Dr. Sarah Lisanby answered questions during the U.S. Food and Drug Administration Neurological Devices Panel examining the reclassification of electroconvulsive therapy (ECT) devices on January 27, 2011. These are her answers as published in the public record of the meeting.
So my name is Dr. Sarah Lisanby. I’m happy to answer your question about the informed consent process for electroconvulsive therapy, which is a very detailed and important process, and guidance is given to practitioners in the APA Task Force guidelines on ECT, and it includes a sample of the informed consent document.
The informed consent process is more than simply having the patient sign a form. The form itself documents a process that occurs between the clinician and the patient, and usually also family members are involved in this, where all of the risks and benefits are carefully detailed, the alternatives to treatments are discussed. Alternative treatments besides ECT include medications or psychotherapy, and these risks and benefits of the alternatives are weighed relative to the risks and benefits of ECT.
This process is quite extensive, and we do carefully go through each of the major and most common side effects of ECT. In particular, the different aspects of the effects of ECT on memory are very thoroughly covered. Also the risk of the anesthesia itself, how long these risks are expected to last, how long their therapeutic benefit is expected to last, all of this is discussed.
I typically perform the informed consent process days to weeks prior to the first treatment when the patient comes for a consultation to discuss whether ECT or other treatments may be appropriate for them. So it’s not typically done, in my practice, on the day of the treatment, but rather in the days to weeks prior to the first treatment. Usually this is, in my own practice, in collaboration and in the presences of the family members of the patient’s choosing. Often it could be the spouse or other family members who are present, and how long the process takes is variable. I would say at minimum we spend at least, in my practice, 90 minutes in my initial consultation, but the duration of time is variable. The informed consent process could last beyond that initial visit. It could be on follow-up visits.
DR. BROTT: How long does the consent process take? I’m sure you don’t take 90 minutes with the form. How long is the consent process itself with the form?
DR. LISANBY: Well, I would say once I’ve presented the form and we’re at that stage — and the typical informed consent forms are several pages long. Our sample APA ECT consent form, I don’t have a copy with me, but it is several pages long. The one that we used at our hospital was multiple pages, and it does take time for the patient to read through this, for the family to read through it. Oftentimes they take it home and come back at the next visit and discuss it and answer their questions. So to answer your question, how many minutes this takes, it is variable. I would say, you know, minimum in my own personal practice, at least 30 minutes face-to-face giving them the form initially and then oftentimes they come back for another visit and we continue the discussion, which is why when I did say 90 minutes, I wasn’t exaggerating. It is a process that —
Persistent Memory Loss with ECT
The rate of persistent memory loss. So in discussing the risks of memory loss with patients who are contemplating ECT, I explain the different types of memory that could be affected by the treatment. One distinction is memory for the ability to learn new events, which is anterograde amnesia. The other form is memory for past events, which is retrograde amnesia.
The evidence shows, and I explain this to patients, that anterograde memory, which is the ability to form new memories, that is typically a transient problem that is not, according to the published literature, anterograde memory loss has not been shown to be persistent over the long term. 106
So when you talk about risk of persistent memory loss, what we’re referring to is the retrograde amnesia, and there are different types of retrograde amnesia depending on how long in the past the memories were formed, and so that can be broken up into recent events and remote events. Recent events could be events that happened in the days or even hours prior to the treatment, and remote events could be the weeks to months prior to the treatment. And I explain to patients what the published evidence suggests about the differential vulnerability of recent and remote memories to memory loss and persistent memory loss, and this has been thoroughly studied.
To summarize that, the events from earlier in life, from the months to years prior to the first treatment, the effects of ECT are less on those more remote memories, whereas the effects of ECT have been more seen in the recent memory, a closer time to the treatment, and so even though there may be cases where there is some memory loss for the near term or remote events, over time, these memories begin to come back. Evidence suggests that there is some recovery of some of that memory, but in terms of persistent retrograde memory loss, that has been, according to the evidence, found to be most marked for the events that occurred close in time to the treatment.
Another View of Informed Consent in ECT
From Lauren Tenney, M.Phil., M.A., M.P.A.
MS. TENNEY: Besides being in special education when I was 15 years old, I’m a Ph.D. candidate, and I’ve spent a lot of time working on issues of informed consent. There’s an article by Michael Cummings and his colleagues called “How Informed Is Informed Consent?” where they looked specifically at mental health treatment and found that well over half of the people that were saying to be giving informed consent weren’t. Informed consent is actually two different processes that need to be held out. The first is informing, which contains four different things of giving information, giving options, giving time, and then reassuring that the person understands what you’re talking about, and the consent, which is a three-step phase process which includes reviewing all the information that they have, making of the options of what they’re taking or doing, and having the amount of time for somebody to then be able to withdraw that consent. One of the most important things about informed consents is that it is an ongoing and continuing process. Once the form is signed, it is not over. At any given point, somebody can revoke their consent. What’s happening in many states, and in New York State specifically, is that people aren’t even being given — well, first, if you don’t have all the information, you can’t really give informed consent. So the idea of down-classifying the shock machine without doing any kind of safety and efficacy testing further removes the opportunity to give real informed consent.
In New York, they don’t require informed consent. They take you to court, and they court-ordered 200 rounds of electroshock to somebody who they later found out was linguistically isolated and spoke Spanish, and that was why they couldn’t communicate with the woman, and the state, they knew the injunction came down, and the state shocked her that day even though they knew that they were supposed to stop doing it.
And so when you’re looking at forced treatment, which the Federal Government has said is a failure of the system, and that that alternative needs to be —
DR. BROTT: I have to ask you to wrap up your answer.
MS. TENNEY: Yeah, absolutely. But I mean to understand, the most essential part of the informed consent is that it is ongoing and that it is hierarchical, and you can’t get to one step without the other. So to say something happens, that somebody gives informed consent in 15 minutes, by the definition of informed consent, it’s impossible because you’re supposed to have a very good amount of time to be able to consider your options and weigh them out before you decide to enter into this.