Crisis Standards of Care: On Justice and the Public Health Approach to the COVID-19 Pandemic
Eriko Sase and Christopher Eddy
Abstract: Introduction Before the COVID-19 pandemic, U.S. hospitalizations were already near surge capacity in many healthcare systems. Presently, 29 states have developed a crisis standards of care (CSC) plan that is designed to enable healthcare systems to continue operations by performing patient triage and rationing scarce resources. Methods This study is a qualitative content analysis of six state CSC plans that meet all five elements recommended by the Institute of Medicine. Justice (ethics and human rights) was considered in patient triage processes, with special attention given to inclusion and exclusion categories and public health disaster and emergency planning/readiness initiatives. Findings CSC plans varied across the six states examined: some set clear “medical utility” categories (e.g., health conditions and age) while others were ambiguous; some mentioned “social utility” categories (e.g., by occupations) while others did not. Public health planning/readiness also varied, though most plans emphasized a pandemic influenza stance rather than a novel virus without an approved vaccine. Discussion and Recommendations This discovery uniquely shows that populations most vulnerable to COVID-19 are generally the same populations that would likely be categorically excluded by CSC patient triage processes. CSC plans need to be periodically adjusted, in accordance with evolving evidence on COVID-19. Preparing for and preventing the conditions contributing to hospital surge may avoid the activation of CSC and ensure respect for human dignity during a public health emergency. Due to uncertainties regarding mass vaccination and herd immunity density requirements, justice must be included in nonpharmaceutical disaster planning and emergency response processes.
I. Introduction
A. COVID-19 Consequences: Impacts on Human Health
As the COVID-19 pandemic continues on an uncertain trajectory, global deaths have exceeded 3.5 million, with India now recording high numbers of new cases and deaths. The majority of COVID-19 patients in the U.S. presented mild illness in the first waves of infection, with 14% of patients developing severe illness requiring oxygen therapy and approximately 5% requiring intensive care unit treatment (Nevada Department of Health and Human Services 2020, 31). However, multiple factors will determine the outcomes of future waves: increasing virus mutation/variants have complicated escalating vaccination campaigns and new models show that the relaxation of nonpharmaceutical preventive interventions, such as wearing face masks and social distancing, may jeopardize current response successes (Moore et al. 2021).
The consequences of COVID-19 disproportionately impact specific vulnerable groups: Black and minority communities, individuals with underlying health conditions, older adults, essential workers in certain occupations and individuals in specific living environments. Below, we briefly summarize the evidence of COVID-19’s impact on each group.
Compared to White Americans, confirmed new COVID-19 cases are nearly two times higher among Native Americans, while hospitalization rates are approximately three times higher among Native Americans, African Americans, and Hispanics, and deaths are two times higher among these three groups (CDC 2021a). COVID-19 infections are influenced significantly by multiple health determinants: socioeconomic status, education, cultural tendencies, genetics/biology, and a broad spectrum of behaviors, among other factors (Abrams and Szefler 2020; Cleveland Manchanda et al. 2020a). The COVID-19 pandemic has deepened health disparities and inequalities among people who were already experiencing a disproportionate burden of health-related problems, especially older adults (Brown et al. 2021; Mueller et al. 2020).
COVID-19 patients with three or more underlying health conditions (e.g., obesity, chronic kidney disease, and chronic obstructive pulmonary disease) are at risk of hospitalization at rates five times higher than those who do not have any of these comorbidities (Advisory Board 2020).
Both hospitalization and death due to COVID-19 are much higher among older adults aged 65 years and over. For example, older adults are at least 90 times more likely to die from COVID-19 than those aged 18 to 29 years old. As of March 2021, at least 179,000 residents and workers at nursing homes had died due to COVID-19 and more than one-third of total COVID-19 deaths in the U.S. were linked to nursing homes for older adults (The New York Times 2021). Furthermore, across more than two dozen states, the COVID-19 death rate was more than 20% higher in nursing homes with a majority of Black residents compared to those with a White majority (Baldauf 2021).
In terms of essential workers, recent evidence confirms that employees of food processing plants (e.g., seafood and other animal food manufacturing industries) face increased risk of exposure to COVID-19. Waltenburg and colleagues (2021) analyzed COVID-19 positivity rates for food processors in 30 states and found that across 742 workplaces, 8,978 employees tested positive for COVID-19 and 55 died. It is suspected that ethnic minorities were disproportionately represented by symptom status, placement under invasive treatment, and percentage of hospitalizations (Waltenburg et al. 2021; Dyal et al. 2020). Currently, a U.S. Congressional Subcommittee is investigating reports that 54,000 food workers were found to be COVID-19 positive and 270 died within 569 meatpacking plants (Select Subcommittee on the Coronavirus Crisis 2021). According to the Subcommittee, “More than two-thirds of employees at meatpacking plants are Black or Hispanic, and almost half of employees live in low-income families” (Select Subcommittee on the Coronavirus Crisis 2021).
Finally, the prison population also exhibits elevated risk of infection. Due to confined environments, one in five prisoners (over 275,000 individuals) have been infected with COVID-19 and 1,700 deaths have been reported due to COVID-19 in U.S. prisons (Schwartzapfel and Park 2020; NPR 2021).
