Download The delivery of futile care is harmful to other patients

The delivery of futile care is harmful to other patients
Michael S. Niederman, MD; Jeffrey T. Berger, MD
Objective: Intensive care units (ICUs) in different parts of the
world provide care to patients with advanced age and terminal
illness at different rates and in different patterns. In the United
States, ICU beds make up a disproportionate number of acute care
beds. Nearly half of all patients who die in U.S. hospitals have
received ICU, some of which may be futile. The objective of this
study was to examine ways in which the delivery of futile care in
the ICU can cause harm to patients other than those receiving the
futile care.
Design: Review of available studies of patient and family
attitudes about cardiopulmonary resuscitation and other supportive modalities, including antibiotic therapy, and the relationship of the delivery of such care to the outcomes of others
treated in the ICU.
Patients: Those treated in ICUs and those receiving futile care.
Measurements and Main Results: Compared with younger patients, the elderly in the United States use more ICU care, at higher
cost, have more serious comorbidities, and have a higher mortality rate. Certain populations demand ICU care more than others
and often with less benefit than less-demanding populations. In a
I
ntensive care units (ICUs) in different parts of the world provide
care to patients with advanced age
and terminal illness at different
rates and in different patterns. In the
United States, ICU beds make up a disproportionate number of acute care beds.
Nearly half of all patients who die in US
hospitals have received ICU care, some of
which may be futile.
The use of ICU care for the
elderly at the end of life
The elderly comprise a large percentage of patients treated in ICUs throughout the United States with patients ⬎65
From the Department of Medicine (MSN, JTB),
Division of Pulmonary and Critical Care Medicine
(MSN), and the Division of Geriatrics and Palliative
Medicine (JTB), Winthrop-University Hospital, Mineola,
NY; and and Department of Medicine (MSN, JTB),
SUNY at Stony Brook, Stony Brook, NY.
The authors have not disclosed any potential conflicts of interest.
For information regarding this article, E-mail:
[email protected]
Copyright © 2010 by the Society of Critical Care
Medicine and Lippincott Williams & Wilkins
DOI: 10.1097/CCM.0b013e3181f1cba5
S518
situation of unlimited resources, the provision of ICU care, even
when futile, has been viewed as an individual patient decision
with no harm to others within the hospital. However, even with
unlimited resources, the use of antibiotics for those who are
receiving futile care can be considered unethical by egalitarian
theory because it can lead to antibiotic resistance that may make
the treatment of other patients impossible. In the setting of
limited resources, like in pandemic influenza, or with the potential
limiting of resources, in a pay-for-performance environment, the
provision of futile care can also harm the hospital population as
a whole.
Conclusions: The delivery of futile care is not only an individual
patient decision, but must be viewed in a broader context. Societal awareness of this problem is necessary, and better scoring
systems to identify when ICU care has limited benefit are needed
to address these difficult and challenging realities. (Crit Care Med
2010; 38[Suppl.]:S518 –S522)
KEY WORDS: futile care; antibiotic use; antimicrobial resistance;
pay for performance; pandemic influenza; end-of-life care; elderly; scoring systems; nonmaleficence; egalitarian theory
yrs accounting for 50% of all ICU care,
although they constitute ⬍15% of the
population (1). In one study, those aged
⬎60 yrs used the ICU in 60% of hospital
admissions compared with 30% in those
⬍60 yrs (1). The highest admission rate
was in those aged 70 –79 yrs, but the
elderly had a higher mortality rate,
longer length of stay, and higher cost of
care than younger patients. Thus, the elderly consume a large amount of resources and present with some of the
most challenging and complex illnesses.
Currently, there is no clear consensus
about how to best allocate critical care
resources to this population. Practices
vary widely in different countries, but the
focus of this discussion is the premise
that the use of resources for elderly individuals can impact on the outcome and
care of other populations. This becomes a
particular problem when we provide futile care, a prospect that often arises in
the elderly, particularly with the use of
antibiotic therapy for patients with no
meaningful chance of recovery.
