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)

Whereas indirect euthanasia is a common clinical practice, active euthanasia remains forbidden in most countries. The reason for this differentiation is usually seen in the principle of double-effect (PDE). PDE states that there is a morally relevant difference between the intended consequences of an action and merely foreseen, unintended side-effects. This article discloses the fundamental assumptions presenting the basis for this application of the PDE and examines whether these assumptions are compatible with the PDE. It is shown that (...) neither a liberal nor a utilitarian point of view makes the utilization of the PDE possible. In accordance with philosophical tradition, only within the doctrine of the sanctity of life does the PDE seem to be applicable. By analysing the premises of this doctrine, and comparing them with those of the PDE, the inconsistency of this idea is demonstrated. It is suggested that the role of the PDE in the current discussion on euthanasia is largely exaggerated. (shrink)

Ethical oversight of clinical research is one of the primary means of ensuring that human subjects are protected from the natural bias of researchers and research institutions in favor of experimentation. At a minimum, effective oversight should ensure that risks are minimized and reasonable in relation to anticipated benefits, protect vulnerable subjects from potential coercion or undue influence, ensure full and informed consent, and promote the equitable distribution of the risks and benefits of research. Because these assessments often involve (...) value judgments for which there are no agreed-upon objective standards, we rely on deliberative procedures thought to have the greatest likelihood of producing the right or best outcomes. Concerns about the potential for improperly functioning IRBs to waste scarce human and institutional resources and impede biomedical progress have motivated a surge in empirical research assessing their procedures and outcomes. Yet within this literature, there has been minimal attention paid to the social scientific evidence regarding how individuals and deliberating groups make decisions, nor how those data might inform IRB practice. This essay seeks to fill that gap, locating recent empirical data on IRB composition and process within the context of data regarding what I call “deliberative pathologies,” or instances when deliberation fails to live up to one or more aspect of the deliberative ideal because of systematic biases in the ways participants interact. The paper goes on to make evidence-based recommendations to reduce the vulnerability of IRB deliberations to the kinds of pathologies discussed and indicate directions for future research. (shrink)

While the importance of mechanisms in determining causality in medicine is currently the subject of active debate, the role of mechanistic reasoning in clinical practice has received far less attention. In this paper we look at this question in the context of the treatment of a particular individual, and argue that evidence of mechanisms is indeed key to various aspects of clinical practice, including assessing population-level research reports, diagnostic as well as therapeutic decision making, and the (...) assessment of treatment effects. We use the pulmonary condition bronchiectasis as a source of examples of the importance of mechanistic reasoning to clinical practice. (shrink)

Our society has long sanctioned, at least tacitly, a degree of conflict of interest in medical practice and clinical research as an unavoidable consequence of the different interests of the physician or clinical investigator, the patient or clinical research subject, third party payers or research sponsors, the government, and society as a whole, to name a few. In the past, resolution of these conflicts has been left to the conscience of the individual physician or clinical investigator (...) and to professional organizations. The public is no longer willing to allow health care providers to wholly govern their own conflicts of interest for several reasons. These include: new forms of health care financing and delivery that provide innovative and lucrative opportunities for physician or insurer enrichment at patient expense; the increased importance of commercial research support as peer-reviewed governmental research support has decreased; evidence that physicians and clinical investigators too frequently resolve conflicts of interest in their own favor; and a general societal mistrust of authority. This volume represents a multidisciplinary effort, drawing from philosophy, medicine, law, economics and public policy to identify and categorize conflicts of interest in medical practice and clinical research, and, where possible, to offer a mechanism for resolving them. Part I addresses conflicts of interest from a theoretical perspective, offering basic concepts and analytical frameworks. The second part discusses two topics prominent in current health care policy debates--self-referral and financial incentives to limit care. Part III examines conflicts of interest generated by pharmaceutical industry involvement in clinical practice and research. The final section deals with conflicts of interest in clinical research in several contexts, including institutional reviews boards, clinical trials, Cooperative Research and Development Agreements between government and private researchers, brokerage of research subjects by Contract Research Organizations, and cost-effectiveness studies. (shrink)

Research suggests that people tend to overweight arguments accompanied by neuroscientific terminology, which is dubbed as the seductive allure of neuroscience explanations (SANE) in the literature. Such an effect might be of particular significance when it comes to physicians and mental health professionals (MHP), given that it has the potential to cause significant bias in their understanding as well as their treatment approaches toward psychiatric symptoms. In this study, we aimed to test the SANE effect among Turkish medical students, and (...) assess its uniqueness by comparing it with a discipline that still maintains an important role in contemporary psychiatric training in Turkey: psychoanalysis. 109 medical students with a basic level of knowledge of psychiatry and clinical neuroscience were asked to rate the credibility of explanations of differing quality (good vs. circular) for psychological phenomena, followed by three types of information: none, neuroscientific (SNI) or psychoanalytical (SPI). Our findings showed that SNI significantly increased the judged quality of explanations for both conditions with the effect being more prominent for circular explanations. On the other hand, SPI had no effect on good explanations but enhanced the judged quality of circular explanations in a level comparable to that of SNI. For the first time, the SANE effect was replicated among medical students and provided preliminary data in favor of a similar effect for psychoanalytically oriented information. (shrink)

The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients' norm perception of information disclosure in other cultures.

A multidisciplinary text for the health professions, with relevance across the various health disciplines. International scholars, researchers, and teachers contribute their ideas, research findings, and experiences to promote discussion on the nature and teaching of clinical reasoning. Models, guidelines, and strategies are presented. These aim to promote effective clinical reasoning in practice, creative and successful clinical reasoning learning programs, and directions for future research. Annotation copyright by Book News, Inc., Portland, OR.

