Uninformed Consent: We Must Do Better

John Mandrola


May 27, 2015

Three out of one hundred.

That's how many patients with stable coronary artery disease received full informed consent before undergoing an elective invasive procedure, according to a recent study published in JAMA Internal Medicine.[1]

I read a lot of studies. Few depress me more than this one. Most of medical practice in 2015 does not require the fast pace of STEMI or acute stroke care. Most decisions are sensitive to patient preferences. There is time to do it right. And doing it right means our patient is informed.

Providing a truthful and complete informed consent lies at the core of being an ethical and moral caregiver. If a patient is harmed during a procedure—one in which benefits were greater than harms, and that patient understood the risk, then we sleep at night. But if a patient is harmed from a procedure in which equipoise existed with conservative measures but the patient felt they "needed" the procedure, then we have a problem—a core problem.

The Study

The background is not controversial: numerous studies involving thousands of patients with stable coronary artery disease have established that elective PCI improves symptoms in the short term but has no effect on the risk of future MI or death.[2] Yet there remains much confusion over the nature of coronary atherosclerosis. Patients continue to believe PCI reduces the risk of MI and death.[3,4] Cardiologists know better but continue to perform the procedure in patients without symptoms. Too often, both parties see systemic atherosclerosis as "fixable" with focal treatments.

One reason patients misunderstand PCI benefits is lack of adequate information. That is where informed consent comes in. There are seven basic elements of informed consent.[5]

  • The patient knows that they have a role in the decision.

  • Discussion of the issue and decision at hand.

  • Discussion of the alternatives.

  • Discussion of the pros and cons of the alternatives.

  • Discussion of the uncertainties.

  • An assessment of the patient's understanding.

  • Exploration of patient preference.

A group of researchers led by Dr Michael Rothberg (Cleveland Clinic, OH) set out to assess the quality of informed decision making and how it affected patient choices. They used taped conversations between cardiologists and patients between 2008 and 2012. They sampled patient-doctor encounters for elements of informed consent surrounding the use of coronary angiography and percutaneous coronary intervention.

The data set included 59 conversations conducted by 23 cardiologists. The patients were typical of an American cardiology practice: the majority were male and white, and the median age was 65. Approximately 80% of patients had positive stress tests. All cardiologists were male, with a median time of practice of 19 years; four geographic regions of the US were represented.

The findings were sobering. Only 3% of discussions included all elements of informed consent, and just 14% met a more limited definition of the procedure, alternatives, and risks. Doctors did well at discussing the procedure (97%) but only half (53%) noted the patient had a role in the decision. Alternative approaches were mentioned in 25% of cases.

Elements of the discussion affected patient choice. If patients knew they had a role in the decision, they were fivefold more likely to avoid intervention. Simply exploring alternatives led to a 10-fold greater chance patients would choose no intervention. And if uncertainty was mentioned, patients were 20 times more likely to choose medical therapy without angiography. The presence or absence of symptoms did not affect the decision. Overall, better-informed patients were less likely to choose angiography and possible PCI.

The research team noted the power of the physician. When the physician recommended intervention (49 of 59 cases), 90% of patients followed the recommendation. When the physician recommended no intervention (six of 59), all patients chose not to have it, and in four cases where the physician made no specific recommendation, all patients chose no intervention.

In the discussion section, the researchers make clear statements of the limits of the study. It was a small sample of physicians who were paid to record the visits. Although they listed that as a limiting factor of the study, I would think knowing you were being recorded would bias the results toward better discussions.


This is bad. These findings confirm the sorry state of informed consent as it exists today. It's a blemish on us as physicians.

I don't want to wrestle with you about the treatment of coronary artery disease. This story is bigger than the specifics of one overused procedure. It gets to the essence of our role as physicians in the current era. We are partners and advisors, not dictators.

Patient-centered care and shared decision making aren't slogans. They are our duty. Most of medical care today is preference-sensitive. That means there are multiple paths with multiple expectations. I start nearly every AF conversation with the statement that there will be no one right answer; it will be your choice; I will help you decide the choice that best fits your situation.

Informed consent should not be complicated. We are the medical experts. We know the studies. We know the absolute risk reductions, the numbers needed to treat and numbers needed to harm. Also, and importantly, we know the uncertainties. Our role is to convey these facts. Then we will have removed ignorance and fear from the medical decision—and the patient is more apt to choose the course most aligned with their goals.

The critics of this argument might say informed consent is a means to ration care. It can be used to scare patients or bias them against expensive therapies. Here I cite our number-one rule as doctors—do no harm. Before we put a fellow human being, a thinking person, in harm's way, candor is a necessity. We must be certain about uncertainty. To make someone better we risk making them worse. That's not morbid; it's truth. Maybe the patient likes their odds where they are now, without that stent, ICD, statin, mammogram, or chemotherapy.

The upside of horrible news is opportunity for improvement. Informed consent doesn't have to be the farce that it is today. We could do better than having a patient sign a fine-print legal document while lying flat in a gown moments before their procedure. Informed consent could be a means to improve medical decisions.

Tomorrow would be a good day for policy makers and doctors alike to work on improving the core process of informed consent.



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