This book explores the ethical implications of managing uncertainty in clinical decision-making during the COVID-19 pandemic. It develops an ethics of clinical uncertainty that brings together insights from the clinical and biomedical ethical literatures. The book sets out to recognize the central role uncertainty plays in clinical decision-making and to acknowledge the different levels, kinds, and dimensions of clinical uncertainty. It also aims to aid clinicians and patients in managing clinical (...) uncertainty, and to recognize the ethical duty they have to manage clinical uncertainty. The book addresses four ethical duties related to clinical uncertainty: (1) the duty to advance the welfare of those in clinical medicine, (2) to respect the rights of those in clinical medicine, (3) to promote just access to health care, and (4) to care for one another in clinical medicine. These duties took on select urgency during the COVID-19 pandemic because clinical risk assessments about COVID-19 were limited, we were asked to give informed consent in the context of limited and changing knowledge, the pandemic unearthed myriad problems about the distribution of health care, and the pandemic raised questions about how we care for each other in medicine. An Ethics of Clinical Uncertainty will appeal to scholars, advanced students, and medical professionals working in philosophy of medicine, biomedical ethics, clinical medicine, nursing, public health care, and gerontology. (shrink)

Evolutionary medicine (EM) is an emerging field of medical studies that uses evolutionary theory to explain the ultimate causes of health and disease. The field’s main objective is to reconceptualize bodily vulnerabilities and pathophysiologies as evolutionary tradeoffs—many the result of an evolutionary mismatch between our ancient genome and modern lifestyle. This conceptual shift allows EM to describe health and disease in terms of adaptive functions and to prescribe treatments that best complement our evolved bodies. The goal is to “transform the (...) way patients and doctors see disease” (Nesse and Williams 1994, p. 245) in order to harness a renewed “feeling for the organism as a product of natural selection” .. (shrink)

: Bioethicists have articulated an ideal of shared decision making between physician and patient, but in doing so the role of clinical uncertainty has not been adequately confronted. In the face of uncertainty about the patient's prognosis and the best course of treatment, many physicians revert to a model of nondisclosure and nondiscussion, thus closing off opportunities for shared decision making. Empirical studies suggest that physicians find it more difficult to adhere to norms of disclosure in situations (...) where there is substantial uncertainty. They may be concerned that acknowledging their own uncertainty will undermine patient trust and create additional confusion and anxiety for the patient. We argue, in contrast, that effective disclosure will protect patient trust in the long run and that patients can manage information about uncertainty. In situations where there is substantial uncertainty, extra vigilance is required to ensure that patients are given the tools and information they need to participate in cooperative decision making about their care. (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)

A probabilistic explication is offered of equipoise and uncertainty in clinical trials. In order to be useful in the justification of clinical trials, equipoise has to be interpreted in terms of overlapping probability distributions of possible treatment outcomes, rather than point estimates representing expectation values. Uncertainty about treatment outcomes is shown to be a necessary but insufficient condition for the ethical defensibility of clinical trials. Additional requirements are proposed for the nature of that uncertainty. (...) The indecisiveness of our criteria for cautious decision-making under uncertainty creates the leeway that makes clinical trials defensible. (shrink)

The evidence-based practice and evidence-based medicine movements have promoted standardization through guideline development methodologies based on systematic reviews and meta-analyses of best available research. EBM has challenged clinicians to question their reliance on practical reasoning and clinical judgement. In this paper, we argue that the protagonists of EBM position their mission as reducing uncertainty through the use of standardized methods for knowledge evaluation and use. With this drive towards uniformity, standardization and control comes a suspicion towards intuition, creativity (...) and uncertainty as integral parts of medical practice. We question the appropriateness of attempts to standardize professional practice through a discussion of the importance of uncertainty. Greenhalgh’s taxonomy of uncertainty is used to inform an analysis of the clinical reasoning occurring in a potentially life threatening emergency situation with a young patient. The case analysis is further developed by the use of the Canadian philosopher Bernard Lonergan’s theory about understanding and objective knowing. According to Lonergan it is not by getting rid of or even by reducing uncertainty, but by attending systematically to it and by relating to it in a self-conscious way, that objective knowledge can be obtained. The paper concludes that uncertainty is not a regrettable and unavoidable aspect of decision making but a productive component of clinical reasoning. (shrink)

This paper introduces taxonomy of clinical uncertaintes and argues that the choice of scientific method should match the underlying level of uncertainty. Clinical trial is one of these methods aiming to resolve clinical uncertainties. Whenever possible these uncertainties should be quantified. The paper further shows that the still ongoing debate about the usage of "equipoise" vs. "uncertainty principle" vs. "indifference" as an entry criterion to clinical trials actually refers to the question "whose uncertainty (...) counts". This question is intimately linked to the control of research agenda, which is not quantifiable and hence is not solvable to equal acceptability to all interested parties. The author finally shows that there is a predictable relation between [acknowledgement of] uncertainty (the moral principle) on which trials are based and the ultimate outcomes of clinical trials. That is, [acknowledgement of] uncertainty determines a pattern of success in medicine and drives clinical discoveries. (shrink)

