Wednesday, January 8, 2014

Informed consent: Must the risk of death be discussed?

Last week, I wrote about the tragic case of a young girl in California who was declared brain-dead after what most media sources called a tonsillectomy. In fact, the patient had a much more extensive procedure for treatment of obstructive sleep apnea. In addition to having her tonsils removed, she underwent a uvulopalatopharyngoplasty (UPPP) and resection (removal) of her inferior nasal turbinate bones.

As I stated before, I will not speculate on whether the surgery was indicated or why the patient died because none of the facts about those two aspects of the case have been disclosed.

Questions have arisen about the informed consent discussion that may have been held with the patient's mother. We obviously do not know exactly what was said. However, some have wondered whether the possibility of death after this procedure was part of the consent process.

The mortality rates for a simple tonsillectomy range from about 1 in 10,000 to 1 in 35,000. For UPPP, the mortality rate for adults is generally quoted at 0.2% or 1 in 500. I was unable to find any information about the mortality rate for that operation in the pediatric age group.

The issue then is—must a surgeon mention death as a possible outcome after this type of surgery?

According to a medico-legal encyclopedia, the disclosure of risk depends on two general elements.

Would other doctors have disclosed the risk of death and would the patient (or family) have made a different decision if the risk of death had been discussed?

A paper from Duke University states the following: "In fact, there is no dictum that death must be included among the risks of every surgical procedure; when the risk of death is so low as to be unexpected and highly improbable, including it may actually be misleading." What they mean is that patients could be unnecessarily dissuaded from agreeing to a procedure they really needed.

The authors of the Duke paper go on to say that the question of how high of a risk requires disclosure is debatable, "but it may range from any chance of death to about 0.1% risk as a reasonable threshold for inclusion." Keep in mind that this is merely an opinion by three surgeons and a medical oncologist.

An informed consent guideline from Harvard says, "The type and the number of risks to be disclosed should depend on the significance the doctor's patient would attach to such risks in deciding whether to consent to the procedure or treatment. (The court recognizes that such disclosure does not apply to all 'remotely possibly risks of proposed treatment' which may be 'almost without limit.')"

The website of Dr. Erik J. Kezirian, a prominent expert in sleep apnea surgery, has information pertinent to this issue. The surgeon lists a number of complications related to UPPP including bleeding, infection, difficulty swallowing, tooth injury, and continued snoring. Notably absent is any mention of death.

I had always heard that adverse outcomes occurring less than 1% of the time need not be part of an informed consent discussion. Again, this is only an opinion. There is no agreed upon standard.

If a malpractice suit is filed, I doubt it will hinge on informed consent, but it is useful to discuss the topic. 

What do you think about informed consent and the risk of death?

[Disclaimer: I am not a lawyer and this is not legal advice.]


artiger said...

I usually mention death as something that can happen but usually doesn't during well as in driving to work, getting on a plane, swimming, eating, talking to a lawyer...OK, I made that last one up. To me, the threshold of significance lies in the beholder, and unfortunately, that seems easily manipulated by our legal colleagues.

One thing I do like to do is to discuss the risk of death without the procedure in question. Then it becomes a little easier for a patient to compare options. All documented, of course.

Josh said...

An analogy from my own practice is that, in covering a rural ED, I do pediatric appendectomies. I do not mention death as a possible outcome. It is unnecessarily worrisome to bring this up given how incredibly unlikely death is. I also think bringing it up in this setting risks seeding doubt in the parent as to the competency of the person they are trusting their child to (as in, "You are saying this is extremely rare but it's important for me to know about it? Has this happened to another patient of yours?"). Completely relevant though in an 80 year-old with perforated diverticulitis and sepsis. The Duke quote is a good one.
I also think that it doesn't matter what is in the informed consent. Even if you stapled the consent form to a surgery textbook to cover every possible outcome, the consent form in no way protects you from lawsuit. We do it out of a sense of ethical obligation (as we should), but any notion that it is a relevant legal document is, I think, misguided.

artiger said...

