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How Informed Are Patients Who Sign Consent Forms?

Before a surgeon does an operation, there is a legal requirement to obtain informed consent from the patient. In theory, this holds true for any treatment plan, although few people sign consent forms before accepting a prescription. How well do consent forms work to let patients know the risks of any given treatment?

Studying Informed Consent Forms:

Researchers analyzed more than 100 procedure consent forms from high volume hospitals (JAMA Internal Medicine, Dec. 11, 2023). They found that most were written using complex language that might be hard for some patients to understand. There was considerable variation in the risks that were disclosed, as well as discussion of the likelihood of success. Hospitals serving vulnerable populations were less likely to mention the risk of foregoing the intervention and also less likely to give patients the opportunity to bow out of the surgery.

Why Informed Consent Matters:

It has been our experience that a consent form is brought to the patient shortly before surgery or a procedure is undertaken. Take a look at the photo at the top of this page. The patient has already put on the infamous hospital gown (with the tie in back). He is no doubt a bit anxious to get the procedure underway. So is the surgeon. This is not the most conducive environment for thoughtful analysis and understanding.

Hospitals and clinics occasionally treat consent forms as a bureaucratic box to be checked before moving a patient into a treatment “assembly line.” However, health care providers are required, ethically and legally, to make sure that the patient is aware of risks and gives voluntary consent for the intervention (StatPearls, June 5, 2023).

That’s why complex language could be a problem. People might not understand what they are getting themselves into. One element of informed consent is assessing how well the patient understands the benefits, risks and alternatives for the intervention.

Experts assert:

“It is the obligation of the provider to make it clear that the patient is participating in the decision-making process and avoid making the patient feel forced to agree to with the provider.”

In principle, patients who sign consent forms agreeing to the procedure have shared in the decision making. In practice, if the consent forms are presented to patients immediately before the procedure, they might feel pressured to agree, whether or not they fully understand all the terms. Often, people are understandably anxious before surgery. They might not notice that they have just signed permission for an intern or resident to operate. That’s why we should all pay attention to informed consent. We’d like to see these forms provided and discussed well before the last minute.

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About the Author
Terry Graedon, PhD, is a medical anthropologist and co-host of The People’s Pharmacy radio show, co-author of The People’s Pharmacy syndicated newspaper columns and numerous books, and co-founder of The People’s Pharmacy website. Terry taught in the Duke University School of Nursing and was an adjunct assistant professor in the Department of Anthropology. She is a Fellow of the Society of Applied Anthropology. Terry is one of the country's leading authorities on the science behind folk remedies..
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Citations
  • Lin GT et al, "Content and readability of US procedure consent forms." JAMA Internal Medicine, Dec. 11, 2023. doi:10.1001/jamainternmed.2023.6431
  • Shah P et al, "Informed consent." StatPearls, June 5, 2023.
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