B. COVID-19 Consequences: Impacts on Healthcare Systems
Prior to COVID-19, hospitals generally were experiencing a wide range of operational challenges. A rapidly aging admission population with increasingly complex medical conditions, coupled with issues related to climate change, severe weather, threat of emerging infectious disease, and new regulatory demands, all placed economic pressure on an industry with a profit margin of only 2% or less (National Academies of Sciences, Engineering, and Medicine 2019). As many as half of all hospital emergency units across the U.S. were functioning at or near surge capacity before the pandemic (National Academies of Sciences, Engineering, and Medicine 2019). Additionally, only 30% of hospitals were rated as top safety performers, based on metrics such as error prevention, nosocomial infection rates, and other standards that could predict hospital performance during a crisis (Farberman et al. 2020).
State crisis standards of care (CSC) plans are typically organized within required all-hazards readiness plans, supported by the National Incident Management System (NIMS) and implemented through standardized and blended Hospital Incident Command Systems (HICS). Readiness systems must be exercised annually to test capabilities in real time with all community stakeholders according to a variety of federal drivers, including Centers for Medicare & Medicaid Services (CMS). Knowledge regarding internal vulnerabilities and external hazard threats is collected during Hazard Vulnerability Assessments (HVA) (Eddy and Sase 2015). The HVA drives planning processes and helps the selection of personal protective equipment and other precautionary considerations that are hazard specific.
II. Crisis Standards of Care: Framework
CSC is a framework for a systems-based approach to preserving healthcare capacities in the event of a crisis leading to hospital surge capacity exceedance. Previously described by the Institute of Medicine (IOM) as “altered standards of care,” CSC guidelines support healthcare rationing systems based upon patient triage, which in the process may result in the limitation of services. “The greatest good for the greatest number,” a key tenet of utilitarianism, is often cited as a justification for CSC plans (Maves et al. 2020; Leider et al. 2017; White et al. 2009).
The literature does not describe well the evolution of historical triage methodologies from ancient military triage practiced on the battlefield to the modern healthcare environment. Traditionally, the triage classification is based on the waiting period for surgery and classified as extreme, first, second, and third emergencies, expectant, and walking wounded (Rigal and Pons 2013).
The application of CSC to a pandemic event may present challenges to achieving justice (biomedical ethics and human rights) in healthcare delivery and principles of public health prevention as U.S. governmental plurality limits standardization of hospital procedure and may produce uneven service. During a crisis, the focus of care provision shifts from individual patients to the good of the community (Fiest et al. 2020; Cleveland Manchanda et al. 2020a and 2020b). This shift challenges conventional concepts of population health designed by public health leaders to best distribute public health activity towards the community with the goal of achieving individual wellness (Rigal and Pons 2013). In contrast, activation of CSC during an emergency will deny some patients life-sustaining treatment.
Five Key Elements in CSC
The Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) requested the IOM to develop guidance that state and local public health services can follow in developing CSC. Accordingly, in 2009, the IOM published five key elements for CSC (IOM 2009). These elements should apply during disasters, both natural and manmade, accidental or intentional. They include:
A strong ethical grounding;
Integrated and ongoing community and provider engagement, education, and communication;
Assurances regarding legal authority and environment;
Clear indicators, triggers, and lines of responsibility; and
Evidence-based clinical processes and operations.
CSC: Resource Allocation Decisions
Prior to the pandemic, some states had developed CSC plans while others had not. Cleveland Manchanda and colleagues (2020b) conducted a systematic review that identified structured and in-place CSC systems in 29 states. These plans varied in terms of patient triage categories. All 29 states incorporate Sequential Organ Failure Assessment (SOFA) scores that assess the performance of organ systems and distinguish the survival likelihood of patients. The study found that 15 states also consider long-term comorbidities, five consider pregnancy, and 10 consider prioritizing essential worker status (Cleveland Manchanda et al. 2020b). By early 2020, the District of Columbia and 41 states had published documents related to CSC (Ingram et al. 2021; Romney et al. 2020).
Arizona was one of the states hardest hit by COVID-19 in the early summer of 2020. As new cases rose, hospitalizations and deaths also increased dramatically. Anticipating potential surge capacity exceedances at hospitals, the state of Arizona ordered refrigerated morgue trucks to store the dead while requesting out-of-state healthcare workers to assist its hospitals. On June 29, 2020, the state of Arizona activated its CSC system, representing the first official implementation of CSC in U.S. history, applying not only to COVID-19 patients but also to all other people seeking medical care in Arizona. Therefore, non-COVID-19 patients with medical emergency scenarios of all kinds were also potentially excluded from access to healthcare under the CSC activation.
Before the CSC activation, some healthcare workers in Arizona were forced to send COVID-19 patients home due to mechanical ventilator shortages at hospitals. This outcome indicates that access to care is already limited when a surge of patients overwhelms hospital capacity, with or without CSC activation. However, while the CSC system was activated in Arizona, we obtained no evidence of the actual utilization of CSC in the state, as of the writing of this article.
