In this paper I argue that evidence based medicine (EBM) offers a more transparent system of knowledge and medical care than complementary medicine (CM). While an individual’s choice to use CM should be respected, users of this form of medicine, nevertheless, risk loss of autonomy. This loss of autonomy is an outcome of CM’s offering fewer transparent possibilities for informed patient consent In both EBM and CM patients risk physical harm(s) but science gives EBM patients the benefit (...) of being able to factor known side effects into their health care decisions. (shrink)

Evidence-based medicine (EBM) puts forward a hierarchy of evidence for informing therapeutic decisions. An unambiguous interpretation of how to apply EBM's hierarchy has not been provided in the clinical literature. However, as much as an interpretation is provided proponents suggest a categorical interpretation. The categorical interpretation holds that all the results of randomised trials always trump evidence from lower down the hierarchy when it comes to informing therapeutic decisions. Most of the critical replies to EBM react to this interpretation. (...) While proponents of EBM can avoid some of the problems raised by critics by suitably limited the claims made on behalf of the hierarchy, further problems arise. If EBM is to inform therapeutic decisions then a considerably more restricted, and context dependent interpretation of EBM's hierarchy is needed. (shrink)

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 was developed to ensure that health-care decisions are based on the best available research evidence. Making this evidence available to patients is supposed to increase their autonomy by putting them in a position to make better-informed choices. In this paper, I draw on work in feminist bioethics to critique EBM’s approach to involving patients in decision making, in which patients are asked merely to select their preferences among various possible treatment outcomes but are not encouraged to actively (...) contend with the effects of illness on their lives as a whole. (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)

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-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)

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 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)

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)

Evidence-Based Medicine (EBM) and Personalized Medicine (PM) share a common goal: reducing the gap between the results of biomedical research and their clinical application. PM is, however, often presented as a “new paradigm” for medicine, just as EBM was in the 1990s. It covers a wide variety of projects but the core idea that generally unites them is the ambition of better taking account of individual specificities than did EBM with its statistical and population-centred approach. In this (...) article, I concentrate on PM in cancerology, the essence of which is to target treatments based on the molecular profile of the patient. This targeting is made possible by gaining better knowledge about the molecular mechanisms of cancers. The classification of patients as a function of their molecular profile entails the creation of patient sub-groups. This creates a problem for the traditional evaluation of therapeutic treatment promoted by EBM, in particular the use of randomized trials using sizeable cohorts. But a better understanding of the mechanisms and the greater precision of treatments could reduce the need for these trials. Does PM thus represent the revenge of a physio-pathological and mechanistic culture in clinical research against the statistical and empirical one of EBM? My objective is to show how current practices of PM leads to epistemological changes in our estimation of what count as relevant types of information and proof in medicine, in particular in the field of therapeutic evaluation. I defend the idea that PM, far from obviating the need for statistical approaches and the search for correlations, ultimately poses new challenges for EBM. PM drives EBM to strengthen the articulation and the integration of statistical and mechanistic data with a view to providing a better service for each patient. (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)

This paper explores some of the important parallels between recent reforms to legal rules for the admissibility of scientific and expert evidence, exemplified by the US Supreme Court's decision in Daubert v Merrell Dow Pharmaceuticals, Inc. in 1993, and similar calls for reforms to medical practice, that emerged around the same time as part of the Evidence-Based Medicine (EBM) movement. Similarities between the “movements” can be observed in that both emerged from a historical context where the quality of (...) class='Hi'>medicine and legal approaches to science were being subjected to growing criticism, and in the ways that proponents of both movements have used appeals to “folk epistemologies” of science to help legitimate their reform aspirations. The term folk epistemology is used to describe the weaving together of formal and informal images of scientific method with normative and pragmatic concerns such as eradicating “junk science”, and promoting medical best practice. Perhaps unsurprisingly, given the unfocused breadth of these aspirations the implications of these “reforms” for medical and legal practice have not been straightforward, although they do represent an important new set of rhetorical resources to critique and or legitimate expertise in medical and legal domains. Discussion closes, by noting the growth of calls for these movements to reciprocate in areas where law and medicine intersect, such as medical negligence litigation. (shrink)

