American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locus of decision making, as well as the risks and benefits of testing, and (2) whether the guidelines conflict (...) or come to different but compatible conclusions because they consider different testing scenarios. These statements differ in ethically significant ways. AAP/ACMG analyzes risks and benefits using best interests of the child and recommends that, absent ameliorative interventions available during childhood, clinicians should generally decline to order testing. Parents authorize focused tests. ACMG analyzes risks and benefits using the interests of the child and other family members and recommends that sequencing results be examined for additional variants that can lead to ameliorative interventions, regardless of age, which laboratories should report to clinicians who should contextualize the results. Parents must accept additional analysis. The ethical arguments in these statements appear to be in tension with each other. (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)

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)

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)

Built-in decision thresholds for AI diagnostics are ethically problematic, as patients may differ in their attitudes about the risk of false-positive and false-negative results, which will require that clinicians assess patient values.

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)

The paper reports results of the very first survey-based study on the prevalence, frequency and nature of ethical or other non-medical difficulties faced by Polish physicians in their everyday clinical practice. The study involved 521 physicians of various medical specialties, practicing mainly in inpatient healthcare. The study showed that the majority of Polish physicians encounter ethical and other non-medical difficulties in making clinical decisions. However, they confront such difficulties less frequently than their foreign peers. Moreover, Polish doctors (...) indicate different circumstances as a source of the experienced problems. The difficulties most often reported relate to (i) patients (or their proxies) requests for medically non-indicated interventions; (ii) problems with communication with patients (or their proxies) due to the patients’ negative attitude, unwillingness to cooperate, or aggression; and (iii) various difficulties with obtaining informed consent. Polish physicians report difficulties associated with disagreements among care givers or scarcity of resources less frequently than doctors from other countries. The study’s findings provide support for the thesis that a significant portion of Polish physicians still follow a traditional, paternalistic, and hierarchical model of healthcare practice. Instead of promoting patient’s empowerment, engagement, and rights, they often consider these ideas as a threat to physicians’ professional authority and autonomy. The study leads to the conclusion that due to insufficient training in medical ethics, communication skills, and medical law, many Polish physicians lack the knowledge and competence necessary to adequately respond to challenges posed by modern healthcare practice. (shrink)

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)

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)

ZusammenfassungDie finanziellen Ressourcen im deutschen Gesundheitssystem sind begrenzt. Diese Mittelknappheit führt im Rahmen der ärztlichen Tätigkeit zu medizinischen, ökonomischen, juristischen und ethischen Problemen, welche sich in den kommenden Jahren weiter verschärfen dürften. Aus ethischer Perspektive sind die Probleme einer gerechten Verteilung knapper Ressourcen sowie mögliche Rollen- oder Gewissenskonflikte der ärztlichen Profession besonders relevant. Mit Hilfe von qualitativen Interviewstudien lässt sich der aktuelle ärztliche Umgang mit der Mittelknappheit in der klinischen Versorgung in seiner Komplexität und seinen ethisch relevanten Aspekten untersuchen. An (...) fünf Kliniken mit unterschiedlichem Versorgungsauftrag wurden Tiefeninterviews mit fünfzehn leitenden Ärzten in den Bereichen Intensivmedizin und Kardiologie durchgeführt. Die auf Tonband aufgezeichneten Interviews wurden nach dem Verfahren der Grounded Theory ausgewertet. Die Ärzte berichten ein heterogenes Spektrum von Einflussfaktoren, Konsequenzen und Reaktionen im Zusammenhang mit ihrem Handeln bei Mittelknappheit. Zuteilungskriterien wie der medizinische Nutzen oder die Kosteneffektivität werden von den befragten Ärzten sehr unterschiedlich interpretiert und führen damit möglicherweise zu inkonsistenten Allokationsentscheidungen. Gleichzeitig bestätigen die Untersuchungen aber auch, dass die Ärzte nicht leichtfertig mit den Allokationsentscheidungen umgehen, im Gegenteil: Die Mittelknappheit und die dadurch hervorgerufenen Verteilungsprobleme können zu Gewissenskonflikten, emotionalem Stress und Gefühlen der Überforderung führen. Um Lösungskonzepte für ethische Probleme im Umgang mit der Mittelknappheit in der klinischen Praxis entwickeln und erfolgreich implementieren zu können, müssen die in dieser Arbeit systematisch zusammengestellten Verständnisweisen, Einflussfaktoren und Konsequenzen im Zusammenhang mit dem Kostendruck berücksichtigt werden. (shrink)

