A guide for everyone involved in medical decision making to plot a clear course through complex and conflicting benefits and risks.

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)

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)

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)

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)

Despite its virtues, lay decision-making in medicine shares with professional decision-making a disturbing common feature, reflected both in formal policies prohibiting high-risk research and in informal policies favoring treatment decisions made when a crisis or change of status occurs, often late in a downhill course. By discouraging patient decision-making but requiring dedication to the patient's interests by those who make decisions on the patient's behalf, such practices tend to preclude altruistic choice on the part of the (...) patient. This eclipse is to be regretted not just because widescale altruism has the capacity to provide important social goods and correct injustices in distribution, but for intrinsic reasons as well. It is argued that preserving the possibility of altruism obliges patients – and future patients – to make decisions about dying and other medical matters in advance, thus avoiding that displacement of decision-making onto lay and professional second parties which results in altruism's eclipse. Keywords: altruism, medical decision-making, patient's interest, self-interest, autonomy, death and dying decisions, refusal of treatment, prolongation of life, allowing to die, high-risk research CiteULike Connotea Del.icio.us What's this? (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)

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)

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 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 (ages 4, 17 years) 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)

This study examines the processes ofdecision-making used by intensive care(critical care) specialists. Ninety-ninespecialists completed a questionnaire involvingthree clinical cases, using a novel methodologyinvestigating the role of uncertainty andtemporal-related factors, and exploring a rangeof ethical issues. Validation and triangulationof the results was done via a comparison studywith a medically lay, but highly informed groupof 37 law students. For both study groups,constructing reasons for a decision was largelyan interpretative and imaginative exercise thatwent beyond the data (as presented), commonlyresulting in different reasons (...) supporting thesame conclusions and similar reasons supportingopposite conclusions. The skills of ethicalimagination and interpretation were related toan individual''s prior lived experience,construed in the broadest sense. Application ofthese skills of ethical imagination andinterpretation always occurred, to some degree,in a state of uncertainty and almost alwaysinvolved temporal relationships.Using these results, a theory of ethicaldecision-making is proffered. Three levels ortypes of reasoning processes may be present.Type I decision-making involves the applicationof rules, usually in a deductive fashion. TypeII decision-making is characterised by aprocess where a plurality of reasons arebalanced, weighed and sifted with each other.Type III decision-making is intimately linkedwith respondents lived experiences and `crafts''the content of type I and II reasoningprocesses, via the application of ethicalimagination and interpretation. Relationshipsbetween these three types of reasoningprocesses, and with narrative ethics, are alsodiscussed. (shrink)

In patient-centred care, shared decision-making is advocated as the preferred form of medical decision-making. Shared decision-making is supported with reference to patient autonomy without abandoning the patient or giving up the possibility of influencing how the patient is benefited. It is, however, not transparent how shared decision-making is related to autonomy and, in effect, what support autonomy can give shared decision-making. In the article, different forms of shared decision-making are analysed in relation to five (...) different aspects of autonomy: (1) self-realisation; (2) preference satisfaction; (3) self-direction; (4) binary autonomy of the person; (5) gradual autonomy of the person. It is argued that both individually and jointly these aspects will support the models called shared rational deliberative patient choice and joint decision as the preferred versions from an autonomy perspective. Acknowledging that both of these models may fail, the professionally driven best interest compromise model is held out as a satisfactory second-best choice. (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)

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)

The ethics of autonomous vehicles has received a great amount of attention in recent years, specifically in regard to their decisional policies in accident situations in which human harm is a likely consequence. Starting from the assumption that human harm is unavoidable, many authors have developed differing accounts of what morality requires in these situations. In this article, a strategy for AV decision-making is proposed, the Ethical Valence Theory, which paints AV decision-making as a type of claim mitigation: (...) different road users hold different moral claims on the vehicle’s behavior, and the vehicle must mitigate these claims as it makes decisions about its environment. Using the context of autonomous vehicles, the harm produced by an action and the uncertainties connected to it are quantified and accounted for through deliberation, resulting in an ethical implementation coherent with reality. The goal of this approach is not to define how moral theory requires vehicles to behave, but rather to provide a computational approach that is flexible enough to accommodate a number of ‘moral positions’ concerning what morality demands and what road users may expect, offering an evaluation tool for the social acceptability of an autonomous vehicle’s ethical decision making. (shrink)

