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

Decision-making depends on bringing evidence together with values: decision theory for example employs probabilities and utilities; health economic decisions employ measures such as quality of life. The hypothesis guiding this chapter is that bringing evidence together with values in clinical decision-making requires an exercise of phronesis. Our aim however is not to justify our guiding hypothesis. It is rather to outline an account of phronesis that is in principle fit for the purposes of (...) class='Hi'>clinical decision-making if our guiding hypothesis is correct. The chapter has three sections. Section 1 describes the growing gap between evidence and values in clinical decision-making: the missing link, we suggest, required to bridge this gap, is an appropriate account of phronesis. Section 2 provides an initial characterisation of the required account of phronesis via Michael Polanyi’s twin stipulation on the nature of tacit knowledge. Section 3 then fills out the required account using John McDowell’s characterisation of phronesis as a situation specific but at the same time conceptually structured form of practical discernment. A McDowellian account of phronesis, we argue, in satisfying Polanyi’s twin stipulation, provides an in-principle bridge between evidence and values. We conclude with a note on some of the further requirements if the gap is to be bridged not only in principle but in practice too. (shrink)

This book is about the ethical issues that clinicians encounter as they care for patients and is written to assist those who serve on hospital ethics committees as they deliberate about appropriate action in difficult ethical cases.

BackgroundHealthcare providers have to make ethically complex clinical decisions which may be a source of stress. Researchers have recently introduced Artificial Intelligence (AI)-based applications to assist in clinical ethical decision-making. However, the use of such tools is controversial. This review aims to provide a comprehensive overview of the reasons given in the academic literature for and against their use.MethodsPubMed, Web of Science, Philpapers.org and Google Scholar were searched for all relevant publications. The resulting set of publications (...) was title and abstract screened according to defined inclusion and exclusion criteria, resulting in 44 papers whose full texts were analysed using the Kuckartz method of qualitative text analysis.ResultsArtificial Intelligence might increase patient autonomy by improving the accuracy of predictions and allowing patients to receive their preferred treatment. It is thought to increase beneficence by providing reliable information, thereby, supporting surrogate decision-making. Some authors fear that reducing ethical decision-making to statistical correlations may limit autonomy. Others argue that AI may not be able to replicate the process of ethical deliberation because it lacks human characteristics. Concerns have been raised about issues of justice, as AI may replicate existing biases in the decision-making process.ConclusionsThe prospective benefits of using AI in clinical ethical decision-making are manifold, but its development and use should be undertaken carefully to avoid ethical pitfalls. Several issues that are central to the discussion of Clinical Decision Support Systems, such as justice, explicability or human–machine interaction, have been neglected in the debate on AI for clinical ethics so far.Trial registrationThis review is registered at Open Science Framework (https://osf.io/wvcs9). (shrink)

Zur patientenorientierten Behandlung bei nichteinwilligungsfähigen Patienten werden aktuell der Einbezug oder auch die Entscheidung durch ein Ethikkonsil oder klinisches Ethikkomitee (KEK) gefordert. Damit die Entscheidung des Entscheidungsträgers durch das KEK unterstützt werden kann, müssen Zuständigkeiten, Besetzung und Arbeitsweise des Gremiums klar umschrieben sein.

