Gadow's understanding of nursing as a relational narrative anchored in a dialectic between the fundamental subjectivity of the individual client and the objectification of his illness poses some interesting questions for nursing ethics and care. For Gadow, nursing is an encounter with the immediate vulnerability of the client and also lends it responsibilities to the medical objectification of illness aiming at disease treatment and control. Hence, nursing agency is divided between its responsibilities induced by the personal vulnerability of the patient (...) and the more impersonal, but benevolent intention shaped by medical knowledge. Medical knowledge is impersonal in the sense that it is knowledge detached from the subjectivity of the patient. But how is nursing able to reconcile the interests derived from personal and experienced vulnerability with the more impersonal and often conflicting demands of medical knowledge? This question is even more intriguing because there seems to be an objective dimension within a patient's subjectivity itself: an autonomous person can critically evaluate his own subjectivity as a basis for informed self‐interest. The sick person is thus confronted with objectivity on two important levels: the objective facts of his disease and his detachment from his own experiential vulnerability when engaged in the critical evaluation of his self‐interest. This paper will discuss the normative dimensions of these complex and, frequently, conflicting perspectives from the theoretical perspectives of Thomas Nagel's normative responsibility and Sally Gadow's clinical epistemology and relational narratives. The empirical basis for the discussion will be an ongoing study of the ethical dimensions of pain relief and sedation in an intensive care unit. (shrink)

Many extant theories of placebo focus on their causal structure wherein placebo effects are those that originate from select features of the therapy (e.g., client expectations or “incidental” features like size and shape). Although such accounts can distinguish placebos from standard medical treatments, they cannot distinguish placebos from everyday occurrences, for example, when positive feedback improves our performance on a task. Providing a social-epistemological account of a treatment context can rule out such occurrences, and furthermore reveal a new way to (...) distinguish clinical placebos from standard medical treatments. (shrink)

This paper attempts to establish the epistemological import and limits of informed consent in clinical research. It points out that informed consent is a necessary requirement in clinical research because it ensures adequate participation of care receivers in issues relating to their health. Besides ensuring that care receivers have knowledge of whatever medical intervention they are consenting to, informed consent, as an ideal, provides assurance that care receivers and others are neither coerced nor deceived. While the question of (...) the value of informed consent in health care delivery is not so much controverted, in contest is the question of whether or not complete and wholly specifically informed consent can indeed be realized in medical intervention. Two orientations are identified in this debate. One insists that an individual will be able to make an informed decision and make reasonable choices amongst alternatives when fully informed. The other orientation sees as an epistemic illusion, achieving full informed consent, and rather opts for informed request. This paper examines this debate by clarifying the notion of informed consent, its components and its nexus with knowledge. The position of the paper is that informed consent is not only an ethical ideal in clinical research and health care; it is also an epistemic virtue that must be continuously strived towards. This paper establishes that health care receivers can only have an epistemic claim of their medical situation if all requirements of informed consent in health care delivery such as provision of adequate information, the risk and benefits of treatment, avoidance of vague/ambiguous statements, voluntariness, etc. are met. (shrink)

Since its introduction in 1987, Benjamin Freedman’s principle of clinical equipoise has enjoyed widespread uptake in bioethics discourse. Recent years, however, have witnessed a growing consensus that the principle is fundamentally flawed. One of the most vocal critics has undoubtedly been Franklin Miller. In a 2008 paper, Steven Joffe and Miller build on this critical work, offering a new conception of clinical research ethics based on science, taking what they call a “scientific orientation” toward the ethics of (...) class='Hi'>clinical research. Though there is much to recommend Joffe and Miller’s scientifically oriented conception of clinical research ethics, I believe that both the critical and constructive projects suffer from the same basic mistake: inattention to context. The internal norms of science cannot be fully specified, let alone satisfied, independently of contextual (external) factors that only come into view when we are attentive to the particular context of that form of inquiry. (shrink)

