If definitive evidence concerning treatment effectiveness becomes available from an ongoing randomized clinical trial, then the trial could be stopped early, with the public release of results benefiting current and future patients. However, stopping an ongoing trial based on accruing outcome data requires methodological rigor to preserve validity of the trial conclusions. This has led to the use of formal interim monitoring procedures, which include inefficacy monitoring that will stop a trial early when the experimental treatment appears (...) not to be working. For participants, inefficacy monitoring is especially important as it ensures that they are not being treated worse than if they had not enrolled on the trial. We discuss the importance of reporting with trial results the formal interim inefficacy monitoring guidelines that were utilized, and, if none were used, the reasons for their absence. A survey of two leading medical journals suggests that this is not current practice. (shrink)

(2011). The Children's Oncology Group Routinely Applies “Lack of Efficacy” Interim Monitoring to Its Randomized Clinical Trials. The American Journal of Bioethics: Vol. 11, No. 3, pp. 18-19.

This paper analyzes statistical decisions during the interim analyses of clinical trials. After some general remarks about the ethical and scientific demands of clinical trials, I introduce the notion of a hard-case clinical trial, explain the basic idea behind it, and provide a real example involving the interim analyses of zidovudine in asymptomatic HIV-infected patients. The example leads me to propose a decision analytic framework for handling ethical conflicts that might arise during the monitoring of hard-case clinical (...) trials. I use computer simulations to show how the framework can assist in reconciling certain ethical conflicts. The framework is partial, lacking the precision of a complete systematization of statistical monitoring procedures in practice. (shrink)

Data monitoring committees often are employed to review interim findings of randomised controlled trials. Interim findings are kept confidential until the data monitoring committee finds that they provide sufficiently compelling evidence regarding efficacy, typically because they have crossed the pre-defined statistical boundaries, or they raise serious concerns about safety. While this practice is vital to maintaining the scientific integrity of controlled trials and thereby ensuring their social value, it has been criticised as unethical. Commentators argue that (...) withholding interim findings from research participants is deceptive, inconsistent with valid informed consent, and a violation of respect for participants’ autonomy. The present article examines these arguments, focusing specifically on confidential data monitoring for efficacy. This practice need not be deceptive provided its use is disclosed to prospective research participants. In addition, confidential data monitoring does not make research participants worse off than they would be in the clinical setting and represents an acceptable limitation on the options available to prospective research participants. Taken together, these considerations suggest confidential data monitoring, subject to adequate safeguards, is ethically acceptable. (shrink)

This article presents a quantitative way of modeling the interim decisions of clinical trials. While statistical approaches tend to focus on the epistemic aspects of statistical monitoring rules, often overlooking ethical considerations, ethical approaches tend to neglect key epistemic dimension. The proposal is a second-order decision theoretic framework. The framework provides means for retrospective assessment of interim decisions based on a clear and consistent set of criteria that combines both ethical and epistemic considerations. The framework is broadly (...) Bayesian and addresses a fundamental question behind many concerns about clinical trials: What does it take for an interim decision (e.g., whether to stop the trial, or continue) to be a good decision? I provide simulation illustrating the modeling of interim decisions counterfactually using the framework. (shrink)

Despite efforts from regulatory agencies (e.g. NIH, FDA), recent systematic reviews of randomised controlled trials (RCTs) show that top medical journals continue to publish trials without requiring authors to report details for readers to evaluate early stopping decisions carefully. This article presents a systematic way of modelling and simulating interim monitoring decisions of RCTs. By taking an approach that is both general and rigorous, the proposed framework models and evaluates early stopping decisions of RCTs based on a clear (...) and consistent set of criteria. The framework allows decision analysts to generate and quickly answer ‘what-if’ questions by simulating alternate trial scenarios. I illustrate the framework with a case study of an RCT that was stopped early due to harm. This was a trial of vitamin A supplement in relation to HIV transmission from mother-to-child through breastfeeding. (shrink)