The use of ICU resources for the elderly is a practice that varies from country to country. In comparing the use of
ICU in western Europe with that in the
United States, investigators observed that
ICU admissions per 100,000 population
were higher in the United States with the
exception of Germany (2). However, unlike European countries, the number of
ICU beds in the United States did not
parallel the number of acute care beds.
The United States had a disproportionately higher percent of acute care beds
devoted to ICU care and spent more
money than other countries per ICU bed.
Another recent study compared practices
in the United States with those in England (3). Age-adjusted acute hospitalization rates were 110.5 per 1000 population
in England vs. 105.3 in the United States
with similar mortality rates. In England,
50.3% of deaths occurred in the hospital,
but only 5.1% of deaths involved ICU
care. In the United States, 36.6% of
deaths occurred in the hospital, whereas
17.2% of deaths involved the ICU. Thus,
overall, 47.1% of hospital deaths in the
United States involved ICU care compared with 10.1% in England. In the
United States, the elderly received ICU
care far more often; in those aged ⬎85
yrs, 31.5% of medical deaths and 61% of
Crit Care Med 2010 Vol. 38, No. 10 (Suppl.)
surgical deaths in the United States involved ICU use compared with 1.9% and
8.5%, respectively, in England.
Advanced age may contribute to ICU
mortality and older patients often have
more severe illness than younger patients. However, age alone does not define risk of death. An Austrian study
found that 52% of all ICU care was given
to patients aged ⬎65 yrs and 5% to those
⬎85 yrs. Age contributed to mortality
with those aged ⬎85 yrs having an odds
ratio for mortality that was 1.8-fold
greater than those aged ⬍65 yrs (4). Although mortality rose with age, it was
also influenced by severity of illness;
when age was removed from severity
scoring, severity of illness was still an
important determinant of mortality.
However, the relationship with aging is
complex because the older patients generally had more severe illness. Similar
data were reported by a US study that
showed increased ICU use and mortality
with age (5). ICU admission rates increased from 0.36 per 1000 person-years
in those aged 18 – 44 yrs to 4.0 per 1000
person-years in those aged 65–74 yrs and
to 18.5 per 1000 person-years in those
aged ⬎85 yrs. ICU use was also more
common as the number of chronic illnesses rose. Nonsurvivors had any
chronic condition more commonly than
survivors. Overall, 26.7% of all ICU days
were used by people in their last 12
months of life, whereas 68% of ICU days
in those aged ⬎85 yrs were used in the
last 12 months of life.
Cardiopulmonary resuscitation (CPR)
is commonly used in the elderly with a
recently reported survival rate in the
United States of 18.3% for those aged
⬎65 yrs (6). In that study, CPR use was
noted to have increased over time in the
elderly, particularly among black patients. Success rates were lower for nonwhites, for men, for those with chronic
illness, and for those coming from nursing homes. Among black patients, CPR
was performed twice as often as in white
patients. The lower survival of black patients after CPR was not easily explained,
although many of the black patients were
treated in hospitals with lower CPR survival rates. Many of the survivors did not
return to their homes but were discharged to chronic care facilities.
Current medical practice in the United
States, with its seemingly unlimited resources, allows physicians to provide, and
patients to receive, treatment of marginal
or even remote medical benefit. The roots
Crit Care Med 2010 Vol. 38, No. 10 (Suppl.)
of this practice can be traced to an overresponse to excessive physician paternalism several decades ago, the rise of the
consumer movement in the 1970s, and
an American cultural emphasis on “rugged individualism.” For most of these
medical treatments, the benefits to the
patient are typically assessed against the
harms of treatment to that patient. If a
patient makes a calculation that a treatment of marginal or symbolic value is
desirable, it is often provided, particularly
if the likelihood of harm is low. However,
the impact to other patients in the ICU
from having provided this therapy is generally not considered. In the setting of
plentiful resources, physicians have little
imperative to limit even marginally beneficial treatments.
