While most of healthcare research and practice fully endorses evidence-based healthcare, a minority view borrows popular themes from philosophy of science like underdetermination and value-ladenness to question the legitimacy of the evidence-based movement’s philosophical underpinnings. While the feminist origins go unacknowledged, those critics adopt a feminist reading of the “gap argument” to challenge the perceived objectivism of evidence-based practice. From there, the critics seem to despair over the “subjective elements” that values introduce to clinical reasoning, demonstrating that they (...) do not subscribe to feminist science studies’ normative program——where contextual values can enable good science and justified decisions. In this paper, I investigate why it is that the critics of evidence-based medicine adopt feminist science’s characterization of the problem but resist the productive solutions offered by those same theorists. I suggest that the common feminist empiricist appeal to idealized epistemic communities is impractical for those working within the current biomedical context and instead offer an alternate stream of feminist research into the empirical content of values (found in the work of Elizabeth Anderson and Sharyn Clough) as a more helpful recourse for facilitating the important task of legitimate and justified clinical decision-making. I use a case study on clinical decision-making to illustrate the fruitfulness of the latter feminist empiricist framework. -/- See response by Sharyn Clough: http://wp.me/p1Bfg0-1aN See reply by Maya Goldenberg: http://wp.me/p1Bfg0-1oY. (shrink)

This thesis discusses how societies should allocate clinical care resources. The first aim of the thesis is to defend the idea that clinical care resource allocation is a matter for deliberative democratic procedures. I argue that deliberative democracy is justified because of its ability to implement equal respect and autonomy. Furthermore, I address several in-principle objections to the project of applying deliberative democracy to clinical care resource allocation. Most notably, I respond to the narrow view of the (...) scope of deliberative democracy and the critiques of explicit rationing. -/- The second aim of the thesis is to determine what is required by deliberative democracy in clinical care resource allocation. I identify the general requirements that resource allocation agencies should meet, namely public reason, public involvement, transparency, accuracy and revisability. I then examine what is required by deliberative democracy with regard to two particularly salient specific topics, namely the substantive values that should govern resource allocation and the involvement of scientific experts in decision-making. -/- I demonstrate that public reason imposes severe constraints on the substantive values that should be employed. Most of these constraints are rooted in the idea that, under a regime of scarcity, public reason requires that resources be allocated so as to minimise the strongest complaint anyone may have. Out of the variety of values that are commonly proposed as relevant, only priority to the worst-off, ability to benefit, specialness of clinical care and cost are consistent with public reason. Turning to expert involvement, I argue that deliberative democracy can overcome several formidable threats, such as the opacity of expert opinions to laypersons and the tendency to hide uncertainty and disagreement from the public. I also discuss how my proposals on substantive values and expert involvement could be implemented, in order to add to the plausibility of my theory. (shrink)

Introduction: Clinical practice guidelines (CPGs) are an important source of justification for clinical decisions in modern evidence-based practice. Yet, we have given little attention to how they argue their evidence. In particular, how do CPGs argue for treatment with long-term medications that are increasingly prescribed to older patients? Approach and rationale: I selected six disease-specific guidelines recommending treatment with five of the medication classes most commonly prescribed for seniors in Ontario, Canada. I considered the stated aims of these (...) CPGs and the techniques employed towards those aims. Finally, I reconstructed and logically analysed the arguments supporting recommendations for pharmacotherapy. Analysis: The primary function of CPGs is rhetorical, or persuasive, and their means of persuasion include both a display of their credibility and their argumentation. Arguments supporting pharmacotherapy recommendations for the target population follow a common inductive pattern: statistical generalization from randomized controlled trial (RCT) and meta-analysis evidence. Two of the CPGs also argue their treatment recommendations for older patients in this style, while three fail to justify pharmacotherapy specifically for the older population. Discussion: The arguments analysed lack the auxiliary assumptions that would warrant making a generalization about the clinical effectiveness of medications for the older population. Guidelines reason using simple induction, while ignoring important inferential gaps. Future guidelines should aspire to be well-reasoned rather than simply evidence-based; argue from a plurality of evidence; be wary of hasty inductions; appropriately limit the scope of their recommendations; and avoid making law-like, prescriptive generalizations. (shrink)

Clinical guidelines are special types of plans realized by collective agents. We provide an ontological theory of such plans that is designed to support the construction of a framework in which guideline-based information systems can be employed in the management of workflow in health care organizations. The framework we propose allows us to represent in formal terms how clinical guidelines are realized through the actions of are realized through the actions of individuals organized into teams. We provide various (...) levels of implementation representing different levels of conformity on the part of health care organizations. Implementations built in conformity with our framework are marked by two dimensions of flexibility that are designed to make them more likely to be accepted by health care professionals than standard guideline-based management systems. They do justice to the fact 1) that responsibilities within a health care organization are widely shared, and 2) that health care professionals may on different occasions be non-compliant with guidelines for a variety of well justified reasons. The advantage of the framework lies in its built-in flexibility, its sensitivity to clinical context, and its ability to use inference tools based on a robust ontology. One disadvantage lies in its complicated implementation. (shrink)

Machine learning algorithms may radically improve our ability to diagnose and treat disease. For moral, legal, and scientific reasons, it is essential that doctors and patients be able to understand and explain the predictions of these models. Scalable, customisable, and ethical solutions can be achieved by working together with relevant stakeholders, including patients, data scientists, and policy makers.