In contentless experience there is an absence of mental content such as thought, perception, and mental imagery. The path to contentless experience in meditation can be taken to comprise the meditation technique, and the experiences on the way to the contentless “goal-state/s”. Shamatha, Transcendental, and Stillness Meditation are each said to access contentless experience, but the path to that experience in each practice is not yet well understood from a scientific perspective. We have employed evidence synthesis to select and review (...) 135 expert texts from those traditions. In this paper we describe the techniques and interim-states based on the expert texts and compare them across the practices on key dimensions. Superficially, Shamatha and Transcendental Meditation appear very different to Stillness Meditation in that they require bringing awareness to a meditation object. The more detailed and systematic approach taken in this paper indicates that posturally Shamatha is closer to Stillness Meditation, and that on several other dimensions Shamatha is quite different to both other practices. In particular, Shamatha involves greater measures to cultivate attentional stability and vividness with respect to an object, greater focusing, less tolerance of mind-wandering, more monitoring, and more deliberate doing/control. Achieving contentless experience in Shamatha is much slower, more difficult, and less frequent. The findings have important implications for taxonomies of meditation and for consciousness, neuroscientific, and clinical research/practice, and will provide new and useful insights for meditation practitioners. (shrink)

Randomized and double-blind clinical trials are widely regarded as the most reliable way of studying the effects of medical interventions. According to received wisdom, if a new drug or treatment is to be accepted in clinical practice, its safety and efficacy must first be demonstrated in such trials. For ethical and scientific reasons, it is generally considered necessary to monitor a trial in various ways as it proceeds and to analyze data as they accumulate. Monitoring and interim analyses (...) are often conducted by a so-called data monitoring committee (DMC), a group of experts independent of both sponsors and investigators. On the basis of DMC recommendations, sponsors sometimes decide to discontinue trials .. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Human Genome Research in an Interdependent WorldAlexander Morgan Capron (bio)This has been the year of agenda-setting conferences for the ambitious ELSI (ethical, legal and social issues) program of the Human Genome Project (HGP). But of the dozen or more major meetings of this sort held across the country, the one held at the National Institutes of Heakh (NIH) in Bethesda, MD, June 2-4, 1991, was distinctive in several respects.1As (...) its name implies, "Human Genome Research in an Interdependent World" was a global look at the issues raised by gene mapping and sequencing. Unlike previous conferences, however, this meeting looked beyond a comparative analysis of clinical and domestic legal issues, and concentrated on topics that may require responses on a truly international level if they are to be successfully resolved.The meeting's organizers gathered an impressive group of more than seventy participants from fifteen countries, including the first significant contingent of Soviet and Japanese scientists, physicians, and philosophers at an ELSI meeting. In addition to talks by the heads of the genome projects in the Soviet Union, Japan, and the United States, the meeting was keynoted by Dr. James Wyngaarden, director general of the Human Genome Organization (HUGO), and I had the honor of serving as its general chairman.The goal of the meeting was to consider an array of issues that scientists, philosophers, and lawyers from around the world suggested might have international significance, with an eye to deciding three things: (1) Does the issue deserve further attention? (2) Is the issue best addressed in an international or domestic context? and (3) Do structures exist to which the issue can be referred for resolution? In the final sessions, the entire group debated proposed resolutions on the various topics and narrowed the list needing further, intensive exploration.To provide an international framework for this process, the conference [End Page 247] established a Global Steering Committee on Ethical and Social Issues in Genome Research, which will coordinate the efforts of several task forces charged with refining the tentative resolutions adopted by the conference participants on June 4. The task forces are expected to be able to complete work on some topics by the time of the steering committee's first meeting, which was described by one participant as a "check point," probably within the coming year; on other topics, the task forces will provide interim reports and arrange to continue their analysis. Several topics—less complex or more embryonic—were referred directly to the steering committee. On all issues, a major objective will be to ascertain what existing or newly created structure or structures are capable of implementing the group's recommendations and then to monitor the issue to ensure that appropriate implementation is occurring.Issues to be Explored by Task ForcesInsurance and EmploymentWhile individuals may derive medically useful information from the expanded range of genetic tests that will flow from the HGP, they could also be harmed if test results become a basis for discrimination. An area of particular concern at the conference in Bethesda was whether genetic information should be used to decide eligibility for employment or the scope and cost of health and life insurance. The complexity of this issue is increased as barriers to worker migration fall (especially in Europe) and as more firms carry on business internationally. Furthermore, questions arise about the limits of required testing and whether individuals may decline to be informed of the results of tests.The task force will not only gather information on practices and legal standards throughout the world—especially in light of the differences among nations with regard to the linkage of employment and various forms of insurance—but will also examine international anti-discrimination laws as a possible means of supplementing domestic statutes and regulations. As a starting point, the Bethesda meeting agreed on a set of principles for the task force to refine.2ForensicsAlthough their legal status is not fully resolved, DNA tests are being used increasingly in judicial proceedings and civil and criminal investigations as a highly probative means to identify people. Most forensic uses of "DNA fingerprints" are domestic, but international cooperation among investigative bodies... (shrink)