Genetic testing has led to the establishment of the concept of the “previvor”: someone who is not yet sick, but who has a genetic predisposition to disease. The previvor experience demonstrates how the practice of medicine and medical decision making is evolving to render current law and policy increasingly inapplicable to modern medical practice. The introduction of previvorship to the medical landscape raises special issues for the physician-patient relationship and the legal doctrine of informed consent. It challenges some (...) of the most basic assumptions underlying the doctrine, is representative of the doctrine’s declining utility, and is illustrative of the need to transition to a shared decision-making model. Thus, we should begin to envision a legal doctrine that supports a robust shared decision-making approach to address individual preferences and values, the increasing complexity of risk/benefit assessment, and inherent (and sometimes irreducible) uncertainty. Such an approach should emphasize a new, more expansive, and inclusive model of illness. (shrink)

Complementary and alternative medicine is used by many in hopes of achieving important health-related goals. Survey data indicate that 42 percent of the U.S. population uses CAM, accounting for 629 million “office” visits a year and expenditures of 27 billion dollars. This high prevalence of use calls for a careful evaluation of CAM so as to ensure the well-being of those using its modalities. Such an evaluation would obviously include assessments of the safety and efficacy of particular approaches, the (...) training and integrity of practitioners, and the appropriateness of modalities for different conditions or uses. Given the lack of published data concerning many of these aspects of CAM, the likely unfamiliarity of its practitioners to the approaches available to clinicians practicing modern scientific medcine, and the need to respect the unique preferences of persons seeking assistance with achieving health-related goals, it is also important to assess the potential roles of informed consent for the use of CAM. Examining such roles is the central task of this paper. (shrink)

Shifting laws and regulations increasingly displace the centrality of women's health concerns in the provision of abortion services. This is exemplified by the growing presence of deceptive Crisis Pregnancy Centers alongside new informed consent laws designed to dissuade women from seeking abortions. Litigation on informed consent is further complicated in the clinical context due to the increased mobilization of facts – such as the gestational age or sonogram of the fetus – delivered with the intent to dissuade women from accessing (...) abortion. In other words, factual information utilized for ideological purpose. To preserve a woman's autonomy and decision-making capacity, there must be a concerted effort on the part of legislators and courts to place a woman's health at the center of abortion law and policy. (shrink)

Informed decision-making (IDM) is considered an important ethical and legal requirement for population-based screening. Governments offering such screening have a duty to enable invitees to make informed decisions regarding participation. Various views exist on how to define and measure IDM in different screening programmes. In this paper we first address the question which components should be part of IDM in the context of cancer screening. Departing from two diverging interpretations of the value of autonomy—as a right and as an (...) ideal—we describe how this value is operationalized in the practice of informed consent in medicine and translate this to IDM in population-based cancer screening. Next, we specify components of IDM, which is voluntariness and the requirements of disclosure and understanding. We argue that whereas disclosure should contain all information considered relevant in order to enable authentic IDM, understanding of basic information is sufficient for a valid IDM. In the second part of the paper we apply the capability approach in order to argue for the responsibility of the government to warrant equal and real opportunities for invitees for IDM. We argue that additional conditions beyond mere provision of information are needed in order to do so. (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)

BackgroundHealth decisions occur in a context with omnipresent social influences. Information concerning what other patients decide may present certain interventions as more desirable than others.ObjectivesTo explore how physicians refer to what other people decide in conversations about the relevancy of cardio-pulmonary resuscitation or do-not-attempt-resuscitation orders.MethodsWe recorded forty-three physician–patient admission interviews taking place in a hospital in French-speaking Switzerland, during which CPR is discussed. Data was analysed with conversation analysis.ResultsReference to what other people decide in regards to CPR is used five (...) times, through reported speech. The reference is generic, and employed as a resource to deal with trouble encountered with the patient’s preference, either because it is absent or potentially incompatible with the medical recommendation. In our data, it is a way for physicians to present decisional paths and to steer towards the relevancy of DNAR orders. By calling out to a sense of membership, it builds towards the patient embracing norms that are associated with a desirable or relevant social group.ConclusionsIntroducing DNAR decisions in terms of what other people opt for is a way for physicians to bring up the eventuality of allowing natural death in a less overt way. Formulating treatment choices in terms of what other people do has implications in terms of supporting autonomous and informed decision making, since it nudges patients towards conformity with what is presented as the most preferable choice on the basis of social norms. (shrink)

