Protocol to assess performance of crisis standards of care guidelines for clinical triage.

During the COVID-19 pandemic, US states developed Crisis Standards of Care (CSC) algorithms to triage allocation of scarce resources to maximize population-wide benefit. While CSC algorithms were developed by ethical debate, this protocol guides their quantitative assessment. For CSC algorithms, this protocol addresses (1) adapting algorithms for empirical study, (2) quantifying predictive accuracy, and (3) simulating clinical decision-making. This protocol provides a framework for healthcare systems and governments to test the performance of CSC algorithms to ensure they meet their stated ethical goals. For complete details on the use and execution of this protocol, please refer to Jezmir et al. (2021).

Rationing With Respect to Age During a Pandemic: A Comparative Analysis of State Pandemic Preparedness Plans.

BACKGROUND: Faced with possible shortages due to COVID-19, many states updated or rapidly developed crisis standards of care (CSCs) and other pandemic preparedness plans (PPPs) for rationing resources, particularly ventilators. RESEARCH QUESTION: How have US states incorporated the controversial standard of rationing by age and/or life-years into their pandemic preparedness plans? STUDY DESIGN AND METHODS: This was an investigator-initiated, textual analysis conducted from April to June 2020, querying online resources and in-state contacts to identify PPPs published by each of the 50 states and for Washington, DC. Analysis included the most recent versions of CSC documents and official state PPPs containing triage guidance as of June 2020. Plans were categorized as rationing by (A) short-term survival (≤ 1 year), (B) 1 to 5 expected life-years, (C) total life-years, (D) "fair innings," that is, specific age cutoffs, or (O) other. The primary measure was any use of age and/or life-years. Plans were further categorized on the basis of whether age/life-years was a primary consideration. RESULTS: Thirty-five states promulgated PPPs addressing the rationing of critical care resources. Seven states considered short-term prognosis, seven considered whether a patient had 1 to 5 expected life-years, 13 rationed by total life-years, and one used the fair innings principle. Seven states provided only general ethical considerations. Seventeen of the 21 plans considering age/life-years made it a primary consideration. Several plans borrowed heavily from a few common sources, although use of terminology was inconsistent. Many documents were modified in light of controversy. INTERPRETATION: Guidance with respect to rationing by age and/or life-years varied widely. More than one-half of PPPs, many following a few common models, included age/life-years as an explicit rationing criterion; the majority of these made it a primary consideration. Terminology was often vague, and many plans evolved in response to pushback. These findings have ethical implications for the care of older adults and other vulnerable populations during a pandemic.

Establishing a South African national framework for COVID-19 surgical prioritisation.

BACKGROUND: Since the start of the COVID-19 pandemic, surgical operations have been drastically reduced in South Africa (SA). Guidelines on surgical prioritisation during COVID-19 have been published, but are specific to high-income countries. There is a pressing need for context-specific guidelines and a validated tool for prioritising surgical cases during the COVID-19 pandemic. In March 2020, the South African National Surgical Obstetric Anaesthesia Plan Task Team was asked by the National Department of Health to establish a national framework for COVID-19 surgical prioritisation. OBJECTIVES: To develop a national framework for COVID-19 surgical prioritisation, including a set of recommendations and a risk calculatorfor operative care. METHODS: The surgical prioritisation framework was developed in three stages: (i) a literature review of international, national and local recommendations on COVID-19 and surgical care was conducted; (ii) a set of recommendations was drawn up based on the available literature and through consensus of the COVID-19 Task Team; and (iii) a COVID-19 surgical risk calculator was developed and evaluated. RESULTS: A total of 30 documents were identified from which recommendations around prioritisation of surgical care were used to draw up six recommendations for preoperative COVID-19 screening and testing as well as the use of appropriate personal protective equipment. Ninety-nine perioperative practitioners from eight SA provinces evaluated the COVID-19 surgical risk calculator, which had high acceptability and a high level of concordance (81%) with current clinical practice. CONCLUSIONS: This national framework on COVID-19 surgical prioritisation can help hospital teams make ethical, equitable and personalised decisions whether to proceed with or delay surgical operations during this unprecedented epidemic.

Ethics of ICU triage during COVID-19.