BackgroundThe worsening COVID-19 pandemic in South Africa poses multiple challenges for clinical decision making in the context of already-scarce ICU resources. Data from national government and the last published national audit of ICU resources indicate gross shortages. While the Critical Care Society of Southern Africa (CCSSA) guidelines provide a comprehensive guideline for triage in the face of overwhelmed ICU resources, such decisions present massive ethical and moral dilemmas for triage teams. It is therefore important for the health system to provide (...) clinicians and critical care facilities with as much support and resources as possible in the face of impending pandemic demand. Following a discussion of the ethical considerations and potential challenges in applying the CCSSA guidelines, the authors propose a framework for regional triage committees adapted to the South African context.DiscussionBeyond the national CCSSA guidelines, the clinician has many additional ethical and clinical considerations. No single ethical approach to decision-making is sufficient, instead one which considers multiple contextual factors is necessary. Scores such as the Clinical Frailty Score and Sequential Organ Failure Assessment are of limited use in patients with COVID-19. Furthermore, the clinician is fully justified in withdrawing ICU care based on medical futility decisions and to reallocate this resource to a patient with a better prognosis. However, these decisions bear heavy emotional and moral burden compounded by the volume of clinical work and a fear of litigation.ConclusionWe propose the formation of Provincial multi-disciplinary Critical Care Triage Committees to alleviate the emotional, moral and legal burden on individual ICU teams and co-ordinate inter-facility collaboration using an adapted framework. The committee would provide an impartial, broader and ethically-sound viewpoint which has time to consider broader contextual factors such as adjusting rationing criteria according to different levels of pandemic demand and the latest clinical evidence. Their functioning will be strengthened by direct feedback to national level and accountability to a national monitoring committee. The potential applications of these committees are far-reaching and have the potential to enable a more effective COVID-19 health systems response in South Africa. (shrink)

Philosophers subscribing to particular principles of statistical inference and evidence need to be aware of the limitations and practical consequences of the statistical approach they endorse. The framework proposed (for statistical inference in the field of medicine) allows disparate statistical approaches to emerge in their appropriate context. My dissertation proposes a decision theoretic model, together with methodological guidelines, that provide important considerations for deciding on clinical trial conduct. These considerations do not amount to more stopping rules. Instead, they are principles (...) that address the complexity of interpreting and responding to interim data, based on a broad range of epistemic and ethical factors. While they are not stopping rules, they would assist a Data Monitoring Committee in judging its position with regard to necessary precautionary interpretation of interim data. By vindicating a framework that accommodates a wide range of approaches to statistical inference in one important setting (clinical trials), my results pose a serious challenge for any approach that advocates a single, universal principle of statistical inference. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Breaking the Readmission CycleBrian HattenI want to share the story of my difficult patient Ms. L. She has twenty-seven current medical issues. Thirty-five active prescriptions. Limited mobility requiring the use of a motorized scooter. Non-medical care gaps. And over twenty hospital admissions since 2020. I met Ms. L approximately five years ago as her hospital attending and have continued to care for her during her frequent hospitalizations. I could (...) recite this 77-year-old female's litany of medical problems. But sufficed to say, her history is complex, with her admitting diagnoses running the gambit from cellulitis to gastrointestinal bleeding to altered mental status. But, her diagnosis and frequent exacerbations of congestive heart failure (CHF) are particularly frustrating for us both and will be my focus today.CHF makes her susceptible to fluid overload leading to feelings of shortness of breath, which progresses to respiratory distress. Like other individuals with CHF, she uses diuretics to prevent herself from becoming fluid overloaded. And, like many individuals who take diuretics, she hates them. She (un)affectionately calls her water pills "the bomb" because the effect is sudden, profound, and explosive when they begin working. The combination of the diuretic effect and her limited mobility causes significant emotional stress for Ms. L, a woman who values presenting herself outwardly as in control, well-dressed, and put together. Her dislike of the medical effect of her diuretics has led to her either taking them less often or outright discontinuing them. So, while discontinuation avoids those frustrating effects, it leads to fluid accumulation, subsequent respiratory distress, and readmission to the hospital.Her medical records mention she has memory issues. It is unclear how much her mild cognitive impairment affects her frequent readmissions. We have had many conversations where I would never suspect something was amiss. But sometimes, she can be forgetful and does not recall our recent discussions. That being said, she knows the names and uses of her medications. She can report to me her home weights when she checks them and knows what her "dry" weight should be. Yet, she does not act when her scales begin reading heavier or when she develops leg swelling. Instead, she presents to the emergency department in extremis. When directly questioned about why she lets her situation deteriorate to such a state that she requires hospitalization, she demurs. She comments that she can often be stubborn, that the diuretic effect of "the bomb" is burdensome, but always reminds me she is honest in admitting she wasn't taking her water pills.During several admissions, I worried for her survival after she had self-discontinued her medications and showed up at the emergency department in respiratory failure. For any patient with recurrent admissions, I discuss their overall goals of care to ensure we are working together toward achievable medical ends. But this conversation was essential to have with Ms. L. The possibility existed that she would present to the hospital too late in her disease process, and we would not be able to correct her respiratory failure. I wanted to ensure that the hospital staff and I respected her wishes regarding her care. Despite raising my concerns, she would [End Page 22] decline to discuss her wishes. Even worse, attempting to have her complete advance care planning documents like advance directives or a Physician Orders for Life-Sustaining Treatment (POLST) form was a futile endeavor. Ms. L was always vague and non-committal. She simply did not want to engage in those types of conversations. When asked why she declined to discuss these issues, Ms. L would reply that she was doing okay, the discussion was unnecessary, and she had family members to make those decisions for her.Caring for her during her hospital stays was a source of professional frustration for me. Her recurrent admissions made me feel like I was failing her. During each hospital stay, we would go over her medications. We repeatedly discussed how she should check her weights daily and monitor for lower extremity edema. We created multiple action plans for when to call her physicians so we could head off another hospital visit. We completed all the... (shrink)