I don't disagree with Josh above, but I think an important point is that the consent form itself is only a document that is signed to acknowledge the conversation we have prior to the surgery. It is more important (in my opinion) to document in our H&P what we have discussed, that we have answered all the questions, and that all involved parties are in agreement to proceed. Informed consent is a process, not a piece of paper.

Skeptical Scalpel said...

Artiger and Josh. I appreciate the comments. I too would not mention death in most cases, particularly those with low risk like appendectomy or hernia.

pamchenko said...

when you ex lap someone for whatever (colon resection/TAH BSO...etc.) do you tell them about ventral hernia risk?

Skeptical Scalpel said...

I always did tell them that a hernia was possible.

Anonymous said...

For elective surgeries, do you hand out (readily-available) pamphlets with a simplified description of the operation and possible "common" complications?

Of course they don't substitute for a face-to-face detailed discussion with the surgeon, but my experiences ( and studies) say that many details never register in the patient's memory.

Skeptical Scalpel said...

I am retired. When I was practicing, I did not use pamphlets. The hospital hands out tons of them which no one reads.

I agree that studies show patients do not retain much of what the informed consent discussion includes.

My own brother-in-law, who has a PhD in literature, had a laparoscopic cholecystectomy a month ago. He had the surgery at a major teaching hospital. A few days after the surgery, he asked me if the gallbladder had been removed or did they just tuck it in a corner of his abdomen. He also thought that his surgeon had said that the gallbladder was as big as a crayon (not likely).

artiger said...

I have found that using pictures, drawings, and other such visual aids during the discussion helps a little. (emphasis on "during the discussion")

Anonymous said...

As a patient, my personal belief is that if there is a risk of death, no matter how remote the possibility, the patient should be told about it. The physician should certainly put the risk into context, eg., the risk of death is high, moderate, low, or very low, but I think the patient still has the right to know or they cannot possibly provide informed consent. After all, if you stay silent on the point, then the patient wasn't informed about it, right? The statistical probability of a certain outcome happening may very well be extremely small, but if it can actually happen, then it will happen to someone. After all, someone always ends up winning the Powerball jackpot despite the astronomical odds that they will not.

I also think informed consent should not be solicited immediately before a medical procedure, at least in those cases where the procedure is not being performed under exigent / emergency circumstances. Last year I had a cardiac cath procedure performed. There was at least a week between when the doctor decided I needed the catheterization and when it was performed. Yet I was not provided the consent form until after I had already been prepped for the procedure (I was literally on the gurney, cap on my head, IV in the arm, ink marks drawn on my legs confirming a nurse had checked the pulses, etc.). I signed the form without any great consternation because I had already educated myself on the risks of the procedure and decided that those risks were acceptable. But a patient needs time to actually think about, and process, the risks before he or she can provide informed consent. In an emergency situation, of course this can't happen, but in my particular case, it was absurd that no one discussed the risks of the procedure with me well in advance.

Skeptical Scalpel said...

Anon, thank you. I agree that the consent should be obtained well ahead of time with ample opportunity for questions.

I'm not quite with you on the inclusion of death in every consent. You must understand that death is possible even with removal of a wart. Also, keep in mind that if you are about to undergo a breast biopsy (extremely low risk of death), and I tell you you might die, you will not be around to discuss whether or not I told you about the risk of death. Your family will be the ones with the questions.

Whether the informed consent discussion included your possible death is immaterial to your family if you pass away after removal of a wart or a breast biopsy. Your death would have been very unexpected and that is what triggers lawsuits, not the consent form.

Anonymous said...

Sure, I suppose one can die from a wart removal, but that's a pretty extreme departure from your initial example, which is the much more involved procedure that Jahni underwent with such tragic consequences.