III. Data and Methods
The purposes of this study are: 1) to identify populations that might be categorically disadvantaged during the triage process of a CSC plan applied to the COVID-19 pandemic; and 2) to determine the relationship between the overall hospital emergency management system and state CSC plans.
A. Data
To identify the state CSC plans for this study, we first conducted a literature review and identified five states (Arizona, Colorado, Minnesota, Nevada, and Vermont) whose CSC plans contained all five of the IOM’s key elements (Institute of Medicine 2009). Second, we cross checked this list with the state CSC list published by the HHS ASPR’s Technical Resources, Assistance Center, and Information Exchange (TRACIE). There, for example, the Maryland entry URL was listed: however, the content only included surgical procedures and not the comprehensive state CSC (ASPR 2020b; Maryland Department of Health 2020); as such, it was not included in this study. On the other hand, we identified one state (Massachusetts) that also met the inclusion criteria from a literature review and examination of state information. Thus, in total, six states met our inclusion criteria: Arizona, Colorado, Massachusetts, Minnesota, Nevada, and Vermont. As supplemental material to further understand the state CSC plans for analysis, we used related academic articles, newspaper articles, news interview materials, and content from online webinars hosted by academic institutions. COVID-19 is an ongoing pandemic and scientific evidence is constantly updated. The latest data was captured as of May 1, 2021. This study may not have covered the latest revisions of policies and guidelines related to the subjects undisclosed to the public.
B. Methods
In our analysis, we pay particular attention to patient triage processes and public health functions, including preparedness during a public health emergency.
First, we focused on patient triage processes in the CSC plans by applying the categories of medical utility and social utility, as indicated in a classic textbook, Principles of Biomedical Ethics (Beauchamp and Childress 2019b, 304-314), which provides a guide to morality for health professionals. Regarding justice (ethics and human rights) and public health perspectives, we considered detailed subcategories for each patient triage category, such as age and comorbidities under “medical utility” and occupational status under “social utility.”
Second, we explored how readiness plans preserve justice while moving towards a public health approach that may protect the human rights of the most vulnerable populations during and beyond the COVID-19 pandemic. We reviewed the plans for mention of an all-hazards approach and utilization of ICS/HICS structures for response effectiveness and consistency with the stated intention to exercise/drill the plan and system. We strove to relate disaster management planning and response process and structure not only to outcome success, but also to the achievement of health equity during a crisis.
IV. Findings
Our analyses revealed that CSC plans varied in depth and breadth even among the studied six states – Arizona, Colorado, Nevada, Massachusetts, Minnesota, and Vermont – that contained all five of the IOM’s key elements (Institute of Medicine 2009). All six states’ CSC plans mention similar purposes. For example, the Vermont CSC plan’s stated purpose is to provide “an ethical, reasonable, transparent and flexible” framework. However, this plan uniquely adds “maximizing self-triage and self-care by the general public,” while also mentioning “optimizing the quality of care that can be provided to the largest number of patients” (Vermont Department of Health 2020, 5). The intention of achieving the greatest good for the greatest number was not necessarily indicated in all of the studied CSC plans.
A. Analysis of Preparedness, Evasion, Activation, and Patient Triage Processes in CSC
CSC Preparedness
The Vermont CSC plan also states an ethical duty to maximize preparedness efforts and adopt prevention strategies that minimize the need to ration scarce resources. It further notes an intention to protect against “systematic unfairness by stewarding resources to reduce significant group differences in mortality and mobility” (Vermont Department of Health 2020, 24). In order not to “delay care for others,” its CSC specifically recommends not providing care to a patient during the triage process except for correcting airways and severe bleeding problems (Vermont Department of Health 2020, 39).
CSC Evasive Measures
While all six states examined in this research developed a thoroughly considered CSC plan with interdisciplinary teams by integrating all five recommended key elements, they emphasize evasive measures to avoid having to activate CSC. Arizona, for example, has specific evasive measures at the state-, county-, and healthcare facility-levels. Evasive measures include: healthcare facilities reuse and repurpose supplies and assign Triage Officers; county health departments activate medical countermeasures; and the state activates the State Disaster Medical Advisory Committee to develop and implement CSC (Arizona Department of Health Services 2020, 23-24).
CSC Activation
When evasive measures can no longer sustain healthcare systems, states can activate CSC. Arizona, the first state that actually activated CSC due to the COVID-19 pandemic on June 29, 2020, has separately itemized checklists for the state, counties, and healthcare facilities to use when determining when to activate CSC (Table 1).
Table 1: Indicators for Crisis Standards of Care (CSC) Activation: Arizona
CSC Patient Triage Process
To analyze the patient triage processes embedded in state CSC plans, we grouped criteria into the categories of medical utility, social utility, and other categories.