Objective: To determine the usefulness of Q methodology to locate and describe shared subjective influences on clinical decision making among participant physicians using hypothetical cases containing common ethical issues. Design: Qualitative study using by-person factor analysis of subjective Q sort data matrix. Setting: University medical center. Participants: Convenience sample of internal medicine attending physicians and house staff (n = 35) at one midwestern academic health sciences center. Interventions: Presented with four hypothetical cases involving urgent decision (...) making near the end of life, participants selected one of three specific clinical actions offered for each case. Immediately afterward and while considering their decision, each respondent sorted twenty-five subjective self-referent items in terms of the influence of each statement on their decision-making process. By-person factor analysis, where participants are defined as variates, yielded information about the attitudinal background the physicians brought to their consideration of each hypothetical case. We performed a second-order factor analysis on all of the subjective viewpoints to determine if a smaller core of shared attitudes existed across some or all of the four case vignettes. Factor scores for each item and post-sort comments from interviews conducted individually with each respondent guided the interpretation of ethical perspective used by these respondents in making clinical decisions about the cases. Measurements and Main Results: Second-order factor analysis on seventeen viewpoints used by physicians in the four hypothetical urgent decision cases revealed three moderately correlated (r 2 < 40%) subjective core attitudinal guides used broadly among all the cases and among sixteen of the seventeen original factors. Across all the cases, our participants were guided in general by: (1) patient-focused beneficence, (2) a patient- and surrogate-focused perspective that includes risk avoidance, and (3) best interest of the patient guided by ethical values. Economic impact on the physician, expediency in resolution of the situation, and the expense of medical treatment were not found to be influential determinants in this study. Conclusions: Q sorting and by-person factor analysis are useful qualitative methodological tools to study the complex structure of subjective attitudes that influence physicians in making medical decisions. This study revealed the subjective viewpoints used by our physician participants as they made ethically challenging treatment decisions. The three second-order factors identified here are grounded in current bioethical values as well as the personal traits of physicians. The participants' decision methods appear to resemble casuistry more than principle-based decision making. Generalizability of results will require further studies. (shrink)

Albert Jonsen and Stephen Toulmin have argued that the best way to resolve complex “moral” issues in clinical settings is to focus on the details of specific cases. This approach to medical decision-making, labeled ‘casuistry’, has met with much criticism in recent years. In response to this criticism, Carson Strong has attempted to salvage much of Jonsen’s and Toulmin’s version of casuistry. He concludes that much of their analysis, including Jonsen’s further elaboration about the casuistic methodology, is (...) on the mark. In this essay, the details of Jonsen’s and Toulmin’s version of casuistry and the major criticisms against their approach to clinical decision-making are explicated. Furthermore, it is argued that Strong’s salvage efforts fail to deflect these criticisms. The upshot of this analysis, which includes a few additional criticisms, is that Jonsen’s and Toulmin’s version of casuistry is not an appropriate framework from which to resolve complex “moral” issues in clinical settings. (shrink)

Medicine is incorporating genetic services into all avenues of health‐care, ranging from the rarest to the most common diseases. Cognitive theories of decision‐making still dominate professionals’ understanding of patient decision‐making about how to use genetic information and whether to have testing. I discovered a conceptual model of decision‐making while carrying out a phenomenological‐hermeneutic descriptive study of a convenience sample of 12 couples who were interviewed while deciding whether to undergo prenatal genetic testing.Thirty‐two interviews (...) were conducted with 12 men and 12 women separately. Interviews were transcribed verbatim and all data were analyzed using three levels of coding that were sorted into 30 categories and then abstracted into three emergent meta‐themes that described men's and women's attempts to make sense and find meaning in how to best use prenatal genetic technology. Their descriptions of how they thought about, communicated, and coped with their decision were so detailed it was possible to discern nine different types of thinking they engaged in while deciding to accept or decline testing.They believed that decision‐making is a process of working through your own personal style of thinking. This might include only one or any combination of the following types of thinking: analytical, ethical, moral, reflective, practical, hypothetical, judgmental, scary, and second sight, as described in detail by these 12 couples. (shrink)

The purpose of this paper is to propose a model of clinical-ethical decision making which will assist the health care professional to arrive at an ethically defensible judgment. The model highlights the integration between ethics and decision making, whereby ethics as a systematic analytic tool bring to bear the positive aspects of the decision making process. The model is composed of three major elements. The ethical component, the decision making component and (...) the contextual component. The latter incorporates the relational aspects between the provider and the patient and the organizational structure. The model suggests that in order to arrive at an ethically, justifiable sound decision one make reference to those three elements. (shrink)

