Using Hyperrealistic Simulations to Improve Digital Informed Consent for Endourological Procedures
Original Article
Víctor Galve Lahoz, David Corbatón Gomollón, Federico Rodríguez-Rubio Cortadellas, Pedro Gil Martínez, Maria Jesús Gil Sanz, Jorge Rioja Zuazu
BJUI International, 25 December 2021
Abstract
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.

Cognitive Testing of an Electronic Consent Platform: Researcher Perspectives
Daniel Robins, Rachel Brody, Irena Parvanova, Joseph Finkelstein
Studies in Health Technology and Informatics, 15 December 2021; 284 pp 457-462
Abstract
This study focuses on feedback from domain experts to assess usability and acceptance of the E-Consent electronic consent platform. Quantitative and qualitative data were captured throughout the usability inspection, which was structured around a cognitive walkthrough with heuristics evaluation. Additional surveys measured biobanking knowledge and attitudes and familiarity with informed consent. A semi-structured qualitative interview captured open-ended feedback. 23 researchers of various ages and job titles were included for analysis. The System Usability Scale (SUS) provided a standardized reference for usability and satisfaction, and the mean result of 86.7 corresponds with an ‘above average’ usability rating in the >90th percentile. Overall, participants believe that electronic consenting using this platform will be faster than previous workflows while enhancing patient understanding, and human rapport is still a key component of the consent process. Expert review has provided valuable insight and actionable information that will be used to further enhance this maturing platform.

To draw or not to draw: Informed consent dilemma
Research Article
Santovito D, Cena G, Tattoli L, Di Vella G, Bosco C
Health and Primary Care, 14 May 2021
Open Access
Abstract
Background
Informed consent is a worldwide standard medical practice. The purpose of this study was to determine whether surgical freehand-drawings do facilitate surgeons in the communication process.
Methods
Authors carried out a questionnaire survey aimed at exploring physicians’ perceptions of the usefulness of drawings, in terms of level of understanding in consent acquisition procedures. A total of 90 anonymous questionnaires were distributed for doctors to fill in, in surgical and interventional medicine wards of the University Hospital of Turin.
Results
Out of the 90 questionnaires delivered, 37.8% (n=34) were filled out. 93.8% (n=30) of the physicians interviewed consider freehand-drawings a useful tool, 90% (n=27) of the surgeons, who confirmed to routinely use drawing for informed consent acquisition purposes. 96.3% (n=26) of the physicians who draw themselves illustrative images of proposed treatments asserted to perceive a real benefit in patients’ comprehension of the information when visually provided. Many respondent surgeons stated to consider drawing an effective means of information for consent acquisition. Nonetheless, just in 7.4% of the cases, personally drawn explicative images are then added in patients’ medical records, with possible detrimental effects on a medico legal point of view.
Conclusions
Graphical representation is useful for breaking down comprehension barriers resulting not only from the modality in which the information is conveyed but also from patients’ relational, social, and psychological factors, ensuring bi-directionalness of communication and prove in Italy, a Civil Law Country, the communicative effort of physicians in the best interest of the patients.