UPenn develops guideline for brain-injured patients
Appropriate treatments outlined
Patients with severe, irreversible brain injuries present unique ethical challenges to physicians and hospital ethics committees. For patients with no chance of recovering an interactive, conscious state, which treatments are appropriate and which are unjustifiably invasive and pointless? It’s a question that has surfaced several times for the ethics committee at the Hospital of the University of Pennsylvania in Philadelphia, says Horace DeLisser, MD, the committee’s co-chair.
Two years ago, the hospital decided it needed a guideline to direct clinicians in making treatment decisions for severely brain-injured patients, specifically those in persistent vegetative states (PVS) or minimally conscious states (MCS), DeLisser explains.
"This guideline is for patients who sustain acute brain injury and are left with impairments that are chronic and severe," he notes. "We have made a distinction between patients in a vegetative state and those in a minimally conscious state."
Patients in both PVS and MCS are no longer capable of "purposeful or intentional" interaction with other people or with their environment, DeLisser explains.
Patients in persistent vegetative states have sustained injuries that have destroyed the upper hemispheres of the brain, leaving only the brain-stem functions intact. PVS patients still experience cycles of sleeping and waking and spontaneously breathe on their own, but are not capable of awareness.
MCS patients may sometimes respond
"Patients in minimally conscious states are, in a sense, one small step above that," he continues. "They have profound disability. They cannot feed themselves, care for themselves, or speak. They may have some residual higher brain functioning, so that, at times, it may appear that there may be some purposeful or intentional response. Occasionally, you may get a patient who, when you ask them to squeeze your hand, they do so. It may not be consistent, but it does occur enough that you know there is something there."
DeLisser objects to the classification of the UPenn guideline as restricting or limiting care because the measure does not cover withdrawing care that is already being given, but instead acts to guide the types of care that are appropriate going forward.
"I don’t see this as a futility guideline," he points out. "This is not a withdrawal-of-care or end-of-life care set of guidelines. In many ways, it speaks to what the goal of medicine is or should be, and in that sense it broaches the issue of futility. Collectively, we believe on some level that certain treatments in certain patients do not advance the goal or are unable to advance the goal of restoring cognition. The treatments may maintain biological life, but medicine is not just about warehousing people and somehow maintaining physiology."
For these patients, for whom there is virtually no hope of restoring cognitive functioning or the ability to interact with their environment, the goal of medical care should be directed at preventing suffering and pain and maintaining the dignity and respect of the individual patient, he asserts.
"We think in these situations that care that is comfort-based or palliative-based, that respects the dignity of the patient and prevents suffering — those goals are much more attainable and achievable, and that is a much better way to expend our efforts for these patients," he explains.
No invasive procedures
In general, the guideline indicates that patients who have remained in specified states for several months should not get invasive procedures or intensive life support.
A draft of the guideline defines "intensive life support" as "invasive therapies that generally require continuous specialized monitoring, typically in an intensive care unit. Examples of these therapies include mechanical ventilation, intravenous infusion of vasopressors, or a variety of types of dialysis. These treatments necessarily entail tissue injury and are associated with a risk of major complications such as infection, stroke, or irreversible major organ failure. A decision to implement intensive life support must include a balancing of the possible benefits and risks for the patient."
The guideline defines "significant invasive procedures" as "any intervention or procedure that involves penetration or entrance of the body that carries more than minimal risk of harm and for which informed consent is obtained."
These are the kinds of treatments hospital officials feel would be inappropriate for patients in the specified conditions.
"The exception would be if there is evidence that the patient would have wanted these kinds of treatments with this level of severe impairments in consciousness," DeLisser says. "If there is evidence that they would have wanted this kind of care in this state, then we are willing to accommodate them as best we can."
A typical scenario would involve a patient presenting to the hospital emergency room who had been in a persistent vegetative state for six months, he explains. If there is no question about the diagnosis and no evidence the patient would want to continue aggressive treatments, the caregivers will focus on comfort care and palliative measures only.