The concept of equipoise is considered by many to be part of the ethical justification for using human subjects in clinical research. In general, equipoise indicates some uncertainty about the relative merits of the experimental intervention compared to existing treatments. Relieving this uncertainty gives scientific value to an experiment, thereby making the risks to human subjects in the trial acceptable, other considerations notwithstanding. But characterizing equipoise remains controversial since Freedman’s groundbreaking publication on the subject. We offer a (...) new account of equipoise that draws on and extends an option Freedman discarded. After establishing the importance of some account of equipoise as part of ethically justified clinical trials, we revisit Freedman’s distinction between clinical and theoretical equipoise. We raise concerns about Freedman’s preferred clinical equipoise and then rehabilitate theoretical equipoise. In particular, we use a variety of arguments from epistemology to show how Freedman was too hasty in rejecting theoretical equipoise. In addition, we argue that theoretical equipoise is a subspecies of epistemic equipoise, which we characterize as a form of uncertainty that is the result of the possibility of error. This type of uncertainty can best be alleviated by research, which produces beliefs supported by strong statistical evidence, which is a key aim of clinical trials. Further, this type of uncertainty can explain why even clinicians with more firsthand experience with an intervention than their peers, and who may not be in theoretical equipoise, could still justifiably support a trial designed to ameliorate the possibility of error due to cognitive bias. (shrink)

This qualitative social scientific interview study delves into the ways in which professional vision is constructed in clinical ethics consultation (CEC). The data consist of 11 semi-structured interviews that were conducted with clinical ethics consultants currently working in hospitals in one major urban area in the U.S. The interviews were analyzed with the qualitative research method of critical discourse analysis, with a focus on identifying the cultural structures of knowledge that shape CEC as a professional practice. The discourses (...) were first identified as belonging to two higher discourse categories, order and agency. Order was divided into three lower categories, emotional, managerial, and rational order, and discourses of agency into the lower categories of exploration, technique, deliberation, and distancing. An additional discourse of neutral interaction was identified as a bridging discourse, activated to level tensions emerging out of conflicting goals and agencies embedded in CEC practice. This analysis brings out as its main observation that clinical ethics consultants draw on and shift between potentially ideologically conflicting social positions that can create built-in tensions within the professional domain. The study calls attention to these tensions and suggests for the professional group to discuss the possibility of defining priorities between different kinds of order, identified in this study, that shape the CEC domain. (shrink)

Ethical justification for clinical research may invoke equipoise, an element of scientific uncertainty regarding the superior choice if presented with different therapeutic options. Given a relativ...

ABSTRACT:The judgments of conscientious and informed experts play a central role in two elements of clinical equipoise. The first, and most widely discussed, element involves ensuring that no participant in a randomized trial is allocated to a level of treatment that everyone agrees is substandard. The second, and less often discussed, element involves ensuring that trials are likely to generate social value by producing the information necessary to resolve a clinically meaningful uncertainty or disagreement about the relative merits (...) of a set of interventions. The distribution of judgments in expert communities can take many forms, each with important implications for whether a trial satisfies one or both elements of clinical equipoise. In this article we use a graphical approach to represent three ways in which expert community uncertainty can vary: by spread, modality, and skew. Understanding these different distributions of expert judgment has three important implications: it helps to make operational the requirement of social value, it shows that some conditions for initiating studies to promote social value diverge from common assumptions about clinical equipoise, and it has important implications for how trials should be designed and monitored, and what patients should be told during informed consent. (shrink)

Working retrospectively in an uncertain field of knowledge, physicians are engaged in an interpretive practice that is guided by couterweighted, competing, sometimes paradoxical maxims. When you hear hoofbeats, don't think zebras, is the chief of these, the epitome of medicine's practical wisdom, its hermeneutic rule. The accumulated and contradictory wisdom distilled in clinical maxims arises necessarily from the case-based nature of medical practice and the narrative rationality that good practice requires. That these maxims all have their opposites enforces in (...) students and physicians a practical skepticism that encourages them to question their expectations, interrupt patterns, and adjust to new developments as a case unfolds. Yet medicine resolutely ignores both the maxims and the tension between the practical reasoning they represent and the claim that medicine is a science. Indeed, resolute epistemological naivete is part of medicine's accommodation to uncertainty; counterweighted, competing, apparently paradoxical (but always situational) rules enable physicians simultaneously to express and to ignore the practical reason that characterizes their practice. (shrink)

The brief article deals with the following questions: Was the adaptive toolbox of heuristics ecologically rational and specifically accurate in the initial stages of COVID-19, which was characterized by epistemic uncertainty? In other words, in dealing with COVID-19 did the environmental structural variables allow the success of a given heuristic strategy?

