Informed consent (IC), randomized controlled trial digital vs conventional IC

Informed consent (IC), randomized controlled trial digital vs conventional IC
Galve La Hoz, J. Rioja, E. Salas, L. Enguita, M. Sanz Del Pozo, D. Corbatón, C. Gareta, S. Ezquerro, M. Muñoz, T. Cabañuz, P. Gil, M.J. Gil
European Urology Supplements, March 2019; 18(1) pp e847
Introduction& Objectives
In order to satisfy the informed consent process, patients must understand the information they receive. We know have support tools, like hyperrealistic simulations, which improve the understanding of informed consent. The objective of the study is to demonstrate that digital informed consent, with hyperrealistic simulations, improved the understanding of information and, therefore, informed consent.
Materials& Methods
The study included 84 participants who underwent a transurethral resection of the bladder, transurethral resection of the prostate or ureterostomy in our department. Participants were randomly assigned to either intervention or control group using the closed envelopes method. Informed consent was obtained in the outpatient clinic and patients were included in the study at hospital admission, when they were informed again. Intervention group watched a hyper realistic simulation from IURO app, consecutive, and completed a validated questionnaire. The control group completed the questionnaire without watching any simulation. The primary outcomes was subjective information perception. We used Mann-Whitney U test for statistical analysis.
Results
42 participants were assigned to each group. 4 participants in the intervention group did not complete the questionnaire versus 5 in the control group. Th intervention group, called digital consent, showed a higher subjective information perception than the control group, called the conventional group (figure 1 p= 0,001). The anxiety level in both groups was similar. In the subgroup analysis we observed that participants who had a basic level in the study or educational showed a higher subjective information perception in th digital group than the conventional group (p=0.006). We did not observe these differences in the subgroup with a higher level of study or educational.