Society is failing in its moral obligation to improve the standard of healthcare provided to vulnerable populations, such as people who lack decision making capacity, by a misguided paternalism that seeks to protect them by excluding them from medical research. Uncertainties surround the basis on which decisions about research participation is made under dual regulatory regimes, which adds further complexity. Vulnerable individuals’ exclusion from research as a result of such regulation risks condemning such populations to poor quality care as a (...) result of ‘evidence biased’ medicine. This paper explores the research regulation provisions for proxy decision making for those unable to provide informed consent for themselves, and the subsequent legal and practical difficulties for decision-makers. There are two separate regulatory regimes governing research involving adults who lack capacity to consent in England and Wales. The Mental Capacity Act 2005 governs how incapacitated adults can be involved in research, however clinical trials of medicinal products are separately regulated by the Medicines for Human Use Regulations 2004. There are significant differences under these dual regimes in the provisions for those lacking capacity to participate in medical research. The level of risk permitted differs, with a greater requirement for justification for participation in a clinical trial than other types of research. Who acts as proxy decision maker, how much information is provided to the person lacking capacity, and whether they retain the power of veto also significantly differs. The development of two separate regulatory regimes has resulted in significant differences between the provisions for clinical trials and other forms of research, and from usual medical practice. The resulting uncertainty has reinforced the tendency of those approving and conducting research to exclude adults lacking capacity to avoid difficult decisions about seeking consent for their participation. Future developments, such as the incoming EU Regulations, may address some of these differences, however the justification and level of risk permitted requires review to ensure that requirements are appropriate and proportionate to the burdens and risks for the individual, and also to the benefits for the wider population represented. (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)

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)

This essay explores the role of informal logicand its application in the context of currentdebates regarding evidence-based medicine. This aim is achieved through a discussion ofthe goals and objectives of evidence-basedmedicine and a review of the criticisms raisedagainst evidence-based medicine. Thecontributions to informal logic by StephenToulmin and Douglas Walton are explicated andtheir relevance for evidence-based medicine isdiscussed in relation to a common clinicalscenario: hypertension management. This essayconcludes with a discussion on the relationshipbetween clinical reasoning, rationality, andevidence. It (...) is argued that informal logic hasthe virtue of bringing explicitness to the roleof evidence in clinical reasoning, and bringssensitivity to understanding the role ofdialogical context in the need for evidence inclinical decision making. (shrink)

Personalised medicine has been discussed as a medical paradigm shift that will improve health while reducing inefficiency and waste. At the same time, it raises new practical, regulatory, and ethical challenges. In this paper, we examine PM strategies epistemologically in order to develop capacities to address these challenges, focusing on a recently proposed strategy for developing patient-specific models from induced pluripotent stem cells so as to make individualised treatment predictions. We compare this strategy to two main PM strategies—stratified (...) class='Hi'>medicine and computational models. Drawing on epistemological work in the philosophy of medicine, we explain why these two methods, while powerful, are neither truly personalised nor, epistemologically speaking, novel strategies. Both are forms of correlational black box. We then argue that the iPSC models would count as a new kind of black box. They would not rely entirely on mechanistic knowledge, and they would utilise correlational evidence in a different way from other strategies—a way that would enable personalised predictions. In arguing that the iPSC models would present a novel method of gaining evidence for clinical practice, we provide an epistemic analysis that can help to inform the practical, regulatory, and ethical challenges of developing an iPSC system. (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)

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

Medicine is moving away from reliance on the proclamations of authorities to the use of numerical methods to estimate the size of effects of its interventions. But a rumbling note of uneasiness underlines present-day medical progress: the more we know, The more questions we encounter about what to do with the hard-won information. The essays in Where's the Evidence examine the dilemmas that have arisen as the result of medicine's unprecedented increase in technical powers. How do doctors draw (...) the line between "knowing" (the acquisition of new medical information) and doing" (the application of that new knowledge)? What are the long-term consequences of responding to the demand that physicians always do everything that can be done? Is medicine's primary aim to increase the length of life? Or is it to reduce the amount of pain and suffering? And who is empowered to choose when these ends are mutually exclusive? This engaging collection of essays will be of interest to professionals interested in the evidence-based medicine debate, including epidemiologists, neonatologists, those involved in clinical trials and health policy, medical ethicists, medical students, and trainees. (shrink)