Medical Utility: All six states recommend using Sequential Organ Failure Assessment (SOFA) scores or Modified SOFA (MSOFA) scores for prioritizing patients for allocation of scarce resources, such as mechanical ventilators (ASPR 2020c). Colorado additionally uses a modified Charlson comorbidity index (MCCI) [1], which predicts risk of death within five years of hospitalization for patients with specific comorbidities (Charlson et al. 1987 and 1994). However, consideration of comorbid conditions during the patient triage process varies from state to state. Minnesota and Vermont consider comorbidities affecting “long-term” survival: cardiac, pulmonary, renal, hepatic, and oncological conditions. Massachusetts considers patients’ short-term (one-year) survival likelihood from conditions of cardiac, neurologic, trauma, and burn injuries. A low likelihood of survival can be used to deprioritize a patient from receiving care. As a note, Massachusetts removed a two- to four-year survival metric (that was included in the original guidelines published in April 2020) in an updated version of its CSC guidance published in October 2020. Nevada does not specify guidance for allocation of critical care resources, including mechanical ventilators, while the five other states do.
Social Utility: Arizona, Colorado, and Massachusetts consider “social utility” or social worth by certain occupations (such as frontline/essential workers and/or first responders) for prioritization for the allocation of critical care resources (e.g., mechanical ventilators) when two or more patients have the same scores as measured under medical utility above.
Other Categories: Pregnant status is considered when prioritizing scare resources in five of the six states; Vermont does not mention pregnancy under priority status. Additionally, Arizona and Colorado prioritize patients who are single caregivers to their family. Arizona also prioritizes patients under 18 years of age for access to scarce resources.
B. Analysis of Ethical Frameworks in CSC
All six of the states in our study demonstrate an explicit ethical framework in their CSC plans. Minnesota, for example, sets three ethical objectives: 1) protect population health by reducing mortality and serious morbidity; 2) respect individuals and groups; and 3) strive for fairness and protect against systematic unfairness and inequity (Minnesota COVID Ethics Collaborative 2020, 2-3). Colorado, in addition, uniquely lists “one’s own and family safety” as a concern when balancing integrated elements (Colorado Department of Public Health and Environment 2021, 10). Additionally, some states consider health equity and specific vulnerable or at-risk populations.
Health Equity: Colorado, Massachusetts, Minnesota, and Vermont set health equity as a guiding principle. No specifications appear in the CSC plans in Arizona or Nevada, while both mention the Code of Ethics in general.
Consideration for Vulnerable or At-Risk Populations: Arizona, for example, states in its CSC plan that it will consider the public health, mental and behavioral health, and medical needs of at-risk populations and marginalized people who may have “additional needs before, during, and after an incident in communication, medical care, independence, supervision, and transportation” (Arizona Department of Health Services 2020, 12). Massachusetts revised its CSC twice due to equity concerns raised by clinicians, politicians, and disability activists since its first publication in April 2020 (Cleveland Manchanda et al. 2020b; Milliken et al. 2020; The Commonwealth of Massachusetts Department of Public Health 2020).
C. Analysis of Hazard Planning/Readiness and CSC
Planning and All-Hazards Readiness
All six state CSC plans were developed by state Departments of Health. This is unsurprising given that states already play a dominant role in hospital crisis/disaster readiness through their involvement in the NIMS-governed incident command structures. The Minnesota CSC plan directly references the state’s all-hazards readiness plan as a baseline for CSC planning. We found that five of the six state CSC plans were pandemic influenza focused. Unlike COVID-19 (a novel pathogen), the threat of influenza is limited by well-established knowledge regarding its pathogenesis and effective and tested vaccine availability. Nevada’s state CSC plan was adjusted for COVID-19 surge capacity exceedance mitigation strategies, with detailed instructions to minimize continuing signs and symptoms of various illnesses and plans to maximize personal protective equipment for health workers. However, we did not find specific hazard readiness triage guidelines for patients when resources are scarce.
COVID-19 hazard threat severity, considering all-hazards readiness approaches, remains relatively uncharacterized: transmission pathways and long-term medical sequelae are uncertain, and vaccination campaigns, which were initiated under emergency use authorizations for the first time in U.S. history, are in process (Eddy and Sase 2020; FDA 2020). As part of required all-hazards readiness planning and hazard vulnerability assessment processes, hospitals are required to test their response capabilities through tabletop and functional disaster simulation exercises (Sase et al. 2021). CSC plans are inherently tied to hospital disaster planning and emergency response systems that are in place to address natural, accidental, and intentional, all-hazards threats.
State CSC plans, while focusing correctly on all-hazards readiness, typically defer to pandemic influenza planning, which is not sufficiently tailored to the COVID-19 pandemic. Patient triage considerations are disadvantaged by lack of knowledge about COVID-19 long-term medical consequences and neurological/cardiovascular disease. The treatment of COVID-19 patients is far different from operating on patients wounded by a terrorist attack or injured by natural disasters. Although we cannot know at this time the final outcomes of this ongoing pandemic, as the COVID-19 pandemic rapidly escalated, concern also rose that hospitals could be a disease amplifying source, with healthcare workers increasingly at risk of contracting the virus. Sufficient number and quality of personal protective equipment (including N-95 masks, gloves, and goggles) is necessary, particularly at institutions more prone to virus exposure and adverse health outcomes (including hospitals, nursing homes, and other assisted living and congregate living situations). Demands on public supply chains as well as the potential for concurrent disasters or emergencies will create competition for scarce resources. The Nevada CSC plan, examined in this analysis, contained an outstanding approach to conserving staff personal protective equipment.