INTRODUCTION: The coronavirus disease 2019 pandemic has placed intensive care units (ICU) triage at the center of bioethical discussions. National and international triage guidelines emerged from professional and governmental bodies and have led to controversial discussions about which criteria-e.g. medical prognosis, age, life-expectancy or quality of life-are ethically acceptable. The paper presents the main points of agreement and disagreement in triage protocols and reviews the ethical debate surrounding them. SOURCES OF DATA: Published articles, news articles, book chapters, ICU triage guidelines set out by professional societies and health authorities. AREAS OF AGREEMENT: Points of agreement in the guidelines that are widely supported by ethical arguments are (i) to avoid using a first come, first served policy or quality-adjusted life-years and (ii) to rely on medical prognosis, maximizing lives saved, justice as fairness and non-discrimination. AREAS OF CONTROVERSY: Points of disagreement in existing guidelines and the ethics literature more broadly regard the use of exclusion criteria, the role of life expectancy, the prioritization of healthcare workers and the reassessment of triage decisions. GROWING POINTS: Improve outcome predictions, possibly aided by Artificial intelligence (AI); develop participatory approaches to drafting, assessing and revising triaging protocols; learn from experiences with implementation of guidelines with a view to continuously improve decision-making. AREAS TIMELY FOR DEVELOPING RESEARCH: Examine the universality vs. context-dependence of triaging principles and criteria; empirically test the appropriateness of triaging guidelines, including impact on vulnerable groups and risk of discrimination; study the potential and challenges of AI for outcome and preference prediction and decision-support.

COVID-19 Pandemic Healthcare Resource Allocation, Age and Frailty.

The current coronavirus pandemic presents the greatest healthcare crisis in living memory. Hospitals across the world have faced unprecedented pressure. In the face of this tidal wave of demand for limited healthcare resources, how are clinicians to identify patients most likely to benefit? Should age or frailty be discriminators? This paper seeks to analyse the current evidence-base, seeking a nuanced approach to pandemic decision-making, such as admission to critical care.

Recommendations by the Uruguayan Society of Intensive Care on the Covid-19 pandemic / Recomendaciones de la Sociedad Uruguaya de Medicina Intensiva sobre los aspectos bioéticos en la pandemia Covid-19 / Recomendações da Sociedade Uruguaia de Medicina Intensiva sobre aspectos bioéticos na pandemia Covid-19

Resumen: Introducción: la pandemia provocada por el SARS-CoV-2 genera un importante desafío para el sistema sanitario y especialmente para la Medicina Intensiva. Es necesario prepararse en múltiples aspectos. Además, considerar plausible una demanda extraordinaria de camas críticas que puede llevar a un desbalance entre las necesidades clínicas y la disponibilidad efectiva de los recursos sanitarios. Objetivos: realizar un análisis bioético para brindar una orientación en la atención a los pacientes críticos. Objetivos específicos: 1) Analizar los principios bioéticos fundamentales en este contexto. 2) Apoyar a los clínicos en la toma de decisiones difíciles. 3) Hacer explícitos los criterios de asignación de recursos. 4) Definir líneas de acción ante un posible escenario de "desastre sanitario". Método: la SUMI ha generado un ámbito de trabajo colectivo cuyo método de trabajo fue la deliberación. En la documentación se utiliza la revisión bibliográfica y los protocolos ya existentes. Resultados: el trabajo plantea un análisis teórico documentado sobre los principios bioéticos involucrados en el contexto de pandemia, sobre los escenarios de demanda asistencial y sobre la fundamentación para un cambio en los criterios éticos ante un escenario de saturación del sistema. Conclusión: se plantean recomendaciones prácticas para: 1) Toma de decisiones de ingreso y egreso en demanda controlada. 2) Criterios de acción ante el aumento de la demanda estableciendo definiciones de los diferentes escenarios. 3) Recomendaciones para aplicar en un escenario de saturación del sistema.

