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The patient signed a piece of paper to indicate agreement to the procedure, so there was informed consent. Right? Not always, warn medical ethicists, who say that patients who don’t get an opportunity to absorb information before consenting to surgery have not experienced informed consent.
"Informed consent involves one person giving information and another person understanding the information and coming to a decision based upon that understanding," says Cynthiane J. Morgenweck, MD, clinical ethicist for the Center for the Study of Bioethics at the Medical College of Wisconsin in Milwaukee. In an ideal world, informed consent should occur over a period of time when the physician and patient have the opportunity to develop a relationship, she says.
"Unfortunately, the real world in outpatient surgery is an emphasis on moving the patient into and out of the operating room. Many times, the anesthesiologist, in particular, has never met the patient before the day of surgery and has to establish a relationship in short order. We currently emphasize giving information, which is the easy part, but the hard part is assessing the patient’s level of understanding," says Morgenweck.
While outpatient surgery is very appealing to patients because of the short time frame and nonhospital environment, there is a possibility that the patient doesn’t understand the seriousness of surgery, she says. "If the physician determines that the patient does understand the benefits and potential risks of the surgery and can make an informed decision to agree to the surgery, that is the informed consent. The signed paper or the note in the chart is just documentation."
Deciding which complications to present to a patient when discussing surgery is another key component of gaining informed consent. "Compli-cations that should be explained are those that occur frequently, those that have some significance for harm to the patient, and those that are irreversible," says Morgenweck. "The patient should be the guide as to how much to disclose, since some patients want to know more or less than others." A good way to have the discussion is to present the key complications and subsequently ask the patient if he or she wants to hear about other things that can occur, she suggests.
The complications discussed with patients vary from physician to physician, says Jeffrey W. Wolf, MD, chief resident at University of Maryland Medical Center in Baltimore. A survey of 1,000 otolaryngologists conducted by Wolf shows that physicians use varying criteria to determine what complications are discussed with patients.1
"I expected the findings to show variability, but I was surprised at some of the complications that are not widely discussed," says Wolf. "For example, bleeding, scarring, and change in sense of smell are common complications for functional endoscopic sinus surgery, but not everyone discussed the three with the same frequency." Bleeding was discussed by 97% of the surgeons, scarring by 86% of the surgeons, and change in sense of smell by only 40% of the surgeons, he says.
Wolf did find that the more experienced the surgeon, the more accurate the discussion of complications. "This shows that the primary surgeon should be the one to discuss complications, not a member of the office staff, or in the case of a teaching hospital, the lowest intern on the totem pole."
When Wolf asked respondents to indicate the frequency level that determined if the complication should be discussed, he found another range of answers. "58% of the physicians said that any complication that occurs at least 1% of the time should be discussed," says Wolf. Eleven percent of the respondents said they discuss complications that occur at least 5% of the time; 2.4% discuss complications that occur in 10% of cases; and 27% of the respondents listed occurrence rates more than 10%, he says.
What isn’t specified in the survey is what occurrence rates the physicians use, says Wolf. "Some physicians may use rates reported by professional organizations or specific studies, but other physicians use rates from their own practice," he says. Experienced surgeons probably should use their own complication rates while surgeons with few years of experience can rely on national or regional rates from professional organizations or studies, Wolf suggests.
Although the physician handles the actual process of obtaining informed consent, an outpatient surgery manager can take several steps to ensure that patients do have an opportunity to give informed consent, says Morgenweck. "First, the manager should be aware of state requirements as well as accreditation requirements for the institution." Legal counsel and guidelines issued by organization such as the Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL, are good sources to help determine your program’s requirements, she says.
Staff also should have clear policies that are communicated to physicians and all staff members, says Morgenweck. "These policies should be reviewed periodically to make sure they are up-to-date and reflect what should be happening in the program." Staff can play an important part in the pre-op testing or pre-op phone call by asking the patient if all aspects of the surgery were explained and giving the patient a chance to ask further questions, she says. "If it is apparent that the patient may not fully understand the procedure and potential risks, the surgeon should be notified."
Wolf points out, "A good discussion of potential complications improves our treatment of the patient and improves the surgery experience."
[For more about informed consent, contact:
• Cynthiane J. Morgenweck, MD, Clinical Ethicist, Center for the Study of Bioethics, Medical College of Wisconsin, 8701 Watertown Plank Road, Milwaukee, WI 53226-0509. E-mail: email@example.com.
• Jeffrey S. Wolf, MD, Chief Resident, University of Maryland Medical System, 16 S. Eutaw St., Suite 400, Baltimore, MD 21201. Telephone: (410) 328-5828. Fax: (410) 328-5827. E-mail: firstname.lastname@example.org.]
1. Wolf JS. Informed consent in functional endoscopic sinus surgery. Presented at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery. Washington, DC; September 2000.