

The notion of causal evidence in medicine has been the subject of wide philosophical debate in recent years. The notion of evidence has been discussed mostly in connection with Evidence Based Medicine and, more in general, with the assessment of causal nexus in medical, and especially research contexts. “Manipulative evidence” is one of the notions of causal evidence that has stimulated much debate. It has been defined in slightly different ways, attributed different relevance, and recently placed at the (...) core of Gillies’ “action-related theory of causality”, a view specifically meant to address causation in medicine. While in general sympathetic to Gillies’ account, and totally convinced of the relevance of manipulative evidence and different sorts of interventions in the biomedical sciences, we believe that some further qualifications are needed to allow the notion of manipulative evidence to better express features of medical practice. In particular, we provide some qualification of the role of “interventional evidence” proposed by Gillies, suggesting a distinction between “interventional evidence” and “evidence for interventions”. A case study from research on rare diseases is analyzed in depth and a multifaceted notion of manipulative evidence put forward that allows better understanding of what manipulations in medical contexts amount to and what their targets are. (shrink)

Good medical practice requires evidence of effectiveness to address deficits in care, strive for further improvements, and justly apportion finite resources. Nevertheless, the potential of palliative care is still held back by a paucity of good evidence. These circumstances are largely attributable to perceived ethical challenges that allegedly distinguish dying patients as a special client class. In addition, practical limitations compromise the quality of evidence that can be obtained from empirical research on terminally ill subjects.This critique aims to (...) appraise the need for focused research, in order to develop clinical and policy decisions that will guide health care professionals in their care of dying patients. Weighted against this need are tenets that value the practical and ethical challenges of palliative care research as unique and insurmountable. The review concludes that, provided investigators compassionately apply ethical principles to their work, there is no justification for not endeavouring to improve the quality of palliative care through research. (shrink)

This article highlights the current controversies around stem cell research and its application in clinical medicine. It aims to discuss the ethical concerns around how corporate involvement is corrupting the ethical progression in this field of research. The author appeals to medical and scientific communities to take cognisance of current practices and to facilitate the regulation of new stem cell therapies being advertised to the public.

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)

Proponents of evidence-based medicine have recently suggested a “4S” approach to clinical decision making in which physicians are advised to rely on increasingly abstract summaries of the available research evidence. This retreat from the original data of medical research is ill-advised: it extends an unjustified evidence hierarchy, overestimates the role of computer systems, divides communities, discards evidence, ignores contexts, and devalues broad critical evaluation. I draw upon feminist social epistemology to evaluate the 4S approach to EBM and (...) to suggest means for improving the evidence base of medical research and practice. (shrink)

Traditionally, surgical practice has been experiential and based on the contemporary understanding of basic mechanisms of disease. It was both a science and an art and depended to far too great an extent on the individualism and self belief of its main exponents. “Evidence based medicine” emerged in the 1980s and a new gospel of “Rules of Evidence” was introduced. There is no doubt that the net effect of EBM has been beneficial, but over reliance on randomised controlled trials and (...) the lack of generalisability of scientific evidence to individual patients has perhaps led to less enthusiasm for its tenets among surgeons. There are valid and spurious reasons for this that are discussed. The situation is improving but inevitable tensions remain between the surgeon committed to the individual patient here and now, and the clinical researcher whose focus is the benefit of future patients in the larger community. (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)

Over the past decade there has been a trend within adapted physical activity (APA) to question the hegemony of the medical understanding of disability. This debate has consequences for professional practice, which some argue should be regarded as a learning situation with a pedagogical orientation. The concept of evidence-based practice and research has spread from its origin in medicine to other allied health fields and education. In this article I discuss the limitations of applying evidence-based practice to a (...) pedagogical approach to APA. More specifically, I use the Aristotelian notion phronesis to show that professional practice of APA is essentially characterized by an indeterminacy that cannot be eradicated through the technological thinking inherent in evidence-based practice. (shrink)

Medical necessity (claiming that a medical intervention or care is – at minimum – reasonable, appropriate and acceptable) depends on empirical evidence and on the interpretation of that evidence. Evidence and its interpretation define the standard of care. This commentary argues that both the evidence base and its interpretation are currently weak gatekeepers. Empirical meta-research suggests that very few medical interventions have high quality evidence in support of their effectiveness and very few of them also have (...) relatively thorough assessments of their potential harms. Therefore, evidence on the risk-benefit ratios carries almost always very large uncertainty. Arbitration about medical necessity is thus left to the interpretation process. Professional guidelines are notoriously unreliable and biased in this regard. Regulatory approval ends up being the key arbitrator, but over the years the regulatory process has been subverted. Regulatory approval currently does not mean that an intervention has a favourable risk-benefit ratio, but simply that it can be marketed, sold and made profit from. The process leads to a tragedy of commons where the final victim is society at large: medical necessity is invoked as an alibi for medicine to absorb societal resources. (shrink)