Certain therapies such as antibiotic
use, particularly in the hospital and ICU
setting, are atypical in this regard because antibiotic use can create bacterial
resistance, which makes subsequent infections, in other patients, potentially
more lethal. Therefore, the purported individual benefits of antibiotic treatment,
particularly if its use is in the context of
futile care, can lead to potential harm to
others. We submit that certain types of
futile care such as continued antibiotic
use in which it no longer provides tangible medical benefit cannot be justified
because of the potential harm to other
patients. Furthermore, we contend that
physicians and patients have ethical obligations to desist from marginal and symbolic use of futile interventions, as can be
exemplified by antibiotics, because of
quantifiable collective harm.
Discriminating between futile
and marginal care
In clinical care, it is important to distinguish between futile and marginal
treatments. Futile treatments are those
that hold no prospect of achieving the
intended outcome. The bioethics community has largely abandoned the notion
of futility after efforts to develop a clinically serviceable definition proved fruitless (7, 8). The reality is that in the clinic,
few treatments hold zero prospect of
achieving the desired result, whereas
those that do rarely lead to clinical dilemmas. To illustrate, consider a ventilated
patient on 100% FIO2 and 15 cm positive
end-expiratory pressure who remains hypoxemic. Because, in its most narrow
sense, the goal of mechanical ventilation
is to achieve satisfactory oxygenation and
the ventilator has proven unable to
achieve that goal, it may be considered
futile.
These situations of physiological futility are not typically the troubling ones in
the ICU. Rather, the challenging cases are
those in which the effect of the intervention is uncontested (for example, achieving an adequate PaO2) but the benefit of
the intervention is unclear. Here, it is
sometimes useful to assess the benefit of
treatments against a general standard of
practice. For example, cardiologists in
general may decline to place an intraaortic balloon pump in a patient with
cardiogenic shock not because it will fail
to raise blood pressure for a period of
time (effect), but because no definitive
remediation of the pump failure is possible (limited benefit) or because the patient has a limited benefit because of poor
clinical status (anoxic encephalopathy)
after a cardiac arrest.
Futility should be viewed in the overall context of the patient and not just
from a physiological perspective. In general, doctors want to withhold certain
therapies if the predicted benefits are limited. In a survey of care of patients with
pneumonia and dementia in The Netherlands, three-fourths of doctors would
withhold antibiotics if the predicted mortality rate was between 75% and 90% (9).
However, although physicians often wish
to limit interventions that do not benefit
the overall well-being of a patient, some
ethicists have argued that this type of
behavior is not acceptable. For example,
one author argued “It is the patient’s life
to lead, and death to die.… It is not for
the physician to say that a patient— one
out of one hundred, but still a patient—
who would have lived will instead die,
because of his, and not the patient’s, decision” (10). Legal support for the failure
to provide futile care is also needed in the
United States as evidenced by the arrest
(but not indictment) of Dr. Anna Pou
who provided end-of-life comfort care to
do-not-resuscitate patients who could not
be evacuated from a nursing home hospital that was flooded and lost power during Hurricane Katrina (11).
Harms, benefits, and why
antibiotic use in the ICU is
different
For treatments that squarely fall into
the realm of medical appropriateness, the
usual approach to questions of benefit is
to clearly define the likely and expected
S519
positive and negative effects of an intervention on the patient and to have the
patient or surrogate make a personal
judgment about its value. The most challenging cases are those that fall between
frank physiological futility, in which decision making is within the domain of the
clinicians, and situations of limited but
defined benefit, in which there is no clear
consensus on medical inappropriateness
and where decision making tends to default to the patient or surrogate. Patients
are given this latitude because, among
other reasons, resources are plentiful in
the United States and because it is the
patient who bears the burdens of treatment in the hope of enjoying its benefits.
However, hospital-based use of antibiotic
therapy, particularly in the ICU, presents
a somewhat novel paradigm for decision
making. Antibiotic use not only contributes to microbial resistance in the patient
receiving the medication (the typical direct linkage of benefit and harm), but it
also increases the prospect of resistant
organisms in the entire ICU, which can
lead to lethal infections in other patients
within the unit (an uncoupling of benefit
and harm). Therefore, antibiotics represent a treatment that holds the potential
to harm nonrecipients. In this case, the
provision of futile or marginally beneficial care may cause limited harm to the
treated patient but creates greater harm
to other patients in the ICU.
