_341_ _Objectives: _In patients with multivessel disease both the detection of the culprit lesion and the exact allocation are important preconditions for sufficient treatment and improved outcome. In a vessel based approach the combination of quantitative coronary angiography and fractional flow reserve measured by a pressure wire should be advantageous compared to myocardial SPECT, as morphological and functional information is delivered simultaneously. Therefore our aim was to evaluate MS in the detection and allocation of hemodynamically significant stenoses obtained by the (...) combined gold standard QCA plus FFR in patients with multivessel disease. _Methods: _FFR and QCA of 95 vessels in 80 patients have been evaluated. Hemodynamically significant target lesions were defined as intermediate stenoses between 50 and 75% with an FFR. (shrink)

It was in the course of one particular clinical encounter that I came to realize the power of narrative, especially for expressing clinically presented ethical matters. In Husserlian terms, the mode of evidence proper to the unique and the singular is the very indirection that is the genius of story-telling. Moreover, the clinical consultant is unavoidably changed by his or her clinical involvement. The individuals whose situation is at issue have their own stories that need telling. (...) class='Hi'>Clinical ethics is in this sense a way of helping patients, families, and, yes, health providers to discover and give voice to those stories. In this way, clinical ethics is an evoking of meaning. Kierkegaard understood this well: Indirect communication is the language for the unique and the otherwise inexpressible. (shrink)

The meaning of being a middle‐aged close relative of a person who has suffered a stroke, 1 month after discharge from a rehabilitation clinicThe sudden and unexpected impact of stroke may have a stressful affect on close relatives. To illuminate the essential meaning in the lived experience of a middle‐aged close relative of a person who has suffered a stroke, narrative interviews were conducted with 10 close relatives of people who had suffered their first stroke where both parties (...) were aged over 18 and under 65. A phenomenological‐hermeneutic interpretation of the narratives was then conducted. Three intimately intertwined themes emerged during the analysis: ‘being called to mission’, ‘feeling lost and set adrift’ and ‘struggling to keep going’. The middle‐aged close relatives felt unreflectively duty bound. There was a struggle with suffering and enduring the process of coping with life and overcoming a feeling of helplessness. Life turned out to be a struggle with overwhelming feelings. They felt alienated in a restricted life situation, disconnected from themselves and others, and from a world that supports feelings of being lost and set adrift (i.e. feeling homeless). Strength was found in moments when the situation improved, in being related to oneself and others, and when feelings of normality were regained. (shrink)

Clinical Pharmacology is a specialty with many attributes and our association with the subject has allowed us to acquire, apply and disseminate myriad aspects of research and practice. Though clinical pharmacologists are conspicuous by virtue of their small number, recent years have shown a growing need for the course. In the review below we navigate through several aspects of the subject as we encountered them from time to time. From critical appraisal of literature, to application of knowledge of (...) drugs, to clinical practice; moving on to clinical and basic research, to drug development process, to policy making - these are but a few of the many fields which constitute the scope of clinical pharmacology. The importance of the subject lies in allowing a trainee to develop a broad overview of the entire process, from drug generation to drug distribution to drug utilization, a process meant for the greater common goal of better health for all. We foresee a bright future for the subject though with a slight skepticism thrown in. In the present article, we make use of personal experiences and reference from literature to help you get a broad view of what clinical pharmacology means to us. (shrink)

_Clinical Interaction and the Analysis of Meaning_ evinces a therapeutic vitality all too rare in works of theory. Rather than fleeing from the insights of other disciplines, Dorpat and Miller discover in recent research confirmation of the possibilities of psychoanalytic treatment. In Section I, "Critique of Classical Theory," Dorpat proposes a radical revision of the notion of primary process consonant with contemporary cognitive science. Such a revised conception not only enlarges our understanding of the analytic process; it also provides analysis (...) with a conceptual language that can articulate meaningful connections with a growing body of empirical research about the development and nature of human cognition. In Section II, "Interactional Theory," Miller reverses the direction of inquiry. He begins with the literature on cognitive development and functioning, and proceeds to mine it for concepts relevant to the clinical process. He shows how a revised understanding of the operation of cognition and affect can impart new meaning to basic clinical concepts such as resistance, transference, and level of psychopathology. In Section III, "Applications and Exemplifications," Dorpat concludes this exemplary collaboration by exploring select topics from the standpoint of his and Miller's new psychoanalytic theory. At the heart of the authors' endeavor it "meaning analysis," a concept that integrates an up-to-date model of human information processing with the traditional goals of psychoanalysis. The patient approaches the clinical encounter, they argue, with cognitive-affective schemas that are the accumulatice product of his life experience to date; the manifold meanings ascribed to the clinical interaction must be understood as the product of these schemas rather than as distortions deriving from unconscious, drive-related fantasies. The therapist's goal is to make the patient's meaning-making conscious and thus available for introspection. (shrink)

Volume 6, Issue 3, September 2015, Page 310-346.