It is well-recognized that uncertainty is an endemic feature and limitation of clinical judgment and practice that cannot be eliminated in many cases. Among the tasks of clinical ethics is the responsible management of uncertainties, first articulated in E. Haavi Morreim’s very nice concept of the "moral management of medical uncertainty." The papers in the 2012 Clinical Ethics issue of the Journal provide philosophically innovative and clinically applicable accounts of the varieties of uncertainty in (...) clinical medicine and therefore in clinical ethics: epistemic uncertainty, metaphysical uncertainty, and relational uncertainty. (shrink)

It can be argued that there is an ethical requirement to classify correctly what is known and what is unknown in decision situations, especially in the context of biomedicine when risks and benefits have to be assessed. This is because other methods for assessing potential harms and benefits, decision logics and/or ethical principles may apply depending on the kind or degree of uncertainty. However, it is necessary to identify and describe the various epistemic states of uncertainty relevant to (...) such estimates in the first place. Therefore, this paper aims to develop a category system of different epistemic states of uncertainty which, although not exclusively, is primarily intended to be applied to early clinical trials. It is formed on the basis—and various combinations—of three dimensions of uncertainty that represent certain parts of incomplete knowledge: outcome (type of event), probability (of outcome) and evaluation (assessment of outcome). Furthermore, it is argued that uncertainty can arise from three different sources (the structure of the object of research, the state of the evidence, or individual handling of the research and already existing knowledge). The categories developed are applied to actual examples from gene therapy and genome editing to illustrate that they can be helpful for a more precise definition of the respective uncertainties, especially in the context of risk–benefit assessment. The categories allow a differentiated perspective of decision-making situations from the point of view of incomplete knowledge in general, but particularly, for example, in early clinical research, and may thereby support a more acceptable ethical assessment of potential harms and benefits. (shrink)

We propose extrapolating Conviction Narrative Theory (CNT) to clinical psychology and psychiatry. We demonstrate how CNT principles may benefit assessment, therapy, and possibly even modify public health views of neuropsychiatric disorders. Our commentary focuses on hoarding disorder as a model, elaborates on discrepancies in the scientific literature and suggests how the CNT may resolve them.

The invisibility of nursing work has been discussed in the international literature but not in relation to learning clinical skills. Evans and Guile's (Practice‐based education: Perspectives and strategies, Rotterdam: Sense, 2012) theory of recontextualisation is used to explore the ways in which invisible or unplanned and unrecognised learning takes place as newly qualified nurses learn to delegate to and supervise the work of the healthcare assistant. In the British context, delegation and supervision are thought of as skills which are (...) learnt “on the job.” We suggest that learning “on‐the‐job” is the invisible construction of knowledge in clinical practice and that delegation is a particularly telling area of nursing practice which illustrates invisible learning. Using an ethnographic case study approach in three hospital sites in England from 2011 to 2014, we undertook participant observation, interviews with newly qualified nurses, ward managers and healthcare assistants. We discuss the invisible ways newly qualified nurses learn in the practice environment and present the invisible steps to learning which encompass the embodied, affective and social, as much as the cognitive components to learning. We argue that there is a need for greater understanding of the “invisible learning” which occurs as newly qualified nurses learn to delegate and supervise. (shrink)

While uncertainty can never be totally eliminated from clinical practice, physicians can at least come to terms with it. In interviews with Canadian physicians in a variety of clinical settings, three sources of uncertainty affecting the allocation of medical resources were identified. Technical uncertainty arises from inadequate scientific data. Personal uncertainty arises from not knowing patients' wishes. Conceptual uncertainty arises from the problem of applying abstract criteria to concrete situations.

This paper uses chronic beryllium disease as a case study to explore some of the challenges for decision-making and some of the problems for obtaining meaningful informed consent when the interpretation of screening results is complicated by their probabilistic nature and is clouded by empirical uncertainty. Although avoidance of further beryllium exposure might seem prudent for any individual whose test results suggest heightened disease risk, we will argue that such a clinical precautionary approach is likely to be a (...) mistake. Instead, advice on the interpretation of screening results must focus not on risk per se, but on avoidable risk, and must be carefully tailored to the individual. These points are of importance for individual decision-making, for informed consent, and for occupational health. (shrink)

