Using Hyperrealistic Simulations to Improve Digital Informed Consent for Endourological Procedures

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

Cognitive Testing of an Electronic Consent Platform: Researcher Perspectives

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
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

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
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.
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.
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.
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.

Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial

Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial
Fuad Abujarad, Peter Peduzzi, Sophia Mun, Kristina Carlson, Chelsea Edwards, James Dziura, Cynthia Brandt, Sandra Alfano, Geoffrey Chupp
JMIR Formative Research, 19 October 2021; 5(10)
The traditional informed consent (IC) process rarely emphasizes research participants’ comprehension of medical information, leaving them vulnerable to unknown risks and consequences associated with procedures or studies.
This paper explores how we evaluated the feasibility of a digital health tool called Virtual Multimedia Interactive Informed Consent (VIC) for advancing the IC process and compared the results with traditional paper-based methods of IC.
Using digital health and web-based coaching, we developed the VIC tool that uses multimedia and other digital features to improve the current IC process. The tool was developed on the basis of the user-centered design process and Mayer’s cognitive theory of multimedia learning. This study is a randomized controlled trial that compares the feasibility of VIC with standard paper consent to understand the impact of interactive digital consent. Participants were recruited from the Winchester Chest Clinic at Yale New Haven Hospital in New Haven, Connecticut, and healthy individuals were recruited from the community using fliers. In this coordinator-assisted trial, participants were randomized to complete the IC process using VIC on the iPad or with traditional paper consent. The study was conducted at the Winchester Chest Clinic, and the outcomes were self-assessed through coordinator-administered questionnaires.
A total of 50 participants were recruited in the study (VIC, n=25; paper, n=25). The participants in both groups had high comprehension. VIC participants reported higher satisfaction, higher perceived ease of use, higher ability to complete the consent independently, and shorter perceived time to complete the consent process.
The use of dynamic, interactive audiovisual elements in VIC may improve participants’ satisfaction and facilitate the IC process. We believe that using VIC in an ongoing, real-world study rather than a hypothetical study improved the reliability of our findings, which demonstrates VIC’s potential to improve research participants’ comprehension and the overall process of IC.

The application and promotion of electronic informed consent

The application and promotion of electronic informed consent
Dong, L. Qin, W. Wu, C. Tang, W. Long, Z. Yang, L. Ling, L. Lu
Chinese Journal of Evidence-Based Medicine, 2021; 21(7) pp 851-857
Under the background of the global COVID-19 pandemic, electronic informed consent (eConsent) utilizes technology to provide a new method and idea for clinical trials. It has the advantages of convenience and efficiency, which greatly improves the efficiency of clinical trials. At present, this concept has not been put forward in China while it has been clarified clearly abroad, and some countries have launched a variety of trials and formulated various regulations to further standardize the eConsent. Based on the current situation of eConsent in China, this study analyzed the design and implementation of eConsent, summarized relevant domestic and foreign laws and regulations, and proposed opportunities and challenges for electronic informed consent as well as the relevant preparations for the implementation of this technology in China.

Personalized Video Consent: A New Tool in the Preoperative Consent-Giving Process

Personalized Video Consent: A New Tool in the Preoperative Consent-Giving Process
Debraj Shome, Komal Doshi, Sapna Vadera, Vaibhav Kumar, Rinky Kapoor
Plastic and Reconstructive Surgery, October 2021; 148(4) pp 677e-679e
Open Access
    Medicolegal jurisprudence is ever increasing, and it is the right of each patient to have in-depth knowledge about their surgical procedure. Consent means voluntary and mutual agreement or permission. Preoperative informed consent should not only delineate the procedure, but also highlight the concerned risks.

However, written consent has certain drawbacks, including language, medical terms, understanding complications, expectations, and queries regarding surgery. An innovative approach to make informed consent simpler and more patient-friendly, such as video informed consent, may help in overcoming these barriers.

Video-augmentation of the Informed Consent Process in Mental Health Research: an Exploratory Study from India

Video-augmentation of the Informed Consent Process in Mental Health Research: an Exploratory Study from India
Abhijit Nadkarn, Sheena Wood, Ankur Garg, Danielle Fernandes, Ethel D’Souza, Urvita Bhatia
Asian Journal of Psychiatry, 23 September 2021
Only around 50-75% of individuals fully understand the various aspects of informed consent in research. The aim of our study was to examine whether supplementing the conventional paper-based informed consent process with an audiovisual aid improves participants’ understanding of the informed consent process and the information conveyed to them. Participants from two mental health/substance use intervention development studies were recruited for this study through consecutive sampling. They were then administered the traditional paper information and consenting process by itself or in combination with a video depicting the procedures of the study. Subsequently a bespoke questionnaire was administered to assess the participants’ understanding of the information conveyed to them about the parent study. The various domains of the questionnaire were compared between those who were administered the two different consenting processes using the chi square test. 27 (58.7%) participants were administered the traditional consenting process and 19 were administered the video-supplemented consenting process. The video-supplemented consenting process was not superior to the traditional paper-based informed consent process on any of the domains examined. In settings with participants having a limited education, and in research involving people with mental health or substance use problems, further research is necessary to identify of contextually relevant best practices for the informed consent process.

