Allocating ventilators during COVID-19: What is 'fair'?

It is hard to imagine a topic more sensitive, and a situation more difficult, than deciding who gets to live and die in the time of a pandemic. Yet this is the reality of the COVID-19 outbreak and the resource shortage it has caused.

In particular, the insufficient number of ventilators very quickly came to the world’s attention, as highlighted by physicians and hospital managers from across the world, including Italy, India, and the United States.

Due to the lack of critical care resources, healthcare professionals, patients, and families around the world must live with the consequences of withdrawing life support from one person for the benefit of another.

Such decisions are so fraught, both emotionally and ethically, that the phrase “fair allocation” of a ventilator may seem inappropriate. These decisions can never truly be “fair.”

Stay informed with live updates on the current COVID-19 outbreak and visit our coronavirus hub for more advice on prevention and treatment.

However, fairness is what frontline hospital workers must strive for in such circumstances. This Special Feature looks at some of the difficulties posed by such decisions and the criteria involved in making them, as explained and recommended by doctors and bioethicists.

The ventilator shortage crisis

Although it is a very difficult thing to calculate, data and analytics company GlobalData estimated on March 23, 2020 that approximately 880,000 more ventilators would be needed globally to tackle the COVID-19 outbreak.

According to the same report, the U.S. had a shortage of 75,000 ventilators, while France, Germany, Italy, Spain, and the United Kingdom collectively lacked 74,000 ventilators.

The Society of Critical Care Medicine recently highlighted that calculations of this type are “gross estimates” because there are many unknowns underpinning them, one of which is the pacing of the pandemic. Our success in “flattening the curve” will affect the extent of the demand for ventilators at any given point in time.

“Ventilator shortages are a crucial reality as the COVID-19 outbreak continues to worsen globally. All ventilator manufacturers have full order books and hold little in stock — receiving orders not only from regular customers such as hospitals, but also directly from governments.”

– Tina Deng, a medical devices analyst at GlobalData

Who should make the decision?

In the context of this scarcity, there are many concerns. Not least of all is the fact that some people, who may not have died had there been enough ventilators, may now perish as a result of this scarcity of resources.

One of the other main concerns is the clinicians’ burden of choosing who gets a ventilator. The psychological distress of having to make such a decision is hard to overestimate.

Dr. Robert Truog — the director of the Center for Bioethics at Harvard Medical School in Boston, MA — and colleagues reflect on the point that less than 50 years ago, doctors argued that taking someone off of a ventilator was an act of killing, and that it was both illegal and unethical.

Today, however, withdrawal from a ventilator is the most common immediate cause of death in an intensive care unit (ICU), and many people see it as an ethical act and a legal obligation.

What makes the COVID-19 crisis very different for these same doctors is that the two ways of justifying such decisions no longer apply. Indeed, “it is not being done at the request of the patient or surrogate, nor can it be claimed that the treatment is futile.”

To help ease the toll that such decisions can take on a person’s mental health, Dr. Truog and colleagues recommend that a “triage committee” should make these decisions — not the clinician.

“[S]uch a committee should be composed of volunteers who are respected clinicians and leaders among their peers and the medical community,” write the authors, adding that such a committee could help “buffer” the clinicians from the potential harm to their mental health.

This kind of committee would also help healthcare workers such as physicians and nurses continue to maintain their roles as “fiduciary advocates” and appeal the committee’s decision when necessary.

Also, having a dedicated committee would enable those in it to constantly adjust their rationing criteria according to the changing situation — for example, should more or fewer ventilators become available — and allow them to consider each individual situation on a case-by-case basis.

“[W]hen a hospital is placed in the unavoidable but tragic role of making decisions that may harm some patients, the use of a committee removes the weight of these choices from any one individual, spreading the burden among all members of the committee, whose broader responsibility is to save the most lives.”

– Dr. Robert Truog, et al.

Dr. Truog and colleagues recommend that the triage committee should also take on the task of accurately and sensitively communicating their decisions to the patients’ families. This would help prevent misunderstandings and inaccuracies.

Finally, they suggest that the healthcare workers who take care of the patients in question “should not be required to carry out the process of withdrawing mechanical ventilation; they should be supported by a team that is willing to serve in this role and that has skills and expertise in palliative care and emotional support of patients and families.”