Outcomes research in healthcare has been a topic much addressed in recent years. Efforts in this direction have been supplemented by work in the areas of guidelines for clinical practice and computer-interpretable workflow and careflow models.In what follows we present the outlines of a framework for understanding the relations between organizations, guidelines, individual patients and patient-related functions. The derived framework provides a means to extract the knowledge contained in the guideline text at different granularities, in ways that can help (...) us to assign tasks within the healthcare organization and to assess clinical performance in realizing the guideline. It does this in a way that preserves the flexibility of the organization in the adoption of the guidelines. (shrink)

Regarding the appropriateness of deception in clinical practice, two (apparently conflicting) claims are often emphasised. First, that ‘clinicians should not deceive their patients.’ Second, that deception is sometimes ‘in a patient’s best interest.’ Recently, Hardman has worked towards resolving this conflict by exploring ways in which deceptive and non-deceptive practices extend beyond consideration of patients’ beliefs. In short, some practices only seem deceptive because of the (common) assumption that non-deceptive care is solely aimed at fostering true beliefs. Non-deceptive care, (...) however, relates to patients’ non-doxastic attitudes in important ways as well. As such, Hardman suggests that by focusing on belief alone, we sometimes misidentify non-deceptive care as ‘deceptive’. Further, once we consider patients’ beliefs and non-doxastic attitudes, identifying cases of deception becomes more difficult than it may seem. In this essay, I argue that Hardman’s reasoning contains at least three serious flaws. First, his account of deception is underdeveloped, as it does not state whether deception must be intentional. The problem is that if intention is not required, absurd results follow. Alternatively, if intention is required, then identifying cases of deception will be much easier (in principle) than Hardman suggests. Second, Hardman mischaracterises the ‘inverse’ of deceptive care. Doing so leads to the mistaken conclusion that common conceptions of non-deceptive care are unjustifiably narrow. Third, Hardman fails to adequately separate questions about deception from questions about normativity. By addressing these issues, however, we can preserve some of Hardman’s most important insights, although in a much simpler, more principled way. (shrink)

The badness of having conflicting emotions is a familiar theme in academic ethics, clinical psychology, and commercial self-help, where emotional harmony is often put forward as an ideal. Many philosophers give emotional harmony pride of place in their theories of practical reason.1 Here we offer a defense of a particular species of emotional conflict, namely, ambivalence. We articulate an conception of ambivalence, on which ambivalence is unresolved inconsistent desire (§1) and present a case of appropriate ambivalence (§2), before considering (...) two alternative defenses of emotional conflict (§3). We then argue that inconsistent desires can be fitting (§4) and that it can be reasonable not to resolve inconsistent desires (§5), before considering an objection (§6) and concluding the discussion (§7). (shrink)

Regarding the appropriateness of deception in clinical practice, two (apparently conflicting) claims are often emphasised. First, that ‘clinicians should not deceive their patients.’ Second, that deception is sometimes ‘in a patient’s best interest.’ Recently, Hardman has worked towards resolving this conflict by exploring ways in which deceptive and non-deceptive practices extend beyond consideration of patients’ beliefs. In short, some practices only seem deceptive because of the (common) assumption that non-deceptive care is solely aimed at fostering true beliefs. Non-deceptive care, (...) however, relates to patients’ non-doxastic attitudes in important ways as well. As such, Hardman suggests that by focusing on belief alone, we sometimes misidentify non-deceptive care as ‘deceptive’. Further, once we consider patients’ beliefs and non-doxastic attitudes, identifying cases of deception becomes more difficult than it may seem. In this essay, I argue that Hardman’s reasoning contains at least three serious flaws. First, his account of deception is underdeveloped, as it does not state whether deception must be intentional. The problem is that if intention is not required, absurd results follow. Alternatively, if intention is required, then identifying cases of deception will be much easier (in principle) than Hardman suggests. Second, Hardman mischaracterises the ‘inverse’ of deceptive care. Doing so leads to the mistaken conclusion that common conceptions of non-deceptive care are unjustifiably narrow. Third, Hardman fails to adequately separate questions about deception from questions about normativity. By addressing these issues, however, we can preserve some of Hardman’s most important insights, although in a much simpler, more principled way. (shrink)

A key objective of the law in the assessment of decision-making capacity in clinical settings is to allow clinicians and judges to avoid making value judgements about the reasons that patients use to refuse treatment. This paper advances two lines of argument in respect of this objective. The first is that authorities cannot rationally avoid significant evaluative judgements in the assessment of a patient’s own assessment of the facts of their case. Assessing reasoning is unavoidably value-laden. Yet the (...) underlying motivation behind clinicians’ and the law’s value-neutral aims, ie, the avoidance of undue paternalism, is worth preserving. That being so, the second line of argument will try to show that that underlying motivation is better served in a limited range of cases by embedding a ‘reversibility standard’ in the assessment process so that the patient can, if they wish, and in due course, bring about the consequences that they were prevented from realising as a result of a determination of incapacity. (shrink)