Now in its fourth edition, Rational Diagnosis and Treatment: Evidence-Based Clinical Decision - Making is a unique book to look at evidence-based medicine and the difficulty of applying evidence from group studies to individual patients._ The book analyses the successive stages of the decision process and deals with topics such as the examination of the patient,_the reliability of clinical data, the logic of diagnosis, the fallacies of uncontrolled therapeutic experience and the need for randomised (...) clinical trials and meta-analyses. It is the main theme of the book that, whenever possible, clinical decisions must be based on the evidence from clinical research, but the authors also explain the pitfalls of such research and the problems involved in applying evidence from groups of patients to the individual patient._ For this new edition, the sections on placebo and meta-analysis and on alternative medicine have been thoroughly updated, and there is more focus on insufficient reporting of harms of interventions. The sections on different research designs describe advantages and limitations, and the increased medicalisation and the effects of cancer screening on health people are noted. A section on academic freedom when clinicians collaborate with industry and ghost authors is added._ This essential reference work integrates the science and statistical approach of evidence-based medicine with the art and humanism of medical practice; distinguishing between data, sets of data, knowledge and wisdom, and their application. Such an intellectually challenging book is ideal for both medical students and doctors who require theoretical and practical clinical skills to help ensure that they apply theory in practice. (shrink)

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

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)

This book is about the ethical issues that clinicians encounter as they care for patients and is written to assist those who serve on hospital ethics committees as they deliberate about appropriate action in difficult ethical cases.

Phenomenology gives rise to certain ontological considerations that have far-reaching implications for standard conceptions of patient autonomy in medical ethics, and, as a result, the obligations of and to patients in clinical decision-making contexts. One such consideration is the phenomenological reduction in classical phenomenology, a core feature of which is the characterisation of our primary experiences as immediately and inherently meaningful. This paper builds on and extends the analyses of the phenomenological reduction in the works of Husserl, (...) Heidegger, and Merleau-Ponty in order to identify and explain its implications for our current understanding of the principle of respect for patient autonomy and the norms of clinical decision making. (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)

As the United States population ages, there is a growing group of aging, elderly, individuals who may consider "preemptive suicide"(Prado, 1998). Healthy aging patients who preemptively attempt to end their life by suicide and who have clearly expressed a desire not to have life -sustaining treatment present a clinical and public policy challenge. We describe the clinical, ethical, and medical-legal decision making issues that were raised in such a case that presented to an academic emergency department. (...) We also review and evaluate a decision making process that emergency physicians confront when faced with such a challenging and unusual situation. (shrink)

Although people who endorse conspiracy theories related to medicine often have negative attitudes toward particular health care measures and may even shun the healthcare system in general, conspiracy theories have received rather meager attention in bioethics literature. Consequently, and given that conspiracy theorizing appears rather prevalent, it has been maintained that there is significant need for bioethics debate over how to deal with conspiracy theories. While the proposals have typically focused on the effects that unwarranted conspiracy theories have in (...) the public health context, Nathan Stout's recent argument concentrates on the impacts that such theories have at the individual level of clinical decision‐making. In this article, I maintain that duly acknowledging the impacts of conspiracy theories that raise Stout's concern does not require bioethics debate over the proper response to the influence of conspiracy theories in healthcare. Having evaluated two possible objections, I conclude by briefly clarifying the purported import of the response to Stout. (shrink)

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

Health care decision making for patients without decisional capacity is ethically and legally challenging. Advance directives (living wills) have proved to be of limited usefulness in clinical practice. Therefore, academic attention should focus more on substitute decision making by the next of kin. In this article, we comparatively analyse the legal approaches to substitute medical decision making in England and Germany. Based on the current ethico-legal discourse in both countries, three aspects of substitute (...) decision making will be highlighted: (1) Should there be a legally predefined order of relatives who serve as health care proxies? (2) What should be the respective roles and decisional powers of patient-appointed versus court-appointed substitute decision-makers? (3) Which criteria should be determined by law to guide substitute decision-makers? (shrink)

Decision making is a key activity, perhaps the most important activity, in the practice of healthcare. Although physicians acquire a great deal of knowledge and specialised skills during their training and through their practice, it is in the exercise of clinical judgement and its application to individual patients that the outstanding physician is distinguished. This has become even more relevant as patients become increasingly welcomed as partners in a shared decision making process. This book translates (...) the research and theory from the science of decision making into clinically useful tools and principles that can be applied by clinicians in the field. It considers issues of patient goals, uncertainty, judgement, choice, development of new information, and family and social concerns in healthcare. It helps to demystify decision theory by emphasizing concepts and clinical cases over mathematics and computation. (shrink)

