The authors consider the legal and ethical considerations of offering a time-limited trial of a potentially non-beneficial intervention in the setting of patient or surrogate requests to pursue aggressive treatment. The likelihood of an intervention’s success is rarely a zero-sum game, and an intervention’s risk-to-benefit ratio may be indiscernible without further information (often, a matter of time).

Interim analyses in clinical trials can take on a multitude of forms. They are often used to guide Data and Safety Monitoring Board (DSMB) recommendations to study teams regarding recruitment targets for large, later-phase clinical trials. As collaborative biostatisticians working and teaching in multiple fields of research and across a broad array of trial phases, we note the large heterogeneity and confusion surrounding interim analyses in clinical trials. Thus, in this paper, we aim to provide a general overview and guidance on interim analyses for a nonstatistical audience. We explain each of the following types of interim analyses: efficacy, futility, safety, and sample size re-estimation, and we provide the reader with reasoning, examples, and implications for each. We emphasize that while the types of interim analyses employed may differ depending on the nature of the study, we would always recommend prespecification of the interim analytic plan to the extent possible with risk mitigation and trial integrity remaining a priority. Finally, we posit that interim analyses should be used as tools to help the DSMB make informed decisions in the context of the overarching study. They should generally not be deemed binding, and they should not be reviewed in isolation.

In The Rhetoric of Reaction, published in 1991, Albert Hirschman identified three standard objections to reform proposals: perversity, futility and jeopardy. In Hirschman's account, these objections define reactionary rhetoric. A proposal would be “perverse” if it would aggravate the very problem it is meant to solve; it would be “futile” if it would not even dent the problem; it would produce “jeopardy” if it would endanger some other goal or value (such as liberty or economic growth). The rhetoric of reaction comes from both left and right, though in Hirschman's account, it is a special favorite of the right. In recent years, the perversity, futility and jeopardy theses have often been invoked to challenge reforms, including nudges. While the three theses are sometimes supported by the evidence, they are often evidence-free speculations, confirming Hirschman's suggestion that the rhetoric of reaction has “a certain elementary sophistication and paradoxical quality that carry conviction for those who are in search of instant insights and utter certainties.”

In this article, we comment on Ciaffa’s article ‘The Ethics of Unilateral Do-Not-Resuscitate Orders for COVID-19 Patients.’ We summarize his argument criticizing futility and utilitarianism as the key ethical justifications for unilateral do-not-resuscitate orders for patients with COVID-19.

This paper examines several decision-making models that have been proposed to limit the use of CPR for COVID-19 patients. My main concern will be to assess proposals for the implementation of unilateral DNRs — i.e., orders to withhold CPR without the agreement of patients or their surrogates.

There is frequently tension in medical education between teaching moments that provide skills and knowledge for medical trainees, and instrumentalizing patients for the purpose of teaching. In this commentary, I question the ethical acceptability of the practice of providing cardiopulmonary resuscitation (CPR) and advanced cardiac life support (ACLS) to dying patients who would be unlikely to survive resuscitation, as a teaching opportunity for medical trainees. This practice violates the principle of informed consent, as the patient agreed to resuscitation for the purpose of potentially prolonging life rather than to futile resuscitation as a teaching opportunity. Justifying futile resuscitation in order to practice normalizes deceptive and nonconsensual teaching cases in medical training. Condoning these behaviors as ethically acceptable trains physicians to believe that core ethical principles are relative and fluid to suit one’s purpose. I argue that these practices are antithetical to the principles espoused by both medical ethics and physician professionalism.

The document is published in collaboration with the following organisations: the European Society of Emergency Medicine (Leuven); the European Resuscitation Council (Antwerpen); the Air Medical Physician Association (Salt Lake City, US); the German Interdisciplinary Association of Critical Care Medicine; and the German Society of Anaesthesiology and Intensive Care. The document is to be published jointly in the following journals: 1) Trauma Care (ITACCS); 2) Resuscitation; 3) Prehospital and Disaster Medicine; 4) European Journal of Emergency Medicine; 5) Trauma and Emergency Medicine Journal (SA); 6) Emergency Medicine(Norway); 7) JEUR; and 8) Notfall und Rettungsmedizin (Germany).