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Neutralizing monoclonal antibodies (mAbs) were authorized for the treatment of COVID-19 outpatients based on clinical trials completed early in the pandemic, which were underpowered for mortality and subgroup analyses. Real-world data studies are promising for further assessing rapidly deployed therapeutics.Did mAb treatment prevent progression to severe disease and death across pandemic phases and based on risk factors, including prior vaccination status?This observational cohort study included nonhospitalized adult patients with SARS-CoV-2 infection from November 2020 to October 2021 using electronic health records from a statewide health system plus state-level vaccine and mortality data. Using propensity matching, we selected approximately 2.5 patients not receiving mAbs for each patient who received mAb treatment under emergency use authorization. The primary outcome was 28-day hospitalization; secondary outcomes included mortality and hospitalization severity.Of 36,077 patients with SARS-CoV-2 infection, 2,675 receiving mAbs were matched to 6,677 patients not receiving mAbs. Compared with mAb-untreated patients, mAb-treated patients had lower all-cause hospitalization (4.0% vs 7.7%; adjusted OR, 0.48; 95% CI, 0.38-0.60) and all-cause mortality (0.1% vs 0.9%; adjusted OR, 0.11; 95% CI, 0.03-0.29) to day 28; differences persisted to day 90. Among hospitalized patients, mAb-treated patients had shorter hospital length of stay (5.8 vs 8.5 days) and lower risk of mechanical ventilation (4.6% vs 16.6%). Results were similar for preventing hospitalizations during the Delta variant phase (adjusted OR, 0.35; 95% CI, 0.25-0.50) and across subgroups. Number-needed-to-treat (NNT) to prevent hospitalization was lower for subgroups with higher baseline risk of hospitalization; for example, multiple comorbidities (NNT = 17) and not fully vaccinated (NNT = 24) vs no comorbidities (NNT = 88) and fully vaccinated (NNT = 81).Real-world data revealed a strong association between receipt of mAbs and reduced hospitalization and deaths among COVID-19 outpatients across pandemic phases. Real-world data studies should be used to guide practice and policy decisions, including allocation of scarce resources.

Neutralizing monoclonal antibody treatments for non-hospitalized patients with COVID-19 have been available since November 2020. However, they have been underutilized and access has been inequitable. To understand, from the clinician perspective, the factors facilitating or hindering monoclonal antibody referrals, patient access, and equity to inform development of clinician-focused messages, materials, and processes for improving access to therapeutics for COVID-19 in Colorado. We interviewed 38 frontline clinicians with experience caring for patients with COVID-19 in outpatient settings. Clinicians were purposely sampled for diversity to understand perspectives across geography (i.e., urban versus rural), practice setting, specialty, and self-reported knowledge about monoclonal antibodies. Interviews were conducted between June and September 2021, lasted 21 to 62 minutes, and were audio recorded and transcribed verbatim. Interview transcripts were then analyzed using rapid qualitative analysis to identify thematic content and to compare themes across practice settings and other variables. Clinicians perceived monoclonal antibodies to be highly effective and were unconcerned about their emergency use status; hence, these factors were not perceived to hinder patient referrals. However, some barriers to access - including complex and changing logistics for referring, as well as the time and facilities needed for an infusion - inhibited widespread use. Clinicians in small, independent, and rural practices experienced unique challenges, such as lack of awareness of their patients' COVID-19 test results, disconnect from treatment distribution systems, and patients who faced long travel times to obtain treatment. Many clinicians held a persistent belief that monoclonal antibodies were in short supply; this belief hindered referrals, even when monoclonal antibody doses were not scarce. Across practice settings, the most important facilitator for access to monoclonal antibodies was linkage of COVID-19 testing and treatment within care delivery. Although clinicians viewed monoclonal antibodies as safe and effective treatments for COVID-19, individual- and system-level barriers inhibited referrals, particular in some practice settings. Subcutaneous or oral formulations may overcome certain barriers to access, but simplifying patient access by linking testing with delivery of treatments that reduce morbidity and mortality will be critical for the ongoing response to COVID-19 and in future pandemics.