In light of recent advances in machine learning for medical applications, the automation of medical diagnostics is imminent. That said, before machine learning algorithms find their way into clinical practice, various problems at the epistemic level need to be overcome. In this paper, we discuss different sources of uncertainty arising for clinicians trying to evaluate the trustworthiness of algorithmic evidence when making diagnostic judgments. Thereby, we examine many of the limitations of current machine learning algorithms (with deep learning (...) in particular) and highlight their relevance for medical diagnostics. Among the problems we inspect are the theoretical foundations of deep learning (which are not yet adequately understood), the opacity of algorithmic decisions, and the vulnerabilities of machine learning models, as well as concerns regarding the quality of medical data used to train the models. Building on this, we discuss different desiderata for an uncertainty amelioration strategy that ensures that the integration of machine learning into clinical settings proves to be medically beneficial in a meaningful way. (shrink)

In the case that triggered this round-table discussion there are three separate factors that contribute to moral uncertainty.1 First, the infant, baby T, is extremely premature with suspected brain injury and potentially poor prognosis. Second, the gestational mother is critically unwell herself and her outlook is guarded. Third, as linked commentaries make clear, the legal status of the intended parents is complex and ambiguous.2 3 Any of these factors on their own would be enough to generate ethical complexity and (...) distress in the neonatal intensive care unit. The combination of the three is likely to be highly stressful for all concerned.4 Commentaries on the case emphasise the complex legal questions and the potential need to involve the court. One resource that is not mentioned is the potential value of clinical ethics input in such a case. This is complementary to the need for legal advice. Its aim would be to help think through the specifically ethical, rather than legal questions. There are several things that I would aim to clarify if chairing a clinical ethics discussion on the case. First, it may be useful to draw on the concept of the …. (shrink)

The model of clinical ethics consultation (CEC) defended in the ASBH Core Competencies report has gained significant traction among scholars and healthcare providers. On this model, the aim of CEC is to facilitate deliberative reflection and thereby resolve conflicts and clarify value uncertainty by invoking and pursuing a process of consensus building. It is central to the model that the facilitated consensus falls within a range of allowable options, defined by societal values: prevailing legal requirements, widely endorsed organizational (...) policies, and professional standards of practice and codes of conduct. Moreover, the model stipulates that ethics consultants must refrain from giving substantive recommendations regarding how parties to a moral disagreement in the clinic should evaluate their options. We argue that this model of CEC is incomplete, because it wrongly assumes that what counts as the proper set of allowable options among which the parties are to deliberate will itself always be clearly discernible. We illustrate this problem with a recent case on which one of us consulted—a neonate born with trisomy 18 (T18). We try to show that law, policy, and standards of practice reveal no clear answer to the question posed by the case: namely, whether forgoing gastrostomy tube feedings for a baby with T18 is allowable. We suggest there may be other kinds of cases in which it may simply be unsettled whether a given choice falls within the set of allowable options within which consensus is to be facilitated. What should an ethicist do when confronting such unsettled cases? We agree with the facilitation model that an ethicist should remain neutral among the allowable options, when it is clear what the allowable options are. But, in unsettled cases, the role of a consultant should be expanded to include a process of moral inquiry into what the allowable options should be. We end by raising the issue of whether this means an ethicist should share his or her own conclusions or views about the allowability of a given clinical option. (shrink)

Background: International developments suggest that providing clinical ethics services to help clinicians negotiate ethical issues that arise in clinical practice is beneficial and reflects best practice in promoting high ethical standards and patient-centered care. The aim of this study was to explore the needs and experiences of clinical staff members to inform the development of future clinical ethics support. Methods: Health professionals at a large regional health service completed an online survey containing questions about the frequency (...) of ethical and legal issues encountered in clinical practice, the type of situations that gave rise to the ethical and/or legal uncertainty or concern, how clinicians currently address these issues, and what support would be welcome. Results: The survey was completed by 369 staff members, including 61% with more than 10 years in the profession and 51% in nursing/midwifery. Two-thirds (66%) indicated they often considered ethical implications of their clinical decisions, and half (49%) often considered the legal implications. More than half (58%) were often/occasionally concerned about the ethically right thing to do. Patient requests for borderline treatment (47%), staff disagreements about patient care (48%), and patients declining recommended treatment (54%) were the most frequent reasons given for ethical or legal uncertainty. Sixty-nine percent of respondents indicated that the way their department addressed ethical issues could be improved and 85% agreed that there is a need for more discussion on ethical issues. The majority (82%) of respondents had encountered ethically challenging clinical situations where additional support would have helped. Common approaches to issues were discussion with colleagues/supervisor (91.1%), discussion at handover/group forums (50.8%), and consultation with guidelines/protocols (60.9%). Conclusions: A majority of clinical staff members surveyed have encountered ethically/legally challenging cases daily for which they have often sought additional advice. This study indicates that many clinical staff members would welcome some form of additional clinical ethics support including advice and education. (shrink)

