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
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?
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?
18 thoughts on “Informed consent: more than just a patient’s signature”
So as I lay almost unable to breathe in the midst of a massive heart attack, the doctor asked me if it was okay if three visiting students, or nurses– or they could have been visiting aliens for all I know — stayed and watched.
I could say no? This was not consent. I didn’t want them there in this intimate moment of dying, but I really couldn’t even talk, let alone resist… It still irritates me that this was done this way…
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Wow. That is appalling, Dr. Steve. I understand that, in a teaching hospital, students are there to learn, but where was the common decency of the doc who asked you (at a time like this?!?!) if was “okay” to have strangers crowding around you to witness? He put the needs of his academic program above YOUR need to be treated humanely during a traumatic crisis.
Honestly, informed consent — and the lack thereof — is half the reason why I started my blog.
Great post, Carolyn.
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Thanks Kathy – I suspect there’s a dramatic story behind every failed informed consent attempt…
This is a great article that I came across while doing my on-line informed consent research. This expectation should be a given; however, I myself have seen both sides of the problem as a clinician as well as a patient! Myself, a Psychologist, and an Attorney created Confirmed Consent, which not only provides a mechanism for patients to get a true standardized, non-pressures informed consent, but also confirms the patient’s cognition and competency to give said consent. I think with today’s technological advancements and every-savvy consumer, there is no reason that the informed consent process can not be improved. Thanks for spreading the word on this important topic!
Wow. This post is great! It is so informative. I had no idea about all the factors that create informed consent. I look back at my medical past and see times when there was no real informed consent. Luckily, my plastic surgeon did have that dialogue with me, and he even gave me a quiz that covered what we had talked about regarding my breast reconstruction!
Thank you for such an eye-opening post.
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Hi Beth – I love that quiz concept. It reflects that recommended “teach-back” method of making sure that both parties participating in the discussion are on the same page!
Another interesting post Carolyn, It made me think about the many times I have thought I was really informed but years later I have had repercussions from procedures either I didn’t have the knowledge to ask about and/or the doctors didn’t have the foresight/knowledge to tell me about at that time.
Small Ex: The pacemaker model I have precludes me from having MRI tests (at least in the USA – I hear Europe standards are different)
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Hello Judy-Judith! Interesting example of your pacemaker. And YES medical knowledge often seems to be in a predictable state of flux: what are standard treatment guidelines one decade are often found to be not as good as what replaces them the next. Just today, I read of a study showing “off-pump” bypass surgery (which was praised at first as a groundbreaking way to perform coronary-artery bypass grafting, or CABG, without stopping the heart) actually has higher mortality rates 5 years out compared to traditional on-pump open heart bypass surgery. Not great news for those who have been convinced by their cardiologists of the amazing benefits of this new off-pump surgery….
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Another problem is drs and nurses rush and only give 15 min or less at an appt; and have to wait forever to even get help at the hospital. I signed a consent for a stress test with contrast and it stated a counter active drug would be given if adverse event occurs. I was left alone and for hours could not get help as trouble breathing and severe vascular pain. I had to argue for hours later with top staff to get the counteractive drug and then respiratory critical team had to come as I went resp critical. And of course, its all ‘covered up in the med records and I’m deficient labelled. I’m a cardiac patient young lady, taught fear to go to hospital! I need to move, just so I can go to a hospital in no fear. In America. I am so distressed by this and cannot find an attorney nor advocacy and searched all over. Im too sick and broke now to advocate…and broke not just financially..but spirit and dignity. Ive been abused for seeking medical, care of my life.. its like extreme domestic violence.
Hi Reb – I’m sorry you are in this distressing situation. I’m not a physician so cannot comment on the events you describe or why they were happening. Remember that all hospitals have some type of patient experience department that will address patient complaints if you feel you have not been treated professionally. You’re so right, being sick does make it tough to be your own best health advocate, so you need to take advantage of everything that’s already in place to help people like you. Take a big deep breath (several of them) and hang in there…
Under two emergency conditions, stroke and heart attack, I think ‘consent’ just means I hope like heck these doctors know what they’re talking about and I’ll sign anything so they can go ahead. Because you know that time left untreated can mean increased damage. Or death. And there’s pain. You’re between a rock and a hard place. There is no true ‘informed’ part to that.
I think I will in the future always ask, “What are the alternatives?” And understand that sometimes they don’t know.
But even in the relative calm of an office visit, when I asked for what the probabilities of adverse effects were with and without a medication, the doctors freaked. They are not used to giving alternatives, with probabilities of success, and letting the patient choose. I was threatened with a massive heart attack if I did not take the medication. I did my own research: actual research on the exact stents I had said my chances were almost identical either way, and the medication was giving me massive side effects. I stopped taking it. My choice. I didn’t tell the doctor until months after.
I have become a much more savvy customer.
I’m still having PTS from the stress of going against doctor’s ‘orders.’
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Hi Alicia – you’re quite correct re emergencies, as the list at the end of this post mentions (in cases of “imminent threat to the life or health of the patient”). The part of the general informed consent discussion that I had not appreciated was this part: “The patient must be free to consent to or refuse treatment. The patient may refuse the procedure or treatment even after it has begun.” So the ability to provide consent lies with the patient, not with the physician’s ability to convince.
Yes to all you wrote!! I have not ever been informed for years in this town not even of warfarin as drs missed doses, INR labs, and changed my doses too high or low, then blackbox FDA allows!
So very true. I still feel aggrieved about the high handed way I was treated 10 years ago, by various members of staff in a London heart hospital. I have a stent, against my better judgement, purely because a nurse stood tapping her foot waiting for my signature. No information, no alternatives, basically, according to them, it was a ‘do or die’ moment, not true, as I later found out, but I signed. Under those circumstances we’re all so very vulnerable.
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Hi Lidia – we are indeed in a vulnerable state at times like these…
I was not informed and given a picc line. After many ER critical of septic, clots and bleeding, it’s found I have known blood disorders and immune deficiencies. This negligence began a med nightmare in this town for me. Not even told sorry but punished for the negligence. I used to admire drs, now I am terrified w ptsd.