Informed Consent Practices for Acute Stroke Treatment Vary
Currently, the two cornerstones of acute ischemic stroke treatment are intravenous (IV) thrombolysis and, for patients with large vessel occlusions, endovascular thrombectomy. “Both of these interventions play roles in improving outcomes but also carry risks,” says Michael Young, MD, MPhil, a neurologist and researcher at Massachusetts General Hospital and Harvard Medical School.
For treating clinicians, the question becomes: How do clinicians ensure that patients (or their surrogate decision-makers) make an informed decision, while avoiding treatment delays that can result in worse outcomes?
“There may be an inherent tension between the traditional norms of informed consent and the clinical imperatives that exist in the context of acute ischemic stroke — and the management decisions that surround this often-devastating condition,” suggests Young.
Young and colleagues conducted a literature review on informed consent practices for patients presenting with acute ischemic stroke who were treated with IV thrombolysis or endovascular thrombectomy.1 Practices varied significantly among physicians and hospitals. Some key findings:
- Among hospitals and physicians, between 21% and 37% always required consent.
- There were discrepancies in the information shared in terms of whether the provider disclosed the stroke diagnosis, benefits, risks, and IV thrombolysis mechanism.
- For endovascular thrombectomy, research on informed consent practices was scarce.
- Consent requirements tended to be stricter for patients presenting within an extended (three- to 4.5-hour) time frame. “The medicine is approved by the FDA for up to three hours. We will often still recommend it up to 4.5 hours based on guidelines and some pretty reasonable data, but it’s a little bit of a gray area,” notes Robert Regenhardt, MD, PhD, another of the study authors and a neurointerventionalist and stroke scientist at Massachusetts General.
Physicians must weigh ethical principles such as autonomy, beneficence, and nonmaleficence alongside practical and legal considerations. Physicians also must consider the nuances of the individual case. “Every situation is a little bit different,” says Regenhardt. If the patient is being transferred for the procedure and physicians are waiting for the patient to arrive, there would be very little downside to calling the family to discuss the risks and benefits of the procedure. Other times, the patient presents directly to the hospital and physicians have to drop everything to make a treatment decision. “In those situations, it’s less clear. Would you want to get informed consent knowing it would delay the procedure?” asks Regenhardt.
Some clinicians prioritize completing the procedure as quickly as possible; others place more weight in ensuring a well-considered analysis of the patient’s preferences, values, and goals takes place. “Some of us are pretty aggressive about always wanting to get informed consent before the procedure; others don’t think it’s hugely important given the evidence of the efficacy and safety of the procedure,” says Regenhardt.
The researchers are currently surveying physicians on informed consent practices. “We are seeing a lot of variability in the free response comments. People have very strong feelings on either side of this,” says Regenhardt.
The researchers expect to see significant variation in terms of regional locations, background specialty, and who gets informed consent. “That can vary from center to center. At one place, it might be the neurology resident; at another, it might be the neurointerventional attending,” says Regenhardt.
Since thrombolysis for acute ischemic stroke was approved in 1996, uncertainty has surrounded the informed consent process.2 “Some clinicians, especially early after the approval of alteplase for acute ischemic stroke treatment in the zero-to-three-hour time window, obtained written consent,” observes Philip B. Gorelick, MD, MPH, a professor in the Division of Stroke and Neurocritical Care at Northwestern University Feinberg School of Medicine. Other clinicians obtained verbal consent only, or none at all. Clinicians now have the following guidance to clarify consent obligations for stroke treatment:
- The American Heart Association (AHA) issued a 2003 guidance statement recommending that written consent was not necessary but that patients and their families should be informed about the potential benefits and risks of acute thrombolytic therapy.3
- In a 2019 guidance statement, the AHA justified administrating IV thrombolysis in an eligible adult patient with an acute ischemic stroke if the patient could not provide consent and a legally authorized representative was not immediately available to provide proxy consent.4
- In 2022, the American Academy of Neurology recommended that the patient and surrogate be informed about the stroke diagnosis, the rationale for thrombolytic therapy, the prospects for a good functional outcome with and without treatment, and the risks of therapy (including brain hemorrhage and angioedema.5
When physicians are contemplating administration of acute stroke therapies, it is important to consider the patient’s preferences, adds Gorelick. This can be done either by directly questioning the patient or through a legally authorized representative if the patient lacks decision-making capacity. In some cases, a surrogate decision-maker is not available. “In such cases, the clinician may provide treatment based on implied consent, which assumes that a reasonable person faced with similar circumstances would agree to treatment,” says Gorelick.
- Mbonde A, Young MJ, Dmytriw AA, et al. Informed consent practices for acute stroke therapy: Principles, challenges and emerging opportunities. J Neurol 2023 Oct 10. doi: 10.1007/s00415-023-12028-y.
- Comer AR, Damush TM, Torke AM, Williams LS. The role of informed consent for thrombolysis in acute ischemic stroke. J Clin Ethics 2019;30:338-346.
- Adams HP Jr, del Zoppo G, Alberts MJ, et al; Stroke Council of the American Stroke Association. Guidelines for the early management of patients with ischemic stroke: A scientific statement from the Stroke Council of the American Stroke Association. Stroke 2003;34:1056-1083.
- Powers WJ, Rabinstein AA, Ackerson T, et al. Guidelines for the early management of patients with acute ischemic stroke: 2019 update to the 2018 guidelines for the early management of acute ischemic stroke: A guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2019;50:e344-e418.
- 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.
Currently, the two cornerstones of acute ischemic stroke treatment are intravenous thrombolysis and, for patients with large vessel occlusions, endovascular thrombectomy. For treating clinicians, the question becomes: How do clinicians ensure that patients (or their surrogate decisionmakers) make an informed decision while avoiding treatment delays that can result in worse outcomes?
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