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COVID Ethical Issues
Michael Aref, MD, PhD, FACP, FHM, FAAHPM, HMDC
Introduction
Disclosures · Objective · Background
Disclosures
• I have no financial disclosures.
• Opinions (and there is always opinion) expressed in this presentation
are my own and I cannot verify with certainty whether or not they
reflect the views of my employers or organization.
Objectives
• Overview ethical decision making models.
• Survey ethical issues in the COVID-19 pandemic.
• Compare and contrast clinical and public health ethics approaches.
• Discuss the concept of ethical resource allocation.
Infectious History
• Germ Theory was postulated by
Louis Pasteur in 1857.
• The first virus was discovered 1892.
• Viral vaccinations preceded the
discovery of viruses!
• The first antiviral medication,
amantadine, was discovered in
1966.
• 2005-2012 AIDS Pandemic – 36
million deaths
• 1968 H3N2 Influenza Pandemic – 1
million deaths
• 1956-1958 H2N2 Influenza
Pandemic – 2 million deaths
• 1918-1920 Influenza Pandemic –
20-50 million deaths
• 1910-1911 6th Cholera Pandemic –
800,000 deaths
• 1889-1890 H3N8 Influenza
Pandemic – 1 million deaths
www.mphonline.org/worst-pandemics-in-history/
Ethics
Background · Framework · Analysis
Ethics Morals
What are they? The rules of conduct recognized in respect to
a particular class of human actions or a
particular group or culture.
Principles or habits with respect to right or
wrong conduct. While morals also prescribe dos
and don'ts, morality is ultimately a personal
compass of right and wrong.
Where do they come from? Social system - External Individual - Internal
Why we do it? Because society says it is the right thing to do. Because we believe in something being right or
wrong.
Flexibility Ethics are dependent on others for definition.
They tend to be consistent within a certain
context, but can vary between contexts.
Usually consistent, although can change if an
individual’s beliefs change.
The "Gray" A person strictly following Ethical Principles
may not have any Morals at all. Likewise, one
could violate Ethical Principles within a given
system of rules in order to maintain Moral
integrity.
A Moral Person although perhaps bound by a
higher covenant, may choose to follow a code of
ethics as it would apply to a system. "Make it fit"
Origin Greek word "ethos" meaning "character" Latin word "mos" meaning "custom"
Acceptability Ethics are governed by professional and legal
guidelines within a particular time and place
Morality transcends cultural norms
www.diffen.com/difference/Ethics_vs_Morals
Bioethical Methods of Analysis
• Principle Based (Principlism)
• Utilizes widely accepted norms of moral agency (the ability of an individual to make judgments of right and wrong) to
identify ethical concerns and determine acceptable resolutions for clinical dilemmas.
• Narrative Ethics
• Uses the nuances and complexities of stories (the narrative sequence), to identify and evaluate ethical dimensions of
situations.
• Virtue Ethics
• Believes that good medical practice requires a virtuous health care provider and the ultimate aim of medicine is the good of
the patient.
• Casuistry (The “Four Boxes”)
• A case-based approach to ethical decision making sharing many features with medical and legal decision making.
Appropriate actions depend on the specific features of a case.
• Religious/Theological Ethics
• Uses religious doctrine for norms of moral agency to identify ethical concerns and determine resolution for ethical
dilemmas.
• Feminist Ethics
• Highlights the potential power differentials that may exist between individuals due to professional standing, gender, race,
language, disability, etc. which can create barriers in the delivery of safe, effective medical care.
www.augusta.edu/institutes/ipph/cbhp/documents/primer_5_1_ethicsinhc.pdf
Principlist Bioethics
Casuistry (The “Four Boxes”)
Medical Indications Preferences of Patients
Beneficence and Non-maleficence
1. What is the patient’s medical problem?
2. Is the problem acute? Chronic? Critical? Reversible? Emergent? Terminal?
3. What are the goals of treatment?
4. In what circumstances are medical treatments not indicated?
5. What are the probabilities of success of various treatment options?
6. What are the risks of treatment?
7. In sum, how can this patient be benefited by medical, nursing or therapy care, and how can
harm be avoided?
Respect for Autonomy
1. Is the patient unwilling or unable to cooperate with medical treatment? If so, why?
2. Has the patient been informed of benefits and risks of diagnostic and treatment
recommendations, understood this information, and communicated consent?
3. Is the patient mentally capable (decision making capacity) and legally competent?
4. If mentally capable/competent, what are the patient’s preferences?
5. If incapacitated, has the patient expressed prior preferences?
6. Who is the appropriate surrogate to make decisions for an incapacitated patient?
7. What standards should govern the surrogate’s decisions?
Quality of Life Contextual Features
Beneficence and Non-maleficence and Respect for Autonomy
1. What are the prospects, with or without treatment, for a return to an acceptable quality of
life and what physical, mental, and social deficits might the patient experience even if
treatment succeeds?
2. On what grounds or by what criteria should evaluate the quality of life of a patient who
cannot make or express such a judgment?
3. Are there biases that might prejudice the provider’s evaluation of the patient’s quality of
life?
4. What ethical issues arise concerning improving or enhancing a patient’s quality of life?
5. Do quality of life assessment raise any questions that might contribute to a change of
treatment plan, such as forgoing life-sustaining treatment?
6. Are there plans to provide pain relief and provide comfort after a decision has been made to
forgo life-sustaining interventions?