Ethics and epistemology in medicine are more closely and more interestingly intertwined than is usually recognized. To explore this relationship, I present a case study, clinical trials of extracorporeal membrane oxygenation (ECMO; an intervention for persistent pulmonary hypertension of the newborn).Three separate ethical issues that arise from this case study-whether or not it is ethical to perform a certain trial at all, whether stopping rules for trials are ethically mandated, and the issue of informed consent-are all shown to be (...) intimately related to epistemological judgments about the weight of evidence. Although ethical issues cannot, of course, be resolved by consideration of epistemological findings, I argue that no informed view of the ethical issues that are raised can be adopted without first taking an informed view of the evidential-epistemological ones. (shrink)

Medicine, like law, is a pragmatic, probabilistic activity. Both require that decisions be made on the basis of available evidence, within a limited time. In contrast to law, medicine, particularly evidence-based medicine as it is currently practiced, aspires to a scientific standard of proof, one that is more certain than the standards of proof courts apply in civil and criminal proceedings. But medicine, as Dr. William Osler put it, is an "art of probabilities," or at best, (...) a "science of uncertainty." One can better practice medicine by using other evidentiary standards in addition to the "scientific." To employ only the scientific standard of proof is inappropriate, if not impossible; furthermore, as this review will show, its application in medicine is fraught with bias. Evidence is information. It supports or undermines a proposition, whether a hypothesis in science, a diagnosis in medicine, or a fact or point in question in a legal investigation. In medicine, physicians marshal evidence to make decisions on how to best prevent, diagnose, and treat disease, and improve health. In law, courts decide the facts and render justice. Judges and juries assess evidence to establish liability, to settle custody and medical issues, and to determine a defendant's guilt or innocence. (shrink)

Evidence‐based medicine (EBM) proponents have argued that mechanistic evidence concerning medical treatments should be considered secondary to evidence derived from randomized controlled trials (RCTs). One common criticism of RCTs is that they often do not yield results that are generalizable to clinical practice, and that for clinical practice application, mechanistic evidence is needed. However, proponents of EBM have argued that mechanistic reasoning is often unreliable and thus not very useful. Here we suggest an important role of mechanistic explanation that (...) has been left out of this discussion entirely, namely, its importance in a patient’s decision of whether or not to take certain drugs. We argue that in certain cases, knowing how a treatment works is just as important for the patient as knowing whether it does. In this paper, we explore how and why giving patients mechanistic information can be an important factor in obtaining informed consent for medical treatment, focusing on the example case of hormonal contraceptives. (shrink)

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

“Democratization” has recently become a popular trope in Western public discourses on medicine, where it refers to patient participation in the gathering and distribution of health-related data using various digital technologies, in order to improve healthcare technically and socially. We critically analyze the usage of the term from the perspective of the “politics of buzzwords.” Our claim is that the phrase works primarily to publicly justify the dramatic increase in the application of information and data technologies in healthcare and (...) therefore fosters the corresponding industry. As a buzzword, “democratizing healthcare” is characterized by vagueness, which is why it receives meaning only through a word collective—a group of words that provide it with a context and are often used together with it. We examine key terms associated with “democratization” in the healthcare discourse—participation, empowerment, and personalized medicine—and show that the buzzword receives rhetorical power through the ambiguous reference to these concepts. As a consequence, the idea of “democracy” becomes diluted into meaning merely “access to,” and “healthcare” is reduced to the notion of a preventive, nonacute, monitored form of medical care. (shrink)

