Sitting across from a patient explaining a complicated treatment proposal, protocol, or medication may be one of the most complex yet crucial tasks you have as a physician. Although informed consent is at the forefront of shared decisions between you and your patient, there's a fine line between providing enough information on the risks and benefits of a particular treatment and knowing you've explained it well enough to fully educate your patient about their choices.
As Medscape reports in Right and Wrong in Medicine: Life, Death, and Wrenching Choices, how you handle the informed consent process can be the difference between a positive outcome and a negative one.
"It is a bit of a fine line because unless your patient happens to be a healthcare provider, medicine is complicated for patients to understand," says David L. Feldman, MD, chief medical officer at The Doctors Company, the nation's largest medical malpractice insurer in New York City.
In addition, documenting the interaction is critical, says James Giordano, PhD, MPhil, professor in the departments of neurology and biochemistry and chief of the Neuroethics Studies Program at the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center in Washington, DC.
"As with anything in medicine, the key rule is that if it's not documented, it's not done," he says. "This also means diligent documentation in all aspects of the medical record, including the electronic medical record and the written one."
That said, it's important to know what's enough and what's too granular when you discuss a procedure with your patients, says Erum N. Ilyas, MD, a board-certified dermatologist at Schweiger Dermatology and a bioethicist near Philadelphia.
"One of the most challenging aspects of informed consent, especially for young physicians, is how to discuss a procedure or a medication in a manner that is both relevant and concise," llyas says. "I've had residents about to perform a skin biopsy spend several minutes covering every aspect of every potential outcome of a routine skin biopsy. The patient is left traumatized and confused as to whether they should proceed with the small procedure."
Instead, the goal of informed consent is to ensure that the patient has a general overview of the procedure and is empowered, knowing that the decision to proceed is, indeed, part of their decision-making process.
How long an informed consent discussion takes depends on the procedure.
"When I was in practice as a plastic surgeon, the conversations varied from the straightforward 'I'm taking this mole off your cheek, and there's a risk of scarring and bleeding' to talking about a mastectomy and breast reconstruction, which could take an hour or more to discuss," Feldman says.
Ultimately, it's as essential for doctors to explain the risks associated with a procedure as it is for patients to understand precisely what's involved, Ilyas adds.
She also recommends creating a flow to the conversation that places the discussion of risks within the context of why the procedure is being performed. This way, clarity about both the risks and the need for the treatment or procedure can be achieved.
When doing so, it's critical to make sure you're speaking your patient's language — literally.
"Have a translator in the room if needed," Feldman adds. "If your patient is hearing or sight impaired, you need to have every contingency ready to ensure that everyone is in complete communication."
Document, Document, Document!
To best protect yourself, the patient must consent to each procedure and intervention via active, informed consent, says Giordano.
"It's not enough to hand a patient a piece of paper and say sign it," he says. "There should be some documented evidence that the patient has not only read the document but that the key parts of the document have been explained and that the patient's level of comprehension has been assessed and verified."
It is vital if the patient has a disability, a neurological impairment, or a neurocognitive or psychiatric condition that might impede his or her ability to understand the consent that's being sought.
In addition, it's best if a 'clinical proxy' handles the consent (eg, a nurse, office worker, or case manager).
"This can be very helpful because it means you've had third-party documentation of informed consent," Giordano says. "It should then be re-documented with you as the clinician and stated that the patient has affirmatively and actively agreed to treatment."
What Happens When Things Go Wrong?
If you're sued over informed consent, with the patient claiming that you didn't fully explain the potential risks, the first thing to consider is why this happened.
"Very often, these situations occur if there was some difficulty or competency of communication," Giordano says. "You may have done everything right, but somehow the patient hasn't gained an understanding of the procedure required."
Physicians must take a hard look at how they're explaining risks and possible side effects. For doctors who perform these procedures regularly, the risks may seem small, and they may unconsciously minimize them to the patient. But when something goes wrong, the patient may then feel that they didn't fully understand the frequency of poor outcomes, or the potential severity.
Next, it's important to perform a 'gap analysis' to assess why something went awry. That means, look at all the potential factors involved to identify which one was the weak link.
"It might be that the patient was on a signing frenzy and signed away but didn't receive active and informed content," Giordano says. "The goal is to learn how to close the gap for this case and for future cases."
To protect yourself, consider using technology to your advantage, especially since lawsuits over informed consent usually happen several years after the procedure. This is when a patient might argue that you didn't tell them about possible complications and that they might have opted out of the procedure if they had known about those issues ahead of time.
"Even before the statute of limitations is up for a lawsuit, it could be five years from the time the procedure occurred due to the length of time a lawsuit can take," Feldman says. "That's why it's important to take a video of your conversation or make a recording of the informed consent conversation. This way if there's a question of what you said, there's a video of it."
For many physicians, this would be a big change — to video record and then store all their informed consent conversations. It could most likely help you if a lawsuit occurs, but some physicians may feel that process to be cumbersome and time-consuming, and they'd rather find another way to ensure that patients understand the risks.
Ultimately, however, if there's a legal question involved with informed consent, the general thinking is that the effect on the patient must be harmful for it to stand up.
"The question becomes whether the outcome rendered that gap in the consenting process forgivable," Giordano says. "The hope is that there was nothing harmful to the patient and that the benefit of the procedure was demonstrable despite any gaps in the informed consent process."
In the end, informed consent should be a matter of good communication before, during, and after any treatment or procedure.
"When you form a relationship with a patient who needs any procedure, small or large, you're going to be guiding them through a very scary thing," Feldman says. "You want to make patients feel like you care about them and that while neither you nor the system is perfect, you'll take care of them. That's the bottom line."
Lambeth Hochwald is a New York City-based journalist who covers health, relationships, trends, and issues of importance to women. She's also a long-time professor at NYU's Arthur L. Carter Journalism Institute.
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Cite this: How Blunt Is Too Blunt for Informed Consent? - Medscape - Dec 02, 2022.