In her paper, ‘Sharing online clinical notes with patients: implications for nocebo effects and health equity’, Blease bridges findings from two research fields to describe possible unintended consequences of providing patients access to clinical notes. 1 She explains how nocebo effects, genuine psychological and physiological reactions following negative expectations, may arise after patients read such notes. Blease emphasises that the likelihood of nocebo may be greater for those patient groups who experience stigmatisation in healthcare. We argue (...) that this is the case for patients with so-called medically unexplained symptoms (MUSs) and that clinicians who work with them should consider nocebo but not for the reasons they may think. MUS is a term used to refer to persistent physical symptoms which cannot be fully or reliably attributed to a structural pathology. They include common symptoms such as chronic or recurrent pain in joints and muscles, fatigue, paresthesia or digestive... (shrink)

Background: The intentions of clinicians are widely considered to be relevant to the ethical assessment of their actions. A better understanding of the psychological factors that influence the ascription of intentions in clinical practice is important for improving the self-understanding of clinical decision-making and, ultimately, the ethics of clinical care. Drawing on empirical research on intentionality that has been done in other contexts, this is the first study to test whether the “asymmetric effect” of intention ascription is (...) exhibited by respondents when presented with clinical decision-making scenarios. Objective: To assess how individuals attribute intentions to clinical actors in clinical decision-making scenarios. Methods: A total of 149 first and second year medical students was randomly assigned to two groups. Subjects in each group read two scenarios and submitted anonymous responses to questions regarding each scenario. Results: The asymmetric effect was strongly exhibited by the responses given to scenario 2, but it was not exhibited by the responses given to scenario 1. Conclusion: The present study provided evidence for the view that people’s ascription of intentions to others is influenced by their previous evaluative judgement of the conduct in question. (shrink)

In clinical trials, it is common practice to follow up significant interactions between the factors under investigation with subgroup analyses. Such analyses pose at least two analytical and interpretational challenges. The first challenge is that performing multiple subgroup analyses increases the likelihood of obtaining spuriously significant results. This has been acknowledged and relevant guidance exists in the medical literature. The second challenge is that the effects that are obtained at the level of subgroup are composite. This has yet (...) to be fully acknowledged and discussed in the context of medical research. This paper aims to fill this lacuna. Using a simple additive model, we use recent findings from the CHARISMA trial on the efficacy of clopidogrel in addition to aspirin in the treatment of patients at risk for atherothrombotic events to demonstrate quantitatively the composition of effects at the level of subgroups. In the simplest case of a design involving an interaction (two crossed factors, with two levels each, i.e. a 2 x 2 design), effects at the level of subgroup consist of influences that stem (i) from the incidence of the measured outcome in the study population as a whole; (ii) from the factor of interest (e.g. treatment vs. placebo); (iii) from the second factor (e.g. patient group membership); (iv) from the interaction between the two factors; and (v) from random error in the measured outcome. The value of the approach illustrated here is that it is generalizable to any research design irrespective of its complexity and that it prompts clinicians to consider the multiple causality underlying medical research findings. (shrink)

Introduction:The effects of specific suggestions are usually studied by measuring parameters that are directly addressed by these suggestions. We recently proposed the use of a uniform, unrelated, and objective measure like maximal muscle strength that allows comparison of suggestions to avoid nocebo effects and thus to improve communication. Since reduced breathing strength might impair respiration and increase the risk of post-operative pulmonary complications, the aim of the present study was to evaluate the effects of the suggestions on (...) respiratory muscle power. Both the identification and neutralization of negative suggestions in the clinical context and stimulating suggestions could improve breathing force, a predictor of physical fitness and convalescence.MethodsIn 50 healthy, adult volunteers, respiratory muscle strength was measured by maximal inspiratory and expiratory pressures, as well as by maximal inspiratory and expiratory flows. Baseline was compared to values after application of eleven suggestions, five out of clinical context, including memory of negative or positive past, risk information for informed consent, and a non-verbal suggestion. Six stimulating suggestions included self-affirmation, empowering words, a heroic mirror image, and an imagination.ResultsAll suggestions showed an impact on respiratory muscle strength, indicating placebo and nocebo effects. No single parameter could represent the breathing force in its complexity, however, trends and different specific aspects of it were measured. The strongest reaction was observed with the recall of a previous negative situation resulting in a reduction in expiratory flow to 96.1% of baseline. After risk information, a decrease was observed in three of the parameters, with the highest extend in expiratory pressure by 4.4%. This nocebo effect was neutralized by adding positive aspects to the risk information. Every intended strengthening suggestion resulted in statistically significant increases of at least one parameter, with changes of up to 10%, indicating placebo effects. Here, expiration was more affected than inspiration. Sex was the only influencing factor reaching statistical significance, with stronger reactions in women.ConclusionRespiratory muscle strength proved to be sensitive to suggestions with clinical context, as well as suggestions intended for stimulation. With this objective measurement, evaluation, and comparison of different suggestions is possible to help avoid nocebo effects. The demonstrated effect of supporting suggestions can be followed up and used in clinical practice. (shrink)

Each of the antiretroviral drugs that are currently used to stop the progression of HIV infection causes its own specific side effects. Despite the expansion, multiplication, and simplification of treatment options over the past decade, side effects continue to affect people living with HIV. Yet, we see a clear disconnect between the way side effects are normalized, routinized, and framed in clinical practice and the way they are experienced by people living with HIV. This paper builds (...) on the premise that new approaches are needed to understand side effects in a manner that is more reflective of the subjective accounts of people living with HIV. Drawing on the work of Deleuze and Guattari, it offers an original application of the theory of ‘assemblage’. This theory offers a new way of theorizing side effects, and ultimately the relationship between the body and antiretroviral drugs (as technologies). Combining theory with examples derived from empirical data, we examine the multiple ways in which the body connects not only to the drugs but also to people, things, and systems. Our objective is to illustrate how this theory dares us to think differently about side effects and allows us to originally (re)think the experience of taking antiretroviral drugs. (shrink)

Background:Nurses and nursing students increasingly confront ethical problems in clinical practice. Moral sensitivity, moral reasoning, and ethical decision-making are therefore important skills throughout the nursing profession. Innovative teaching methods as part of the ethics training of nursing students help them acquire these fundamental skills.Aim:This study investigated the effects and potential benefits of using standardized patients in ethics education on nursing baccalaureate students’ moral sensitivity, moral reasoning, and ethical decision-making by comparing this method with in-class case analyses.Research (...) design:This is a quasi-experimental study.Participants and research context:The sample comprised 89 students in Hacettepe University’s Faculty of Nursing. Following lectures describing the theoretical components of ethics, students were randomly assigned to two working groups, one using standardized patients and the other using in-class case analyses. Data were collected using the Moral Sensitivity Questionnaire, Rest’s Defining Issues Test, and the Nursing Dilemma Test. All data were analysed using IBM SPSS Statistics Version 23.Ethical considerations:Ethical approval and official permission were obtained. All participating students completed informed consent forms.Findings:According to the results, the moral sensitivity of students in the standardized patient group significantly improved over time compared to those in the case analysis group, while the mean scores of students in both groups for moral reasoning and ethical decision-making were not statistically significant.Conclusion:Based on our results, we recommend the use of both standardized patients and case analysis as appropriate teaching methods in ethics education. (shrink)

