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J Pediatr Surg. 2017 May;52(5):859-863. doi: 10.1016/j.jpedsurg.2017.01.023. Epub 2017 Jan 28.

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

Author information

1
Faculty of Medicine, University of Toronto, Toronto, ON.
2
York University, Toronto, ON.
3
The Hospital for Sick Children (SickKids), Toronto, ON.
4
The Hospital for Sick Children (SickKids), Toronto, ON. Electronic address: annie.fecteau@sickkids.ca.

Abstract

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 (X2=0.069, p=0.793), US (X2=0, p=1) or the overall sample (X2=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.

KEYWORDS:

Checklist; Communication; Informed consent; Patient satisfaction; Pediatric surgery

PMID:
28216078
DOI:
10.1016/j.jpedsurg.2017.01.023
[Indexed for MEDLINE]

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