Summary Background Self-binding directives instruct clinicians to overrule treatment refusal during future severe episodes of illness. These directives are promoted as having potential to increase autonomy for individuals with severe episodic mental illness. Although lived experience is central to their creation, service users’ views on self-binding directives have not been investigated substantially. This study aimed to explore whether reasons for endorsement, ambivalence, or rejection given by service users with bipolar disorder can address concerns regarding self-binding directives, decision-making capacity, and human (...) rights. Methods This study used qualitative data from an internet-based survey distributed to the mailing list of the UK charity Bipolar UK, which contained multiple closed and open questions on advance decision-making in bipolar disorder. Quantitative analysis of a closed question about self-binding directives had already demonstrated endorsement amongst a very high proportion of participants with bipolar disorder who completed the survey. We conducted thematic analysis of responses from those participants who answered a subsequent open question about reasons for their view. Research was co-produced within a multi-disciplinary team, with clinical, legal, and ethical expertise, and lived experience of bipolar disorder. Ideas and methodologies associated with all these areas of expertise were used in the analysis of these reasons and to gain insight into the thoughts of individuals with bipolar disorder about self-binding directives and associated issues. Findings Between Oct 23 and Dec 5, 2017, 932 individuals with a self-reported clinical diagnosis of bipolar disorder completed the internet survey, with 565 (154 men; 400 women; 11 transgender or other) providing free text answers to the open question. A large majority of respondents endorsed self-binding directives, nearly all describing a determinate shift to types of distorted thinking and decision-making when unwell as their key justification. Responses indicating ambivalence were dominated by logistical concerns about the drafting and implementation of self-binding directives, while those who rejected self-binding directives also cited logistical concerns, validity of their thinking when unwell, and potential contravention of human rights. Interpretation This study is, to our knowledge, the first large study of reasons why mental health service users might endorse or reject the use of self-binding directives. The findings provide empirical support for introducing self-binding directives into mental health advance decision-making practice and policy and may help to address enduring ethical concerns surrounding possible implementation of the directive while a person retains decision-making capacity. The opinions expressed here in responses given by multiple service users with bipolar disorder challenge a prominent view within international disability rights debates that involuntary treatment and recognition of impaired mental capacity constitute inherent human rights violations. Funding The Wellcome Trust . (shrink)

This dissertation addresses the problem of how to evaluate and compare the theories that inform diverse approaches to psychotherapy. It is argued that the field needs a superordinate epistemology to provide legitimacy for its theories and for the clinical work that these theories guide. Such a superordinate epistemology would occupy a higher level of analysis than the theories it is used to evaluate. ;Using a constructivist framework, it is argued that much of the epistemological confusion currently characterizing clinical (...) psychology can be traced to a traditional failure to distinguish among levels of analysis when evaluating clinical psychology theories. It is demonstrated that evaluations of such theories often conflate theory and epistemology. ;The received view of a natural science epistemology and hermeneutics provide the usual terms in which epistemology is debated. These are found inadequate to fill the necessary role of superordinate epistemology. The received view is criticized, in part, for "bracketing" the domain of meaning, and hermeneutics is criticized, in part, for "bracketing" the domain of extra-linguistic reality. For these reasons, it is shown that neither of these approaches can be considered to be superordinate to clinical theories. ;Next, some preliminary theoretical groundwork for the development of a constructivist superordinate epistemology for clinical psychology is offered. The domain of clinical psychology is defined as the conjunction of the domains of meaning and reality. A constructivist reformulation of the role of empirical research and observational knowledge is outlined. A reconceptualization of clinical theories as narratives and "expert languages" is suggested as well. ;It is argued that theoretical propositions first should be evaluated according to whether they conform to observational knowledge about the unintentional constraints on human intentionality. Then theories should be evaluated according to the coherence of their accounts of the transactions between the domains of meaning and reality. The hermeneutic circle is suggested as a methodology for choosing among different interpretations in a given therapeutic encounter. ;Finally, some directions for future work are suggested. (shrink)

Editors' introduction to 3rd thematic issue on philosophy of medicine.

A background assumption of this paper is that the repertoire of inference schemes available to humanity is not fixed, but subject to change as new schemes are invented or refined and as old ones are obsolesced or abandoned. This is particularly visible in areas like health and environmental sciences, where enormous societal investment has been made in finding ways to reach more dependable conclusions. Computational modeling of argumentation, at least for the discourse in expert fields, will require the possibility of (...) modeling change in a stock of schemes that may be applied to generate conclusions from data. We examine Randomized Clinical Trial, an inference scheme established within medical science in the mid-20th Century, and show that its successful defense by means of practical reasoning allowed for its black-boxing as an inference scheme that generates (and warrants belief in) conclusions about the effects of medical treatments. Modeling the use of a scheme is well-understood; here we focus on modeling how the scheme comes to be established so that it is available for use. (shrink)

Clinical ethics consultants (CECs) are not moral authorities. Standardization of CECs’ professional role does not confer upon them moral authority. Certification of particular CECs does not confer upon them moral authority (nor does it reflect such authority). Or, so we will argue. This article offers a distinctly Orthodox Christian response to those who claim that CECs—or any other academically trained bioethicist—retain moral authority (i.e., an authority to know and recommend the right course of action). This article proceeds in three (...) parts. First, we discuss recent movements toward the certification of CECs in the United States, focusing primarily on proposals and programs put forth by the American Society for Humanities and Bioethics (ASBH). Second, we outline two secular reasons to be concerned about the relevant trends toward certification. For one thing, certification is currently being advanced via political dominance, rather than gaining authority by reliance on rigorous philosophical argument or reason. For another, the trends operate on the assumption that there exists a secular, content-full, canonical, morality. There is no such morality. Next, we argue that Orthodox Christians should resist the current trends toward certification of CECs. Specifically, we unpack ways in which the ASBH’s certification program (and those like it) conflict with Orthodox claims about moral authority and the moral life more generally. We conclude that Orthodox Christians should resist the current certification trends. (shrink)

Recent work on the quality assurance of the Gene Ontology (GO, Gene Ontology Consortium 2004) from the perspective of both linguistic and ontological organization has made it clear that GO lacks the kind of formalism needed to support logic-based reasoning. At the same time it is no less clear that GO has proven itself to be an excellent terminological resource that can serve to combine together a variety of biomedical database and information systems. Given the strengths of GO, it (...) is worth investigating whether, by overcoming some of its weaknesses from the point of view of formal-ontological principles, we might not be able to enhance a version of GO which can come even closer to serving the needs of the various communities of biomedical researchers and practitioners. It is accepted that clinical and bioinformatics need to find common ground if the results of data-intensive biomedical research are to be harvested to the full. It is also widely accepted that no single method will be sufficient to create the needed common framework. We believe that the principles-based approach to life-science data integration and knowledge representation must be one of the methods applied. Indeed in dealing with the ontological representation of carcinomas, and specifically of colon carcinomas, we have established that, had GO (and related biomedical ontologies) followed some of the basic formal-ontological principles we have identified (Smith et al. 2004, Ceusters et al. 2004), then the effort required to navigate successfully between clinical and bioinformatics systems would have been reduced. We point here to the sources of ontologically-related errors in GO, and also provide arguments as to why and how such errors need to be resolved. (shrink)

We argue that the universal recommendations against “off-label” pediatric use of approved COVID-19 issued by the FDA, CDC, and AAP are overbroad. Especially for higher-risk children, vaccination can be ethically justified even before FDA authorization or approval – and similar reasoning is relevant for even younger patients. Legal risks can also be managed, although the FDA, CDC, and Department of Health and Human Services (HHS) should move quickly to provide clarity.