Timely and accurate data on COVID-19 cases and COVID-19‒related deaths are essential for making decisions with significant health, economic, and policy implications. A new report from the National Academies of Sciences, Engineering, and Medicine proposes a uniform national framework for data collection to more accurately quantify disaster-related deaths, injuries, and illnesses. This article describes how following the report’s recommendations could help improve the quality and timeliness of public health surveillance data during pandemics, with special attention to addressing gaps in the data necessary to understand pandemic-related health disparities.

Sotrovimab effectively prevented progression to severe disease and mortality following infection with pre-Omicron SARS-CoV-2 variants. We sought to determine whether sotrovimab is similarly effective against SARS-CoV-2 Omicron variant infection.Observational cohort study of non-hospitalized adult patients with SARS-CoV-2 infection from December 26, 2021 to March 10, 2022, using electronic health records from a statewide health system. We propensity matching patients not receiving authorized treatment for each patient treated with sotrovimab. The primary outcome was 28-day hospitalization; secondary outcomes included mortality. We also propensity matched sotrovimab-treated patients from the Omicron and Delta phases. Logistic regression was used to determine sotrovimab effectiveness during Omicron and between variant phases.Of 30,247 SARS-CoV-2 Omicron variant infected outpatients, we matched 1,542 receiving sotrovimab to 3,663 not receiving treatment. Sotrovimab treatment was not associated with reduced odds of 28-day hospitalization (2.5% versus 3.2%; adjusted OR 0.82, 95% CI 0.55, 1.19) or mortality (0.1% versus 0.2%; adjusted OR 0.62, 95% CI 0.07, 2.78). Between phases, the observed treatment odds ratio was higher during Omicron than during Delta (OR 0.85 vs. 0.39, respectively; interaction p=0.053).Real-world evidence demonstrated sotrovimab was not associated with reduced 28-day hospitalization or mortality among COVID-19 outpatients during the Omicron BA.1 phase.

As described in two articles in the September-October 2021 issue of the Hastings Center Report, most crisis standards of care (CSC) plans include triage algorithms to guide the allocation of critical care resources to some patients and not others under conditions of extreme scarcity. The plans also include other important CSC strategies, but it is the notion of rationing scarce resources via triage that especially captured the imaginations of ethicists. Vigorous arguments have arisen over whether triage algorithms should be designed to prioritize patients based on predictions of short-, near-, or long-term survival. Additionally, there are ongoing debates about the ability of current algorithms to estimate patient survival accurately enough to be useful in triage and about the role of values like equity in triage protocols. Relatively few debates have noted, however, that while the development of CSC triage protocols has been based in medicine, public health, and ethics, the activation of CSC plans remains a political decision.

Neutralizing monoclonal antibodies (mAbs) are authorized for early symptomatic COVID-19 patients. Whether mAbs are effective against the SARS-CoV-2 Delta variant, among vaccinated patients, or for prevention of mortality remains unknown.To evaluate the effectiveness of mAb treatment in preventing progression to severe disease during the Delta phase of the pandemic and based on key baseline risk factors.Observational cohort study of non-hospitalized adult patients with SARS-CoV-2 infection from November 2020-October 2021, using electronic health records from a statewide health system plus state-level vaccine and mortality data. Using propensity matching, we selected approximately 2.5 patients not receiving mAbs for each patient who received mAbs.Neutralizing mAb treatment under emergency use authorization.The primary outcome was 28-day hospitalization; secondary outcomes included mortality and severity of hospitalization.Of 36,077 patients with SARS-CoV-2 infection, 2,675 receiving mAbs were matched to 6,677 not receiving mAbs. Compared to mAb-untreated patients, mAb-treated patients had lower all-cause hospitalization (4.0% vs 7.7%; adjusted OR 0.48, 95%CI 0.38-0.60) and all-cause mortality (0.1% vs. 0.9%; adjusted OR 0.11, 95%CI 0.03-0.29) to day 28; differences persisted to day 90. Among hospitalized patients, mAb-treated patients had shorter hospital length of stay (5.8 vs. 8.5 days) and lower risk of mechanical ventilation (4.6% vs. 16.6%). Relative effectiveness was similar in preventing hospitalizations during the Delta variant phase (adjusted OR 0.35, 95%CI 0.25-0.50) and across subgroups. Lower number-needed-to-treat (NNT) to prevent hospitalization were observed for subgroups with higher baseline risk of hospitalization (e.g., multiple comorbidities (NNT=17) and not fully vaccinated (NNT=24) vs. no comorbidities (NNT=88) and fully vaccinated (NNT=81).Real-world evidence demonstrated mAb effectiveness in reducing hospitalization among COVID-19 outpatients, including during the Delta variant phase, and conferred an overall 89% reduction in 28-day mortality. Early outpatient treatment with mAbs should be prioritized, especially for individuals with highest risk for hospitalization.

