@article {Friedlander194, author = {Joel A Friedlander and Greg S Loeben and Patricia K Finnegan and Anita E Puma and Xuemei Zhang and Edwin F de Zoeten and David A Piccoli and Petar Mamula}, title = {A novel method to enhance informed consent: a prospective and randomised trial of form-based versus electronic assisted informed consent in paediatric endoscopy}, volume = {37}, number = {4}, pages = {194--200}, year = {2011}, doi = {10.1136/jme.2010.037622}, publisher = {Institute of Medical Ethics}, abstract = {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{\textquoteright} 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.Clinical trial registration number ClinicalTrials.gov Identifier NCT00899392.}, issn = {0306-6800}, URL = {https://jme.bmj.com/content/37/4/194}, eprint = {https://jme.bmj.com/content/37/4/194.full.pdf}, journal = {Journal of Medical Ethics} }