The American Academy of Neurology (AAN) has issued a new position statement on "Consent Issues in the Management of Acute Ischemic Stroke," the first update in more than 20 years.
The statement was published online in Neurology on January 10.
"The impetus for this new statement was that the stroke field has changed enormously in the past 20 years," first author of the new document, Justin Sattin, MD, University of Wisconsin, Madison, told theheart.org | Medscape Cardiology. "There have been several new treatments with decision-making considerations and we felt it was time to revisit the topic of consent."
Sattin noted that the last AAN guidance on consent in acute stroke was published in 1999. "At that time, thrombolysis for stroke had only recently been approved. Since then, thrombolysis has expanded into the late time window and endovascular treatment has been introduced, as well as use of MRI and perfusion imaging to enable later endovascular treatment in certain patients. We are trying to offer ethical guidelines for decision-making around these treatment as well as an ethical framework for intermediate and future treatments," he said.
The authors point out that there is a rapidly evolving repertoire of treatments that are highly effective in preserving neurologic function after stroke — but only if administered quickly, which is during a time when patients often lack decisional capacity and surrogate decision-makers may be unavailable.
The position statement reviews the principle of informed consent, the elements of decisional capacity, and how acute stroke may affect this capacity. It further reviews the role of surrogate decision-making, including advance directives, next of kin, physician orders for life-sustaining treatment, and guardianship.
It explains that in some cases of acute stroke in which the patient lacks decisional capacity and no advance directives or surrogates are available, consent to treatment may be presumed. The document describes the rationale for this position and various considerations regarding its application to IV thrombolysis, neuroendovascular intervention, decompressive craniectomy, and pediatric stroke. The document also reviews consent issues in acute stroke research.
"The most important point is that a physician's first duty is to respect an individual's choices," Sattin commented. "But in the case of patients who have a stroke and do not have capacity to make such decisions, we need ethical guidelines as to how to make those decisions. These guidelines allow clinicians to make an ethical case to treat people to current standards even if they can't consent."
He added: "It is always paramount to try and seek consent from the patient themselves if possible. If this is not possible, then we try to ascertain if they have some legal documents on how to go forward or a power of attorney to identify as a proxy."
Sattin stressed that in the situation of acute stroke, decisions have to made quickly. "In the real world, we might have to rely on family members at the bedside as we might not always have a legal document or power of attorney. Most hospitals have a policy that sets forth the hierarchy of surrogate decision makers — for example spouse, adult children, so forth."
If a relative is not available for consent, the neurologist can go ahead with treatment if that treatment is considered standard practice for this situation, but as the medical factors deviate more from the standard of care, then the justification to go ahead with the treatment on the presumption of consent becomes weaker, Sattin explained.
"The principle of receiving emergency treatment is not new. If a person goes into cardiac arrest, we generally do not wait for consent to start CPR," he said. "The argument we are making is that stroke falls into the category of a medical emergency, so we can go ahead with treatments that are considered standard care. But stroke is a complex condition, and there can be a big gray zone."
He says that in circumstances where there is a gray zone, stroke clinicians have to think about how close the situation is to the clinical guidelines, and also to use scientific guidance on indications and contraindications to inform decision-making.
"Our purpose is to inform clinical decision-making — to provide ethical guidance in how to apply the science to patients who may be unrepresented," Sattin said.
He points out that, in practice, stroke patients are cared for by a team — including the emergency room physician, neurologist, and also possibly an interventionalist — who are all included in the decision.
While the document sets out recommendations for many circumstances, Sattin stresses that it cannot cover every single situation. "This document is to provide useful guidance without evolving into endless scenarios. There has to be a little clinical judgement."
He gives a classic example of standard of care as a patient presenting with an acute ischemic stroke within 3 hours of symptoms who meets the criteria for thrombolysis. "Even if they cannot speak and cannot consent that would be a classic example to proceed with thrombolysis as the indication is clear-cut," Sattin says.
But he notes that there can be many situations where the decision is not so clear-cut. He gives one example of patients with a mild stroke, defined as those with a National Institutes of Health Stroke Scale score of less than 5.