7. Is medically assisted dying ethically or legally permissible?
Justice
1. Do decisions about treatment and diagnosis raise issues of fairness?
2. Are there professional, interprofessional, personal, interpersonal or business interests that
might create conflicts of interest in the clinical treatment of patients?
3. Are there parties other than clinicians and patient, such as family members, who have a
legitimate interest in clinical decisions?
4. What are the limits imposed on patient confidentiality by the legitimate interests of third
parties?
5. Are there financial factors that create conflicts of interest in clinical decisions?
6. Are there problems of allocation of resources that affect clinical decisions?
7. Are there religious factors that might influence clinical decisions?
8. What are the legal issues that might affect clinical decisions?
9. Are there considerations of clinical research and medical education that affect clinical
decisions?
10. Are there considerations of public heath and safety that influence clinical decisions? Does
institutional affiliation create conflicts of interest that might influence clinical decisions?
Clinical Ethics versus Public Health Ethics
Duty of Care
Recognize moral equality of persons
Promote equity in distribution of risks and benefits
www.thehastingscenter.org/wp-content/uploads/SlideDeck-HECCEC-COVID-19-Readiness.pdf
Case #1
Visitor Restrictions
Case #1: Visitor Restrictions
• Healthcare facilities across the country have imposed visitor
restrictions during the SARS-CoV-2 pandemic that either greatly limit
or completely eliminate visitor access. Is this ethical?
Case #1: Visitor Restrictions
Medical Indications Preferences of Patients
Quality of Life Contextual Features
Case #1: Visitor Restrictions
Medical Indications Preferences of Patients
“Social distancing” has shown to decrease
transmission of SARS-CoV-2
Proper facemask usage decreases spread of SARS-CoV-
2
Patients would likely prefer visitors and avoid SARS-
CoV-2 infection.
Quality of Life Contextual Features
Immediate quality of life is likely decreased with the
limitation of visitors. Overall quality of life for patients
in a healthcare system is likely improved with a
“flatter” curve. Long-term isolation is having a
negative quality of life impact. Compassionate care
waivers that allow more visitors at the end-of-life
raises questions whether patients are electing comfort
focused care to see family or because they are
accepting that death is a preferable outcome to more
treatment.
SARS-CoV-2 is in community spread which has the
assumption everyone is transmitting the virus. WHO
and CDC are both advocating for mask use and social
distancing as a strategy to mitigate transmission.
We are seeing increasing morbidity and mortality in
patients who do not have bedside advocates.
Case #2
Goals of Care
Case #2: Goals of Care
• Is it ethically appropriate to engage in goals of care conversations
with patients prior to presentation with symptoms of COVID-19?
Case #2: Goals of Care
Medical Indications Preferences of Patients
Quality of Life Contextual Features
Case #2: Goals of Care
Medical Indications Preferences of Patients
This diagnosis, like many illnesses, has a much poorer
prognosis as we age and our immune systems wane,
approximately 1/6 hospitalized patients die, nearly
100% do not survive in-patient cardiac arrest. If placed
on mechanical ventilation it is likely prolonged, e.g.
weeks. Advance care planning with someone older
than 65 or someone who has COPD, heart failure,
and/or chronic kidney disease stage 3B or worse, is
likely indicated in context that this is a new piece of
clinical information that changes the future for all of
us.
Goals of care discussions are the only way to
determine patient preferences. However, it is
important to ask permission to engage in these
conversations. Of note, there are patients who will
wish to live as long as they can but do not want to be
admitted to the hospital should they develop
respiratory failure from infection.
Quality of Life Contextual Features
Patients have generally reported improved quality of
life after goals of care conversations as this helps them
understand they may have less time than they
expected and may motivate them to complete things
on their “bucket list.”
Goals of care conversations are indicated whenever
there is an expected or new clinical change that may
make previous statements inaccurate or irrelevant.
Case #3
Code Status and Novel Coronavirus
Case #3: Code Status and Novel Coronavirus
• Across the country there have been discussions regarding the
appropriateness of ACLS in COVID-19 patients.
Case #3: Code Status and Novel Coronavirus
Medical Indications Preferences of Patients
Quality of Life Contextual Features
Case #3: Code Status and Novel Coronavirus
Medical Indications Preferences of Patients
Patients in cardiopulmonary arrest must have
treatment whether it is (a) focused on trying to
correct arrest with appropriate disease-focused
interventions or (b) focused on comfort to allow
natural death. ACLS does not have to be initiated in
cases where it will not benefit the patient, e.g.
decapitation, rigor mortis, or even refractory shock.
Must be established prior to arrest usually as reflected
by previous advance care planning or by direction
given by healthcare surrogates.
Quality of Life Contextual Features
Return of spontaneous circulation in cardiopulmonary
arrest particularly with chronic, life-limiting
comorbidities is associated with decreased functional
baseline, increased chronic comorbidity burden,
increased symptom burden, and decreased
independence.
Both intubation and advance cardiac life support have
increased risk of transmission of SARS-CoV-2 to both
responding providers (via direct transmission) but also
to other patients (via both direct and indirect
transmission). Infected healthcare providers are
removed from the healthcare workforce decreasing
ability to care for increasing volume of patients.
Case #4
COVID-19 Vaccine
Case #4: COVID-19 Vaccine
• Emergency use authorization (EUA) for two SARS-CoV-2 vaccines have
been granted. They provide approximately 50% protection after the
first dose and over 90% protection after the second. Should
vaccination be mandated?
