Informed Consent

by John Graham-Pole

Ed’s* cancer is rising up out of his pelvis, pressing on his left kidney and transverse colon. Clumps of malignant cells are strewn through his bone marrow. NHL—non-Hodgkin lymphoma—stage four. At eighteen, he’s one of the most compliant adolescents I’ve cared for in twenty years of pediatric oncology. He sails through six hefty rounds of chemo and looks on the road to cure. He makes the dean’s list in our university pre-med program, switches to clinical psych for his PhD.

Then five years almost to the day, his cancer recurs. At twenty-three, Ed is his own man. He decides it’s time for medical oncology to take over from us peds guys. He makes it through four more rounds of chemo plus a couple of thousand rads abdominal irradiation. Hardly plain sailing this time, but he emerges in total remission once more. We run a joint SCT—stem cell unit—with the internists, and we all agree: Ed’s heading for a transplant. At our weekly SCT meeting, Hal, the oncologist on service this month, announces his plans.

“An allogeneic transplant’s not an option—no matched donor. But we checked Ed’s marrow yesterday. It’s ninety percent repopulated, not a cancer cell in sight. I’m thinking to harvest and freeze his stem cells next week, then bring him straight into the unit. We’ll use our busulfan-cytoxan protocol for myeloablation, plus T-cell immunotherapy, then reinfuse his stem cells. Strike while the iron is hot.”

But Ed has been keeping in touch with me. And he’s been sharing a very different scenario.

“There’s a wrinkle,” I tell Hal. “He maybe didn’t mention it, but Ed’s planning on getting married. This coming weekend.”

“Hell, he kept that close to his chest.” Hal looks disconcerted for about ten seconds. “So can’t he rearrange his schedule?”

He doesn’t get it.

“No, Hal. He’s been figuring out the odds against coming out of the unit alive. With his immunity shot to hell after you ablate him, ten rounds of heavy chemo, and that abdominal RT under his belt already. That’s the very reason they’ve moved their wedding date up.”

I let this sink in. We’ve all had our private conversations. Knowing what we know, would we put ourselves through SCT? Our partners? Children? Six weeks-plus of utter misery, twelve months or more of recovering to full function. A real likelihood of permanent organ damage—liver, lungs, heart, kidney, psyche. You name it.

“He hasn’t consented yet, has he?”

Everyone around the table is still groping with this whole exchange. Hal’s pause lasts a little longer than ten seconds.

“No.”

I don’t say it out loud, but Hal had better be ready for a tough informed consent session. For Ed taking charge. We all pay lip service to that word “autonomy.” To Ed, though, it really does mean, ‘You don’t decide. I do. No imposing your own opinions about what’s best for me.’ He’s not just smart, he’s feisty. He’ll want chapter and verse on what he’s in for—complete with every stat Hal can come up with. Ed knows his Nuremberg Code; he’s read all those bioethics issues our institutional review board likes to press on us with every SCT protocol we submit for approval. He had already put his senior undergrad thesis proposal through, planning to look at children and their placebo response in ADHD drug trials. And he’d tripped over more than a few ethical stumbling blocks of his own with the IRB.

“Well, we sure can’t afford to wait too long,” Hal says finally. “Surely he’ll see that. How long a honeymoon are they planning?”

“You’d have to ask him that. Why don’t you just plan to hold off a couple of weeks?”

*

A month later, Hal is sitting down to consent Ed in our social worker Penny’s office. His new bride, Alice, sits close beside him on the couch, with Penny on the seen-better-days spare chair. Later on, Penny gives me feedback. Ed had listened intently as Hal had run through the five-page consent form and finished up his spiel. Then he pressed his oncologist on the exact risks of not emerging alive. How big was the danger of fatal infection? How about long-term damage to his liver, kidneys, and lungs? And what about fathering children with his bride-to-be? He’d finished up by requesting copies of every research study Hal had to back up his recommendations. Hal had hurriedly set up a second meeting, this time arming himself with even more research articles and citations on SCT for relapsed and heavily pre-treated NHL.

Penny must have been taking notes of her own; she has this second session down verbatim. Once again, Ed had listened carefully, then plunged Hal into hitherto uncharted waters.

“What exactly is your nursing coverage at night?”

“Well, I’d need to check on that.”

“Do any of you SCT docs sleep in the unit?”

“No. But the on-call attending is always a quick phone call away. Twenty-four-seven.”

“So—you’ve got dedicated resident coverage at night?”

“Pretty close to it. There’s a senior resident covering the oncology floor, with ready access to the SCT unit. And the ICU guys are three floors above us.”

