Kirstin Borgerson

Valuing evidence: bias and the evidence hierarchy of evidence-based medicine.

Proponents of evidence-based medicine (EBM) suggest that a hierarchy of evidence is needed to guide medical research and practice. Given a variety of possible evidence hierarchies, however, the particular version offered by EBM needs to be justified. This article argues that two familiar justifications offered for the EBM hierarchy of evidence—that the hierarchy provides special access to causes, and that evidence derived from research methods ranked higher on the hierarchy is less biased than evidence ranked lower—both fail, and that this indicates that we are not epistemically justified in using the EBM hierarchy of evidence as a guide to medical research and practice. Following this critique, the article considers the extent to which biases influence medical research and whether meta-analyses might rescue research from the influence of bias. The article concludes with a discussion of the nature and role of biases in medical research and suggests that medical researchers should pay closer attention to social mechanisms for managing pervasive biases.

Philosophy, ethics, medicine and health care: the urgent need for critical practice

Reader in Applied Philosophy, Department of Interdisciplinary Studies, MMU Cheshire, Crewe, UK Director, University of Toronto Joint Centre for Bioethics, Toronto, Ontario, Canada Assistant Professor, Department of Philosophy, University of Guelph, Guelph, Ontario, Canada Assistant Professor, Department of Philosophy and Religious Studies, Old Dominion University, Norfolk, Virginia, USA Assistant Professor, Department of Philosophy, Dalhousie University, Halifax, Nova Scotia, Canada

Reason and value: making reasoning fit for practice

Reader in Applied Philosophy, Department of Interdisciplinary Studies, MMU Cheshire, Crewe, UK Assistant Professor, Department of Philosophy and Religious Studies, Old Dominion University, Norfolk, VA, USA Associate Professor, Department of General Practice, University of Auckland, Auckland, New Zealand Director, University of Toronto Joint Centre for Bioethics, Toronto, ON, Canada Assistant Professor, Department of Philosophy, University of Guelph, Guelph, ON, Canada Assistant Professor, Department of Philosophy, Dalhousie University, Halifax, NS, Canada Professor of Values in Health Care, Associate Director, Social Dimensions of Health Institute, University of Dundee, Dundee, UK Research Fellow, King’s College Centre for Humanities and Health/Department of Philosophy; King’s College London, London, UK

The Nature of Evidence in Evidence-Based Medicine: Guest Editors' Introduction

164 WILLIAM HARVEY, the 17th-century English physician and champion of Enlightenment ideals, captured the intellectual passage from medievalism to modernity with this instructive remark:“It is base to receive instructions from others’ comments without examination of the objects themselves, especially as the book of nature lies so open and is so easy of consultation” (quoted in Rawlins 2008, p. 1).Today, the Harveian appeal to empirical evidence and the critical examination of conventional practices still resonates among health researchers and practitioners; however, the alleged ease of access to the empirical world has proven more constrained than Harvey suggested. The introduction of evidence-based medicine (EBM) to the medical world initially reflected an anti-authoritarian spirit similar to Harvey’s. In the Evidence Based Medicine Working Group’s programmatic 1992 JAMA article, “Evidence Based Medicine:A NewWay of Teaching the Practice of Medicine,” EBM was framed as “the way of the future”: a radical new framework for clinical medicine, where junior clinicians would eschew the advice of senior colleagues and instead directly consult the research literature in order to inform

Virtue, progress and practice.

Reader in Applied Philosophy, Department of Interdisciplinary Studies, MMU Cheshire, Crewe, UK and Visiting Professor of Philosophy as Applied to Medicine, University of Buckingham, Uk Assistant Professor, Department of Philosophy and Religious Studies, Old Dominion University, Norfolk, VA, USA Associate Professor, Department of General Practice, University of Auckland, Auckland, New Zealand Director, University of Toronto Joint Centre for Bioethics, Toronto, ON, Canada Assistant Professor, Department of Philosophy, University of Guelph, Guelph, ON, Canada Assistant Professor, Department of Philosophy, Dalhousie University, Halifax, NS, Canada Professor of Values in Health Care, Associate Director, Social Dimensions of Health Institute, University of Dundee, Dundee, UK