Since its advent, predictive DNA testing has been perceived as a technology that may have considerable impact on the quality of people’s life. The decision whether or not to use this technology is up to the individual client. However, to enable well considered decision making both the negative as well as the positive freedom of the individual should be supported. In this paper, we argue that current professional and public discourse on predictive DNA-testing is lacking when it comes (...) to supporting positive freedom, because it is usually framed in terms of risk and risk management. We show how this ‘risk discourse’ steers thinking on the good life in a particular way. We go on to argue that empirical research into the actual deliberation and decision making processes of individuals and families may be used to enrich the environment of personal deliberation in three ways: (1) it points at a richer set of values that deliberators can take into account, (2) it acknowledges the shared nature of genes, and (3) it shows how one might frame decisions in a non-binary way. We argue that the public sharing and discussing of stories about personal deliberations offers valuable input for others who face similar choices: it fosters their positive freedom to shape their view of the good life in relation to DNA-diagnostics. We conclude by offering some suggestions as to how to realize such public sharing of personal stories. (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)

Paediatric Intensive Care Units (PICU) are complex interdisciplinary environments where challenging, high stakes decisions are frequently encountered. We assert that appropriate decisions are more likely to be made if the decision-making process is comprehensive, reasoned, and grounded in thoughtful deliberation. Strategies to overcome barriers to high quality decision-making including, cognitive and implicit bias, group think, inadequate information gathering, and poor quality deliberation should be incorporated. Several general frameworks for decision-making exist, but specific guidance is scarce. In this (...) paper, we provide specific guidance on collaborative complex decision-making for PICUs. The proposed approach is on principles of procedural justice and pragmatic hermeneutics. The process encompasses set-up/planning, information gathering, question formulation, analysis (perspectives, values, and principles), action plan development, decision documentation, and a review and appeal mechanism. The process can be adapted to suit other clinical contexts. Research evaluating the process, exploring how best to develop education for clinicians, and how to build a culture that values high quality deliberation, is worthwhile. (shrink)

During the COVID-19 pandemic, global healthcare systems faced unprecedented challenges, with a lack of resources and suboptimal patient care emerging as primary concerns. Our research, using a comprehensive 24-item electronic questionnaire, “Reflections on the Provision of Healthcare during the COVID-19 Pandemic,” delved into the experiences of 938 physicians across the Czech Republic. Over fifty per cent observed a “lower standard of care” compared to pre-pandemic levels. A division arose among physicians regarding a decision’s medical, ethical, or legal basis, with (...) a notable gender disparity: male doctors leaned towards medical perspectives, whereas females accented the ethical perspective. Decision-making concerning health care limitations required agreement among the physicians on duty, interdisciplinary teams, or shift supervisors. Physicians reported varying degrees of patient or family participation in health care decisions. Variables such as age, pre-existing health conditions, and life expectancy influenced care decisions. Surprisingly, half of the physicians faced refusals of patients’ transportation to better-equipped facilities due to resource constraints. One-third of physicians never discuss the decision about care limitation and other options with patients or their families. As a result, almost fifty per cent of the physicians rarely or never imparted information about care limitations to patients. The survey shed light on the profound ethical dilemmas hospital physicians face across different types of healthcare facilities during the pandemic. It uncovered the need for open dialogue and scholarly debate on resource allocation and strengthening the role of patients and their families in care decisions in future healthcare crises. (shrink)