"They would essentially be getting the same care available to them as an outpatient," he says. "If they are on a ventilator, we maintain that. If they have a feeding tube in, that would stay in place. We would not do anything to end those services. They would still get intravenous medications and treatments. For example, if they came in and cultures showed that the patient had an infection, they could get intravenous antibiotics or antibiotics through their percutaneous feeding tube."
But if the patient needed a medication to maintain his or her blood pressure or some kind of exploratory procedure to identify the source of an infection, or if the patient developed pneumonia and required mechanical ventilation, those treatments would not routinely be a part of the patient’s care, DeLisser says.
"These guidelines state that this is the routine and ordinary’ recommendation, but there may be some situations where we need to deviate from this," he adds. "The attending physician would just need to document this. That is the big difference between this guideline and hospital policy. There is still the flexibility to deviate from the guideline, but we hope that won’t be the case in most situations."
Conditions must be chronic and persistent
The guideline is not meant to apply to any MCS or PVS patient. It specifically stipulates that the conditions must have persisted for three months for anoxic brain injuries or six months for traumatic brain injuries.
"We have been very careful to specify that the label persistent and chronic’ is only applied after three months for someone with an anoxic injury, such as someone who went into cardiac arrest and was resuscitated but remains in a persistent vegetative or minimally conscious state. Then we have a threshold of six months for a brain injury due to trauma."
Prior to that point, clinicians and families may decide together to limit or refocus treatment that they believe is not in the best interest of the patient. But if the guideline is going to be used to substantiate the treatment decision, those are the thresholds that should be used.
Guideline reflects evidence base, consensus
The university’s guideline was painstakingly developed by a subcommittee of the hospital ethics committee that thoroughly researched the literature to determine appropriate treatments for patients with these conditions, DeLisser notes.
In addition, the subcommittee sought input from the whole ethics committee, the hospital’s medical board, other hospital staff (both clinical and non-clinical personnel), and experts with the University of Pennsylvania’s Center for Bioethics, DeLisser adds.
"The process behind the guideline did not represent a secret conspiratorial process involving a couple of people trying to impose their prejudice and bias on the institution," he states. "It is more of a collective consensus."
To avoid any misunderstanding, hospital officials are making careful efforts to educate those most likely to be affected by the guideline, such as personnel at nursing homes and assisted living facilities who might send patients to the hospital, members of the public, and other health care providers at the hospital and beyond.
"Since the guideline has been on the books, I am not aware of any instance when it has been used, but we are working to get the word out to people about what is involved in the guidelines, their purpose and intent, and making sure people are educated," he notes.
Because the document is a guideline and not a policy, families who disagree with the care plan for their relatives under the guideline can appeal to the ethics committee, and physicians are not required to adhere to the guideline’s recommendations if the families disagree.
"In the end, because it is a guideline, physicians can just acquiesce to the wishes of family members [who want invasive therapies for MCS and PVS patients]. But we hope they will not do that but will instead make a real effort to talk to the families and follow through on the guideline," DeLisser says.
Invasive and intensive treatments have side effects of their own that will eventually cause health complications in these patients, he points out. Family members need to understand the true risks and benefits that "doing everything" will have for their loved ones, and health care professionals have a responsibility to take a role in helping families make such difficult decisions.
"We are trying to get away from just saying to families, Here is the situation, what do you want us to do?’" he says. "We know that something tragic has occurred; it is three months to six months to a year later, and their loved one is not going to recover. Given that, we need to emphasize that what we intend to do is focus our care on making sure the patients do not suffer in any way, and we do things that will affirm their dignity."
(Editor’s note: The Hospital of the University of Pennsylvania has not yet published its guideline, "Care for Patients with Severe Impairments in Consciousness Following Acute Brain Injury," but the hospital will soon do so and will feature the guideline on its web site for other institutions to see. The web address is www.upenn.edu.)
Patients with severe, irreversible brain injuries present unique ethical challenges to physicians and hospital ethics committees. For patients with no chance of recovering an interactive, conscious state, which treatments are appropriate and which are unjustifiably invasive and pointless?You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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