Experimental balance is usually understood as the control for the value of the conditions, other than the one under study, which are liable to affect the result of a test. We will discuss three different approaches to balance. ‘Millean balance’ requires to identify and equalize ex ante the value of these conditions in order to conduct solid causal inferences. ‘Fisherian balance’ measures ex post the influence of uncontrolled conditions through the analysis of variance. In ‘efficiency balance’ the value of the (...) antecedent conditions is decided ex ante according to the efficiency they yield in the estimation of the treatment outcome. Against some old arguments by John Worrall, we will show that in both Fisherian and efficiency balance there are good reasons to randomize the allocation of treatments, in particular when there is no agreement among experimenters as to the antecedent conditions to be controlled for. (shrink)

Jake Greenblum and Ryan K Hubbard argue that physicians, nurses, clinical ethicists and ethics committee members should not cite religious considerations when helping patients (or their proxies) make medical decisions. They provide two arguments for this position: The Public Reason Argument and the Fiduciary Argument. In this essay, I show that the Public Reason Argument fails. Greenblum and Hubbard may provide good reason to think that physicians should not invoke their own religious commitments as reasons for a particular medical (...) decision. But they fail to show that it is wrong for physicians to cite the patient’s own religious commitments as reasons for a particular decision. As such, if Greenblum and Hubbard’s thesis is to survive, the Fiduciary Argument (or some unmentioned argument) will have to do the bulk of the work. (shrink)

Proposals for allocating scarce lifesaving resources in the face of the Covid-19 pandemic have aligned in some ways and conflicted in others. This paper attempts a kind of priority setting in addressing these conflicts. In the first part, we identify points on which we do not believe that reasonable people should differ—even if they do. These are (i) the inadequacy of traditional clinical ethics to address priority-setting in a pandemic; (ii) the relevance of saving lives; (iii) the flaws of (...) first-come, first-served allocation; (iv) the relevance of post-episode survival; (v) the difference between age and other factors that affect life-expectancy; and (vi) the need to avoid quality-of-life judgments. In the second part, we lay out some positions on which reasonable people can and do differ. These include (i) conflicts between maximizing benefits and priority to the worst off; (ii) role-based priority; and (iii) whether patients’ existing lifesaving resources should be subject to redistribution. (shrink)

Most people are completely oblivious to the danger that their medical data undergoes as soon as it goes out into the burgeoning world of big data. Medical data is financially valuable, and your sensitive data may be shared or sold by doctors, hospitals, clinical laboratories, and pharmacies—without your knowledge or consent. Medical data can also be found in your browsing history, the smartphone applications you use, data from wearables, your shopping list, and more. At best, data about your health (...) might end up in the hands of researchers on whose good will we depend to avoid abuses of power.2 Most likely, it will end up with data brokers who might sell it to a future employer, or an insurance company, or the government. At worst, your medical data may end up in the hands of criminals eager to commit extortion or identity theft. In addition to data harms related to exposure and discrimination, the collection of sensitive data by powerful corporations risks the creation of data monopolies that can dominate and condition access to health care. -/- This chapter aims to explore the challenge that big data brings to medical privacy. Section I offers a brief overview of the role of privacy in medical settings. I define privacy as having one’s personal information and one’s personal sensorial space (what I call autotopos) unaccessed. Section II discusses how the challenge of big data differs from other risks to medical privacy. Section III is about what can be done to minimise those risks. I argue that the most effective way of protecting people from suffering unfair medical consequences is by having a public universal healthcare system in which coverage is not influenced by personal data (e.g., genetic predisposition, exercise habits, eating habits, etc.). (shrink)

The International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) COVID-19 dataset is one of the largest international databases of prospectively collected clinical data on people hospitalized with COVID-19. This dataset was compiled during the COVID-19 pandemic by a network of hospitals that collect data using the ISARIC-World Health Organization Clinical Characterization Protocol and data tools. The database includes data from more than 705,000 patients, collected in more than 60 countries and 1,500 centres worldwide. Patient data are available (...) from acute hospital admissions with COVID-19 and outpatient follow-ups. The data include signs and symptoms, pre-existing comorbidities, vital signs, chronic and acute treatments, complications, dates of hospitalization and discharge, mortality, viral strains, vaccination status, and other data. Here, we present the dataset characteristics, explain its architecture and how to gain access, and provide tools to facilitate its use. (shrink)

We offer a model of moral reform and regeneration that involves a wrong-doer making two movements: on the one hand, he identifies with himself as the one who did the act, while he also intentionally moves away from that self (or set of desires and intentions) and moves toward a transformed identity. We see this model at work in the formal practice of contrition and reform in Christian and Buddhist rites. This paper is part of a broader project we are (...) undertaking on the philosophy of forgiveness. (shrink)