Many clinical ethics services issue recommendations about ethical controversies that arise in patient care. Their role is configured to be arbiters of moral permissibility, rendering verdicts on which option of those available constitute the morally superior course of action. They produce moral judgements on questions, such as: Should dialysis be started or foregone? Should life-sustaining care be withdrawn or continued? Is it permissible for the clinician to refuse a course of treatment desired by a particular patient or family? But (...) decisions in such cases presume a type of expertise that ethics consultants do not plausibly possess: i.e., the insight to know whose values – which ethical priorities – should trump in situations that are morally ambiguous and normatively contested. This is especially worrisome against the backdrop of the values-pluralism that exists in diverse, heterogeneous societies. This kind of authoritative response to moral uncertainty teeters on hubris, and can have a profoundly negative impact on the lives touched by these decisions. This chapter will argue that the moral arrogance that stems from a conviction of expertise is one of the gravest dangers of contemporary clinical ethics consultation. (shrink)

Generalized anxiety disorder is among the world’s most prevalent psychiatric disorders and often manifests as persistent and difficult to control apprehension. Despite its prevalence, there is no integrative, formal model of how anxiety and anxiety disorders arise. Here, we offer a perspective derived from the free energy principle; one that shares similarities with established constructs such as learned helplessness. Our account is simple: anxiety can be formalized as learned uncertainty. A biological system, having had persistent uncertainty in its (...) past, will expect uncertainty in its future, irrespective of whether uncertainty truly persists. Despite our account’s intuitive simplicity—which can be illustrated with the mere flip of a coin—it is grounded within the free energy principle and hence situates the formation of anxiety within a broader explanatory framework of biological self-organization and self-evidencing. We conclude that, through conceptualizing anxiety within a framework of working generative models, our perspective might afford novel approaches in the clinical treatment of anxiety and its key symptoms. (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)

One of the most important questions in the ethics of human clinical research asks what obligations investigators owe the people who enroll in their studies. Research differs in many ways from standard care - the added uncertainties, for instance, and the nontherapeutic interventions such as diagnostic tests whose only purpose is to measure the effects of the research intervention. Hence arises the question whether a physician engaged in clinical research has the same obligations toward research subjects that he (...) owes his medical patients, or whether they differ in any fundamental way.Perhaps the most common answer is that the relationship is the same. Investigators, like physicians, are said to be fiduciaries of the volunteers who enroll in research trials. Each owes the best available medical care, which means that a physician can only justify enrolling his patient in research if the study meets the requirements of clinical equipoise, namely, that there is legitimate disagreement within the medical community as to whether the standard treatment or the investigational intervention is superior. (shrink)

One of the most important questions in the ethics of human clinical research asks what obligations investigators owe the people who enroll in their studies. Research differs in many ways from standard care - the added uncertainties, for instance, and the nontherapeutic interventions such as diagnostic tests whose only purpose is to measure the effects of the research intervention. Hence arises the question whether a physician engaged in clinical research has the same obligations toward research subjects that he (...) owes his medical patients, or whether they differ in any fundamental way.Perhaps the most common answer is that the relationship is the same. Investigators, like physicians, are said to be fiduciaries of the volunteers who enroll in research trials. Each owes the best available medical care, which means that a physician can only justify enrolling his patient in research if the study meets the requirements of clinical equipoise, namely, that there is legitimate disagreement within the medical community as to whether the standard treatment or the investigational intervention is superior. (shrink)

Negotiating clinical knowledge: a field study of psychiatric nurses’ everyday communication Nursing practices at psychiatric hospitals have changed significantly over the last decades. In this paper, everyday nursing practices were interpreted in light of these institutional changes. The objective was to examine how mental health nurses’ production of clinical knowledge was influenced by the particular social relations on hospital wards. Empirical data stemming from an extended fieldwork at two Danish psychiatric hospital wards were interpreted using interactionistic theory and (...) the metaphor: ‘the game of clinical knowledge’. The results indicated that the nurses’ production of clinical knowledge was highly dependent on the individual nurses’ practical ability to participate in the game. Furthermore, the nurses colluded in their mutual communication to enable the collective display and sense of knowing that protected them against explicit signs of uncertainty about the clinic. The game of clinical knowledge influenced processes of clinical decision‐making among the nurses as the game added to a distorted widening of a ‘fictional distance’ between patients and the representations produced by the nurses. (shrink)