Public health agencies regularly survey randomly selected anonymous students to track drug use, sexual activities, and other risk behaviors. Students are unidentifiable, but a recent project that included school-level analysis discovered a school with alarmingly prevalent student suicidality. Given confidentiality protocols typical of surveillance, the surveyors were uncertain whether and how to intervene. We searched literature for duties to warn at-risk groups discovered during public health surveillance, but we found no directly applicable guidance or cases. Reasoning by analogy, we conclude that surveyors should contact the school's leaders to call attention to its outlier status, but public warning is unwarranted. However, such an ad hoc decision to issue a warning, even if only to school leaders, raises significant practical, legal and ethical issues. National public health and education associations should produce guidance that clarifies ethical and legal duties owed to schools and students involved in population health-risk surveillance.

In this issue, we report on an ethical challenge arising from the chance discovery of a suicidality cluster in a middle school that participated in an anonymous student health survey (Levinson et a...

BACKGROUND: Physicians play a key role in mitigating and managing costs in healthcare which are rising. OBJECTIVE: Conduct a cross-sectional survey in 2017, comparing results to a 2012 survey to understand US physicians’ evolving attitudes and strategies concerning healthcare costs. PARTICIPANTS: Random sample of 1200 US physicians from the AMA Masterfile. MEASURES: Physician views on responsibility for costs of care, enthusiasm for cost-saving strategies, cost-consciousness scale, and practice strategies on addressing cost. KEY RESULTS: Among 1200 physicians surveyed in 2017, 489 responded (41%). In 2017, slightly more physicians reported that physicians have a major responsibility for addressing healthcare costs (32% vs. 27%, p = 0.03). In 2017, more physicians attributed “major responsibility” for addressing healthcare costs to pharmaceutical companies (68% vs. 56%, p 70%). After adjusting for specialty, political affiliation, practice setting, age, and gender, only democratic/independent affiliation remained a significant predictor of cost-consciousness. CONCLUSIONS AND RELEVANCE: US physicians increasingly attribute responsibility for rising healthcare costs to organizations and express less enthusiasm for strategies that increase patient out-of-pocket cost. Interventions that focus on physician knowledge and communication strategies regarding cost of care may be helpful. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11606-020-05807-0) contains supplementary material, which is available to authorized users.

This article reassesses and recontextualizes findings of an independent writing group commissioned in 2005 by what was then known as the Institute for Ethics of the American Medical Association (AMA). The authors were members of this group, which uncovered a paradigm case of structural racism that has perpetuated health inequity since the issue of admitting African Americans was first raised at the AMA's national meetings immediately after the Civil War ended, in 1868. Upon publication of the writing group's findings, the AMA publicly apologized for its social, cultural, and political roles in the racist history of organized medicine. Now, in 2021, the authors of this article seek to situate this aspect of the AMA's history as it prepares itself for antiracist leadership in the health care sector.

