Informed consent: more than just a patient’s signature

by Carolyn Thomas  ♥  @HeartSisters

The cardiologist was called to the ER, and told me that he could tell by my T-waves and other diagnostic test results that I had “significant heart disease.” From that moment on, I could see his lips moving. I could hear sounds coming out of his mouth. I think I also may have signed something before I was urgently moved upstairs to have what turned out to be a blocked left anterior descending coronary artery unblocked. I was so stunned and overwhelmed, however, that I simply could not comprehend anything that was happening around me once I realized I was in fact having a heart attack. He may have been speaking Swahili. . .

Yet I’m now pretty sure that the fact I signed a piece of paper somehow meant that I had participated in the informed consent process required of hospital patients who are about to receive treatment.

Does informed consent actually mean that it’s informed at all? 

Studies have suggested that many patients have little understanding of what’s being said to them when they’re asked for medical consent – but they sign anyway.

Most research on the causes of this phenomenon has focused on factors like a patient’s age, education, culture or socioeconomic background. For example, the readability of many consent forms (historically written at a relatively high 12th grade reading level) is often blamed for the inability of some patients to understand. In fact, some researchers have even found that patients who reported reading their consent forms were no better informed than those who did not.(1)

I’m just a dull-witted heart attack survivor, but I suggest that pain, illness, fear, or the doctor’s use of confusing medical jargon can further contribute to difficulties in obtaining truly informed consent. And sometimes, patients may be reluctant to interrupt a physician’s explanation with a clarifying question even when they’re having trouble understanding any of it. See also: Say what? Do patients really hear what doctors tell them?

Here’s another wrinkle in this informed consent issue: we may feel better informed about an upcoming medical procedure than we actually are. Harvard researchers, for example, found that about two-thirds of patients they studied reported feeling “well-informed” or “extremely well-informed” about the medical information they’d been given by physicians regarding one of three different upcoming events: cancer screenings, a change in prescribed medications, or surgery. But analyses showed no relationship between their actual knowledge scores and their personal perceptions of feeling informed.(2)

It turns out that “trust in the doctor” makes patients feel extremely well-informed for all three types of decisions. Researchers also found that lower education and lower income levels were associated with feeling extremely well-informed for screening and medication decisions. It’s not that they were informed at all, but they felt they were informed at the time.

Or, did they tell the researchers that they were appropriately informed because they were too embarrassed to admit, as I was, that I didn’t have one single clue about what I’d just consented to?

This conclusion ties in with this common belief frequently mentioned by a number of my Heart Sisters blog readers, among others: if a treatment is offered, it must have curative benefits. Why else, after all, would the doctor be talking about this procedure if it weren’t the preferred option for me? 

Here’s an example of what failed informed consent can look like in real life, via Sheryl Martin, a Colorado patient advocate, researcher and also a survivor of a devastating heart attack called SCAD (Spontaneous Coronary Artery Dissection) – which typically hits younger women with few if any cardiac risk factors.  Sheryl told me that she was acting as a patient liaison for another SCAD patient who’d had a device called an Intra-Aortic Balloon Pump implanted for several days after her heart attack. This kind of pump has been used (usually short-term) to control blood flow through the heart for something called cardiogenic shock. Sheryl knew that the most recent research suggests that there can be serious complications in patients with this pump (e.g. injury to an artery,  rupture of the balloon, infection, stroke or worse). Despite those known concerns, Sheryl noted that:

• this patient was conscious, oriented and stable at the time
  
• no info regarding specific risks or the lack of studies on SCAD patients (or on women in general) was provided to the patient by physicians
  
• no specific informed consent was given by the patient for this treatment

Essentially, this patient had become merely a lab rat who had not consented to treatment.  And really, what could go wrong?

Even the official signing of informed consent forms can be influenced by the consent-requesting physician. Here’s how NOT to ask for consent, from actual research reported in The Social Organization of Doctor-Patient Communication.(3)

Doctor: “I need to get you to sign a couple of consent forms just to say that I talked to you about it and the fact that we’re not going to use it for anything except our own uses.”

Dr. Richard Frankel, a Regenstrief Institute research scientist at the Indiana University School of Medicine, once offered this observation on the classic doctor/patient miscommunication problem:

“  We don’t assume when a pilot and an air traffic controller converse that they have understood each other until there is an affirmation of understanding.

“That acknowledgement is lacking in most patient-physician encounters.”

Dr. Frankel, who studies ways to improve the doctor-patient relationship, adds:

“   From previous work, we know that doctors ask patients whether they understand what was just discussed less than 2% of the time.(4)

“Doctors should be trained to routinely check for understanding to ensure that there is neither miscommunication nor mismatch between what the patient wants and what doctors assume the patient wants.”

