The Challenge of Informed Consent for Good Outcomes

Not every good outcome is benign.

The Frontier Psychiatrists is a daily-enough health-themed newsletter. Today is a meditation on a topic that's been bugging me.

What happens when we have outcomes of our treatments that can profoundly disrupt the lives of our patients, but not because they're bad? Not because they're adverse, per se, but because lives were built around living with an illness. An illness, after treatment, they no longer have to grapple with. What information do we have to include in our informed consent, then?

Do we have to have a process or special consideration to consent for treatment…that might work?

So here's the deal. With accelerated transcranial magnetic stimulation, particularly with SAINT neuromodulation (which targets the most anti-correlated region of the left dorsolateral prefrontal cortex with the subgenual cingulate cortex), the remission rate from depression is extremely high. In published studies, it's on the order of 79%.¹ What those numbers don't tell you? They leave out what it's like to live your life with crippling depression—so bad you're sure it's never gonna change. And then, all of a sudden, after just five days of treatment, you can have that whole story you've been telling yourself your whole life abruptly turn.

People with chronic depression and other chronic medical conditions make lives that are a giant series of compromises. They're constantly negotiating little cease-fires with their own lives. It's an uneasy truce. I'm gonna take this job, which won't challenge me too much, so that when the depression gets bad, I can coast. I will not get fired, that way. I can get into a relationship with somebody who will put up with me when I'm depressed! I can make a compromise. I can make another compromise. Lives are built around a series of compromises with illness. Everything is a calculated decision to avoid the catastrophe that is the next relapse, the next exacerbation, the next medicine not working. This makes sense, when you think everything's going to fall apart the next minute, because that's happened to you throughout your entire life.

Then, a treatment comes along, like this fMRI guided treatment that works all at once. And now, all of a sudden, not only is your depression over, but so is the story you told yourself about that depression. Instead of assuming your entire life will be a series of depressions, some deep, some more shallow? You can tell yourself a different story. You can hope for more.

And this hope for more? It means you might hope for a different job. It means you might choose a different partner in life. You might leave the person you're with when you realize that they were a compromise, too. You might leave your job but when you realize it was a hedge. You might stop negotiating little treaties with the annoyances of life, and you might go big, and take a risk. That risk? It could go badly. Having the energy and enthusiasm to fall in love again? You could fall in love with someone who's bad for you. You could leave a partner who is actually pretty good for you, on the basis of a new state of mind.

You could leave a job. You might make a move…that goes badly. You might buy a new house. You might move to a beach. You might do all sorts of things. Some of these things can go badly. Some can be very disruptive, even if they go well.

But if you spent decades building your life around depression, you probably don't have the same practice making decisions of the kind that people who are not depressed do. You're making new decisions about a new life without the experience of everybody else! They have been doing this not depressed life the whole time! That, itself, can be disruptive.

We don't have a great model for this, as healers. We don't have great language to describe it, we don't track excellent outcomes in the same way we track adverse events. Is it an adverse event to leave a partner…who's not a good fit for you? It does seem like the kind of thing we'd want to know. When I'm describing what a treatment is likely to do for somebody, I probably want know if it's apt lead to a divorce. Does it only add risk for divorces from bad partnerships? Is it causing divorces from great partnerships also? I just don't know, because we don't have a systematic way to capture this information.

We don't have a great outcome tracking system. We don't know what to do with the complexities of people's dynamic lives. We are so used to looking at the adverse events we cause—movement disorders, obesity, dry mouth— that we don't contemplate capturing someone's mouth getting dry because they met someone they fell in love with, even if they run away from everything in their life that they knew before. We don't contemplate the remarkable and rapid change that can happen on depression lifts.

When treatment goes well, it can still be unsettling, sometimes just as unsettling as the illness itself. For now, I include this information in my informed consent process, because I've seen enough of it. I know having a better life is a risk. I know it's a risk people need to prepare for. I know it it's a risk they can almost, axiomatically, not prepare for while they're still depressed. I tell them in advance, and I'm not sure they believe me.

If you're one of my patients reading this, and you think I'm writing this about you specifically? I’m not. It turns out there enough of you in this position for this to not be about you, specifically. Having an abruptly different life, even a better one, is not a trivial outcome, and we need to be prepared for it.

1. Cole, E. J., Stimpson, K. H., Bentzley, B. S., Gulser, M., Cherian, K., Tischler, C., ... & Williams, N. R. (2020). Stanford accelerated intelligent neuromodulation therapy for treatment-resistant depression. American Journal of Psychiatry, 177(8), 716-726.