Summary: Introduction: the pandemic caused by SARS-CoV2 constitutes a significant challenge for the health system, and especially for Critical Care Units, so we need to prepare in many aspects. Likewise, we need to consider there could be an extraordinary demand for beds in critical care units, what would lead to an imbalance between clinical needs and the effective availability of health resources. Objectives: the study aims to perform a bioethical analysis that could provide guidelines for the assistance of patients in critical care. Specific objectives: 1) to analyse the main bioethical principles in this context, 2) to support clinicians in the making of difficult decisions, 3) to make the resource allocation criteria specific, 4) to define action lines upon a potential "health's disastrous" scenario Method: the Uruguayan Society of Intensive Care has generated a space for collective work based on discussion processes. Documents include a bibliographic review and the existing protocols. Results: the study presents a theoretical analysis that is backed up by the bioethical principles involved in the pandemic context on the scenarios of demand for assistance and, by the arguments calling for a change in the ethical criteria upon the saturation of the health system. Conclusion: practical recommendations are made: 1) for the making of decisions about admission and discharge in a controlled demand. 2) to define action criteria upon an increase in demand, clearly defining the different scenarios, 3) to apply upon the saturation of the health system.

Resumo: Introdução: a pandemia causada pelo SARS-CoV2 gera um importante desafio para o sistema de saúde e principalmente para a Medicina Intensiva. É preciso se preparar em vários aspectos. Além disso, considera plausível uma demanda extraordinária por leitos críticos, que pode levar a um desequilíbrio entre as necessidades clínicas e a disponibilidade efetiva de recursos de saúde. Objetivos: realizar uma análise bioética para orientar o cuidado ao paciente crítico. Objetivos específicos: 1) Analisar os princípios bioéticos fundamentais neste contexto, 2) Apoiar os médicos na tomada de decisões difíceis, 3) Tornar explícitos os critérios de alocação de recursos, 4) Definir linhas de ação perante um possível cenário de " desastre de saúde ". Métodos: a SUMI gerou um ambiente de trabalho coletivo cujo método de trabalho era deliberativo. A documentação usa a revisão da literatura e os protocolos existentes. Resultados: o trabalho propõe uma análise teórica documentada sobre os princípios bioéticos envolvidos no contexto da Pandemia, sobre os cenários da demanda de saúde e sobre os fundamentos para uma mudança de critérios éticos em um cenário de saturação do sistema. Conclusão: são propostas recomendações práticas para: 1) tomada de decisão para admissão e alta sob demanda controlada. 2) critérios de atuação frente ao aumento da demanda, estabelecendo definições dos diferentes cenários. 3) recomendações a serem aplicadas em um cenário de saturação do sistema.

Prioritising 'already-scarce' intensive care unit resources in the midst of COVID-19: a call for regional triage committees in South Africa.

BACKGROUND: The worsening COVID-19 pandemic in South Africa poses multiple challenges for clinical decision making in the context of already-scarce ICU resources. Data from national government and the last published national audit of ICU resources indicate gross shortages. While the Critical Care Society of Southern Africa (CCSSA) guidelines provide a comprehensive guideline for triage in the face of overwhelmed ICU resources, such decisions present massive ethical and moral dilemmas for triage teams. It is therefore important for the health system to provide clinicians and critical care facilities with as much support and resources as possible in the face of impending pandemic demand. Following a discussion of the ethical considerations and potential challenges in applying the CCSSA guidelines, the authors propose a framework for regional triage committees adapted to the South African context. DISCUSSION: Beyond the national CCSSA guidelines, the clinician has many additional ethical and clinical considerations. No single ethical approach to decision-making is sufficient, instead one which considers multiple contextual factors is necessary. Scores such as the Clinical Frailty Score and Sequential Organ Failure Assessment are of limited use in patients with COVID-19. Furthermore, the clinician is fully justified in withdrawing ICU care based on medical futility decisions and to reallocate this resource to a patient with a better prognosis. However, these decisions bear heavy emotional and moral burden compounded by the volume of clinical work and a fear of litigation. CONCLUSION: We propose the formation of Provincial multi-disciplinary Critical Care Triage Committees to alleviate the emotional, moral and legal burden on individual ICU teams and co-ordinate inter-facility collaboration using an adapted framework. The committee would provide an impartial, broader and ethically-sound viewpoint which has time to consider broader contextual factors such as adjusting rationing criteria according to different levels of pandemic demand and the latest clinical evidence. Their functioning will be strengthened by direct feedback to national level and accountability to a national monitoring committee. The potential applications of these committees are far-reaching and have the potential to enable a more effective COVID-19 health systems response in South Africa.

The Value of Triage during Periods of Intense COVID-19 Demand: Simulation Modeling Study.