Although a triage committee would help alleviate clinicians’ burdens, the question remains: What are the ethical values that such a committee would need to base their decisions on?

Current triage criteria

In the state of New York, such a committee is already in place. A “triage officer or a triage committee composed of people who have no clinical responsibilities for the care of the patient” is responsible for rationing ventilators, write Dr. Truog and colleagues.

The rationing criteria in the state of New York aim to “save the most lives” by prioritizing “patients for whom ventilator therapy would most likely be life saving.”

Such criteria mean that both patients most likely to die without medical intervention and patients least likely to die with medical intervention have the most restricted access to ventilators.

By contrast, “patients who are most likely to survive without the ventilator, together with patients who will most likely survive with ventilator therapy” are the most likely to receive one.

The committee or officer do not have direct contact with the patient, only assessing the data at hand.

Triage occurs in three steps:

• First, the committee or officer will exclude patients who experience certain outcomes, such as irreversible shock or cardiac arrest, from the allocation process.
• Then, they will assess mortality risk using the Sequential Organ Failure Assessment score to determine who should get a ventilator first.
• Then, they will continue to repeat these assessments over time, “such that patients whose condition is not improving are removed from the ventilator to make it available for another patient.”

Ethical values and recommendations

In a paper entitled, “Fair allocation of scarce medical resources in the time of Covid-19,” Dr. Ezekiel J. Emanuel — a bioethicist, oncologist, and professor of healthcare management at the University of Pennsylvania in Philadelphia — and his colleagues review the ethical values behind ventilator allocation in conditions of scarcity.

Based on existing research as well as their own, Dr. Emanuel and colleagues conclude that there are four fundamental values that must inform the allocation of health resources. These are:

• maximizing the benefits produced by scarce resources
• treating people equally
• promoting and rewarding instrumental value
• giving priority to the worst off

The authors caution, however, that the way in which people understand and implement these four values is open to interpretation.

For instance, maximizing benefits “can be understood as saving the most individual lives or as saving the most life-years by giving priority to patients likely to survive longest after treatment.”

“Instrumental value” may mean saving those who can save others, or rewarding “those who have saved others in the past.”

Also, “priority to the worst off could be understood as giving priority either to the sickest or to younger people who will have lived the shortest lives if they die untreated.”

Using these four generic ethical values as guidelines, Dr. Emanuel and team devised six recommendations with specific application to the COVID-19 pandemic.

These recommendations are as follows:

• “Maximize benefits.”
• “Prioritize health workers.”
• “Do not allocate on a first-come, first-served basis.”
• “Be responsive to evidence.”
• “Recognize research participation.”
• “Apply the same principles to all COVID-19 and non-COVID-19 patients.”

The first recommendation includes the fact that “people who are sick but could recover if treated are given priority over those who are unlikely to recover even if treated.”

Also, “[b]ecause young, severely ill patients will often comprise many of those who are sick but could recover with treatment,” this recommendation could also mean prioritizing those who are “worst off” in the sense that they would be at risk of dying without having lived a “full life.”

The authors also support withdrawing a ventilator from someone to give it to someone else in need as the ethical thing to do. Dr. Emanuel and team also recommend “that patients should be made aware of this possibility at admission.”

The authors also mention that allocating beds and ventilators according to this value of benefit maximization in the first place could reduce the need for ventilator withdrawal later on.

According to the second recommendation, critical care resources “should go first to frontline healthcare workers,” not because they are somehow more worthy of receiving treatment, but because they are “essential to the pandemic response.”

“If physicians and nurses are incapacitated, all patients — not just those with COVID-19 — will suffer greater mortality and years of life lost […]. Priority for critical workers must not be abused by prioritizing wealthy or famous persons or the politically powerful above first responders and medical staff — as has already happened for testing.”

– Dr. Ezekiel J. Emanuel, et al.

Why patient prioritization should vary

The third recommendation says that patients with similar outcomes and who are equally likely to survive as a result of receiving a ventilator should not receive them based on a first-come, first-served basis — as is the case with kidney transplants, for example. Instead, healthcare workers should base the allocation on a randomized, lottery-like process.