Volume 6, Issue 3, September 2015, Page 310-346.

This research examines the current status of clinical ethics consultation (CEC) in Japan through a nationwide study conducted with chairs of ethics committees and clinical ethics committees among 1028 post-graduate clinical teaching hospitals. We also qualitatively analyzed their viewpoints of the CEC’s benefits and problems related to hospital consultation services to identify the critical points for CEC and inform the development of a correctly functioning system. The questionnaire included structured questions about hospital CEC organization and service purpose (...) and operation and open-ended questions about the benefits and problems of initiating CEC. The questionnaire comprised the presence/absence of an ethics committee, CEC services and membership when services were implemented, users, and the number of cases handled since inception. In addition, the respondents also provided their impressions of the CEC system’s impact on their hospital by describing (a) the benefits of CEC services and (b) the ineffectual or harmful aspects of the CEC system. Qualitative data were examined using qualitative content analysis to determine the impact of establishing a CEC and the difficulties of practice. One hundred twenty-five questionnaires were returned from either the chair of the ethics committee or clinical ethics committee in teaching hospitals. Of these, 90 (72%) reported they provided CEC services. Additionally, 36 respondents (34.6%) reported that their existing research and clinical ethics committees had conducted CEC services, and 35 (33.7%) reported having a newly established clinical ethics committee conducting CEC services. Three positive effects of establishing and four challenges in managing CEC were also identified. (shrink)

IN THINKING ABOUT the wonderfully helpful comments by Eric Cassell, Suzanne Jaeger, and Deborah Spitz, I find myself grappling with three central questions: How reliable a guide is world traveling? What kind of knowledge can be obtained by world traveling? and, What are the goals of treatment such that world traveling might be thought to serve a purpose? These questions arise from the insights, criticisms, and cautions the commentators provide, and I will weave together possible answers from ideas drawn from (...) the commentaries. (shrink)

There have been repeated calls to ensure that clinical artificial intelligence (AI) is not discriminatory, that is, it provides its intended benefit to all members of society irrespective of the status of any protected characteristics of individuals in whose healthcare the AI might participate. There have also been repeated calls to ensure that any clinical AI is tailored to the local population in which it is being used to ensure that it is fit-for-purpose. Yet, there might be a (...) clash between these two calls since tailoring an AI to a local population might reduce its effectiveness when the AI is used in the care of individuals who have characteristics which are not represented in the local population. Here, I explore the bioethical concept of local fairness as applied to clinical AI. I first introduce the discussion concerning fairness and inequalities in healthcare and how this problem has continued in attempts to develop AI-enhanced healthcare. I then discuss various technical aspects which might affect the implementation of local fairness. Next, I introduce some rule of law considerations into the discussion to contextualise the issue better by drawing key parallels. I then discuss some potential technical solutions which have been proposed to address the issue of local fairness. Finally, I outline which solutions I consider most likely to contribute to a fit-for-purpose and fair AI. (shrink)

This manuscript explores intersubjectivity through a conceptual construct for meaning-making that emphasizes three major interrelated elements–meaning making in interaction, making meaning with the body as well as the mind, and meaning making within an open dynamic system. These three elements are present in the literature on intersubjectivity with a wide range of terms used to describe various theoretical formulations. One objective of this manuscript is to illustrate how such a construct can be useful to understand the (...) meaning-making observed in psychoanalysis, such as in the treatment of a young child on the autistic spectrum. The challenges in establishing an intersubjective state with a child on the autistic spectrum serve to highlight important features of intersubjectivity. As an important background to this clinical illustration, we illustrate the construct with the scientific paradigm of the well-known face-to-face still-face. (shrink)

Volume 19, Issue 5, May 2019, Page 64-66.