Robust clinical decision-making depends on valid reasoning and sound judgment and is essential for delivering quality healthcare. It is often susceptible, however, to a clinician’s biases such as towards a patient’s age, gender, race, or socioeconomic status. Gender bias in particular has a deleterious impact, which frequently results in cognitive myopia so that a clinician is unable to make an accurate diagnosis because of a patient’s gender—especially for female patients. Virtue epistemology provides a means for confronting gender bias in (...) clinical decision-making and for correcting or even preventing its impact. The medical literature on cardiovascular and coronary heart disease is used to illustrate the role intellectual virtues can play in redressing the deleterious impact of gender bias on clinical decision-making and practice. Finally, questions are considered surrounding the pedagogy of intellectual virtues for medical students and practicing clinicians in order to provide quality care for patients, regardless of gender. (shrink)

Clinical equipoise has been proposed as an ethical principle relating uncertainty and moral leeway in clinical research. Although CE has traditionally been indicated as a necessary condition for a morally justified introduction of a new RCT, questions related to the interpretation of this principle remain woefully open. Recent proposals to rehabilitate CE have divided the bioethical community on its ethical merits. This paper presents a new argument that brings out the epistemological difficulties we encounter in justifying CE as (...) a principle to connect uncertainty and moral leeway in clinical ethics. The argument proposes, first, that the methodology of hypothetical retrospection is applicable to the RCT design and that it can accommodate uncertainty. As currently understood, however, HR should give up its reliance on the assumption of uncertainty transduction, because the latter assumes the principle of indifference, which does not accommodate uncertainty in the right way. The same principle is then seen to distort also the received interpretations of CE. (shrink)

Epistemological realism was postulated as a prolegomenon to clinical research. Observation of single cases must precede any effort for generalization. Observation of men by men is always a field process. In clinical research the experimenter exercises a great amount of power over the subject, thus a naive empirical approach and operationism may be misleading. Clinical theory must be coated in a language different from empirical data and enable the formation of causal chains of events.

Abstract:In the fields of psychoanalysis and psychotherapy, case study researchers rarely justify their knowledge claims on formal epistemological grounds. This poses several issues to the case study method. First, without articulating the standards by which our knowledge is being justified, we are potentially enabling the criticism that case studies are mere anecdotal reports and should not be treated as forms of evidence. Second, without the guidance of wider epistemological standards for case study research, we risk falling into arbitrary justifications of (...) other as well as our own case studies. This paper seeks to address these issues by examining and developing epistemic practices in psychoanalytic and psychotherapy case studies. Drawing from different social science resources, the paper describes three epistemological concepts appropriate for case study research: retroductive reasoning, analytic generalization and working hypothesis. The paper demonstrates how each epistemological concept can be used in psychotherapy research and explicates specific methodological guidelines. Social science definitions and principles are applied in a psychotherapy and/or psychoanalytic research context, and further considerations about canons of evidence are provided. The impetus of this paper is to strengthen qualitative research standards, particularly case study research standards, in clinical case study writing. (shrink)

This paper raises questions about the epistemological foundations of evidence-based medicine . We argue that EBM is based upon reliabilist epistemological assumptions, and that this is appropriate - we should focus on identifying the most reliable processes for generating and collecting medical knowledge. However, we note that this should not be reduced to narrow questions about which research methodologies are the best for gathering evidence. Reliable processes for generating medical evidence might lie outside of formal research methods. We also question (...) the notion of the knower that is assumed by EBM. We argue that EBM assumes an enlightenment conception of knowers as autonomous, substitutable individuals. This conception is troubled by the way that clinicians learn the role of anecdote in health care and the role of patient choice, all of which bring into play features of clinicians and patients as situated individuals with particular backgrounds and experiences. EBM's enlightenment conception of the knower is also troubled by aspects of the way evidence is produced. Given these limitations, we argue that EBM should retain its reliabilist bent, but should look beyond formal research methodologies in identifying processes that yield reliable evidence for clinical practice. We suggest looking to feminist epistemology, with its focus on the standpoints of individual situated knowers, and the role of social context in determining what counts as knowledge. (shrink)