BackgroundNeutralizing monoclonal antibodies (mAbs) are authorized for early symptomatic COVID-19 patients. Whether mAbs are effective against the SARS-CoV-2 Delta variant, among vaccinated patients, or for prevention of mortality remains unknown.ObjectiveTo evaluate the effectiveness of mAb treatment in preventing progression to severe disease during the Delta phase of the pandemic and based on key baseline risk factors.Design, Setting, and PatientsObservational cohort study of non-hospitalized adult patients with SARS-CoV-2 infection from November 2020-October 2021, using electronic health records from a statewide health system plus state-level vaccine and mortality data. Using propensity matching, we selected approximately 2.5 patients not receiving mAbs for each patient who received mAbs.ExposureNeutralizing mAb treatment under emergency use authorizationMain OutcomesThe primary outcome was 28-day hospitalization; secondary outcomes included mortality and severity of hospitalization.ResultsOf 36,077 patients with SARS-CoV-2 infection, 2,675 receiving mAbs were matched to 6,677 not receiving mAbs. Compared to mAb-untreated patients, mAb-treated patients had lower all-cause hospitalization (4.0% vs 7.7%; adjusted OR 0.48, 95%CI 0.38-0.60) and all-cause mortality (0.1% vs. 0.9%; adjusted OR 0.11, 95%CI 0.03-0.29) to day 28; differences persisted to day 90. Among hospitalized patients, mAb-treated patients had shorter hospital length of stay (5.8 vs. 8.5 days) and lower risk of mechanical ventilation (4.6% vs. 16.6%). Relative effectiveness was similar in preventing hospitalizations during the Delta variant phase (adjusted OR 0.35, 95%CI 0.25-0.50) and across subgroups. Lower number-needed-to-treat (NNT) to prevent hospitalization were observed for subgroups with higher baseline risk of hospitalization (e.g., multiple comorbidities (NNT=17) and not fully vaccinated (NNT=24) vs. no comorbidities (NNT=88) and fully vaccinated (NNT=81).ConclusionReal-world evidence demonstrated mAb effectiveness in reducing hospitalization among COVID-19 outpatients, including during the Delta variant phase, and conferred an overall 89% reduction in 28-day mortality. Early outpatient treatment with mAbs should be prioritized, especially for individuals with highest risk for hospitalization.

This paper reviews three competing ways of organizing health care delivery—professionalism, consumerism and statism—and explores how Germany’s exclusively statist model facilitated the ascendency of an alternative Nazi medical ethics predicated on eugenic conceptions of national “race hygiene.” The primary obligation of health care personnel became using their skills and knowledge to achieve the aims of the Nazi state, which justified forcible eugenic sterilization programs, and then the killing of children and adults with mental or physical disabilities and, eventually, the medicalized mass murder of other groups seen to pose a genetic threat to the health of the state, such as homosexuals, Jews, and Roma. The evolving international response to these medical crimes would come to affect medical professional approaches to virtually every issue in contemporary Bioethics, from abortion to xenotransplantation. In the early post-war years, news of German health care professionals’ participation in these actions shocked fellow health care professionals. Many denied these accounts, some defended German researchers, others dismissed the Germans’ justifications of their actions as madness parading as medicine or medical ethics. Ultimately, however, reformers seeking to remedy or prevent actions reminiscent of Nazi medicine created the foundational documents of modern health care professional ethics and the new field of Bioethics. These are the Nuremberg Code, the Declaration of Geneva, and the Belmont Report. In firmly rejecting Nazi medical ethics, these documents emphasize the rights of autonomous individuals, with health professionals serving as their agents, thus cementing modern ideals of health care professionalism.

There is an urgent need to identify and address factors influencing uptake and equitable access to monoclonal antibody (mAb) treatment for high-risk outpatients with COVID-19.To assess clinician knowledge, beliefs, and experiences regarding obtaining mAb treatment for eligible patients.Survey of clinicians (N = 374) practicing in the state of Colorado who care for patients with COVID-19 in primary care, emergency medicine, and other clinical settings.Diffusion of innovation theory concepts including knowledge, perceived strength of evidence, barriers, and experience with, ease of use, preparedness, and feasibility, appropriateness, and acceptability of mAb referral systems and processes.Most respondents indicated little to no knowledge about mAb therapies for COVID-19 (67%, 74%, 77%, for bamlanivimab, bamlanivimab+etesivimab, and casirivimab+imdevimab, respectively). About half reported little to no familiarity with eligibility criteria (50.9%) and did not know the strength of evidence (31%, 43%, 52%, for bamlanivimab, bamlanivimab+etesivimab, and casirivimab+imdevimab, respectively). Lack of knowledge or confidence in treatment was a top barrier to mAbs use; other barriers included complicated referral processes, patients not eligible when seen, and out-of-pocket costs concerns. Respondents rated four mAb referral steps as generally acceptable, appropriate, and feasible to complete in their primary outpatient clinical setting. Only 24% indicated their clinical setting was very prepared to facilitate referrals, 40% had ever referred a patient for mAbs, and 43% intended to refer a patient in the next month.Clinician education on strength of evidence and eligibility criteria for mAbs is needed. However, education alone is not sufficient. Given the urgent need to rapidly scale up access to treatment and reduce hospitalizations and death from COVID-19, more efficient, equitable systems and processes for referral and delivery of care, such as those coordinated by health systems, public health departments, or disaster management services, are warranted.

