Updated Guidance on Informed Consent in Stroke Management
There is a rapidly evolving repertoire of treatments that are highly effective in preserving brain function after stroke, “but only if administered quickly, during a time when patients often are unable to make decisions for themselves, and those who could make decisions for them may be unavailable,” says Justin A. Sattin, MD, professor at the University of Wisconsin (UW) School of Medicine and Public Health and medical director of the UW Health Comprehensive Stroke Program.
A 2022 position statement from the American Academy of Neurology, American Neurologic Association, and Child Neurology Society offers guidance for this ethically complex situation.1 “The position statement aims to help neurologists provide the highest quality patient care for ischemic stroke by providing ethical guidance on how to navigate the decision-making process for stroke patients who may have difficulty providing consent,” reports Sattin, lead author of the position statement.
Strokes affect the faculties patients require to make informed decisions for themselves — speech, comprehension, and reasoning. “At the same time, advances in stroke treatment demand careful consideration of many clinical and scientific facts in conjunction with patients’ values and preferences in order to arrive at an optimal treatment plan,” Sattin observes.
Ethical challenges arise when patients’ understanding, reasoning, and values cannot be discerned while there is great time pressure to render treatments when they are most likely to be effective. Some recommendations in the position statement:
- A surrogate decision-maker may not be adequately prepared to represent a stroke patient’s wishes, in which case neurologists may need to guide the decision-maker. Neurologists should prioritize the patient’s preferences if those are documented. If nothing has been documented, the goal is to decide based on the patient’s beliefs. If those are unknown, decisions should be made based on the person’s best interests.
- If there is a generally accepted treatment (e.g., a clot-busting drug), neurologists can proceed on the presumption of consent, if necessary. 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. “When a lawful surrogate is available, consideration must be given to preferences previously expressed by the patient. In cases of stroke, such statements are usually lacking. Surrogates must consider what the patients would choose if they could speak for themselves,” Sattin says.
Some treatments involve a more complex risk-benefit analysis (e.g., endovascular treatments to remove clots). If the neurologist must treat on the presumption of consent, the main consideration is whether the facts of the case are such that most neurologists would offer treatment and most patients would accept it. In other words, does the case align with currently accepted practices and guidelines? “The further a case falls outside of these, the less justification there would be for treatment on the basis of presumed consent,” Sattin says.
The most difficult cases do not fall squarely within or outside of current guidelines, where the patient lacks decisional capacity and a lawful surrogate, and where the neurologist must determine whether treatment based on presumed consent is warranted. “There are many ‘relative’ contraindications to alteplase treatment, for example. The position statement can’t provide guidance for every nuance in the complex field of cerebrovascular disease,” Sattin notes.
Neurologists must determine how closely the facts of such cases match current practices and guidelines, and use that determination to guide treatment.
Significant ethical issues involving informed consent in the care of stroke patients include whether the patient still possesses decisional capacity. If not, who will make decisions on the patient’s behalf? Since stroke occurs on a spectrum of severity, one should not assume the patient lacks capacity to give informed consent to care and treatment.
“In cases of mild or less severe stroke, careful examination of the patient’s cognitive capacity is called for,” says Robert S. Olick, JD, PhD, associate professor emeritus of bioethics and humanities at Upstate Medical University in Syracuse, NY.
Patients need the ability to understand and reason about the nature of their condition and the risks and benefits of the proposed treatment and treatment options. “It may be advisable to involve a stroke specialist and/or psychiatry in this process,” Olick suggests.
The healthcare team should be mindful that some patients can make some decisions, but not others. Sometimes, patients with impaired capacity can choose a family member to act as their surrogate, but may not be able to make a specific treatment decision. “Some patients may regain cognitive capacity with treatment and time for recovery,” Olick says.
Olick has responded to several ethics consult requests involving stroke patients’ capacity to give consent. Ethics consultants do not make formal determinations of capacity. “Ethicists can, however, clarify the parameters of informed consent and capacity, the meaning of the patient’s stated wishes, and who is the appropriate surrogate decision-maker if the patient is determined to lack capacity,” Olick explains.
In cases of serious stroke, loss of decisional capacity may be evident and possibly permanent. Consequently, a healthcare proxy, spouse, or family member must be identified to assume the responsibilities of making decisions on behalf of the patient. “Family members may struggle with the trauma of sudden loss, the uncertainty of prognosis, and the burdens of decision,” Olick says.
Ethics can help with this situation, particularly if there is disagreement among the proxy, family, physician, or others directly involved in the stroke patient’s care. “Ethics consultants often provide support and assistance in understanding the patient’s wishes, determining who is the appropriate decision-maker, and resolving disagreements,” Olick says. Still, it is important to bear in mind that ethics consultants serve as a supportive and advisory role. “They do not make decisions,” Olick cautions. “The right and responsibility for treatment decisions rests within the patient-family-physician relationship.”
- Sattin JA, Chiong W, Bonnie RJ, et al. Consent issues in the management of acute ischemic stroke. AAN Position Statement. Neurology 2022;98:73-79.
A new position statement aims to help neurologists provide the highest quality patient care for ischemic stroke by providing ethical guidance on how to navigate the decision-making process for stroke patients who may struggle to provide consent.
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