Related Experiment Video
Updated: Jun 5, 2026
E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
Published on: August 1, 2019
A novel method to enhance informed consent: a prospective and randomised trial of form-based versus electronic
Joel A Friedlander1, Greg S Loeben, Patricia K Finnegan
1Division of Gastroenterology, Department of Pediatrics, Doernbecher Children's Hospital, Center for Ethics in Health Care, Oregon Health and Science University, 707 SW Gaines Street, Mailcode CDRCP, 707 SW Gaines Street, Portland, OR 97239, USA. friedlan@ohsu.edu
Insights
Electronic assisted informed consent significantly improved understanding in pediatric endoscopy patients compared to standard forms. However, full informed consent was still incompletely achieved, indicating a need for further research.
Area of Science:
- Pediatric Gastroenterology
- Medical Ethics
- Health Informatics
Background:
- Informed consent is crucial for pediatric procedures.
- Traditional form-based consent may be inadequate for children undergoing endoscopy.
- Augmenting consent with technology could improve comprehension.
Purpose of the Study:
- To assess the effectiveness of standard informed consent versus electronic-assisted informed consent in pediatric endoscopy.
- To evaluate the impact of an interactive computer-based module on informed consent attainment.
Main Methods:
- A randomized controlled trial involving 101 children undergoing upper endoscopy.
- Comparison of standard form-based consent with electronic-assisted consent using an interactive module.
- Assessment of informed consent attainment, anxiety, satisfaction, and questions asked using validated instruments.
Main Results:
- Electronic-assisted consent increased the ability to achieve informed consent from 10% to 33% (p<0.0001).
- The electronic module did not negatively affect patient satisfaction, anxiety levels, or the number of questions asked.
- Despite improvements, informed consent remained incompletely achieved even with supplemental electronic information.
Conclusions:
- Standard form-based informed consent is insufficient for pediatric endoscopy.
- Electronic-assisted informed consent enhances understanding but does not fully achieve the goal.
- Further research is needed to optimize informed consent processes in pediatric procedures.
Objectives:
To evaluate the adequacy of paediatric informed consent and its augmentation by a supplemental computer-based module in paediatric endoscopy.
Methods:
The Consent-20 instrument was developed and piloted on 47 subjects. Subsequently, parents of 101 children undergoing first-time, diagnostic upper endoscopy performed under moderate IV sedation were prospectively and consecutively, blinded, randomised and enrolled into two groups that received either standard form-based informed consent or standard form-based informed consent plus a commercial (Emmi Solutions, Inc, Chicago, Il), sixth grade level, interactive learning module (electronic assisted consent). Anonymously and electronically, the subjects' anxiety (State Trait Anxiety Inventory), satisfaction (Modified Group Health Association of America), number of questions asked, and attainment of informed consent were assessed (Consent-20). Statistics were calculated using t test, paired t test, and Mann Whitney tests.
Results:
The ability to achieve informed consent, as measured by the new instrument, was 10% in the control form-based consent group and 33% in the electronic assisted consent group (p<0.0001). Electronically assisting form-based informed consent did not alter secondary outcome measures of subject satisfaction, anxiety or number of questions asked in a paediatric endoscopy unit.
Conclusions:
This study demonstrates the limitations of form-based informed consent methods for paediatric endoscopy. It also shows that even when necessary information was repeated electronically in a comprehensive and standardised video, informed consent as measured by our instrument was incompletely achieved. The supplemental information did, however, significantly improve understanding in a manner that did not negatively impact workflow, subject anxiety or subject satisfaction. Additional study of informed consent is required.