Physicians are aware that the known risks of any procedure must be carefully explained in full to each patient, yet the courts have continued to show that this does not always happen.

In a landmark case (Reibl v Hughes, 1980), for example, the Supreme Court of Canada ruled on a case that introduced the doctrine of informed consent into Canadian law. The court found that Hughes, the surgeon, had performed a procedure properly, but had not specifically informed the patient, Reibl, about the known risk of stroke. Reibl consented to the surgery, but during or immediately after the procedure, suffered a massive stroke. In a unanimous decision based on what’s known as a modified objective test, the court ruled that any reasonable person in the plaintiff’s position would not have agreed to undergo this surgical procedure had the risks been explained beforehand.

As the American Medical Association warned its members:

“Informed consent is more than simply getting a patient to sign a written consent form.”

When two people who are on equal footing are communicating calmly using a similar knowledge base, we might expect a reasonable level of mutual comprehension.  Two auto mechanics can talk shop together trusting that they absolutely understand each other. Ditto for two oceanographers. Two sign painters. Two accountants.

But just try putting one of those two people in a drafty hospital gown, lying confused and vulnerable on a gurney while suffering distressing physical symptoms. Put the other person with many years of brainiac medical training into a starched white coat, standing overhead coolly rattling off a jargon-filled explanation of potential risk. Even on a good day, it’s a tragic recipe for miscommunication.

Should it be up to the person in the drafty gown to ensure that doctor-patient communication is accurate or effective during the informed consent process?

The Basics of Informed Consent

• A consent form itself is not the consent. The dialogue with the patient is the key element of the consent process.
  
• Consent must be voluntary.
• The patient must be free to consent to or refuse treatment. The patient may refuse the procedure or treatment even after it has begun.
  
• The patient must have the mental capacity to consent or not.
• Reasonable steps must be taken by the physician to confirm that the patient comprehends the consent (especially if there are language difficulties, emotional issues, or questions of mental function). One way to confirm this is the teach-back technique: asking the patient to re-phrase what they have just been told, and inviting the patient to ask questions.
• A physician may wish to encourage a patient to invite a family member or friend to attend the consent discussion.
• The patient must be properly informed.
• The physician must indicate the realistic chances of success. (This is particularly significant because studies have shown that how physicians recall what was said to patients about benefits of a proposed procedure can differ significantly from what patients recall hearing. In one study on informed consent, for example, heart patients believed that their cardiac interventions had far greater benefits than they actually do. The research, published in the journal Annals of Internal Medicine, found that over 80% of the heart patients studied who had undergone angioplasty with one or more stents implanted believed that the procedure would lower their risk of having a future heart attack – which is NOT true. But about the same proportion of cardiologists told researchers that they had told their patients that stents could do nothing more than simply relieve chest pain – which is true). 
• Patients should be informed about the consequences of leaving the medical condition untreated.
• In case of an emergency when the patient or substitute decision maker cannot consent, the physician may proceed if there is demonstrable severe suffering or an imminent threat to the life or health of the patient.

Sources: Canadian Medical Protective Association, Agency for Healthcare Research and Quality (US), RN Central

(1)  Lavelle-Jones C et al. “Factors affecting quality of informed consent.” BMJ. 1993;306(6882):885–90. 

(2) Sepucha KR et al. “How does feeling informed relate to being informed? The DECISIONS survey.” Medical Decision Making. 2010 Sep-Oct;30(5 Suppl):77S-84S.

(3) Robillard AB et al.  Between doctor and patient: informed consent in conversational interaction, in “The Social Organization of Doctor-Patient Communication”. Edited by Fisher S, Todd, AD. Washington, DC: Center for Applied Linguistics, 1983, pp 107–33

(4). Braddock et al. “Informed Decision Making in Outpatient Practice”, JAMA. 1999;282(24):2313-23

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NOTE FROM CAROLYN:   I wrote much more about doctor-patient communication in my book, “A Woman’s Guide to Living with Heart Disease” . You can ask for it at your local library or favourite bookshop, or order it online (paperback, hardcover or e-book) at Amazon, or order it directly from my publisher, Johns Hopkins University Press (use the code HTWN to save 30% off the list price).

Q: Have you ever signed a patient consent form you didn’t understand?

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See also:

Say what? Do patients really hear what doctors tell them?

Cardiovascular Business article called Doc, Patient Perceptions Differ on PCI, Consent Needs Overhaul

Your health care decisions: don’t worry your pretty little head over them

Should you bring that list of questions to your doctor?

Medical jargon: do you need a translator?

No, really – patient education that’s actually useful!