In clinical practice, decision-making is not performed by individual knowers but by an assemblage of people and instruments in which no one member has full access to every piece of evidence. This is due to decision making teams consisting of members with different kinds of expertise, as well as to organisational and time constraints. This raises important questions for the epistemology of medicine, which is inherently social in this kind of setting, and implies epistemic dependence on others. Trust in (...) these contexts is a highly complex social practice, involving different forms of relationships between trust and reasons for trust: based on reasons, and not based on reasons; based on reasons that are easily accessible to reflection and others that are not. In this paper, we focus on what it means to have reasons to trust colleagues in an established clinical team, collectively supporting or carrying out every day clinical decision-making. We show two important points about these reasons, firstly, they are not sought or given in advance of a situation of epistemic dependence, but are established within these situations; secondly they are implicit in the sense of being contained or nested within other actions that are not directly about trusting another person. The processes of establishing these reasons are directly about accomplishing a task, and indirectly about trusting someone else’s expertise or competence. These processes establish a space of reasons within which what it means to have reasons for trust, or not, gains a meaning and traction in these team-work settings. Based on a qualitative study of decision-making in image assisted diagnosis and treatment of a complex disease called pulmonary hypertension, we show how an intersubjective framework, or ‘space of reasons’ is established through team members forging together a common way of identifying and dealing with evidence. In dealing with images as a central diagnostic tool, this also involves a common way of looking at the images, a common mode or style of perception. These frameworks are developed through many iterations of adjusting and calibrating interpretations in relation to those of others, establishing what counts as evidence, and ranking different kinds of evidence. Implicit trust is at work throughout this process. Trusting the expertise of others in clinical decision-making teams occurs while the members of the team are busy on other tasks, most importantly, building up a framework of common modes of seeing, and common ways of identifying and assessing evidence emerge. It is only in this way that trusting or mistrusting becomes meaningful in these contexts, and that a framework for epistemic dependence is established. (shrink)

Background Ethical decision‑making and behavior of nurses are major factors that can affect the quality of nursing care. Moral development of nurses to making better ethical decision-making is an essential element for managing the care process. The main aim of this study was to examine and comparison the effect of training in ethical decision-making through lectures and group discussions on nurses’ moral reasoning, moral distress and moral sensitivity. Methods In this randomized clinical trial study with a pre- and (...) post-test design, 66 nurses with moral reasoning scores lower than the average of the community were randomly assigned into three equal groups (n = 22) including two experimental groups and one control group. Ethical decision-making training to experimental groups was provided through the lectures and group discussions. While, the control group did not receive any training. Data were collected using sociodemographic questionnaire, the nursing dilemma test (NDT), the moral distress scale (MDS) and the moral sensitivity questionnaire (MSQ). Unadjusted and adjusted binary logistic regression analysis was reported using the odds ratio (OR) and 95% confidence intervals. Results Adjusted regression analysis showed that the probability of increasing the nursing principle thinking (NPT) score through discussion training was significantly higher than lecture (OR: 13.078, 95% CI: 3.238–15.954, P = 0.008), as well as lecture (OR: 14.329, 95% CI: 16.171–2.005, P < 0.001) and discussion groups compared to the control group (OR: 18.01, 95% CI: 22.15–5.834, P < 0.001). The possibility of increasing moral sensitivity score through discussion training was significantly higher than lecture (OR: 10.874, 95%CI: 6.043–12.886, P = 0.005) and control group (OR: 13.077, 95%CI: 8.454–16.774, P = 0.002). Moreover, the moral distress score was significantly reduced only in the trained group compared to the control, and no significant difference was observed between the experimental groups; lecture group vs. control group (OR: 0.105, 95% CI: 0.015–0.717, P = 0.021) and discussion group vs. control group (OR: 0.089, 95% CI: 0.015–0.547, P = 0.009). Conclusions The results of this study indicate that ethical decision-making training is effective on empowerment of ethical reasoning. Whereas the group discussion was also effective on increasing the ethical sensitivity, it is recommended the training plan provided in this study to be held as workshop for all nurses in health and treatment centers and placed in curricular plan of nursing students. Registration This randomized clinical trial was registered in Iranian Registry of Clinical Trials under code (IRCT2015122116163N5) in 02/07/2016. (shrink)

