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Consent for Thrombolysis: More Ethics than Science

By Currents Editor posted 18 days ago

  
Matthew N. Jaffa, DO and Evie G. Marcolini, MD

Nearly every clinical decision presents us with the opportunity to lean into the historical ethos attributed to Hippocrates to “first, do no harm”, and to provide appropriate, beneficial, and safe care for our patients. If there is potential for harm, we of course will disclose this to the patients and family. The process of shared decision making and consent takes time; how should one balance the importance of informed consent against the risk that the passage of time would decrease efficacy of care? Such a conundrum arises regularly in the case of acute ischemic stroke (AIS). 

Bill is 81 years old and arrives to the Emergency Department 3.5 hours after the sudden development of garbled speech and right sided weakness.  The well-oiled machine of the stroke code team is activated.  Medical students observe the following discussion between the Emergency Medicine (EM) and Neurology (Neuro) teams: 

EM: Hey Neuro, we have another stroke patient down here.  Pretty clear story and no hemorrhage on imaging. 
Neuro: OK, you’ve mixed the tPA right? 
EM: Slow your roll, Neuro, let’s take a minute to talk about this case before jumping to therapy.  I’m concerned that this patient doesn’t know what is happening to him, and he is in no state to appreciate the risks and benefits, or make a reasoned decision on whether he wants thrombolysis. 
Neuro: But for every second we wait millions of neurons are dying!  Thrombolysis is standard of care and will make a real difference in Bill’s life. 
EM: ACEP guidelines only provide Level B evidence that tPA should be offered within 3 hours of last known well and may be offered to select patients within 4.5 hours. 
Neuro: Multiple meta-analyses have shown that tPA benefits patients up to 4.5 hours from stroke onset, regardless of age, stroke severity, or the potential increased risk of symptomatic bleeding.  Haven’t you read the studies showing that older patients regard severe deficits following stroke as the same or even worse than death?1 
EM: Yes, but we’ve also read Dr. Creutzfeldt’s work on the disability paradox and decision making for the future self.  She might argue that some patients may adapt well to their deficits, so prognostication and previously noted decisions may be less certain.2  There is still a nonzero risk of Bill ending up worse than when he arrived. 

This conundrum plays out frequently.  As physicians, we regularly slide along the continuum between a paternalistic or more customer-oriented approach.  At one extreme, physicians simply prescribe therapies, while at the other end, clinicians are more customer-oriented and offer a menu of possible therapies for patients to select.  It is important to be cognizant of our position on this continuum, as well as our potential for biases in interpreting clinical evidence. 

In the setting of AIS, similar to cardiac arrest, time is of the essence.  CPR is lifesaving and thus started with the presumption of implied consent.  While treatment for AIS is rarely lifesaving, its omission can be life changing.  As time passes, therapy becomes less effective and potentially unsafe.  One survey found that desire for thrombolysis in stroke is as desirable as CPR for cardiac arrest.3  In fact, the AAN endorses the use of tPA within three hours of symptom onset as standard of care, qualifying for implied consent, and has recently published a position statement noting that “when surrogates are not present, it may be reasonable to proceed with treatment on the presumption of consent when patients’ cases fit extant inclusion/exclusion criteria, contraindications (particularly, absolute contraindications) are absent, and the overall balance of risks and benefits strongly favors intervention.4” 

There are limits to the physician-patient discussion, even in the ideal scenario in which all parties have ample opportunity to discuss AIS and the therapies available. Physicians come to the table with biases that affect how they frame discussions and hence may sway the patient/surrogate’s decision.  The medical community has not come to universal agreement on the risk/benefit profile of tPA in AIS, and thus may give mixed messages to patients and their families. On the other hand, a physician’s approach to the physician-patient discussion may be as important as the intervention itself. 

Let’s review the common arguments for and against obtaining thorough informed consent for tPA in the setting of AIS. 

Consent Is Necessary

  • The patient deserves to know that this is a medication with associated risk.
  • It is ethical to involve the patient/surrogate in every decision that can affect his outcome
  • We have agreed to “do no harm”.
  • Consent does not significantly prolong the time to administration (For those obtaining consent, one study showed that more than half of physicians spent between 0- and 1-minute providing information and obtaining consent about tPA, while none considered spending more than five minutes on this aspect of care.)5  

Consent Not Needed

  • tPA is a medication, not a procedure – thus doesn’t need consent.
  • Systemic thrombolysis is the standard of care.
  • Consent prolongs time to administration of tPA, which is associated with worse outcome.
  • There is no agreement within the medical community, and there is an abundance of scientific technical data to weed through; we can’t possibly provide an unbiased consent process to a patient or surrogate.
  • The patient is under stress in a crisis situation and cannot be expected to understand the implications of risk or make a rational decision. 

This conflict of opinions on the importance of consent creates a palpable ethical tension between respect for patient autonomy and the desire to optimize patient outcome.  If we prioritize autonomy and decide to obtain consent, patient outcomes may be affected if the patient’s  decision making capacity is impaired by the situation, stress, and/or lack of understanding of the risks and benefits. Either way, we may not be able to recognize and restrain our bias. Is it ethical to let our bias influence our conversation?  What if the family asks “What would you do?” – is it ethical to show our preference? 

These are challenging ethical questions, not easily answered through the lens of Beauchamp and Childress’ principles of respect for autonomy, beneficence, non-maleficence and justice.   

In this scenario, we suggest invoking narrative ethics in order to discern who Bill is, what his values are, and whether the care that we are offering is concordant with his goals.  Once these questions are answered, if possible, then the physician can be an invaluable asset to help determine which course of action would suit the patient’s narrative.  There is no foolproof method of figuring this out, and the most ethical course of action is to do our best to bring the patient’s story and the physician’s knowledge together to make the decision that seems to fit the patient’s goals best. 

References

  1. Hanger HC, Fogarty B, Wilkinson TJ, Sainsbury R. Stroke patients’ views on stroke outcomes: death versus disability. Clinical Rehabilitation. 2000;14(4):417-424. doi:10.1191/0269215500cr330oa.
  1. Creutzfeldt CJ, Holloway RG. Treatment Decisions for a Future Self: Ethical Obligations to Guide Truly Informed Choices. JAMA. 2020 Jan 14;323(2):115-116. doi: 10.1001/jama.2019.19652. PMID: 31895421.
  1. Chiong W, Kim AS, Huang IA, Farahany NA, Josephson SA. Testing the Presumption of Consent to Emergency Treatment for Acute Ischemic Stroke. JAMA. 2014;311(16):1689–1691. doi:10.1001/jama.2014.3302.
  1. Sattin JA, Chiong W, Bonnie RJ, Kirschen MP, Russell JA, on behalf of the Ethics, Law, and Humanities Committee, a joint committee of the American Academy of Neurology, American Neurological Association, and Child Neurology Society. Consent Issues in the Management of Acute Ischemic Stroke: AAN Position Statement. Neurology. 2022;98(2): 73-79. doi: 10.1212/WNL.0000000000013040.
  1. Zonjee, VJ, Slenders, JPL, de Beer, F et al.Practice variation in the informed consent procedure for thrombolysis in acute ischemic stroke: a survey among neurologists and neurology residents. BMC Med Ethics. 2021; 22: 114. doi.org/10.1186/s12910-021-00684-6.

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