The informed consent is an ethical and legal requirement for potential participants to enroll in a study. There is ample of evidence that understanding consent information and enrollment is challenging for participants in clinical trials. On the other hand, the reasoning process behind decision-making in HIV clinical trials remains mostly unexplored. This study aims to examine the decision-making process of people living with HIV currently participating in antiretroviral clinical trials and their understanding of (...) informed consent. We conducted a qualitative socio-constructivist study using semi-structured interviews. Eleven participants were selected by purposive sampling in Argentina until data saturation was reached. A content analysis was performed. The findings highlight the fact that some participants decided to enroll on the spot, while others made the decision a few days later. In all cases, the decision was based on different aspects of trust (in doctors, in the clinical research site, in the clinical trials system) but also on emotions associated with HIV and/or treatment. Moreover, while people living with HIV felt truly informed after the consent dialogue with a researcher, consent forms were unintelligible and unfriendly. The immediacy of patient decision-making has rarely been described before. Enrollment in an HIV clinical trial is mainly a trust-based decision but this does not contradict the ethical values of autonomy, voluntariness, non-manipulation, and non‐exploitation. Thus, trust is a key issue to be included in reshaping professional practices to ensure the integrity of the informed consent process. (shrink)

This article reviews the strengths and limitations of five major paradigms of medical computer-assisted decision making (CADM): (1) clinical algorithms, (2) statistical analysis of collections of patient data, (3) mathematical models of physical processes, (4) decision analysis, and (5) symbolic reasoning or artificial intelligence (Al). No one technique is best for all applications, and there is recent promising work which combines two or more established techniques. We emphasize both the inherent power of symbolic reasoning and the (...) promise of artificial intelligence and the other techniques to complement each other. Keywords: Diagnosis, Computer Assisted Decision Making, Artificial Intelligence * Current address: Intelligenetics, 124 University Avenue, Palo Alto, CA. 94301, U.S.A. ** Dr. Shortliffe is a Henry J. Kaiser Family Foundation Faculty Scholar in General Internal Medicine and recipient of research career development award LM0048 from the National Library of Medicine. CiteULike Connotea Del.icio.us What's this? (shrink)

In caring for pediatric patients, a multifaceted approach in decision-making is utilized. The role of the medical team in complementary and alternative medicine is controversial. In cases of conventional treatment refusal by parents in pursuit of complementary and alternative medicine, there must be balanced decision-making, autonomy, and the best interest of the child. This report highlights two illustrative cases of patients with brain tumor, whereby parents refused postoperative conventional therapy involving chemoradiotherapy, in pursuit of (...) complementary and alternative medicine alone. Parental decision-making in complementary and alternative medicine, in lieu of medical recommendations, poses an ethical and legal dilemma that may impede care of the pediatric patient and compromise outcome of oncological care. (shrink)

Background Non-invasive prenatal testing (NIPT), which can screen for aneuploidies such as trisomy 21, is being implemented in several public healthcare systems across Europe. Comprehensive communication and information have been highlighted in the literature as important elements in supporting women’s reproductive decision-making and addressing relevant ethical concerns such as routinisation. Countries such as England and France are adopting broadly similar implementation models, offering NIPT for pregnancies with high aneuploidy probability. However, we do not have a deeper understanding of (...) how professionals’ counselling values and practices may differ between these contexts. Methods In this paper, we explore how professionals in England and France support patient decision-making in the provision of NIPT and critically compare professional practices and values. We draw on data from semi-structured interviews with healthcare professionals. Results Both English and French professionals emphasised values relating to patient choice and consent. However, understandings and application of these values into the practice of NIPT provision differed. English interviewees placed a stronger emphasis on interpreting and describing the process of counselling patients and clinical care through a “principle” lens. Their focus was on non-directiveness, standardisation, and the healthcare professional as “decision-facilitator” for patients. French interviewees described their approach through a “procedural” lens. Their focus was on formal consent, information, and the healthcare professional as “information-giver”. Both English and French professionals indicated that insufficient resources were a key barrier in effectively translating their values into practice. Conclusion Our findings illustrate that supporting patient choice in the provision of NIPT may be held as an important value in common on a surface level, but can be understood and translated into practice in different ways. Our findings can guide further research and beneficially inform practice and policy around NIPT provision. (shrink)