Allocation of antibiotics is different
from typical rationing dilemmas because
the issue is not a direct shortage of the
material resource; the same antibiotic
may very well be plentiful. Rather, antibiotic use may render supplies of the antibiotic useless to the next patient and
cause a widespread increase in the clinical impact of hospital-acquired infections. Conceivably, at some future point,
current antibiotic use will have created
completely resistant bacteria for which
no other therapeutic resource exists,
thereby leading to high rates of mortality
(12). Antibiotic allocation is not a zerosum game as it occurs with typically limited resources. This is potentially exponential. Many studies have documented
that mortality from infection in the ICU
increases with inappropriate therapy and
that such therapy is more likely if patients harbor multidrug-resistant pathogens (13). The use of antibiotics is directly related to the development of
multidrug-resistant pathogens; if this use
is for futile care, the harm that results is
impossible to justify.
S520
In limited studies of physician, patient, and family attitudes, antibiotics
are among the least refused therapies.
Doctors often agree to use antibiotics
when they would not provide CPR. Even
in patient scenarios when ⬎90% of physicians would not provide CPR, almost half of
doctors would still prescribe antibiotics if
needed (14). Similarly, in surveys of patients and families, even in the setting of
a patient with coma or a persistent vegetative state, 20% to 30% still want antibiotics (14).
Therefore, the ethical implications of
antibiotic use in certain critical care settings warrant particular consideration.
Antibiotics can delay dying, without adding to life quality, and can expand the
reservoir of resistant pathogens in the
ICU. Certainly, when continued use of
antibiotics has merely symbolic value or
is done to respond to the emotional needs
of a patient or surrogate, it cannot be
justified against its serious collateral
harm to others. Continued antibiotic use
in these situations is an indulgence that
antibiotic recipients have little moral
right to impose on other patients. Clinicians should seek alternative ways to support such patients.
Antibiotic use and application
of the principle of justice
In situations in which antibiotic use
offers patients waning prospects of benefit, the use of such therapy must be assessed against not only the burdens or
harms to the patient, but also the harms
to all other relevant patients. What moral
claims do these patients with unsalvageable illness have on antibiotics, a shared
resource, where its use has a low likelihood of benefit and has measurable
harms to the community? Who should
make the calculation of relative benefit to
the patient vs. harm to others? How
should this assessment be made? One approach to these assessments involves applying the ethical principle of justice.
Of the various theories of justice, the
pertinent ones for this analysis are communitarian theory and egalitarian theory
(15). Communitarian theory holds that
there are mutual obligations and responsibilities between an individual and a
community of individuals with solidarity
rather than liberty being a central virtue.
Communities decide which resources
should be apportioned to its members,
and individuals accept foregoing some
opportunities for the good of the group
because the shared standard of just distribution exists. Within egalitarian theories of justice, the idea of “fair opportunity” requires that every individual
receive sufficient resources to equalize
opportunities to achieve a particular benefit (16). For example, persons who are
disadvantaged through no fault of their
own (e.g., genetic predisposition causing
diabetes) would be entitled to a greater
amount of community resources (medical,
ophthalmologic, nutritional, etc) than
healthy persons so that persons with
diabetes can achieve fair opportunities
for life expectancy, being productively
employed, etc.
In the case of antibiotic use, if survival
from an infection is the defined benefit,
egalitarian theory could support a physician not to provide treatment to patients
who have already received a substantial
attempt at antibiotic cure to preserve a
fair opportunity for the next similarly infected patient to be cured. This fair opportunity concept is particularly appropriate for antibiotic use because
providing treatment to one person could
diminish the opportunity of others to secure the same benefit. Thus, the principle
of nonmaleficence would need to be applied to the community at large and not
just to the patient being treated. Of
course, for these arguments to hold, empiric evidence is needed for the effects of
antibiotic use and nonuse on clinical outcomes for individual patients and for
communities.
