According to the article, the fundamental concept of informed consent is that the patient has the right to make a decision regarding treatment, including refusal to accept treatment, after being given adequate information about disease, condition, and therapy in simple, concise terms. In order for informed consent to be given, surgeons must inform their patients of the following:
- The nature of the disease, condition or injury
- The nature, purpose, benefits, disadvantages and limitations of any treatment plan
- Available alternatives to any treatment, including the consequences of no treatment at all
- The risks and complications of the treatment
- Who will be performing the treatment
Several studies have investigated how much a patient remembers of what they are told during the informed consent process. One study revealed that patients undergoing cosmetic surgery remembered less than half of the information verbally communicated to them. Few studies have explored the use of additional, non-verbal means of communicating surgical risk and improving patient recall of those risks.
Ara Samuel Makdessian, M.D., F.R.C.S.C., from West-Med Facial Cosmetic Surgery Center, Plantation, Fla., and colleagues evaluated the effectiveness of verbal communication about the risks of facial cosmetic procedures compared with verbal and written communication in the form of pamphlets outlining procedures and risks.
The researchers enrolled 120 consecutive patients (average age, 41 years), who came to a facial plastic surgery center for a consultation for rhinoplasty (nasal reconstructive surgery, commonly referred to as a "nose job"), rhytidectomy (facelift), or laser resurfacing (a laser procedure used to reduce the appearance of facial wrinkles and blemishes). Patients were randomly assigned to one of two groups: the "no pamphlet group" discussed the risks of their procedure during the initial consultation (n=57); or the "pamphlet group" both discussed the risks and received a pamphlet outlining the risks (n=63). Demographic information was collected during the consultation on age, sex, occupation, and highest level of formal education attained. Patients were contacted by telephone approximately two weeks after the initial consultation and asked to recall the risks associated with their particular facial surgeries.
Of the 120 patients enrolled in the study, 48 underwent surgery. The researchers found that "the overall recall rate of the risks and complications of the three facial cosmetic procedures at 15 days after the initial consultation was approximately 40 percent (two risks of a total of five for each procedure). There was an increase in recall rate from 1.5 to 2.5 when patients were given printed pamphlets outlining those surgical risks," the authors write.
The researchers also found that university-educated patients, patients who had a rhinoplasty or laser resurfacing, and female patients had better risk recall.
"Written disclosure of the risks of cosmetic procedures enables patients to retain and understand more clearly those potential risks. They are, therefore, able to give an informed consent to the proposed procedure," the authors write.
(Arch Facial Plast Surg. 2004;6:26-30. Available post-embargo at http://www.archfacial.com)
Editorial: Informed Consent in Facial Plastic Surgery
In an accompanying editorial, Arlen D. Meyers, M.D., M.B.A., of the University of Colorado Health Sciences Center, Denver outlines several elements which should be included when obtaining and documenting informed consent, including frank discussion with the patient regarding risks, benefits and alternatives to treatment, adequate time for answering questions, and the amendment and re-signing of informed consent documents when necessary.
"As noted by the authors, 'failure to inform' can precipitate a lawsuit," writes Dr. Meyers. "Obtaining consent prior to surgery is a process, not merely having a patient sign a form. Facial plastic surgeons should review their informed consent risk management plan, institute a compliance program, and periodically audit it."
To contact Ara Samuel Makdessian, M.D., F.R.C.S.C., call 954-472-1212. To contact editorialist Arlen D. Meyers, M.D., M.B.A., call Dana Berry at 303-315-3056
(Arch Facial Plast Surg. 2004;6:62. Available post-embargo at http://www.archfacial.com))
For more information, contact JAMA/Archives Media Relations at 312-464-JAMA (5262) or e-mail mediarelations@jama-archives.org .
Journal
Archives of Facial Plastic Surgery