Informed Consent in Otologic Surgery: Prospective Study of Risk Recall by Patients and Impact of Written Summaries of Risk

Objectives: To evaluate how much patients remember of the risks discussed with them about their otologic surgery and to evaluate whether a simple intervention, the addition of an information handout, improves recall. Study Design: A prospective, randomized trial was undertaken in the setting of an academic tertiary care centre. Methods: Fifty patients undergoing a variety of otologic procedures, including mastoidectomy, tympanoplasty, ossiculoplasty, and stapedectomy, were verbally consented by the operating surgeon with a standard checklist of potential surgical complications and side effects. Two surgeons participated in the study (40 patients and 10 patients). Patients were stratified into two groups: a higher education group and a lower education group. Within each group, patients were randomized to either a control group, consisting of a verbal explanation only, or an intervention group, which added a written handout to the verbal explanation. A follow-up telephone interview was conducted at an average of 20.6 days (range 14-53) to survey for recall of the complications discussed. Main Outcome Measures: The main outcome measure is risk recall. This is analyzed by education level and written sheet intervention. Other parameters examined are patient demographics, time elapsed from when the consent was obtained, and surgeon obtaining the consent. Results: All 50 patients were interviewed in follow-up. Twenty-two patients received the handout (intervention arm), and 28 patients served as the control group. Overall recall, expressed as a percentage of risks explained, was 54% for the entire study group. For those who received the handout, the recall rate was 51%, whereas the rate was actually higher, at 56%, for those who did not receive the handout. This difference was not statistically significant. Of the specific risks discussed, patient recall was consistently high for the complications of facial nerve paralysis, 88%, and for complete hearing loss, at 88%. Other risks, such as dizziness, 31%, and change in taste, 36%, were not as commonly recalled. Receiving the handout made only a significant difference with one complication, facial nerve paralysis. Conclusion: The addition of a handout did not significantly alter recall of potential complications of otologic surgery with the exception of facial nerve paralysis.