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This month Health goes to the hospital.

Uninformed Consent

Hospital Forms Are so Full of Gobbledygook That Patients Often Don't Know What They're Signing, a Report Finds


If you've ever checked into a hospital to undergo a laparotomy with a cholecystectomy and colectomy with colostomy, you know just how ponderous those consent forms you're asked to sign can be.

(In English, you would be consenting to abdominal surgery with removal of your gallbladder, part of your colon and an opening made from the colon to the abdominal wall.)

Who knew?

That is precisely the point of a praiseworthy analysis reported recently in the medical journal Surgery. Researchers perusing informed consent documents used for surgery and other medical procedures found them to be so complicated that patients need to be high school graduates to understand most forms. About one-quarter of the forms required education at the college level. And a patient would need the equivalent of a PhD to comprehend 9% of them.

That means people may sign documents with only the vaguest notion of what they are consenting to. Only 28% of Americans have attended college, and 72 million people are marginally or functionally illiterate.

Which sort of makes the term "informed" consent a joke.

"The forms are very complex," says the lead author of the paper, Dr. Kenneth Hopper, a professor of radiology at Penn State University's College of Medicine. "I think what happens is a lot of them are written by hospital lawyers and have a lot of legalese, and many patients won't understand the verbiage. But the biggest value of a consent form is not as a legal tool, but as a tool to inform patients."

The analysis is important, says Rick Wade, senior vice president of the American Hospital Assn., because medical professionals need to continually assess their efforts to educate patients.

"Studies like this are very useful. If you look at where these studies appear, they are in publications read by physicians. And that is the way you motivate change."

The study analyzed 616 consent forms submitted from hospitals around the country. A computerized writing program measured the forms' readability, quality of writing, use of descriptive words, jargon, excessive number of words or words that most people don't understand.

"The uniform criticism on sentence structure was to shorten and simplify sentences," the report noted.

Not only are the forms nearly incomprehensible, they are lacking in information that most patients--perhaps were they not so nervous--would want to know. For instance, our cholecystectomy patient mentioned earlier would have learned the specific risks of the surgery in about only 30% of consent forms and would have been told of specific alternatives to the surgery in about 5% of forms, according to Hopper's study.

"It's amazing to me that a lot of forms don't have more information," Hopper says. "Overwhelmingly, the lesson is that people need advocates. They need someone with them that helps them and helps ask the right questions."

Yeah, like a lawyer.


Legally, informed consent is based on three elements.

1) The patient must understand the procedure, its risks, potential benefits and the alternatives, if any.

2) Consent must be given willingly and without duress.

3) The patient must be mentally competent.

Still, the particulars of the informed-consent process have been the subject of debate for many years. Typically, the major issue is: Just how much information should the patient have or need?

"What sparked my interest is that, in radiology, there is always the question of should you tell, and how much should you tell?" Hopper says. "There have been some [suggestions] that doctors have to be careful not to upset the patient with too much information. I felt the more patients know, the better."

Clearly, most people are nervous before a medical procedure. Moreover, people who are sick are rarely thinking as clearly as they might otherwise. And, Hopper notes, being sick makes people feel powerless and more willing to turn their fate over to anyone who might help them.

"I think patients who are sick just want to get well. I wonder if sick patients don't ask enough questions because they just want to get well," he says.

But, Hopper says, a patient's trust shouldn't be abused by medical personnel who fail to inform them fully.

"I'm still amazed day to day that I can introduce myself to someone I've never met, and some of them give me more trust than they would their minister, their priest or their spouse. Only a few patients will ask you your qualifications. But they'll undress for you, and they'll tell you their secrets."

Moreover, he says, there is no proof that a lot of information makes patients more nervous.

"All patients are anxious. The more you tell them, the more knowledgeable they are, the less upset they are. Also, I think they are more able to tolerate the procedure."

The written consent form, Hopper says, is only half of the informed-consent procedure. In most cases, a doctor or nurse also reviews the consent form with patients and discusses the information.

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