Informed Consent for ECT
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.