In clinical practice, decision-making is not performed by individual knowers but by an assemblage of people and instruments in which no one member has full access to every piece of evidence. This is due to decision making teams consisting of members with different kinds of expertise, as well as to organisational and time constraints. This raises important questions for the epistemology of medicine, which is inherently social in this kind of setting, and implies epistemic dependence on others. Trust in (...) these contexts is a highly complex social practice, involving different forms of relationships between trust and reasons for trust: based on reasons, and not based on reasons; based on reasons that are easily accessible to reflection and others that are not. In this paper, we focus on what it means to have reasons to trust colleagues in an established clinical team, collectively supporting or carrying out every day clinical decision-making. We show two important points about these reasons, firstly, they are not sought or given in advance of a situation of epistemic dependence, but are established within these situations; secondly they are implicit in the sense of being contained or nested within other actions that are not directly about trusting another person. The processes of establishing these reasons are directly about accomplishing a task, and indirectly about trusting someone else’s expertise or competence. These processes establish a space of reasons within which what it means to have reasons for trust, or not, gains a meaning and traction in these team-work settings. Based on a qualitative study of decision-making in image assisted diagnosis and treatment of a complex disease called pulmonary hypertension (PH), we show how an intersubjective framework, or ‘space of reasons’ is established through team members forging together a common way of identifying and dealing with evidence. In dealing with images as a central diagnostic tool, this also involves a common way of looking at the images, a common mode or style of perception. These frameworks are developed through many iterations of adjusting and calibrating interpretations in relation to those of others, establishing what counts as evidence, and ranking different kinds of evidence. Implicit trust is at work throughout this process. Trusting the expertise of others in clinical decision-making teams occurs while the members of the team are busy on other tasks, most importantly, building up a framework of common modes of seeing, and common ways of identifying and assessing evidence emerge. It is only in this way that trusting or mistrusting becomes meaningful in these contexts, and that a framework for epistemic dependence is established. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Clinical CommentaryTor Phern Chern, Associate ConsultantThe case scenario describes a difficult clinical and ethical challenge of a psychiatric patient refusing treatment in the context of a treatment-resistant condition that may be affecting her capacity to refuse treatment.The patient described in the case scenario displayed partial treatment refusal as evidenced by her refusal of ECT and adherence with medication and her voluntary hospital admission. Partial treatment refusal (...) is generally more common than absolute treatment refusal1 and can be sporadic, time-limited, periodic or continuous. It is important for the medical team to clarify which category of treatment refusal this patient’s refusal falls under. These broad categories include the doctor-patient relationship, religion, secondary gain, treatment- or illness-based refusals.2 The proper identification of category of treatment refusal will guide subsequent management.Refusal of treatments may be in response to reality-based transference issues like fear, distrust or pressure from the patient’s family. In this particular case, there is little data about her relationship with her treating psychiatrist, but the lack of a trusting doctor-patient relationship could be a factor for treatment refusal. The treating psychiatrist at the inpatient setting could be different from the patient’s routine outpatient psychiatrist and this could result in the lack of a trusting doctor-patient relationship. The remedy for this would be to develop a trusting relationship between her treating psychiatrist and the patient via understanding the patient’s needs and concerns. A useful adjunct would be to identify someone with whom the patient has a trusting relationship and recruit that person to help develop trust in the doctor-patient relationship. On this point, it is interesting to note that the patient’s family was noted to be highly supportive and influential in previous treatment decisions, agreed [End Page 235] with the treating psychiatrist’s treatment recommendation and yet both the treating psychiatrist and the patient’s family were unable to convince her to accept ECT. One possibility is that the patient may see her family’s support of the treating psychiatrist’s recommendation as one reason to refuse treatment. This possibility warrants deeper explorations of her premorbid underlying cultural and religious beliefs and attitudes towards her family and her perceived role in her community.Religion-based refusals of treatment (e.g. blood transfusions for Jehovah’s Witnesses) are less prominent in psychiatry than in general medicine but may manifest in treatment refusal due to advice from religious leaders on the need for spiritual solutions to the patient’s challenges. Religion-based refusals need to be distinguished from an illness-based refusal but if truly present will require the support of appropriate religious leaders to allow the patient more management options other than spiritual support for her psychiatric disorder. There is no specific information about the patient’s religion and religion-based refusals of ECT are not particularly common so this is unlikely to be a major reason for treatment refusal in this case.Treatment-based refusals of care are related to the specific treatment modality being offered and are often motivated by concerns about the side effects of treatment or past traumas that the treatment elicits. In this particular case, the patient has demonstrated some degree of treatment resistance as evidenced by the relapse of her bipolar disorder despite adherence to medication, and a change in management is certainly warranted. However, a change in medication management may be possible before proceeding to ECT in view of the patient’s acceptance of medication and no clear evidence of violent or disturbed behaviour in the ward. The occasional refusal of food and water is worrying, but if the patient can be coaxed to continue oral nutrition, there is no absolute indication to have ECT for rapid treatment response. Other options that may be acceptable to the patient are to optimise the dosage of current medications, switch medications or add augmenting pharmacological agents before proceeding to ECT. A change in pharmacotherapy must take into account her past treatment response and side effects to individual medications. Psychotherapy may also be considered to augment treatment response before ECT is considered.3Illness-based refusals are the most challenging category and... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Clinical CommentaryChong Siow Ann, Associate ProfessorDr. G appears to experiencing symptoms of schizophrenia, which is arguably the most severe mental disorder and which afflicts about one in a hundred people. This is a psychotic disorder that causes disturbances and distortions in thinking, including neurocognitive impairments, perception and behaviour. There is no cure for this often devastating disorder. Current antipsychotic medications can alleviate some of the symptoms but it (...) often comes at a price as these antipsychotics have burdensome side effects.A feature of this disorder is anosognosia, which is a lack of awareness or “insight” that an illness is present. This lack of insight presents a particular challenge because these individuals would, as in the case of Dr. G, refuse needed treatment as they do not perceive that they are ill. This is not necessarily an all-or-none phenomenon but is rather more complex and multidimensional; there might be an unawareness or recognition on behalf of the patient that they are suffering from a mental illness, the failure to appreciate the necessity of treatment; and/or the inability to recognise and define the psychotic symptoms like unusual thoughts and hallucinations as signs of illness1 and in many instances, all three are present. It is also by no means uncommon. Studies have found that between 60% and 80% of people with schizophrenia lack awareness of their illness to varying degrees.2This phenomenon remains an enigma. Some regard it as a form of psychological defence against the harsh reality of a psychotic illness — awareness of having a chronic and devastating illness might lead to demoralisation, hopelessness and suicide.3 Recent research, however, [End Page 250] indicates that this psychological denial plays a small part, if any, and instead has found an association with certain neuropsychological and neurocognitive deficits,4 as well as functional and structural brain abnormalities in the frontal lobe of the brain.5The prevailing clinical view thus is that this is an intrinsic and organic aspect of the schizophrenic illness which has nothing to do with wilfulness but rather the incapacity to perceive the presence of the illness. Edwin Fuller Torrey, an eminent psychiatrist and executive director of the Stanley Medical Research Foundation, calls anosognosia the “single largest reason why individuals with schizophrenia and bipolar disorder do not take their medications”, and he has remarked that “to keep talking about civil liberty is illogical. Patients are anything but free when they’re at the beck and call of their own delusions”.6It is also this view that it is a product of a brain disorder that some — particularly patients — find unacceptable. At one level, it does not take into context the person’s own experiences, and at a deeper level it calls into question the conception of the self with its capacity to exercise judgements and the autonomy to make decisions.This is a perennial ethical issue in psychiatry when people with severe mental illnesses refuse treatment. This becomes a Catch-22 situation where part of the illness that needs treatment is also preventing any treatment to be given: implicit in the principle of informed consent for treatment is that the person should be aware of the nature and course of their illness and acknowledge the need for treatment. While there are laws for involuntary commitment, the bar is usually high in that there must be a clear and present risk of harm to the person or others. Alan Stone, a professor of law and psychiatry at Harvard University proposed a possible justification for involuntary treatment based on his “thank-you theory” which assumes that patients will become well and subsequently agree that the intervention was in their best interests but research suggests that only half of these patients would admit so.7One suggested mechanism is the use of advance directives — psychiatry’s version of the living will in which people can specify what sort of medical care they would like should they become mentally unwell and unable to exercise appropriate judgement. An intrinsic part of this might include a “Ulysses contract” — just as Ulysess instructed his crew to lash him to the mast of the his ship so that he could... (shrink)

Design of clinical trials for germline gene editing stretches current accepted standards for human subjects research. Among the challenges involved is a set of issues concerningintergenerational monitoring—long-term follow-up study of subjects and their descendants. Because changes made at the germline would be heritable, germline gene editing could have adverse effects on individuals’ health that can be passed on to future generations. Determining whether germline gene editing is safe and effective for clinical use thus may require intergenerational monitoring. (...) The aim of this paper is to identify and argue for the significance of a set of ethical issues raised by intergenerational monitoring in future clinical trials of germline gene editing. Though long-term, multigenerational follow-up study of this kind is not without precedent, intergenerational monitoring in this context raises unique ethical challenges, challenges that go beyond existing protocols and standards for human subjects research. These challenges will need to be addressed if clinical trials of germline gene editing are ever pursued. (shrink)