This paper describes one possible origin point for fraudulent behavior within the American pharmaceutical industry. We argue that during the late nineteenth century therapeutic reformers sought to promote both laboratory science and increasingly systematized forms of clinical experiment as a new basis for therapeutic knowledge. This process was intertwined with a transformation in the ethical framework in which medical science took place, one in which monopoly status was replaced by clinical utility as the primary arbiter of pharmaceutical legitimacy. (...) This new framework fundamentally altered the set of epistemic virtues—a phrase we draw from the philosophical field of virtue epistemology—considered necessary to conduct reliable scientific inquiry regarding drugs. In doing so, it also made possible new forms of fraud in which newly emergent epistemic virtues were violated. To make this argument, we focus on the efforts of Francis E. Stewart and George S. Davis of Parke, Davis & Company. Therapeutic reformers within the pharmaceutical industry, such as Stewart and Davis, were an important part of the broader normative and epistemic transformation we describe in that they sought to promote laboratory science and systematized clinical trials toward the twin goals of improving pharmaceutical science and promoting their own commercial interests. Yet, as we suggest, Parke, Davis & Company also serves as an example of a company that violated the very norms that Stewart and Davis helped introduce. We thus seek to describe one possible origin point for the widespread fraudulent practices that now characterize the pharmaceutical industry. We also seek to describe an origin point for why we conceptualize such practices as fraudulent in the first place. (shrink)

This article is intended to revive, through a critical reinterpretation, the bio-psychosocial model of George Engel. Engel’s first description in 1977, was very broad, encompassing too many aspects of medicine. In his later work, he focused his model as an epistemology for clinical medicine. However, what medicine mostly retained were minor aspects of the 1977 article, namely a multi-factorial approach to the etiology of diseases and a call to complement biomedicine with a psychosocial concern in order to re-humanize medicine. (...) We suggest that, properly understood as a clinical epistemology, Engel’s model retains its transformative potential for contemporary medicine.Our discussion begins with a.. (shrink)

The traditional medical epistemology, resting on a biomedical paradigmatic monopoly, fails to display an adequate representation of medical knowledge. Clinical knowledge, including the complexities of human interaction, is not available for inquiry by means of biomedical approaches, and consequently is denied legitimacy within a scientific context. A gap results between medical research and clinical practice. Theories of knowledge, especially the concept of tacit knowing, seem suitable for description and discussion of clinical knowledge, commonly denoted the art of (...) medicine. A metaposition allows for inquiry of clinical knowledge, inviting an expansion of the traditional medical epistemology, provided that relevant criteria for scientific knowledge within this field are developed and applied. The consequences of such approaches are discussed. (shrink)

The aim of this article is to explore the complex forms of knowledge involved in diagnostic and interventional decision making by comparing the processes in medicine and nursing, including nurse practitioners. Many authors assert that the practice of clinical decision making involves the application of theoretical knowledge (acquired in the classroom and textbooks) as well as research evidence, upon concrete particular cases. This approach draws on various universal principles and algorithms to facilitate the task. On the other hand, others (...) argue that this involves an intuitive form of judgement that is difficult to teach, one that is acquired principally through experience. In an exploration of these issues, this article consists of three sections. A clarification of terms commonly used when discussing decision making is provided in the first section. In the second section, an epistemological analysis of decision making is presented by examining several perspectives and comparing them for their use in the nursing and medical literature. Bunge's epistemological framework for decision making (based on scientific realism) is explored for its fit with the aims of medicine and nursing. The final section presents a discussion of knowledge utilization and decision making as it relates to the implications for the education and ongoing development of nurse practitioners. It is concluded that Donald Schön's conception of reflective practice best characterizes the skilful conduct of clinical decision making. (shrink)

