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.

An Argument for Fewer Clinical Trials.

The volume of clinical research is increasing exponentially-far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I c onsider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees (RECs) should prohibit all other, lower-quality research, even when it might appear to meet some minimal ethical standard. Following a close analysis of the social-value requirement of ethical clinical research, I argue that this proposal is defensible. The problem identified in this paper has two parts, quantity and quality, and some clarification is needed about the latter because "quality" is a highly contested term in the medical literature. When some scholars advocate for high-quality trials, they mean large-scale, simple, explanatory randomized controlled trials. Others, including myself, have defended a different characterization of high-quality research that tends more toward pragmatic trial design and the use of methods other than RCTs. Pragmatic trials aim to provide evidence that directly supports clinical decision-making in "usual" care settings. Unlike explanatory trials, which aim to abstract away from particular settings and patients, in the hopes of creating ideal conditions for the success of an intervention, pragmatic trials deliberately pursue knowledge of high applicability, through the use of representative subjects, clinically important questions, flexible treatment protocols, patient-oriented outcome measures, and so on. I see applicability as a marker of high-quality research. The context in which research is meant to be applied should be the context in which new interventions are evaluated.

Theory, experience and practice.

Despite its potential hazards, the activity of questioning theoretical frameworks and proposing solutions is necessary if progress is even to be possible. Intellectual history has by no means ended, so we cannot expect to have all the answers, and from time to time the activity of critical questioning will be frustrating. But intellectual progress requires us to continue the process of asking fundamental questions. The alternative to thinking in this way is indeed unthinkable.

Diseases, patients and the epistemology of practice: mapping the borders of health, medicine and care.

Last year saw the 20th anniversary edition of JECP, and in the introduction to the philosophy section of that landmark edition, we posed the question: apart from ethics, what is the role of philosophy 'at the bedside'? The purpose of this question was not to downplay the significance of ethics to clinical practice. Rather, we raised it as part of a broader argument to the effect that ethical questions - about what we should do in any given situation - are embedded within whole understandings of the situation, inseparable from our beliefs about what is the case (metaphysics), what it is that we feel we can claim to know (epistemology), as well as the meaning we ascribe to different aspects of the situation or to our perception of it. Philosophy concerns fundamental questions: it is a discipline requiring us to examine the underlying assumptions we bring with us to our thinking about practical problems. Traditional academic philosophers divide their discipline into distinct areas that typically include logic: questions about meaning, truth and validity; ontology: questions about the nature of reality, what exists; epistemology: concerning knowledge; and ethics: how we should live and practice, the nature of value. Any credible attempt to analyse clinical reasoning will require us to think carefully about these types of question and the relationships between them, as they influence our thinking about specific situations and problems. So, the answers to the question we posed, about the role of philosophy at the bedside, are numerous and diverse, and that diversity is illustrated in the contributions to this thematic edition.

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.

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.

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.

Evidence-based alternative medicine?

The validity of evidence-based medicine (EBM) is the subject of ongoing controversy. The EBM movement has proposed a "hierarchy of evidence," according to which randomized controlled trials (RCTs) and meta-analyses of RCTs provide the most reliable evidence concerning the efficacy of medical interventions. The evaluation of alternative medicine therapies highlights problems with the EBM hierarchy. Alternative medical researchers-like those in mainstream medicine-wish to evaluate their therapies using methods that are rigorous and that are consistent with their philosophies of medicine and healing. These investigators have three ways to relate their work to EBM. They can accept the EBM hierarchy and carry out RCTs when possible; they can accept the EBM standards but argue that the special characteristics of alternative medicine warrant the acceptance of "lower" forms of evidence; or they can challenge the EBM approach and work to develop new research designs and new standards of evidence that reflect their approach to medical care. For several reasons, this last option is preferable. First, it will best meet the needs of alternative medicine practitioners. Moreover, because similar problems beset the evaluation of mainstream medical therapies, reevaluation of standards of evidence will benefit everyone in the medical community--including, most importantly, patients.