Case #4: COVID-19 Vaccine
Medical Indications Preferences of Patients
Quality of Life Contextual Features
Case #4: COVID-19 Vaccine
Medical Indications Preferences of Patients
The SARS-CoV-2 vaccine is effective with minimal
short-term adverse effects. No data on long-term
effects.
People don’t want COVID for any number of reasons.
Some people deny that COVID is a problem and
believe that fear around COVID is a greater issue.
Historically “religious and philosophical” objections to
vaccines have been honored by both private and
public institutions.
Quality of Life Contextual Features
Both doses of the vaccine induce flu-like symptoms.
Getting four shots every 12-18 months is challenging
for individuals but is achievable logistically. Peace of
mind of decreased risks to you and your loved ones.
Nothing changes without herd immunity, the more
people vaccinated the closer we get toward normal
and the less strain we place on the healthcare system.
Vaccine-induced herd immunity ONLY occurs if
between 70-80% of the population is vaccinated. The
vaccine, at this time, is only effective for 6-9 months
and only indicated for 16 years and older.
Resource Allocation
When Patients > Resources
inkvessel.com/2020/03/18/palliative-care-in-the-time-of-covid/
Organ Transplantation
• The classical ethical dilemma of too many patients with too few resources
occurs in organ transplantation: On average 17 people die per day due to
limitations on available organ allocation.
• Individual institutions determine who is “active” on their transplant list
through an organ allocation board composed of members of the transplant
team. Thus decisions are based on criteria as agreed upon by the
transplant board.
• Using the combination of donor and candidate information, the UNOS
computer system generates a “match run,” a rank-order list of candidates
to be offered each organ. This match is unique to each donor and each
organ. The candidates who will appear highest in the ranking are those
who are in most urgent need of the transplant, and/or those most likely to
have the best chance of survival if transplanted.
optn.transplant.hrsa.gov/learn/about-transplantation/how-organ-allocation-works/
unos.org/transplant/how-we-match-organs/
Chronic US National Drug Shortages
Chronic US National Drug Shortages
• US drug shortages are a chronic issue at baseline, only to be
exacerbated by insults to the supply chain like Hurricane Maria
destroying factories in Puerto Rico or our current pandemic leading to
supply shortages.
• These shortages direct care everyday by changing medical
management to use alternatives that may not be as effective as the
originally ordered medication.
Staffing Shortages
• It is estimated at there is 1,200 patients with life-limiting illness for
each specialty palliative care provider.
• By comparison there are 141 cancer patients per oncologist.
• It is estimated that 30% of hospital patients “need” a palliative care
consult:
• At Carle Foundation Hospital that would be a 120 patient service, currently
we see about 30 in-patients per day.
• There a staffing shortages for techs, nurses, respiratory therapists,
and other specialties…everyday.
www.capc.org/about/press-media/press-releases/2016-9-9/Hospital-Palliative-Care-Programs-Understaffed/
www.ajmc.com/journals/evidence-based-oncology/2015/april-2015/how-and-why-oncologists-should-do-palliative-careor-get-some-assistance-doing-it-
Disparities in Care
• If you are upper class, heterosexual, white, male you have a better
morbidity or mortality than someone
Lower class
Homosexual
Non-white
Female
• Due to implicit biases within the healthcare system.
Disparities in Care
Rubix Life Sciences, COVID-19 and Minority Health Access, Infectious Disease Insights, March, 2020
Disparities in Care
Health Affairs 39(7); 2020: 1253–1262
Adjusted odds of hospital admission among confirmed COVID-19 cases in California, 2020
Date of download: 12/16/2020
From: Racial Disparities in Incidence and Outcomes Among Patients With COVID-19
JAMA Netw Open. 2020;3(9):e2021892. doi:10.1001/jamanetworkopen.2020.21892
Distribution of Coronavirus Disease 2019 (COVID-19) Cases Based on Socioeconomically Disadvantaged Zip Codes in Milwaukee,
WisconsinPatient postal codes were mapped using blur and jitter to maintain confidentiality and were categorized based on COVID-
19 test results. Socially disadvantaged areas are defined as those 9-digit zip codes with a score of 7 or higher in the Area
Deprivation Index. Map created using Excel 2016 3D Maps (Microsoft Corp).
Figure Legend:
Changing Personal Protective Equipment
(PPE) Recommendations
• Recommendations regarding use of PPE are excessively fluid. Three
weeks ago the proper use of an N95 was use once and dispose. This
week I could reuse it multiple times and handkerchiefs suddenly
became approved PPE. It’s the same virus but different rules, is it
ethical to expect me to do this?
Changing PPE Recommendations
• Conventional capacity
• Measures consist of providing patient care without any change in daily contemporary
practices. This set of measures, consisting of engineering, administrative, and PPE
controls should already be implemented in general infection prevention and control
plans in healthcare settings.
• Contingency capacity
• Measures may change daily standard practices but may not have any significant
impact on the care delivered to the patient or the safety of HCP. These practices may
be used temporarily during periods of expected N95 respirator shortages.
• Crisis capacity
• Strategies that are not commensurate with U.S. standards of care. These measures,
or a combination of these measures, may need to be considered during periods of
known N95 respirator shortages.
Triage
To Pick or Cull
Triage comes from an Old French word for “to
pick or cull”
Ethical Processes During a Disaster
Value Description
Accountability There should be mechanisms in place to ensure that ethical decision making is sustained throughout
the crisis.