Are explanatory trials ethical? Shifting the burden of justification in clinical trial design

Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under “ideal” conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under “usual” conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals is frustrating for everyone involved, and explains some of the challenges inherent in attempts to enhance knowledge translation and encourage evidence-based practice. The situation is more than simply frustrating, however; it is potentially unethical. Clinical trials must be socially valuable in order to (1) warrant the risks they impose on human research subjects and (2) fairly and efficiently assess new clinical interventions. Most bioethicists would agree that trials that have no social value, for instance, because their results do not have the potential to advance clinical care, should not be performed. What is less widely appreciated is that given limited research resources, trials that are more socially valuable should be preferred to trials that are less socially valuable when all else is equal. With respect to clinical trial design, I argue that while explanatory trials often have some social value, many have less social value than their pragmatic counterparts. On the basis of this general ethical assessment, I provide a preliminary defense of the position that clinical researchers should aim to conduct pragmatic trials, that is, that researchers face a burden of justification related to any idealizing elements added to trial designs.

Redundant, Secretive, and Isolated: When Are Clinical Trials Scientifically Valid?

Clinical research has at least three problematic features: it tends to be redundant, secretive, and isolated. Research with these features not only wastes resources and causes harm, it also fails to meet a basic ethical requirement of research: scientific validity. According to a recent editorial in the BMJ, bioethicists and members of research ethics committees have been “notable by their absence” among those exposing persistent problems with clinical research and proposing solutions (Chalmers, Glasziou, and Godlee, BMJ 346, 2013, f105). In this paper I offer a theoretical diagnosis for the complicity of bioethicists and research ethics committees in these ongoing problems, as well as a partial solution in the form of a modified ethical requirement of scientific integrity.

An Epistemic Argument for Research-Practice Integration in Medicine

Arguments in favor of greater research-practice integration in medicine have tended to be ethical, political, or pragmatic. There are good epistemic reasons to pursue greater integration, and it is important to think through these reasons in order to avoid inadvertently designing new systems in ways that replicate the epistemic elitism common within current systems. Meaningful transformation within health care is possible with close attention to all reasons in favor of greater research-practice integration, including epistemic reasons.

Reasoning, evidence, and clinical decision-making: The great debate moves forward

When the editorial to the first philosophy thematic edition of this journal was published in 2010, critical questioning of underlying assumptions, regarding such crucial issues as clinical decision making, practical reasoning, and the nature of evidence in health care, was still derided by some prominent contributors to the literature on medical practice. Things have changed dramatically. Far from being derided or dismissed as a distraction from practical concerns, the discussion of such fundamental questions, and their implications for matters of practical import, is currently the preoccupation of some of the most influential and insightful contributors to the on-going evidence-based medicine debate. Discussions focus on practical wisdom, evidence, and value and the relationship between rationality and context. In the debate about clinical practice, we are going to have to be more explicit and rigorous in future in developing and defending our views about what is valuable in human life.

Philosophy, medicine and health care – where we have come from and where we are going

Professor of Applied Philosophy, Department of Interdisciplinary Studies, MMU Cheshire, Crewe, UK Associate Professor, Department of Philosophy and Religious Studies, Old Dominion University, Norfolk, VA, USA PhD student, Faculty of Medicine, University of Toronto, Toronto, ON, Canada Associate Professor, Department of General Practice, University of Auckland, Auckland, New Zealand Director, Department of Family and Community Medicine, University of Toronto Joint Centre for Bioethics, Toronto, ON, Canada Assistant Professor, Department of Philosophy, Dalhousie University, Halifax, NS, Canada Assistant Professor, Department of Philosophy, University of Guelph, Guelph, Ontario, Canada Senior Lecturer, Department of Philosophy, University of Southampton, Southampton, UK Socrates Professor in Philosophy and Technology, Technical University, Eindhoven, The Netherlands