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.

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 EducationA: ControlB: Intervention

Surgical consent

Appendectomy EnrolmentResearch consent

ParentChild

Questionnaire

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

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

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

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

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

Hypothesis 2

• Portable computer technology would

enhance parental recall of information

– Follow-up questionnaire at 3 weeks

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

*

*

***

‡

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 Institute2. Children’s Institute for Pediatric Education

Acknowledgement

S E R FAdviser: Reed Williams, PhD