This paper contends, following Plato and Broekman, that seeing images as images is crucial to theorizing medicine and that considering clinical pictures as images of images is a much-needed epistemic complement to the domineering view that sees clinical pictures as mirrors of disease. This does not only offer epistemic, but also ethical benefits to individual patients, especially in those cases where patients suffer from chronic, debilitating, and terminal illnesses and where medicine provides no, or limited, answers in terms (...) of treatment, intervention, and meaning. By creating room for a theory of clinical pictures that rightfully emphasizes its pictorial nature, patients and doctors alike may be encouraged to consider under what authorship, and with which epistemic tools, alternative, supplemental images may be produced to get at the existential reality of disease and suffering. Ultimately, this paper argues that the epistemic tools provided by aesthetics may offer such glimpses into the reality of disease and suffering, and I conclude by discussing a few artistic renditions of breast cancer to illustrate my point. (shrink)

While in Europe the debate over clinical ethics consultants’ expertise and professionalization is ongoing, in France it remains rather marginal. In this article, we illustrate how the “commitment model” adopted by the Clinical Ethics Center of the Greater Paris University Hospitals situates itself in such a debate. We first present the commitment model by drawing upon an emblematic case of consultation, and then describe, in turn, its understandings of democratic expertise and of the professionalization of clinical ethics (...) consultation. Accordingly, the commitment model advocates against individual consultants’ certification, but it does not rule out the need for training nor a certain form of professionalization of clinical ethics consultation services. (shrink)

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

It is often argued that clinical research should not violate the Kantian principle that people must not be used merely as a means for the purposes of others. At first sight, the practice of clinical research itself, however, seems to violate precisely this principle: clinical research is often beneficial to future people rather than to participants; even if participants benefit, all things considered, they are exposed to discomforts which are absent both in regular care for their diseases (...) and in other areas of daily life. Therefore, in this paper we will consider whether people are used merely as a means by being enrolled in clinical research. On the basis of recent studies of Kantian scholars we will argue that clinical research is compatible with the Kantian principle if the conditions of possible consent and end-sharing have been met. Participants are not used merely as a means if they have sufficient reasons to consent to being enrolled in clinical research and can share the ends of the researchers who use them. Moreover, we will claim that even if people are used merely as a means by participating in clinical research, it may not always be morally wrong to use them in this way. (shrink)

Ontological realism aims at the development of high quality ontologies that faithfully represent what is general in reality and to use these ontologies to render heterogeneous data collections comparable. To achieve this second goal for clinical research datasets presupposes not merely (1) that the requisite ontologies already exist, but also (2) that the datasets in question are faithful to reality in the dual sense that (a) they denote only particulars and relationships between particulars that do in fact exist and (...) (b) they do this in terms of the types and type-level relationships described in these ontologies. While much attention has been devoted to (1), work on (2), which is the topic of this paper, is comparatively rare. Using Referent Tracking as basis, we describe a technical data wrangling strategy which consists in creating for each dataset a template that, when applied to each particular record in the dataset, leads to the generation of a collection of Referent Tracking Tuples (RTT) built out of unique identifiers for the entities described by means of the data items in the record. The proposed strategy is based on (i) the distinction between data and what data are about, and (ii) the explicit descriptions of portions of reality which RTTs provide and which range not only over the particulars described by data items in a dataset, but also over these data items themselves. This last feature allows us to describe particulars that are only implicitly referred to by the dataset; to provide information about correspondences between data items in a dataset; and to assert which data items are unjustifiably or redundantly present in or absent from the dataset. The approach has been tested on a dataset collected from patients seeking treatment for orofacial pain at two German universities and made available for the NIDCR-funded OPMQoL project. (shrink)

In this chapter, we explore how themes of existential philosophy have been used to develop a formal orientation of psychotherapy, and we discuss the main principles of existential psychotherapy and their application in practice. We also draw upon case examples to specifically illustrate how the approach of existential psychotherapy is utilized in clinical practice. In the case examples, each patient's identify has been disguised to maintain confidentiality. The new science of meaning, represented by the chapters in this volume, (...) not only offers therapists a deep conceptual framework within which to practice older, more established techniques but should also suggest new approaches. By recognizing the centrality of meaning as sense making and acknowledging the distinction between the what and the why of sense making, therapists should be armed with a variety of epistemic and teleological tools with which to fashion therapy strategies that are unique for each individual. (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)

It is often argued that clinical research should not violate the Kantian principle that people must not be used merely as a means for the purposes of others. At first sight, the practice of clinical research itself, however, seems to violate precisely this principle: clinical research is often beneficial to future people rather than to participants; even if participants benefit, all things considered, they are exposed to discomforts which are absent both in regular care for their diseases (...) and in other areas of daily life. Therefore, in this paper we will consider whether people are used merely as a means by being enrolled in clinical research. On the basis of recent studies of Kantian scholars we will argue that clinical research is compatible with the Kantian principle if the conditions of possible consent and end-sharing have been met. Participants are not used merely as a means if they have sufficient reasons to consent to being enrolled in clinical research and can share the ends of the researchers who use them. Moreover, we will claim that even if people are used merely as a means by participating in clinical research, it may not always be morally wrong to use them in this way. (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)