Interim measures are procedural means that allow persons or States to have their rights preserved when a case is pending. Application of these measures especially in environmental cases is very important. In many of these cases (e.g. cases dealing with territorial planning, IPPC permits, environmental impact assessment, etc.) the claims deal with the protection of environment or its components (water, air, soil, etc.) as well as with the protection of public interest. Legal regulation of application of interim measures (...) provided by Lithuanian Law on Administrative Proceedings is not optimal. That is why the first part of the article is dedicated to the analysis of the possibilities and problems of application of interim measures in the administrative proceedings in Lithuania, paying special attention to environmental cases. The second part of the article reflects the findings of a workshop of the Association of European Administrative Judges on „Interim relief in environmental matters” held in Vilnius on 22 September 2011. It briefly describes various national rules on interim relief procedures, especially in the German and the French legislation, with an assessment from the German point of view. This part of the article focuses on provisional legal protection where a permit is challenged by a third party whose rights are allegedly afflicted. In such a constellation the rights of the plaintiff compete with the rights of the operator. The article concludes that, when deciding on the necessity of interim measures, it is vital to ensure the balance of interests: both by ensuring effective access to justice and by protecting the respondent and the third party (in environmental cases - usually the operator) from the violation of their rights and the damage caused by the abuse of the right to request interim measures. In such cases short time limits for procedural steps both of the parties and the court are not advisable and a prima facie prognosis on the outcome in the main proceedings meets the interests of the parties. (shrink)

Schopenhauer repeatedly claims that suicide is both foolish and futile. But while many commentators have expressed sympathy for his charge of foolishness, most regard his charge of futility as indefensible even within his own system. In this paper, I offer a defense of Schopenhauer’s futility charge, based on metaphysical and psychological considerations. On the metaphysical front, Schopenhauer’s view implies that psychological connections extend beyond death. Drawing on Parfit’s discussion of personal identity, I argue that those connections have personal (...) significance, such that suicide does not allow one, as Hamlet hopes, simply “not to be.” On the psychological front, I argue that a distinction between agents’ intentions and underlying desires makes room for Schopenhauer to claim that paradigmatic suicidal agents ultimately desire the opposite of what suicide accomplishes. I conclude by showing how the resulting account of futility can buttress the charge of foolishness as well. My interpretation still leaves Schopenhauer vulnerable to certain objections, but shows that his account is significantly more defensible than previous commentators have realized. (shrink)

This chapter addresses the close association between withholding and withdrawing futile life-sustaining medical treatments and assisting patients with hastening ending their lives. Section 12.2 sets forth a definition of medical futility and places this concept in the broader context of bioethical principles of autonomy, beneficence, nonmaleficence and justice. Section 12.3 draws out futility’s ethical implications and considers the view that physicians are ethically permitted to refrain from medically futile treatments, should be encouraged to refrain, or have a duty (...) to refrain. Section 12.4 examines ethical arguments that physicians also have a positive duty to assist patients with terminal conditions who are imminently dying to end their lives. It explores ethical arguments for assisted dying that appeal to the physicians’ significant responsibility and relationship with patients, the claimed moral equivalence of actions and omissions, and the medical goal of helping patients have a peaceful and dignified death. (shrink)