This article reviews the strengths and limitations of five major paradigms of medical computer-assisted decision making (CADM): (1) clinical algorithms, (2) statistical analysis of collections of patient data, (3) mathematical models of physical processes, (4) decision analysis, and (5) symbolic reasoning or artificial intelligence (Al). No one technique is best for all applications, and there is recent promising work which combines two or more established techniques. We emphasize both the inherent power of symbolic reasoning and the (...) promise of artificial intelligence and the other techniques to complement each other. (shrink)

Much discussion of decision-making processes in medicine has been patient-centred. It has been assumed that there is, most often, one patient. Less attention has been given to shared decision-making processes where two or more patients are involved. This article aims to contribute to this special area. What conditions need to be met if decision-making can be said to be shared? What is a shared decision-making process and what is a shared autonomous (...) decision-making process? Why make the distinction? Examples are drawn from the area of new reproductive medicine and clinical genetics. Possible gender-differences in shared decision-making are discussed. (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)

Clinical judgment has traditionally been left to be acquired chiefly through personal experience and conversations with experienced practitioners. Given the explosion of knowledge and technology of recent years, a more lystematic approach to managing information has become increasingly important. Ethical issues, both of a social and more individual nature, also increasingly demand attention. This paper describes one effort to address these problems through medical education. A three quarter pre-clinical course was revised to incorporate decision analysis and ethical (...) analysis. The approach, results and problems of the two-year-old innovation are discussed, and general recommendations are offered. (shrink)

AimIn case of extremely rare diseases, case reports are often the only experience to draw from for evidence-based management. Carmi syndrome is a rare, mostly lethal combination of junctional epidermolysis bullosa and pyloric atresia. During an ethical board, there were differences in perception of mortality rate. We tested the hypothesis that the cumulative mortality of single case reports is lower than that of multiple case series.CaseA baby girl was born at 33 weeks gestation with Carmi syndrome. The treatment options discussed (...) in an interdisciplinary ethics board were a palliative approach versus surgical gastrojejunostomy. Because about one third of operated children described in case reports survived, we opted for surgical treatment. The patient died a painful death 4 weeks later.MethodsThe PubMed database was systematically searched for reports of Carmi syndrome. Single case reports were compared to case series in terms of outcome.ResultsA total of 102 cases of Carmi syndrome were identified in the literature. Mortality of single case reports was 17 out of 27 patients (63%), while that of case series was higher at 62 out of 74 patients (84%,p = 0.036).ConclusionsSelection and publication bias may lead to inflation of survival rates in single case reports because successful cases are more likely to be published in the literature. These biases may lead to inappropriately aggressive treatment in futile cases. Clinicians should be cautious when discussing prognosis and making decisions based on the cumulative experience of case reports of extremely rare or novel diseases. (shrink)

Walton offers a comprehensive, flexible model for physician-patient decision making, the first such tool designed to be applied at the level of each particular case. Based on Aristotelian practical reasoning, it develops a method of reasonable dialogue, a question- and-answer process of interaction leading to informed consent on the part of the patient, and to a decision--mutually arrived at--reflecting both high medical standards and the patient's felt needs. After setting forth his model, he applies it to three (...) vital ethical issues: acts of omission, the cessation of treatment, and possible side effects of treatments. In the final chapter, Walton shows how his method functions in light of the real-life complexities of the clinical encounter and how it bears on ethical questions concerning health-care policy, attitudes toward treatment and toward the medical profession, reasonableness of expectations, and the setting of realistic goals of treatment. (shrink)

Over several decades, ethics and law have been applied to medical education and practice in a way that reflects the continuation during the twentieth century of the strong distinction between facts and values. We explain the development of applied ethics and applied medical law and report selected results that reflect this applied model from an empirical project examining doctors’ decisions on withdrawing/withholding treatment from patients who lack decision-making capacity. The model is critiqued, and an alternative “constitutive” model is (...) supported on the basis that medicine, medical law, and medical ethics exemplify the inevitable entanglement of facts and values. The model requires that ethics and law be taught across the medical education curriculum and integrated with the basic and clinical sciences and that they be perceived as an integral component of medical evidence and practice. Law, in particular, would rank as equal in normative authority to the relevant clinical scientific “facts” of the case, with graduating doctors having as strong a basic command of each category as the other. The normalization of legal knowledge as part of the clinician’s evidence base to be utilized in practice may provide adequate consolation for clinicians who may initially resent further perceived incursions on their traditional independence and discretion. (shrink)