This viewpoint proposes why and how Holocaust Remembrance Day, January 27, should be honored in all health professions schools. A public letter, from which this viewpoint is adapted, has been endorsed by over 50 teachers of medicine, ethics, and history.

COVID-19 has fundamentally challenged the delivery of health care services across the world, forcing difficult choices on health professionals and laying bare many preexisting health, medical, and public health sector frailties. Extreme shortages of key resources and worries that patients would not receive the care they needed were frequent features of the response beginning in the spring of 2020 and were recurrent during subsequent regional and national peaks. Crisis standards of care (CSC) occur when the degree of resource shortage requires decisions that place a patient or provider at risk of a poor outcome. These situations arose in most jurisdictions and required a systematic, coordinated response [1]. Often, state and health care CSC plans were used or revised, or they did not apply to the situations encountered. In several critical instances, potentially useful CSC plans were ignored or actively subverted. The authors of this paper describe some of the successes and shortfalls of CSC principles and practices during COVID-19 and identify issues to be addressed for future events. This paper focuses on hospital application of CSC, though emergency medical services (EMS) experienced similar issues. EMS and health care planning and response must be linked to ensure consistency of expectations as well as optimal patient distribution and redistribution. Both EMS and hospital resources and staff require stewardship during disasters, particularly ones that are protracted in nature. Recognition of clinical care interdependency (long-term care, EMS, hospitals, outpatient care) in planning and response is critical for avoiding CSC conditions and improving consistency across the spectrum of care as well as across any given geographic region. Revision of CSC doctrine is needed and should be a focus for health care institutions and local, state, and federal governments alike to ensure that the best care possible is delivered when the next disaster strikes. In the following sections, the authors discuss some key CSC domains as well as successes, issues, and action steps.

There is perhaps no clinical situation where this truism of ethics should be more important than when making potentially life-ending triage decisions. Any ethical triage system must, at minimum, sa...

Sisk et al. (2020) argue that once a normative claim is developed, there is an imperative to effect changes based on this norm; therefore, ethicists should adopt an “implementation mindset” and col...

The consent process for publication of clinical images in medical journals varies widely. The extent of this variation is not known. It is also not known whether journals follow their own stated best practices or the guidance of the International Committee of Medical Journal Editors (ICMJE). We assessed consent requirements in a sample of 10 top impact factor general medicine journals that publish clinical images, examining variability in consent requirements for clinical image publication and congruence of requirements with the recommendations of the ICMJE. Clinical image consent requirements varied widely from journal to journal. None of the studied journals, even amongst n = 4 ICMJE members or n = 8 journals who self-report adherence to ICMJE guidelines, comply with all of the recommendations of the ICMJE. Half of studied journals require a journal-specific consent form. Among top medical journals there is significant heterogeneity in consent requirements for clinical images. Variability of consent requirements is neither practical nor rational; inconsistent requirements create uncertainty for authors, present impediments to dissemination of scholarship, and undermine a shared professional understanding of how best to protect patient privacy. We propose adopting a standardized consent form and process for publication of identifiable images in medical journals, with uniform elements and explicit definitions.

The legacy of health professionals' roles in the Holocaust is fundamental to understanding modern health care ethics, but teaching it is difficult. The University of Colorado Center for Bioethics and Humanities has developed a program that addresses 4 main pedagogical challenges of this content. This article identifies 3 core lessons and proposes 5 specific learning objectives related to health professionals' involvement in the Holocaust for any health professional training program.