Within contemporary penal philosophy, the view that punishment can only be justified if the offender is a moral agent who is responsible and hence blameworthy for their offence is one of the few areas on which a consensus prevails. In recent literature, this precept is associated with the retributive tradition, in the modern form of ‘just deserts’. Turning its back on the rehabilitative ideal, this tradition forges a strong association between the justification of punishment, the attribution of responsible agency in (...) relation to the offence, and the appropriateness of blame. By contrast, effective clinical treatment of disorders of agency employs a conceptual framework in which ideas of responsibility and blameworthiness are clearly separated from what we call ‘affective blame’: the range of hostile, negative attitudes and emotions that are typical human responses to criminal or immoral conduct. We argue that taking this clinical model of ‘responsibility without blame’ into the legal realm offers new possibilities. Theoretically, it allows for the reconciliation of the idea of ‘just deserts’ with a rehabilitative ideal in penal philosophy. Punishment can be reconceived as consequences—typically negative but occasionally not, so long as they are serious and appropriate to the crime and the context—imposed in response to, by reason of, and in proportion to responsibility and blameworthiness, but without the hard treatment and stigma typical of affective blame. Practically, it suggests how sentencing and punishment can better avoid affective blame and instead further rehabilitative and related ends, while yet serving the demands of justice. (shrink)

Clinical ethics committees (CECs) in the United Kingdom (UK) have developed significantly over the past 15 years. The issue of access to and participation in clinical ethics consultation by patients and family members has, however, gone largely unrecognized. There are various dimensions to this kind of contact, including patient notification, consent and participation. This study reports the first specific investigation of patient contact with UK CECs. A questionnaire study was carried out with representatives from UK CECs. Results suggest (...) that patient participation in clinical ethics consultation is low and unlikely to change significantly in the near future. Attitudes towards patients having a role in clinical ethics consultation are mixed, with a variety of reasons put forward both for and against patient participation. These results are discussed in the light of common themes in the literature and the practical and political context of clinical ethics support in the UK. (shrink)

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)

Side effects are a concern in medical decision making and a robust area of biomedical research. However, there is relatively little philosophical investigation into side effects as such, especially given that side effects are appealed to for various applications in philosophy of medicine. In addition, health authorities like the FDA, CDC, and WHO have contrary definitions of ‘side effect.’ Moreover, these definitions have clear counterexamples. This dissertation aims to provide a complete account of what side effects (...) are. I posit that an account of side effects ought to draw clean conceptual lines between side effects and related treatment outcomes. I contend that an account of side effects must address two components: the reasons behind an intervention that produced the side effect, and the causal powers of the intervention that brought about that effect. With this account in mind, I address contemporary philosophical models that distinguish placebo effects from side effects. These arguments, respectively in chapters 2 and 3, yield a more complete, less problematic account of side effects than previous accounts. The dissertation then turns to the process of discovering side effects, specifically in the post-market context. Given the paucity of external validity in pre-market drug trials, chapter 4 argues that post-market ‘phase IV’ trials blur the received distinction of ‘confirmatory’ versus ‘exploratory’ experimentation in philosophy of science. The other component of post-market drug research is spontaneous reporting, or the voluntary reporting of a suspected side effect to a regulatory body. Chapter 5 uses the framework of risks and values in science to examine why clinicians underreport, which hinders our ability to prevent drug-related harms. Chapter 6 looks at how patients could mitigate underreporting and develops a social-epistemic, pragmatic, and ethical framework which can evaluate proposals to engage patients to spontaneously report their suspected side effects. In short, this dissertation aims to firstly address the conceptual problems in how we define ‘side effect’ and relate it to other treatment outcomes, and secondly it addresses issues that hinder the scientific investigation of side effects. (shrink)

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

Background: Clinical research nurses experience unique challenges in the context of their role that can lead to conflict and moral distress. Although examined in many areas, moral distress has not been studied in clinical research nurses. Research aim: The aim of this study was to examine moral distress in clinical research nurses and the relationship between moral distress scores and demographic characteristics of clinical research nurses. Research design: This was a descriptive quantitative study to measure (...) moral distress in clinical research nurses using the Measure of Moral Distress – Healthcare Professionals (MMD-HP) administered electronically. Demographic data were also collected. Participants and research context: Registered nurses working in the clinical research nurse role ( N = 322) were recruited through use of social media, emails, digital flyers, and snowball recruitment. Data was analyzed using SPSS. Pearson’s correlation, independent t-test, and one-way ANOVA were performed to explore differences among the demographic variables. Ethical considerations: This study was approved by the Institutional Review Board at Texas Woman’s University. A consent statement was included, and completion of the questionnaire was construed as consent. Findings/results: Analysis revealed a mean overall moral distress score of 79.58 (SD = 64.27) and median of 67, with a range of 0–354. Moral distress scores were negatively correlated with clinical research nurse age ( r = 0-.156, p < 0.05). Reliability of the MMD-HP was demonstrated with a Cronbach’s alpha of 0.93. Conclusions: The findings demonstrate that clinical research nurses do experience moral distress and revealed a wide range of scores. Further research is necessary to determine potential patient impact due to moral distress and to develop processes to minimize moral distress in the clinical research setting. This study was conducted during the COVID-19 pandemic, and the digital recruitment methods proved effective in recruiting a wide range of clinical research nurses, both nationally and internationally. (shrink)

Syphilis occupies a unique position in the history of U.S. medicine and medical ethics. Given its widespread prevalence and variable presentation, syphilis was a major professional concern among late nineteenth‐ and early twentieth‐century physicians. Syphilis was also at the center of perhaps the most famous example of medical racism in our history, the U.S. Public Health Service Syphilis Study at Tuskegee, in which officials followed the natural history of the disease in a cohort of black men for forty years without (...) offering treatment, even once penicillin became available. In this essay, I call attention to a less well‐known aspect of syphilis and its history. I examine one of the disease's most dreaded manifestations, neurosyphilis (also known as general paresis or general paralysis of the insane), and its treatment via malarial inoculation from the 1920s into the 1950s. The goal of this treatment, dramatic even to observers at the time, was to produce spiking fevers that would kill the syphilitic spirochete and arrest the disease process. My focus will be on developments at St. Elizabeths Hospital, a large‐scale federal psychiatric facility in the District of Columbia that served the city's residents and members of the U.S. military. Physicians at St. Elizabeths were the first in the United States to experiment with malarial fever therapy, treating their initial cohort of patients in December of 1922.Malarial fever therapy raised a host of ethical questions, rendered all the more complex from today's vantage point by efforts to understand them within the context of the time. What sorts of risks, both from malaria and via indirect exposure, might be deemed acceptable in the treatment of a devastating and almost invariably fatal disease? How ought researchers and clinicians to have approached the question of consent, itself an evolving concept in the early decades of the twentieth century, when the disease they were targeting impaired a patient's ability to reason effectively? Finally, at a time when segregated and inferior care for black Americans was the norm and when the black community bore a disproportionate burden of disease, who would have had access to malarial fever therapy, and at what cost? (shrink)