The prescient 2019 national functional disaster exercise “Crimson Contagion” (Aug. 13-16, 2019) drilled state, local, tribal, and territorial public health agencies and partners in a simulated influenza pandemic only months before the beginning of the COVID-19 pandemic. Although the Avian Influenza H7N9 functional exercise target pathogen was not novel and transmission pathways are well-characterized, “medical surge operations” test results can still provide a baseline measure of readiness for a novel virus such as COVID-19. Researchers found that “the extent of crisis standards of care planning and implementation” varied significantly “across local, state, territorial, tribal, and federal stakeholders,” including planning for scarce resource allocation (mechanical ventilators were mentioned specifically), and that collaborating stakeholder input is insufficient (ASPR 2020a).
Compound Hazards/Disasters
COVID-19 coincided with the record breaking 2020 Atlantic hurricane season, which displaced people through structured evacuations and abandoned destroyed homes. Some of these displaced individuals ended up in shelters, where they were vulnerable to the COVID-19 virus due to limited social distancing and personal protective equipment. CSC plans would likely be challenged to address compound hazards/disasters and patients with other life-threatening medical conditions (for instance, COVID-19 patients with severe burns). Moreover, patients admitted for emergencies unrelated to COVID-19 would be vulnerable to infection during their stay. Patient triage (exclusion categories) may not be thorough enough to properly vet modern threats exacerbated by climate change and extreme weather that often trigger natural disasters.
The Public Health Approach
The core objective of public health is prevention. The three public health functions – assessment, policy development, and assurance of system success – were developed to support that primary role. The “public health approach” further expands to identify necessary components that support justice (fairness): evidence- and population-based program policy and community participation; ethics and human rights; and an emphasis on health disparity and health determinants (Sase and Eddy 2016). However, U.S. government pluralism, the concurrent existence of multiple layers of agency at federal, state, local, and territorial levels, results in variations in capacity through laws and guidelines (Gable 2012). Authority is distributed variously among multiple agencies: both the FEMA National Response Plan and the National Response Frameworks are examples of guidelines, while the Pandemic All-hazards Preparedness Act is established law (Federal Emergency Management Agency 2020; ASPR 2019). Funding tends to move from federal “down” through state to local agency, while authority is greatest at the local level and moves “upward” towards federal agency (ASPR 2019). Additionally, the literature has included discussions regarding indemnity and suggestions that CSC should be enacted after a declared emergency/disaster (Ingram et al. 2020).
V. Discussion
A. A Systematic Disease Burden for the Most Vulnerable
Our overarching research findings indicate that the populations most vulnerable to COVID-19 are often the most disadvantaged by determinants of health that fall under the umbrella of traditional public health programs. These populations are most likely to be categorically excluded from life-sustaining treatment (e.g., mechanical ventilators) in CSC patient triage processes. Our analysis of CSC plans in six states shows that a patient triage system disadvantages some vulnerable populations that are medically impacted by the COVID-19 pandemic (Figure 1).
Figure 1: Categorical Exclusions by Patient Triage in Crisis Standards of Care (Examples)
Health equity and social justice concerns are associated with CSC during the COVID-19 pandemic. For example, physicians in Boston warned in the New England Journal of Medicine, “Crisis Standards of Care…de-prioritize people with coexisting conditions, or with a higher likelihood of death within five years, [and] penalize people for having conditions rooted in historical and current inequities…” (Cleveland Manchanda et al. 2020a). Another study by Harvard researchers found a significant association between a “high rate of COVID-19” and socioeconomic status and citizenship status, both of which impact education and income level and may in turn result in older adults living in crowded housing environments that increase the risk of transmission (Figueroa et al. 2020).
The evidence shows that older adults (Kilaru and Gee 2020) and/or persons with existing medical conditions are more likely to develop severe illness due to COVID-19 (Advisory Board 2020), yet the current patient triage system potentially excludes these populations from access to healthcare under the CSC activation. This exclusion process applies to all patients (with or without COVID-19 infection) during the CSC activation period, thus expanding the spectrum of healthcare inequities across various demographics.
Furthermore, the activation of CSC could negatively impact already overburdened populations of color, who make up a growing proportion of the population in some parts of the U.S. Approximately 60% of the U.S. population identifies as non-Hispanic White, however, Hispanics, Blacks, or smaller racial and ethnic groups made up a majority of the population in 151 counties in 2018 (Shaeffer 2019). These populations experienced health disparities prior to the pandemic. For example, Black adults had the highest prevalence of self-reported obesity (39.8%), followed by Hispanic adults (33.8%), and White adults (29.9%). Over 35% of Black adults in 34 states and the District of Columbia are obese (CDC 2021b). Factors including lower socioeconomic status (SES), living/home environment (e.g., multigenerational housing), and/or at-risk occupations (e.g., meatpackers, bus drivers) contributed to these and other health inequalities among minority populations. This multilayered disease burden and associated risk factors might disproportionately impact those suffering from a novel pathogen-driven pandemic (e.g., COVID-19) and adverse CSC patient triage processes.