Resumen En este artículo propongo un análisis crítico de varias tendencias filosóficas contrarias al uso de la noción de verdad en el ámbito epistemológico, especialmente la de Rorty. En particular, sostengo que la verdad es un concepto clave para el estudio del conocimiento, especialmente el científico, en cuanto toma una forma concisa en los procedimientos experimentales de carácter probatorio-empírico. Gracias a este enfoque, busco socavar varias tesis de los enfoques de la ‘posverdad’ por medio del uso de un conjunto de (...) procedimientos científicos de obtención de evidencias en varios campos vinculados a la disciplina práctica de la medicina.In thispaper, I present a critical analysis of several philosophical tendencies that go against the use of the notion of truth in epistemology, especially Rorty’s one. Particularly, I claim that truth is a key conceptfor the study of knowledge, especially the scientific knowledge, as it takes a concise form through the experimentalprocedures for eliciting evidences. With the help of this analysis, I seek to undermine some ‘post-truth’ theses by means of analyying some scientific procedures to get evidences in severalfields related to the practical discipline of medicine. (shrink)

: This paper investigates epistemological differences in the cognitive neuroscientific and phenomenological approaches to outstanding questions in psychiatry. We argue that clinical neuroscience provides scientific explanation in line with a mechanistic approach and describe several examples from computational approaches that illustrate what research on neural processing can tell us about psychiatric diseases. By contrast, phenomenology offers complex descriptions of experiential phenomena. Through a discussion of executive function and the related construct of impulsivity, we show that both cognitive neuroscience and (...) phenomenology provide valuable types of explanation. Our focus on psychopathology also allows us to address some important epistemic differences between these two disciplines. Keywords: Phenomenology; Consciousness; Clinical Neuroscience; Computational Neuroscience; Cognitive Mechanisms Coscienza e meccanismi cerebrali: ricerche epistemologiche tra fenomenologia e neuroscienza clinica Riassunto: Il presente lavoro propone di esaminare le differenze epistemologiche tra la fenomenologia e le neuroscienze cognitive riguardo dibattiti psichiatrici. Le neuroscienze cliniche saranno discusse in linea con un approccio meccanicista della spiegazione scientifica, mentre descrizioni fenomenologiche saranno proposte nel momento in cui complessi fenomeni esperenziali dovranno essere indagati. Un’interpretazione meccanicista delle neuroscienze cognitive sarà esemplificata ricorrendo ad alcuni esempi dagli approcci computazionali che si occupano di questi temi, i quali ci aiuteranno a definire cosa le ricerche sui processi neurali ci stanno dicendo rispetto alle sintomatologie psichiatriche. Questi argomenti saranno sviluppati attraverso una discussione che verterà sulle funzioni esecutive e il costrutto di impulsività a esse legato. Sarà discusso come sia le neuroscienze cognitive sia la fenomenologia possano fornire specifiche forme di spiegazione. Allo stesso tempo, si proporrà un’argomentazione che consentirà di discernere differenze epistemiche che caratterizzano i suddetti approcci, le quali potranno con più facilità emergere nel dibattito psichiatrico. Parole chiave : Fenomenologia; Coscienza; Neuroscienza clinica; Neuroscienza computazionale; Meccanismi cognitivi. (shrink)

All major research ethics policies assert that the ethical review of clinical trial protocols should include a systematic assessment of risks and benefits. But despite this policy, protocols do not typically contain explicit probability statements about the likely risks or benefits involved in the proposed research. In this essay, I articulate a range of ethical and epistemic advantages that explicit forecasting would offer to the health research enterprise. I then consider how some particular confidence levels may come into conflict (...) with the principles of ethical research. (shrink)

Using the theoretical constructs “biographical disruption” and “limit experience” and also methodological frameworks from autoethnography and discourse analysis, we discuss the divergent ways in which language and healing are conceptualized and performed, first in an American medical clinic and then by traditional healers in Kwara‘ae (Solomon Islands). Discourses at the Dallas clinic draw on allopathic and complementary medicine and in emphasizing a scientific approach to talk about illness and treatment, were found to create ambiguity in patients’ sense of their physical (...) and metaphysical identities. In contrast, Kwara‘ae healing involves disappearing into silence, in which the physical and metaphysical are never separated, and where healing occurs. (shrink)

