Protocols for Scarce Resources Draw on Ethical Principles, Empirical Data
When COVID-19 cases filled ICUs to capacity in 2020, hospitals needed to determine the criteria used to allocate scarce resources. Ethicists were asked to develop crisis standards of care; now, some are scrutinizing those criteria. “Many of us were tasked with writing these plans. We thought some data on the ethical consequences of each of these plans would be incredibly useful,” says William F. Parker, MD, PhD, assistant director of the University of Chicago MacLean Center for Clinical Medical Ethics.
In the wake of shocking disasters, such as Hurricane Katrina in 2005, and the 2009-2010 H1N1 influenza pandemic, the Institute of Medicine produced a series of workshops about providing healthcare in worst-case scenarios.1 “They coined the term ‘crisis standards of care.’ But in practice, few states had well-developed crisis standards of care,” Parker says.
When COVID-19 case counts skyrocketed in spring 2020, states and individual hospitals scrambled to come up with their own specific plans.2 Even if hospitals started with the same set of agreed-upon ethical principles, they still created different protocols to achieve those ethical principles. “The protocol can be more or less successful in doing it. Even if you can agree on the ethics, the protocol still needs testing and refinement,” Parker notes.
Parker and colleagues recently compared survival to hospital discharge rates of four triage strategies used during the pandemic: lottery, youngest-first, Sequential Organ Failure Assessment (SOFA) scores only, and “multiprinciple” (SOFA scores and severe comorbidities).3 The authors simulated a ventilator shortage in 998 critically ill patients with COVID-19 who were receiving mechanical ventilation. The sample was about one-third Black, one-third Hispanic, and one-third white, which was fairly representative of COVID-19 patients in the Chicago area.
Researchers picked two patients randomly from the group and determined who would go on the ventilator based on each protocol. “Until you actually simulate it, you don’t know if the protocol will achieve the ethical framework that was written down,” Parker explains. Some key findings:
- The youngest-first protocol saved more lives than the SOFA-only protocol, but it led to significantly lower survival and allocation in the oldest patients.
- The SOFA-only protocol and the multiprinciple protocol saved more lives than allocating ventilators randomly with a lottery.
- The lottery system/random assignment of ventilators saved the fewest lives, but it produced equal survival rates by race/ethnicity.
- Black patients were less likely to survive with protocols that used SOFA scores, but were equally likely to survive with a lottery system.
- Critically ill Black and Hispanic patients were younger than white patients, and were most likely to be allocated ventilators with the youngest-first system.
“The question is: What do we want to have happen, based on our ethical framework? We then need to determine if it actually did happen,” Parker says. “You can’t answer this question without empirical data.”
Some ethicists have suggested subtracting points on SOFA scores for patients who live in certain ZIP codes to combat disparities.4 But exactly how many points should one subtract?
“Ethics, in general, needs a lot more empiricism,” Parker offers. “We should move beyond well-intentioned people writing down a score that seems OK to something that’s actually providing a mathematical realization of an ethical framework.”
Ethical principles and empirical data are needed, and not just in cases of scarce resource allocation. More routinely, empirical data and ethics are used to address questions on risks and benefits of a procedure.
“This type of work could be extended to any scarce resource, and should be,” Parker says. “To just ignore resource scarcity or cost — all the things that ethicists like to conveniently forget exist — you can’t do that anymore.”
Crisis standards of care were used to make difficult tradeoffs during the pandemic. “But it’s a mistake to say that nothing like this has ever happened in the history of bioethics,” Parker argues.
One example is the ongoing debate on how to take ethical principles and translate them into a ranking system for allocation of organs. “The marriage of ethical principles and empirical data is really important. The protocol doesn’t get derived just from ethical principles. You need to reference empirical data,” Parker says. “If you are the empiricist developing the protocol, you need to understand the ethics.”
The same is true for efforts to address inequities. It is one thing to say SOFA-based systems will disadvantage Black patients who tend to produce higher SOFA scores. “But it’s another thing to prove that with data,” Parker says. “To really put the meat on the bone with inequities, you need empirical data.”
- Institute of Medicine of the National Academies. Crisis Standards of Care: Summary of a Workshop Series. 2010.
- Piscitello GM, Kapania EM, Miller WD, et al. Variation in ventilator allocation guidelines by US state during the coronavirus disease 2019 pandemic: A systematic review. JAMA Netw Open 2020;3:e2012606.
- Bhavani SV, Luo Y, Miller WD, et al. Simulation of ventilator allocation in critically ill patients with COVID-19. Am J Respir Crit Care Med 2021; Sep 9. doi: 10.1164/rccm.202106-1453LE.
- White DB, Lo B. Mitigating inequities and saving lives with ICU triage during the COVID-19 pandemic. Am J Respir Crit Care Med 2021;203:287-295.
The combination of ethical principles and empirical data is critical. The protocol is not derived only from ethical principles. The empiricist developing the protocol must understand the ethics.
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