1. 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.

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

3. 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)

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

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

6. 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

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

8. 2 page questionnaire “Informed Consent: What information should be disclosed” American College of Surgeons. Giving your informed consent. http://www.facs.org/public_info/operation/consent.html/#srgbysrg Likert scale Domains: –Autonomy –Beneficence –Content –Assent

9. 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

10. Demographics ControlIntervention n%n% Total 4536 Child's Sex M26581747 F19421953 Child's Age <512411 5-1019421336 >1025561953 Proxy Mother38842467 Father7161131 Other0013

11. ControlIntervention n%n% Total 4536 Ethnicity Caucasian42933185 Black25412 Other1213 School completed Up To High School13291439 Some College14311028 Bachelor Degree1329822 Graduate Degree5114 Income <$50,00014331644 $50-100,00020471233 >$100,000921822 Demographics

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

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

14. Results 2

15. 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

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

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

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