Informed Consent for Emergency Operations in Children: Does Portable Computer-assisted Education Enhance Parental Recall? Nwomeh BC 1, Caniano DA 1, Upperman JS 2, Hayes J 1, Kelleher KJ 1 1 Columbus Children's Hospital, Columbus, OH, 2 Childrens Hospital Los Angeles, Los Angeles, CA.

Background Central goals of Informed Consent Autonomy Beneficence Justice Unique challenges Children Emergency

Objective To facilitate the informed consent process during emergency surgery To improve communication between –pediatric surgeons and parents (informed permission) –Pediatric surgeons and the child (assent)

Hypothesis 1 Portable computer technology would facilitate preoperative education of the parent/child and enhance informed consent during emergency operations

Methods Demonstration project Prospective, non-randomized Consecutive patients 2 study periods A: Control (standard practice) B: Intervention (preoperative education enhanced by portable computer presentation)

Intervention Windows Tablet PC with PowerPoint™ Content –Images and cartoons to explain diagnosis, treatment, risks, outcome –Input from panel of pediatric surgeons –Pilot tested among Parent Group and initial 5 patients 10 slides, duration 5-10 minutes

Methods Acute Appendicitis Preoperative Education A: Control B: Intervention Surgical consent Appendectomy Enrolment Research consent ParentChild Questionnaire

2 page questionnaire “Informed Consent: What information should be disclosed” American College of Surgeons. Giving your informed consent. Likert scale Domains: –Autonomy –Beneficence –Content –Assent

Domains “Domains”Definition AutonomyQuestions that address respect for right of parents to make medical decisions for their child. BeneficenceQuestions that address the surgeon’s ethical obligation to propose only those interventions intended for the well-being of the child. ContentQuestions that address the surgeon’s skills in communicating appropriate details of operative procedure including risks, benefits, technique, and potential outcomes AssentQuestions that address the surgeon’s sensitivity to the feelings and opinion of the child, as appropriate to their age, development, and understanding

Demographics ControlIntervention n%n% Total 4536 Child's Sex M F Child's Age < > Proxy Mother Father Other0013

ControlIntervention n%n% Total 4536 Ethnicity Caucasian Black25412 Other1213 School completed Up To High School Some College Bachelor Degree Graduate Degree5114 Income <$50, $50-100, >$100, Demographics

Results 1 P=0.025P=0.047P=0.0035P=0.005

Hypothesis 2 Portable computer technology would enhance parental recall of information –Follow-up questionnaire at 3 weeks

Results 2

Summary Demonstration project Communication gaps during emergency surgery Preoperative educational intervention can improve parental perception of adequacy of informed consent Recall greatest for content domain Perception of autonomy degrades over time

Pitfalls Study design No validated measures of efficacy of informed consent for surgical procedures Questionnaire Vs. scoring by trained observer

Future Directions Communication Skills Training (CST) Prospective randomized design Audio recording Skilled observer

1.Columbus Children’s Research Institute 2.Children’s Institute for Pediatric Education Acknowledgement S E R F Adviser: Reed Williams, PhD