This paper demonstrates how argumentation schemes can be used in decision support systems that help clinicians in making treatment decisions. The work builds on the use of computational argumentation, a rigorous approach to reasoning with complex data that places strong emphasis on being able to justify and explain the decisions that are recommended. The main contribution of the paper is to present a novel set of specialised argumentation schemes that can be used in the context of a (...) class='Hi'>clinical decision support system to assist in reasoning about what treatments to offer. These schemes provide a mechanism for capturing clinical reasoning in such a way that it can be handled by the formal reasoning mechanisms of formal argumentation. The paper describes how the integration between argumentation schemes and formal argumentation may be carried out, sketches how this is achieved by an implementation that we have created and illustrates the overall process on a small set of case studies. (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 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)

Philosopy of medicine focuses inter alia on metaphysics and epistemology that are instantiated in biomedicine as physicalism (or materialism) and empiricism. The Golubchuck case reveals how the clinicans failed to recognize the relation between medical science and medical ethics and made biomedical decsions devoid of medical ethics. That is, they failed to make medical judgments that by defintion include a normative ethical component.

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)

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)

Artificially intelligent systems (AISs) are being created by software developing companies (SDCs) to influence clinical decision‐making. Historically, clinicians have led healthcare decision‐making, and the introduction of AISs makes SDCs novel actors in the clinical decision‐making space. Although these AISs are intended to influence a clinician's decision‐making, SDCs have been clear that clinicians are in fact the final decision‐makers in clinical care, and that AISs can only inform their decisions. As such, the default position is that clinicians (...) should hold responsibility for the outcomes of the use of AISs. This is not the case when an AIS has influenced a clinician's judgement and their subsequent decision. In this paper, we argue that this is an imbalanced and unjust position, and that careful thought needs to go into how personal moral responsibility for the use of AISs in clinical decision‐making should be attributed. This paper employs and examines the difference between prospective and retrospective responsibility and considers foreseeability as key in determining how personal moral responsibility can be justly attributed. This leads us to the view that moral responsibility for the outcomes of using AISs in healthcare ought to be shared by the clinical users and SDCs. (shrink)

When a patient's treatment decisions are the product of delusion, this is often taken as a paradigmatic case of undermined decisional capacity. That is to say, when a patient refuses treatment on the basis of beliefs that in no way reflect reality, clinicians and ethicists tend to agree that their refusal is not valid. During the COVID-19 pandemic, however, we have witnessed many patients refuse potentially life-saving interventions not based on delusion but on conspiracy beliefs. Importantly, many of the (...) beliefs espoused by conspiracy theorists resemble delusions in a number of relevant ways. For instance, conspiracy beliefs often posit states of affairs that could not possibly exist in the world, they are recalcitrant in the face of disconfirming evidence, and they tend to put the believer in a state of paranoia. Given these similarities, how should we think about conspiracy theorists' capacity for making clinical decisions? In this paper, I attempt to answer this question by first offering an account of just what makes some set of beliefs count as a conspiracy theory. Second, I attempt to disambiguate conspiracy beliefs from delusions by exploring important conceptual and psychological features of both. Finally, I apply standard criteria for assessing a patient's decision-making capacity to instances of conspiracy beliefs and argue that, although the picture is muddy, there may be cases in which conspiracy beliefs undermine capacity. I end by exploring the implications that this might have for surrogate decision-making and addressing potential objections. (shrink)

Background: Patient autonomy has been promoted as the most important principle to guide difficult clinical decisions. To examine whether practising physicians indeed value patient autonomy above other considerations, physicians were asked to weight patient autonomy against three other criteria that often influence doctors’ decisions. Associations between physicians’ religious characteristics and their weighting of the criteria were also examined. Methods: Mailed survey in 2007 of a stratified random sample of 1000 US primary care physicians, selected from the American (...) Medical Association masterfile. Physicians were asked how much weight should be given to the following: (1) the patient’s expressed wishes and values, (2) the physician’s own judgment about what is in the patient’s best interest, (3) standards and recommendations from professional medical bodies and (4) moral guidelines from religious traditions. Results: Response rate 51% (446/879). Half of physicians (55%) gave the patient’s expressed wishes and values “the highest possible weight”. In comparative analysis, 40% gave patient wishes more weight than the other three factors, and 13% ranked patient wishes behind some other factor. Religious doctors tended to give less weight to the patient’s expressed wishes. For example, 47% of doctors with high intrinsic religious motivation gave patient wishes the “highest possible weight”, versus 67% of those with low (OR 0.5; 95% CI 0.3 to 0.8). Conclusions: Doctors believe patient wishes and values are important, but other considerations are often equally or more important. This suggests that patient autonomy does not guide physicians’ decisions as much as is often recommended in the ethics literature. (shrink)