A study was undertaken of the views of users of two genitourinary medicine (GUM) clinics in England on unlinked anonymous testing (UAT) for HIV. The UAT programme measures the prevalence of HIV in the population, including undiagnosed prevalence, by testing residual blood (from samples taken for clinical purposes) which is anonymised and irreversibly unlinked from the source. 424 clinic users completed an anonymous questionnaire about their knowledge of, and attitudes towards, UAT. Only 1/7 (14%) were aware that blood left (...) over from clinical testing may be tested anonymously for HIV. A large majority (89%) said they would agree to their blood being tested, although 74% wanted the opportunity to consent. These findings indicate broad support for UAT of blood in a group of patients whose samples are included in the HIV surveillance programme. The findings suggest the need for greater attention to be given to the provision of information and, if replicated in a larger survey, may justify a reappraisal of UK policy on UAT. (shrink)

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

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)

The evidence-based practice and evidence-based medicine movements have promoted standardization through guideline development methodologies based on systematic reviews and meta-analyses of best available research. EBM has challenged clinicians to question their reliance on practical reasoning and clinical judgement. In this paper, we argue that the protagonists of EBM position their mission as reducing uncertainty through the use of standardized methods for knowledge evaluation and use. With this drive towards uniformity, standardization and control comes a suspicion towards intuition, creativity and (...) uncertainty as integral parts of medical practice. We question the appropriateness of attempts to standardize professional practice through a discussion of the importance of uncertainty. Greenhalgh’s taxonomy of uncertainty is used to inform an analysis of the clinical reasoning occurring in a potentially life threatening emergency situation with a young patient. The case analysis is further developed by the use of the Canadian philosopher Bernard Lonergan’s theory about understanding and objective knowing. According to Lonergan it is not by getting rid of or even by reducing uncertainty, but by attending systematically to it and by relating to it in a self-conscious way, that objective knowledge can be obtained. The paper concludes that uncertainty is not a regrettable and unavoidable aspect of decision making but a productive component of clinical reasoning. (shrink)

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

RATIONALE: The concept of evidence-based medicine is important in providing efficient health care. The process uses research findings as the basis for clinical decision making. Evidence-based practice helps optimize current health care and enables the practitioners to be suitably accountable for the interventions they provide. Little work has been undertaken to examine how allied health professionals change their clinical practice in light of the latest evidence. The use of opinion leaders to disseminate new evidence around the management of low (...) back pain into practice has been proposed. AIMS: The aim of this study was to investigate if physiotherapists' clinical management of patients with low back pain would change following an evidence-based education package, which utilized local opinion leaders and delivered the best evidence. METHOD: Thirty musculoskeletal physiotherapists from a Community Trust in North Staffordshire were cluster randomized by location of work, to two groups. The intervention group received an evidence-based programme on the management of low back pain, including advice regarding increasing activity levels and return to normal activity and challenging patients' fears and beliefs about their pain. The control group received a standard in-service training package on the management of common knee pathologies. The physiotherapists' clinical management of patients with low back pain was measured prior to training and 6 months post training. Outcome measures were based on physiotherapists completing 'discharge summary' questionnaires, which included information relating to the use and importance of therapies for treating their low back pain patients. RESULTS: There were few significant differences in treatment options between the intervention and control groups post training. Whilst there was some indication that physiotherapists were already utilizing aspects of psychosocial management for patients with low back pain, there was little change in what physiotherapists perceived to be important to patient recovery and actual clinical practice following the intervention. CONCLUSIONS: Psychosocial factors have been identified as an important factor in the recovery of patients with low back pain. This project incorporated the latest evidence on the management of low back pain and utilized the theory of opinion leaders to disseminate this evidence into clinical practice. Whilst there were some limitations in the overall size of the study, the results help to give an insight into the challenges faced by the health care system and researchers alike to ensure quality evidence is actually utilized by practitioners for the benefits of patient care. (shrink)