The Covid‐19 crisis has accelerated a trend toward burnout in health care workers, making starkly clear that burnout is especially likely when providing health care is not only stressful and sad but emotionally alienating; in such situations, there is no mental space for clinicians to experience authentic clinical empathy. Engaged curiosity toward each patient is a source of meaning and connection for health care providers, and it protects against sympathetic distress and burnout. In a prolonged crisis like Covid‐19, (...) clinicians provide care out of a sense of duty, especially the duty of nonabandonment. We argue that when duty alone is relied on too heavily, with fear and frustration continually suppressed, the risk of burnout is dramatically increased. Even before Covid‐19, clinicians often worked under dehumanizing and unjust conditions, and rates of burnout were 50 percent for physicians and 33 percent for nurses. The Covid‐19 intensification of burnout can serve as a wake‐up call that the structure of health care needs to be improved if we are to prevent the loss of a whole generation of empathic clinicians. (shrink)

Monothematic delusions involve a single theme, and often occur in the absence of a more general delusional belief system. They are cognitively atypical insofar as they are said to be held in the absence of evidence, are resistant to correction, and have bizarre contents. Empiricism about delusions has it that anomalous experience is causally implicated in their formation, whilst rationalism has it that delusions result from top down malfunctions from which anomalous experiences can follow. Within empiricism, two approaches to the (...) nature of the abnormality/abnormalities involved have been touted by philosophers and psychologists. One-factor approaches have it that monothematic delusions are a normal response to anomalous experiences whilst two-factor approaches seek to identify a clinically abnormal pattern of reasoning in addition to anomalous experience to explain the resultant delusion. In this paper we defend a one-factor approach. We begin by making clear what we mean by atypical, abnormal, and factor. We then identify the phenomenon of interest and overview one and two-factor empiricism about its formation. We critically evaluate the cases for various second factors, and find them all wanting. In light of this we turn to our one-factor account, identifying two ways in which ‘normal response’ may be understood, and how this bears on the discussion of one-factor theories up until this point. We then conjecture that what is at stake is a certain view about the epistemic responsibility of subjects with delusions, and the role of experience, in the context of familiar psychodynamic features. After responding to two objections, we conclude that the onus is on two-factor theorists to show that the one-factor account is inadequate. Until then, the one-factor account ought to be understood as the default position for explaining monothematic delusion formation and retention. We don’t rule out the possibility that, for particular subjects with delusions there may be a second factor at work causally implicated in their delusory beliefs but, until the case for the inadequacy of the single factor is made, the second factor is redundant and fails to pick out the minimum necessary for a monothematic delusion to be present. (shrink)

Both patients and clinicians frequently report problems around communicating and assessing pain. Patients express dissatisfaction with their doctors and doctors often find exchanges with chronic pain patients difficult and frustrating. This chapter thus asks how we could improve pain communication and thereby enhance outcomes for chronic pain patients. We argue that improving matters will require a better appreciation of the complex meaning of pain terms and of the variability and flexibility in how individuals think about pain. We start by (...) examining the various accounts of the meaning of pain terms that have been suggested within philosophy and suggest that, while each of the accounts captures something important about our use of pain terms, none is completely satisfactory. We propose that pain terms should be viewed as communicating complex meanings, which may change across different communicative contexts, and this in turn suggests that we should view our ordinary thought about pain as similarly complex. We then sketch what a view taking seriously this variability in meaning and thought might look like, which we call the “polyeidic” view. According to this view, individuals tacitly occupy divergent stances across a range of different dimensions of pain, with one agent, for instance, thinking of pain in a much more “bodycentric” kind of way, while another thinks of pain in a much more "mindcentric” way. The polyeidic view attempts to expand the multidimensionality recognised in, e.g., biopsychosocial models in two directions: first, it holds that the standard triumvirate— dividing sensory/cognitive/affective factors— needs to be enriched in order to capture important distinctions within the social and psychological dimensions. Second, the polyeidic view attempts to explain (at least in part) why modulation of experience by these social and psychological factors is possible in the first place. It does so by arguing that because the folk concept of pain is complex, different weightings of the different parts of the concept can modulate pain experience in a variety of ways. Finally, we argue that adopting a polyeidic approach to the meaning of pain would have a range of measurable clinical outcomes. (shrink)