This paper is predicated on the understanding that clinical encounters between clinicians and patients should be seen primarily as inter-relations among persons and, as such, are necessarily moral encounters. It aims to relocate the discussion to be had in challenging medical decision-making situations, including, for example, as the end of life comes into view, onto a more robust moral philosophical footing than is currently commonplace. In our contemporary era, those making moral decisions must be cognizant of the existence (...) of perspectives other than their own, and be attuned to the demands of inter-subjectivity. Applicable to clinical practice, we propose and justify a Habermasian approach as one useful means of achieving what can be described as dialogic consensus. The Habermasian approach builds around, first, his discourse theory of morality as universalizable to all and, second, communicative action as a cooperative search for truth. It is a concrete way to ground the discourse which must be held in complex medical decision-making situations, in its actual reality. Considerations about the theoretical underpinnings of the application of dialogic consensus to clinical practice, and potential difficulties, are explored. (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)

Statistics is the science of collection, summarizing, presentation and interpretation of data. Moreover, it yields methods used in the verification of research hypotheses. The presence of a statistician in a research group remarkably improves both the quality of design and research and the optimization of financial resources. Moreover, the involvement of a statistician in a research team helps the physician to effectively utilize the time and energy spent on diagnosing, which is an important aspect in view of limited healthcare resources. (...) Precise, properly designed and implemented Computerized Clinical Decision Support Systems certainly lead to the improvement of healthcare and the quality of medical services, which increases patient satisfaction and reduces financial burdens on healthcare systems. (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 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)

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)

Hastings Center Report, Volume 52, Issue 1, Page 2-2, January/February 2022.

Transtheoretical integrative decision-making models help clinicians to use patient factors that are known to predict outcomes in order to inform individualized treatment. Patient factors with a strong evidence base include: functional impairment, social support and interpersonal functioning, complexity and comorbidity, coping style, level of resistance, and subjective distress. Among those with binge-eating disorder (BED), patient factors have not been extensively characterized relative to norms or other clinical samples. We used an integrative decision-making model of these six domains of patient (...) factors related to patient outcomes to characterize a sample of 424 adult treatment-seeking patients with BED. Data were from medical charts, a demographics questionnaire, and validated psychometric scales. We then compared these data to published data from normative and other eating disorder (ED) samples. Results showed that the average patient with BED: (1) was significantly more functionally impaired compared to non-clinical norms but somewhat less impaired than other patients with ED, (2) demonstrated clinically significant problems in social support and interpersonal functioning, (3) presented with complex comorbid pathology and high levels of chronicity, (4) used a more internalizing coping style compared to the norm and other ED samples, (5) had low levels of resistance to interventions, and (6) experienced a moderately high level of subjective distress indicating good motivation for treatment. Corresponding recommendations to these findings are that the average patient with BED should be provided higher intensity treatment that is longer in duration, interpersonally-focused, directive in nature, and emphasizing self-reflection and insight. Despite the nomothetic nature of the findings, clinicians are encouraged to assess these patient domains in order to come to an ideographic case conceptualization and to tailor precision treatment to the individual patient with BED. (shrink)

The aim of the present investigation was to describe and to classify significant ethical problems encountered by the members of the staff during the daily clinical work at a hospital medical department. A set of definitions was prepared for the purpose, including the definition of a 'significant ethical problem'. During a three month period 426 inpatients and 173 outpatients were admitted. Significant ethical problems were encountered during the management of 106 in-patients (25 per cent) and 9 out-patients (5 per (...) cent). No significant difference was found between the frequency of ethical problems in female and male patients, but a positive correlation was noted between the number of problems and the patients' age. The problem types were classified according to a problem list. The results of this investigation suggest that greater attention must be paid to discussions about ethical problems among doctors and other categories of health personnel and that, among others, medical students ought to be taught the analysis of ethical problems. (shrink)