Inclusiveness Decisions should be made explicitly with stakeholder views in mind and there should be opportunities
for stakeholders to be engaged in the decision-making process. For example, decision making related to
staff deployment should include the input of affected staff.
Openness and
transparency
Decisions should be publicly defensible. This means that the process by which decisions were
made must be open to scrutiny and the basis upon which decisions are made should be publicly
accessible to affected stakeholders. For example, there should be a communication plan developed in
advance to ensure that information can be effectively disseminated to affected stakeholders and that
stakeholders know where to go for needed information.
Reasonableness Decisions should be based on reasons (ie, evidence, principles, values) that stakeholders can agree are
relevant to meeting healthcare needs in a pandemic influenza crisis, and they
should be made by people who are credible and accountable. For example, decision makers should
provide a rationale for prioritizing particular groups for antiviral medication and for limiting access to
elective surgeries and other services.
Responsiveness There should be opportunities to revisit and revise decisions as new information emerges throughout
the crisis, as well as mechanisms to address disputes and complaints. For example, if elective surgeries
are cancelled or postponed, there should be a formal mechanism for stakeholders to voice any
concerns they may have with the decision.
Farmer JC et al. Preparing Your ICU For Disaster Response, Society of Critical Care Medicine, 2012
Resources Capacity (Operational Quality)
Stuff
Conservation
and use of
alternative
medications
Emergency
stockpiles
accessed
Reuse of critical
supplies
authorized
Triage protocols
activated
Supplies
unavailable or
unusable
Space
All usual beds
full / elective
discharges
All in-place and
reserve beds
activated and
filled
All facility areas
(e.g. hallways)
used and filled
Some areas
unsafe
Move patients
Infrastructure
destroyed
Staff
Reserve staff
needed
External staff
needed
Staff must
perform atypical
tasks
Lay volunteers
must perform
key aspects of
care
Few or no staff
available
Usual
operational
quality
“Conventional
operations”
Minimal or
transiently
degraded
quality
“Contingency
operations”
Modest or brief
degraded
quality
“Crisis
operations”
Significant or
ongoing
degraded
quality
Catastrophic
system failure
No care possible
www.thehastingscenter.org/wp-content/uploads/SlideDeck-HECCEC-COVID-19-Readiness.pdf
ICU Triage Protocol: Inclusion and Exclusion
Inclusion
• Shock requiring vasopressor
support
• Respiratory failure requiring
invasive positive pressure
ventilation
Exclusion
• Severe trauma
• Severe burns
• Cardiac arrest
• Advanced untreatable neuromuscular
disease
• Metastatic malignant disease
• Advanced and irreversible
immunocompromise
• Severe and irreversible neurologic event
or condition
• End-stage organ failure
CMAJ, November, 2006; 175(11):1377-1381
ICU Triage Protocol: Prioritization
Triage Code Criteria Action
Blue Exclusion criteria met or Sequential Organ Failure
Assessment (SOFA) score > 11
• Provide comfort focused care
• Discharge from critical care
Red SOFA score < 8 or single-organ failure Highest priority
Yellow SOFA score 8–11 Intermediate priority
Green No significant organ failure • Defer or discharge
• Reassess as needed
CMAJ, November, 2006; 175(11):1377-1381
Triage Process
• In the event of needing to triage resources, it cannot be expected that
a clinical individual at the bedside make these decisions.
• A committee of stakeholders needs to establish the criteria for when
to initiate and cease triaging resources.
• This triage protocol needs to be evidenced-based but adjustable with
changing clinical conditions.
• The triage decision making is performed by an independent allocation
committee, this allows the bedside provider to give the best care to
the patient as we are able in a crisis.
Case #5
Triage For Severe Rather Than Critical Illness
Triage Process
• In the event of needing to triage resources, it cannot be expected that
a clinical individual at the bedside make these decisions.
• A committee of stakeholders needs to establish the criteria for when
to initiate and cease triaging resources.
• This triage protocol needs to be evidenced-based but adjustable
with changing clinical conditions.
• The triage decision making is performed by an independent allocation
committee, this allows the bedside provider to give the best care to
the patient as we are able in a crisis.
Case #5: Triage For Severe Rather Than
Critical Illness
• Frameworks around triage for disasters such as pandemics have
largely been theoretical and focused on “ICU beds” and “mechanical
ventilation.”
• We are finding that we are running short on med/surg beds, Optiflow,
and hemodialysis machines, that is, capacity can be filled with severe
rather than critically ill patients.
• Outside the pandemic this happens routinely, but there is a safety net
as some, not all hospitals are at capacity.
Case #5: Triage For Severe Rather Than
Critical Illness
Medical Indications Preferences of Patients
Quality of Life Contextual Features
Case #5: Triage For Severe Rather Than
Critical Illness
Medical Indications Preferences of Patients
Patients with severe illness will benefit from
hospitalization likely for both quantity and quality of
life. The intent of hospitalizing these patients is that
their morbidity and mortality if they were not
admitted.
Most patients would prefer hospitalization if
indicated.
Quality of Life Contextual Features
Symptom relief by either disease-focused or
symptom-focused treatment that is more available in
the hospital.
Prognostication is more difficult when death is not
imminent, thus it is much harder to determine who
would NOT benefit from in-patient medical resources.
Using “first come, first serve” does not adequately
address this issue when capacity is being reached
across the region.
Conclusion
Like a kidney stone, this too shall pass
From Horror Springs Hope
• In a pandemic without the ability to treat, public health saves more
lives than clinical care. W
• Why aren’t more clinicians engaged in public health?