Alternative medicine is hugely popular; about 40% of the US general population have used at least one type of alternative treatment in the past year, and in Germany this figure is around 70%. The money spent on AM is considerable: the global market is expected to reach nearly US $ 200 billion by 2025, with most of these funds coming directly out of consumers’ pockets. The reasons for this popularity are complex, but misinformation is certainly a prominent factor. The (...) media seem to have an insatiable appetite for the subject and often report uncritically on it. Misinformation about AM on the Internet is much more the rule than the exception. Consumers are thus being bombarded with misinformation on AM, and they are ill-protected from such misinformation and therefore prone to making wrong, unwise or dangerous therapeutic decisions, endangering their health and wasting their money. This book is a reference text aimed at guiding consumers through the maze of AM. The concept of the book is straightforward. It has two main parts. The first, short section provides essential background on AM, explaining in simple terms what is good, reliable evidence, and addressing other relevant issues like, for instance, the placebo response, informed consent, integrative medicine, etc. The second and main part consists of 150 short chapters, topically grouped and each dedicated to one single alternative therapeutic or diagnostic method. In each of them, seven critical points are raised. These points relate to issues that are important for consumers’ decisions whether it is worth trying the method in question. Restricting the discussion to just seven points means that issues must be prioritized to those themes which are most relevant in the context of each given modality. (shrink)

‘Individualized medicine’ is an emerging paradigm in clinical life science research. We conducted a socio-empirical interview study in a leading German clinical research group, aiming at implementing ‘individualized medicine’ of colorectal cancer. The goal was to investigate moral and social issues related to physician–patient interaction and clinical care, and to identify the points raised, supported and rejected by the physicians and researchers. Up to now there has been only limited insight into how experts dedicated to individualized medicine (...) view its problems. Interviews with researchers and clinicians (n= 19) were based on a prestructured questionnaire. The content analysis revealed a broad spectrum of opinions. Major findings were (a) disappointments with the limits of the current therapy regimen and clinical practice; (b) problematic impacts on physician–patient relationship; and (c) an informed consent procedure which is mainly based on paternalistic assumptions. According to our analysis, major problems will be uncertainties related to the biomarker's sensitivity and specificity, and the identification of ‘non-responders’. However, the findings also indicate that experts expect evidence-based medicine to replace decisions based on gut feeling or hierarchical structures. (shrink)

Background: There is a lack of empirical data on lay attitudes toward different sorts of deception in medicine. However, lay attitudes toward deception should be taken into account when we consider whether deception is ever permissible in a medical context. The objective of this study was to examine lay attitudes of U.S. citizens toward different sorts of deception across different medical contexts. Methods: A one-time online survey was administered to U.S. users of the Amazon “Mechanical Turk” website. Participants were (...) asked to answer questions regarding a series of vignettes depicting different sorts of deception in medical care, as well as a question regarding their general attitudes toward truth-telling. Results: Of the 200 respondents, the majority found the use of placebos in different contexts to be acceptable following partial disclosure but found it to be unacceptable if it involved outright lying. Also, 55.5% of respondents supported the use of sham surgery in clinical research, although 55% claimed that it would be unacceptable to deceive patients in this research, even if this would improve the quality of the data from the study. Respondents supported fully informing patients about distressing medical information in different contexts, especially when the patient is suffering from a chronic condition. In addition, 42.5% of respondents believed that it is worse to deceive someone by providing the person with false information than it is to do so by giving the person true information that is likely to lead them to form a false belief, without telling them other important information that shows it to be false. However, 41.5% believed that the two methods of deception were morally equivalent. Conclusions: Respondents believed that some forms of deception were acceptable in some circumstances. While the majority of our respondents opposed outright lying in medical contexts, they were prepared to support partial disclosure and the use of placebos when it is in the patient's interests or when it is what the person would want. These results support the position that physicians should be allowed a greater degree of authority to make a professional judgment about whether deception might be morally warranted by the circumstances, provided that it doesn't involve outright lying. (shrink)

The use of information raises a perplexing new set of questions in bioethics. One familiar subset of these has to do with the goal of improving medical practice by collecting information about it, in effect integrating practice and research. This topic was discussed in the January‐February 2013 issue of the Report and in this issue is taken up again in Policy and Politics, where Michelle Meyer connects the issue to the evidence‐based medicine movement. A somewhat less familiar set has (...) to do with potentially dangerous information. In the lead article in this issue, David Resnik discusses the publication last year of two articles that described how researchers had developed new and more dangerous forms of H5N1, also known as bird flu, which has produced an extraordinary death rate when it has infected people but has not so far evolved into a form that can be easily transmitted from one person to another. Yet another set has to do with sharing clinical medical information using newly developed tools such as electronic health records. In an essay in this issue, Kyle Galbraith argues that these technologies also need to be usable for patients, but that “those who have the most to gain from increased access to their health information are often unlikely to be able to decipher that information and respond in a meaningful way.”. (shrink)

