IA Stroke Treatment: Informed Consent Issues

I just posted this to the AAN’s Stroke Section ListServ and figured I’d cross-post it here as well. For those interested in stroke, I encourage you to join the ListServ. I’m actually not sure about how to register, but this link takes you to the main page, and I think it will prompt you to register if you haven’t done so already. Over the past few days, there has been some very interesting discussion of how different centers are changing (or not changing) their practices after the 3 negative IA trials. Heavy hitters such as Joe Broderick, Jim Grotta, and Bill Powers have been weighing in . . .



I’ve appreciated the recent discussion about the evolving state of affairs in acute endovascular stroke treatment. Much of that discussion has understandably centered on the recent trials and various perspectives on how to interpret the data and incorporate them into our practices. I thought that it might be worth sharing with the group a recent Wisconsin Supreme Court Decision that, in this state, may have implications for the debate.

The case was of a man who presented to an ED with unilateral facial weakness. After a clinical evaluation and head CT, the ED physician diagnosed Bell’s palsy. A short time after, the patient had a severe stroke and was found to have a high-grade contralateral carotid stenosis. The patient sued the ED physician for malpractice on account of what was allegedly a missed diagnosis in the ED. (And from what I can tell from reading the decision, the diagnosis probably was missed–there were aspects to the presentation that should have raised such concerns, such as abrupt onset, dysarthria, etc.) Nonetheless, the jury found that the ED physician’s care fell within the standard.

However, the patient also claimed that the ED physician, by not offering him a carotid Doppler study, had failed to fulfill her duty to obtain informed consent. On this count, the jury found for the patient and this was affirmed by the appellate court. The Supreme Court issued a divided opinion, but at the end of the day, they ruled that Wisconsin’s informed consent statute pertains not only to the treatment of a patient’s condition, but to the evaluation of a patient’s condition. If a “reasonable patient would want to know” that a diagnostic test exists that could affect the final diagnosis and treatment plan, then the physician is obligated to offer it even if she feels that she’s ruled out the diagnosis in question. Fuller commentary can be found here, and the actual decision is here.

Assuming that a target lesion is present, whether to pursue IA therapy for an acute stroke patient is a treatment rather than a diagnostic question. Still, the above ruling may have to affect the discussion with the patient and family. It is arguable that a “reasonable patient would want to know” that IA treatment exists, that although some neurologists are conservative in recommending IA therapy given current evidence, others, and especially neurosurgeons and neuroradiologists, remain convinced of its benefit. To not offer it at all might open the door to an informed consent claim should the outcome be poor and the patient and family inclined toward legal remedies.

So how has my practice changed in response to the recent trial results? I used to describe IA treatments as unproven but showing some promise–a reasonable consideration for someone, especially younger patients, having a severe stroke. Now, I describe them as a technologies that seemed to be quite promising, but for which recent studies were unfortunately negative. The technology continues to evolve and intervention can still be considered in certain cases, but we must all be clearly aware that we just don’t know if and for whom they are beneficial. Those two statements might not look very different on screen, but basically I’ve shifted my tone of voice from slightly bullish to moderately bearish. My point, however, is that I do still discuss the option and give the patient and family a say in their care and document this. Although I think that the jury verdicts and the courts’ decisions in the above case were flawed, I won’t argue against the principle of patient- and family-centered care.

For the record, I would very much prefer to have an endovascular trial to offer such patients, but navigating the political and financial hurdles has been very difficult. I’m still plugging away . . .

Disclaimer: I’m a neurologist and not a lawyer; the above is my personal commentary and not legal advice.

About Justin A. Sattin

I'm a vascular neurologist and residency program director. I created this blog in order to share some thoughts with my resident and other colleagues, and to foster my own learning as well.
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