The issue of how to incorporate the individual's first‐hand experience of illness into broader medical understanding is a major question in medical theory and practice. In a philosophical context, phenomenology, with its emphasis on the subject's perception of phenomena as the basis for knowledge and its questioning of naturalism, seems an obvious candidate for addressing these issues. This is a review of current phenomenological approaches to medicine, looking at what has motivated this philosophical approach, the main problems it faces and (...) suggesting how it might become a useful philosophical tool within medicine, with its own individual, but interrelated, contribution to make to current medical debates. After the general background, there is a brief summary of phenomenological ideas and their current usage in a medical context. Next is a critique of four key claims within current phenomenological medical works, concerning both the role phenomenology plays and the supposedly clear divide between phenomenology and other approaches. There are significant problems within these claims, largely because they overlook the complexity of the questions they consider. Finally, there is some more in‐depth examination of phenomenology itself and the true complexity of phenomenological debate concerning subjectivity. The aim is to show that it will be both more productive and truer to phenomenology itself, if we use phenomenology as a philosophical method for explicating and gaining deeper understanding of complex and fundamental problems, which are central to medicine, rather than as providing simple, but flawed solutions. (shrink)

The widespread application of technology in health care has imposed a broad range of challenges. The field of health technology assessment (HTA) is developed in order to face some of these challenges. However, this strategy has not been as successful as one could hope. One of the reasons for this is that social and ethical considerations have not been integrated in the HTA process. Nowadays however, such considerations have been included in many HTAs. Still, the conclusions and recommendations of the (...) HTAs are not followed. The reason for this may be that the methods for integrating ethics for HTA are not sufficiently developed, or that they are not adequate. This article presents a supplementary approach to the ethical inquiry in HTA. It is argued that a value analysis is crucial in order to address the ethical issues of health care technology in a fruitful way and to make viable decisions about such technology. (shrink)

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

Advanced medical imaging, such as CT, fMRI and PET, has undergone enormous progress in recent years, both in accuracy and utilization. Such techniques often bring with them an illusion of immediacy, the idea that the body and its diseases can be directly inspected. In this paper we target this illusion and address the issue of the reliability of advanced imaging tests as knowledge procedures, taking positron emission tomography in oncology as paradigmatic case study. After individuating a suitable notion of reliability, (...) we argue that PET is a highly theory-laden and non-immediate knowledge procedure, in spite of the photographic-like quality of the images it delivers; the diagnostic conclusions based on the interpretation of PET images are population-dependent; PET images require interpretation, which is inherently observer-dependent and therefore variable. We conclude with a three-step methodological proposal for enhancing the reliability of advanced medical imaging. (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 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)

What makes a high-quality biomarker experiment? The success of personalized medicine hinges on the answer to this question. In this paper, I argue that judgment about the quality of biomarker experiments is mediated by the problem of theoretical underdetermination. That is, the network of biological and pathophysiological theories motivating a biomarker experiment is sufficiently complicated that it often frustrates valid interpretation of the experimental results. Drawing on a case-study in biomarker diagnostic development from neurooncology, I argue that this problem of (...) underdetermination can be overcome with greater coordination across the biomarker research trajectory. I then sketch an account for how coordination across a research trajectory can be evaluated. I ultimate conclude that what makes a high-quality biomarker experiment must be judged by the epistemic contribution it makes to this coordinated research effort. (shrink)

We claim that if a complete philosophy of evidence-based practice is intended, then attention to the nature of causation in health science is necessary. We identify how health science currently conceptualises causation by the way it prioritises some research methods over others. We then show how the current understanding of what causation is serves to constrain scientific progress. An alternative account of causation is offered. This is one of dispositionalism. We claim that by understanding causation from a dispositionalist stance, many (...) of the processes within an evidence-based practice framework are better accounted for. Further, some of the problems associated with the health research, e.g. external validity of causal findings, dissolve. (shrink)

Public health involves the application of a wide variety of scientific and non-scientific disciplines to the very practical problems of improving population health and preventing disease. Public health has received surprisingly little attention from philosophers of science. In this chapter we consider some neglected but important philosophical aspects of the science of public health.

It is surely obvious that medicine, like any other rational activity, must be based on evidence. The interest is in the details: how exactly are the general principles of the logic of evidence to be applied in medicine? Focussing on the development, and current claims of the ‘Evidence-Based Medicine’ movement, this article raises a number of difficulties with the rationales that have been supplied in particular for the ‘evidence hierarchy’ and for the very special role within that hierarchy of randomized (...) controlled trials (and meta-analyses of the results of randomized controlled trials). The point is not at all to question the application of a scientific approach to evidence in medicine, but, on the contrary, to indicate a number of areas where philosophers of science can contribute to a proper implementation of exactly that scientific-evidential approach. (shrink)

Measurement outcomes are frequently used as evidence in favor of or against medical and surgical interventions, health policies, and system designs. Indeed, in the medical and health services research literature, outcomes are the currency of policy debate and decision making. Yet in the philosophy of science and philosophy of medicine, the measures used in evidence-based medicine (EBM) are rarely discussed. Rather, the focus here is almost exclusively on study design and hierarchies of evidence. This concentration on the methodology of study (...) design has meant that for practical purposes the measures used in randomized controlled trials, observational studies, audits, and so forth, appear as a “black box.” Yet as I argue in the first part of this article, an engagement with measurement can improve our understanding of EBM and the quality of our evidence. In the second part of the article, I develop such an engagement with one aspect of measurement, namely, the validity of patient-reported outcome measures. Here, I illustrate some of the complexity that is required to improve the validity of these measures and hence the validity of our study outcomes, that is, evidence. The concentration in philosophy of science on study design over measurement methodology perhaps reveals the interest that many philosophers of medicine have in causation, but there is more to the production of high-quality scientific evidence than securing the causal inference. (shrink)