A key question for evidence-based medicine is how best to model the way in which EBM should “[integrate] individual clinical expertise and the best external evidence”. We argue that the formulations and models available in the literature today are modest variations on a common theme and face very similar problems. For example, both the early and updated models of evidence-based clinical decisions presented in Haynes, Devereaux and Guyatt assume that EBM consists of, among other things, evidence from clinical research (...) and clinical expertise. On this A-view, EBM describes all that goes on in a specific justifiable medical decision. There is, however, an alternative interpretation of EBM, the B-view, in which EBM describes just one component of the decision situation and in which, together with other types of evidence, EBM leads to a justifiable clincial decision but does not describe the decision itself. This B-view is inspired by a 100-years older version of EBM, a Swedish standard requiring medical decision-making and practice to be in accordance with ‘science and proven experience’. In the paper we outline how the Swedish concept leads to an improved understanding of the way in which scientific evidence and clinical experience can and cannot be integrated in light of EBM. In addition the paper sketches the as yet unexplored historical background to EBM. (shrink)

Proponents of evidence-based medicine have recently suggested a “4S” approach to clinical decision making in which physicians are advised to rely on increasingly abstract summaries of the available research evidence. This retreat from the original data of medical research is ill-advised: it extends an unjustified evidence hierarchy, overestimates the role of computer systems, divides communities, discards evidence, ignores contexts, and devalues broad critical evaluation. I draw upon feminist social epistemology to evaluate the 4S approach to EBM and (...) to suggest means for improving the evidence base of medical research and practice. (shrink)

A key question for evidence-based medicine is how best to model the way in which EBM should‘[integrate] individual clinical expertise and the best external evidence’. We argue that the formulations and models available in the literature today are modest variations on a common theme and face very similar problems when it comes to risk analysis, which is here understood as a decision procedure comprising a factual assessment of risk, the risk assessment, and the decision what to do based on this (...) assessment, the risk management. Both the early and updated models of evidence-based clinical decisions presented in the writings of Haynes, Devereaux and Guyatt assume that EBM consists of, among other things, evidence from clinical research together with information about patients’ values and clinical expertise. On this A-view, EBM describes all that goes on in a specific justifiable medical decision. There is, however, an alternative interpretation of EBM, the B-view, in which EBM describes just one component of the decision situation and in which, together with other types of evidence, EBM leads to a justifiable clincial decision but does not describe the decision itself. This B-view is inspired by a 100-years older version of EBM, a Swedish standard requiring medical decision-making, professional risk-taking and practice to be in accordance with‘science and proven experience’. In the paper, we outline how the Swedish concept leads to an improved understanding of the way in which scientific evidence and clinical experience can and cannot be integrated in light of EBM. How scientific evidence and clinical experience is integrated influences both the way we do risk assessment and risk management. In addition, the paper sketches the as yet unexplored historical background to VBE and EBM. (shrink)

Relationships, jobs, and health behaviors-these are what New Year's resolutions are made of. Every year millions resolve to adopt a better diet, exercise more, become fit, or lose weight but few put into practice the health behaviors they aspire to. For those who successfully begin, the likelihood that they will maintain these habits is low. Healthcare professionals recognize the importance of these, and other, health behaviors but struggle to provide their patients with the tools necessary for successful maintenance of their (...) medical regimens. The thousands of research papers that exist on patient adherence and health behavior change can leave professionals overwhelmed. This book synthesizes the results from more than 50 years of empirical research, resulting in simple, powerful, and practical guidance for health professionals who want to know the most effective strategies for helping their clients to put long-term health-relevant behavior changes into practice. It advocates a straightforward 3-ingredient model: Before a person can change, they must know what change is necessary ; desire the change ; and then have the tools to achieve and maintain the change. This book is designed to be informative and compelling, but its numerous anecdotes and examples render it engaging and entertaining, as well. Written for a practitioners and students of medicine, chiropractic, osteopathy, nursing, health education, physician assistant programs, dentistry, clinical and health psychology, marriage and family counseling, social work, school psychology, and care administrators -- and for lay persons who wish to take an active role in their health, this book brings together major empirically-based findings within the field and provides succinct, evidence-based recommendations and strategies for using these findings to make real changes. (shrink)