This case and commentary explore health professionals' duties to advocate for individual patients, protect their communities, and navigate conflicts between them. The perils of physicians intentionally harming individuals in misguided attempts to strengthen a community have been illuminated by the Holocaust. It is too simplistic to say, however, that public health can never outweigh individual preferences or even needs. The commentary herein articulates criteria that might justify physicians taking action to protect the public that is contrary to their individual patients' interests.

Background The left ventricular assist device (LVAD) has become a common medical option for patients with end-stage heart failure. Although patients’ chances of survival may increase with an LVAD compared with medical therapy, the LVAD poses many risks and requires major lifestyle changes, thus making it a complex medical decision. Our prior work found that a decision aid for LVADs significantly increased decision quality for both patients and caregivers and was successfully implemented at 6 LVAD programs. Methods In follow-up, we are conducting a nationwide dissemination and implementation project, with the goal of implementing the decision aid at as many of the 176 LVAD programs in the United States as possible. Guided by the Theory of Diffusion of Innovations, the project consists of 4 phases: (1) building a network; (2) promoting adoption; (3) supporting implementation; and (4) encouraging maintenance. Developing an LVAD network of contacts occurs by using a national baseline survey of LVAD clinicians, existing professional relationships, and an internet-based strategy. A suite of resources targeted to promote adoption and support implementation of the decision aid into standard LVAD education processes are provided to the network. Evaluation is guided by the Reach, Effectiveness, Adoption, Implementation, Maintenance framework, where clinician and patient surveys and qualitative interviews determine the reach, effectiveness, adoption, implementation, and maintenance achieved. Conclusions This project is a true dissemination study in that it targets the entire population of LVAD programs in the United States and is unique in its use of social marketing principles to promote adoption and implementation. The implementation plan is intended to serve as a test case and model for dissemination and implementation of other evidence-based decision support aids and strategies.

Meat is a multi-billion-dollar industry that relies on people performing risky physical work inside meat-processing facilities over long shifts in close proximity. These workers are socially disempowered, and many are members of groups beset by historic and ongoing structural discrimination. The combination of working conditions and worker characteristics facilitate the spread of SARS-CoV-2, the virus that causes COVID-19. Workers have been expected to put their health and lives at risk during the pandemic because of government and industry pressures to keep this "essential industry" producing. Numerous interventions can significantly reduce the risks to workers and their communities; however, the industry's implementation has been sporadic and inconsistent. With a focus on the U.S. context, this paper offers an ethical framework for infection prevention and control recommendations grounded in public health values of health and safety, interdependence and solidarity, and health equity and justice, with particular attention to considerations of reciprocity, equitable burden sharing, harm reduction, and health promotion. Meat-processing workers are owed an approach that protects their health relative to the risks of harms to them, their families, and their communities. Sacrifices from businesses benefitting financially from essential industry status are ethically warranted and should acknowledge the risks assumed by workers in the context of existing structural inequities.

A research participant's right to withdraw from all research procedures is widely accepted, but there can be justifiable limits to a participant's exercise of autonomy to withdraw from some procedures. Clinical outcomes trials depend on complete subject follow-up for accurate assessment of the safety and efficacy of investigational therapies. Subjects' refusal to complete follow-up, even through passive medical record review, can cause failure to detect safety signals, inaccurate estimation of efficacy, or lack of acceptance of trial results, which alters the study's benefit-risk ratio. Allowing participant refusal of follow-up data collection therefore creates tension between respect for persons and beneficence. With minimal risk study procedures that can help preserve trial benefit, such as passive data collection, we argue that the importance of upholding the principle of beneficence outweighs individual autonomy concerns. Furthermore, a consent process that prospectively informs participants of mandatory passive follow-up is ethically justified and optimizes the balance between autonomy and beneficence.

Stakeholder engagement is increasingly expected by funders and valued by researchers in clinical and translational science, yet many researchers lack access to expert consultation or training in selecting appropriate stakeholder engagement methods. We describe the development of a novel Stakeholder Engagement Navigator webtool. We conducted an environmental scan and literature review, along with investigator interviews, surveys, and engagement expert facilitated group discussion. We formally reviewed and cataloged 29 distinct engagement methods. To develop the webtool, we used an iterative design process that followed Design Thinking phases: empathize, define, ideate, prototype, and test. As prioritized during user testing, the Stakeholder Engagement Navigator webtool both educates and guides investigators in selecting an engagement method based on key criteria. The V1.0 Navigator webtool filters methods first by purpose of engagement (noted by 62% of users as the highest priority criteria), then by budget, time per stakeholder interaction, and total interactions. The tool is available at DICEMethods.org. The Stakeholder Engagement Navigator webtool is a user-centered, interactive webtool suitable for use by researchers seeking guidance on appropriate stakeholder engagement methods for clinical and translational research projects.