This book offers a philosophically-based, yet clinically-oriented perspective on current medical reasoning aiming at 1) identifying important forms of uncertainty permeating current clinical reasoning and practice 2) promoting the application of an abductive methodology in the health context in order to deal with those clinical uncertainties 3) bridging the gap between biomedical knowledge, clinical practice, and research and values in both clinical and philosophical literature. With a clear philosophical emphasis, the book investigates themes lying at the (...) border between several disciplines, such as medicine, nursing, logic, epistemology, and philosophy of science; but also ethics, epidemiology, and statistics. At the same time, it critically discusses and compares several professional approaches to clinical practice such as the one of medical doctors, nurses and other clinical practitioners, showing the need for developing a unified framework of reasoning, which merges methods and resources from many different clinical but also non-clinical disciplines. In particular, this book shows how to leverage nursing knowledge and practice, which has been considerably neglected so far, to further shape the interdisciplinary nature of clinical reasoning. Furthermore, a thorough philosophical investigation on the values involved in health care is provided, based on both the clinical and philosophical literature. The book concludes by proposing an integrative approach to health and disease going beyond the so-called “classical biomedical model of care”. (shrink)

Most clinicians take for granted a simple, reductionist understanding of medical knowledge that is at odds with how they actually practice medicine; routine medical decisions incorporate more complicated kinds of information than most standard accounts of medical reasoning suggest. A better understanding of the structure and function of knowledge in medicine can lead to practical improvements in clinical medicine. This understanding requires some familiarity with epistemology, the study of knowledge and its structure, in medicine. Michael Polanyi's theory of tacit (...) knowing is advanced as the basis for developing a more accurate understanding of medical knowledge. Tacit knowing, which explores the taken-for-granted background knowledge that underlies all human knowing, is explained in detail with a focus on its relevance for clinical medicine. The implications of recognizing tacit knowing in medicine and medical decisions are discussed. These include the ability to explain the importance of the clinical encounter in medical practice, mechanisms for analysing patient and doctor as persons, and the need for humility given the uncertainty that the tacit dimension injects into all medical decisions. This more robust medical epistemology allows clinicians to better articulate the nature and importance of patient-centred care, to avoid pitfalls inherent in reductionist approaches to medical knowledge, and to think more clearly about the relationships between medicine and health care at the individual and population levels. (shrink)

In this paper, we first classify different types of second opinions and evaluate the ethical and epistemological implications of providing those in a clinical context. Second, we discuss the issue of how artificial intelligent could replace the human cognitive labour of providing such second opinion and find that several AI reach the levels of accuracy and efficiency needed to clarify their use an urgent ethical issue. Third, we outline the normative conditions of how AI may be used as second (...) opinion in clinical processes, weighing the benefits of its efficiency against concerns of responsibility attribution. Fourth, we provide a ‘rule of disagreement’ that fulfils these conditions while retaining some of the benefits of expanding the use of AI-based decision support systems in clinical contexts. This is because the rule of disagreement proposes to use AI as much as possible, but retain the ability to use human second opinions to resolve disagreements between AI and physician-in-charge. Fifth, we discuss some counterarguments. (shrink)

Disputes about theory in bioethics almost invariablyrevolve around different understandings of morality or practicalreasoning; I here suggest that the field would do well to becomemore explicitly contentious about knowledge, and start the taskof putting together a clinical epistemology. By way of providingsome motivation for such a discussion, I consider two cases ofresistance to shifts in clinical practice that are, by and large,not ethically controversial, highlighting how differentconceptions of epistemic authority may contribute to clinicians'unwillingness to adopt these changes, and (...) sketching out someinitial suggestions for epistemic analysis of clinical practice. (shrink)

In this article, we argue that a critical examination of epistemological and anthropological presuppositions might lead to a more fruitful use of theory in clinical-ethical practice. We differentiate between two views of conceptualizing ethics, referring to Charles Taylors' two epistemological models: ‘monological’ versus ‘dialogical consciousness’. We show that the conception of ethics in the model of ‘dialogical consciousness’ is radically different from the classical understanding of ethics in the model of ‘monological consciousness’. To reach accountable moral judgments, ethics cannot (...) be conceptualized as an individual enterprise, but has to be seen as a practical endeavor embedded in social interactions within which moral understandings are being negotiated. This view has specific implications for the nature and the role of ethical theory. Theory is not created in the individual mind of the ethicist; the use of theory is part of a joint learning process and embedded in a cultural context and social history. Theory is based upon practice, and serves practical purposes. Thus, clinical ethics support is both practical and theoretical. (shrink)