B. Evidence-Based Medicine and Public Health: Considerations for CSC
Both evidence-based medicine (Sackett et al. 1996) and evidence-based public health utilize proven science for decision-making processes. Evidence-based medicine has three major pillars: 1) best available research information; 2) clinical experience; and 3) patient values (Masic et al. 2008) [2]. Because the virus (SARS-Cov-2) is a novel pathogen, one that humans have previously not encountered, the “best available research information” is adjusted and updated daily by scientists and healthcare experts around the world. Likewise, some CSC plans established/revised only a few months ago might not adequately reflect the latest scientific evidence.
SOFA, for instance, “cannot accurately predict which patients will survive” and “will not assist in the triage process” in CSC plans during the COVID-19 pandemic (ASPR 2020). In fact, the ASPR concluded that using SOFA score thresholds to make patient triage decisions is “not ethically justifiable,” based on findings from 2010 to early 2021 (ASPR 2021). Separately, the WHO stated that “it may be inappropriate to use critical care triage guidelines that have age cut-offs” that deprioritize or exclude those aged over 60 years (WHO 2020a). When considering novel pathogens and/or diseases, it is advisable for patient triage processes to be periodically reviewed as evidence progresses.
For the same reason, “clinical experience,” which is developed by healthcare workers treating patients with the specific disease, is also under development and growing daily. China shared the genetic structure of SARS-Cov-2 with the world on Jan. 12, 2020 (WHO 2020b). Both “best available research information” and “clinical experience” have accumulated since then. As a point of comparison, the Zika virus was originally known to be spread primarily among adolescents with light symptoms; it was only later that healthcare workers found an association between Zika and babies born with microcephaly (Eddy and Sase forthcoming). Medical discussion regarding long-term COVID-19 symptoms has only recently begun in earnest, and clinical sequelae are still relatively unknown and underrepresented in the research. In lieu of perfect information regarding the threat of this hazard, we must plan conservatively and stay alert to possible changes in disease pathogenesis and other prevention/mitigation considerations (Eddy and Sase 2020).
“Patient values,” the third pillar of evidence-based medicine, might be partially incorporated through advanced directives or advance care planning that express the preferences of patients for their care under the CSC plans during the COVID-19 pandemic. Nevertheless, as our examinations showed, “patient values” (such as personal preference regarding place of care or types of medications to be used) could be extremely diminished as healthcare systems struggle to maintain continuity of operations while aiming for “the greatest good for the greatest number” (Robert et al. 2020; Romney et al. 2020; DePergola 2020; Beauchamp and Childress 2019a; Cleveland Manchanda et al. 2020a; Toner et al. 2020).
Finally, public health has long utilized an evidence-based approach to population health. While the role of the medical model during a crisis is to administer medicines that treat the symptoms of those affected by disease, the public health approach aims to reduce the threats that cause crisis and mitigate loss and harm (Figure 2).
Figure 2: The Public Health Approach
C. Virus Mutations and A New Threat Calculus
A significant new challenge has entered the COVID-19 threat calculus: multiple variations of the virus, originating in South Africa, Brazil, and European nations, have been detected throughout the U.S. Furthermore, the U.K. virus mutation is reportedly 50% to 70% more virulent than the virus strain that was used to formulate current vaccines and has been detected in approximately 35 countries at the time of writing. New evidence must be generated to assure the public that we are confident that current personal protective equipment and social distancing measures are adequate, while considering the possibility for more draconian prevention and assurance systems, which would be overseen by public health stakeholders.
However, in a call for action signed by leading medical organizations, including the American Medical Association and the American Nurses Association, the National Academy of Medicine announced that the consortium acknowledged that “government, public health agencies, and the public should be doing everything possible to curb the spread of the disease and flatten the curve,” and draconian recommendations are made regarding triage, emphasizing outcomes for people of color, to prevent the “functional collapse” of health systems (National Academy of Medicine 2020).
D. The Greatest Good for The Greatest Number
The purpose of CSC is generally to optimize results through application of utilitarian theory, such as “the greatest good for the greatest number” (Robert et al. 2020; Romney et al. 2020; DePergola 2020; Beauchamp and Childress 2019a; Cleveland Manchanda et al. 2020a; Toner et al. 2020). Such ethical discussion of distributive justice just began in terms of patient triage in CSC plans. There is no consensus regarding patient triage in CSC plans whether a greater number of persons (lives) or a smaller number of younger age persons (life-years) should be saved (Milliken et al. 2020; Solomon et al. 2020; White and Lo 2021) in the context of fair, equitable, and appropriate distribution of treatment (Fleischacker 2005; Beauchamp and Childress 2019b).
This study and other studies indicated that certain populations are more vulnerable to hazards (e.g., a virus). As the world population ages, themes relating to death and dying are attracting attention. The Lancet, a leading international medical journal, commissioned a group of researchers worldwide to study relationships between death and healthcare for the first time in 2018 (Smith 2018). The ongoing commissioned study also discusses death and dying issues associated with the COVID-19 pandemic (Smith et al. forthcoming).
CSC plans attempt to treat/save a patient by withholding or withdrawing scarce medical treatment (e.g., a mechanical ventilator) from another patient who is less likely to survive during a crisis. Such direct exchange of life-saving opportunities should be further debated among all stakeholders.
