Neither Ethical nor Prudent: Why Not to Choose Normothermic Regional Perfusion.

In transplant medicine, the use of normothermic regional perfusion (NRP) in donation after circulatory determination of death raises ethical difficulties. NRP is objectionable because it restores the donor's circulation, thus invalidating a death declaration based on the permanent cessation of circulation. NRP's defenders respond with arguments that are tortuous and factually inaccurate and depend on introducing extraneous concepts into the law. However, results comparable to NRP's-more and higher-quality organs and more efficient allocation-can be achieved by removing organs from deceased donors and using normothermic machine perfusion (NMP) to support the organs outside the body, without jeopardizing confidence in transplantation's legal and ethical foundations. Given the controversy that NRP generates and the convoluted justifications made for it, we recommend a prudential approach we call "ethical parsimony," which holds that, in the choice between competing means of achieving a result, the ethically simpler one is to be preferred. This approach makes clear that policy-makers should favor NMP over NRP.

The Unsuccessful Effort to Revise the Uniform Determination of Death Act.

This Viewpoint summarizes the major issues that led to the decision to draft a revision of the Uniform Determination of Death Act, the alternatives that were considered, why there was failure to reach consensus, and what this means for the future.

Editors' statement on the responsible use of generative AI technologies in scholarly journal publishing.

Generative artificial intelligence (AI) has the potential to transform many aspects of scholarly publishing. Authors, peer reviewers, and editors might use AI in a variety of ways, and those uses might augment their existing work or might instead be intended to replace it. We are editors of bioethics and humanities journals who have been contemplating the implications of this ongoing transformation. We believe that generative AI may pose a threat to the goals that animate our work but could also be valuable for achieving those goals. In the interests of fostering a wider conversation about how generative AI may be used, we have developed a preliminary set of recommendations for its use in scholarly publishing. We hope that the recommendations and rationales set out here will help the scholarly community navigate toward a deeper understanding of the strengths, limits, and challenges of AI for responsible scholarly work.

Editors' Statement on the Responsible Use of Generative AI Technologies in Scholarly Journal Publishing.

Generative artificial intelligence (AI) has the potential to transform many aspects of scholarly publishing. Authors, peer reviewers, and editors might use AI in a variety of ways, and those uses might augment their existing work or might instead be intended to replace it. We are editors of bioethics and humanities journals who have been contemplating the implications of this ongoing transformation. We believe that generative AI may pose a threat to the goals that animate our work but could also be valuable for achieving those goals. In the interests of fostering a wider conversation about how generative AI may be used, we have developed a preliminary set of recommendations for its use in scholarly publishing. We hope that the recommendations and rationales set out here will help the scholarly community navigate toward a deeper understanding of the strengths, limits, and challenges of AI for responsible scholarly work.

Editors' Statement on the Responsible Use of Generative AI Technologies in Scholarly Journal Publishing.

Generative artificial intelligence (AI) has the potential to transform many aspects of scholarly publishing. Authors, peer reviewers, and editors might use AI in a variety of ways, and those uses might augment their existing work or might instead be intended to replace it. We are editors of bioethics and humanities journals who have been contemplating the implications of this ongoing transformation. We believe that generative AI may pose a threat to the goals that animate our work but could also be valuable for achieving those goals. In the interests of fostering a wider conversation about how generative AI may be used, we have developed a preliminary set of recommendations for its use in scholarly publishing. We hope that the recommendations and rationales set out here will help the scholarly community navigate toward a deeper understanding of the strengths, limits, and challenges of AI for responsible scholarly work.

Stronger regulation of AI in biomedicine.

Regulatory agencies need to ensure the safety and equity of AI in biomedicine, and the time to do so is now.

Vagueness in Goals-of-Care Conferences for Critically Ill Patients: Types of Hedge Language Used by Physicians.

