Title: Does app-based consent enhance participant comprehension and satisfaction by parents in pediatric clinical research? - A randomized controlled equivalence trial
Background
•Fewer in-person hospital visits and increased implementation of virtual care = fewer opportunities for research recruitment1
•Presents the opportunity to implement electronic consenting processes2,3
•App-based consent: limited comprehensive evaluation in pediatric settings = more information required to improve feasibility and acceptability4
Objectives
1. Investigate the effectiveness of app-based versus paper consent
2. Determine if app-based consenting methods increase trust in research
Methods:
REB-approved non-inferiority randomized controlled trial of app-based versus paper consent
Sample size: ~ 120 parents of children being enrolled in a separate study that runs in tandem under the same ethical approval
Analysis: Wilcoxon rank sum tests for the differences between
•Composite correctness scores of multiple-choice questions, using a non-inferiority target of 2.5/4 points with a margin of 0.5 points for comparison
•Groups compared elementwise for Likert scale questions
Results
Demographics (n = 120)
•85 (71%) female; 16 (13%) <30, 80 (67%) 30-39, 22 (18%) 40-49 years, and 2 (2%) >50 years old
•62 paper (control) consent and 58 app-based (intervention) consent
Primary outcome and secondary outcomes:
•Comprehension: Median composite comprehension scores were 3.0/4.0 [IQR (interquartile range) 2.5, 3.5] for paper and 3.5/4.0 [2.5, 4.0] app-based consent; median difference: 0.0 (95% CI-0.5 to 0.0), p=0.481. Participants responded to each question similarly (Figure 1)
•Satisfaction & trust ratings: Participants rated satisfaction and trust statements similarly (Figure 2)
•16/33 (49%) participants who experienced paper-based and 17/30 (57%) app-based consent felt their consenting process was better than others.
Limitations
•Use of a simulated, not fully-functioning app
•Parental consent only
•Simple evaluation
Future Research
•Creation of a functional app
•Usage of accessibility tools (auto-translation, speech-to-text, etc.) to accommodate a wider variety of patients
Conclusion: App-based consent did not diminish comprehension, satisfaction, or trust in the pediatric clinical research setting
References:
[1] PLoS One. 2013;8(3):e58603 [2] J Empir Res Hum Res Ethics. 2020;15(4):252-260
[3] Contemp Clin Trials Commun. 2016;17(3):32-38
[4] JMIR MhealthUhealth. 2017;5(2):e14.