VI. Recommendations
A. Public Health Approach
Early Detection, Prevention, Containment, and Mitigation
Unlike natural disasters where case fatalities are limited by a short-term incident and largely unpreventable, lowering new infection cases, hospitalizations, and deaths in a pandemic is achievable. Public health prevention countermeasures (nonpharmaceutical interventions) are a scientifically proven approach to contain and mitigate hazards. Social distancing keeps human hosts away from the hazards, similar to the primary prevention measure recommended for radiation safety. Wearing masks prevents virus spread from an infected host to other people. Hand washing prevents the virus from infecting human hosts, entering via mucus membranes (eyes, nose, mouth) transferred by the hands. Other infection pathways, including the potential transmission of the virus from animals and contaminated environmental surfaces (fomites) and the potential for the cross-contamination of food and drink (by droplets, aerosol, etc.), must be considered. These nonpharmaceutical interventions must be better understood and communicated to the public (Eddy and Sase 2020). The key to success for these public health countermeasures is for public health agencies to present a coherent and universal series of infection prevention instructions to all populations affected by a pandemic.
All-Hazards Readiness
Our analysis of state CSC plans reveals an attention to all-hazards readiness by following NIMS ICS/HICS command and control frameworks. However, we also find that national planning strategies and many state-level plans focus on pandemic influenza, which is only partly appropriate and applicable to readiness planning associated with a novel virus or other pathogen. As the U.S. battled an escalating and worsening pandemic, it also edged closely towards the implementation of CSC plans in multiple states. As increasing mutations/variants emerge, we are moving into a more uncertain phase of the pandemic, the severity of which is currently unknowable. In order for combined government and public health agencies and individuals within our communities to “flatten the curve,” greater attention must be placed on basic public health tenets.
New vaccines have been made available since December 2020 through unprecedented emergency use authorization processes. Yet, questions remain about how long these vaccines provide protection. Furthermore, there will be considerable lag time between the start and end of a nationwide vaccination campaign. Unlike other types of disasters (such as natural disasters or terrorist attacks), healthcare workers share an increased burden of risk by being continuously exposed to infectious patients during their work. Therefore, public health prevention interventions are key: isolation, quarantine, restrictions on movement and travel advisories or warnings, social distancing, external decontamination, hygiene, and precautionary protective behaviors (CDC 2019).
Main federal drivers, including requirements from CMS, require annual disaster/emergency exercises to test capacities and staffing knowledge through a real time simulation. Knowledge developed from hazard vulnerability assessments should be utilized to form baseline understandings of potential external threats, such as natural disaster and acts of terrorism, internal vulnerabilities, and related supply chain and readiness needs.
Two salient aspects must be added to all hospital all-hazards plans immediately: 1) COVID-19 specific planning and response metrics based upon most current evidence and understanding of community population dynamics; and 2) CSC plan input, including patient triage, mitigation strategies, and performance metrics that can be measured during simulation exercises/drills. In the midst of the COVID-19 pandemic, CSC preparedness guidance was issued in a report that emphasized the securing and training of staff, among other preparations necessary for the assurance of health systems and space (such as hospital beds) (National Academies of Sciences, Engineering, and Medicine 2020). While advocating the inclusion of COVID-19 planning and exercise/simulation in updated emergency operations plans to catch up with the changing pandemic threat environment, future exercises should also target novel viruses and pathogens.
B. Human Rights Approach: Respect for Human Dignity
The World Health Organization (WHO) affirmed the right of all people to the highest attainable standard of health (or “the right to health”) in its Constitution (WHO 1946). The right to health is stipulated in one of the key human rights treaties, the International Covenant on Economic, Social, and Cultural Rights, ratified by 170 member states, excluding the U.S. However, these indicators are not limited for use exclusively by ratified countries. Moreover, other treaties ratified by the U.S. contain provisions related to health or the right to life [3]. Promoting human rights, such as by a human-rights based approach to health, would benefit both patients and the public (Table 2).
Table 2: A Human Rights-Based Approach to Healthcare: Essential Elements
All domains of health and human rights for all people should be promoted even in a complicated political moment (Gruskin 2019). Engagement of individuals and communities is essential for effectively managing the spread of disease (Yamin and Habibi 2020). The U.S. HHS Office of Civil Rights also states that civil rights laws “remain in effect and cannot be waived” during COVID-19 and other disasters (FEMA 2021).
Cultural Competence and Public Health Outreach
Cultural competence (to engage knowledgeably with people across cultures) and cultural humility (a lifelong process focusing on self-reflection and personal critique) are important skill sets necessary to successful care and effective communications to the public (Khan 2021). Most people find medical forms complicated and challenging. Healthcare workers should be able to simplify instructions in explanations provided to patients. This is especially important during the COVID-19 pandemic, when highly scientific information about the novel virus is not easily understood by the general public, especially those with limited health literacy (an ability to use health information).
Mortalities due to misinformation about COVID-19 were reported in the U.S. (Sy et al. 2020). Experts including health scientists, healthcare workers, and public health officials should collaborate to disseminate accurate information, including transmission pathways (CDC 2020; Eddy and Sase 2020) and public health countermeasures in prevention, early detection, containment, and mitigation (CDC 2021c; Sase and Eddy 2016).