The first-served approach would unfairly benefit those living nearer health facilities, the authors argue, and disadvantage those who get sick later in the pandemic — perhaps because of their “strict adherence to recommended public health measures.”

The authors note that prioritization should vary according to intervention and scientific guidance. So, although they may not receive priority access to ventilators, older adults should get priority access to vaccines after healthcare workers and first responders.

Similarly, the allocation of antivirals and experimental treatments “may produce the most benefit if preferentially allocated to patients who would fare badly on ventilation,” depending on the scientific evidence.

Recognizing research participation means that those “who participate in research to prove the safety and effectiveness of vaccines and therapeutics should receive some priority for COVID-19 interventions,” add the researchers. However, staff would only invoke this if there are patients with very similar outlooks.

Finally, applying the same principles of scarcity to all COVID-19 and “non-COVID-19” patients means that, for example, “a doctor with an allergy who goes into anaphylactic shock and needs life saving intubation and ventilator support should receive priority over COVID-19 patients who are not frontline healthcare workers.”

Excluding patients is ‘ethically flawed’

In a viewpoint article appearing in the journal JAMA, bioethicist and intensivist Dr. Douglas B. White — the director of the Program on Ethics and Decision Making in Critical Illness at the University of Pittsburgh, PA — explains some ethical concerns he has with existing guidelines for allocating ventilators.

For one thing, he says, the recommendations in some states to exclude certain categories of patients from receiving ICU care are ethically flawed.

“Categorically excluding patients will make many feel that their lives are ‘not worth saving,’ which may lead to perceptions of discrimination.”

The authors explain that excluding some people, such as patients with “class 3 or 4 heart failure, severe chronic lung disease, end stage renal disease, and severe cognitive impairment […] violates the principle of justice because it applies additional allocation criteria to some patients but not others.”

In this exclusionary framework, they say, the criteria for exclusion — that is, long-term prognosis and functional status — are “selectively applied to only some types of patients, rather than to all patients being considered for critical care.”

Instead, the authors propose an allocation framework wherein “all patients who meet usual medical indications for ICU beds and ventilators are eligible and are assigned a priority score using a 1 to 8 scale.” The bases for the score would be:

• “(1) patients’ likelihood of surviving to hospital discharge, assessed with an objective measure of acute illness severity”

• “(2) patients’ likelihood of achieving longer-term survival based on the presence or absence of comorbid conditions that influence survival”

They argue that integrating multiple criteria into a single score is a preferable system because “no single criterion captures all morally relevant values.”

In an interview for JAMA Network, Dr. White explains the score system, saying:

“What’s important about this framework and this allocation scheme is that every patient who would normally be eligible for intensive care is considered and is given an allocation score. No one is excluded. […] Instead, we would treat with intensive care as many patients as we could in terms of the resources available. […] The provision of intensive care is resource-driven, rather than exclusion-driven.”

More guidance for ventilator withdrawal

In their paper, Dr. White and colleague Dr. Bernard Lo caution that more guidance is necessary for withdrawing a ventilator from one person to provide it to another.

Firstly, “when discussing the use of mechanical ventilation with patients and families, ventilator use should be presented as a time limited therapeutic trial, not an unlimited promise,” recommend the authors.

Secondly, clinicians must make sure that such a trial is not too brief, preventing a situation wherein patients would have survived had their life support not been taken away too quickly in a “rapid cycling” of ventilator withdrawal.

Thirdly, the authors also recommended that “a triage officer or team, not the treating physician, should make decisions about allocating and discontinuing ventilators.”

The scheme that Drs. White and Lo propose may assuage some of the concerns expressed by people with disabilities and those who advocate that clinicians should not abandon the principle of nondiscrimination during the pandemic.

Although the expert insights above offer some valuable ethical guidance, the diversity of opinions also illustrates how difficult it is to settle a matter that is truly of life or death.

There are different ways of establishing what is ethical, but we may still be a long way from knowing what is “fair.” Crucially, we have very little time to figure it out.

For live updates on the latest developments regarding the novel coronavirus and COVID-19, click here.

Source: Read Full Article