OBJECTIVES: Hedge language is a category of language that refers to words or phrases that make statements "fuzzier." We sought to understand how physicians use hedge language during goals-of-care conferences in the ICU. DESIGN: Secondary analysis of transcripts of audio-recorded goals-of-care conferences in the ICU. SETTING: Thirteen ICUs at six academic and community medical centers in the United States. PATIENTS: Conferences were between clinicians and surrogates of incapacitated, critically ill adults. INTERVENTIONS: Four investigators performed a qualitative content analysis of transcripts using deductive followed by inductive methods to identify types of hedge language used by physicians, then coded all instances of hedge language across 40 transcripts to characterize general patterns in usage. MEASUREMENTS AND MAIN RESULTS: We identified 10 types of hedge language: numeric probabilistic statement ("there's an 80% chance"), qualitative probabilistic statement ("there's a good chance"), nonprobabilistic uncertainty statement ("hard to say for her"), plausibility shield ("we expect"), emotion-based statement ("we're concerned"), attribution shield ("according to Dr. X"), adaptor ("sort of"), metaphor ("the chips are stacking up against her"), time reference ("too soon to tell"), and contingency statement ("if we are lucky"). For most types of hedge language, we identified distinct subtypes. Physicians used hedge language frequently in every transcript (median: 74 hedges per transcript) to address diagnosis, prognosis, and treatment. We observed large variation in how frequently each type and subtype of hedge language was used. CONCLUSIONS: Hedge language is ubiquitous in physician-surrogate communication during goals-of-care conferences in the ICU and can be used to introduce vagueness to statements in ways beyond expressing uncertainty. It is not known how hedge language impacts decision-making or clinician-surrogate interactions. This study prioritizes specific types of hedge language for future research based on their frequency and novelty.

"No Escalation of Treatment" Designations: A Multi-institutional Exploratory Qualitative Study.

BACKGROUND: No Escalation of Treatment (NoET) designations are used in ICUs internationally to limit treatment for critically ill patients. However, they are the subject of debate in the literature and have not been qualitatively studied. RESEARCH QUESTION: How do physicians understand and perceive NoET designations, especially regarding their usefulness and associated challenges? What mechanisms do hospitals provide to facilitate the use of NoET designations? STUDY DESIGN AND METHODS: Qualitative study at seven US hospitals, employing semistructured interviews with 30 physicians and review of relevant institutional records (eg, hospital policies, screenshots of ordering menus in the electronic health record). RESULTS: At all hospitals, participants reported the use of NoET designations, which were understood to mean that providers should withhold new or higher-intensity interventions ("escalations") but not withdraw ongoing interventions. Three hospitals provided a specific mechanism for designating a patient as NoET (eg, a DNR/Do Not Escalate code status order); at the remaining hospitals, a variety of informal methods (eg, verbal hand-offs) were used. We identified five functions of NoET designations: (1) Defining an intermediate point of treatment limitation, (2) helping physicians navigate prearrest clinical decompensations, (3) helping surrogate decision-makers transition toward comfort care, (4) preventing patient harm from invasive measures, and (5) conserving critical care resources. Across hospitals, participants reported implementation challenges related to the ambiguity in meaning of NoET designations. INTERPRETATION: Despite ongoing debate, NoET designations are used in a varied sample of hospitals and are perceived as having multiple functions, suggesting they may fulfill an important need in the care of critically ill patients, especially at the end of life. The use of NoET designations can be improved through the implementation of a formal mechanism that encourages consistency across providers and clarifies the meaning of "escalation" for each patient.

Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials.

Stepped-wedge cluster randomized trial (SW-CRT) designs are increasingly employed in pragmatic research; they differ from traditional parallel cluster randomized trials in which an intervention is delivered to a subset of clusters, but not to all. In a SW-CRT, all clusters receive the intervention under investigation by the end of the study. This approach is thought to avoid ethical concerns about the denial of a desired intervention to participants in control groups. Such concerns have been cited in the literature as a primary motivation for choosing SW-CRT design, however SW-CRTs raise additional ethical concerns related to the delayed implementation of an intervention and consent. Yet, PCT investigators may choose SW-CRT designs simply because they are concerned that other study designs are infeasible. In this paper, we examine justifications for the use of SW-CRT study design, over other designs, by drawing on the experience of the National Institutes of Health's Health Care Systems Research Collaboratory (NIH Collaboratory) with five pragmatic SW-CRTs. We found that decisions to use SW-CRT design were justified by practical and epistemic reasons rather than ethical ones. These include concerns about feasibility, the heterogeneity of cluster characteristics, and the desire for simultaneous clinical evaluation and implementation. In this paper we compare the potential benefits of SW-CRTs against the ethical and epistemic challenges brought forth by the design and suggest that the choice of SW-CRT design must balance epistemic, feasibility and ethical justifications. Moreover, given their complexity, such studies need rigorous and informed ethical oversight.