“So how do folks deal with living twenty-four hours day-in, day-out under that laminar air flow set-up? For six weeks, maybe longer?”

“Yeah, it’s tough.” Hal doesn’t come up with anything more on that one.

“How about privacy? How much can Alice and I expect? We wouldn’t be too crazy about docs and nurses wandering in and out at all hours without a by-your-leave.”

This is way outside Hal’s purview, and he’s not about to quiz Ed. Exactly what conjugal rights does he plan to exercise during his prolonged spell of close-to-zero white cells and platelets?

“I’d have to talk to our nurse manager about that. I mean, just how far we can stretch things.”

Penny pauses, grins wryly at me. “It was getting pretty tense in there, John. Ed had all these questions off pat. But I could sense his fear right there under the surface. And he’s trying to keep it from Alice, with her all set to break into tears any moment. Meanwhile, Hal’s getting more and more frustrated, and beginning to show it. He’s just not used to this kind of interrogation. And I don’t think he was getting that this wasn’t just Ed wanting every last clinical fact. That a lot of it was simply cover-up for the emotional turmoil he was in. His way of coping, and trying to take care of both his bride and himself. I really don’t think he could absorb all that information he was trying to get out of Hal.

The session had finally wrapped up. Ed had shaken Hal’s hand and thanked him warmly for all the trouble he’d gone to. Then announced he was going to interview us two peds guys too.

“It’s not that I don’t have every faith in your oncology team. It’s just I’ve known those docs a whole lot longer. And I want to be sure you’re all on the same page.”

He interviews my pediatric buddy first, then finally gets around to me. Alice is again sitting beside him on the couch in Penny’s office. She makes it clear the final decision is Ed’s and Ed’s alone. I spend time chitchatting about the wedding, and about their honeymoon plans once everything’s behind them. I feel the atmosphere ease as Ed and Alice let themselves glimpse beyond the ordeal ahead, contemplate their future together. I finally cut to the chase.

“Ed, Alice, I don’t think you want me to snow you with lots more facts and figures. You’ve had a fistful of those already. But maybe just a bit more about what to expect if you do decide to go ahead with the transplant. There’ll be some real rough patches, for sure. It’s something I wouldn’t want my own family to have to go through. But I know you, Ed, and I know you can do this. Of course there are options, though. You don’t have to put yourself and Alice through it. Maybe you want to talk some more about those options?”

“We pretty much understand that, doc. Essentially, we could buy some time with lighter therapy. But we know what the outcome would come down to in the end.”

We chat back and forth for another thirty minutes, Penny adding her own comments about how others get through. Some things she knows have been helpful. I do a lot more listening than talking. Then Ed sits back, his arm still round Alice, and looks full on at me.

“Thanks. You didn’t pull any punches. But you sound pretty hopeful. Gives me the confidence I’ve been needing. I’m ready to sign.”

*

The day he enters the SCT unit, Ed gives our nurse manager copies of his own documents: his power of attorney and personal directive, both naming Alice, and their typed-up personal privacy requests.

“Look, I know your nurses have got to check me out at least once a shift. Absolutely fine. And if any staff decide there’s a problem, then I’m cool with whatever they need to do. But Alice will be there with me twenty-four-seven, and she’s seen me through plenty already. I think she’s going to know right off if I’m in any kind of trouble.”

I check in with Ed and Alice that first evening before I head out. I come away trying to picture for myself just what it has to be like, this time bomb of an illness. It could have so easily carried him off already. And here they are, putting themselves in the hands of nursing team number three. Ed had got to know all the nurses on our peds floor, and treated them as buddies. Then he’d come to trust the oncology nurses on the floor above while he was going through his tough reinduction treatments. But the SCT unit is a whole different ballpark. It rates intensive care designation for good reason. And there’ll be a whole new set of faces. Ed and Alice will have to take on faith their competence or otherwise in this life-or-death ordeal. No wonder he wants control over something. Would I ever have got this far?

*

In the end, Ed weathers the ordeal and comes through with flying colors. He’d almost breezed through the immediate recovery phase post-SCT. Though the usual six weeks had stretched out to eight, and breeze hardly captures life in that goldfish bowl. The inevitable plague of excruciating mucositis, skin peeling off in raw patches, long days of nausea and diarrhea and fever—mostly unexplained. The near-solitary confinement, days stretching into weeks. Ed’s emotions, and Alice’s, seesawing between the limits of boredom and nameless dread.

But six months later, he shows up in my office, looking the very picture of health. He’s back to his fighting weight, his cheeks are aglow, and his scalp is a mass of fine dark curls.

“You look fantastic, Ed. Married life suits you!”