Machine learning algorithms are expected to improve referral decisions. In this article I discuss the legitimacy of deferring referral decisions in primary care to recommendations from such algorithms. The standard justification for introducing algorithmic decision procedures to make referral decisions is that they are more accurate than the available practitioners. The improvement in accuracy will ensure more efficient use of scarce health resources and improve patient care. In this article I introduce a proceduralist framework for discussing the (...) legitimacy of algorithmic referral decisions and I argue that in the context of referral decisions the legitimacy of an algorithmic decision procedure can be fully accounted for in terms of the instrumental values of accuracy and fairness. I end by considering how my discussion of procedural algorithmic legitimacy relates to the debate on algorithmic fairness. (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)

Assessment of decision-making capacity (DMC) can be difficult in acquired brain injury (ABI) particularly with the syndrome of organic personality disorder (OPD) (the “frontal lobe syndrome”). Clinical neuroscience may help but there are challenges translating its constructs to the decision-making abilities considered relevant by law and ethics. An in-depth interview study of DMC in OPD was undertaken. Six patients were purposefully sampled and rich interview data were acquired for scrutiny using interpretative phenomenological analysis. Interview data revealed that awareness of (...) deficit and thinking about psychological states can be present. However, the awareness of deficit may not be “online” and effectively integrated into decision-making. Without this online awareness of deficit the ability to appreciate or use and weigh information in the process of deciding some matters appeared absent. We argue that the decision-making abilities discussed are: (1) necessary for DMC, (2) threatened by ABI, and (3) assessable at interview. Some advice for practically incorporating these abilities within assessments of DMC in patients with OPD is outlined. (shrink)

Ethics consultation, while often a process of negotiation between diverse opinions, sometimes requires deeper moral inquiry. The form of such inquiry is suggested by classical casuistry and its attendant doctrine of probabilism.

Background Ethics positions, consisting of the two fundamental dimensions of idealism and relativism, influence individuals’ decision-making significantly. Particularly in an applied field such as nursing, the ethics positions of nurses can play a significant role in clinical decisions. Therefore, it is important to know the factors affecting the ethics positions of nurses in clinical decision-making. Aim The aim of the study is to examine the factors affecting the ethics positions of nursing students in clinical decision-making. Research (...) design This is a two-phase sequential explanatory mixed methods study designed in accordance with the COREQ criteria. A participant Information Form and the Ethics Position Questionnaire were used to collect quantitative data. Qualitative data were obtained through focus group interviews. Ethical considerations This study was conducted after receiving written permission from X University Ethics Board. Additionally, permission was obtained from the participating nursing faculty. Participants Among the fourth-year nursing students, 180 students participated in the quantitative phase and 30 students in the qualitative phase of the study. Results The quantitative data analysis showed that the idealism sub-dimension mean scores of the participants were higher than the relativism sub-dimension mean scores. The analysis of the qualitative data resulted in four main themes that influence participants’ ethics positions in clinical decision-making: (1) attitudes of role models in clinical practice (staff nurses/mentors/lecturers), (2) resources related to clinical practice (labs, hospitals/classrooms), (3) health system (hospital policies/school policies), and (4) personal differences (act with emotion/act with logic). Conclusion The results showed that the health system, role models in the clinic, personal differences, and skill-related resources affect the ethics positions of nursing students in clinical decision-making. In this regard, awareness can be raised by providing training to nursing students by academic instructors on ethics positions and the factors that are determined to affect ethics positions in clinical decision-making. (shrink)

Research regarding the drivers of acceptance of clinical decision support systems by physicians is still rather limited. The literature that does exist, however, tends to focus on problems regarding the user-friendliness of CDSS. We have performed a thematic analysis of 24 interviews with physicians concerning specific clinical case vignettes, in order to explore their underlying opinions and attitudes regarding the introduction of CDSS in clinical practice, to allow a more in-depth analysis of factors underlying acceptance of CDSS. (...) We identified three general themes from the results. First, ‘the perceived role of the AI’, including items referring to the tasks that may properly be assigned to the CDSS according to the respondents. Second, ‘the perceived role of the physician’, referring to the aspects of clinical practice that were seen as being fundamentally ‘human’ or non-automatable. Third, ‘concerns regarding AI’, including items referring to more general issues that were raised by the respondents regarding the introduction of CDSS in general and/or in clinical medicine in particular. Apart from the overall concerns expressed by the respondents regarding user-friendliness, we will explain how our results indicate that our respondents were primarily occupied by distinguishing between parts of their job that should be automated and aspects that should be kept in human hands. We refer to this distinction as ‘the division of clinical labor.’ This division is not based on knowledge regarding AI or medicine, but rather on which parts of a physician’s job were seen by the respondents as being central to who they are as physicians and as human beings. Often the respondents’ view that certain core parts of their job ought to be shielded from automation was closely linked to claims concerning the uniqueness of medicine as a domain. Finally, although almost all respondents claimed that they highly value their final responsibility, a closer investigation of this concept suggests that their view of ‘final responsibility’ was not that demanding after all. (shrink)

In their target article, Moore and colleagues offer a valuable overview of the various ambivalence-related phenomena that may impede swift clinical decision-making. They argue that patients...