The state of the art of contemporary philosophy and psychiatry is reviewed. Section 1 describes the new field as an international open society of ideas. Section 2 introduces values-based practice. Although originally a philosophy-into-practice initiative, values-based practice is now developing more strongly in areas of bodily medicine such as surgery. An example from surgery illustrates how values-based practice has been implemented as a partner to evidence-based practice in supporting shared clinical decision-making as the basis of best (...) practice in contemporary person-centered clinical care. Section 3 explores the difficulties presented by implementing values-based practice in mental health as illustrated by a case example of anorexia. This shows that these difficulties derive from the particularly intense challenges of values pluralism presented by anorexia. The resources of phenomenology provide the basis for an effective response to these challenges. Section 4 generalizes the argument of Section 3 showing that an effective response to the wider range of challenges of values pluralism arising across the board in mental health is available from the resources of the international open society of ideas of contemporary philosophy and psychiatry. The article concludes with a promissory note on values and a cautionary note on science. (shrink)

Advances in psychopharmacology raise the prospects of enhancing neurocognitive functions of humans by improving attention, memory, or mood. While general ethical reflections on psychopharmacological enhancement have been increasingly published in the last years, ethical criteria characterizing physicians’ role in neurocognitive enhancement and guiding their decision-making still remain highly unclear. Here it will be argued that also in the medical domain the use of cognition-enhancing drugs is not intrinsically unethical and that, in fact, physicians should assume an important role (...) in gating their usage. For finding normative orientation, concepts of disease, normality or medicine will not be helpful since—due to their cryptonormative nature—they rather hamper than allow targeted discussion and decision-making. As an alternative, the common and widely accepted bioethical criteria of beneficence, non-maleficence, autonomy and distributive justice allow a clinically applicable, highly differentiated context- and case-sensitive approach. By embedding decision-making in a participative physician–patient relationship extrinsic objections against neurocognitive enhancement (e.g. invalid perceptions about efficacy, benefit or risk; questionable voluntariness; restrained decision-making capacity) can be curtailed. (shrink)

During the last thirty years different methods have been proposed in order to manage and resolve ethical quandaries, specially in the clinical setting. Some of these methodologies are based on the principles of Decision-making theory. Others looked to other philosophical traditions, like Principlism, Hermeneutics, Narrativism, Casuistry, Pragmatism, etc. This paper defends the view that deliberation is the cornerstone of any adequate methodology. This is due to the fact that moral decisions must take into account not only principles (...) and ideas, but also emotions, values and beliefs. Deliberation is the process in which everyone concerned by the decision is considered a valid moral agent, obliged to give reasons for their own points of view, and to listen to the reasons of others. The goal of this process is not the reaching of a consensus but the enrichment of one's own point of view with that of the others, increasing in this way the maturity of one's own decision, in order to make it more wise or prudent. In many cases the members of a group of deliberation will differ in the final solution of the case, but the confrontation of their reasons will modify the perception of the problem of everyone. This is the profit of the process. Our moral decisions cannot be completely rational, due to the fact that they are influenced by feelings, values, beliefs, etc., but they must be reasonable, that is, wise and prudent. Deliberation is the main procedure to reach this goal. It obliges us to take others into account, respecting their different beliefs and values and prompting them to give reasons for their own points of view. This method has been traditional in Western clinical medicine all over its history, and it should be also the main procedure for clinical ethics. (shrink)

