Informed consent forms are a waste of paper’

New study suggests changes

The informed consent forms used in your facility are most likely worthless to you and the patient, according to a new study that calls for a complete revamping of the informed consent process.

Informed consent documents are considered among the most important risk management tools in most health care facilities, but Melissa Bottrell, MPH, says the typical documents amount to nothing more than a waste of time and may create more of a litigation problem than they could ever prevent. Bottrell is project director at the New York University Division of Nursing in New York City and lead author of the recent study. She tells Healthcare Risk Management that she and her colleagues were amazed at how rarely most informed consent forms achieve their goals.

"The forms in no way demonstrate that you’ve informed the patient," she says. "The forms are a waste of paper. They’re worthless."

The documents used by most hospitals to obtain informed consent are written so much from the hospital’s perspective that they do not even make a good faith effort at informing the patient, Bottrell says. They are written so clearly with the hospital’s interest in mind that they often become a complicated legal document no typical patient could possibly understand, she says. When that happens, the document becomes nothing more than a legal formality, and Bottrell says she is surprised that courts do not reject them more often.

When the document reaches that level of legal complexity and one-sidedness, she says, it does not even achieve protection for the hospital and may backfire in that regard.

"When it is so clearly written from the hospital’s perspective, the form becomes worthless. It just doesn’t function as intended," she says. "All they do is create more paperwork and lead the patient to believe that you’re only out to protect the hospital rather than inform the patient. That can lead to some real animosity if things go wrong later."

Unfortunately, Bottrell is not talking about just a few informed consent forms. She’s talking about nearly all the forms currently used by hospitals. In her recent study, Bottrell and her colleagues analyzed 540 informed consent forms from 157 hospitals nationwide and found that "most forms did not meet accepted standards of informed consent or patient physician interactions."1

Researchers examined the forms to see if they included the basic elements of informed consent — the nature of the procedure, risks, benefits, and alternatives — as well as features that might enhance physician-patient interactions and encourage shared decision making. They found that only 26% of the forms included all four basic elements of informed consent; 35% had three; 23% had two; 14% had only one; and 2% had none. Ninety-six percent of the forms indicated the nature of the procedure.

Seventy-five percent of the forms authorized treatment; 59% appeared to protect the hospitals and caregivers from liability, but only 40% clarified information about the procedures, and only 14% aided patients in decision making.

Bottrell found that forms from the states that actually require all four informed consent elements to be included were no more likely to have those elements. The researchers noted that many of the forms included phrases such as "I certify that no guarantee or assurance has been made as to the results that may be obtained," making the tone of the form more like a waiver to get the hospital off the hook.

"Such a construction may even reduce the likelihood of a quality informed consent process by increasing the perception of physician or institutional self-protection over patient care and causing patient anxiety and annoyance from having to sign another piece of paper," the researchers conclude. The irony, they say, is that trying to use the forms that way does not provide much legal protection for the hospital, and it thwarts any effort to inform the patient.

"Forms with a solely legalistic appearance may lead to either cursory or suspicious reading of forms and, therefore, an inadequate or distorted understanding," they say. Necessary legal statements might be better handled in a separate document, they suggest, such as in a general statement on the conditions of admission.

Bottrell also points out that many of the forms in her study were distressingly generic. "Some times we had 10 or 30 forms from one hospital, and they all were the same except for the name of the procedure at the top," she says. "That’s not helping anybody."

Document should encourage discussion

Bottrell acknowledges that the informed consent document often does not represent the entire informed consent process in a health care setting. Ideally, the doctor and the patient have had a careful, meaningful conversation before signing the form, which some risk managers would argue is only an administrative record of the actual informed consent process. That may be the case sometimes, Bottrell says, but a faulty informed consent document can unravel much of the doctor’s work by making it seem as though the hospital wants a free ride if anything goes wrong.

Besides, she says, what is the point of the document if it does not represent the informed consent process? "The forms are supposed to attest to something, that some sort of information exchange occurred and that the patient is making a decision after being given the right information. If you’re saying that happened some other way and the form is just a piece of paper that has to be signed and so it doesn’t matter what’s in it, then why bother?"

Bottrell and her colleagues recommend a wholesale revamping of the informed consent process so it revolves around a worksheet the patient and doctor can complete together. Rather than anything resembling a legal document, the worksheet should be a form they can use to facilitate a personal discussion about the medical treatment, with plenty of questions prompting the patient to respond. Questions could include wording such as "This is a reasonable decision for me because," followed by a blank in which patients write the rest of the sentence as a demonstration that they have been adequately informed.

"That kind of worksheet represents what the doctor and patient should have been doing all along," Bottrell says. "The difference is that the worksheet shows you really did it, rather than putting some meaningless form in front of the patient to sign."

(Editor’s note: A sample worksheet, which is included in Bottrell and colleagues’ research report, is available at no charge from Linda Emanuel, MD, PhD, at the American Medical Association, The Institute for Ethics, 515 N. State St., Chicago, IL 60610.)

Reference

1. Bottrell MM, Alpert H, Fischbach RL, et al. Hospital informed consent for procedure forms: Facilitating quality-patient interaction. Arch Surg 2000; 135:26-33.