Consent: More than a signature

March 1, 2011

Consent forms signed before refractive surgery procedures do not suffice as evidence of informed consent.

Dublin, Ireland-Consent forms signed before refractive surgery procedures do not suffice as evidence of informed consent, said Marc B. Guerin, MD, MRCOphth, Barrister-at-Law.

Dr. Guerin described the understanding and recall of patients, the law relevant to the informed consent, and his legal and commonsense recommendations.

Focus on consent process

Patients are instructed to read and sign the consent form, which is returned at the time of surgery, Dr. Guerin said. He and Professor Michael O'Keefe, FRCSI, conducted a prospective, randomized study in which they evaluated patient understanding and recall of the informed consent process before LASIK and LASEK.

A total of 102 patients (average age, 35 years) received an anonymous questionnaire that was completed immediately preoperatively.

"The questionnaire was designed to measure their understanding and recall of their preoperative assessment, their understanding of what would happen during the surgery, and their understanding of the postoperative process," Dr. Guerin said.

LASIK procedures were performed on 33% of patients, LASEK on 63% of patients, and 4% did not know which procedure would be performed.

Dr. Guerin reported that 100% of patients believed that the surgical risks were outlined in the preoperative consent process, 99% of patients felt encouraged to ask questions, and no patients felt pressured to undergo a procedure.

The vast majority, 96%, believed that taking the consent form home was a good idea and that it served as a memory aid. Most patients spend 7 minutes reviewing the form; in one case, a patient spent 6 hours reviewing the form, Dr. Guerin recounted.

Almost two-thirds, 65%, of the patients learned more about the procedure on the Internet; however, of that two-thirds, only 23% learned any additional information about surgical procedures.

Regarding patient satisfaction with the refractive procedure, 37% were very satisfied, 63% were satisfied, and 0% were less than satisfied.