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

BackgroundThe research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent may be used to assess the research subject’s comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby adhering to the beneficence and nonmaleficence (...) principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes.MethodsThe search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews : Checklist and Explanation guideline was used to report this work.ResultsOf 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs followed by accessibility, comprehension engagement, autonomy, confidentiality, language, and parental consent. Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.ConclusionThe current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/rec members during a review process on electronic informed consent and useful to the future preparation of a checklist. (shrink)

This book sheds light on important philosophical assumptions made by professionals working in clinical and research medicine. In doing so, it aims to make explicit how active philosophy is in medicine and shows how this awareness can result in better and more informed medical research and practice. -/- It examines: what features make something a scientific discipline; the inherent tensions between understanding medicine as a research science and as a healing practice; how the “replication crisis” in medical (...) research asks us to rethink the structure of knowledge production in our modern world; whether explanations have any real scientific values; the uncertainties about probabilistic claims; and whether it is possible for evidence-based medicine to truly be value free. The final chapter argues that the most important question we can ask is not, “How can we separate values from science?” but, “In a democratic society, how can we decide in a politically and morally acceptable way what values should drive science?”. (shrink)

With the increased acceptance of complementary and alternative medicine (CAM) within society, new research reflects deeper folk health histories beyond formal medical spaces. The contested relationships between formal and informal medicine have deep provenance and as scientific medicine began to professionalise in the 19th century, lay health knowledges were simultaneously absorbed and disempowered (Porter 1997). In particular, the ‘medical gaze’ and the responses of informal medicine to this gaze were framed around themes of power, regulation, authenticity (...) and narrative reputation. These responses were emplaced and mobile; enacted within multiple settings by multiple agents and structures over time. The work is drawn from secondary material from Ireland, which identify more indigenous narratives of health and act as potential sources for medical humanities. While assumptions have been made as to the place of folk-medicine being essentially rural, evidence will be presented which shows a more complex network of health beliefs and practices. The narratives of informal practice and folk-medicine drawn from evidence from Ireland point to more fluid and hybrid relations with formal medicine and suggest that the complementary nature of the two models reflected wider cultural debates and models of belief (Del Casino Jnr., Health & Place 10:59-73, 2004). (shrink)

The Swedish medico-legal concept of “science and proven experience” is both legally important and ambiguous. The conceptual uncertainty associated with it can hamper effective assessment of medical evidence in legal proceedings and encourage medical professionals to distrust legal regulation. We examine normative criteria a functioning medico-legal notion should presumably meet, e.g. clarity, acceptability and consistency with existing laws. We also survey healthcare professionals to see how they understand science and proven experience and thus determine the extent to which their understanding (...) meets the normative criteria. The survey suggests that medical professionals feel more certain about “science and proven experience” in the medical context than they do in a legal context. They still have substantial trust in the legal use of the notion, but they do not believe that legal professionals should be allowed to determine the meaning of “science and proven experience” in the legal context. With these results in mind, we argue that the best way to meet the normative criteria and resolve conceptual uncertainty is to specify sub-questions that clarify the notion. We recommend an analytical-deliberative approach that will close the gap between the medical and legal professions’ perceptions of how law and medicine relate. (shrink)

Physicians working in the world of competitive sports face unique ethical challenges, many of which center around conflicts of interest. Team-employed physicians have obligations to act in the club's best interest while caring for the individual athlete. As such, they must balance issues like protecting versus sharing health information, as well as issues regarding autonomous informed consent versus paternalistic decision making in determining whether an athlete may compete safely. Moreover, the physician has to deal with an athlete's decisions about performance (...) enhancement and return to play, pursuit of which may not be in the athlete's long-term best interests but may benefit the athlete and team in the short term. These difficult tasks are complicated by the lack of evidence-based standards in a field influenced by the lure of financial gains for multiple parties involved. In this article, we review ethical issues in sports medicine with specific attention paid to American professional football. (shrink)