Evidence-based medicine (EBM) calls for medical practitioners to “integrate” our best available evidence into clinical practice. A significant amount of the literature on EBM takes this integration to be unproblematic, focusing on questions like how to interpret evidence and engage with patient values, rather than critically looking at how these features of EBM can be implemented together. Other authors have also commented on this gap in the literature, for example, identifying the lack of clarity about how patient preferences and (...) evidence from trials is supposed to be integrated in practice. In this paper, I look at this issue from an epistemological perspective, (looking at how different types of knowledge in EBM can be used to make sounds judgements). In particular, I introduce an epistemological issue for this integration problem, which I call the epistemic integration problem. This is essentially the problem of how we can use information that is both general (eg, about a population sample) and descriptive (eg, about what expected outcomes are) to reach clinical judgements that are individualized (applying to a particular patient) and normative (about what is best for their health). (shrink)

Over the past several decades, we devoted much energy to generating, reviewing and summarizing evidence. We have given far less attention to the issue of how to thoughtfully apply the evidence once we have it. That’s fine if all we care about is that our clinical decisions are evidence-based, but not so good if we also want them to be well-reasoned. Let us not forget that evidence based medicine (EBM) grew out of an interest in making medicine ‘rational’, with (...) the idea that rational clinical evaluations should be evidence-based. I agree with the uncontroversial statement that the best decision is supported, at least in part, by the best available evidence. Rationality, however, is constituted by reasoning, not evidence. Complete arguments are necessary for rational evaluations, arguments that begin with general evidence and end in a conclusion about a particular patient. In order to traverse these inferential gaps, medicine must address the issue of how to establish, as an intermediate premise, what the evidence has to say about the efficacy of an intervention for particular patients in a particular practice setting. (shrink)

Decision-making by a Data and Safety Monitoring Board (DSMB) regarding clinical trial conduct and termination is intricate and largely limited by cases and rules. Decision-making by legal jury is also intricate and largely constrained by cases and rules. In this paper, I argue by analogy that legal decision-making, which strives for a balance between competing demands of conservatism and innovation, supplies a good basis to the logic behind DSMB decision-making. Using the doctrine of precedents in legal reasoning as (...) my central analog will lead us to a decision-theoretic analogy for much more systematic documentation of decisions in clinical trials. My conclusion is twofold: every DSMB decision should articulate a clear general principle (a ratio decidendi) that gives reason for the decision; and all such decisions should be made public. I use Bartha’s (2010) theory of analogical arguments to both frame and assess my argument by analogy. (shrink)

Proponents of evidence-based medicine have argued convincingly for applying this scientific method to medicine. However, the current methodological framework of the EBM movement has recently been called into question, especially in epidemiology and the philosophy of science. The debate has focused on whether the methodology of randomized controlled trials provides the best evidence available. This paper attempts to shift the focus of the debate by arguing that clinical reasoning involves a patchwork of evidential approaches and that the emphasis (...) on evidence hierarchies of methodology fails to lend credence to the common practice of corroboration in medicine. I argue that the strength of evidence lies in the evidence itself, and not the methodology used to obtain that evidence. Ultimately, when it comes to evaluating the effectiveness of medical interventions, it is the evidence obtained from the methodology rather than the methodology that should establish the strength of the evidence. (shrink)

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, what it is that we feel we can claim to know, 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. (shrink)

Thirty years after the rise of the evidence-based medicine (EBM) movement, formal training in philosophy remains poorly represented among medical students and their educators. In this paper, I argue that EBM’s reception in this context has resulted in a privileging of empiricism over rationalism in clinical reasoning with unintended consequences for medical practice. After a limited review of the history of medical epistemology, I argue that a solution to this problem can be found in the method of the (...) 2nd-century Roman physician Galen, who brought empiricism and rationalism together in a synthesis anticipating the scientific method. Next, I review several of the problems that have been identified as resulting from a staunch commitment to empiricism in medical practice. Finally, I conclude that greater epistemological awareness in the medical community would precipitate a Galenic shift toward a more epistemically balanced, scientific approach to clinical research. (shrink)

Even though the evidence‐based medicine movement (EBM) labels mechanisms a low quality form of evidence, consideration of the mechanisms on which medicine relies, and the distinct roles that mechanisms might play in clinical practice, offers a number of insights into EBM itself. In this paper, I examine the connections between EBM and mechanisms from several angles. I diagnose what went wrong in two examples where mechanistic reasoning failed to generate accurate predictions for how a dysfunctional mechanism would respond (...) to intervention. I then use these examples to explain why we should expect this kind of mechanistic reasoning to fail in systematic ways, by situating these failures in terms of evolved complexity of the causal system(s) in question. I argue that there is still a different role in which mechanisms continue to figure as evidence in EBM: namely, in guiding the application of population‐level recommendations to individual patients. Thus, even though the evidence‐based movement rejects one role in which mechanistic reasoning serves as evidence, there are other evidentiary roles for mechanistic reasoning. This renders plausible the claims of some critics of evidencebased medicine who point to the ineliminable role of clinical experience. Clearly specifying the ways in which mechanisms and mechanistic reasoning can be involved in clinical practice frames the discussion about EBM and clinical experience in more fruitful terms. (shrink)

Introduction In 2013, Dr. J. Muizelaar and Dr. R. Schrot, two neurosurgeons at the University of California Davis Medical Center (UCDMC), were found guilty of research misconduct due to failure to comply with institutional policies as well as Food and Drug Administration (FDA) regulations governing human subjects research. At issue here, however, is the difference between research and innovative therapy in the clinical setting of patient care where clinical judgment is reasonably to be privileged. Methods The UCDMC investigative (...) document is reviewed along with standard literature on clinical ethics and clinical data about glioblastoma multiforme (GBM) cancer. Results In this paper I argue that, by tendentiously focusing on policies, regulations, and procedures governing human subjects research, the UCDMC investigation failed to account for the centrality of clinical judgment and clinical ethics pertinent to judicious review of this matter, especially given the unique clinical context of terminally ill patients having exhausted standard care treatment options for glioblastoma multiforme (GBM) cancer. Conclusions The UCDMC investigation raises serious problems for clinicians who are engaged in innovative therapy in the clinical setting, requiring a regulatory framework separate from the normal Institutional Review Board (IRB) process. (shrink)