No matter how far medicine advances, incurable disease will inevitably exist; and the dying patient's last resort will likewise look to medical research. In this report, we examine a case concerning the use of experimental medical therapy on a critically ill child. We discuss the ethical argument pertaining to the recommending of experimental medical therapy to the family of a dying patient.Under the circumstances of having to face the impending death of one's own child, parents of a terminally ill child (...) are extremely vulnerable to suggestion and often loose the ability to make a composed decision._Moreover, there exists the possibility of not only patients, but also medical staff and researchers, to fall into therapeutic misconception. Likewise, for the terminal patient and his/her family though, experimental medical therapy is often the only hope, which is, however, always accompanied by a factor of uncertainty and is considered to be merely an unapproximated gamble. The proposing of experimental medical therapy can result in being cruel by shattering the parent's expectations of saving their child._We examine the issues involved in proposing an experimental medical therapy to patients who are in dire need of a last hope; and conclude that, in times of emergency, we must take great consideration in recommending an experimental medical therapy as an "innovative treatment." In extreme circumstances where an individual's life is on the line, doing nothing can be quite trying; yet, what is right is not necessarily doing something, but rather making the right decision. (shrink)

Aims and objectivesTo qualitatively explore COVID-19-related experiences of mothers of preterm infants in the Neonatal Intensive Care Unit, the main challenges they face, and the resources available for them.BackgroundThe birth of a preterm infant is a stressful event under otherwise normal circumstances. The outbreak of COVID-19, the uncertainty about the virus and how it spreads, and the restrictions imposed, may have exacerbated the stress of caring for a preterm infant.DesignRetrospective interviews.MethodsIn-depth interviews with 12 mothers of preterm infants who were (...) hospitalized in the NICU at the time of study. The interview addressed challenges and resources related to coping with the pandemic. The interviews were transcribed and content analyzed, based on Lieblich et al’s model for narrative analysis. This research was conducted in accordance with the COREQ checklist.ResultsThe overarching experience shared by all mothers was accumulative stress caused by a combination of factors related to the infant’s health and COVID-19-related stressors. A central theme was the dissonance between the mothers’ expectations from the birth and infant, and the reality they encountered. Other themes included fear of infecting the infant, loneliness, and stress caused by the restrictions that disrupted daily routines. Resources included a sense of shared fate regarding the pandemic, improvements in the infant’s condition, religious faith, emotional support from the partner, and support from professional staff.ConclusionCaring for a preterm infant during a pandemic is a challenging experience on many levels. The loss of significant support resources puts mothers of these infants at a higher risk for psychological distress.Relevance to clinical practiceAwareness of mothers’ accumulative stress due to the COVID-19 pandemic may assist the staff in developing procedures that can alleviate parental stress, for example by enabling mothers to connect to each other, giving clear information to compensate for physical and social distancing and providing professional mental health support. (shrink)

Forensic psychiatry is pervaded by moral dilemmas. Although professionals in forensic psychiatry are trained in law and psychiatry and are certainly aware of ethical issues in the care for patients, they tend to make decisions in an implicit way and not to discuss their moral concerns or doubts. More structural attention for ethics seems to be required. In this paper, we show the value of moral case deliberation in forensic psychiatry. Moral case deliberation is a specific kind of clinical (...) ethics support in which healthcare professionals discuss a moral issue from practice in a structured way, facilitated by an ethicist or specifically trained facilitator. It is applicable to a wide array of situations in healthcare practice. In contrast to other models of clinical ethics support, such as individual consultation, the focus is on the moral experience of professionals and using a structured method to foster dialog and joint moral learning. In this paper, an example of case on a forensic ward is presented. The case shows that moral case deliberation leads to reflection on values and stimulates openness and honesty regarding uncertainties. Moreover, the deliberation provides room for new insights and creates a basis for a joint decision on how to proceed further, recognizing the tensions and difficulties involved. (shrink)

Something is not working in ethics consultation: in certain situations, relationships within families and with careproviders and surrogates have become so emotionally charged and destabilized that attention is dominated by conflict and misunderstanding, foreshadowing a loss of dignity and hope. In a compelling, urgent article, informed by events in the Schiavo case, with examples from the literature on theory, practice, and outcomes, Caplan and Bergman address this situation: redirecting our attention to what they see as “a lack of effective mechanisms” (...) for dealing with a “painful class of disputes in which families disagree with one another, or with doctors, about the care of those who cannot communicate.”1 It is no small matter that many of these cases are situated in the immediate, intense environment of end-of-life decision making. -/- How might we understand these encounters, and their limits? What can we hope? Following the tack of Caplan and Bergman, I will extend the discussion of the complex relationships between patients, families, surrogates, and physicians, and “hope for consensual resolution,” offering a somewhat different account of what is lacking. While Caplan and Bergman foreground an apparent irreconcilability of appeals to competing biomedical principles as what is lacking, I will suggest that a “salient characteristic” among participants, what Caplan and Bergman identify as a common concern for the patient’s best interests, may be far less stable and more complex, and thereby less directive, than first imagined. When Caplan and Bergman sketch their expectations for mediation and for mediators, they are right in noting that abstract principles “articulated as dispositive by designated ‘experts’ fail to capture, and arguably respect, the unique and complex nature of each such individual decision-making process,” and that “patients and families are at the extreme end of a power imbalance.” It is less clear that their descriptions — or their hope for mediation — capture this enormous challenge. (shrink)