Background Given that AI-driven decision support systems (AI-DSS) are intended to assist in medical decision making, it is essential that clinicians are willing to incorporate AI-DSS into their practice. This study takes as a case study the use of AI-driven cardiotography (CTG), a type of AI-DSS, in the context of intrapartum care. Focusing on the perspectives of obstetricians and midwives regarding the ethical and trust-related issues of incorporating AI-driven tools in their practice, this paper explores the conditions (...) that AI-driven CTG must fulfill for clinicians to feel justified in incorporating this assistive technology into their decision-making processes regarding interventions in labor. Methods This study is based on semi-structured interviews conducted online with eight obstetricians and five midwives based in England. Participants were asked about their current decision-making processes about when to intervene in labor, how AI-driven CTG might enhance or disrupt this process, and what it would take for them to trust this kind of technology. Interviews were transcribed verbatim and analyzed with thematic analysis. NVivo software was used to organize thematic codes that recurred in interviews to identify the issues that mattered most to participants. Topics and themes that were repeated across interviews were identified to form the basis of the analysis and conclusions of this paper. Results There were four major themes that emerged from our interviews with obstetricians and midwives regarding the conditions that AI-driven CTG must fulfill: (1) the importance of accurate and efficient risk assessments; (2) the capacity for personalization and individualized medicine; (3) the lack of significance regarding the type of institution that develops technology; and (4) the need for transparency in the development process. Conclusions Accuracy, efficiency, personalization abilities, transparency, and clear evidence that it can improve outcomes are conditions that clinicians deem necessary for AI-DSS to meet in order to be considered reliable and therefore worthy of being incorporated into the decision-making process. Importantly, healthcare professionals considered themselves as the epistemic authorities in the clinical context and the bearers of responsibility for delivering appropriate care. Therefore, what mattered to them was being able to evaluate the reliability of AI-DSS on their own terms, and have confidence in implementing them in their practice. (shrink)

Background While there are many guidelines on how to make ethical decisions at the end of life, there is little evidence regarding the quality of this sort of ethical guidelines. Objectives First, this study aims to demonstrate the conceptual transferability of the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument for the quality assessment of ethical guidelines. Second, it aims to illustrate the status quo of the quality of guidelines on end-of-life decision-making by using the AGREE instrument (...) in a first practice test. Method The transferability of the AGREE instrument on the quality assessment of ethical guidelines is demonstrated by conceptual analysis. Guidelines on end-of-life decisions in medicine are identified through a systematic search in MEDLINE (from June 1999 to June 2009). The quality of all included guidelines was assessed with a slightly modified AGREE instrument. Results Of 103 guidelines identified, 34 were included as relevant. The majority of the guidelines analysed in this study were assessed as qualitatively insufficient in five out of six AGREE quality domains. A few guidelines demonstrated, however, that a high level of quality in accordance with the AGREE requirements is possible. Conclusion This review concludes that the quality of many ethical guidelines should and can be improved in all quality domains specified by the AGREE instrument. Furthermore, conceptual analysis indicates that a slightly modified AGREE instrument is transferable to the comprehensive evaluation of the quality of ethical guidelines. Nevertheless, future research is needed to improve the assessment of the presentation of the guidelines' normative basis. (shrink)

One of the main challenges in medicine is to guarantee an appropriate drug supply according to the real needs of patients. Closed-loop strategies have been widely used to develop automatic solutions based on feedback variables. However, when the variable of interest cannot be directly measured or there is a lack of knowledge behind the process, it turns into a difficult issue to solve. In this research, a novel algorithm to approach this problem is presented. The main objective of this (...) study is to provide a new general algorithm capable of determining the influence of a certain clinical variable in the decision making process for drug supply and then defining an automatic system able to guide the process considering this information. Thus, this new technique will provide a way to validate a given physiological signal as a feedback variable for drug titration. In addition, the result of the algorithm in terms of fuzzy rules and membership functions will define a fuzzy-based decision system for the drug delivery process. The method proposed is based on a Fuzzy Inference System whose structure is obtained through a decision tree algorithm. A four-step methodology is then developed: data collection, preprocessing, Fuzzy Inference System generation, and the validation of results. To test this methodology, the analgesia control scenario was analysed. Specifically, the viability of the Analgesia Nociception Index as a guiding variable for the analgesic process during surgical interventions was studied. Real data was obtained from fifteen patients undergoing cholecystectomy surgery. (shrink)