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

I argue that clinical medicine can best be understood not as a purified science but as a hermeneutical enterprise: that is, as involved with the interpretation of texts. The literary critic reading a novel, the judge asked to apply a law, must arrive at a coherent reading of their respective texts. Similarly, the physician interprets the text of the ill person: clinical signs and symptoms are read to ferret out their meaning, the underlying disease. However, I suggest (...) that the hermeneutics of medicine is rendered uniquely complex by its wide variety of textual forms. I discuss four in turn: the experiential text of illness as lived out by the patient; the narrative text constituted during history-taking; the physical text of the patient's body as objectively examined; the instrumental text constructed by diagnostic technologies. I further suggest that certain flaws in modern medicine arise from its refusal of a hermeneutic self-understanding. In seeking to escape all interpretive subjectivity, medicine has threatened to expunge its primary subject — the living, experiencing patient. (shrink)

The prevalence and negative impact of brain disorders are increasing. Clinical Neuropsychology is a specialty dedicated to understanding brain-behavior relationships, applying such knowledge to the assessment of cognitive, affective, and behavioral functioning associated with brain disorders, and designing and implementing effective treatments. The need for services goes beyond neurological diseases and has increased in areas of neurodevelopmental and psychiatric conditions, among others. In Europe, a great deal of variability exists in the education and training of Clinical Neuropsychologists. Training (...) models include master’s programs, continuing education courses, doctoral programs, and/or post-doctoral specialization depending on the country, with no common framework of requirements, although patients’ needs demand equal competencies across Europe. In the past five years, the Standing Committee on Clinical Neuropsychology of the European Federation of Psychologists’ Association has conducted a series of surveys and interviews with experts in the field representing 30 European countries. The information, along with information from the existing literature, is used in presenting an overview of current and relevant topics related to policy and guidelines in the training and competencies in Clinical Neuropsychology. An option for the way forward is the EuroPsy Specialist Certificate which is currently offered in Work- and Organizational psychology and Psychotherapy. It builds upon the Basic Certificate and complements national standards without overriding them. General principles can be found that can set the basis for a common, solid, and comprehensive specialty education/training, sharpening the Neuropsychologists’ competencies across Europe. The requirements in Clinical Neuropsychology should be comparable to those for the existing specialty areas in the EuroPsy model. Despite the perceived challenges, developing a Specialist Certificate appears a step forward for the development of Clinical Neuropsychology. Recommendations are proposed towards a shared framework of competencies by the means of a common level of education/training for the professionals in Europe. Benchmarking training standards and competencies across Europe has the potential of providing protection against unqualified and ethically questionable practice, creating transparency, raising the general European standard, and promoting mobility of both Clinical Neuropsychologists and patients in Europe, for the benefit of the professional field and the population. (shrink)

Background: Clinical ethics support services have been advocated in recent decades. In clinical practice, clinical ethics support services are often requested for difficult decisions near the end of life. However, their contribution to improving healthcare has been questioned and demands for evaluation have been put forward. Research indicates that there are considerable challenges associated with defining adequate outcomes for clinical ethics support services. In this systematic review, we report findings of qualitative studies and surveys, which have (...) been conducted to evaluate clinical ethics support services near the end of life. Methods: Electronic databases and other sources were queried from 1970 to May 2018. Two authors screened studies independently. Methodological quality of studies was assessed. For each arm of the review, an individual synthesis was performed. Prospero ID: CRD42016036241. Ethical Considerations: Ethical approval is not needed as it is a systematic review of published literature. Results: In all, 2088 hits on surveys and 2786 on qualitative studies were found. After screening, nine surveys and four qualitative studies were included. Survey studies report overall positive findings using a very wide and heterogeneous range of outcomes. Negative results were reported only occasionally. However, methodological quality and conceptual justification of used outcomes was often weak and limits generalizability of results. Conclusion: Evidence points to positive outcomes of clinical ethics support services. However, methodological quality needs to be improved. Further qualitative or mixed-method research on evaluating clinical ethics support services may contribute to the development of evaluating outcomes of clinical ethics support services by means of broaden the range of appropriate (process-oriented) outcomes of (different types of) clinical ethics support services. (shrink)

