Simulation Research on Awareness Rate and Satisfaction with Remote Multimedia Electronic Informed Consent

OBJECTIVE To evaluate the application effect of remote multimedia electronic informed consent mode and traditional informed consent mode in the context of the widespread use of electronic informed consent and the impact of COVID-19 on drug clinical trials. METHODS A randomized controlled trial involving patients presenting to a gastroenterology department within the last 6 months was conducted. Subjects were randomly assigned to one of two informed consent modalities. The subjects in the intervention group would complete the informed consent through the remote electronic informed consent applet, and the subjects in the control group would complete the informed consent under the in-person notification of the doctor. The research results of this experiment were the results of questionnaires on the awareness and satisfaction of the two groups of respondents. RESULTS A total of 101 subjects were recruited to participate in the study (intervention group, n=51; control group, n=50). Compared with the control group, subjects in the intervention group showed high satisfaction with no statistically significant difference, but they showed better awareness (median correct rate: intervention group 50.00% vs control group 37.5%), and the difference remained statistically significant(P<0.001). Through a stratified analysis of age(≥50 years old, <50 years old), gender and education(undergraduate and above, junior college, high school and below), the low education(junior college and below), elderly and female groups of intervention group had higher rate of informed awareness than those of control group, and the difference was statistically significant. CONCLUSION This study confirms the feasibility of the electronic informed consent model and the application effect of improving the subject’s informed awareness. electronic informed consent can provide a more convenient way of informed consent and save the cost of subjects participating in clinical trials. To meet the needs of more target populations, future optimization and research on electronic informed consent is valuable.