Introduction: This study, the first of its kind in Iran, was to assess Iranian patients’ preferences for receiving information and participating in decision-making and to evaluate their satisfaction with how medical information is given to them and with their participation in decision-making at present. Method and materials: 299 of 312 eligible patients admitted to general internal medicine or surgery wards from May to December 2006 were interviewed according to a structured questionnaire. The questionnaire contained questions (...) about patients’ preferences regarding four domains of information and their participation in decision-making. Patients’ responses were measured on a visual analogue scale graded from 1 to 10. Results: The mean (SD) score for desire to receive information was 8.88 out of 10 (1.5) and for participation in medical decision-making was 7.75 out of 10 (3). The desire to receive information was greater in women than men (9.0 (1.5) vs 7.8 (1.4), p = 0.025). It was also correlated with their education (r = 0.2, p = 0.001) and their estimation of the severity of their own disease (r = 0.13, p = 0.027). The score for preference to participate in decision-making was higher in women than in men (7.95 (2.8) and 7.0 (3.2), respectively; β = 0.8, p = 0.022) and was negatively correlated with education (r = −0.14, p = 0.015). Discussion: This study shows that Iranian patients are highly interested in receiving information about their condition and participating in clinical decision-making. No predictive variable for such attitudes was found; therefore, the only way for the physician to recognise patients’ desire is to ask them explicitly. (shrink)

What role, if any, should emotions play in clinical reasoning and decision making? Traditionally, emotions have been excluded from clinical reasoning and decision making, but with recent advances in cognitive neuropsychology they are now considered an important component of them. Today, cognition is thought to be a set of complex processes relying on multiple types of intelligences. The role of mathematical logic or verbal linguistic intelligence in cognition, for example, is well documented and accepted; (...) however, the role of emotional intelligence has received less attention—especially because its nature and function are not well understood. In this paper, I argue for the inclusion of emotions in clinical reasoning and decision making. To that end, developments in contemporary cognitive neuropsychology are initially examined and analyzed, followed by a review of the medical literature discussing the role of emotions in clinical practice. Next, a published clinical case is reconstructed and used to illustrate the recognition and regulation of emotions played during a series of clinical consultations, which resulted in a positive medical outcome. The paper’s main thesis is that emotions, particularly in terms of emotional intelligence as a practical form of intelligence, afford clinical practitioners a robust cognitive resource for providing quality medical care. (shrink)

This article will be concerned with the phenomenon of vitality, which emerged as one of the main findings in a larger grounded theory study about life and death decisions in hospitals' neonatal units. Definite signs showing the new-born infant's energy and vigour contributed to the clinician's judgements about life expectancy and the continuation or termination of medical treatment. In this paper we will discuss the normative importance of vitality as a diagnostic cue and will argue that vitality, as a sign (...) perceived by doctors and nurses, has moral significance and represents a legitimate contribution to clinical decision-making in difficult cases where the child's life is at stake. We will argue that these clinical intuitions can be justified on a moral basis but only with certain qualifications that accounts for a certain objectivity and intersubjective reliability in the therapeutic judgements. (shrink)

Aristotle’s ethical system was guided by his vision of human flourishing (also, but potentially misleadingly, translated as happiness). For Aristotle, human flourishing was a rich holistic concept about a life lived well until its ending. Both living a long life and dying well were integral to the Aristotelian ideal of human flourishing. Using Aristotle’s concept of human flourishing to inform the goals of medicine has the potential to provide guidance to clinical decision-makers regarding the provision of burdensome (...) treatments, such as intensive care treatment, where pursuing a chance of survival must be balanced against the risk of exposing patients to a negative dying experience. By conceptually uniting potentially competing goals of medicine, such as prolonging life and the promotion of peaceful deaths, Aristotle’s understanding of human flourishing creates an argument for the integration of palliative care considerations into intensive care decision-making and for advanced care planning with healthy patients. (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)

Within the evidence-based medicine construct, clinical expertise is acknowledged to be both derived from primary experience and necessary for optimal medical practice. Primary experience in medical practice, however, remains undervalued. Clinicians’ primary experience tends to be dismissed by EBM as unsystematic or anecdotal, a source of bias rather than knowledge, never serving as the “best” evidence to support a clinical decision. The position that clinical expertise is necessary but that primary experience is untrustworthy in (...) class='Hi'>clinical decision-making is epistemically incoherent. Here we argue for the value and utility of knowledge gained from primary experience for the practice of medicine. Primary experience provides knowledge necessary to diagnose, treat, and assess response in individual patients. Hierarchies of evidence, when advanced as guides for clinical decisions, mistake the relationship between propositional and experiential knowledge. We argue that primary experience represents a kind of medical knowledge distinct from the propositional knowledge produced by clinical research, both of which are crucial to determining the best diagnosis and course of action for particular patients. (shrink)