Bishop and Trout here present a unique and provocative new approach to epistemology. Their approach aims to liberate epistemology from the scholastic debates of standard analytic epistemology, and treat it as a branch of the philosophy of science. The approach is novel in its use of cost-benefit analysis to guide people facing real reasoning problems and in its framework for resolving normative disputes in psychology. Based on empirical data, Bishop and Trout show how people can improve their reasoning by relying (...) on Statistical Prediction Rules. They then develop and articulate the positive core of the book. Their view, Strategic Reliabilism, claims that epistemic excellence consists in the efficient allocation of cognitive resources to reliable reasoning strategies, applied to significant problems. The last third of the book develops the implications of this view for standard analytic epistemology; for resolving normative disputes in psychology; and for offering practical, concrete advice on how this theory can improve real people's reasoning. This is a truly distinctive and controversial work that spans many disciplines and will speak to an unusually diverse group, including people in epistemology, philosophy of science, decision theory, cognitive and clinical psychology, and ethics and public policy. (shrink)

Despite its phenomenal success since its inception in the early nineteen-nineties, the evidence-based medicine movement has not succeeded in shaking off an epistemological critique derived from the experiential or tacit dimensions of clinical reasoning about particular individuals. This critique claims that the evidence-based medicine model does not take account of tacit knowing as developed by the philosopher Michael Polanyi. However, the epistemology of evidence-based medicine is premised on the elimination of the tacit dimension from clinical judgment. This is (...) demonstrated through analyzing the dichotomy between clinical and statistical intuition in evidence-based medicine’s epistemology of clinical reasoning. I argue that clinical epidemiology presents a more nuanced epistemological model for the application of statistical epidemiology to the clinical context. Polanyi’s theory of tacit knowing is compatible with the model of clinical reasoning associated with clinical epidemiology, but not evidence-based medicine. (shrink)

Up to now neither the question, whether all theoretical medical knowledge can at least be described as scientific, nor the one how exactly access to the existing scientific and theoretical medical knowledge during clinical problem-solving is made, has been sufficiently answered. Scientific theories play an important role in controlling clinical practice and improving the quality of clinical care in modern medicine on the one hand, and making it vindicable on the other. Therefore, the vagueness of unexplicit interrelations (...) between medicine''s stock of knowledge and medical practice appears as a gap in the theoretical concept of modern medicine which can be described as Hiatus theoreticus in the anatomy of medicine. A central intention of the paper is to analyze the role of philosophy of medicine for the clarification of the theoretical basis of medical practice. Clinical relevance and normativity in the sense of modern theory of science are suggested as criteria to establish a differentiation between philosophy of medicine as a primary medical discipline and the application of general philosophy in medicine. (shrink)

Domestic violence and abuse (DVA) are at last coming to be recognised as serious global public health problems. Nevertheless, many women with personal histories of DVA decline to disclose them to healthcare practitioners. In the health sciences, recent empirical work has identified many factors that impede DVA disclosure, known as barriers to disclosure. Drawing on recent work in social epistemology on testimonial silencing, we might wonder why so many people withhold their testimony and whether there is some kind of epistemic (...) injustice afoot here. In this paper, I offer some philosophical reflections on DVA disclosure in clinical contexts and the associated barriers to disclosure. I argue that women with personal histories of DVA are vulnerable to a certain form of testimonial injustice in clinical contexts, namely, testimonial smothering, and that this may help to explain why they withhold that testimony. It is my contention that this can help explain the low rates of DVA disclosure by patients to healthcare practitioners. (shrink)

At least since the seminal work of the (US) National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the 1970s, a fundamental distinction between research and practice has underwritten both conceptual work in research ethics and regulations governing research involving human subjects. Notwithstanding its undoubted historical importance, I believe the distinction is problematic because it misrepresents clinical inquiry. In this essay, I aim to clarify the character of clinical inquiry by identifying crucial contextual (...) constraints on justification constitutive of clinical science. This analysis shows that, from an epistemological point of view, clinical research and clinical practice are not sharply distinct but intimately intertwined. This result is important in its own right—an enriched understanding of the epistemology of clinical research is valuable in and of itself. But this result is also important because it has profound implications for the ethics of human subjects research. (shrink)