The quest for effective medicines is very old. In modern times two important tools have been developed to evaluate efficacy of drugs: superiority and non-inferiority types of clinical trials. The former tests the null hypothesis of μ (the difference between a tested drug and comparator) ≤ 0 against μ > 0; the latter tests the null hypothesis of μ ≤ - Δ against, μ > - Δ, where Δ is the clinical difference from the comparator. In a superiority (...) trial, a new drug is tested against a placebo; in a non-inferiority trial, a new drug is tested against active treatment. In this paper, arguments are presented to show that a superiority trial against a placebo is scientifically sound but ethically unacceptable, whereas a non-inferiority trial against active treatment is ethically sound but scientifically not reliable. Switching from a superiority type of trial with placebo to a non-inferiority trial with an active-control — following the latest revision of Declaration of Helsinki — is in practice switching from the violation of the uncertainty principle to uncertainty of results. Given human and financial resources, it appears an academic question as to which is more unethical: to violate patients’ rights or to produce results without scientific value. All presented considerations lead to the conclusion that the use of a superiority trial of design with an active control instead of placebo will satisfy scientific needs, expectation of patients, and the ancient quest for effective medicines. In the era of Good (Clinical, Laboratory, Manufacture) Practice, the attention of those performing clinical trials is focused on the procedure, not always on its essence. However even the excellent performance of a trial which is not worth doing is fruitless. (shrink)

Nanomedicine promises unprecedented innovations for diagnosis and therapy as well as for predicting and preventing diseases. On the other hand it raises fears linked to new and unknown characteristics of nanoscale materials. Both, promises and fears, are closely linked to the realm of uncertainty. To a large extent it is currently not known which expectations could become reality and which suspected adverse events might come true. Medicine is quite familiar with decision-making under uncertainty. Rules and regulations for (...) class='Hi'>clinical research have been developed to reduce possible harm for research participants without abandoning necessary investigations. Here we examine whether clinical research trials of nanomedicine need new regulations and conclude that the established rules should suffice. (shrink)

BackgroundClinical ethics case consultations (CECCs) provide a structured approach in situations of ethical uncertainty or conflicts. There have been increasing calls in recent years to assess the quality of CECCs by means of empirical research. This study provides detailed data of a descriptive quantitative and qualitative evaluation of a CECC service in a department of cardiology and intensive care at a German university hospital.MethodsSemi-structured document analysis of CECCs was conducted in the period of November 1, 2018, to May 31, (...) 2020. All documents were analysed by two researchers independently.ResultsTwenty-four CECCs were requested within the study period, of which most (n = 22; 92%) had been initiated by physicians of the department. The patients were an average of 79 years old (R: 43–96), and 14 (58%) patients were female. The median length of stay prior to request was 12.5 days (R: 1–65 days). The most frequent diagnoses (several diagnoses possible) were cardiology-related (n = 29), followed by sepsis (n = 11) and cancer (n = 6). Twenty patients lacked decisional capacity. The main reason for a CECC request was uncertainty about the balancing of potential benefit and harm related to the medically indicated treatment (n = 18). Further reasons included differing views regarding the best individual treatment option between health professionals and patients (n = 3) or between different team members (n = 3). Consensus between participants could be reached in 18 (75%) consultations. The implementation of a disease specific treatment intervention was recommended in five cases. Palliative care and limitation of further disease specific interventions was recommended in 12 cases.ConclusionsTo the best of our knowledge, this is the first in-depth evaluation of a CECC service set up for an academic department of cardiology and intensive medical care. Patient characteristics and the issues deliberated during CECC provide a starting point for the development and testing of more tailored clinical ethics support services and research on CECC outcomes. (shrink)