As an important professional value, dignity has always been an ethical concern in nursing education and practice. However, the dignity of nursing students in clinical environments has remained a little-discussed topic. This study aims to explore and describe nursing students’ dignity in clinical learning environments. This study is a qualitative descriptive work in which data were collected via semi-structured, in-depth, individual interviews and subsequently analyzed according to conventional content analysis. Based on the inclusion criteria of the study, nursing (...) students were selected from different departments of university hospitals in the south of Iran from October 2019 to December 2020. Sampling continued to the point of data saturation. This study has been approved by the institutional review board of the university. Two themes emerged from the data collected in the interviews: trust-based relationships and formation of professional identity. The findings of the study show that nursing students need to be supported by their instructors and perceive that the personnel and patients believe in their ability. In an effectively supportive, trust-based atmosphere, these factors can contribute to maintaining nursing students dignity. Also, showing respect for their personal identity, projecting a positive image of nursing, and giving them authority to perform executive and clinical tasks in hospital departments play a major role in the formation of nursing students’ professional identity and development of their dignity. Accordingly, it is recommended that in cultural contexts and clinical learning environments, more attention should be given to nursing students’ dignity. (shrink)

Find out what connects logic and humor in this alternative guide to logical reasoning. Combining jokes, stories, and ironic situations, Stan Baronett shows how it is possible to always ground the formal, symbolic language of logic in everyday experience. Each chapter introduces a basic logical reasoning concept through a plausible premise based on happenings in daily life. Using jokes as his examples, Baronett reveals the inner workings of logic. After all an effective joke often relies on an unanticipated (...) assumption that leads to an unexpected result. The assumption changes the normal context of an everyday situation, so we are surprised by the ending. A complex mind that learns from experience, and builds a storehouse of regularly recurring patterns, is a great survival tool. But for a joke to work, the punch line has to be something our minds don't logically anticipate. The ending jolts our minds for a split second while we grasp the absurdity of the situation. This is how logic works: one part of your mind determines whether the information you are receiving is true or false, while another part of your mind deals with logical consequences of fact. These ideas are explained and illustrated by showing how an effective joke may rely on an unanticipated assumption that leads to an unexpected result. Injecting a sense of humor into logical language, Baronett helps us understand how to analyze basic causal reasoning and provides light relief for anyone daunted by the complex world of logic. (shrink)

Four experiments investigated uncertainty about a premise in a deductive argument as a function of the expertise of the speaker and of the conversational context. The procedure mimicked everyday reasoning in that participants were not told that the premises were to be treated as certain. The results showed that the perceived likelihood of a conclusion was greater when the major or the minor premise was uttered by an expert rather than a novice (Experiment 1). The results also showed (...) that uncertainty about the conclusion was higher when the major premise was uttered by a novice and an alternative premise by an expert, compared to when the major premise was uttered by an expert and the alternative by a novice (Experiment 2). Similarly, the believability of a conclusion was considerably lower when the minor premise was uttered by a novice and denied by an expert, as opposed to when an expert uttered the minor premise and a novice denied it (Experiment 3). Experiment 4 showed that the nature of the uncertainty induced by a denial of the minor premise depended on whether or not the context was a conversation. These results pose difficult problems for current theories of reasoning, as current theories are based on the results of experiments in which the premises are treated as certain. Our discussion of the results emphasises the importance of pragmatics in reasoning, namely, the role of general knowledge about the world in assessing the probability of a premise uttered by an expert or a novice and the role of interpretations of the premise based on pragmatic inferences in revising these initial probabilities. (shrink)

In a clinic-wide approach to establish liberal policies, a closed psychiatric ward was planned to be opened. The leaders of the multi-professional team of this ward requested continuous ethics support during the first few months after the transition from their previously closed ward into an open one. During the process of accompanying the team through this ethically sensitive period of institutional change, several variations of ethics consultation were developed: the ‘context-adjusted’ clinical ethics support. Some ethics consultations focused on (...) a retrospective evaluation of a patient case, in other ethics consultations consolidation of a previous case discussion was worked out, and/or reflections on fundamental ethical issues were included. Based on our experiences and the feedback of the team, we consider this context-adjusted clinical ethics support as feasible and effective. (shrink)

Among medical researchers and clinicians the dominant view is that it is unethical to deceive patients by prescribing a placebo. This opinion is formalized in a recent policy issued by the American Medical Association (AMA [Chicago, IL]). Although placebos can be shown to be always safe, often effective, and sometimes necessary, doctors are now effectively prohibited from using them in clinical practice. I argue that the deceptive administration of placebos is not subject to the same moral objections that face (...) other forms of deception in clinical practice and medical research. Although deception is normally objectionable on the grounds that it limits autonomy and breaches trust, these grounds do not apply to placebos when they are prescribed within appropriate ethical limits. Patients have reason to prefer that doctors can prescribe placebos in ethically responsible ways. Hence, the AMA has an obligation to endorse and to promote the responsible use of deceptive placebos in clinical practice. (shrink)

Professional statements guide neonatal resuscitation thresholds at the border of viability. A 2015 systematic review of international guidelines by Guillen et al. found considerable variability between statements’ clinical recommendations for infants at 23–24 weeks gestational age (GA). The authors concluded that differences in the type of data included were one potential source for differing resuscitation thresholds within this “ethical gray zone.” How statements present ethical considerations that support their recommendations, and how this may account for variability, has not been (...) as rigorously explored. We performed a mixed-methods exploratory analysis of 25 current international guidelines for neonatal resuscitation at 22+0−25+0 weeks GA. Qualitative analysis using a modified grounded theory yielded 34 distinct codes, eight categories, and four overarching themes. Three themes, consequentialism, principlism, and rights-based, consisted of concepts central to these ethical frameworks. The fourth theme, clinical reasoning, described counseling practices, medical management, outcomes data, and prognostic uncertainty, without any ethical context. The theme of clinical reasoning appeared in 22 of 25 guidelines. Ten guidelines lacked any ethical theme. Guidelines with an identified ethical theme were more likely to recommend comfort care than guidelines without an identified ethical theme, and recommended it at a higher average GA (22.7 weeks vs. 22.0 weeks, p = 0.03). Thus, how ethical concepts are incorporated into guidelines potentially impacts resuscitation thresholds. We argue that inclusion of explicit discussion of ethical considerations surrounding resuscitation in the “gray zone” would clarify values that inform recommendations and facilitate discussions about how neonatology ought to approach periviability as outcomes continue to evolve. (shrink)