Clinical practice is a part of the integral learning method in nursing education. The use of information and communication technologies (ICT) in clinical learning is highly encouraged among nursing students to support evidence-based nursing and student-centered learning. Through the information-processing lens of the mindsponge theory, this study views performance expectancy (or perceived usefulness) and effort expectancy (or perceived ease of use) as results of subjective benefit and cost judgments determining the students’ ICT using intention for supporting clinical (...) learning, respectively. Therefore, the study examines whether effort expectancy moderates the relationship between performance expectancy and the intention to use ICT among Moroccan nursing students. The Bayesian Mindsponge Framework (BMF) analytics was employed on a dataset of 702 Moroccan nursing students. We found that nursing students’ performance expectancy is positively associated with the intention to adopt ICT and social media, while effort expectancy positively moderates this relationship. Moreover, the model with effort expectancy as the moderator was discovered to have a significantly larger weight than the model with effort expectancy as the direct predictor, validating our information-processing reasoning. This study provides a new perspective on the interplay between the benefit and cost perceptions of ICT use to support clinical learning methods in nursing education. Moreover, given the limited education resources, especially in developing countries like Morocco, we recommend nursing education and training prioritize communicating the benefits of ICTs and social media over ease of use. Doing so would help improve the effectiveness and efficiency of nursing education and training while lowering costs. (shrink)

The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially, (4) (...) when there are compelling methodological reasons for using placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive. The concept of methodological reasons is essential to assessing the ethics of placebo controls in these controversial last two cases. This article sets out key considerations relevant to considering whether methodological reasons for a placebo control are compelling. (shrink)

We ask whether it is reasonable to delay or refuse to take COVID-19 vaccines that have been shown in clinical trials to be safe and effective against infectious diseases. We consider two kinds of vaccine hesitancy. The first is geared to scientifically informed open questions about vaccines. We argue that in cases where the data is not representative of relevant groups, such as pregnant women and ethnic minorities, hesitancy can be reasonable on epistemic grounds. However, we argue that hesitancy (...) is not reasonable if a vaccine has passed well-conducted clinical trials. The second kind of hesitancy is to do with beliefs about the institutions offering a successfully trialled vaccine and the justifiability of cooperating with those institutions. For example, in the UK, distrust of the UK Government or the National Health Service is identified as a factor in the vaccine hesitancy of minority ethnic populations. We ask whether this sort of hesitation is reasonable given normative requirements of fair co-operation, both with those institutions and the wider population. We suggest that the answer is not straightforward. Sometimes the hesitation is unreasonable but understandable. -/- . (shrink)

In the American medical system, patients do not know the final price of treatment until long after the treatment is given, at which point it is too late to say “no.” I argue that without price disclosure many, perhaps all, tokens of consent in clinical medicine fall below the standard of valid, informed consent. This is a sweeping and broad thesis. The reason for this thesis is surprisingly simple: medical services rarely have prices attached to them that are known (...) to the patient prior to treatment. Yet, for many patients, knowledge of the price is relevant to whether they would give consent. If informed consent requires that patients know all information about their treatment that is relevant to their decision, then consent to a medical intervention in the absence of the price is not informed consent. (shrink)

This chapter aims to distinguish between pathologies of agency in the strict sense and mere sources of impediments or distortion. Expanding on a recent notion of necessarily less-than-successful agency, it complements a mainstream approach to mental disorders and anomalous psychological conditions in the philosophy of mind and action. According this approach, the interest of such clinical case studies is heuristic, to differentiate between facets of agency that are functionally and conceptually separate even though they typically come together. Yet, in (...) the absence of independent criterion for a pathology of as opposed to inner obstacle to agency, this heuristic is at risk of becoming circular or uninformative, falling back on a clinical diagnosis it is meant to take as a starting point only. The chapter develops such a criterion and shows how it could work tracking agential achievement across two core dimensions of agency: planning and responsiveness to reasons. The discussion concludes with some implications on assessing decisional capacity and safeguarding agent autonomy in psychiatric settings. (shrink)

Popular two-factor accounts of thought insertion hold that this symptom of psychosis is caused by two elements working in tandem: an anomalous experience of some kind (the first factor) and a reasoning deficit or bias (the second factor). This chapter develops a very different alternative to explaining and treating thought insertion—one that views thought insertion as a form persecutory delusion. If this thesis is correct, clinical interventions for persecutory delusions may be successful for thought insertion as well. The (...) chapter begins by presenting several difficulties for two-factor accounts of thought insertion and for two-factor accounts of delusions more generally. It then discusses positive reasons for seeing thought insertion as a form of persecutory delusion. The positive case begins with reflection on first-person descriptions of thought insertion gleaned from online discussion forums. It continues by considering ways in which clinical diagnostic tools may create the appearance of deep differences between symptoms such as thought insertion and persecutory delusions where there are none. This case is bolstered by evidence for considerable variability in the content of delusions patients present with over time. Implications for the treatment of thought insertion are then considered. (shrink)

The distinction between clinical research and clinical practice directs how we partition medicine and biomedical science. Reasons for a sharp distinction date historically to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, especially to its analysis of the “boundaries” between research and practice in the Belmont Report (1978). Belmont presents a segregation model of the research-practice distinction, according to which research and practice form conceptually exclusive sets of activities and (...) interventions. This model is still the standard in federal regulations today. However, the Commission’s deliberations and conclusions about the boundaries are more complicated, nuanced, and instructive than has generally been appreciated. The National Commission did not conclude that practice needs no oversight comparable to the regulation of research. It debated the matter and inclined to the view that the oversight of practice needed to be upgraded, though the Commission stopped short of proposing new regulations for its oversight, largely for prudential political reasons. (shrink)

