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Informed Consent for Emergency Operations in Children: Does Portable Computer-assisted
Education Enhance Parental Recall?
Nwomeh BC1, Caniano DA1, Upperman JS2, Hayes J1, Kelleher KJ1
1Columbus Children's Hospital, Columbus, OH, 2Childrens Hospital Los Angeles, Los Angeles, CA.
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Background
• Central goals of Informed Consent
• Autonomy
• Beneficence
• Justice
• Unique challenges
• Children
• Emergency
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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)
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Hypothesis 1
• Portable computer technology would
facilitate preoperative education of the
parent/child and enhance informed
consent during emergency operations
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Methods• Demonstration project
• Prospective, non-randomized
• Consecutive patients
• 2 study periods
A: Control (standard practice)
B: Intervention (preoperative education enhanced by
portable computer presentation)
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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
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Methods
Acute Appendicitis
Preoperative EducationA: ControlB: Intervention
Surgical consent
Appendectomy EnrolmentResearch consent
ParentChild
Questionnaire
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Questionnaire
• 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
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Domains
“Domains” Definition
Autonomy Questions that address respect for right of parents to make medical decisions for their child.
Beneficence Questions that address the surgeon’s ethical obligation to propose only those interventions intended for the well-being of the child.
Content Questions that address the surgeon’s skills in communicating appropriate details of operative procedure including risks, benefits, technique, and potential outcomes
Assent Questions that address the surgeon’s sensitivity to the feelings and opinion of the child, as appropriate to their age, development, and understanding
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Demographics
Control Intervention
n % n %
Total 45 36
Child's Sex
M 26 58 17 47
F 19 42 19 53
Child's Age
<5 1 2 4 11
5-10 19 42 13 36
>10 25 56 19 53
Proxy Mother 38 84 24 67
Father 7 16 11 31
Other 0 0 1 3
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Control Intervention
n % n %Total 45 36
Ethnicity Caucasian 42 93 31 85
Black 2 5 4 12
Other 1 2 1 3
School completed
Up To High School 13 29 14 39
Some College 14 31 10 28
Bachelor Degree 13 29 8 22
Graduate Degree 5 11 4 11
Income <$50,000 14 33 16 44
$50-100,000 20 47 12 33
>$100,000 9 21 8 22
Demographics
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Results 1
-0.4
-0.3
-0.2
-0.1
0
0.1
0.2
0.3
0.4
Autonomy Beneficence Content Assent
Control I ntervention
P=0.025 P=0.047 P=0.0035 P=0.005
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Hypothesis 2
• Portable computer technology would
enhance parental recall of information
– Follow-up questionnaire at 3 weeks
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Results 2
-1.4
-1.2
-1
-0.8
-0.6
-0.4
-0.2
0
0.2
0.4
0.6
Control Intervention
-1.4
-1.2
-1
-0.8
-0.6
-0.4
-0.2
0
0.2
0.4
0.6
Control Intervention
-1.4
-1.2
-1
-0.8
-0.6
-0.4
-0.2
0
0.2
0.4
0.6
Control Intervention
-1.4
-1.2
-1
-0.8
-0.6
-0.4
-0.2
0
0.2
0.4
0.6
Control Intervention
autonomy assentcontentbeneficence
Initial
Follow-up
*
*
***
‡
-1.4
-1.2
-1
-0.8
-0.6
-0.4
-0.2
0
0.2
0.4
0.6
Control Intervention
-1.4
-1.2
-1
-0.8
-0.6
-0.4
-0.2
0
0.2
0.4
0.6
Control Intervention
-1.4
-1.2
-1
-0.8
-0.6
-0.4
-0.2
0
0.2
0.4
0.6
Control Intervention
-1.4
-1.2
-1
-0.8
-0.6
-0.4
-0.2
0
0.2
0.4
0.6
Control Intervention
autonomy assentcontentbeneficence
Initial
Follow-up
*
*
***
‡
-1.4
-1.2
-1
-0.8
-0.6
-0.4
-0.2
0
0.2
0.4
0.6
Control Intervention
-1.4
-1.2
-1
-0.8
-0.6
-0.4
-0.2
0
0.2
0.4
0.6
Control Intervention
-1.4
-1.2
-1
-0.8
-0.6
-0.4
-0.2
0
0.2
0.4
0.6
Control Intervention
autonomy assentcontentbeneficence
Initial
Follow-up
*
*
***
‡
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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
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Pitfalls
• Study design
• No validated measures of efficacy of
informed consent for surgical procedures
• Questionnaire Vs. scoring by trained
observer
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Future Directions
• Communication Skills
Training (CST)
• Prospective randomized
design
• Audio recording
• Skilled observer
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1. Columbus Children’s Research Institute2. Children’s Institute for Pediatric Education
Acknowledgement
S E R FAdviser: Reed Williams, PhD