For many years a debate has raged over what constitutes futile medical care, if patients have a right to demand what doctors label as futile, and whether physicians should be obliged to provide treatments that they think are inappropriate. More recently, the argument has shifted away from the difficult project of definitions, to outlining institutional policies and procedures that take a measured and patient-by-patient approach to deciding if an existing or desired intervention is futile. The prototype is the Texas Advance (...) Directives Act, but similar procedures have been widely implemented both with and without the protection of the law. While this method has much to recommend it, there are inherent moral flaws that have not received as much discussion as warranted. Because these strategies adopt a semblance of procedural justice, it is assumed that the outcomes of such proceedings will be both correct and fair. In this paper, I argue that there are three main irremediable defects in the policy approach: there is the potential for arbitrary decision-making about futility in specific cases; there are structural, pre-ordained consequences for ethnic minorities who would be disproportionately affected by the use of these procedures; and the use of rationing justifications to support the use of these policies. These flaws detract so much from any benefit that could be derived that they make such strategies more harmful than helpful. (shrink)

Between States is the first book that assesses systematically the broad implications of interim governments in the establishment of democratic regimes and on the existence of states. Based on historical and contemporary democratisation experiences, the book presents four ideal types of interim government: opposition-led provisional governments, power-sharing interim governments, incumbent-led caretaker governments, and international interim government by the United Nations. The first part explores the theoretical problems of each of these models from a broad comparative perspective. (...) It uses as illustrations historical and contemporary cases that present a wide spectrum of contexts for comparison. The second part provides extensive case studies that are intended to illustrate, appraise, amplify and criticise the analysis in volume one. These include Iran, East Germany, Portugal, Afghanistan, and Yugoslavia. (shrink)

Confronting the challenges of the 20th century, from modernity and the Great War to the Holocaust and postmodern culture, Jewish thinkers have wrestled with such fundamental issues as redemption and revelation, eternity and history, messianism and politics. From the turn of the century through the 1920s, European Jewish intellectuals confronted alienation and the challenges of modernity by seeking secure grounds for a meaningful life. After the Holocaust and the fall of Nazism, the rich results of their thinking—on topics such as (...) transcendence, redemption, revelation, and politics—were reinterpreted in an atmosphere of increasing disillusion and fragmentation. In Interim Judaism, Michael L. Morgan traces the evolution of this shift in values, as expressed in the work of social thinkers, novelists, artists, and poets as well as philosophers and theologians at the beginning and end of the century. Focusing on the problem of objectivity, the experience of the transcendent, and the relationship between redemption and politics, he argues that the outcome for contemporary Jews is a pragmatic style of religiosity that has abandoned traditional conceptions of Judaism and is searching and waiting for new ones, a condition that he describes as "interim Judaism." Published with the generous support of Hebrew Union College–Jewish Institute of Religion, Cincinnati. (shrink)

Since its introduction in the 1980s, futility as a concept has held contested meaning and applications throughout medicine. There has been little discussion within the psychiatric literature about the use of futility in the care of individuals experiencing severe and persistent mental illness, despite some tacit acceptance that futility may apply in certain cases of psychiatric illness. In this paper, we explore the literature surrounding futility and argue that its connotation within medicine is to describe situations (...) where patients believe that interventions will almost certainly provide no meaningful benefit. We then provide two arguments in support of the use of futility within the care of individuals experiencing SPMI: that some SPMI can be considered a terminal illness, and that the risk-benefit ratio is a dynamic entity such that futility can help describe what Gillett calls the ‘risk of unacceptable badness’ when it comes to considering how an intervention might impact a patient’s quality of life. We posit that capacity should not pose an obstacle to declaring futility when caring for individuals experiencing SPMI and explain how futility is not antithetical to recovery in mental health. Finally, we describe how using futility within psychiatric practice can allow for a reorientation of care by signalling the need to shift to a palliative approach. (shrink)

