Despite the consensus promoted by the evidence-based medicine framework, many authors continue to express doubts about the superiority of randomized controlled trials. This paper evaluates four objections targeting the legitimacy, feasibility, and extrapolation problems linked to the experimental practice of random allocation. I argue that random allocation is a methodologically sound and feasible practice contributing to the internal validity of controlled experiments dealing with heterogeneous populations. I emphasize, however, that random allocation is solely designed to ensure the validity of causal (...) inferences at the level of groups. By itself, random allocation cannot enhance test precision, doesn’t contribute to external validity, and limits the applicability of causal claims to individuals. (shrink)

With twentieth- and twenty-first-century philosophy of science’s unfolding acceptance of the nature of scientific inquiry being value-laden, the persistent worry has been that there are no means for legitimate negotiation of the social or non-epistemic values that enter into science. The rejection of the value-free ideal in science has thereby been coupled with the spectres of indiscriminate relativism and bias in scientific inquiry. I challenge this view in the context of recently expressed concerns regarding Canada's death of evidence controversy. The (...) worry, raised by Stathis Psillos, is that as constructivist accounts of science demoted the previously secure status of evidence for drawing justified conclusions in science, we were left with no rational delineation between the right and wrong values for science. The implication for the death of evidence controversy is that we may have no rational grounds for claiming that the Canadian Government is wrong to interfere with scientific enterprise. But he does offer another avenue for reaching the conclusion that the wrong social values are directing the current stifling of some sectors of Canadian science. Psillos draws from standpoint epistemologies to devise a salient defence of ‘valuing evidence’ as a universalizable social value. That is, government bodies ought to enable scientific research via adequate funding as well as political non-interference. In this paper, I counter that non-epistemic values can be rationally evaluated and that standpoint epistemology’s universalizable standpoint provides an inadequate framework for negotiating social values in science. Regarding, I draw from the evidence-based medicine debate in philosophy of medicine and from feminist empiricist investigations into the science–values relationship in order to make the argument for empirically driven value arbitration. If social values can be rationally chosen in the context of justification, then we can have grounds for charging the Canadian leadership with being ‘at war with science’. I further argue that my recommended empiricist methodology is preferable to Psillos’s search for universalizable perspectives for negotiating social values in science because the latter method permits little more than the trivial conclusion that evidence is valuable to science. (shrink)

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 ideas and terminology of person-centred care have been part of health discourse for a very long time. Arguments that in healthcare one treats the whole person, not her/his component parts, date back at least to antiquity and the need to treat the patient as a person is articulated persuasively by clinical authors in the early twentieth century. Yet it is only in recent years that we have seen a growing consensus in health policy and practice literature that PCC, and (...) associated ideas including patient expertise, co-production and shared decision-making, are not simply “fine ideals” or “ethical add-ons” to sound scientific clinical practice, but rather they represent indispensable components of any genuinely integrated, realistic and conceptually sound account of healthcare practice. The underlying conviction of this volume - one belief that, despite their differences, unites all of its contributors - is that PCC should not become the latest “revolutionary” concept to be “operationalised” before being “conceptualised”. It is imperative that we develop an open and inclusive dialogue about what we do and do not mean by “person-centred” to inform our attempts to implement PCC. (shrink)

In 1973, Rittel and Webber coined the term ‘wicked problems’, which they viewed as pervasive in the context of social and policy planning. 1 Wicked problems have 10 defining characteristics: they are not amenable to definitive formulation; it is not obvious when they have been solved; solutions are not true or false, but good or bad; there is no immediate, or ultimate, test of a solution; every implemented solution is consequential, it leaves traces that cannot be undone; there are no (...) criteria to prove that all potential solutions have been identified and considered; every wicked problem is essentially unique; every wicked problem can be considered to be a symptom of another problem; a wicked problem can be explained in numerous ways and the choice of explanation determines what will count as a solution and the actors are liable... (shrink)

Hierarchies of evidence are an important and influential tool for appraising evidence in medicine. In recent years, hierarchies have been formally adopted by organizations including the Cochrane Collaboration [1], NICE [2,3], the WHO [4], the US Preventive Services Task Force [5], and the Australian NHMRC [6,7]. The development of such hierarchies has been regarded as a central part of Evidence-Based Medicine, a movement within healthcare which prioritises the use of epidemiological evidence such as that provided by Randomised Controlled Trials. Philosophical (...) work on the methodology of medicine has so far mostly focused on claims about the superiority of RCTs, and hence has largely neglected the questions of what hierarchies are, what assumptions they require, and how they affect clinical practice. This thesis shows that there is great variation in the hierarchies defended and in the interpretations they are, and can be, given. The interpretative assumptions made in using hierarchies are crucial to the content and defensibility of the underlying philosophical commitments concerning evidence and medical practice. Once this variation is been identified, it becomes clear that the little philosophical work that has been done so far affects only some hierarchies, under some interpretations. Modest interpretations offered by La Caze [11], conditional hierarchies like GRADE [12-14], and heuristic approaches such as that defended by Howick et al. [15,16] all survive previous philosophical criticism. This thesis extends previous criticisms by arguing that modest interpretations are so weak as to be unhelpful for clinical practice; that GRADE and similar conditional models omit clinically relevant information, such as information about variation in treatments’ effects and the causes of different responses to therapy; and that heuristic approaches lack the necessary empirical support. The conclusion is that hierarchies in general embed untenable philosophical assumptions: principally that information about average treatment effects backed by high-quality evidence can justify strong recommendations, and that the impact of evidence from individual studies can and should be appraised in isolation. Hierarchies are a poor basis for the application of evidence in clinical practice. The Evidence-Based Medicine movement should move beyond them and explore alternative tools for appraising the overall evidence for therapeutic claims. (shrink)