People including policymakers should be informed about the patient triage processes in CSC in advance so that they understand what lies ahead if appropriate measures and behaviors are not taken. Furthermore, they should be given opportunities to participate in the formulation or revision of these processes, as the United Nations recommends in relation to decision-making processes for health-related issues (United Nations Economic and Social Council 2000).
VII. Conclusion
COVID-19 has accelerated modern, high tech-supported scientific capabilities and the rapid development of vaccines. At the same time, however, the pandemic has also exacerbated existing socioeconomic health issues: health disparities among different populations separated by race, socioeconomic status, disability status, and age (Cleveland Manchanda et al. 2020a; Kilaru and Gee 2020).
One of the worst-case scenarios in healthcare delivery during a pandemic is to exceed hospital surge capacity. CSC activation is designed to enable a hospital to systematically respond by making its primary objective operational continuity. As we outlined earlier, the success of disaster/emergency planning cannot be practically assured without exercise simulation/drills. In lieu of the activation of CSC plans, there is still time to augment hazard vulnerability assessments with contemporary knowledge about COVID-19 threat severity, mitigation strategies, and other tactics developed to mitigate hospital surge capacity and the associated adverse outcomes. Additionally, all staff who could potentially become involved in the triage decision-making processes should be required to immediately participate in exercise simulation/drills designed to test procedures and individual abilities.
When scientific and medical evidence is under development, the patient triage process should be carefully intertwined with justice (ethics and human rights). Even with the best possible plan, it is inevitable that certain groups of patients in exclusion categories will experience negative consequences (Auriemma et al. 2020). To avoid such a tragedy, a public health approach should be adopted when implementing relevant public policies to identify, contain, and mitigate hazards (e.g., virus) as a part of prevention and mitigation strategies.
Justice supported by ethics and human rights should be paired with the public health approach in implementation and practice, including the development and use of disaster and emergency response plans. “Leave no one behind” is the slogan presented at the 2030 United Nations Agenda for Sustainable Development. It reflects the members’ commitment to eradicate the social complexities of poverty, eliminate all forms of discrimination and other acts of exclusion, and “reduce…inequalities and vulnerabilities” (United Nations n.d.).As a member state, the U.S. should strive to “leave no one behind” by developing crisis readiness systems that eliminate the need to activate CSC plans, which could potentially negatively impact already-burdened populations.
+ Author Biographies
Eriko Sase, Ph.D. is a health scientist specializing in health and human rights. Dr. Sase is a member of The Lancet Commission on the Value of Death and is currently researching Justice in End-of-Life Care at the Kennedy Institute of Ethics at Georgetown University, with funding from the Abe Fellowship. Her 60-plus publications include a book chapter in Advancing the Human Right to Health from the Oxford University Press (2013), a guest editorial on COVID-19 in the Journal of Environmental Health (2020), and articles on pandemic influenza H1N1, Ebola virus disease, and Hansen’s disease (leprosy), as well as on disaster preparedness and response (e.g., the 2011 Great East Japan Earthquake and Fukushima Nuclear Disaster). She received her Ph.D. from the University of Tokyo, Japan, and completed her postdoctoral fellowship at the Harvard T.H. Chan School of Public Health. She was the inaugural Director of the Global Health Systems Program at Wright State University in Ohio and was a research fellow at the Japan Medical Association Research Institute.
Christopher Eddy, M.P.H., REHS, CP-FS, led the U.S. national COVID-19 response for the first 13 months of the incident. As a government contractor, he served as both subject matter expert and scientific writer in disaster planning and public health emergency response. He has taught at the Grand Canyon University College of Nursing and Health Care Professions for eight years as a lecturer on global health, environmental health, and occupational safety. Previously, he served as an adjunct faculty member at Georgetown University and as a disaster management curriculum developer. Mr. Eddy has 30 years of experience in public health in both field and academic capacities. He was the chairman of a Cincinnati Metro area all-hazards and counterterrorism strike force and was appointed to the Ohio Public Health Council and the Ohio Retail Food Safety Committee.
+ Acknowledgement
The authors would like to thank the editors and reviewers of the Georgetown Public Policy Review for their constructive comments on our manuscript. ES would like to acknowledge the Abe Fellowship for supporting a part of this study.
+ Endnotes
[1] Colorado inactivated CSC including the "triage score worksheet" as of April 1, 2021 (colorado Department of Public HEalth and Enviornment 2021).
[2] “Evidence based medicine (EBM) is the conscientious, explicit, judicious and reasonable use of modern, best evidence in making decisions about the care of individual patients. EBM integrates clinical experience and patient values with the best available research information. It is a movement which aims to increase the use of high quality clinical research in clinical decision making. EBM requires new skills of the clinician, including efficient literature-searching, and the application of formal rules of evidence in evaluating the clinical literature,” (Masic et al. 2008).
[3] These include: The International Covenant on the Elimination of all Forms of Racial Discrimination (Race Convention, 1965) and the International Covenant on Civil and Political Rights (1966).
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