Objectives

To show that digital informed consent (DIC) improves the subjective understanding of information and, therefore, informed consent.

Patients and Methods

A nonblinded randomized controlled trial was performed with 84 patients who had undergone a transurethral resection of bladder, transurethral resection of prostate, or ureterorenoscopy between July 2017 to March 2018. The DIC group watched a hyperrealistic simulation on a tablet device before surgery. After surgery and again 30 days later, both groups completed a validated questionnaire that measured subjective understanding, anxiety, and utility of and need for information.

Results

The mean±SD age of participants was 68.7±11.1 years. Nine of 84 patients (10.7%) did not complete the questionnaire. 42 patients were allocated to the DIC group and 42 to the control group. The mean±SD score on immediate subjective understanding in the DIC group was 14.5% higher than in control group (72%±17.5% vs 57.5%±23.5%, respectively; p=0.006). There was no statistical difference among anxiety, utility of and need for information relative to delayed subjective understanding. In subgroup analysis, subjective understanding scores were higher, but not significantly so, among patients with low and higher education levels in the DIC group than in the control group (68%±18.1% vs 54%±22.5%, respectively, p=0.06; and 76%±18.3% vs and 66%±21.9%, respectively, (p=0.89).

Conclusion

Hyperrealistic simulations improved subjective understanding of information and, therefore, informed consent for endourological procedures.