"These patients were excluded from the initial trials of thrombolysis, but they can still be incapacitated by the stroke and can often still benefit from thrombolysis. We have to use our clinical judgment as to how mild is too mild for thrombolysis," he noted. "If they lack capacity to give consent, then we have to examine whether they fit the criteria for presumed consent, which can be difficult. Often, if they have lost decisional capacity, they probably have a severe enough stroke to justify treatment."
The position statement advises a careful discussion of individual risks and benefits of treatment with the patient or surrogate in such cases. When the balance of these risks and benefits is uncertain, and the patient lacks decisional capacity and lacks a surrogate, then the neurologist "should adhere more closely to guideline-based inclusion and exclusion criteria," it states.
"Sometimes we have to think about whether most reasonable people would agree to it or not," Sattin adds.
One of the reasons the field has become more complex revolves around the introduction of endovascular therapy for acute stroke.
The position statement points out that in cases of large hemispheric stroke for which endovascular therapy would be considered, patients are much more likely to be cognitively impaired. Moreover, when patients are evaluated in comprehensive stroke centers remote from their local communities, their families may be unavailable at the time that a treatment decision needs to be made.
It recommends that patients who meet established criteria for endovascular therapy but who lack both decisional capacity and a surrogate decision maker should be treated on an emergency basis. The patient or surrogate should later be informed about what was done and how the time-sensitive circumstance precluded the usual consent process.
"The further outside of published criteria that a patient's condition falls, the less justified would be emergency treatment absent patient or surrogate consent," the document notes.
On decompressive craniectomy, the position statement notes that this procedure is conducted to reduce the potentially fatal effects of cerebral edema, a complication of a large-territory ischemic stroke, but that most patients in whom decompressive craniectomy is considered will be unable to consent to the procedure because they often have decreased levels of consciousness.
The position statement advises that when patients with large-territory ischemic strokes are admitted to the hospital, the possibility of developing malignant edema should be communicated to patients who retain decisional capacity or to their surrogates, which may help to avoid hasty and emotionally fraught decisions in the setting of a patient's clinical decompensation.
The statement points out that in malignant cerebellar edema, decompressive surgery generally results in good outcomes, and if surrogate decision makers are lacking, surgical treatment on the presumption of consent is often justified given the favorable balance of risks and benefits.
In malignant hemispheric edema due to middle cerebral or internal carotid territory infarctions, decompressive hemicraniectomy can be lifesaving while also leaving patients with significant functionally limiting deficits. Thus, decision-making is more difficult and may involve a tradeoff between mortality and major dependency.
"This is a challenging decision that must be guided as much as possible by consideration of the patient's own health-related values," the statement says. "The patient's premorbid functional status and life expectancy may be informative. Surrogates and clinicians faced with such decisions may take some comfort in the observation that most patients do not retrospectively regret having undergone surgery, even when this results in major disability," the authors add.
In pediatric stroke, the statement notes that many therapies, including thrombolysis and mechanical thrombectomy, are not FDA-approved in children and are used off label.
To help with the process of obtaining informed consent from parents or guardians, it recommends that institutions create acute stroke treatment protocols and physicians should rely on these opinion-based institutional standards to counsel families.
The document also covers stroke research and clinical trial enrollment.
It notes that in patients without decisional capacity who also lack available surrogates at the time when enrollment decisions must be made, US regulations allow informed consent to be waived for research with minimal risks. While this may be relevant to systems-level interventions or qualitative studies of care delivery processes, it is unlikely to be met by physiologic interventions directed at reperfusion or neuroprotection, the AAN guidance suggests.
Investigators may apply to the US Food and Drug Administration for an Exception From Informed Consent to permit research involving human subjects in need of emergency interventions whose ability to consent is impaired due to life-threatening conditions.
"The main point is that it is feasible to enroll patients into a clinical trial as long as there is careful attention to both national and local regulations," Sattin added.
The authors of the position statement have disclosed no relevant financial relationships.
Neurology. 2022;98:73-79. Full text
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Cite this: Sue Hughes. New Guidance on Consent in Acute Ischemic Stroke - Medscape - Jan 19, 2022.