BACKGROUND: During the COVID-19 pandemic, many intensive care units have been overwhelmed by unprecedented levels of demand. Notwithstanding ethical considerations, the prioritization of patients with better prognoses may support a more effective use of available capacity in maximizing aggregate outcomes. This has prompted various proposed triage criteria, although in none of these has an objective assessment been made in terms of impact on number of lives and life-years saved. DESIGN: An open-source computer simulation model was constructed for approximating the intensive care admission and discharge dynamics under triage. The model was calibrated from observational data for 9505 patient admissions to UK intensive care units. To explore triage efficacy under various conditions, scenario analysis was performed using a range of demand trajectories corresponding to differing nonpharmaceutical interventions. RESULTS: Triaging patients at the point of expressed demand had negligible effect on deaths but reduces life-years lost by up to 8.4% (95% confidence interval: 2.6% to 18.7%). Greater value may be possible through "reverse triage", that is, promptly discharging any patient not meeting the criteria if admission cannot otherwise be guaranteed for one who does. Under such policy, life-years lost can be reduced by 11.7% (2.8% to 25.8%), which represents 23.0% (5.4% to 50.1%) of what is operationally feasible with no limit on capacity and in the absence of improved clinical treatments. CONCLUSIONS: The effect of simple triage is limited by a tradeoff between reduced deaths within intensive care (due to improved outcomes) and increased deaths resulting from declined admission (due to lower throughput given the longer lengths of stay of survivors). Improvements can be found through reverse triage, at the expense of potentially complex ethical considerations.

To comfort always: Are we ignoring this duty in Covid protocols?

COVID-19 is an amplifier of serious physical suffering and emotional trauma, which together could be all-consuming. It is important for health systems to go beyond methods of prevention and treatment, and focus on the palliation of suffering, and to systematically integrate palliative care into Covid-19 management.

Further, in cases where the triage process indicates poor chances of survival, it is particularly important to respect autonomy by honest and sensitive disclosure of prognosis, and to jointly arrive at goals of care. Hooking every dying person to a ventilator would violate the ethical principles of beneficence and non-maleficence. It is also important to ensure at least electronic communication between the patient and family members.

Keywords: Covid-19, palliative care, end of life care, isolation, quarantine, intensive care, ethics of intubation, consent

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[Ethical, deontologic and legal considerations about SIAARTI Document "Clinical ethics recommendations for the allocation of intensive care treatments, in exceptional, resource-limited circumstances".] / Considerazioni etiche, deontologiche e giuridiche sul Documento SIAARTI "Raccomandazioni di etica clinica per l'ammissione a trattamenti intensivi e per la loro sospensione, in condizioni eccezionali di squilibrio tra necessità e risorse disponibili".

On 6 March 2020, the Italian Society of Anaesthesia Analgesia Resuscitation and Intensive care (SIAARTI) published the document "Clinical Ethics Recommendations for Admission to and Suspension of Intensive Care in Exceptional Conditions of Imbalance between Needs and Available Resources". The document, which aims to propose treatment decision-making criteria in the face of exceptional imbalances between health needs and available resources, has produced strong reactions, within the medical-scientific community, in the academic world, and in the media. In the current context of international public health emergency caused by the CoViD-19 epidemic, this work aims to explain the ethical, deontological and legal bases of the SIAARTI Document and to propose methodologic and argumentative integrations that are useful for understanding and placing in context the decision-making criteria proposed. The working group that contributed to the drafting of this paper agrees that it is appropriate that healthcare personnel, who is particularly committed to taking care of those who are currently in need of intensive or sub-intensive care, should benefit from clear operational indications that are useful to orient care and, at the same time, that the population should know in advance which criteria will guide the tragic choices that may fall on each one of us. This contribution therefore firstly reflects on the appropriateness of the SIAARTI standpoint and the objectives of the SIAARTI Document. It then turns to demonstrate how the recommendations it proposes can be framed within a shared interdisciplinary, ethical, deontological and legal perspective.

Withdrawing critical care from patients in a triage situation.

The advent of COVID-19 has been the occasion for a renewed interest in the principles governing triage when the number of critically ill patients exceeds the healthcare infrastructure's capacity in a given location. Some scholars advocate that it would be morally acceptable in a crisis to withdraw resources like life support and ICU beds from one patient in favor of another, if, in the judgment of medical personnel, the other patient has a significantly better prognosis. The paper examines the arguments for and against this approach from the point of view of natural law theory, especially using the principle of double effect. We conclude that it is inadmissible to withdraw life-saving medical interventions from patients who are still benefiting from them, on the sole grounds that other patients might benefit more. Those who are currently using such technology should only interrupt their treatment if, in the judgment of medical personnel and, if possible, taking into account the wishes and needs of the patient and his family, the treatment is deemed futile, burdensome, or disproportionate.

