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. Design, Setting, and Participants: This cohort study included intubated patients in a single health system in New York City from March through July 2020. A total of 20 000 simulations were conducted of ventilator triage (10 000 following NYVAG and 10 000 following a proposed improved NYVAG) during a crisis period, defined as the point at which the prepandemic ventilator supply was 95% utilized. Exposures: The NYVAG protocol for triage ventilators. Main Outcomes and Measures: Comparison of observed survival rates with simulations of scenarios requiring NYVAG ventilator rationing. Results: The total cohort included 1671 patients; of these, 674 intubated patients (mean [SD] age, 63.7 [13.8] years; 465 male [69.9%]) were included in the crisis period, with 571 (84.7%) testing positive for COVID-19. Simulated ventilator rationing occurred for 163.9 patients over 15.0 days, 44.4% (95% CI, 38.3%-50.0%) of whom would have survived if provided a ventilator while only 34.8% (95% CI, 28.5%-40.0%) of those newly intubated patients receiving a reallocated ventilator survived. While triage categorization at the time of intubation exhibited partial prognostic differentiation, 94.8% of all ventilator rationing occurred after a time trial. Within this subset, 43.1% were intubated for 7 or more days with a favorable SOFA score that had not improved. An estimated 60.6% of these patients would have survived if sustained on a ventilator. Revising triage subcategorization, proposed improved NYVAG, would have improved this alarming ventilator allocation inefficiency (25.3% [95% CI, 22.1%-28.4%] of those selected for ventilator rationing would have survived if provided a ventilator). NYVAG ventilator rationing did not exacerbate existing health disparities. Conclusions and Relevance: In this cohort study of intubated patients experiencing simulated ventilator rationing during the apex of the New York City COVID-19 2020 surge, NYVAG diverted ventilators from patients with a higher chance of survival to those with a lower chance of survival. Future efforts should be focused on triage subcategorization, which improved this triage inefficiency, and ventilator rationing after a time trial, when most ventilator rationing occurred.

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 (83.9%) would have had their ventilator reallocated during the 11-day observation period, 280 (37.7%) of whom would have otherwise survived to hospital discharge if provided with a ventilator. Only 65 (18.1%) of the observed surviving patients would have survived by NYSVAG. Extending ventilator time trials from 2 to 5 days resulted in a 49.2% increase in simulated survival to discharge. CONCLUSIONS: In the setting of a protracted respiratory pandemic, implementation of NYSVAG or similar protocols could lead to a high degree of ventilator reallocation, including withdrawal from patients who might otherwise survive. Longer ventilator time trials might lead to improved survival for COVID-19 patients given their protracted respiratory failure. Further studies are needed to understand the survival of patients receiving reallocated ventilators to determine whether implementation of NYSVAG would improve overall survival.

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. We describe an ethical framework to inform planning and implementation for COVID-19 contingency surge responses and apply this framework to 3 use cases. Examining the unique ethical challenges of this mediating phase will facilitate proactive ethics conversations about healthcare operations during the contingency phase and ideally lead to ethically stronger health care practices.

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. We offer a stepwise framework for communication with seriously ill patients and describe a systems approach to transforming the process of eliciting, documenting, and honoring patients' life-sustaining treatment preferences in the U. S. Veterans Health Administration.

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

Background: 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. The aim is to recognize competent and incompetent clinical ethics consultation skills by watching and evaluating a videotaped CEC performance. We report how we set a criterion cut score (i.e., minimally acceptable score) for judging the ability of users of the ACES tool to evaluate simulated CEC performances. Methods: A modified Angoff standard-setting procedure was used to establish the cut score for an end-of-life case included on the ACES training website. The standard-setting committee viewed the Futility Case and estimated the probability that a minimally competent CEC would correctly answer each item on the ACES tool. The committee further adjusted these estimates by reviewing data from 31 pilot users of the Futility Case before determining the cut score. Results: Averaging over all 31 items, the proposed proportion correct score for minimal competency was 80%, corresponding to a cut score that is between 24 and 25 points out of 31 possible points. The standard-setting committee subsequently set the minimal competency cut score to 24 points. Conclusions: The cut score for the ACES tool identifies the number of correct responses a user of the ACES tool training website must attain to "pass" and reach minimal competency in recognizing competent and incompetent skills of the CECs in the simulated ethics consultation videos. The application of the cut score to live training of CECs and other areas of practice requires further investigation.