How to improve clinical practice and, in particular, that of physical therapy? Currently, several strategies are used which all fit the label scientification. These scientific strategies have to make physical therapy''s clinical practice more homogeneous. Sometimes this homogenization is thought to be necessary for other strategies of innovation including effectiveness research. But it has also been suggested that more homogeneity in the clinic is already itself an improvement. In this article we comment on these strategies. More specifically, we (...) direct our attention at attempts in physical therapy to establish a uniform, generally adopted scientific language. We argue that these attempts fail to appreciate the specificity of therapeutic work. The effectiveness research that follows is therefore liable to take irrelevant variables into account. We illustrate this argument with examples taken from analyses of diverging therapies for stroke patients. (shrink)

Evidence-based medicine (EBM) has thus far failed to adequately account for the appropriate incorporation of other potential warrants for medical decision making into clinical practice. In particular, EBM has struggled with the value and integration of other kinds of medical knowledge, such as those derived from clinical experience or based on pathophysiologic rationale. The general priority given to empirical evidence derived from clinical research in all EBM approaches is not epistemically tenable. A casuistic alternative to EBM approaches (...) recognizes that five distinct topics, 1) empirical evidence, 2) experiential evidence, 3) pathophysiologic rationale, 4) patient goals and values, and 5) system features are potentially relevant to any clinical decision. No single topic has a general priority over any other and the relative importance of a topic will depend upon the circumstances of the particular case. The skilled clinician must weigh these potentially conflicting evidentiary and non-evidentiary warrants for action, employing both practical and theoretical reasoning, in order to arrive at the best choice for an individual patient. (shrink)

In After God: Morality and Bioethics in a Secular Age, H. Tristram Engelhardt, Jr. explores the broad implications for moral reasoning once a culture has lost a God’s-eye perspective. In this paper, I focus on the implications of Engelhardt’s views for clinical ethics consultation. I begin by examining the question of whether clinical ethics consultants should advocate a particular viewpoint and/or process during consultations or adopt a neutral stance. I then examine the implications of Engelhardt’s views for this (...) question. Finally, I discuss some of Engelhardt’s foundational ontological, metaphysical, meta-ethical, and epistemological commitments and how these commitments connect to his views on clinical ethics consultation. (shrink)

: This response to Lynn Jansen's critique of clinical pragmatism concentrates on two themes: (1) contrasting approaches to moral epistemology and (2) the connection between theory and practice in clinical ethics. Particular attention is paid to the status of principles and the role of consensus, with some closing speculations on how Dewey might view the current state of bioethics.

This article is an introduction to a special issue of Theoretical Medicine and Bioethics on clinical reasoning. Clinical reasoning encompasses the gamut of thinking about clinical medical practice—the evaluation and management of patients’ medical problems. Theories of clinical reasoning may be normative or descriptive; that is, they may offer recommendations on how clinicians ought to think or they may simply attempt to describe how clinicians actually do think. This article briefly surveys these approaches in order to (...) show the complexity of clinical reasoning and the inadequacy of any one theory for capturing the full richness of clinical reasoning. The authors of this issue offer both normative and descriptive elements in their accounts. Topics discussed include the importance for clinical reasoning of tacit knowing, risk assessment, narrative and hermeneutics, wisdom, and virtue epistemology. (shrink)