Ableist attitudes and structures regarding disability are increasingly recognized across all sectors of healthcare delivery. After Dobbs, novel questions arose in the USA concerning how to protect reproductive autonomy while avoiding discrimination against and devaluation of disabled persons. As a case study, we examine the Louisiana’s Department of Public Health August 1st Emergency Declaration, “List of Conditions that shall deem an Unborn Child ‘Medically Futile.’” We raise a number of medical, ethical, and public health concerns that lead us to argue (...) the declaration should be rescinded. The ethically objectionable declaration provides valuable lessons concerning how to uphold both reproductive and disability justice in a post-Dobbs landscape. (shrink)

‘Futility’ is a contentious term that has eluded clear definition, with proposed descriptions either too strict or too vague to encompass the many facets of medical care. Requests for futile care are often surrogates for requests of a more existential character, covering the whole range of personal, emotional, cultural and spiritual needs. Physicians and other practitioners can use requests for futile care as a valuable opportunity to connect with their patients at a deeper level than the mere biomedical diagnosis. (...) Current debate around Canada’s changing regulatory and legal framework highlights challenges in appropriately balancing the benefits and burdens created by requests for futile care. (shrink)

“Futility” is a word which means the absence of benefit. It has been used to describe an absence of utility in resuscitation endeavours but it fails to do this. Futility does not consider the harms of resuscitation and we should consider the balance of benefit and harm that results from our resuscitation endeavours. If a resuscitation is futile then any harm that ensues will bring about an unfavourable benefit/harm balance. However, even if the endeavour is not futile, by (...) any definition, the benefit/harm balance may still be unfavourable if the harms that ensue are great.It is unlikely that we will ever achieve a consensus definition of futility and certainly not one that is applicable to every patient undergoing resuscitation. In the meantime our use of the term “futile”, in the mistaken belief that it tells us whether it is worth resuscitating or not, has no utility as it will never succeed in telling us this. Furthermore we risk causing offence by use of the term and we risk harming the patient's autonomy by using futility as an overriding force. Instead we should consider the utility of our endeavours, for which an assessment of the harms of resuscitation should be added to our considerations of its benefit. This balance of benefit and harm should then be evaluated as best it can be from the patient's perspective. The words futile and futility should be abandoned by resuscitationists. (shrink)

Death and futility are among a cluster of themes that closely track discussions of life’s meaning. Moreover, futility is thought to supervene on naturalistic meta-narratives because of how they will end. While the nature of naturalistic meta-narrative endings is part of the explanation for concluding that such meta-narratives are cosmically or deeply futile, this explanation is truncated. I argue that the reason the nature of the ending is thought to be normatively important is first anchored in the fact (...) that narrative ending qua ending is thought to be normatively important. Indeed, I think futility is often thought to characterize naturalistic meta-narratives because a narrative’s ending has significant proleptic power to elicit a wide range of broadly normative human responses on, possibly, emotional, aesthetic, and moral levels towards the narrative as a whole. (shrink)

It has been reported as an ethical problem within prehospital emergency care that ambulance professionals administer physiologically futile cardiopulmonary resuscitation (CPR) to patients having suffered cardiac arrest to benefit significant others. At the same time it is argued that, under certain circumstances, this is an acceptable moral practice by signalling that everything possible has been done, and enabling the grief of significant others to be properly addressed. Even more general moral reasons have been used to morally legitimize the use of (...) futile CPR: That significant others are a type of patient with medical or care needs that should be addressed, that the interest of significant others should be weighed into what to do and given an equal standing together with patient interests, and that significant others could be benefited by care professionals unless it goes against the explicit wants of the patient. In this article we explore these arguments and argue that the support for providing physiologically futile CPR in the prehospital context fails. Instead, the strategy of ambulance professionals in the case of a sudden death should be to focus on the relevant care needs of the significant others and provide support, arrange for a peaceful environment and administer acute grief counselling at the scene, which might call for a developed competency within this field. (shrink)

This paper introduces the medical factual matrix as a new and potentially valuable tool in medical ethical analysis. Using this tool it demonstrates the idea that a defined medical intervention can only be meaningfully declared futile in relation to a defined goal of treatment. It argues that a declaration of futility made solely in relation to a defined medical intervention is inchoate. It recasts the definition of goal futility as an intervention that cannot alter the probability of the (...) existence of the important outcome states that might flow from a defined intervention. The idea of value futility and the extent of physician obligations in futile situations are also addressed. It also examines the source of substantive conflicts which commonly arise within the doctor-patient relationship and the ensuing power relations that operate between doctor and patient when questions of futility arise. (shrink)