Machine learning-driven clinical decision support systems (ML-CDSSs) seem impressively promising for future routine and emergency care. However, reflection on their clinical implementation reveals a wide array of ethical challenges. The preferences, concerns and expectations of professional stakeholders remain largely unexplored. Empirical research, however, may help to clarify the conceptual debate and its aspects in terms of their relevance for clinical practice. This study explores, from an ethical point of view, future healthcare professionals’ attitudes to potential changes of (...) responsibility and decision-making authority when using ML-CDSS. Twenty-seven semistructured interviews were conducted with German medical students and nursing trainees. The data were analysed based on qualitative content analysis according to Kuckartz. Interviewees’ reflections are presented under three themes the interviewees describe as closely related: (self-)attribution of responsibility, decision-making authority and need of (professional) experience. The results illustrate the conceptual interconnectedness of professional responsibility and its structural and epistemic preconditions to be able to fulfil clinicians’ responsibility in a meaningful manner. The study also sheds light on the four relata of responsibility understood as a relational concept. The article closes with concrete suggestions for the ethically sound clinical implementation of ML-CDSS. (shrink)

BackgroundMachine learning-based clinical decision support systems (ML_CDSS) are increasingly employed in various sectors of health care aiming at supporting clinicians’ practice by matching the characteristics of individual patients with a computerised clinical knowledge base. Some studies even indicate that ML_CDSS may surpass physicians’ competencies regarding specific isolated tasks. From an ethical perspective, however, the usage of ML_CDSS in medical practice touches on a range of fundamental normative issues. This article aims to add to the ethical discussion by using (...) professionalisation theory as an analytical lens for investigating how medical action at the micro level and the physician–patient relationship might be affected by the employment of ML_CDSS.Main textProfessionalisation theory, as a distinct sociological framework, provides an elaborated account of what constitutes client-related professional action, such as medical action, at its core and why it is more than pure expertise-based action. Professionalisation theory is introduced by presenting five general structural features of professionalised medical practice: (i) the patient has a concern; (ii) the physician deals with the patient’s concern; (iii) s/he gives assistance without patronising; (iv) s/he regards the patient in a holistic manner without building up a private relationship; and (v) s/he applies her/his general expertise to the particularities of the individual case. Each of these five key aspects are then analysed regarding the usage of ML_CDSS, thereby integrating the perspectives of professionalisation theory and medical ethics.ConclusionsUsing ML_CDSS in medical practice requires the physician to pay special attention to those facts of the individual case that cannot be comprehensively considered by ML_CDSS, for example, the patient’s personality, life situation or cultural background. Moreover, the more routinized the use of ML_CDSS becomes in clinical practice, the more that physicians need to focus on the patient’s concern and strengthen patient autonomy, for instance, by adequately integrating digital decision support in shared decision-making. (shrink)

Despite concerns about the relationships between health professionals and the medical device industry, the issue has received relatively little attention. Prevalence data are lacking; however, qualitative and survey research suggest device industry representatives, who are commonly present in clinical settings, play a key role in these relationships. Representatives, who are technical product specialists and not necessarily medically trained, may attend surgeries on a daily basis and be available to health professionals 24 hours a day, 7 days a week, to (...) provide advice. However, device representatives have a dual role: functioning as commissioned sales representatives at the same time as providing advice on approaches to treatment. This duality raises the concern that clinical decision-making may be unduly influenced by commercial imperatives. In this paper, we identify three key ethical concerns raised by the relationship between device representatives and health professionals: impacts on healthcare costs, the outsourcing of expertise and issues of accountability and informed consent. These ethical concerns can be addressed in part through clarifying the boundary between the support and sales aspects of the roles of device representatives and developing clear guidelines for device representatives providing support in clinical spaces. We suggest several policy options including hospital provision of expert support, formalising clinician conduct to eschew receipt of meals and payments from industry and establishing device registries. (shrink)