Evaluating the potential utility of three-dimensional printed models in preoperative planning and patient consent in gastrointestinal cancer surgery

Evaluating the potential utility of three-dimensional printed models in preoperative planning and patient consent in gastrointestinal cancer surgery
M Povey, S Powell, N Howes, D Vimalachandran, P Sutton
Annals: Royal College of Surgeons of England, September 2021; 103(8) pp 615-620
The Future of Surgery report from the Royal College of Surgeons of England acknowledges the important role that three-dimensional imaging will play in support of personalised surgical interventions. One component of this is preoperative planning. We investigated surgeons’ and patients’ perceptions of this evolving technology.
Materials and methods
Ethical approval was obtained. From a normal computed tomography scan, three-dimensional models of the stomach, pancreas and rectum were rendered and printed on an Ultimaker™ three-dimensional printer. Semi-structured interviews were performed with surgeons and patients to explore perceived model effectiveness and utility. Likert scales were used to grade responses (1 = strongly disagree; 10 = strongly agree) and qualitative responses recorded.
A total of 26 surgeons (9 rectal, 9 oesophagogastric, 8 pancreatic) and 30 patients (median age 62 years, interquartile range, IQR, 68–72 years; 57% male) were recruited. Median surgeon scores were effectiveness for preoperative planning, 6 (IQR 3–7), authenticity, 5 (IQR 3–6), likability, 6 (IQR 4–7), promoting learning, 7 (IQR 5–8), utility, 6 (IQR 5–7) and helping patients, 7 (IQR 5–8). Median patient scores were usefulness to the surgeon, 8 (IQR 7–9), authenticity, 8 (IQR 6–8), likability, 8 (IQR 7–8), helping understanding of condition, 8 (IQR 8–9), helping understanding of surgery, 8 (IQR 7–9) and feeling uncomfortable, 1 (IQR 1–4). Median overall decisional conflict score (0 = no; 100 = high) was 22 (IQR 19–28) and decision effectiveness was 25 (IQR 19–30).
Overall, patients and surgeons considered that three-dimensional printed models were effective and had potential utility in education and, to a lesser extent, preoperative planning. Patient decisional conflict and effectiveness scores were weighted towards certainty in decision making but had room for improvement, which three-dimensional models may help to facilitate.

Impact of animation-supported consent on complaints and serious incidents due to failure to inform

Impact of animation-supported consent on complaints and serious incidents due to failure to inform
D S Wald, L Arrol
QJM: An International Journal of Medicine, 17 August 2021
Introduction of digital animations to explain medical procedures before consent to treatment (animation-supported consent) has been shown to improve patient-reported understanding of a procedure’s benefits, risks and alternatives.
We examined whether introduction of animation-supported consent is associated with a change in the incidence of complaints and serious incidents due to failure to inform.
Multi-language animations explaining 10 cardiac procedures, in coronary intervention, electrophysiology and cardiac surgery, ( were introduced at a London cardiac centre from April 2019. Complaints and serious incidents due to failure to inform were identified from the hospital Datix database for the two years before introducing animation-supported consent (no animation group) and the two years afterwards (animation group), together with the total number of procedures and major complications recorded during these periods. We compared the incidence of complaints and serious incidents, expressed as a proportion of the number of major complications, recorded during each period.
There were 580 complications among 21 855 procedures performed in the no animation group and 411 complications among 18 254 procedures in the animation group. There were 14 complaints or serious incidents due to failure to inform in the no animation group and 3 in the animation group; rates of 2.41% (14/580) and 0.73% (3/411), respectively (P < 0.001 for difference).
In this observational comparison, introduction of animation-supported consent was associated with a 70% reduction in complaints or serious incidents due to failure to inform before consent. This has significant quality and cost implications for improving consent pathways in clinical practice.

Graphic narrative based informed consent for bronchoscopy improves satisfaction in patients after lung-transplantation: A randomized controlled trial

Graphic narrative based informed consent for bronchoscopy improves satisfaction in patients after lung-transplantation: A randomized controlled trial
Benjamin Seeliger, Moritz Z. Kayser, Nora Drick, Jan Fuge, Christina Valtin, Mark Greer, Jens Gottlieb
Patient Education and Counseling, 13 August 2021
This study investigated the effects of supplementing standard informed consent (IC) with a graphic narrative on patient satisfaction, periprocedural anxiety and experience.
Patients due to undergo first conscious surveillance bronchoscopy following lung transplantation were randomized to receive IC with (intervention group) or without (control group) a graphic narrative illustrating the procedure. The primary endpoint was overall patient satisfaction with the IC. Key secondary endpoints were change in state anxiety level, as measured by State Trait Anxiety Inventory, and a questionnaire assessing satisfaction with IC and adverse experience during bronchoscopy (judged by patient and examiners).
Sixty patients were randomized, and 59 patients were included in the analysis (30 intervention-group; 29 control-group). Overall patient satisfaction was higher in the intervention group 9.5 (25Q–75Q: 8.6–9.8) vs. 8.6 (25Q–75Q: 8.1–9.2), p = 0.028). Change in state anxiety level (before vs after informed consent) was similar between the groups. There were no significant differences in adverse experience during bronchoscopy.
Addition of a graphic narrative illustrating bronchoscopy improved patient satisfaction with IC but did not influence anxiety before and adverse experience during the procedure.
Practice implications
Supplementing the IC process with a procedure-specific graphic narrative may be a simple tool to improve patient satisfaction.