True consent: Study says it doesn't exist

Put your emphasis on process, not forms

Most informed consent forms used for surgical procedures don't really inform the patient or obtain true consent, according to a new study. But while the study should be disconcerting for risk managers, it's important to remember that true informed consent comes from a process, not a piece of paper.

The research was done by Kenneth Hopper, MD, and colleagues at Penn State University in Hershey, PA.1 They reported their findings in a recent issue of Surgery, which isn't a journal found on most risk managers' desks, so the troubling conclusions could be overlooked by the hospital administrators most in a position to react. The researchers concluded that "the majority of surgical/procedural informed consent forms used by U.S. hospitals are complex and are not easily understood by the average patient. In addition, the majority of reviewed consent forms do not list specific benefits or potential complications of the planned surgery/procedure."

That should make every risk manager question the effectiveness of the consent forms at their own facilities, says Malcolm Parsons, ARM, vice president for risk management at Doctors Hospital in Columbus, OH.

"After reading this study, I pulled out our informed consent form and looked to see if we need to revisit how that form is worded and designed," Parsons says. "That's probably a good idea for everyone to do."

Study examines 616 forms

Hopper conducted the study by requesting a copy of the informed consent form from 10% of all U.S. hospitals. The forms were digitized and then assessed for readability, and each form was assessed for completeness and applicability of the content. The researchers received 616 consent forms to study.

They found that the average grade level of education required to understand the forms was 12.6 - very high in terms of the average person's reading ability. The bed size, which could be related to the hospital location or population served, had no effect on the reading level required by the forms. People reading at less than an eighth-grade reading level could understand only 5% of the 616 forms. Those reading at an eighth-grade level could understand 23%; those reading at a 10th-grade level could understand 56%; and those reading at a 12th-grade level could understand 75% of the forms. A surprising 21% of the forms required the reading level of college sophomore to understand them, and 9% required a reading level of a college graduate.

The content of the forms also varied a great deal. Almost all required the names of the patient, physician, and procedure, and most stated in general terms a description of the procedure, its benefits, risks, and alternatives. But only a small number of the consent forms provided specific details for each of those items. Only 6.2% listed specific benefits of the planned procedure, and only 5.4% listed spec -ific alternatives.

A larger percentage, 30.1%, listed specific risks. A minority of the forms, 21.7%, stated that there were risks of not having the procedure at all, and only 2.3% listed specific risks of not having the procedure.

One finding may seem particularly troubling to some risk managers. Though the forms were intended for surgery or other procedures, 87.4% also obtained consent for the anesthesia to be used during the procedure. But less than half of the forms, 47.7%, stated there were additional risks from the anesthesia itself, and only 14.9% provided any specific risks of anesthesia. Parsons says he would be troubled by a surgeon obtaining anesthesia consent. That clearly is the role of the anesthesiologist, he says.

"Is the surgeon really appropriate for explaining the risks of anesthesia, a well-recognized subspecialty of medicine?" he asks. "My understanding is that most do it separately, even though the article suggests it is very common for the surgeon to do both. That would not be appropriate in our organization."

Here are some of the study's other findings:

· 28.2% of the forms requested permission to transfuse blood if necessary.

· 86.3% asked permission to dispose of tissue removed in the procedure.

· 95.2% asked for consent to perform other procedures if the surgeon decided they were necessary.

· 99% specifically stated that the patient authorized the procedure.

· Only 50.9% specifically stated that the patient understood the procedure.

· Only 27.1% stated that the patient's questions had been answered.

· 87.4% noted that there was no guarantee of success.

· 60.1% included the name of the individual obtaining the consent.

· Though almost all forms included the patient's signature and date, the physician's signature was required on only 43.2%.

Forms don't educate

The researchers say the findings are disturbing because they suggest that hospitals use informed consent forms just to cover themselves and head off legal liabilities, rather than to truly educate patients about upcoming procedures. They note that only 28% of Americans have attended any college and that 72 million people are marginally or functionally illiterate, putting most of the informed consent forms beyond their level of understanding. Using data on literacy and American reading skills, the researchers estimate that only 3% to 20% of American adults can understand most informed consent forms.

A short consent form isn't necessarily easier to read, Hopper says. One of the briefest forms in the study had only 82 words, but they were difficult words requiring a 12th-grade reading level. Another form contained only 209 words but required at least 19 years of education to understand it. That form consisted of only three sentences - a final 19-word sentence preceded by two whoppers of 99 and 91 words each. Factor in the inevitable stress faced by a surgery patient and the desire to trust the doctor, and it's likely that most patients sign the forms without a true understanding of the information.

Hopper also points out that a complex, difficult-to-read form doesn't necessarily convey more information, even if the patient can read it. Some of the most difficult-to-read forms actually left out a great deal of what the researchers considered important content such as specific risks and alternatives. The better, more readable forms used a lot of blanks where the physician could fill in specific information about the patient's situation, Hopper says. While the content of a form is crucial to its value, the researchers also caution that it's possible to overload patients with information. That often is done in hopes of eliminating all potential liability, he says.

"A consent form that contains every detail of every eventuality would likely be unread, not understood, and self-defeating," he says.

While the study is important in revealing the readability problems of informed consent forms, Parsons says it's important to keep the results in perspective. They don't necessarily reflect the facilities' ability to provide informed consent to patients, he says. The form doesn't represent the entire informed consent process but instead is the final step documenting that the process took place. If you're depending on the form to educate the patient, that's a mistake.

"If you don't read it carefully, the study might suggest that the surgeon walks down the hall, hands a form to the patient, asks him to sign, and that's all the patient knows about the procedure," Parsons says. "I don't think that's what's happening in medicine today. There's much more to the process."

Parsons suggests the researchers may have overreached when they concluded that patients are ill-informed about the procedures they undergo simply because the informed consent forms seem inadequate when studied as stand-alone items. In reality, the conversations that make up the informed consent process usually are documented throughout the progress notes and medical record.

In his own facility, the medical staff have settled on a fairly simple informed consent form with several blanks, which is meant to finalize the conversations that have taken place up to that point. (See insert for a the consent form used by Parsons' facility.) Hospital policy requires physicians to take full responsibility for informing their patients. "We do not allow nurses or interns or residents to participate in this dialogue," he says. "They may witness it, but they are not going to be the informant."

Reference

1. Hopper KD, TenHave TR, Tully DA, et al. The readability of currently used surgical/procedure consent forms in the United States. Surgery 1998; 123:496-503.