BackgroundSystems medicine is the name for an assemblage of scientific strategies and practices that include bioinformatics approaches to human biology ; “big data” statistical analysis; and medical informatics tools. Whereas personalized and precision medicine involve similar analytical methods applied to genomic and medical record data, systems medicine draws on these as well as other sources of data. Given this distinction, the clinical translation of systems medicine poses a number of important ethical and epistemological challenges for researchers working to generate (...) systems medicine knowledge and clinicians working to apply it.DiscussionThis article focuses on three key challenges: First, we will discuss the conflicts in decision-making that can arise when healthcare providers committed to principles of experimental medicine or evidence-based medicine encounter individualized recommendations derived from computer algorithms. We will explore in particular whether controlled experiments, such as comparative effectiveness trials, should mediate the translation of systems medicine, or if instead individualized findings generated through “big data” approaches can be applied directly in clinical decision-making. Second, we will examine the case of the Riyadh Intensive Care Program Mortality Prediction Algorithm, pejoratively referred to as the “death computer,” to demonstrate the ethical challenges that can arise when big-data-driven scoring systems are applied in clinical contexts. We argue that the uncritical use of predictive clinical algorithms, including those envisioned for systems medicine, challenge basic understandings of the doctor-patient relationship. Third, we will build on the recent discourse on secondary findings in genomics and imaging to draw attention to the important implications of secondary findings derived from the joint analysis of data from diverse sources, including data recorded by patients in an attempt to realize their “quantified self.”SummaryThis paper examines possible ethical challenges that are likely to be raised as systems medicine to be translated into clinical medicine. These include the epistemological challenges for clinical decision-making, the use of scoring systems optimized by big data techniques and the risk that incidental and secondary findings will significantly increase. While some ethical implications remain still hypothetical we should use the opportunity to prospectively identify challenges to avoid making foreseeable mistakes when systems medicine inevitably arrives in routine care. (shrink)

Evidence based medicine has been a topic of considerable controversy in medical and health care circles over its short lifetime, because of the claims made by its exponents about the criteria used to assess the evidence for or against the effectiveness of medical interventions. The central epistemological debates underpinning the debates about evidence based medicine are reviewed by this paper, and some areas are suggested where further work remains to be done. In particular, further work is needed on the theory (...) of evidence and inference; causation and correlation; clinical judgment and collective knowledge; the structure of medical theory; and the nature of clinical effectiveness. (shrink)

Ethically permissible clinical trials must not expose subjects to risks that are unreasonable in relation to anticipated benefits. In the research ethics literature, this moral requirement is typically understood in one of two different ways: as requiring the existence of a state of clinical equipoise, meaning a state of honest, professional disagreement among the community of experts about the preferred treatment; or as requiring an equilibrium between individual and collective ethics. It has been maintained that this second interpretation (...) makes it mandatory to minimize the number of patients receiving the treatment that will eventually be shown to be inferior by the trial. This requirement has led to the development of adaptive trials, i.e., trials in which treatment allocation is determined by data accumulated during interim analysis. Many statisticians argue that in some circumstances—typically with potentially high benefits, as in the much discussed ECMO trial—adaptive design is the only ethically permissible experimental design. Nevertheless, some proponents of clinical equipoise argue that adaptive trials are neither ethically required nor permissible. More specifically, they argue that clinical trials using adaptive designs fail to meet the moral requirement of clinical equipoise, since these trials presuppose an epistemic state that is incompatible with a physician’s duty of care to her subjects. This paper emphasizes that the debate is to a large extent resting on an epistemological confusion. Specifically, I argue that this response conflates two different conceptions of statistical evidence, and that recognizing this distinction elucidates an epistemological framework in which adaptive trials are both consistent with and recommended by the moral requirement of clinical equipoise. (shrink)

Robert Truog describes the controversial randomized controlled trials (RCTs) of extracorporeal membrane oxygenation (ECMO) therapy in newborns. Because early results with ECMO indicated that it might be a great advance, saving many lives, Truog argues that ECMO should not have been tested using RCTs, but that a long-term, large-scale observational study of actual clinical practice should have been conducted instead. Central to Truog’s argument, however, is the idea that ECMO is an unusual case. Thus, it is an open question (...) whether Truog’s conclusions can be extended to other areas of medical research. In this paper, I look at epistemological and ethical issues arising in the care of patients with chronic diseases, using ECMO as a starting point. Both the similarities and the dissimilarities of these two cases highlight important issues in biomedical research and support a conclusion similar to Truog’s. Observational studies of clinical practice provide the best evidence to inform the treatment of patients with chronic disease. (shrink)