Abstract
Background and study aims Youth undergoing pediatric endoscopic procedures
and their parents demonstrate suboptimal comprehension of the informed consent
(IC) process. We developed informational videos discussing key IC elements for
pediatric endoscopy and evaluated their effects on youth and parental
comprehension of the IC process.
Patients and methods A randomized controlled trial of the video
intervention was performed among youth undergoing endoscopy and their parents at
an academic children’s hospital. Randomization occurred at the time of
enrollment using permutated blocks. Following the IC process with the
proceduralist, subjects underwent structured interviews to assess IC
comprehension. An Informed Consent Overall Score (ICOS: range 0 – 4) for
comprehension was calculated.
Results Seventy-seven pairs of children and their parents participated.
Intervention recipients (N = 37 pairs) demonstrated higher ICOS scores as
compared to control counterparts (mean (standard deviation): 3.6 (0.7) v. 2.9
(0.9), intervention v. control parents, P < 0.0001 and 2.7 (1.1) v.
1.7 (1.1), intervention v. control youth, P < 0.0001).
Conclusions A media intervention addressing key elements of the IC process
for pediatric endoscopy was effective in improving comprehension of IC for youth
undergoing endoscopic procedures and their
parents.
Pediatric Endoscopy Quality Improvement Network (PEnQuIN) Quality Standards and Indicators for Pediatric Endoscopists and Endoscopists in Training
