Simulation of New York City's Ventilator Allocation Guideline During the Spring 2020 COVID-19 Surge.

Importance: The spring 2020 surge of COVID-19 unprecedentedly strained ventilator supply in New York City, with many hospitals nearly exhausting available ventilators and subsequently seriously considering enacting crisis standards of care and implementing New York State Ventilator Allocation Guidelines (NYVAG). However, there is little evidence as to how NYVAG would perform if implemented.

Objectives: To evaluate the performance and potential improvement of NYVAG during a surge of patients with respect to the length of rationing, overall mortality, and worsening health disparities.

Tertiary Healthcare Ethics Consultation: Enhancing Access to Expertise.

Tertiary healthcare ethics (HCE) consultation occurs when an HCE consultant at a healthcare facility requests guidance from one or more senior HCE consultants who are not members of that facility's HCE consultation service. Tertiary HCE consultants provide advanced HCE guidance and/or mentoring to facility (secondary) HCE consultants, mirroring healthcare consultation in clinical practice. In this article, we describe advantages and challenges of providing tertiary HCE consultation through a hub-and-spoke model administered by a national integrated HCE service.

How Common SOFA and Ventilator Time Trial Criteria Would Have Performed During the COVID-19 Pandemic: An Observational Simulated Cohort Study.

Objectives: To evaluate how key aspects of New York State Ventilator Allocation Guidelines (NYSVAG)-Sequential Organ Failure Assessment score criteria and ventilator time trials -might perform with respect to the frequency of ventilator reallocation and survival to hospital discharge in a simulated cohort of coronavirus disease (COVID-19) patients.

Methods: Single center retrospective observational and simulation cohort study of 884 critically ill COVID-19 patients undergoing ventilator allocation per NYSVAG.

Results: In total, 742 patients (83.

COVID-19 Ethics Debrief: Pearls and Pitfalls of a Hub and Spoke Model.

A hub and spoke model offers an effective and efficient approach to providing informed guidance to those who need it. The National Center for Ethics in Health Care (NCEHC) at the Veterans Health Administration, Department of Veterans Affairs, is the largest known hub and spoke healthcare ethics delivery model. In this article, we describe ways NCEHC's hub and spoke configuration succeeded during the COVID-19 pandemic, as well as limitations of the model and possible improvements to inform adoption at other healthcare systems.

Between Usual and Crisis Phases of a Public Health Emergency: The Mediating Role of Contingency Measures.

Much of the sustained attention on pandemic preparedness has focused on the ethical justification for plans for the "crisis" phase of a surge when, despite augmentation efforts, the demand for life-saving resources outstrips supply. The ethical frameworks that should guide planning and implementation of the "contingency" phase of a public health emergency are less well described. The contingency phase is when strategies to augment staff, space, and supplies are systematically deployed to forestall critical resource scarcity, reduce disproportionate harm to patients and health care providers, and provide patient care that remains functionally equivalent to conventional practice.

A Health Care Systems Approach to Improving Care for Seriously Ill Patients.

Health care systems can go beyond advance care planning to create mechanisms for eliciting and documenting the goals of care and life-sustaining treatment decisions of patients with serious life-limiting illnesses. These systems can help ensure that patients receive care that is consistent with their values and preferences. We describe a case in which even though a patient with a serious illness had completed an advance directive and had discussed preferences with family, clinicians failed to identify the patient's authentic preferences for life-sustaining treatment.

What Is the Minimal Competency for a Clinical Ethics Consult Simulation? Setting a Standard for Use of the Assessing Clinical Ethics Skills (ACES) Tool.

The field of clinical ethics is examining ways of determining competency. The Assessing Clinical Ethics Skills (ACES) tool offers a new approach that identifies a range of skills necessary in the conduct of clinical ethics consultation and provides a consistent framework for evaluating these skills. Through a training website, users learn to apply the ACES tool to clinical ethics consultants (CECs) in simulated ethics consultation videos.

Training to Increase Rater Reliability When Assessing the Quality of Ethics Consultation Records with the Ethics Consultation Quality Assessment Tool (ECQAT).

The Ethics Consultation Quality Assessment Tool (ECQAT) establishes standards by which the quality of ethics consultation records (ECRs) can be assessed. These standards relate to the ethics question, consultation-specific information, ethical analysis, and recommendations and/or conclusions, and result in a score associated with one of four levels of ethics consultation quality. For the ECQAT to be useful in assessing and improving the quality of healthcare ethics consultations, individuals who rate the quality of ECRs need to be able to reliably use the tool.

Ethics Consultation Quality Assessment Tool: A Novel Method for Assessing the Quality of Ethics Case Consultations Based on Written Records.

Although ethics consultation is offered as a clinical service in most hospitals in the United States, few valid and practical tools are available to evaluate, ensure, and improve ethics consultation quality. The quality of ethics consultation is important because poor quality ethics consultation can result in ethically inappropriate outcomes for patients, other stakeholders, or the health care system. To promote accountability for the quality of ethics consultation, we developed the Ethics Consultation Quality Assessment Tool (ECQAT).

Drug Safety and the Cost of Monitoring: The Role of REMS in Risk Management.

Background: The mission of the US Food and Drug Administration (FDA) can be viewed as a pendulum that swings between protecting public health and patient safety and promoting the public health through the drug review and approval process. Two decades of legislation have by and large provided the FDA with additional resources under the successive reauthorizations of the Prescription Drug User Fee Acts (PDUFA) to provide a necessary infusion of funds to hire medical experts, scientists, and epidemiologists, among other disciplines, to expedite review of new drug and biologic applications. However, a renewed attention to potential adverse drug experiences, culminating in the Vioxx withdrawal, has resulted in the passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA).

Ethical considerations: care of the critically ill and injured during pandemics and disasters: CHEST consensus statement.

Background: Mass critical care entails time-sensitive decisions and changes in the standard of care that it is possible to deliver. These circumstances increase provider uncertainty as well as patients' vulnerability and may, therefore, jeopardize disciplined, ethical decision-making. Planning for pandemics and disasters should incorporate ethics guidance to support providers who may otherwise make ad hoc patient care decisions that overstep ethical boundaries.

HCEC pearls and pitfalls: suggested do's and don't's for healthcare ethics consultants.

Members of the Clinical Ethics Consultation Affairs Standing Committee of the American Society for Bioethics and Humanities present a collection of insights and recommendations developed from their collective experience, intended for those engaged in the work of healthcare ethics consultation.

Definitive care for the critically ill during a disaster: a framework for allocation of scarce resources in mass critical care: from a Task Force for Mass Critical Care summit meeting, January 26-27, 2007, Chicago, IL.

Background: Anticipated circumstances during the next severe influenza pandemic highlight the insufficiency of staff and equipment to meet the needs of all critically ill victims. It is plausible that an entire country could face simultaneous limitations, resulting in severe shortages of critical care resources to the point where patients could no longer receive all of the care that would usually be required and expected. There may even be such resource shortfalls that some patients would not be able to access even the most basic of life-sustaining interventions.