Objectives Medical futility at the end of life is a growing challenge to medicine. The goals of the authors were to elucidate how clinicians define futility, when they perceive life-sustaining treatment (LST) to be futile, how they communicate this situation and why LST is sometimes continued despite being recognised as futile. Methods The authors reviewed ethics case consultation protocols and conducted semi-structured interviews with 18 physicians and 11 nurses from adult intensive and palliative care units at a tertiary (...) hospital in Germany. The transcripts were subjected to qualitative content analysis. Results Futility was identified in the majority of case consultations. Interviewees associated futility with the failure to achieve goals of care that offer a benefit to the patient's quality of life and are proportionate to the risks, harms and costs. Prototypic examples mentioned are situations of irreversible dependence on LST, advanced metastatic malignancies and extensive brain injury. Participants agreed that futility should be assessed by physicians after consultation with the care team. Intensivists favoured an indirect and stepwise disclosure of the prognosis. Palliative care clinicians focused on a candid and empathetic information strategy. The reasons for continuing futile LST are primarily emotional, such as guilt, grief, fear of legal consequences and concerns about the family's reaction. Other obstacles are organisational routines, insufficient legal and palliative knowledge and treatment requests by patients or families. Conclusion Managing futility could be improved by communication training, knowledge transfer, organisational improvements and emotional and ethical support systems. The authors propose an algorithm for end-of-life decision making focusing on goals of treatment. (shrink)

Partly because physicians can “never say never,” partly because of the seduction of modern technology, and partly out of misplaced fear of litigation, physicians have increasingly shown a tendency to undertake treatments that have no realistic expectation of success. For this reason, we have articulated common sense criteria for medical futility. If a treatment can be shown not to have worked in the last 100 cases, we propose that it be regarded as medically futile. Also, if the treatment fails (...) to restore consciousness or alleviate total dependence on intensive care, we propose such treatment be judged futile. This definition provides clear end points and encourages the profession to review data from the past and perform, prospective clinical studies that not only report treatments that work but also treatments that do not work. We have also argued that, in a variety of settings, physicians have no ordinary ethical obligation to offer futile interventions. Although physicians should inform, and discuss all decisions to withhold or withdraw medical treatments with patients, they need not obtain the patient's permission to desist from futile interventions. (shrink)

One hypothesis concerning the human dorsal anterior cingulate cortex (ACC) is that it functions, in part, to signal the occurrence of conflicts in information processing, thereby triggering compensatory adjustments in cognitive control. Since this idea was first proposed, a great deal of relevant empirical evidence has accrued. This evidence has largely corroborated the conflict-monitoring hypothesis, and some very recent work has provided striking new support for the theory. At the same time, other findings have posed specific challenges, especially concerning (...) the way the theory addresses the processing of errors. Recent research has also begun to shed light on the larger function of the ACC, suggesting some new possibilities concerning how conflict monitoring might fit into the cingulate's overall role in cognition and action. (shrink)

One of the promising approaches to the problem of consciousness has been the Higher-Order Monitoring Theory of Consciousness. According to the Higher-Order Monitoring Theory, a mental state M of a subject S is conscious iff S has another mental state, M*, such that M* is an appropriate representation of M. Recently, several philosophers have developed a Higher-Order Monitoring theory with a twist. The twist is that M and M* are construed as entertaining some kind of constitutive relation, (...) rather than being logically independent of each other. We may call this the Same-Order Monitoring Theory of Consciousness. In this paper, I discuss the nature of the Same-Order Monitoring Theory and argue for its superiority over the more traditional Higher-Order Monitoring Theory. (shrink)

Comparatively little scholarly attention has been given to the question of futility in chronic psychiatric disorders, with the exception of a small body of work on so-called end-stage anorexia nervosa. A review of this literature provides the background for a critical examination of whether the concept of futility has any clinically meaningful, ethically justifiable, and legally defensible application to AN. In this article, the arguments for and against futility judgments in AN are analyzed with special emphasis on (...) determinations of capacity in this serious mental illness. Parallels between the futility disputes in medical and psychiatric disorders, where applicable, will be drawn to further illuminate whether or not the concept that continued psychiatric treatment for AN is ever truly futile. (shrink)

The concept of medical futility has come to be seen in some quarters as a value-neutral trump card when dealing with issues of power and conflicting values in medicine. I argue that this concept is potentially useful, but only in a social context that provides a normative framework for its use. This social context needs to include a broad consensus about the purpose of medicine and the nature of the physician-patient relationship.

