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

PURPOSE

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

METHODS

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.

RESULTS

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 (X=0.069, p=0.793), US (X=0, p=1) or the overall sample (X=0.143, p=0.706) following the intervention.

CONCLUSION

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

TYPE OF STUDY

Prognosis study.

LEVEL OF EVIDENCE

Level III.