Friday, September 26, 2014

Informed Consent is a Chimera

This post by Paul Levy got me thinking about informed consent, and a case I saw recently got me to take a little time and write about an issue frequently ignored in medical school.

A bit of background for non-medical readers: Informed Consent is a term in medicine for when doctors get the agreement of the patient to do something to said patient.  For example, before a patient is cut open for surgery, the patient has to say "yes I want to be cut open and have _____ happen".  Less extreme examples abound- the patient has to consent to anything from a blood draw for a lab test to a CT scan.  Part of informed consent is that the patient has to be "informed".  It is acceptable for a patient to say "tell me nothing, just do it", but the patient has to be offered information regarding their disease as well as the risks and benefits of the procedure they are consenting to.  For example, "This x-ray will tell us whether or not you have pneumonia or something else, but may slightly increase your risk of cancer in the long run.  I recommend you get it.  Do you agree?"



But here's the thing: I increasingly think informed consent is a chimera, a concept more than a concrete thing.  I believe it is whatever the provider wants it to be.

As an example, consider this case that I recently saw on the wards:

One day on call, my team had a patient in labor with pre-eclampsia superimposed upon hypertension.  Pre-eclampsia is a condition in which the placenta that supplies blood to the fetus is malfunctioning in some way.  In response, the mom's body bumps up the blood pressure to force through more blood to the fetus.  This can result in damage to vulnerable organs like the kidneys, the liver, the lungs, the eyes, and most importantly the brain.  This patient was in labor, and her blood pressures fluctuated between 140 and 160.  However, taking into account her baseline hypertension my team found this not as worrisome.  She had other no severe features of pre-eclampsia- kidney failure, liver problems, threatened strokes, vision changes, etc.

The team was informed by the nurse that the patient desired a c-section, and my senior resident went in to talk to the patient.  There, we found that the patient had been watching her own blood pressure’s rise and fall on the monitor- she was worried that her fluctuations in blood pressure would result in a stroke or heart attack. 

My senior resident talked to the patient for 10 minutes, explaining clearly her options: if she truly wanted it, she could have a c-section now.  But, we didn’t recommend it at this point.  We had medications to bring her blood pressure down if her pressure went above 160, and that there were risks to both a c-section and to continuing to labor.  The fluctuations were not concerning to us.  It was a very balanced counseling- we explained that the risks to her health were small and controllable but present, and that we would push her more strongly towards a c-section if we felt she needed one.  We left, and gave the woman and her partner time to think.  I thought my senior had done an excellent job of presenting all the options, addressing concerns, and giving the patient time to think.

After we left, we ran our management of the patient by the attending.  Upon hearing of her blood pressures without any signs of severe problems, and then learning that she was considering a c-section after a balanced counseling, the attending promptly ordered senior resident to, “Get back in there and convince her to deliver this baby vaginally.”  My senior resident did indeed go back, and talk to the patient (I was unable to be present for the conversation), and she did indeed end up having a vaginal delivery many hours later.

My senior resident was concerned with patient autonomy- he legitimately wanted to present the options to the patient.  My attending was more concerned with beneficence- he felt that the women would be harmed by a c-section and that she needed to be pushed towards a vaginal delivery.  In effect, he felt that the "balanced" counseling that was given was too pro-c-section.

Both perspectives were not incorrect: after all how one presents the options can make a huge difference.  Imagine the senior resident saying either of these two things to the patient the first time around:

1) “A c-section is dangerous, especially if you want more kids.  Its major surgery- and a lot can go wrong.  Even worse, your ability to have future children is threatened.  There may be so much bleeding that we have to take out your uterus.  Your blood pressure isn't concerning to us- we'll do something if it becomes a problem- your risks are quite low at this point.  How about we keep trying to push this baby out naturally?“

2) “You have pre-eclampsia, a dangerous condition.  It puts you at increased risk of all kinds of problems, and the only cure for pre-eclampsia is delivery.  We are controlling those risks, but we can't make them go away entirely.  Why don’t we get your kid into this world now and further reduce the chance of liver and kidney damage?”

Both statements are entirely true- but imagine if you're a relatively uninformed pregnant women- hearing those spiels, which option would you choose?

There is such a massive knowledge imbalance between doctors and patients.  How can any patient who is not a doctor ever be truly "informed"?  They would logically need to understand the amount of knowledge contained in 7-10 years of medical training in 5 minutes.

Ultimately, all patients end up trusting their doctors to some degree.  What that degree is varies from provider to provider- but depends on the provider.  Throw in the fact that most people don't read what they sign (or they'll be stuck reading a novel in most hospitals) and you get the present reality.  Just because a doctor spends 5 minutes discussing risks and benefits does not make consent informed, and consent may never be truly and fully informed- and that's not necessarily a bad thing.

Indeed, informed consent has always been recognized by the legal profession as something that does not absolve the physician of responsibility- the physician is still held liable to some degree for what is offered or done, unless the patient refuses everything the doctor offers.  What that means is that regardless of if the patient above chose as a vaginal delivery or c-section, if anything went wrong the physician could be held liable.  ONLY if the physician tells the patient that they absolutely need a c-section and the patient refuses it against medical advice is the physician more insulated.  (This creates an obvious incentive for physicians, which manifests itself in a nearly 1/3 c-section rate in high malpractice lawsuit areas like New York City.)  Still, no physician can say "the patient consented, that means that anything bad that happened is on them."  That defense would be laughed out of court- the physician is held responsible by law and by society for everything that happens.

The real problem is when physicians don't realize the power that they have.  Our knowledge of medicine lets us convince most patients to do anything, and it is easy to blindly use that power without realizing the biases that might influence our advice.  If we fool ourselves, saying "I'm merely providing information and options", we risk doing a serious disservice to our patients.