Patient decision-making autonomy refers to the patients’ ability to freely exert their own choices and make their own decisions, given sufficient resources and information to do so. In pain medicine, it is accepted that appropriate beneficial management aims to propose an individualized treatment plan shared with the patients, as agents, to help them live as autonomously as possible with their pain. However, are patients in chronic pain centers sufficiently autonomous to participate in the therapeutic decisions that concern them? (...) As this question still remains unanswered, a pilot study was set up to that aim. Over a 2-month period, first-time patients within a tertiary multidisciplinary pain center underwent a systematic evaluation of their autonomy using the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), considered the benchmark tool for measuring a patient’s ability to consent to treatment. Demographic data and pain characteristics of the patients were collected and their respective attending pain physicians were asked to clinically assess their patients’ degree of autonomy. Another physician, who had not participated in the initial patient evaluation, subsequently administered the MacCAT-T questionnaire to the same patients. Twenty-seven patients were included during the study period (21 women and 6 men), with an average age of 50 years. The average duration of pain was 8 years. Based on their clinical experience, the 4 different pain physicians in charge of these patients considered that out of 25 assessed patients, 22 of them (89%) had full decision-making capacity, with no deficit in autonomy. According to the MacCAT-T results, only 13 of these 25 patients (48%) had no deficit, while 7 (26%) had a major deficit in autonomy. The only patient characteristic that appeared to be related to autonomy was pain type, specifically nociplastic pain. The average time taken to complete the test was 20 min, and patients were very satisfied with the interview. Results from the present pilot study suggest that patients suffering from chronic pain do not appear to be entirely autonomous in their decision to consent to the proposed treatment plan according to the MacCAT-T questionnaire, and physicians seem to find it difficult to properly assess this competence in a clinical setting. Further studies with larger samples are needed to better evaluate this concept to improve the complex management of these patients. (shrink)

Over the past decades, great strides have been made to professionalize and increase access to transgender medicine. As the evidence base grows and conceptualizations regarding gender dysphoria/gender incongruence evolve, so too do ideas regarding what constitutes good treatment and decision-making in transgender healthcare. Against this background, differing care models arose, including the ‘Standards of Care’ and the so-called ‘Informed Consent Model’. In these care models, ethical notions and principles such as ‘decision-making’ and ‘autonomy’ are often referred to, (...) but left unsubstantiated. This not only transpires into the consultation room where stakeholders are confronted with many different ethical challenges in decision-making, but also hampers a more explicit discussion of what good decision-making in transgender medicine should be comprised of. The aim of this paper is to make explicit the conceptual and normative assumptions regarding decision-making and client autonomy underpinning the ‘Standards of Care’ and ‘Informed Consent Model’ currently used in transgender care. Furthermore, we illustrate how this elucidation aids in better understanding stakeholders’ ethical challenges related to decision-making. Our ethical analysis lays bare how distinct normative ambiguities in both care models influence decision-making in practice and how foregrounding one normative model for decision-making is no moral panacea. We suggest that the first steps towards good decision-making in gender-affirming medical care are the acknowledgement of its inherent normative and moral dimensions and a shared, dialogical approach towards the decision-making process. (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)

BackgroundDeciding whether to resuscitate extremely preterm infants (EPIs) is clinically and ethically problematic. The aim of the study was to understand neonatologists’ clinical–ethical decision-making for resuscitation of EPIs.MethodsWe conducted a qualitative study in Belgium, following a constructivist account of the Grounded Theory. We conducted 20 in-depth, face-to-face, semi-structured interviews with neonatologists. Data analysis followed the qualitative analysis guide of Leuven.ResultsThe main principles guiding participants’ decision-making were EPIs’ best interest and respect for parents’ autonomy. Participants agreed that justice as (...) resource allocation should not be considered in resuscitation decision-making. The main ethical challenge for participants was dealing with the conflict between EPIs’ best interest and respect for parents’ autonomy. This conflict was most prominent when parents and clinicians disagreed about births within the gray zone (24–25 weeks). Participants’ coping strategies included setting limits on extent of EPI care provided and rigidly following established guidelines. However, these strategies were not always feasible or successful. Although rare, these situations often led to long-lasting moral distress.ConclusionsParticipants’ clinical–ethical reasoning for resuscitation of EPIs can be mainly characterized as an attempt to balance EPIs’ best interest and respect for parents’ autonomy. This approach could explain why neonatologists considered conflicts between these principles as their main ethical challenge and why lack of resolution increases the risk of moral distress. Therefore, more research is needed to better understand moral distress in EPI resuscitation decisions.Clinical Trial Registration: The study received ethical approval from the ethics committee of UZ/ku Leuven (S62867). Confidentiality of personal information and anonymity was guaranteed in accordance with the General Data Protection Regulation of 25 May 2018. (shrink)

