Uninformed Consent
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.
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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.
“Informed consent is a process, not a form,” Hopper says. “You also have what the doctor says. But these patients are sick--how much are they going to remember? How much do you remember when you hear it versus when you read it? And what happens on a busy day when the doctor is in a hurry and forgets to mention something? A lot of times, you may not evenget the doctor to explain it to you.”
Detailed written information is more likely to prompt a detailed verbal discussion.
“There is no ill intent here” on the part of hospital personnel, Hopper says. “But patients want to learn and know.”
Generally, there should be enough time for the patient to read a detailed consent form and discuss it with the doctor or friends and relatives. Only emergency room doctors are authorized to dispense with consent forms and act in the patient’s best interest if there is no time to do otherwise, he says.
“But even in most emergencies, there is usually time to consent--an hour or two,” Hopper says. “And 95% to 98% of consent forms are routine forms, and there is plenty of time.”
Most states have laws stipulating the minimum of what informed consent forms should include and when they expire. Most consent forms expire in a few days, but that varies by state.
For example, Hopper found that, in general, Texas hospitals tended to have the longest consent forms and New Hampshire the shortest. In California, there is no standardized consent form except for special procedures with permanent consequences, such as sterilization or hysterectomy.
In most states, there is great latitude among individual hospitals, surgery centers and doctors’ offices. In the study, the number of words in consent forms ranged from 58 for a hospital in Georgia to 4,217 for one in Louisiana. Hopper and his colleagues are urging medical associations to create a standard, simplified consent form.
“Even if it’s not mandatory [that it be used], a standard consent form would be a good idea. And it should be [tested] by having people read it to see if they understand it,” he says.
There have been discussions in California about the value of using a standardized consent form. But the California Medical Assn., which represents most physicians in the state, is opposed to such a form, says Alice Mead, legal counsel for the CMA.
“Our position has been that consent forms are fine, but the most important thing is an adequate dialogue between the patients and physician,” she says. “We think [a standard consent form] can lead to detriment as far as patient information. Physicians may be more apt to rely on a form if it’s required and may falsely believe that it’s OK with the patient.”
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Barring a move to a standardized form, Hopper and others offer the following suggestions for improvements:
* Foremost, Hopper encourages the use of consent forms with a lot of blank spaces.
“I love blank lines because then the doctor has to fill [them] in with specifics. For example, ‘For gallbladder removal the specific complications are. . . .’ ”
* He also applauds the use of videotapes, brochures and pamphlets that help explain procedures to patients.
* People should ask to speak to a patient education expert at the hospital and request to see the consent form in advance, says Wade, of the American Hospital Assn.
“The smart patient should begin to educate themselves about all of their options. They should ask, ‘If I have any concerns about this consent form, whom do I call?’ We should back up and involve the patient earlier.”
* Finally, Hopper recommends that patients be accompanied by a relative or friend who will read the consent form and ask critical questions.
“The best person to ask a lot of questions is the person with the patient,” Hopper advises. “The more advocates you have, the better off you are.”
(BEGIN TEXT OF INFOBOX / INFOGRAPHIC)
Yes, It Helps to Be a Rocket Scientist
Many Americans would be unable to understand hospital consent forms based on the complexity of the forms and levels of education.
Years of education: At least 8 years
How many forms could be understood: 146
Years of education: At least 10 years
How many forms could be understood: 347
Years of education: At least 12 years
How many forms could be understood: 461
Years of education: At least 14 years
How many forms could be understood: 131
Years of education: At least 16 years
How many forms could be understood: 55
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What’s Provided, What’s Not
Many consent forms fail to include information considered to be important for patients to know before agreeing to a medical procedure.
* Content information: Patient’s name
% of forms that contained the information: 90.6%
* Content information: Physician’s name
% of forms that contained the information: 97.4%
* Content information: Procedure name
% of forms that contained the information: 99.5%
* Content information: General description of procedure
% of forms that contained the information: 92.9% (27% were specific)
* Content information: General benefits
% of forms that contained the information: 71.8% (6.2% were specific)
* Content information: General risks
% of forms that contained the information: 96.2% (30.1% were specific)
* Content information: General alternatives
% of forms that contained the information: 87.1% (5.2% were specific)
* Content information: Asks whether patient authorizes procedure
% of forms that contained the information: 99.0
* Content information: Asks whether patient understands procedure
% of forms that contained the information: 50.9%
* Content information: Asks whether patient’s questions were answered
% of forms that contained the information: 27.1%
* Content information: Patient’s signature required
% of forms that contained the information: 99.8%
* Content information: Physician’s signature required
% of forms that contained the information: 43.2%
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Source: “The Readability of Currently Used Surgical/Procedure Consent Forms in the United States,” Dr. Kenneth Hopper, Penn State University. Published in Surgery, May 1998.