“Two hundred and fifty days today. Don’t let my looks fool you, though. I thought once I got shot of the unit I’d get my life straight back into the fast lane. Wrong! Hardly a day I don’t wake from some bad dream, scared like a baby the cancer is back. Taking three-hour naps after lunch. Barely enough energy for classes, let alone my master’s thesis.”

“Sounds like some version of PTSD to me. And I’m not sure I’ve seen much written about that. I mean, exploring how long it takes to put the whole thing behind you. Reach a place where you’re really moving on, no more nightmare flashbacks. That could be good thesis material for you.”

“Yeah. But it would cut just too close to the bone right now. I still get recurrences of those dreams I had in the unit, the ones I think those continuing fevers brought on. Maybe it was all those drugs you guys snowed me with. Or just a whole lot of panic I was never going to get out of there alive.

“Anyway, that is what I want to talk to you about. I mean, about my master’s thesis. Alice thinks getting my teeth into it would be good therapy. And she’s right, of course. A whole sight better than watching TV movie reruns. So I’m gearing up to put my proposal together. I want to look at what I’ve learned from all I’ve been through. I think I’ve got some things others could benefit from. ”

“That’s for sure. So…what have you got in mind?”

“Well, maybe it’s good that this whole experience is still fresh in my mind. In my psyche really. I want to hone in on all those informed consent sessions. I’ve been on the wrong side of a lot of doctor-patient conversations. And there’s not too much out there on that subject either.” He grins. “I know I was a bit of an outlier, interviewing each one of you guys, pitching a zillion curved balls before I’d sign the go-ahead. Most patients don’t push it the way I did, right?”

“Right. Mostly they’re too scared. Or it’s just easier to put it back on us docs, trust us to make the right decisions for them.”

“Maybe we don’t want to risk making you mad, so you wouldn’t give us all the care and attention we need. But you know, I used to sit there in front of you guys, with my long list of questions, and pretty soon it got harder and harder to hold onto all those answers. Let alone take anything useful away from them.”

“Well, the IRB certainly doesn’t let us hold back. We have to hit you with all the scary stuff—every potentially fatal side effect.”

“That’s the thing. What research I have uncovered suggests you docs don’t have a clear picture of how much your patients can take in. Before we shut down and stop listening, that is.”

“I wonder about it every time I sit down with my bunch of informed consents. How much does this person really need to know? And how much do they want to? So have you got something in mind?”

“Yes. I want to look at our whole decision-making when we do get sick. And especially how our psychological state of mind affects this. I’ve talked to some of my faculty, they think it has great research potential. And that I’m the right one to do it.

“I’ve thought a lot about all those informed consent sessions. Why couldn’t I just say ‘enough already, just get on with it’? I about drove Hal crazy. I come back to the same thing every time. I’m positive my emotional comfort level affected how clearly I could concentrate, and take in what I was hearing. You docs are so different, in the whole way you relate to your patients. Some of you seem relaxed and comfortable, and like you have all the time in the world. Keep good eye contact. And listen at least as much as you talk. Really respond to the questions you’re posed, rather than talk from some prepared script.

“But others can hardly bring themselves to sit down. And start straight in, filling the air with technical stuff. Giving off all these non-verbal cues when they’re getting antsy or impatient or whatever. Folding their arms across their chest, avoiding my eye, shuffling papers around. Altogether wanting to get done with the whole thing. All of which triggers people’s anxieties. And my theory is that that’s when people stop taking things in and thinking straight. And feeling like they can’t ask all their questions. But from what I’ve been able to find, this just hasn’t been tested empirically.”

He cuts to the chase. “Okay. So I want to take a look at all this. Especially how physician cues influence patient decision-making. Not just how Joe or Josephine patient feels afterwards, but how much they can take in and understand. I want to set up mock patient-doctor interviews, and study how varying the way the doc behaves affects the patient’s response. See if my theory bears out in a valid research setting.”

He stops and beams at me. “You’ve done quite a bit of acting, haven’t you?”

“Just how d’you come to know that?”

“Oh, you know, you mentioned it one time. Told me how sitting and talking with patients is like role-playing. And you had to learn to play that part well, just as an actor on stage has to. And how this doesn’t get the attention or credit it deserves. You talked about those non-verbal cues, and how crucial they are for doctor-patient rapport. “

“I don’t remember talking about that. You really pay good attention! Okay, so keep going.”

“Supposing I created a situation where you had to report to patients some ambiguous and scary x-ray findings. You’d have to do this with two groups of patients, but vary your affect—your demeanor—in how you behaved in their presence, and in the way you reported these x-ray findings. Okay?”

