Do you understand what I'm saying?


Signing a surgical consent form is a common and required part of the healthcare process. Before under-going almost any medical procedure, patients must read and sign a form stating that they understand the treatment and agree to have it performed.

A study presented on Thursday, however, found that few patients really understand the consent form, even when a physician, physician’s assistant, or other healthcare provider discusses the form with them in advance .This lack of comprehension should be a matter of great concern to patients and physicians who want to ensure good communication regarding medical treatment.

“Several factors may prevent patients from fully comprehending their consent forms,” said Allison E. Crepeau, MD, lead author of the study. “Age and level of education had a significant effect on whether the patient understood the form and remembered the information later. In addition, the stress of upcoming surgery may also affect a patient’s comprehension.”

In this study, patients about to undergo elective orthopaedic surgery were given a consent form by a physician’s assistant, who also spent 10 to 20 minutes reading the standardized form to the patient, explaining each aspect of the form in detail. Immediately following the discussion, the patients signed the forms. They were then given a 24-item questionnaire to test their recall of points specifically detailed on the consent form.

The patient questionnaire included true/false statements such as “A trainee (resident) may be present in my surgery” and “A sales representative may participate in the procedure.” It also included multiple choice statements such as “In the event that a healthcare provider sustains a needlestick/exposure to my blood or bodily fluid, they may draw my blood and test me for: a. HIV; b. hepatitis; c. both; d. neither.”

Patients answered an average of 71.5 percent of all the questions correctly. Patient comprehension of the consent form dropped even further following surgery. At the first postoperative visit with the physician—about 1 to 2 weeks after surgery—patients responded to the same questionnaire again; patients who had a second postoperative visit—1 to 2 months after surgery—were given the questionnaire a third time. Both groups answered only 60 percent of questions correctly.

Age was found to be a major factor in a patient’s ability to recall the specific points of the consent form. Patients older than age 50 answered fewer questions correctly than those who were under age 50. Education level also appeared to have an effect. For example, patients with only an eighth-grade education got the lowest percentage of questions correct, and the percentage of correct answers increased as the patient’s level of education increased. Patients who had graduate degrees answered the highest percentage correctly. This trend was most notable on the post-operative scores.

“Informed consent has been shown to be an important protection for both the patient and the physician, ensuring that patients undergoing surgery fully grasp the entire process,” said Dr. Crepeau. “Both physicians and patients need to take responsibility by asking questions and openly communicating to help ensure a good result.”

Co-authors of “Prospective Study Evaluating Patient Comprehension of Surgical Consent” are Bart McKinney, MD; Maya Fox, PA; Jennifer Castelli, OTRK; James Penna, MD; and Edward D Wang, MD. The authors received no compensation for this study.