• There is a need for clinicians at all levels of administration, local, state
and federal government.
• Why aren’t we there?
• Weaknesses, injustices, and ethical issues in our healthcare system
are not necessarily caused by crisis rather they are exposed by it.
• Now that these problems are exposed, what are we going to do
about it?
Thank You
Questions? Comments? Concerns?

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COVID Ethical Issues

  • 1. COVID Ethical Issues Michael Aref, MD, PhD, FACP, FHM, FAAHPM, HMDC
  • 3. Disclosures • I have no financial disclosures. • Opinions (and there is always opinion) expressed in this presentation are my own and I cannot verify with certainty whether or not they reflect the views of my employers or organization.
  • 4. Objectives • Overview ethical decision making models. • Survey ethical issues in the COVID-19 pandemic. • Compare and contrast clinical and public health ethics approaches. • Discuss the concept of ethical resource allocation.
  • 5. Infectious History • Germ Theory was postulated by Louis Pasteur in 1857. • The first virus was discovered 1892. • Viral vaccinations preceded the discovery of viruses! • The first antiviral medication, amantadine, was discovered in 1966. • 2005-2012 AIDS Pandemic – 36 million deaths • 1968 H3N2 Influenza Pandemic – 1 million deaths • 1956-1958 H2N2 Influenza Pandemic – 2 million deaths • 1918-1920 Influenza Pandemic – 20-50 million deaths • 1910-1911 6th Cholera Pandemic – 800,000 deaths • 1889-1890 H3N8 Influenza Pandemic – 1 million deaths www.mphonline.org/worst-pandemics-in-history/
  • 7. Ethics Morals What are they? The rules of conduct recognized in respect to a particular class of human actions or a particular group or culture. Principles or habits with respect to right or wrong conduct. While morals also prescribe dos and don'ts, morality is ultimately a personal compass of right and wrong. Where do they come from? Social system - External Individual - Internal Why we do it? Because society says it is the right thing to do. Because we believe in something being right or wrong. Flexibility Ethics are dependent on others for definition. They tend to be consistent within a certain context, but can vary between contexts. Usually consistent, although can change if an individual’s beliefs change. The "Gray" A person strictly following Ethical Principles may not have any Morals at all. Likewise, one could violate Ethical Principles within a given system of rules in order to maintain Moral integrity. A Moral Person although perhaps bound by a higher covenant, may choose to follow a code of ethics as it would apply to a system. "Make it fit" Origin Greek word "ethos" meaning "character" Latin word "mos" meaning "custom" Acceptability Ethics are governed by professional and legal guidelines within a particular time and place Morality transcends cultural norms www.diffen.com/difference/Ethics_vs_Morals
  • 8. Bioethical Methods of Analysis • Principle Based (Principlism) • Utilizes widely accepted norms of moral agency (the ability of an individual to make judgments of right and wrong) to identify ethical concerns and determine acceptable resolutions for clinical dilemmas. • Narrative Ethics • Uses the nuances and complexities of stories (the narrative sequence), to identify and evaluate ethical dimensions of situations. • Virtue Ethics • Believes that good medical practice requires a virtuous health care provider and the ultimate aim of medicine is the good of the patient. • Casuistry (The “Four Boxes”) • A case-based approach to ethical decision making sharing many features with medical and legal decision making. Appropriate actions depend on the specific features of a case. • Religious/Theological Ethics • Uses religious doctrine for norms of moral agency to identify ethical concerns and determine resolution for ethical dilemmas. • Feminist Ethics • Highlights the potential power differentials that may exist between individuals due to professional standing, gender, race, language, disability, etc. which can create barriers in the delivery of safe, effective medical care. www.augusta.edu/institutes/ipph/cbhp/documents/primer_5_1_ethicsinhc.pdf
  • 10. Casuistry (The “Four Boxes”) Medical Indications Preferences of Patients Beneficence and Non-maleficence 1. What is the patient’s medical problem? 2. Is the problem acute? Chronic? Critical? Reversible? Emergent? Terminal? 3. What are the goals of treatment? 4. In what circumstances are medical treatments not indicated? 5. What are the probabilities of success of various treatment options? 6. What are the risks of treatment? 7. In sum, how can this patient be benefited by medical, nursing or therapy care, and how can harm be avoided? Respect for Autonomy 1. Is the patient unwilling or unable to cooperate with medical treatment? If so, why? 2. Has the patient been informed of benefits and risks of diagnostic and treatment recommendations, understood this information, and communicated consent? 3. Is the patient mentally capable (decision making capacity) and legally competent? 4. If mentally capable/competent, what are the patient’s preferences? 5. If incapacitated, has the patient expressed prior preferences? 6. Who is the appropriate surrogate to make decisions for an incapacitated patient? 7. What standards should govern the surrogate’s decisions? Quality of Life Contextual Features Beneficence and Non-maleficence and Respect for Autonomy 1. What are the prospects, with or without treatment, for a return to an acceptable quality of life and what physical, mental, and social deficits might the patient experience even if treatment succeeds? 2. On what grounds or by what criteria should evaluate the quality of life of a patient who cannot make or express such a judgment? 3. Are there biases that might prejudice the provider’s evaluation of the patient’s quality of life? 4. What ethical issues arise concerning improving or enhancing a patient’s quality of life? 5. Do quality of life assessment raise any questions that might contribute to a change of treatment plan, such as forgoing life-sustaining treatment? 6. Are there plans to provide pain relief and provide comfort after a decision has been made to forgo life-sustaining interventions? 7. Is medically assisted dying ethically or legally permissible? Justice 1. Do decisions about treatment and diagnosis raise issues of fairness? 2. Are there professional, interprofessional, personal, interpersonal or business interests that might create conflicts of interest in the clinical treatment of patients? 3. Are there parties other than clinicians and patient, such as family members, who have a legitimate interest in clinical decisions? 4. What are the limits imposed on patient confidentiality by the legitimate interests of third parties? 5. Are there financial factors that create conflicts of interest in clinical decisions? 6. Are there problems of allocation of resources that affect clinical decisions? 7. Are there religious factors that might influence clinical decisions? 8. What are the legal issues that might affect clinical decisions? 9. Are there considerations of clinical research and medical education that affect clinical decisions? 10. Are there considerations of public heath and safety that influence clinical decisions? Does institutional affiliation create conflicts of interest that might influence clinical decisions?