Within the research community, it is generally accepted that consent processes for research should be culturally appropriate and tailored to the context, yet researchers continue to grapple with what valid consent means within specific stakeholder groups. In this study, we explored the consent practices and attitudes regarding essential information required for the consent process within hospital-based trial communities from four referral hospitals in Vietnam. We collected surveys from and conducted semi-structured interviews with study physicians, study nurses, ethics committee members, (...) and study participants and family members regarding their experiences of participating in research, their perspectives toward research, and their views about various elements of the consent process. In our findings, we describe three interrelated themes related to the consent process: words and regulation; reimbursement, suspicions, and joining; and responsibilities. In general, stakeholders had highly varied perspectives of nghiên cứu and researchers used varying levels of detail regarding all aspects of the study in the consent process to build trust with and/or promote potential research participants’ choices about taking part in research. Findings additionally highlight how researchers felt that offering financial reimbursements in a hospital setting, where payment for services was routine, would be unfamiliar to participants and could raise suspicions about the research. Participants, however, focused their discussions on reimbursement or alternative reasons for joining the study, such as health related benefits or altruism. Finally, participants often relied on their physician to help them decide about joining a study or not. Further research is needed to understand how researchers and participants make sense of and practice consent, and how that impacts participants’ decision-making about research participation. To promote valid consent within this context, it is important to engage with hospital-based trial communities as a whole. The data from this study will inform future research on consent, guide the revisions of consent related policies within our research sites and point to several larger issues surrounding researcher-participant expectations, communication, and trust. (shrink)

While discussions of the ethics of the placebo have usually dealt with their use in a research context, the authors address here the question of the placebo in clinical practice. It is argued, firstly, that the placebo can be an effective treatment. Secondly, it is demonstrated that its use does not always entail deception. Finally guidelines are presented according to which the placebo may be used for clinical purposes. It is suggested that in select cases, use of (...) the placebo may even be morally imperative. The argument is illustrated by three case vignettes. (shrink)

In bioethics, the predominant categorization of various types of influence has been a tripartite classification of rational persuasion (meaning influence by reason and argument), coercion (meaning influence by irresistible threats—or on a few accounts, offers), and manipulation (meaning everything in between). The standard ethical analysis in bioethics has been that rational persuasion is always permissible, and coercion is almost always impermissible save a few cases such as imminent threat to self or others. However, many forms of influence fall into the (...) broad middle terrain—and this terrain is in desperate need of conceptual refining and ethical analysis in light of recent interest in using principles from behavioral science to influence health decisions and behaviors. This paper aims to address the neglected space between rational persuasion and coercion in bioethics. First, I argue for conceptual revisions that include removing the “manipulation” label and relabeling this space “nonargumentative]influence,” with two subtypes: “reason-bypassing” and “reason-countering.” Second, I argue that bioethicists have made the mistake of relying heavily on the conceptual categories themselves for normative work and instead should assess the ethical permissibility of a particular instance of influence by asking several key ethical questions, which I elucidate, that relate to (1) the impact of the form of influence on autonomy and (2) the relationship between the influencer and the influenced. Finally, I apply my analysis to two examples of nonargumentative influence in health care and health policy: (1) governmental agencies such as the Food and Drug Administration (FDA) trying to influence the public to be healthier using nonargumentative measures such as vivid images on cigarette packages to make more salient the negative effects of smoking, and (2) a physician framing a surgery in terms of survival rates instead of mortality rates to influence her patient to consent to the surgery. (shrink)

The aim of the current study was to investigate important pathways of the Environmental Stress Hypothesis concerning the role of peer relations. First, we examined (1) the mediating role of peer problems in the association between the motor performance in daily activities and internalizing problems as a main pathway of the Environmental Stress Hypothesis. Furthermore, we explored the role of (2) children’s popularity as a mediator and (3) best friendship quality as a moderator path of the effect of motor performance (...) on both peer problems and internalizing problems. The non-clinical sample of the present study consisted of 189 children (48.6% females) aged nine to eleven years (Mage = 9.69, SDage = 0.46). Parents reported on their child’s motor performance in daily activities by completing the Developmental Coordination Disorder Questionnaire. In addition, the Strengths and Difficulties Questionnaire was used to assess peer problems as well as internalizing problems. The Self Description Questionnaire provided a measure of children’s self-reported popularity. Finally, the Friendship Quality Questionnaire was used to investigate children’s best friendship quality. Results of a structural equation model suggest that peer problems fully mediated the association between the motor performance in daily activities and both popularity and internalizing problems. However, no evidence for the mediating effect of popularity in the association between peer problems and internalizing problems was found. Further, best friendship quality had small but non-significant positive moderating effect on the relation between peer problems and internalizing problems. The mediating role of peer problems highlights the importance of peer relations in the motor performance of daily activities. Possible reasons for the lack of some of the expected mediating and moderating effects as well as practical implications are discussed. (shrink)

Popular and neurobiological accounts of addiction tend to treat it as a form of compulsion. This contrasts with personality disorder, where most problematic behaviours are treated as voluntary. But high levels of co-morbidity, overlapping diagnostic traits, and the effectiveness of a range of comparable clinical interventions for addiction and personality disorder suggest that this difference in treatment is unjustified. Drawing on this range of clinical interventions, we argue that addiction is not a form of compulsion. Rather, the misuse (...) of drugs and alcohol is like many of the problematic behaviours associated with personality disorder: it is typically a way of coping with psychological distress. We suggest that a satisfying explanation of why many addicts struggle to control their use can be given without departing from concepts employed in our basic folk psychological understanding of agency. In particular, we appeal to five rough-and-ready folk psychological factors to explain addiction: (i) strength of desire and habit; (ii) willpower; (iii) motivation; (iv) functional role; and (v) decision and resolve. (shrink)