“For sure. Mind you, I’d need to have some sort of a script, and a chance for rehearsing this whole scenario. But Ed, surely there’d be a huge ethical problem. From what I’m hearing, you’re going to have me tell these real live patients the same information, but change the way I do it each time?”

“No, no, nothing like that. You know what an analog study is?”

“Why don’t you try me?”

“Well, it’s when you replicate a real-life situation under artificially controlled conditions. It gets us psych folks around a bunch of ethical problems the IRB would otherwise shoot us down for. What I’m proposing is to recruit as many women as I can from around our health center who have definitely higher breast cancer risks than normal. They might have a family history, or have gone through early menarche. Or they’ve got a history of benign breast lumps, or they’re on menopausal estrogen.

“Then I’d make two separate videos of you presenting the results of a recent mammogram report that is purportedly their own. Our consent form would explain fully that they were taking part in a completely simulated research study. I don’t think too many women would balk at doing that. But the important thing is, the mammogram report would show ambiguous results. And it would include the same information each time, with a clear recommendation for further testing. Then I’d randomly assign the women to two groups. The first group would watch a video of you appearing tense and anxious as you read and interpret the results to them. For the second video, you’d do the same thing, but you’d appear relaxed and confident. The single difference in the script would be that you’d say “I’m worried” several times in the first tape, and “I’m not worried” several times in the second. In addition, you’d introduce lots of appropriate “worried” and “not worried” non-verbal cues to match your words. So what do you think?”

“Sounds like fun. What are you planning to measure?”

“Several things. We’d get an immediate record of how anxious the women were right after watching the tape. We’d measure their pulse rates before, during, and afterwards. And we’d also obtain their scores before and after on Spielberger’s State Anxiety Subscale. These are both reliable measures of immediate anxiety levels. Third, we’d judge how medically serious the subjects viewed their situation, using a 9-point Likert scale. Fourth and last, we’d collect measurements of just how much factual information the two groups had understood everything you’d presented to them. We’d use a seven-point multi-choice questionnaire of their recall and understanding for that.”

“Okay. So if you find differences, it would have implications for training us docs, right? Certainly our students and residents, maybe even our whole profession. About the importance of the effect on our patients of how we deliver such ambiguous information. And I don’t have to tell you, medicine’s chock full of ambiguities.”

“So you’re up for it?”

“You bet. Thanks for asking me.”

Making the two films proves easy enough. Ed coaches me a few times, and reminds me I won’t have to learn the script by heart. I’ll have the sheet with the simulated mammogram reports right there in front of me. Meanwhile, he goes ahead and recruits forty suitably at-risk subjects through ads posted around the health center and around the city.

*

Another six months, and I’m sitting in on one of Clinical Psych’s research seminars. Ed is presenting his results for the first time. In his Sunday best—I’ve never seen him so dressed up. He sets the scene, then gets to the meat of his findings.

“You’ll see there’s a striking difference between the two groups of women in their pulse rates and state anxiety measures. Those watching the ‘worried’ videotape had significantly faster rates both during and right afterwards—p-value < 0.0001 on a two-tailed t test. And those watching the ‘worried’ tape also scored significantly higher on the state anxiety scale than the ‘non-worried’ group—same p-value. Third, the ‘worried’ watchers perceived the situation as significantly more serious than the ‘non-worried’ watchers—same stats again. Fourth—and perhaps the key difference—the group of women watching the ‘non-worried’ physician got more answers correct on our multi-choice questionnaire than those watching the ‘worried’ tape—once more, same significance.

No one present is left in any doubt. It goes without saying accurate information is vital for patients to make their best decisions in whatever medical circumstance they’re in. But how the doctor presents that information seems to matter just as much—perhaps even more. Not just for its effect on people’s emotional response, but also the understanding they take away from these sessions. One of the senior faculty pipes up.

“This is jaw-dropping stuff, Ed. And this isn’t even real life, far from it. You’ve got a doctor on a videotape simulating the whole thing, and with twenty women watching simultaneously. But by the end of it, the ‘worried’ watchers aren’t fit to decide on Corn Flakes or Wheaties for breakfast! Beautiful work.”

A year later, Ed presents me with a copy of an article he’s just published in a prestigious psych journal, under a suitably scholarly title twenty-one words long. “Analogue,” “Physician affect,” and “Subject recall,” all feature prominently.

*The events recorded here are true. The names have been changed.

 

John Graham-Pole is a retired professor of pediatric oncology and palliative care (University of Florida). He writes essays, short stories and poems, and is looking for a publisher for his memoir.

 

 

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