Resuscitation Ethics

A reader asked my opinion on an article in the Washington Post regarding critical care without consent. The article (read it in its entirety) deals with the ethical dilemma of studies that deal with resuscitation science, ie how to obtain consent from a patient who is either in cardiac arrest or imminent danger of arresting.

First we need to discuss the concept of consent. Every treatment we provide requires some form of permission from the patient or a legal guardian. Likewise, a mentally competent patient can refuse any part of care at any point, even if that refusal may mean their death.

Now in most situations, this consent is verbally expressed from the patient to the caregiver. I'll introduce myself to the patient, offer a handshake and ask if I may examine the patient. Most times they'll take the proffered hand and tell me to go right ahead - hey, they already called 911 and asked me to come, right?

Now as a practical matter, any consent from that point is pretty much a given between the two parties. If there is anything I may try to do that John Q Patient doesn't want, all he need do is say no, but it's pretty much assumed they want the help I provide.

Now legally, the issue is somewhat thornier. To be legally defensible, a consent or refusal must be informed, ie the patient must understand the expected benefits, risks and complications of a proposed treatment. If they refuse treatment, they must also understand the risk of refusing.

For example, if I were to start an IV on a dehydrated little old lady, I'm supposed to say something along the lines of:

"Ma'am, judging by the orthostatic changes in your vital signs and clinical presentation, it is my belief that you are volume deficient and may benefit from the intravenous infusion of isotonic crystalloid solutions. This infusion will increase your intravascular fluid volume and also replace any depleted electrolytes lost through your vomiting and diarrhea. This should raise your blood pressure and may serve to relieve some of the cramps you are feeling, and the electrolyte replacement may also alleviate that myocardial irritability that is causing your heart to beat irregularly.

Now in the debit column, this intravenous infusion has a number of inherent risks, not the least of which is pain. You may experience some discomfort, and due to your depleted volume state and the condition of your veins, it may take a number of venipunctures to obtain a patent IV site. Other risks include venous irritation, thrombophlebitis or systemic infection, air embolus and even death. Plus I'm an evil bastard and don't care for little needles, so this will probably hurt like a mofo, and we'll have to roll you over and pull the sheets out of your ass afterwards."

Or something along those lines.

But most often, that instead gets shortened to, "I need to start an IV on you, Ma'am. Give me your arm...big stick!...now, that wasn't so bad, was it?"

In the event that the patient is a minor child, or is too incapacitated to express their consent, verbally or otherwise, we treat under the legal doctrine of implied consent, ie the assumption that if the patient were able to communicate, that they would want any standard medical treatment applied.

And herein lies the turd in the ethical punchbowl with regard to resuscitation studies. By their very nature, they are experimental. Not the accepted norm. Outside-the-box thinking.

A fine ethical line is tread here, lest we find ourselves venturing into Joseph Mengele territory. Typically, most IRBs (Institutional Review Boards, effectively research ethics committees) approach the problem in this way:

Before starting the research at each site, researchers complete a "community consultation" process. Local organizers try to notify the public about the study and gauge the reaction through public meetings, telephone surveys, Internet postings and advertisements, and through reports in local news media. Anyone who objects can get a special bracelet to alert medical workers that they refuse to participate.

Now, one bioethicist interviewed in the article took a contrary view to this approach:

"Suppose a 15-year-old child is in the back of a car that is in a terrible accident," Annas said. "The EMTs arrive and say: 'We are doing an experiment with two techniques. We think they are about equal. Is it okay if we flip a coin to see how we treat your son? Or would you rather we just give him the treatment we think is best?' Unless you think all parents would have the EMTs flip a coin, consent here is necessary."

He neglects to consider here the fact that such a scenario wouldn't occur in a double-blinded study - neither the patient nor the medical providers know whether they're getting the experimental drug. In the studies where blinding is impossible, it is paramount that the EMTs observe strict adherence to the protocol. To do otherwise would render the results invalid.

The Brain Trust and I were discussing this the other day, and the consensus was that the EMTs are not necessarily going to be using the treatment they think is best - they're going to use the one that's in the protocol. When the patient gets to the ER, the staff there is going to use a treatment that, while it may be the most popular and well established one today, is not necessarily well-grounded in science.

The general public, and to a large extent medical professionals fail to understand this:

Most of the crap we do is based on conjecture and animal studies, not science. Until the past few years, pretty much everything you read in an ACLS book was either well-compensated product placement or something that worked on pigs, rabbits and dogs.

Until we started looking at amiodarone in VF (ventricular fibrillation) arrest, not a single drug we used was proven to actually work on an adult human in cardiac arrest.

Not a single one.

As it stands now, even amidoarone can only be proven to temporarily revive a corpse long enough to run up a whopping medical bill in the ICU, after which the patient dies anyway.

Patients enrolled in experimental resuscitation studies, at least the ones that involve cardiac arrest resuscitation, will still die 95% of the time using the currently accepted treatment methods.

If y'all will permit me to venture into medical punditry for a moment, I fail to see the ethical dilemma here. The only way we are going to advance resuscitation science is through randomized, controlled trials on cardiac arrest patients. The worst thing that can happen with the study drug is death. Death will occur 95% of the time with the standard treatment.

So instead of getting a "opt-out" bracelet like the ones typically offered, I think I'll get a universal, "opt-in" tee shirt that says:

I'm a gambler. Please give me the research drug, because I don't like the odds with the traditionally accepted ones.

That answer your question, Marla?