Excerpt: 1. Introduction This chapter provides insight into the diverse ethical debates on genetics and epigenetics. Much controversy surrounds debates about intervening into the germline genome of human embryos, with catchwords such as genome editing, designer baby, and CRISPR/Cas. The idea that it is possible to design a child according to one’s personal preferences is, however, a quite distorted view of what is actually possible with new gene technologies and gene therapies. These are much more limited than the editing and (...) design metaphors suggest. Such metaphors are therefore highly problematic phrases in the context of new gene technologies, for two reasons. On one hand, to design a child of choice by modifying the genome would require modifying any gene of choice, which is more than can be done with current gene technologies, such as CRISPR/Cas. On the other hand, a modification of genes would need to be enough to create any characteristic of choice in the future child. The latter presupposes the assumption of genetic determinism. Moreover, the CRISPR/Cas technology can not only be used in a potentially therapeutic manner at the germline level. In addition, there is the (more likely) scenario of a future clinical therapeutic use of these new gene technologies for modifying the DNA sequence of other cells of the body (somatic genome editing). There is also the option of modifying the epigenome, that is, the spatial configuration of DNA (epigenome editing) (see table 1). Like genetics and genome editing, epigenetics has been at the center of recent popular scientific and ethical discourse as well as scientific debates. The concept of epigenetics has given rise to very different notions of inheritability and responsibility for health, which, however, are oftentimes based on scientifically controversial basic assumptions. That there continues to be covert genetic determinism in the form of epigenetic determinism (see table 2) in debates about epigenetics has been pointed out in ethical analyses of epigenetics. Neither genetic determinism nor epigenetic determinism has been confirmed scientifically. It is therefore important to recognize the concepts that are discussed (and sometimes harshly criticized) in debates about genome editing and epigenetics—for example, concepts about the causal role of DNA for our own life course. This importance is based on the fact that if we understand such controversial concepts, we will be able to remain critical when evaluating scientific knowledge and ethical arguments about genome editing and epigenetics. This chapter, therefore, explains some of these concepts. For an ethical analysis of epigenetics as well as of genome editing, it is necessary to understand and critically reflect upon the underlying concepts of genetic determinism and other, related -isms. The following section offers a detailed introduction to these -isms (section 2; see also table 2). Section 3 provides an ethical analysis of genome editing and epigenetics based on the explanations in section 2. Section 3 focuses on inheritability and responsibility, justice, safety, the problem of consent, and the effects of genome editing and epigenetics on embryos and future generations. This section does not discuss in detail further points that can be found in ethical debates about epigenetics as well as in ethical debates about genome editing. These points include (among others): • fear that the findings of epigenetics and that the methods of genome editing are misused—this also with respect to eugenics and enhancement; • naturalness—an issue we mention in passing a few times in the following analysis; • a possible connection between the genome/epigenome and the concept of human dignity, and the derived danger of instrumentalization and infringement of autonomy when intervening in the genome or epigenome. Since current discourse about ethical issues associated with genome editing focuses mainly on germline interventions, which are, for instance, interventions into a human embryo’s genome, we mainly focus on germline interventions when comparing the debates on genome editing and on epigenetics in section 3. (shrink)

There is too much that we do not know about COVID-19. The longer we take to find it out, the more lives will be lost. In this paper, we will defend a principle of risk parity: if it is permissible to expose some members of society (e.g. health workers or the economically vulnerable) to a certain level of ex ante risk in order to minimize overall harm from the virus, then it is permissible to expose fully informed volunteers to a (...) comparable level of risk in the context of promising research into the virus. We apply this principle to three examples of risky research: skipping animal trials for promising treatments, human challenge trials to speed up vaccine development, and low-dose controlled infection or “variolation.” We conclude that if volunteers, fully informed about the risks, are willing to help fight the pandemic by aiding promising research, there are strong moral reasons to gratefully accept their help. To refuse it would implicitly subject others to still graver risks. (shrink)

Background: Patient participation in clinical ethics support services has been marked as an important issue. There seems to be a wide variety of practices globally, but extensive theoretical or empirical studies on the matter are missing. Scarce publications indicate that, in Europe, patient participation in CESS varies from region to region, and per type of support. Practices vary from being non-existent, to patients being a full conversation partner. This contrasts with North America, where PP seems more or less standard. (...) While PP seems to be on the rise in Europe, there is no data to confirm this. This study sought a deep understanding of both habits and the attitudes towards PP in the Netherlands, including respondents’ practical and normative perspectives on the matter. Methods and Results: We developed a national survey on PP for Dutch CESS staff. Our survey comprised a total of 25 open and close-ended questions, focused on four topics related to PP goals of CESS, status quo of PP, ideas and ideals concerning PP, and obstacles for PP. Discussion: The four most important findings were that: Patient participation in Dutch CESS is far from standard. Views on patient participation are very much intertwined with the goals of ethics support. Hesitations, fears and perceived obstacles for PP were not on principle and Most respondents see PP as a positive opportunity, yet requiring additional training, practical guidance and experience. Conclusions: Various normative reasons require PP. However, PP seems far from standard and somewhat rare in Dutch CESS settings. Our respondents did not raise many principled objections to PP. Instead, reasons for the lack of PP are intertwined with viewpoints on the goals of CESS, which seemingly focus on supporting health care professionals. Training and practical guidance was thought to be helpful for gaining experience for both CESS staff and HCPs. (shrink)