In justice theory, the requirement of
an “impartial participant” or a “veil of
ignorance” suggests that groups of persons deciding on fair distributions within
a society must be plausibly vulnerable to
the consequences of such decisions (17).
For example, a group of male health benefit administrators would never be subject to the consequences of their decisions about allocating resources for
gynecologic care. For decision making,
this principle would require specific involvement from constituencies vulnerable to infectious critical illness in the
development of policies limiting antibiotic use.
This last point raises an important distinction between macroallocation and
microallocation decisions. Physicians are
not ethically empowered to make bedside
rationing judgments or to make assessments about duration of antibiotic therapy where the therapy continues to have
defined but low benefit to the patient
simply because of concerns that its use
Crit Care Med 2010 Vol. 38, No. 10 (Suppl.)
also harms the community. These sorts
of decisions are vulnerable to violating
the ethical requirement of fairness because of interphysician variability in
making such judgments (18). Furthermore, bedside rationing creates an untenable ethical position for the physician
who, at once, is divided between the role
of patient advocate and steward of societal resources. Physicians may justifiably
engage in allocation activities when processes and procedures for allocation have
been authorized by appropriate and publicly accountable bodies.
Other examples of futile care
creating harm to others
Although antibiotic therapy provides a
tangible example of how providing futile
care, even in the absence of limited resources, can create harm to those not
involved in the decision to provide such
care, other examples also exist. In some
settings, these examples relate to how the
provision of futile care, in the setting of
actual or potentially limited resources,
may create adverse consequences. Thus,
if a patient and family demand the delivery of mechanical ventilation and pressors for a patient with no meaningful
chance of recovery, this decision will
have no immediate harm to others if
there are unlimited ICU resources available. However, this type of care may be
unjustified and unethical if it means that
in the midst of an influenza pandemic, a
young, potentially salvageable patient
with respiratory failure cannot get an ICU
bed or a ventilator because these resources are already being used by others,
including some with no likelihood of personal benefit. Of course, this situation
becomes less clear if care for both patients is not futile and if, for each, there is
a potential benefit and resources are limited, particularly if this leads to comparing the “value” of one life vs. another.
Such a situation has been discussed in
New York State in anticipation of pandemic influenza. In a publicly circulated
draft document from a Department of
Health Working Group, the concept of
ventilator allocation during a flu pandemic was discussed (19). In this document, which was not adopted because of a
lack of legal and legislative support for
physicians making these difficult decisions, the group considered the idea that
a limited supply of ventilators should be
used for those most likely to benefit. To
make such decisions, we need new alloCrit Care Med 2010 Vol. 38, No. 10 (Suppl.)
cation scoring systems, which, at present,
do not exist. The New York document
stated that certain principles should be
followed, including: expanding resources
before developing a triage system for allocating ventilators when demand exceeds supply; categorizing all patients for
triage; having consistency among hospitals with regard to the triage criteria
used; using clinical assessment with objective criteria, but applying support in a
time-based trial, in which priority could
change with the clinical evolution of the
patient; that decision making should be
made by supervising doctors and not the
primary physician caring for the patient;
offering palliative care for those who do
not receive ventilator therapy; having an
appeal process regarding triage decisions;
and communicating to the community at
large about the triage system.
One scoring system approach to this
problem that was discussed in the New
York document is the Ontario Health
Plan for an Influenza Pandemic, which is
based on the Sepsis-related Organ Failure
Assessment score (20). The triage scoring
is based on inclusion criteria (patients
can get a physiological benefit from critical care), exclusion criteria (no severe,
terminal illness), and an assessment of
minimum qualifications for survival. The
Sepsis-related Organ Failure Assessment
score is assessed in treated patients in a
serial fashion, and care may be withdrawn if the patient fails to improve in a
specified time period. In this system, the
highest priority for critical care is the
patient with severe illness, but only with
a single organ failure and showing a good
response to treatment. Those with a high
probability of death, or who deteriorate
during therapy, are considered for removal from ventilator support. One unresolved question in this discussion is
whether chronically ventilated patients
are exempt from evaluation or if they too
would be compared with all patients
needing ventilator support.