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. We developed a short course to train ethics consultants in using the ECQAT, and evaluated whether the participants (1) achieved an acceptable level of calibration in matching expert-established quality scores for a set of ethics consultations, and (2) were satisfied with the course. We recruited 28 ethics consultants to participate in a virtual, six-session course. At each session participants and faculty reviewed, rated, and discussed one to two ECRs. The participants' calibration in matching expert-established quality scores improved with repeated exposure at all levels of ethics consultation quality. Participants were generally more accurate when assessing consultation quality at the dichotomous level of "acceptable" (scores of three or four) versus "unacceptable" (scores of one or two) than they were with more a specific score. Participants had higher rates of accuracy with the extreme ratings of "strong" (level four) or "poor" (level one). Although participants were highly satisfied with the course, only a minority of participants achieved the prespecified acceptable level of calibration (that is, 80 percent or greater accuracy between their score and expert-established scores). These results suggest that ECQAT training may require more sessions or need modification in the protocol to achieve higher reliability in scoring. Such trainings are an important next step in ensuring that the ECQAT is a tool that can be used to promote improvement in ethics consultation quality.

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). ECQAT enables raters to assess the quality of ethics consultations based on the written record. Through rigorous development and preliminary testing, we identified key elements of a quality ethics consultation (ethics question, consultation-specific information, ethical analysis, and conclusions and/or recommendations), established scoring criteria, developed training guidelines, and designed a holistic assessment process. This article describes the development of the ECQAT, the resulting product, and recommended future testing and potential uses for the tool.

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). Under this act, the FDA was authorized to impose postapproval requirements on the biopharmaceutical industry through the imposition of risk evaluation and mitigation strategies (REMS) and postmarketing trial (PMT) requirements to improve drug safety. Despite the extensive dialogue between stakeholders and lawmakers in the development of the FDAAA, there remains some uncertainty as to the exact impact of REMS on not only operational costs for both industry and health care professionals but also product sales and prescribing habits in the 5 years since its implementation. METHODS: Recognizing that in the past 2 years, the use of REMS has shifted markedly, we sought to provide greater clarity on the duration of REMS requirements and impact of REMS on drug sales. RESULTS: While in absolute terms, the use of REMS may be declining, the REMS experience has provided an important, perhaps even critical, step in the development of current risk management strategies aimed at improving patient safety.

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. This article provides consensus-developed suggestions about ethical challenges in caring for the critically ill or injured during pandemics or disasters. The suggestions in this article are important for all of those involved in any pandemic or disaster with multiple critically ill or injured patients, including front-line clinicians, hospital administrators, and public health or government officials. METHODS: We adapted the American College of Chest Physicians (CHEST) Guidelines Oversight Committee's methodology to develop suggestions. Twenty-four key questions were developed, and literature searches were conducted to identify evidence for suggestions. The detailed literature reviews produced 144 articles. Based on their expertise within this domain, panel members also supplemented the literature search with governmental publications, interdisciplinary workgroup consensus documents, and other information not retrieved through PubMed. The literature in this field is not suitable to support evidence-based recommendations. Therefore, the panel developed expert opinion-based suggestions using a modified Delphi process. RESULTS: We report the suggestions that focus on five essential domains: triage and allocation, ethical concerns of patients and families, ethical responsibilities to providers, conduct of research, and international concerns. CONCLUSIONS: Ethics issues permeate virtually all aspects of pandemic and disaster response. We have addressed some of the most pressing issues, focusing on five essential domains: triage and allocation, ethical concerns of patients and families, ethical responsibilities to providers, conduct of research, and international concerns. Our suggestions reflect the consensus of the Task Force. We recognize, however, that some suggestions, including those related to end-of-life care, may be controversial. We highlight the need for additional research and dialogue in articulating values to guide health-care decisions during disasters.

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. Rationing of critical care in this circumstance would be difficult, yet may be unavoidable. Without planning, the provision of care would assuredly be chaotic, inequitable, and unfair. The Task Force for Mass Critical Care Working Group met in Chicago in January 2007 to proactively suggest guidance for allocating scarce critical care resources. TASK FORCE SUGGESTIONS: In order to allocate critical care resources when systems are overwhelmed, the Task Force for Mass Critical Care Working Group suggests the following: (1) an equitable triage process utilizing the Sequential Organ Failure Assessment scoring system; (2) the concept of triage by a senior clinician(s) without direct clinical obligation, and a support system to implement and manage the triage process; (3) legal and ethical constructs underpinning the allocation of scarce resources; and (4) a mechanism for rapid revision of the triage process as further disaster experiences, research, planning, and modeling come to light.