Medical assistance in dying, which includes voluntary euthanasia and assisted suicide, is legally permissible in a number of jurisdictions, including the Netherlands, Belgium, Switzerland and Canada. Although medical assistance in dying is most commonly provided for suffering associated with terminal somatic illness, some jurisdictions have also offered it for severe and irremediable psychiatric illness. Meanwhile, recent work in the philosophy of psychiatry has led to a renewed understanding of psychiatric illness that emphasises the role of the relation between the person (...) and the external environment in the constitution of mental disorder. In this paper, I argue that this externalist approach to mental disorder highlights an ethical challenge to the practice of medical assistance in dying for psychiatric illness. At the level of the clinical assessment, externalism draws attention to potential social and environmental interventions that might have otherwise been overlooked by the standard approach to mental disorder, which may confound the judgement that there is no further reasonable alternative that could alleviate the person’s suffering. At the level of the wider society, externalism underscores how social prejudices and structural barriers that contribute to psychiatric illness constrain the affordances available to people and result in them seeking medical assistance in dying when they otherwise might not have had under better social conditions. (shrink)

Philosophers of science and medicine now aspire to provide useful, socially relevant accounts of mechanism. Existing accounts have forged the path by attending to mechanisms in historical context, scientific practice, the special sciences, and policy. Yet, their primary focus has been on more proximate issues related to therapeutic effectiveness. To take the next step toward social relevance, we must investigate the challenges facing researchers, clinicians, and policy makers involving values and social context. Accordingly, we learn valuable lessons about the connections (...) between mechanistic processes and more fundamental reasons for medical interventions, particularly moral, ethical, religious, and political concerns about health, agency, and power. This paper uses debates over the controversial morning-after pill to gain insight into the deeper reasons for the production and use of mechanistic knowledge throughout biomedical research, clinical practice, and governmental regulation. To practice socially relevant philosophy of science, I argue that we need to account for mechanistic knowledge beyond immediate effectiveness, such as how it can also provide moral guidance, aid ethical categorization in the clinic, and function as a political instrument. Such insights have implications for medical epistemology, including the value-laden dimensions of mechanistic reasoning and the “epistemic friction” of values. Furthermore, there are broader impacts for teaching research ethics and understanding the role of science advisors as political advocates. (shrink)

A long-standing puzzle for moral philosophers and psychologists alike is the concept of psychopathy, a personality disorder marked by tendencies to defy moral norms despite cognitive knowledge about right and wrong. Previously, discussions of the moral deficits of psychopathy have focused on willingness to harm and cheat others as well as reasoning about rule-based transgressions. Yet recent research in moral psychology has begun to more clearly define the domains of morality, en- compassing issues of harm, fairness, loyalty, authority, and (...) spiritual purity. Clinical descriptions and theories of psychopathy suggest that deficits may exist primarily in the areas of harm and fairness, although quantitative evidence is scarce. Within a broad sample of participants, we found that scores on a measure of psychopathy predicted sharply lower scores on the harm and fairness subscales of a measure of moral concern, but showed no relationship with authority, and very small relationships with ingroup and purity. On a measure of willingness to violate moral standards for money, psychopathy scores predicted greater willingness to violate moral concerns of any type. Results are further explored via potential mediators and analyses of the two factors of psychopathy. (shrink)

In the debates regarding the ethics of human organoid biobanking, the locus of donor autonomy has been identified in processes of consent. The problem is that, by focusing on consent, biobanking processes preclude adequate engagement with donor autonomy because they are unable to adequately recognise or respond to factors that determine authentic choice. This is particularly problematic in biobanking contexts associated with organoid research or the clinical application of organoids because, given the probability of unforeseen and varying purposes for (...) which a donor’s organoids could be employed and given the different ways in which a donor can relate to her biospecimens, a donor can value her organoids differently in different contexts and her reasons for autonomously permitting use of her cells and tissues in one case may not support an autonomous decision in another. In response, this paper has three aims: firstly, to make the case for why organoid biobanks ought to respect donor autonomy conceived as authentic choice; secondly, to explore the autonomy-respecting limits of established and widely prevalent models of biobank consent; and thirdly, to propose certain conditions that organoid biobanks ought to support or facilitate in order to respect donor autonomy. (shrink)

The problem of standard of care in clinical research concerns the level of treatment that investigators must provide to subjects in clinical trials. Commentators often formulate answers to this problem by appealing to two distinct types of obligations: professional obligations and natural duties. In this article, I investigate whether investigators also possess institutional obligations that are directly relevant to the problem of standard of care, that is, those obligations a person has because she occupies a particular institutional role. (...) I examine two types of institutional contexts: (1) public research agencies – agencies or departments of states that fund or conduct clinical research in the public interest; and (2) private-for-profit corporations. I argue that investigators who are employed or have their research sponsored by the former have a distinctive institutional obligation to conduct their research in a way that is consistent with the state's duty of distributive justice to provide its citizens with access to basic health care, and its duty to aid citizens of lower income countries. By contrast, I argue that investigators who are employed or have their research sponsored by private-for-profit corporations do not possess this obligation nor any other institutional obligation that is directly relevant to the ethics of RCTs. My account of the institutional obligations of investigators aims to contribute to the development of a reasonable, distributive justice-based account of standard of care. (shrink)

In this article, I ask whether a principle analogous to the principle of clinical equipoise should govern the design and conduct of RCTs evaluating the effectiveness of policy interventions. I answer this question affirmatively, and introduce and defend the principle of policy equipoise. According to this principle, all arms of a policy RCT must be, at minimum, in a state of equipoise with the best proven policy that is also morally and practically attainable and sustainable. For all arms of (...) a policy RCT, policy experts must either reasonably disagree about whether the trial arms are more effective than this policy, or know that they are. (shrink)