Checklist to improve informed consent process in pediatric surgery: A pilot study.

The purpose of this study was to develop and validate a checklist to standardize surgical informed consent process.

A checklist was created following a literature search. Consent processes were observed from general surgery (GS) and urology (US) in the pre- and post-intervention phases. Competent patients/guardians were asked to complete a satisfaction questionnaire. All trainees and staff surgeons were interviewed on the checklist's utility.

73 observations (GS=39, US=34) and 66 observations (GS=30, US=36) were made in the pre- and post-intervention phase, respectively. Our checklist increased the frequency with which surgeons explained alternative treatments (pre-intervention 23.3% vs. post-intervention 81.8%), the role of trainees (15.1% vs. 72.7%), and the potential outcomes of not pursuing surgery (60.3% vs. 87.9%). The patient/guardian average satisfaction score increased between phases within GS (mean[standard deviation] 3.55[0.58] vs. 3.85[0.24]); p=0.002), but not within US (3.53[0.61] vs. 3.52[0.54]); p=0.705) or the overall sample (3.54[0.59] vs. 3.67[0.46]); p=0.329). Interestingly, there was no significant improvement in patient/guardian average anxiety levels in GS (X2=0.069, p=0.793), US (X2=0, p=1) or the overall sample (X2=0.143, p=0.706) following the intervention.

Our checklist aids in standardizing the informed consent process. However, it did not significantly change satisfaction or anxiety levels of patients and guardians.

Prognosis study.

Level III.

Journal of pediatric surgery. 2017 Jan 28 [Epub]

Mohammed Firdouse, Amy Wajchendler, Martin Koyle, Annie Fecteau

Faculty of Medicine, University of Toronto, Toronto, ON., York University, Toronto, ON., The Hospital for Sick Children (SickKids), Toronto, ON., The Hospital for Sick Children (SickKids), Toronto, ON. Electronic address: .