  • 11. Clinical Ethics versus Public Health Ethics Duty of Care Recognize moral equality of persons Promote equity in distribution of risks and benefits www.thehastingscenter.org/wp-content/uploads/SlideDeck-HECCEC-COVID-19-Readiness.pdf
  • 13. Case #1: Visitor Restrictions • Healthcare facilities across the country have imposed visitor restrictions during the SARS-CoV-2 pandemic that either greatly limit or completely eliminate visitor access. Is this ethical?
  • 14. Case #1: Visitor Restrictions Medical Indications Preferences of Patients Quality of Life Contextual Features
  • 15. Case #1: Visitor Restrictions Medical Indications Preferences of Patients “Social distancing” has shown to decrease transmission of SARS-CoV-2 Proper facemask usage decreases spread of SARS-CoV- 2 Patients would likely prefer visitors and avoid SARS- CoV-2 infection. Quality of Life Contextual Features Immediate quality of life is likely decreased with the limitation of visitors. Overall quality of life for patients in a healthcare system is likely improved with a “flatter” curve. Long-term isolation is having a negative quality of life impact. Compassionate care waivers that allow more visitors at the end-of-life raises questions whether patients are electing comfort focused care to see family or because they are accepting that death is a preferable outcome to more treatment. SARS-CoV-2 is in community spread which has the assumption everyone is transmitting the virus. WHO and CDC are both advocating for mask use and social distancing as a strategy to mitigate transmission. We are seeing increasing morbidity and mortality in patients who do not have bedside advocates.
  • 17. Case #2: Goals of Care • Is it ethically appropriate to engage in goals of care conversations with patients prior to presentation with symptoms of COVID-19?
  • 18. Case #2: Goals of Care Medical Indications Preferences of Patients Quality of Life Contextual Features
  • 19. Case #2: Goals of Care Medical Indications Preferences of Patients This diagnosis, like many illnesses, has a much poorer prognosis as we age and our immune systems wane, approximately 1/6 hospitalized patients die, nearly 100% do not survive in-patient cardiac arrest. If placed on mechanical ventilation it is likely prolonged, e.g. weeks. Advance care planning with someone older than 65 or someone who has COPD, heart failure, and/or chronic kidney disease stage 3B or worse, is likely indicated in context that this is a new piece of clinical information that changes the future for all of us. Goals of care discussions are the only way to determine patient preferences. However, it is important to ask permission to engage in these conversations. Of note, there are patients who will wish to live as long as they can but do not want to be admitted to the hospital should they develop respiratory failure from infection. Quality of Life Contextual Features Patients have generally reported improved quality of life after goals of care conversations as this helps them understand they may have less time than they expected and may motivate them to complete things on their “bucket list.” Goals of care conversations are indicated whenever there is an expected or new clinical change that may make previous statements inaccurate or irrelevant.
  • 20. Case #3 Code Status and Novel Coronavirus
  • 21. Case #3: Code Status and Novel Coronavirus • Across the country there have been discussions regarding the appropriateness of ACLS in COVID-19 patients.
  • 22. Case #3: Code Status and Novel Coronavirus Medical Indications Preferences of Patients Quality of Life Contextual Features
  • 23. Case #3: Code Status and Novel Coronavirus Medical Indications Preferences of Patients Patients in cardiopulmonary arrest must have treatment whether it is (a) focused on trying to correct arrest with appropriate disease-focused interventions or (b) focused on comfort to allow natural death. ACLS does not have to be initiated in cases where it will not benefit the patient, e.g. decapitation, rigor mortis, or even refractory shock. Must be established prior to arrest usually as reflected by previous advance care planning or by direction given by healthcare surrogates. Quality of Life Contextual Features Return of spontaneous circulation in cardiopulmonary arrest particularly with chronic, life-limiting comorbidities is associated with decreased functional baseline, increased chronic comorbidity burden, increased symptom burden, and decreased independence. Both intubation and advance cardiac life support have increased risk of transmission of SARS-CoV-2 to both responding providers (via direct transmission) but also to other patients (via both direct and indirect transmission). Infected healthcare providers are removed from the healthcare workforce decreasing ability to care for increasing volume of patients.
  • 25. Case #4: COVID-19 Vaccine • Emergency use authorization (EUA) for two SARS-CoV-2 vaccines have been granted. They provide approximately 50% protection after the first dose and over 90% protection after the second. Should vaccination be mandated?
  • 26.