Clinical research must be understood to be the foundation of scientific medicine of the clinical type. But the essence of scientific clinical medicine remains a matter of profound confusion, even in clinical academia, and so does the essence of clinical research. The confusion now revolves, principally, around ‘clinical epidemiology’. We address clinical research in the meaning of quintessentially ‘applied’ clinical research, which we take to be the foundation of the scientific knowledge (...) base of clinical medicine, of gnosis (dia‐, etio‐, pro‐) in it. More specifically, we address the essence, priorities, and status quo of this research – and argue that the requisite theory of this is not a matter of ‘clinical epidemiology’ but of theory of clinical research endogenous to clinical (rather than epidemiological) academia. (shrink)

It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is limited, as it often is, trials essentially compete for participants. There is evidence that such a competition is a predictor of low study accrual, with increased competition tied to increased recruitment shortfalls. But there is no consensus on what steps, if any, institutions should take to approach this issue. In this article, we (...) argue that an institutional policy that prioritises some trials for recruitment ahead of others is ethically permissible and indeed prima facie preferable to alternative means of addressing recruitment competition. We motivate this view by appeal to the ethical importance of minimising the number of studies that begin but do not complete, thereby exposing their participants to unnecessary risks and burdens in the process. We then argue that a policy of prioritisation can be fair to relevant stakeholders, including participants, investigators and funders. Finally, by way of encouraging and helping to frame future debate, we propose some questions that would need to be addressed when identifying substantive ethical criteria for prioritising between studies. (shrink)

The practice of surgery requires consideration of a number of specific aspects of clinical medical ethics that are different from those most influential in other areas of medical care. The nature of surgical care alters the sense of responsibility that surgeons feel for their actions and also alters the relationship between surgeons and patients. Because surgical care requires patients to place such great trust in their surgeons, surgical informed consent must emphasize the importance of that trust. Surgeons must use (...) innovative means to solve individual patient problems even if the result is a novel operation. Surgical procedures may be altered due to the unexpected findings in the operating room and therefore surgeons must have considered how to respond in such situations. The future of surgical practice will inevitably lead to increasing ethical concerns in maintaining the ethical dimension of surgery, in allowing autonomy for trainees while maintaining patients’ safety, and in balancing surgical risks of prophylactic surgery with the genetic predisposition to develop cancer. (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)

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)

Clinical ethics, like the broader field of bioethics from which it emerged, is at a critical crossroads in its development, with conflicting paths ahead. It can either claim its distinctive place in the clinical arena, insisting unapologetically on certain minimal standards of professional training, practice and competence, addressing head on debates about various models of and methodological approaches to consultation, and establishing a shared vision of the purpose and meaning of the enterprise of clinical ethics itself. (...) Or, it can devolve into a hobby that untrained, albeit interested, and generally well intentioned individuals can dabble in for fun or even profit, as they see fit, and without regard to the deep history and rich disciplinary roots of the field, the serious debates in the academic literature of bioethics, the foundational case histories and legal theories, or even any sense of professional accountability. (shrink)

Bioethics laws in France have just undergone a revision process. The bioethics debate is often cast in terms of ethical principles and norms resisting emerging social and technological practices. This leads to the expression of confrontational attitudes based on widely differing interpretations of the same principles and values, and ultimately results in a deadlock. In this paper I would like to argue that focusing on values, as opposed to norms and principles, provides an interesting perspective on the evolution of norms. (...) As Joseph Raz has convincingly argued, “life-building” values and practices are closely intertwined. Precisely because values have a more indeterminate meaning than norms, they can be cited as reasons for action by concerned stakeholders, and thus can help us understand how controversial practices, e.g. surrogate motherhood, can be justified. Finally, norms evolve when the interpretations of the relevant values shift and cause a change in the presumptions implicit in the norms. Thus, norms are not a prerequisite of the ethical solution of practical dilemmas, but rather the outcome of the decision-making process itself. Struggling to reach the right decision in controversial clinical ethics situations indirectly causes social and moral values to change and principles to be understood differently. (shrink)

Clinical ethics, like the broader field of bioethics from which it emerged, is at a critical crossroads in its development, with conflicting paths ahead. It can either claim its distinctive place in the clinical arena, insisting unapologetically on certain minimal standards of professional training, practice and competence, addressing head on debates about various models of and methodological approaches to consultation, and establishing a shared vision of the purpose and meaning of the enterprise of clinical ethics itself. (...) Or, it can devolve into a hobby that untrained, albeit interested, and generally well intentioned individuals can dabble in for fun or even profit, as they see fit, and without regard to the deep history and rich disciplinary roots of the field, the serious debates in the academic literature of bioethics, the foundational case histories and legal theories, or even any sense of professional accountability. (shrink)