Informed consent requires clear communication in acute ischemic stroke

 With an objective damage diagnosis and EXACT REHAB PROTOCOLS THAT GET YOU TO 100% RECOVERY informed consent is a no-brainer, so solve this problem the correct way; 

1. Objective damage diagnosis

2. Exact 100% recovery protocols
   

Informed consent requires clear communication in acute ischemic stroke

Key takeaways:

• Researchers conducted a literature review for informed consent with acute ischemic stroke.
• Decisions should balance a patient’s wishes, decision of a surrogate and physicians’ knowledge of treatment options.

DENVER — In acute ischemic stroke requiring thrombolysis, informed consent requires communication and balance between the wishes of the patient, surrogates and physicians, according to a literature review.

“Any physician that is treating acute stroke patients at the bedside knows that there are perfect candidates for thrombolysis and less ideal candidates,” Alexis N. Kaiser, MD, resident appointee in the department of neurology at Indiana University School of Medicine, told Healio in a poster presentation at the American Academy of Neurology annual meeting.

Results of a literature review found that informed consent in acute ischemic stroke requires the patient, surrogates and physicians to communicate as much as possible to provide the clearest picture for treatment. Image: Adobe Stock

“We are put under time pressure to make these determinations very quickly.”

The American Academy of Neurology’s 2022 position statement on consent in case of acute stroke stipulated that verbal consent of patients “should be obtained and documented in the medical record by the treating physician.”

Kaiser and colleagues sought to review existing literature that related to ethical issues of informed consent in this patient population. Prior research shows a division among health care providers on the necessity of consent prior to thrombolysis, with 38% disagreeing that consent is necessary, while 33% of neurology trainees and 215 of neuro-related staff reported rigorous pursuit of informed consent prior to the procedure.

Their review encompassed 15 academic works that addressed the nature of consent when thrombolysis may be necessary with acute ischemic stroke, yielding three separate modes of thought:

• Emergency consent, where the decision is made by a physician team when either the patient or surrogate is unable to participate;
• Shared decision-making, which embraces a collaborative approach that matches best with the treatment plan as well as the patient’s wishes;
• Informed consent, meaning the decision is made by the patient after receiving the best available evidence for intervention by the treating physician.

Additionally, Kaiser and colleagues’ review revealed perspectives from patients, surrogates and physicians, with opinions ranging from the patient’s view that acute stroke treatment is akin to more intensive responses like cardiopulmonary resuscitation and some patients might prefer death to disability; surrogates face uncertainty and a lack of preparation to make such a decision and advanced care documents lack nuance to properly guide their course of action; and care teams proceed with the mantra “time is brain” while attempting to balance mental and physical capacity assessments and legal ramifications.

The review further elucidated issues of framing discussions of care based on benefit/risk analyses, the lack of a standardized approach to treatment plans as well as perceptions of disability that differ between patient and physician.

“There is some discord in the field on ‘should we frame something positively or negatively, is that unethical?’” Kaiser noted. “It is our responsibility to give our best medical recommendation ... as long as the patient is able to ask questions.”

Reference:

Sattin JA, et al. Neurology. 2022:doi: 10.1212/WNL.000000000013040. Published Jan. 10, 2022. Accessed April 16, 2024.

Sources/Disclosures

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Source:

Kaiser AN, et al. Defining informed consent in acute ischemic stroke: Patient, surrogate decision maker and physician perspectives. Presented at: American Academy of Neurology annual meeting; April 13-18, 2024; Denver.

Disclosures: Kaiser reports no relevant financial disclosures.

Ethics Consult: Inform Patient of Lower Success Rate? MD/JD Weighs In

What do you think? Should your emergency room doctor tell you that getting tPA has only a 12% full recovery rate and if you don't get it you'll be massively disabled or die in 30 days? Your spouse might have a conniption fit upon hearing such miserable odds.  Or do you want to know if your doctor has performed 50 cases of this type?

To Master Stroke Thrombectomy, It Takes Way More Than 50 Cases

The latest here:

Ethics Consult: Inform Patient of Lower Success Rate? MD/JD Weighs In

Welcome to Ethics Consult -- an opportunity to discuss, debate (respectfully), and learn together. We select an ethical dilemma from a true, but anonymized, patient care case, and then we provide an expert's commentary.

Last week, you voted on whether a doctor should disclose another surgeon's higher survival rate.

Yes: 86%

No: 14%

And now, bioethicist Jacob M. Appel, MD, JD, weighs in.

Informed consent is one of the foundations of modern Western medicine. In order for patients to make meaningful decisions about their healthcare, they have to know the potential risks and benefits of each of these decisions. In fact, being able to state the risks and benefits of a given medical intervention is one of the requirements for determining whether a patient is mentally sound enough to make his or her own choices.

At the same time, physicians are not expected to outline all of the risks of a particular intervention. For example, during an appendectomy, it is theoretically possible that a patient might fall off the operating table, hit their head, and suffer brain damage -- but the chances are rather remote, so this is not a part of the standard informed consent for the procedure.