Withdrawal of intensive care during times of severe scarcity: Triage during a pandemic only upon arrival or with the inclusion of patients who are already under treatment?

Many countries have adopted new triage recommendations for use in the event that intensive care beds become scarce during the COVID-19 pandemic. In addition to establishing the exact criteria regarding whether treatment for a newly arriving patient shows a sufficient likelihood of success, it is also necessary to ask whether patients already undergoing treatment whose prospects are low should be moved into palliative care if new patients with better prospects arrive. This question has led to divergent ethical guidelines. This paper explores the distinction between withholding and withdrawing medical treatment during times of scarcity. As a first central point, the paper argues that a revival of the ethical distinction between doing and allowing would have a revisionary impact on cases of voluntary treatment withdrawal. A second systematic focus lies in the concern that withdrawal due to scarcity might be considered a physical transgression and therefore more problematic than not treating someone in the first place. In light of the persistent disagreement, especially concerning the second issue, the paper concludes with two pragmatic proposals for how to handle the ethical uncertainty: (1) triage protocols should explicitly require that intensive care attempts are designed as time-limited trials based on specified treatment goals, and this intent should be documented very clearly at the beginning of each treatment; and (2) lower survival prospects can be accepted for treatments that have already begun, compared with the respective triage rules for the initial access of patients to intensive care.

COVID 19: prioritise autonomy, beneficence and conversations before score-based triage.

At the start of the COVID-19 pandemic, mounting demand overwhelmed critical care surge capacities, triggering implementation of triage protocols to determine ventilator allocation. Relying on triage scores to ration care, while relieving clinicians from making morally distressing decisions under high situational pressure, distracts clinicians from what is essentially deeply humanistic issues entrenched in this protracted public health crisis. Such an approach will become increasingly untenable as countries flatten their epidemic curves. Decisions regarding intensive care unit admission are particularly challenging in older people, who are most likely to require critical care, but for whom benefits are most uncertain. Before applying score-based triage, physicians must first discern if older people will benefit from critical care (beneficence) and second, if he wants critical care (autonomy). When deliberating beneficence, physicians should steer away from solely using age-stratified survival probabilities from epidemiological data. Instead, decisions must be based on individualised risk-stratification that encompasses evidence-based predictors of adverse outcomes specific to older adults. Survival will also need to be weighed against burden of treatment, as well as longer term functional deficits and quality-of-life. By identifying the robust older people who may benefit from critical care, clinicians should proceed to elicit his values and preferences that would determine the treatment most aligned with his best interest. During these dialogues, physicians must truthfully convey the emergent clinical reality, discern the older person's therapeutic goals and discuss the feasibility of achieving them. Given that COVID-19 is here to stay, these conversations aimed at achieving goal-cordant care must become a new clinical norm.

The Ethics of Emergent Health Technologies: Implications of the 21st Century Cures Act for Nursing.

The 21st Century Cures Act, passed in December 2016 by the United States Congress, is a public law aimed at accelerating the time it takes to get pharmaceutical drugs and medical devices into the market, in addition to shifting connected review processes from randomized controlled trials to real-world efficacy tests. As of December 2019, efforts are underway to introduce a "Cures Act 2.0" bill, with particular attention to the implementation of digital health within health systems. Research on the development of emergent health technologies is nascent; research examining health technology implications of 21st Century Cures Act for the health care workforce is nonexistent. This article fills a crucial gap in public awareness, discussing ethical implications of the 21st Century Cures Act and centering nursing. Nursing is a profession frequently acknowledged as practicing on "the front lines of care" and frequently responsible for the trialing of products in clinical settings. The article summarizes and evaluates key components of the 21st Century Cures Act related to health technology development. Discrete health technologies addressed are (a) breakthrough devices, (b) digital health software, and (c) combination products. It then connects these provisions to ethical considerations for nursing practice, research, and policy. The article concludes by discussing the relevance of emerging digital health technologies to the crafting of a "Cures 2.0" bill, with particular attention to this moment in light of digital care precedents set during the COVID-19 pandemic.