Self-driving vehicles (SDVs) will need to make decisions that carry ethical dimensions and are of normative significance. For example, by choosing a specific trajectory, they determine how risks are distributed among traffic participants. Accordingly, policymakers, standardization organizations and scholars have conceptualized what (shall) constitute(s) ethical decision-making for SDVs. Eventually, these conceptualizations must be converted into specific system requirements to ensure proper technical implementation. Therefore, this article aims to translate critical requirements recently formulated in scholarly work, existing standards, regulatory drafts (...) and guidelines into an explicit five-step ethical decision model for SDVs during hazardous situations. This model states a precise sequence of steps, indicates the guiding ethical principles that inform each step and points out a list of terms that demand further investigation and technical specification. By integrating ethical, legal and engineering considerations, we aim to contribute to the scholarly debate on computational ethics (particularly in autonomous driving) while offering practitioners in the automotive sector a decision-making process for SDVs that is technically viable, legally permissible, ethically grounded and adaptable to societal values. In the future, assessing the actual impact, effectiveness and admissibility of implementing the here sketched theories, terms and the overall decision process requires an empirical evaluation and testing of the overall decision-making model. (shrink)

This book clarifies the meaning of the most important and pervasive concepts and tools in bioethical argumentation and assesses the methodological suitability of the main methods for clinical decision-making and argumentation. The first part of the book is devoted to the most developed or promising approaches regarding bioethical argumentation, namely those based on principles, values and human rights. The authors then continue to deal with the contributions and shortcomings of these approaches and suggest further developments by means of substantive (...) and procedural elements and concepts from practical philosophy, normative systems theory, theory of action, human rights and legal argumentation. Furthermore, new models of biomedical and health care decision-making, which overcome the aforementioned criticism and stress the relevance of the argumentative responsibility, are included. (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)

McCarthy and Howard (2023) present a “Non-Domination” approach to supported decision-making, specially to help intellectually and developmentally disabled (IDD) patients rather than “Mental Prosthe...

Decision-making capacity (DMC) is the gatekeeping element for a patient’s right to self-determination with regard to medical decisions. A DMC evaluation is not only conducted on descriptive grounds but is an inherently normative task including ethical reasoning. Therefore, it is dependent to a considerable extent on the values held by the clinicians involved in the DMC evaluation. Dealing with the question of how to reasonably support clinicians in arriving at a DMC judgment, a new tool is presented that fundamentally (...) differs from existing ones: the U-Doc. By putting greater emphasis on the judgmental process rather than on the measurement of mental abilities, the clinician as a decision-maker is brought into focus, rendering the tool more of an evaluation guide than a test instrument. In a qualitative study, the perceived benefits of and difficulties with the tool have been explored. The findings show on the one hand that the evaluation aid provides basic orientation, supports a holistic perspective on the patient, sensitizes for ethical considerations and personal biases, and helps to think through the decision, to argue, and to justify one’s judgment. On the other hand, the room for interpretation due to absent operationalisations, related ambiguities, and the confrontation with one’s own subjectivity may be experienced as unsettling. (shrink)

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

Background: In order to fully understand nurses’ ethical decision-making in cases of physical restraint in acute older people care, contextual influences on the process of decision-making should be clarified. Research questions: What is the influence of context on nurses’ decision-making process in cases of physical restraint, and what is the impact of context on the prioritizing of ethical values when making a decision on physical restraint? Research design: A qualitative descriptive study inspired by the Grounded Theory (...) approach was carried out. Participants and research context: In total, 21 in-depth interviews were carried out with nurses working on acute geriatric wards in Flanders, Belgium. Ethical considerations: The research protocol was approved by the Ethics Committee of the Faculty of Medicine, Leuven. Findings: Relationships with nursing colleagues and the patient’s family form an inter-personal network. Nurses also point to the importance of the procedural–legal context as expressed in an institutional ethics policy and procedures, or through legal requirements concerning physical restraint. Furthermore, the architectural structure of a ward, the availability of materials and alternatives for restraint use can be decisive in nurses’ decision-making. All interviewed nurses highlighted the unquestionable role of the practical context of care. Context can have a guiding, supportive, or decisive role in decision-making concerning the application of physical restraint. Discussion: The discussion focuses on the role of the inter-personal network of nurses on the process of decision-making. Conclusion: An institutional ethics policy and a value-supportive care environment can support nurses in their challenge to take ethically sound decisions. (shrink)