There seem to be some misunderstandings abroad in the literature about medical epistemology and person-centered medicine concerning the nature of 'modest' or aetiological foundationalism, and some vagueness about 'emergence'. This paper urges a greater tolerance for a modest, Humean variety of foundationalism, not least because it seems to offer significant support for person-centred medicine. It also suggests a closer examination of emergence as an explanation or justification for medicine, since emergence is a complex concept that does nothing to rule out (...) foundationalism. Foundationalism has been condemned tout court without recognizing that it comes in various styles and degrees. Emergence has been used as a property of medicine to dismiss any need to seek its foundations. But emergence too comes in different forms, not all of them at odds with modest foundationalism. Modest or aetiological foundationalism is far more flexible than Cartesian foundationalism, and is compatible with modern understandings of emergence. Modest foundationalism and a particular understanding of emergence support the ontological and epistemological underpinning of person-centered medicine. (shrink)

Scientism is a philosophy which purports to define what the world ‘really is’. It adopts what the philosopher Thomas Nagel called ‘an epistemological criterion of reality’, defining what is real as that which can be discovered by certain quite specific methods of investigation. As a consequence all features of experience not revealed by those methods are deemed ‘subjective’ in a way that suggests they are either not real, or lie beyond the scope of meaningful rational inquiry. This devalues capacities that (...) (we argue) are in fact essential components of good reasoning and virtuous practice. Ultimately, the implications of scientism for statements of value undermine value-judgements essential for science itself to have a sound basis. Scientism has implications, therefore, for ontology, epistemology and also for which claims we can assert as objective truths about the world. Adopting scientism as a world view will have consequences for reasoning and decision-making in clinical and other contexts. We analyse the implications of this approach and conclude that we need to reject scientism if we are to avoid stifling virtuous practice and to develop richer conceptions of human reasoning. (shrink)

In 1973, Rittel and Webber coined the term ‘wicked problems’, which they viewed as pervasive in the context of social and policy planning.1 Wicked problems have 10 defining characteristics: they are not amenable to definitive formulation; it is not obvious when they have been solved; solutions are not true or false, but good or bad; there is no immediate, or ultimate, test of a solution; every implemented solution is consequential, it leaves traces that cannot be undone; there are no criteria (...) to prove that all potential solutions have been identified and considered; every wicked problem is essentially unique; every wicked problem can be considered to be a symptom of another problem; a wicked problem can be explained in numerous ways and the choice of explanation determines what will count as a solution and the actors are liable for the consequences of the actions they generate.1 One needs only a passing familiarity with the history of HIV prevention research, and with the intellectual traditions of research ethics, to appreciate that the perils and opportunities arising from proposals to conduct research with people who inject drugs in some of the most precarious social and political circumstances around the world and the challenges associated with implementing the findings satisfy Rittel's and Webber's criteria for ‘wicked problems’. HIV prevention research has contributed important new knowledge about the feasibility, efficacy or relative efficacy of various prevention strategies in a variety of contexts around the world. But the pathways and timelines for how this knowledge has contributed to improvements in public health practice and/or the establishment of policies that ensure unfettered access to appropriate healthcare services for PWID are less clear and decidedly non-linear. One account of the transition from trial to policy …. (shrink)

This paper evaluates attempts to defend established concepts of expertise and clinical judgement against the incursions of evidence‐based practice. Two related arguments are considered. The first suggests that standard accounts of evidence‐based practice imply an overly narrow view of ‘evidence’, and that a more inclusive concept, incorporating ‘patterns of knowing’ not recognised by the familiar evidence hierarchies, should be adopted. The second suggests that statistical generalisations cannot be applied non‐problematically to individual patients in specific contexts, and points out that this (...) is why we need clinical judgement. In evaluating the first argument, I propose a criterion for what counts as evidence. It is a minimalist criterion but the ‘patterns of knowing’, referred to in the literature, still fail to meet it. In evaluating the second argument, I will outline the powerful empirical reasons we have for thinking that decisions based on research evidence are usually better than decisions based on clinical judgement; and show that current efforts to rehabilitate clinical judgement seriously underestimate the strength of these reasons. By way of conclusion, I will sketch the ways in which the concept of expertise will have to be modified if we accept evidence‐based practice as a template for health‐care. (shrink)

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

Rationale, aims and objectives : Evidence-based medicine (EBM) claims to be based on 'evidence', rather than 'intuition'. However, EBM's fundamental distinction between quantitative 'evidence' and qualitative 'intuition' is not self-evident. The meaning of 'evidence' is unclear and no studies of quality exist to demonstrate the superiority of EBM in health care settings. This paper argues that, despite itself, EBM holds out only the illusion of conclusive scientific rigour for clinical decision making, and that EBM ultimately is unable to fulfil its (...) own structural criteria for 'evidence'. Methods : Our deconstructive analysis of EBM draws on the work of the French philosopher, Jacques Derrida. Deconstruction works in the name of justice to lay bare, to expose what has been hidden from view. In plain language, we deconstruct EBM's paradigm of 'evidence', the randomized controlled trial (RCT), to demonstrate that there cannot be incontrovertible evidence for EBM as such. We argue that EBM therefore 'auto-deconstructs' its own paradigm, and that medical practitioners, policymakers and patients alike ought to be aware of this failure within EBM itself. Results : EBM's strict distinction between admissible evidence (based on RCTs) and other supposedly inadmissible evidence is not itself based on evidence, but rather, on intuition. In other words, according to EBM's own logic, there can be no 'evidentiary' basis for its distinction between admissible and inadmissible evidence. Ultimately, to uphold this fundamental distinction, EBM must seek recourse in (bio)political ideology and an epistemology akin to faith. (shrink)