How blunt is too blunt for informed consent?


Document, document, document!

To best protect yourself, the patient must consent to each procedure and intervention via active, informed consent, said Dr. Giordano.

“It’s not enough to hand a patient a piece of paper and say sign it,” he said. “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 (for example, a nurse, office worker, or case manager).

“This can be very helpful because it means you’ve had third-party documentation of informed consent,” Dr. Giordano said. “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,” Dr. Giordano said. “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,” Dr. Giordano said. “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,” Dr. Feldman said. “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,” Dr. Giordano said. “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,” Dr. Feldman said. “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.”

A version of this article first appeared on Medscape.com.


Recommended Reading

Will ICER review aid bid for Medicare to pay for obesity drugs?
MDedge Endocrinology
Highly processed foods ‘as addictive’ as tobacco
MDedge Endocrinology
Don’t call me ‘Dr.,’ say some physicians – but most prefer the title
MDedge Endocrinology
U.S. biosimilar competition, use, and availability still lags behind European countries
MDedge Endocrinology
Analysis of doctors’ EHR email finds infrequent but notable hostility
MDedge Endocrinology