It can be assumed that value judgements, which are needed to judge what is ‘good’ or ‘better’ and what is ‘bad’ or ‘worse’, are involved in every decision-making process. The theoretical understanding and analysis of value judgements is, therefore, important in the context of bioethics, for example, to be able to ethically assess real decision-making processes in biomedical practice and make recommendations for improvements. However, real decision-making processes and the value judgements inherent in them must first be (...) investigated empirically (‘empirical bioethics’). For this to succeed, what exactly a ‘value judgement’ is and of what components it might consist must initially be theoretically clarified. A corresponding conceptual model can then support or even enable empirical data collection and analysis and, above all, subsequent ethical analysis and evaluation. This paper, therefore, presents a value judgement model with its theoretical derivation. It also illustrates its application in an interview study of decision-making between animal experimentation and alternative methods in the context of biomedical research. Though the model itself can be theoretically deepened and extended, the application of the model works in general and helps to uncover what value judgements can enter into decision-making. However, the empirical methods, for example, qualitative interviews, can also be better oriented towards eliciting value judgements (as understood according to the model). Further applications of the model to other topics or by means of other empirical methods are conceivable. (shrink)

The computer revolution has had an enormous effect on all aspects of the practice of medicine, yet little thought has been given to the role of social media in identifying treatment choices for incompetent patients. We are currently living in the ?Internet age? and many people have integrated social media into all aspects of their lives. As use becomes more prevalent, and as users age, social media are more likely to be viewed as a source of information regarding medical (...) care preferences. This article explores the ethical and legal issues raised by the use of social media in surrogate decision making. (shrink)

There are marked differences between countries with regard to reimbursement decision-making, yet few studies have tried to understand this process and its consequences by a detailed analysis of the local context and decision-making structure. This article describes reimbursement decision-making and subsequent prescribing patterns of new pharmaceuticals by means of a case study on glitazones in treatment of type 2 diabetes mellitus patients in Denmark. The study shows that institutional arrangements, providing the context in which evidence is used, (...) are highly important for understanding the reimbursement decision-making process. In particular the Danish Medicines Agency (DMA) has shaped the decision to reimburse glitazones on the basis of physician-mediated requests of individual patients. Relatively few patients have been prescribed glitazones since their introduction in 2000, suggesting that individual reimbursement may be an effective instrument in controlling overall expenditure of selected pharmaceuticals, although in the case of glitazones this has likely been achieved at the expense of equality in access to the products. The discussion focuses on the generalizability of the findings to both other pharmaceuticals in the individual reimbursement scheme in Denmark, and to other countries that are trying to balance the need to control overall pharmaceutical care expenditure with the need to secure equality in access to new drugs with therapeutic added value. (shrink)

Shared decision-making has become a new focus of health policy. Though its core elements are largely agreed upon, there is little consensus regarding which outcomes to prioritize for policy-mandated shared decision-making.

In our current era, a new rapidly spreading pandemic disease called coronavirus disease, caused by a virus identified as a novel coronavirus, is becoming a crucial threat for the whole world. Currently, the number of patients infected by the virus is expanding exponentially, but there is no commercially available COVID-19 medication for this pandemic. However, numerous antiviral drugs are utilized for the treatment of the COVID-19 disease. Identification of the appropriate antivirus medicine to treat the infection of COVID-19 is (...) still a complicated and uncertain decision. This study’s key objective is to develop a novel approach called _q_-rung orthopair probabilistic hesitant fuzzy rough set, which incorporates the _q_-rung orthopair fuzzy set, probabilistic hesitant fuzzy set, and rough set structures. New _q_-ROPHFR aggregation operators have been established: the _q_-ROPHFR Einstein weighted averaging operator and the _q_-ROPHFR Einstein weighted geometric operator. In this study, we explored some basic features of the developed operators. Afterward, to demonstrate the viability and feasibility of the established decision-making approach in real-world applications, a case study related to selecting drugs for COVID-19 pandemic is addressed. Furthermore, a comprehensive comparison with the _q_-rung orthopair probabilistic hesitant fuzzy rough TOPSIS technique is also presented to illustrate the benefits of the new framework. The obtained results confirm the reliability and effectiveness of the proposed approach for finding uncertainty in real-world decision-making. (shrink)