The truth is that, with regard to cognitively intact patients, "informed consent" is actually a misnomer. It does not matter whether the patient actually understood enough to consent meaningfully; what matters is that the physician provided sufficient information for a "reasonable" or ordinary person to have understood the risks and benefits. Some plastic surgeons even record their informed consent process on video, so that in cases of alleged malpractice they can prove to a jury precisely what they said.

Why such an objective "reasonable person" yardstick? Because a subjective approach (i.e., one that asks whether this particular patient actually understood the risks) would open the door to second-guessing and even outright perjury by the patient at a future malpractice trial. Hindsight is 20/20. Football fans understand how easy it is to play Monday morning quarterback. Unfortunately, even with rigorous standards, informed consent often fails to serve patients' needs. Medical historian David Rothman reported in 2006 that "anywhere from 25% to 50% of patients and subjects do not understand what they have agreed to."

Physicians are generally not expected to share the success rates of other providers -- although there might be an exception at the extremes: a physician who has never performed the operation before, for instance, might be expected to reveal this information to a patient. However, society generally places the burden on the patient to "shop around" or to get a second opinion.

If Bonnie had asked the doctor directly whether other physicians could perform the aneurysm repair better, he would be wrong to lie point-blank, but he could probably get away with simply telling her that he cannot speak for the success rates of other providers.

One should note that an alternative rule, which would compel physicians to share their comparative success rates, might have the unintended consequence of steering traffic toward a handful of first-rate providers.

Over time, fewer surgeons would master the technique for aneurysm repair, and overall access to quality care might be reduced. Success rates can also reflect the patient population served, so compelling surgeons to share their outcome data might lead them to cherry-pick their patients -- making it more difficult for the sickest patients to find providers.

Finally, in many cases, sharing such information would help only wealthy patients: if a patient lives in poverty in a housing project in New York City, being told that the success rate for treating a particular condition is better at the Mayo Clinic in Minnesota may not prove very helpful. If the patient cannot get to the Mayo Clinic, this knowledge will not help medically, and could harm the patient psychologically.

Jacob M. Appel, MD, JD, is director of ethics education in psychiatry and a member of the institutional review board at the Icahn School of Medicine at Mount Sinai in New York City. He holds an MD from Columbia University, a JD from Harvard Law School, and a bioethics MA from Albany Medical College.

And check out some of our past Ethics Consult cases:

 

 

Shifting From Informed Consent to Informed Refusal of Intravenous Tissue-Type Plasminogen Activator

I don't know what the percentage is of hemorrhage after tPA administration but it is non zero.
This problem could be solved by directed use of tPA via magnetic  nanoparticles carrying a much smaller bolus of drug because it would be delivered directly to the site.  But we seem to have no one in the stroke world that publicly acknowledges the problems in stroke and is working on a strategy to solve those problems. This is so fucking easy. You specifically describe the problem, hire researchers to solve that problem. Write up a stroke protocol based on the research that addresses the problem in real time.We must have incredibly stupid people out there.
http://circoutcomes.ahajournals.org/content/8/6_suppl_3/S69.extract?etoc

1. Lee H. Schwamm, MD

+ Author Affiliations

1. From the Department of Neurology, MGH Stroke Services, Fireman Vascular Center, Massachusetts General Hospital, Harvard Medical School, Boston.

1. Correspondence to Lee H. Schwamm, MD, Department of Neurology, ACC 720, Massachusetts General Hospital, 55 Fruit St, Boston, MA 02114. E-mail Lschwamm@partners.org

Key Words:

• Editorials
• decision making
• health services research
• thrombolytic therapy
• tissue plasminogen activator

In this issue of Circulation: Cardiovascular Quality and Outcomes, Decker et al¹ have described a qualitative study to better define the type of information and the best methods of display to enable patients to express their preferences toward emergency treatment of stroke with intravenous tissue-type plasminogen activator (tPA). Ten focus group interviews were conducted among stroke survivors, caregivers, emergency physicians, and nurses, and then based on their findings, the Rapid Evaluation for Stroke Outcomes using Lytics in a Vascular Event (RESOLVE) decision aid tool was developed. This work is an extension of the previous work by the authors in developing a similar tool for shared decision making in nonurgent percutaneous cardiac interventions. They found that patients and caregivers want simple graphs that show the increased chance of recovering to independence, not to perfection, in general and for their individual circumstances, while understanding the risks involved.(But are you going to tell them that tPA only fully works 12% of the time?) Providers had concerns about the process itself and voiced skepticism about the underlying efficacy and safety data of tPA, particularly the risk of hemorrhage and the ability to have meaningful discussions of risk and benefit in such an emergent setting. This skepticism is echoed in the recent modification of the American College of Emergency Physicians statement downgrading the level of evidence supporting the use intravenous tPA in stroke and calling for shared decision making, when feasible, between the patient (and his or her surrogate) and a member of the healthcare team that includes a discussion of potential benefits and harms before the decision …