I think you have to agree that a death is less "unexpected" if there is a discussion about its very possibility. And in many cases, there are family members around to hear the discussion. Is that going to stop someone from suing you if mom dies from the low-risk biopsy? Probably not, but there is a difference between having to acknowledge in court that mom died of a rare complication that you told her (and perhaps even some of her family members) about, versus having to admit that you never even raised the possibility with her. We can certainly debate exactly how much the former admission will help you at trial, but it's got to be better than having to testify to the latter.

This is a good discussion, but I am definitely a bit puzzled as to how anyone can argue that informed consent can be given if not all the potential complications are laid out to the patient being asked to give consent. If a physician chooses to only highlight the most probable complications, then let's at least not use the term "informed" consent.

artiger said...

Anon, going by your last paragraph, there is no such thing as "informed" consent, because if we have to cover every possible complications, not just the most probable ones, we'd never be able to get to the surgery. Death is not always the least likely complication in a procedure; if we mention death but not a hangnail, we haven't given truly "informed" consent, have we?

To reiterate, informed (or at least partially informed) consent is a process, not a piece of paper. In you earlier heart cath example, signing the consent form was only an acknowledgement that you understood what the procedure was and what the pertinent risks were, and that you were in agreement to proceed. The understanding part of all that should take place in the office visit beforehand (although it sounds like you took a lot of that part upon yourself, which is highly admirable but rare), or during a patient visit (consultation request) if it's an inpatient but not emergent situation. It doesn't really matter when you sign the piece of paper, although I think most hospitals have a certain cutoff, like 30 days, for which they are valid. You can have a 5 page consent form outlining all kinds of improbable events, but I feel it is more important to document what was discussed and that all questions were answered in the H&P, consult note, progress note, or clinic note. I also like to mention that the opportunity for a second opinion was offered, and I mention death as a possible outcome as well, with a relative estimate of the probability.

It should come as no surprise that half of the time in my office visits and inpatient consultations are spent on consent.

Skeptical Scalpel said...

Yes, it would be difficult to mention every possible complication let alone discuss them in detail. And how many people who might really benefit from an operation might decide not to if they heard a list of 50 complications including death for a simple case? You have to weigh the risks and benefits and not over emphasize risks that are very unlikely to occur.

Anonymous said...

To the last anon: it is rare to have a patient knowledgeable enough to weigh various risk/benefits. Heck, physicians have trouble with it.

Interestingly, I have given my standard consent talk to patients who I found out later to be lawyers - including med-mal lawyers. They don't ask any more or different questions than other patients.

Skeptical Scalpel said...

Anon, good points. As I mentioned in a previous comment, intelligence does not necessarily correlate with either understanding or retention of the information given in an informed consent discussion.

Anonymous said...

I'm with Anon above. Don't call it informed consent if you aren't informing the patient of known (no matter how remote) complications. That term is doing you, the physician, a disservice, because it implies that you have, in fact, informed the patient, when in reality you have only partially done so.

Anonymous said...

I don't know.... Big pharma doesn't seem to scare anyone away from their recitation of the laundry list of side effects and complications that go with the drugs they are advertising on TV.

artiger said...

OK, so it's not "completely informed" consent. What do we want to call it then?

If someone knows of a way we can cover every last possibility that could occur that could occur with every single patient, please share it. One thing in medicine, and especially in surgery, is that there is often (always?) a bit of unknown. That is where judgment, trust, and concern fit in.

Skeptical Scalpel said...

I'm with you on this.

pamchenko said...

to the anon poster about your cardiac cath. did you have a discussion with your doctor about whether or not the cath was truly necessary? did you discuss the goals of the cath? what kind of information was trying to be obtained? was there going to be an intervention and if so what would be the benefits of such an intervention? were you provided medical alternatives?
there's no way you can educate yourself adequately. the way to do it is to have an intimate conversation with your physician and understand the goals of care rather than linger on the risks.
its really straightforward for infection or cancer. people seem to say do whatever. when its for lifestyle limitation...etc...that's when there should be more pause....

Skeptical Scalpel said...

Excellent questions. The risks, benefits, and alternatives, as well as the risks and benefits of those alternatives, should be thoroughly covered.

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