Informed consent for strabismus surgery: the importance of patient information sheets.

PURPOSE

To analyze the additive effect of supplementing verbal consent with written patient information sheets in optimizing patients' and families' understanding of strabismus surgery.

METHODS

A prospective randomized study was conducted with 28 patients for strabismus surgery randomized into two groups: group 1 with standardized oral informed consent, and group 2 with standardized oral consent and a written information sheet. A confidential questionnaire with 13 questions was completed by patients and families before surgery.

RESULTS

A total of 7 adults and 21 children were included in the study. The mean score (number of correct answers) for group 1 was 4.14 ± 1.99; for group 2, 5.79 ± 2.12 (P = 0.044), indicating that patients and families in group 2 understood their strabismus surgery better than those in group 1. Areas needing more emphasis during the consent process were identified, including risk of under- or overcorrection or repeat surgery and use of eyedrops postoperatively.

CONCLUSIONS

In this study, patient information sheets seemed to help patients and families better understand information about their surgery. Patient recall of information provided is poorly reliable and must be considered in decision making for medicolegal cases.