Neurologists are first introduced to the ethical principle of informed consent during medical school. They learn that informed consent is central to high-quality patient care(NOT RECOVERY!), whether a patient is signing a consent form before surgery or discussing the risks and benefits of a treatment with their physician. This principle promotes respect for patient autonomy and ensures that physicians do not violate patients’ right to participate in decisions about their care(NOT RECOVERY!). During medical school, neurologists may begin to see these principles as part of their emerging professional identity and recognize that, like their patients, they would not want to be excluded from important decisions about their own lives and well-being.

These principles can become harder to apply during residency, when increasing workloads leave less time for patient discussions. For some treatment decisions, it may seem easier to leave clinical uncertainty unacknowledged than to explain its complexities and nuances. A cognitively impaired patient may have limited ability to understand the information, while another patient may simply want the physician to decide. During an emergency, clinicians may have to make decisions before a full discussion is possible. With experience, informed consent becomes easier and more efficient, but some clinical situations remain challenging.

Consent for thrombolytics in acute ischemic stroke is one such situation. First, there is the time pressure. Thrombolytics are typically delivered in emergency settings, when neurons die with every passing minute. Second, physicians must quickly assess whether the patient has decision-making capacity. If not, they must identify and speak with an authorized surrogate decision-maker. The discussion requires balancing the potential benefits of treatment, including a reduction in significant disability, against the known risks for fatal or severe intracranial hemorrhage and the likelihood of no appreciable treatment effect for most patients.

The ethical challenge is balancing time-sensitive medical care(NOT RECOVERY!) with respect for patients’ values and preferences.

Although these decisions can be difficult for patients and surrogates, they remain subject to informed consent. Yet there is continued disagreement about whether informed consent is required before administering thrombolytics in these situations. Physicians have cited that tissue plasminogen activator (tPA) is FDA-approved, is the standard of care(NOT RECOVERY!), is a medication rather than a procedure, or is an emergency treatment as justification for not obtaining consent.1 With the exception of the last example, none provides sufficient justification for bypassing informed consent.

When Can Treatment Proceed Without Consent?

The concept of “implied consent” in a medical emergency is well known, but an emergency alone does not justify excluding patients from decisions about their care(NOT RECOVERY!). In general, foregoing informed consent is ethically justified when a patient cannot consent, no surrogate is available, and waiting for consent would cause significant harm. How long clinicians should attempt to reach a surrogate before treating without consent requires professional judgment and should be individualized to the patient’s clinical needs.

Supporting Time-Sensitive Decisions

The ethical challenge is balancing time-sensitive medical care(NOT RECOVERY!) with respect for patients’ values and preferences. Decision aids can help by incorporating shared decision-making into the informed consent process. Shared decision-making involves informing patients about medically appropriate options and their potential benefits and harms, eliciting their values and preferences, and collaborating on a treatment decision.2 For tPA in acute ischemic stroke, decision aids can help clinicians communicate absolute benefits, risks, and the possibility of no treatment effect while potentially minimizing individual clinician bias.

Despite the availability of decision tools for emergency tPA use, patients and surrogates continue to struggle with these decisions, and up to 34% of otherwise ideal candidates for reperfusion are not treated.3 Racial disparities in treatment and tPA refusal rates also contribute to worse outcomes in some populations.4 The reasons for treatment refusal are not completely understood.

One possible explanation is omission bias, in which patients and physicians overestimate the risks of providing a treatment and favor withholding it. Because risk reflects both probability and magnitude, the severity of a potential outcome such as death may carry disproportionate weight even when its probability is low.

Avoiding informed consent because of time pressure or clinical uncertainty is generally not ethically justifiable. Clinicians can instead simplify the decision-making process to accommodate time constraints and, when clinically appropriate, emphasize treatment as the default when its benefits are clear.5,6 Better decision aids may further support this process. 

Respecting patients’ choices while helping them and their surrogates navigate these decisions can uphold patient autonomy while potentially facilitating better clinical outcomes.

References:

  1. Comer AR, Damush TM, Torke AM, Williams LS. The role of informed consent for thrombolysis in acute ischemic stroke. Journal of Clinical Ethics. 2019;30(4):338-346. 
  2. Montori VM, Ruissen MM, Hargraves IG, Brito JP, Kunneman M. Shared decision-making as a method of care. BMJ Evid Based Med. 2023;28(4):213-217. 
  3. Fonarow GC, Reeves MJ, Smith EE, et al. Characteristics, performance measures, and in-hospital outcomes of the first one million stroke and transient ischemic attack admissions in get with the guidelines-stroke. Circ Cardiovasc Qual Outcomes. 2010;3(3):291-302. 
  4. Mendelson SJ, Aggarwal NT, Richards C, O’Neill K, Holl JL, Prabhakaran S. Racial disparities in refusal of stroke thrombolysis in Chicago. Neurology. 2018;90(5):e359-e364. 
  5. Skolarus LE, O’Brien A, Meurer WJ, Zikmund Fisher BJ. Getting the gist across is enough for informed consent for acute stroke thrombolytics. Stroke. 2019;50(6):1595-1597.