  • 27. Case #4: COVID-19 Vaccine Medical Indications Preferences of Patients Quality of Life Contextual Features
  • 28. Case #4: COVID-19 Vaccine Medical Indications Preferences of Patients The SARS-CoV-2 vaccine is effective with minimal short-term adverse effects. No data on long-term effects. People don’t want COVID for any number of reasons. Some people deny that COVID is a problem and believe that fear around COVID is a greater issue. Historically “religious and philosophical” objections to vaccines have been honored by both private and public institutions. Quality of Life Contextual Features Both doses of the vaccine induce flu-like symptoms. Getting four shots every 12-18 months is challenging for individuals but is achievable logistically. Peace of mind of decreased risks to you and your loved ones. Nothing changes without herd immunity, the more people vaccinated the closer we get toward normal and the less strain we place on the healthcare system. Vaccine-induced herd immunity ONLY occurs if between 70-80% of the population is vaccinated. The vaccine, at this time, is only effective for 6-9 months and only indicated for 16 years and older.
  • 31. Organ Transplantation • The classical ethical dilemma of too many patients with too few resources occurs in organ transplantation: On average 17 people die per day due to limitations on available organ allocation. • Individual institutions determine who is “active” on their transplant list through an organ allocation board composed of members of the transplant team. Thus decisions are based on criteria as agreed upon by the transplant board. • Using the combination of donor and candidate information, the UNOS computer system generates a “match run,” a rank-order list of candidates to be offered each organ. This match is unique to each donor and each organ. The candidates who will appear highest in the ranking are those who are in most urgent need of the transplant, and/or those most likely to have the best chance of survival if transplanted. optn.transplant.hrsa.gov/learn/about-transplantation/how-organ-allocation-works/ unos.org/transplant/how-we-match-organs/
  • 32. Chronic US National Drug Shortages
  • 33. Chronic US National Drug Shortages • US drug shortages are a chronic issue at baseline, only to be exacerbated by insults to the supply chain like Hurricane Maria destroying factories in Puerto Rico or our current pandemic leading to supply shortages. • These shortages direct care everyday by changing medical management to use alternatives that may not be as effective as the originally ordered medication.
  • 34. Staffing Shortages • It is estimated at there is 1,200 patients with life-limiting illness for each specialty palliative care provider. • By comparison there are 141 cancer patients per oncologist. • It is estimated that 30% of hospital patients “need” a palliative care consult: • At Carle Foundation Hospital that would be a 120 patient service, currently we see about 30 in-patients per day. • There a staffing shortages for techs, nurses, respiratory therapists, and other specialties…everyday. www.capc.org/about/press-media/press-releases/2016-9-9/Hospital-Palliative-Care-Programs-Understaffed/ www.ajmc.com/journals/evidence-based-oncology/2015/april-2015/how-and-why-oncologists-should-do-palliative-careor-get-some-assistance-doing-it-
  • 35. Disparities in Care • If you are upper class, heterosexual, white, male you have a better morbidity or mortality than someone Lower class Homosexual Non-white Female • Due to implicit biases within the healthcare system.
  • 36. Disparities in Care Rubix Life Sciences, COVID-19 and Minority Health Access, Infectious Disease Insights, March, 2020
  • 37. Disparities in Care Health Affairs 39(7); 2020: 1253–1262 Adjusted odds of hospital admission among confirmed COVID-19 cases in California, 2020
  • 38. Date of download: 12/16/2020 From: Racial Disparities in Incidence and Outcomes Among Patients With COVID-19 JAMA Netw Open. 2020;3(9):e2021892. doi:10.1001/jamanetworkopen.2020.21892 Distribution of Coronavirus Disease 2019 (COVID-19) Cases Based on Socioeconomically Disadvantaged Zip Codes in Milwaukee, WisconsinPatient postal codes were mapped using blur and jitter to maintain confidentiality and were categorized based on COVID- 19 test results. Socially disadvantaged areas are defined as those 9-digit zip codes with a score of 7 or higher in the Area Deprivation Index. Map created using Excel 2016 3D Maps (Microsoft Corp). Figure Legend:
  • 39. Changing Personal Protective Equipment (PPE) Recommendations • Recommendations regarding use of PPE are excessively fluid. Three weeks ago the proper use of an N95 was use once and dispose. This week I could reuse it multiple times and handkerchiefs suddenly became approved PPE. It’s the same virus but different rules, is it ethical to expect me to do this?
  • 40. Changing PPE Recommendations • Conventional capacity • Measures consist of providing patient care without any change in daily contemporary practices. This set of measures, consisting of engineering, administrative, and PPE controls should already be implemented in general infection prevention and control plans in healthcare settings. • Contingency capacity • Measures may change daily standard practices but may not have any significant impact on the care delivered to the patient or the safety of HCP. These practices may be used temporarily during periods of expected N95 respirator shortages. • Crisis capacity • Strategies that are not commensurate with U.S. standards of care. These measures, or a combination of these measures, may need to be considered during periods of known N95 respirator shortages.