This thesis analyses the use of 'Evidence-Based' methodologies of evidence assessment and intervention and policy design from medicine, and their use in sport and exercise science. It argues that problems exist with the application of Evidence-Based methodologies in sports science, meaning that the quality of evidence used to inform decision-making is lower than is often assumed. This thesis also offers realistic solutions to these problems, broadly arguing for the importance of taking evidence from mechanistic studies seriously, in addition to evidence (...) from RCTs. (shrink)

During the past decade, screening tests using computed tomography have disseminated into practice and been marketed to patients despite neither conclusive evidence nor professional agreement about their efficacy and cost-effectiveness at the population level. This phenomenon raises questions about physicians' professional roles and responsibilities within the setting of medical innovation, as well as the appropriate scope of patient autonomy and access to unproven screening technology. This article explores how physicians ought to respond when new screening examinations that lack conclusive evidence (...) of overall population benefit emerge in the marketplace and are requested by individual patients. To this end, the article considers the nature of evidence and how it influences decision-making for screening at both the public policy and individual patient levels. We distinguish medical and ethical differences between screening recommended for a population and screening considered on an individual patient basis. Finally, we discuss specific cases to explore how evidence, patient risk factors and preferences, and physician judgment ought to balance when making individual patient screening decisions. (shrink)

Clinical trials play a prominent role today in medicine, but are not without controversy. These issues start from the day physicians begin their specialization process in medical school and continues onto their day-to-day practice as attendings with referral patterns and resulting financial incentives. This combined with the lack of training in basic issues of epistemology and statistics, allows poor interpretations of clinical trials to reign free. A proposal to integrate the notion of severity to help remedy these issues are made (...) by ensuring that studies are tested “As Severe As Reasonably Possible” will put P-values, multiplicity adjustments, and model checking in their rightful place. In light of this, multiple clinical trials are examined with an in-depth analysis of erroneous statistical inferences taken from phase III randomized trials, non-inferiority, early phase, as well as observational studies. Severe testing in the setting of medicine will help with alleviate some of the issues with the current misinterpretation of clinical studies. (shrink)

What makes a high-quality biomarker experiment? The success of personalized medicine hinges on the answer to this question. Unfortunately, as many commentators have now emphasized, the quality of most biomarker experiments to date has been quite low. Although the technical side of this problem has received considerable attention, the philosophical issues remain largely unexplored. In this paper, I argue that understanding what constitutes a high-quality biomarker experiment requires some fundamental shifts in how we think about the epistemology, ontology, and methodology (...) of clinical translation. (shrink)

What clinicians, biomedical scientists, and other health care professionals know as individuals or as groups and how they come to know and use knowledge are central concerns of medical epistemology. Activities associated with knowledge production and use are called epistemic practices. Such practices are considered in biomedical and clinical literatures, social sciences of medicine, philosophy of science and philosophy of medicine, and also in other nonmedical literatures. A host of different kinds of knowledge claims have been identified, each with different (...) uses and logics of justification. A general framework is needed to situate these diverse contributions in medical epistemology, so we can see how they fit together. But developing such a framework turns out to be quite tricky. In this survey, three possible frameworks are considered along with the difficulties associated with each of them. The essay concludes with a fourth framework, which considers any epistemology as part of a practice that is oriented toward overcoming errors that emerge in antecedently given practices where knowledge is developed and used. As medicine indirectly advances health by directly mitigating disease, so epistemology indirectly advances knowledge by directly mitigating error. (shrink)

Abstract In this paper I offer an anti-Humean interpretation of the causal interactions in somatic medicine. I focus on life-threatening pathological states and show how Nancy Cartwright’s capacities can offer a plausible epistemology for medical processes and the singular causal claims advanced in medical diagnoses. I argue that the capacities manifested in the emergence of symptoms and signs could be tracked down if healthy organisms are construed as nomological machines and suggest that the causal reasoning from current medical practice bears (...) a tacit adherence to anti-Humean assumptions. Content Type Journal Article Pages 1-28 DOI 10.1007/s12136-011-0141-1 Authors Stefan Dragulinescu, Drumul Taberei 20, Bucharest, Romania Journal Acta Analytica Online ISSN 1874-6349 Print ISSN 0353-5150. (shrink)

The convergence of complementary and alternative medicine (CAM) and evidence-based medicine (EBM) is a prominent feature of healthcare in western countries, but it is currently undertheorised, and its implications have been insufficiently considered. Two models of convergence are described – the totally integrated evidence-based model (TI) and the multicultural-pluralistic model (MP). Both models are being incorporated into general medical practice. Against the background of the reasons for the increasing utilisation of CAM by the public and by general practitioners, TI-convergence is (...) supported and MP-convergence is rejected. MP-convergence is epistemologically and clinically incoherent, and it cannot be regulated. It is also inconsistent with developments in the legal determination of the standard of care for both diagnosis/treatment and disclosure. These claims concerning MP-convergence are justified by the fact that science is not a member of the group of perspectives or world-views which postmodernism treats as equally valid, and this is especially important for healthcare. (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)

Surgery is an important part of contemporary health care, but currently much of surgery lacks a strong evidence base. Uptake of evidence-based medicine (EBM) methods within surgical research and among practitioners has been slow compared with other areas of medicine. Although this is often viewed as arising from practical and cultural barriers, it also reflects a lack of epistemic fit between EBM research methods and surgical practice. In this paper we discuss some epistemic challenges in surgery relating to this lack (...) of fit, and investigate how resources from feminist epistemology can help to characterize them. We point to ways in which these epistemic challenges may be addressed by gathering and disseminating evidence about what works in surgery using methods that are contextual, pluralistic, and sensitive to hierarchies. (shrink)