This paper distinguishes four major types of futility (physiological, imminent demise, lethal condition, and qualitative) that have been advocated in the literature either in a patient dependent or a patient independent fashion. It proposes five criteria (precision, prospective, social acceptability, significant number, and non-agreement) that any definition of futility must satisfy if it is to serve as the basis for unilaterally limiting futile care. It then argues that none of the definitions that have been advocated meet the criteria, (...) primarily because their proponents have not paid sufficient attention to the problematic nature of the data supporting the use of their definitions. (shrink)

Storchak, Ehlis, and Fallgatter provide an extensive literature review on electrophysiological measurements, which indicate that general predictive deficits in self‐monitoring are associated with various positive symptoms in patients with schizophrenia.

Our response to death may differ depending on the patient’s age. We may feel that death is a sad, but acceptable event in an elderly patient, yet feel that death in a very young patient is somehow unfair. This paper explores whether there is any ethical basis for our different responses. It examines in particular whether a patient’s age should be relevant to the determination that an intervention is medically futile. It also considers the responsibilities of health professionals and the (...) rights of family members in situations where an interventions is clearly futile. (shrink)

In this essay I examine the formal structure of the concept of futility, enabling identification of the appropriate roles played by patient, professional, and society. I argue that the concept of futility does not justify unilateral decisions to forego life-sustaining medical treatment over patient or legitimate surrogate objection, even when futility is determined by a process or subject to ethics committee review. Furthermore, I argue for a limited positive ethical obligation on the part of health care professionals (...) to assist patients in achieving certain restricted goals, including the preservation of life, even in circumstances in which most would agree that that life is of no benefit to the patient. Finally, I address the objection that professional integrity overrides this limited obligation and find the objection unconvincing. In short, my aim in this essay is to see the concept of futility finally buried, once and for all. (shrink)

In traditional decision theory, utility is regarded as a mathematical representation of preferences to be inferred from agents hedonic experiences. Some go as far as to contend that utility is literally computed by specific neural areas and urge economists to complement or substitute their notion of utility with some neuro-psychological construct. In this paper, I distinguish three notions of utility that are frequently mentioned in debates about decision theory and examine some critical issues regarding their definition and measurability. Moreover, I (...) provide various empirical and conceptual reasons to doubt that economists should base decision theoretic analyses on some neuro-psychological notion of utility. (shrink)

... and the baby has a large VSD. Otherwise appears well, gaining weight, smiling. No apnea, never been on ventilator. Local cardiac surgeon refused to operate, saying that surgery would be inappropriate. Have reached out to other centers, and some state that they never perform what they said was “futile” heart surgery on children with Trisomy 18, while other sites say they have and will continue to perform these operations. Can someone explain to me what is going on? In the (...) realm of medical care—given enough patients, clinicians, and time—conflict is inevitable. Someone will want to do something, such as give a drug or start a new form of technologic support, and someone else will think that this is a... (shrink)

Acts of futile resistance—harms against an aggressor which could not reasonably hope to avert the threat the aggressor poses—give rise to a puzzle: on the one hand, many such acts are intuitively permissible, yet on the other, these acts fail to meet the justificatory standards of defensive action. The most widely accepted solution to this puzzle is that victims in such cases permissibly defend against a secondary threat to their honour, dignity, or moral standing. I argue that this solution fails, (...) because futile resistance is not plausibly regarded as defensive in the relevant sense. I propose instead that futile resistance is justified as a form of protest, where protest is analysed as an expression of rejection of victims’ wrongs. Such protest is justified, I argue, when and because it is the fitting response to the circumstances of futility. (shrink)

Futility is not a purely medical concept. Its subjective nature requires a balanced procedural approach where competing views can be aired and in which disputes can be resolved with procedural fairness. Law should play an important role in this process. Pure medical models of futility are based on a false claim of medical sovereignty. Procedural approaches avoid the problems of such claims. This paper examines the arguments for and against the adoption of a procedural approach to futility (...) determination. (shrink)

Like the authors of some of the other responses to Schneiderman, Jecker, and Jonsen, I too was one of the group that produced “An Official ATS/AACN/ACCP/ESICM/SCCM Policy Statement: Responding to Requests for Futile and Potentially Inappropriate Treatments in Intensive Care Units”. Furthermore, ethical and legal issues surrounding futile and potentially inappropriate medical treatment have been a primary focus of my scholarship for more than a decade. Schneiderman, Jecker, and Jonsen offer a strong critique of the Multiorganization Statement, but they do (...) not describe it with sufficient precision. There are points of true normative disagreement between the... (shrink)