  • 42. Triage comes from an Old French word for “to pick or cull”
  • 43. Ethical Processes During a Disaster Value Description Accountability There should be mechanisms in place to ensure that ethical decision making is sustained throughout the crisis. Inclusiveness Decisions should be made explicitly with stakeholder views in mind and there should be opportunities for stakeholders to be engaged in the decision-making process. For example, decision making related to staff deployment should include the input of affected staff. Openness and transparency Decisions should be publicly defensible. This means that the process by which decisions were made must be open to scrutiny and the basis upon which decisions are made should be publicly accessible to affected stakeholders. For example, there should be a communication plan developed in advance to ensure that information can be effectively disseminated to affected stakeholders and that stakeholders know where to go for needed information. Reasonableness Decisions should be based on reasons (ie, evidence, principles, values) that stakeholders can agree are relevant to meeting healthcare needs in a pandemic influenza crisis, and they should be made by people who are credible and accountable. For example, decision makers should provide a rationale for prioritizing particular groups for antiviral medication and for limiting access to elective surgeries and other services. Responsiveness There should be opportunities to revisit and revise decisions as new information emerges throughout the crisis, as well as mechanisms to address disputes and complaints. For example, if elective surgeries are cancelled or postponed, there should be a formal mechanism for stakeholders to voice any concerns they may have with the decision. Farmer JC et al. Preparing Your ICU For Disaster Response, Society of Critical Care Medicine, 2012
  • 44. Resources Capacity (Operational Quality) Stuff Conservation and use of alternative medications Emergency stockpiles accessed Reuse of critical supplies authorized Triage protocols activated Supplies unavailable or unusable Space All usual beds full / elective discharges All in-place and reserve beds activated and filled All facility areas (e.g. hallways) used and filled Some areas unsafe Move patients Infrastructure destroyed Staff Reserve staff needed External staff needed Staff must perform atypical tasks Lay volunteers must perform key aspects of care Few or no staff available Usual operational quality “Conventional operations” Minimal or transiently degraded quality “Contingency operations” Modest or brief degraded quality “Crisis operations” Significant or ongoing degraded quality Catastrophic system failure No care possible www.thehastingscenter.org/wp-content/uploads/SlideDeck-HECCEC-COVID-19-Readiness.pdf
  • 45. ICU Triage Protocol: Inclusion and Exclusion Inclusion • Shock requiring vasopressor support • Respiratory failure requiring invasive positive pressure ventilation Exclusion • Severe trauma • Severe burns • Cardiac arrest • Advanced untreatable neuromuscular disease • Metastatic malignant disease • Advanced and irreversible immunocompromise • Severe and irreversible neurologic event or condition • End-stage organ failure CMAJ, November, 2006; 175(11):1377-1381
  • 46. ICU Triage Protocol: Prioritization Triage Code Criteria Action Blue Exclusion criteria met or Sequential Organ Failure Assessment (SOFA) score > 11 • Provide comfort focused care • Discharge from critical care Red SOFA score < 8 or single-organ failure Highest priority Yellow SOFA score 8–11 Intermediate priority Green No significant organ failure • Defer or discharge • Reassess as needed CMAJ, November, 2006; 175(11):1377-1381
  • 47. Triage Process • In the event of needing to triage resources, it cannot be expected that a clinical individual at the bedside make these decisions. • A committee of stakeholders needs to establish the criteria for when to initiate and cease triaging resources. • This triage protocol needs to be evidenced-based but adjustable with changing clinical conditions. • The triage decision making is performed by an independent allocation committee, this allows the bedside provider to give the best care to the patient as we are able in a crisis.
  • 48. Case #5 Triage For Severe Rather Than Critical Illness
  • 49. Triage Process • In the event of needing to triage resources, it cannot be expected that a clinical individual at the bedside make these decisions. • A committee of stakeholders needs to establish the criteria for when to initiate and cease triaging resources. • This triage protocol needs to be evidenced-based but adjustable with changing clinical conditions. • The triage decision making is performed by an independent allocation committee, this allows the bedside provider to give the best care to the patient as we are able in a crisis.
  • 50. Case #5: Triage For Severe Rather Than Critical Illness • Frameworks around triage for disasters such as pandemics have largely been theoretical and focused on “ICU beds” and “mechanical ventilation.” • We are finding that we are running short on med/surg beds, Optiflow, and hemodialysis machines, that is, capacity can be filled with severe rather than critically ill patients. • Outside the pandemic this happens routinely, but there is a safety net as some, not all hospitals are at capacity.
  • 51. Case #5: Triage For Severe Rather Than Critical Illness Medical Indications Preferences of Patients Quality of Life Contextual Features
  • 52. Case #5: Triage For Severe Rather Than Critical Illness Medical Indications Preferences of Patients Patients with severe illness will benefit from hospitalization likely for both quantity and quality of life. The intent of hospitalizing these patients is that their morbidity and mortality if they were not admitted. Most patients would prefer hospitalization if indicated. Quality of Life Contextual Features Symptom relief by either disease-focused or symptom-focused treatment that is more available in the hospital. Prognostication is more difficult when death is not imminent, thus it is much harder to determine who would NOT benefit from in-patient medical resources. Using “first come, first serve” does not adequately address this issue when capacity is being reached across the region.
  • 53. Conclusion Like a kidney stone, this too shall pass
  • 54. From Horror Springs Hope • In a pandemic without the ability to treat, public health saves more lives than clinical care. W • Why aren’t more clinicians engaged in public health? • There is a need for clinicians at all levels of administration, local, state and federal government. • Why aren’t we there? • Weaknesses, injustices, and ethical issues in our healthcare system are not necessarily caused by crisis rather they are exposed by it. • Now that these problems are exposed, what are we going to do about it?

Editor's Notes

  1. If this is our “Pearl Harbor” moment, what happened at the six other harbors in the last 130 years?