Reading Alfandre and colleagues’ (2021) compelling paper in this issue of the Journal—in which the authors outline a useful process for navigating the ethics of “contingency” standards of care—brou...

The COVID-19 pandemic has raised a host of ethical challenges, but key among these has been the possibility that health care systems might need to ration scarce critical care resources. Rationing policies for pandemics differ by institution, health system, and applicable law. Most seem to agree that a patient's ability to benefit from treatment and to survive are first-order considerations. However, there is debate about what clinical measures should be used to make that determination and about other factors that might be ethically appropriate to consider. In this paper, we discuss resource allocation and several related ethical challenges to the healthcare system and society, including how to define benefit, how to handle informed consent, the special needs of pediatric patients, how to engage communities in these difficult decisions, and how to mitigate concerns of discrimination and the effects of structural inequities.

Covid-19 Crisis Triage Crisis triage protocols should seek to optimize health outcomes, but doing so requires explicit protection of core values, such as the equal moral worth of all people, includ...

As we write, U.S. cities and states with extensive community transmission of Covid-19 are in harm's way-not only because of the disease itself but also because of prior and current failures to act. During the 2009 influenza pandemic, public health agencies and hospitals developed but never adequately implemented preparedness plans. Focused on efficiency in a competitive market, health systems had few incentives to maintain stockpiles of essential medical equipment. Just-in-time economic models resulted in storage of only those supplies needed then. At the same time, global purchasing in search of lower prices reduced the number of U.S. suppliers, with hospitals dependent on foreign companies. There is still a possibility that the pandemic will be manageably bad rather than unmanageably catastrophic in this country. Immediate, powerful, and sustained federal action could make the difference.

Background: The coronavirus disease 2019 pandemic has or threatens to overwhelm health care systems. Many institutions are developing ventilator triage policies. Objective: To characterize the development of ventilator triage policies and compare policy content. Design: Survey and mixed-methods content analysis. Setting: North American hospitals associated with members of the Association of Bioethics Program Directors. Participants: Program directors. Measurements: Characteristics of institutions and policies, including triage criteria and triage committee membership. Results: Sixty-seven program directors responded (response rate, 91.8%); 36 (53.7%) hospitals did not yet have a policy, and 7 (10.4%) hospitals' policies could not be shared. The 29 institutions providing policies were relatively evenly distributed among the 4 U.S. geographic regions (range, 5 to 9 policies per region). Among the 26 unique policies analyzed, 3 (11.3%) were produced by state health departments. The most frequently cited triage criteria were benefit (25 policies [96.2%]), need (14 [53.8%]), age (13 [50.0%]), conservation of resources (10 [38.5%]), and lottery (9 [34.6%]). Twenty-one (80.8%) policies use scoring systems, and 20 of these (95.2%) use a version of the Sequential Organ Failure Assessment score. Among the policies that specify the triage team's composition (23 [88.5%]), all require or recommend a physician member, 20 (87.0%) a nurse, 16 (69.6%) an ethicist, 8 (34.8%) a chaplain, and 8 (34.8%) a respiratory therapist. Thirteen (50.0% of all policies) require or recommend those making triage decisions not be involved in direct patient care, but only 2 (7.7%) require that their decisions be blinded to ethically irrelevant considerations. Limitation: The results may not be generalizable to institutions without academic bioethics programs. Conclusion: Over one half of respondents did not have ventilator triage policies. Policies have substantial heterogeneity, and many omit guidance on fair implementation., The coronavirus disease 2019 pandemic has overwhelmed health care systems or threatens to do so, and many institutions are developing ventilator triage policies. This study describes policies developed at hospitals associated with members of the Association of Bioethics Program Directors.