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Original Article
March 15, 2010

Informed Consent in Pediatric Surgery: Do Parents Understand the Risks?

Author Affiliations

Author Affiliations: Department of Otolaryngology–Head and Neck Surgery, Walter Reed Army Medical Center, Washington, DC.

Arch Otolaryngol Head Neck Surg. 2010;136(3):265-269. doi:10.1001/archoto.2010.5

Objective  To investigate parent understanding of the risks of pediatric ear, nose, and throat surgery after counseling with and without the use of informational aids.

Design  Prospective, randomized trial.

Setting  Academic tertiary care center.

Participants  Parents of children undergoing ear, nose, and throat surgery.

Interventions  Parents were randomized to receive standard informed consent with or without detailed informational aids.

Main Outcome Measures  Parents completed identical questionnaires testing their general procedure knowledge and their recall of 9 specific surgical risks both immediately after counseling and on the day of surgery.

Results  Thirty-four parents enrolled in and completed the study (18 in the control group and 16 in the test group). The mean time from informed consent to surgery was 6.3 days (range, 1-22 days). Parents in the test group scored significantly higher on identifying the 9 risks on both the preoperative questionnaire (mean score, 6.00 vs 4.44; P = .007, 2-tailed t test) and the postoperative questionnaire (6.25 vs 4.17; < .001). There was a negative correlation (inverse relationship) between parent education score and risk recall, with parents with lower education levels scoring higher on both the preoperative (Pearson r = −0.36; P = .04) and the postoperative (r = −0.35; P = .04) surveys. The maternal parent recalled risks significantly better than the paternal parent, with surgical risk recall scores of 5.46 out of 9 vs 3.67 out of 9 (P = .02, 2-tailed t test).

Conclusions  Parents of children undergoing ear, nose, and throat surgery recall far less than 100% of counseled risks. The use of detailed surgical risk counseling improves measured parental understanding of surgical risk. Parental educational level and maternal vs paternal parent may affect risk counseling recall.