Like other Arab countries, Jordan must find ways of responding to the rapid processes of change affecting many aspects of social life. This is particularly urgent in healthcare, where social and technical change is often manifested in tensions about ethical decision-making in the clinic. To explore the attitudes, beliefs and concerns relating to ethical decision-making among health professionals in Jordanian hospitals, a qualitative study was conducted involving face-to-face interviews with medical personnel in four hospitals in Amman, the capital of Jordan. (...) Data were analysed thematically in relation to a pre-existing set of ethical categories. Interviews were conducted with thirty-eight doctors covering most medical specialities. Five major themes emerged from the interviews: ethical awareness, ethical issues, the impact of religion on ethical decision-making, practical and theoretical resources for ethical decision-making, and challenges. While uncertainty was expressed about some aspects of Western approaches to ethics, participants strongly supported adoption of a range of Western bioethical principles, including cultural and ethical diversity, along with adherence to Islamic religious norms. A range of serious ethical challenges facing the Jordanian health system were identified, covering social, legal, managerial, and technical issues. Ethical decision-making in Jordan is complex, having to accommodate the needs of patients, the opinions of doctors and their families, the views of religious authorities, managerial considerations, and both local norms and international standards. Health professionals struggle with three sets of tensions that emerge out of the struggle between traditional, community-embedded forms of social organization and the demands generated by globalization and the influence of Western culture: the tensions between tradition and modernity, conservatism and pragmatism, and religion and secularism. Doctors in Jordan prefer approaches to ethical decision-making that realize a balance between the extremes, although the exact nature of where that balance should lie remains uncertain. (shrink)

Since trauma is a thoroughly relational phenomenon, it is highly unpredictable, and cannot be made to fit within the scientific framework Freud so admired. In _Toward a Psychology of Uncertainty: Trauma-Centered Psychoanalysis,_ Doris Brothers urges a return to a trauma-centered psychoanalysis. Making use of relational systems theory, she shows that experiences of uncertainty are continually transformed by the regulatory processes of everyday life such as feeling, knowing, forming categories, making decisions, using language, creating narratives, sensing time, remembering, forgetting, (...) and fantasizing. Insofar as trauma destroys the certainties that organize psychological life, it plunges our relational systems into chaos and sets the stage for the emergence of rigid, life-constricting relational patterns. These trauma-generated patterns, which often involve denial of sameness and difference, the creation of complexity-reducing dualities, and the transformation of certainty into certitude, figure prominently in virtually all of the complaints for which patients seek analytic treatment. Analysts, she claims, are no more strangers to trauma than are their patients. Using in-depth clinical illustrations, Dr. Brothers demonstrates how a mutual desire to heal and to be healed from trauma draws patients and analysts into their analytic relationships. She recommends the reconceptualization of what has heretofore been considered transference and countertransference in terms of the transformation of experienced uncertainty. In her view the increased ability of both analytic partners to live with uncertainty is the mark of a successful treatment. Dr. Brothers’ perspective sheds fresh light on a variety of topics of great general interest to analysts as well as many of their patients, such as gender, the acceptance of death, faith, cult-like training programs, and burnout. Her discussions of these topics are enlivened by references to contemporary cinema and theatre. (shrink)

Our purpose in this paper is to characterize the methodological role of judges in clinical psychology. What, methodologically speaking, do the judges do for the experimenter in this area? Why, and in what ways, are the experimenter's procedures more respectable, his results more valid, when he employs judges? In order to present a concrete example of the use of judges we begin by describing in some detail a procedure actually employed in the testing of an hypothesis. Next we contrast (...) this procedure with a prima facie analogous one from chemistry, noting that an appeal to judges here would be clearly superfluous. Our problem then presents itself in the form: “Why these sorts of differences between chemistry and clinical psychology?”. As the argument develops it becomes clear that the methodological significance of what is called “clinical insight” must be carefully considered in any attempt to understand the peculiar importance of the judges’ role in psychology. It is argued that the absence of precise criteria for typical concepts of clinical psychology is closely connected with the frequent appeals to clinical insight. And it is urged that the full significance of the employment of judges emerges only when seen in the light of this conceptual uncertainty, and of the clinician's attempt to operate scientifically in spite of that uncertainty. (shrink)

_The Code of Ethics and Professional Responsibilities for Healthcare Ethics Consultants_ instructs clinical ethics consultants to preserve their professional integrity by “not engaging in activities that involve giving an ethical justification or stamp of approval to practices they believe are inconsistent with agreed-upon standards” (ASBH, 2014, p. 2). This instruction reflects a larger model of how to address value uncertainty and moral conflict in healthcare, and it brings up some intriguing and as yet unanswered questions—ones that the drafters (...) of the _Code_, and the profession more broadly, should seek to address in upcoming revisions. The objective of this article is to raise these questions as a way of urging greater clarification of the _Code’s_ overall approach to professional integrity, its meaning, and implications. (shrink)

In this study, 10 hematologists and 10 lung oncologists were interviewed regarding the information they provide to patients in four situations of uncertainty: determining the treatment that is in the patient’s best interest; recurrence or progression of the patient’s disease; determining when to withdraw life-prolonging treatment; discussing death, addressing questions such as whether the patient will die from the disease, and when. The primary finding is that delivery of information to patients with low survival rates can be improved by (...) more and better disclosure by physicians at an earlier stage. The crucial point for physicians is to ascertain the wishes of patients, to learn what to reveal about what patients should expect, short term and long term, as death approaches. (shrink)