A recent study applied this system to
all patients admitted to a multidisciplinary ICU to see how it would have
affected allocation of resources (21). The
triage system was not used to make decisions but the impact of using such a
system was evaluated. Of the 255 patients
admitted to the ICU, 116 (46%) would
have been denied ICU care under the Ontario triage system, yet many of these
patients survived. Of those 48 patients
categorized as too ill to warrant ICU admission, 69% survived, whereas of the 66
with no significant organ failure, 95%
survived (with ICU care). The study concluded that the triage system did not accurately predict benefit from ICU care
and that it should not be used. Although
we clearly need a better system, the study
is limited because the overall survival
rate of all ICU patients was 80%, patients
managed out of the ICU were not studied,
and management in a non-ICU setting for
those admitted to the ICU was obviously
not evaluated.
In the United States, we are practicing
medicine in a “pay-for-performance” environment, which creates a situation of
potential limiting of resources to certain
hospitals that perform less well than the
norm. Certain medical events are already
classified as “never events” with insurance payers threatening nonpayment for
these conditions. The current never
events include catheter-associated urinary tract infections, pressure ulcers, and
vascular catheter-associated infections.
All these events could easily occur in patients whose lives are prolonged by futile
care (22). Ventilator-associated pneumonia is not on this list but is an illness that
has also been proposed as a “never event.”
If this were to occur, it is likely that
regardless of efforts at prevention, certain
patient populations will have a high frequency of ventilator-associated pneumonia, if mechanically ventilated, because of
the seriousness of their underlying illnesses (23). Thus, if a decision is made to
ventilate patients with terminal illness, in
a setting where ventilation can be defined
as futile care, some of these patients will
get ventilator-associated pneumonia. If
this were to occur, the hospital will earn
a reputation as a place with a high infection rate, reimbursements may be then
withheld, and so the hospital would have
less financial resources to treat other patients without futile illness. This may be a
particular problem in hospitals that serve
indigent populations and are already limited in their reimbursements and resources. As discussed earlier, certain indigent populations, which have a high
mix of nonwhite patients, are more likely
to ask for CPR and advanced care, even
when such care could be futile, and these
patients have a lower survival rate than
white patients (6). If these patients receive futile care and they develop ventilator-associated pneumonia and other
complications in the process, reimbursement to the hospital may decline further
and harm future patients. Unfortunately,
pay for performance has been imposed
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without needed health system and tort
reforms to allow hospitals to define and
limit marginal treatments. The Texas Advance Directives Act of 1999 offers one
legislative approach to this issue (24).
with limited benefit of aggressive, intensive care, we need enhanced societal appreciation of the fact that the delivery of
such care is not always a private decision
with impact on a specific patient and his
family, but sometimes a decision with a
broader impact on others that are not
directly involved in the decision making
process. For this reason, we need better
tools for limiting certain therapies in the
elderly and in those with terminal illness,
and we will need to find ways not to offer
ICU care and certain other therapies in
this setting. To achieve this end, we will
need an enlightened society, but we must
also equip our ICU physicians with better
methods of defining futile care. Invariably, this will require better scoring systems that provide information not only
about survival, but also on the quality of
that survival.
Summary
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Table 1. Harm to others from the delivery of
futile care
In the setting of unlimited resources
Use of antibiotics to treat infections in
patients with no hope of meaningful
recovery
In the setting of limited or potentially limited
resources
Providing futile care in the midst of an
influenza pandemic
Providing futile care in a pay-for
performance environment
May create future limitation of resources if
“never events” occur
No member or group of members of a
just society has unlimited claims on
shared resources. Futile care can lead to
harm to other patients (that is, those not
receiving the futile care) in a variety of
circumstances, including situations in
which resources are either limited or not
(Table 1). Even in the absence of limited
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