Background Whether patients' life-style should involve lower priority for treatment is a controversial question in bioethics. Less is known about clinicians' views. Aim To study how clinical doctors' attitudes to questions of patient responsibility and priority vary over time. Method Surveys of doctors in Norway in 2008, 2014, 2021. Questionnaires included statements about patients' lifestyle's significance for priority to care, and vignettes of priority cases (only in 2014). Results Attitudes were fairly stable between 2008 and 2021. 17%/14% agreed that (...) patients' lifestyle should count, while 19%/22% agreed that it should involve lower priority to scarce organs. 42/44% agreed that smokers should have lower priority. Substantially more agreed in 2014. Regression analyses showed that being male, working in hospital, and younger age increased the likelihood of agreeing. Conclusion A substantial minority of doctors agreed that lifestyle should be a priority criterion, possibly contrary to Norwegian legislation and professional ethics. The finding might be explained by the unspecified meaning of priority, increased scarcity-awareness, or socio-cultural trends towards individualism. The 2014 results indicate a framing effect; the vignettes may have primed the respondents towards accepting lifestyle as a criterion. We conclude that attitudes to normative questions are unstable and depend on context. A substantial minority of doctors seems to be positive to deprioritizing patients allegedly responsible for their illness. However, what deprioritization implies in practice is not clear. (shrink)

At the University of Newcastle, health law and ethics is taught and assessed in each year of the five-year curriculum. However, the critical question for assessment remains: 'Does teaching ethics have a measurable effect on the clinical activity of medical students who have had such courses?' Those responsible for teaching confront this question each year they sit down to construct their assessment tools. Should they assess what the student knows? Should they assess the student's moral reasoning, that is, (...) what decisions the student makes, and, how these decisions are justified, or should they assess what the student actually does when dealing with patients in the clinical setting, and how he or she does it? From 1982 to 1991, assessment at Newcastle was primarily aimed at determining the quality of the students' ethics knowledge base. This paper describes the strengths and limitations of a purely knowledge-based method of evaluation and why in 1992, we are now attempting to redefine and assess, what we call 'clinical ethical competence' in terms of how students actually apply this knowledge base in a controlled clinical context. (shrink)

Objectives: To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and information. Design: Focus groups, short self-administered questionnaires. Setting: Boston, Dallas, Detroit, Oklahoma City. Participants: Current and recent subjects in clinical trials, primarily for chronic diseases. Results: 93 individuals participated in 10 focus groups. Many thought researchers, sponsors, health insurers and others share obligations to facilitate PTA to the (...) trial drug, if it benefited the subject, or to a therapeutic equivalent. Some thought PTA obligations include providing transition care (referrals to non-trial physicians or other trials, limited follow-up, short-term drug supply) or care for long-term adverse events. Others held, in contrast, that there are no PTA obligations regarding drugs or care. However, there was agreement that former subjects should receive information (drug name, dosage received, market approval date, long-term adverse effects, trial results). Participants frequently appealed to health need, cost, relationships, reciprocity, free choice and sponsor self-interest to support their views. Many of their reasons overlapped with those commonly discussed by bioethicists. Conclusion: Many participants in US trials for chronic conditions thought there are obligations to facilitate PTA to the trial drug at a “fair” price; these views were less demanding than those of non-US subjects in other studies. However, our participants’ views about informational obligations were broader than those of other subjects and many bioethicists. Our results suggest that the PTA debate should expand beyond the trial drug and aggregate results. (shrink)

There is no doubt that emotions have an important effect on practices of moral reasoning such as clinical ethics consultation. Empathy is not only a basic human emotion but also an important and learnable skill for health care professionals. A basic amount of empathy is essential both in patient care and in clinical ethics consultation. This article debates the “adequate dose” of empathy in ethics consultations in clinical settings and tries to identify possible situations within the (...) process of consultation in which this crucial feeling is at risk. (shrink)

BackgroundThe informed consent process in clinical trials has been extensively studied to inform the development processes which protect research participants and encourage their autonomy. However, ensuring a meaningful informed consent process is still of great concern in many research settings due to its complexity in practice and interwined socio-cultural factors.ObjectivesThis study explored the practices and meaning of the informed consent process in two clinial trials conducted by Oxford University Clinical Research Unit in collaboration with the Hospital for Tropical (...) Diseases in Ho Chi Minh City, Vietnam.MethodsWe used multiple data collection methods including direct observervations, in-depth interviews with study physicians and trial participants, review of informed consent documents from 2009 to 2018, and participant observation with patients’ family members. We recruited seven physicians and twenty-five trial participants into the study, of whom five physicians and thirteen trial participants completed in-depth interviews, and we held twenty-two direct observation sessions.ResultsWe use the concept “fragmented understanding” to describe the nuances of understanding about the consent process and unpack underlying reasons for differing understandings.ConclusionsOur findings show how practices of informed consent and different understanding of the trial information are shaped by trial participants’ characteristics and the socio-cultural context in which the trials take place. (shrink)

Clinical ethics committees aim to resolve conflict, facilitate communication and ease moral distress in health care. Dialogue in committee discussions is complex and involves a balance between implicitly and explicitly expressed values of patients, families and professionals. Evaluating effectiveness and concrete outcomes is challenging and most studies focus on broad benefits such as quality of care and reduction of unnecessary or unwanted treatments. In this paper we propose ‘physician satisfaction’ as a valuable outcome. We refer to the clinical (...) ethics approach followed at one large paediatric hospital in Australia, propose reasons for the often-expressed feeling of satisfaction and discuss why this feeling matters. We conclude that physician satisfaction is a valid measure of an effective ethics consultation because it implies the person has been listened to and respected by others, and has perhaps developed greater understanding of and insights into their own work and values, and those of others. (shrink)

Previous studies have explored the impact of magic tricks on different basic cognitive processes yet there is a need of examining effectiveness of a cognitive training program through magic tricks for children with attention deficit hyperactivity disorder. The present study examines the effectiveness and feasibility of the MAGNITIVE program, a manualized intervention for cognitive training through the learning of magic tricks. A total of 11 children with ADHD participated in separated groups of two different community settings, and were assessed at (...) pre-treatment, post-treatment, and a 3-month later follow-up in different tasks involving processing speed, sustained attention, selective attention, and mental flexibility. Using non parametric statistical analyses and Reliable Change Index, the results showed that these children receiving MAGNITIVE particularly improved their performance in sustained attention, shifting attention, and mental flexibility, changes were also observed in processing speed performance yet further research is needed in terms of selective attention and inhibition, given the great individual differences within this sample. Changes were maintained when the program was finished. In terms of viability, the study proved a good treatment integrity in different contexts, adherence to the curriculum, and high levels of engagement satisfaction. In this second clinical trial, MAGNITIVE program appears to be a feasible training program for children with ADHD, as an alternative for medication when possible. (shrink)