Improving the Consent Process with an Informed Consent Video Prior to Outpatient Colonoscopy
Original Research
Emily W. Lopes, Leo Boneschansker, Jacqueline N. Chu, James M. Richter, Amiko M. Uchida, Paul Lochhead
Gastro Hep Advances, 28 July 2023
Abstract
Background & Goals
Informed consent should allow patients appropriate time and conditions to make decisions about their care. However, consent is often obtained immediately prior to colonoscopy. We conducted a quality improvement study to assess how a pre-procedure consent video two days prior to outpatient colonoscopy impacts patient satisfaction.
Study
Patients undergoing outpatient colonoscopy at a large academic medical center opted-in to a text-messaging platform for procedural information. Our intervention was an informed consent video two days before colonoscopy. Our primary outcome was a composite patient satisfaction score. Pre- and post-intervention scores were compared using ordinal or multinomial logistic models to calculate odds ratios (OR) or relative risk ratios (RRR) and 95% confidence intervals (CI), adjusting for age and sex.
Results
1,109 and 1,452 patients completed ≥1 survey question in the pre- and post-intervention phases, respectively. Overall patient satisfaction did not differ between groups [OR for a 1-point increment in satisfaction score between post- vs. pre-intervention groups=1.05; 95% CI: 0.90-1.22; p=0.51]. Compared to pre-intervention, post-intervention respondents were more likely to report higher satisfaction with time available to talk with their physician (OR of a 1-point increase in individual question response=1.29; 95% CI: 1.09-1.54; p=0.004). Compared to pre-intervention, more physicians in the post-intervention phase rated satisfaction with consent process efficiency as “very satisfied” or “satisfied” (p<0.001).
Conclusion
An informed consent video prior to colonoscopy resulted in similar overall patient satisfaction. However, post-intervention, patients were more likely to report sufficient time to talk with their physician, and physicians reported higher satisfaction with consent efficiency.

Use of an educational video with mobile technology for the informed consent process: A randomised controlled trial on patients undergoing surgery for an impacted lower third molar
Yoshiko Myoken, Takeshi Kawamoto, Yoshinori Fujita, Yohei Tsubahara, Shigeaki Toratani, Souichi Yanamoto, Yoshinari Myoken
British Journal of Oral and Maxillofacial Surgery, 13 July 2023
Abstract
The purpose of this study was to determine whether audiovisual presentation of consent information would significantly improve patients’ postoperative recall of risks and complications regarding surgical removal of impacted lower third molars compared to the presentation of traditional written consent information. A randomised controlled study on 59 patients undergoing third molar removal was conducted. Patients in the intervention group (n = 30) viewed an educational video on risks and complications related to surgery using mobile tablets. Control-group patients (n = 29) received written information of the risks and complications. Patients’ postoperative recall of potential risks for dysesthesia of the lower lip and tongue, infection, and bleeding along with surgical complications of facial oedema, trismus, and pain were assessed using true-false tests. The effect of audiovisual information on postoperative recall of the risks and complications was determined by comparing accuracy scores between the intervention group and control group using independent t-test. The intervention group was found to have significantly better recall scores of the potential risks and complications, due to much higher accuracy recall of bleeding and dysesthesia of the lower lip or/and tongue, compared to the control group [mean 4.70 (SD 0.94) vs. 3.76 (SD 1.50), p = 0.003]. The use of an educational video in mobile tablets rather than a written pamphlet may lead to better patient understanding in the informed consent process.

Electronic consent in clinical care: an international scoping review
Original research
Susan Chimonas, Allison Lipitz-Snyderman, Konstantina Matsoukas, Gilad Kuperman
BMJ Health & Care Informatics, 9 July 2023
Abstract
Objective
Digital technologies create opportunities for improvement of consenting processes in clinical care. Yet little is known about the prevalence, characteristics or outcomes of shifting from paper to electronic consenting, or e-consent, in clinical settings. Thus questions remain around e-consent’s impact on efficiency, data integrity, user experience, care access, equity and quality. Our objective was to scope all known findings on this critical topic.
Materials and methods
Through an international, systematic scoping review, we identified and assessed all published findings on clinical e-consent in the scholarly and grey literatures, including consents for telehealth encounters, procedures and health information exchanges. From each relevant publication, we abstracted data on study design, measures, findings and other study features.
Main outcome measures
Metrics describing or evaluating clinical e-consent, including preferences for paper versus e-consenting; efficiency (eg, time, workload) and effectiveness (eg, data integrity, care quality). User characteristics were captured where available.
Results
A total of 25 articles published since 2005, most from North America or Europe, report on the deployment of e-consent in surgery, oncology and other clinical settings. Experimental designs and other study characteristics vary, but nearly all focus on procedural e-consents. Synthesis reveals relatively consistent findings around improved efficiency and data integrity with, and user preferences for, e-consent. Care access and quality issues are less frequently explored, with disparate findings.
Discussion and conclusion
The literature is nascent and largely focused on issues that are immediate and straightforward to measure. As virtual care pathways expand, more research is urgently needed to ensure that care quality and access are advanced, not compromised, by e-consent.

Applications of Extended Reality (XR) in obtaining informed consent: A narrative review
Research Article
Michelle Lai, Rob (Hongbo) Chen, Andrew Evanyshyn, Zeina Shaltout, Myrtede Alfred
Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care, 7 June 2023
Abstract
Informed consent in healthcare requires patients to have a sufficient understanding of their upcoming procedure before deciding to proceed. Unfortunately, education prior to a surgical procedure is constrained by barriers including poor health literacy, language barriers, one-sided dialogue during consultations, anxiety, and knowledge retention. Extended reality (XR), which includes virtual reality (VR), augmented reality (AR), and mixed reality (MR) has the potential to improve informed consent processes by creating an immersive, interactive, and multimodal sensory experience that supports patient education. The purpose of the study was to review the extant literature on the effectiveness of XR technology in improving patient education, a vital component of informed consent. We screened fifty-two articles and ten relevant papers from PubMed, Scopus, and Compendex, which were included in the review based on our eligibility criteria. We found that VR and AR proved effective in enhancing patient education in eight studies, and thus improving informed consent processes. MR was not utilized in the studies reviewed. The studies were conducted in several countries and positives findings were reported from a broad range of clinical settings and procedures. Though further investigation is needed, this is a promising finding that may encourage health systems to implement similar interventions prior to procedures. The review also provided an overview of the existing XR technology utilized for patient education such as a downloadable mobile application with a virtual chatbot character, and an environment designed to simulate the MRI patient’s perspective. These applications provide immersive and interactive experiences when paired with a head mounted headset such as Google VR Cardboard. The findings also revealed that XR tools are customizable and can be tailored to specific surgical procedures, which makes the potential of implementation applicable to a broader range of settings.

Educate Before You Operate: Improving the Informed Consent Process
Brian Piatkowski, Jeanne Lee, Eli Strait
Journal of Burn Care & Research, 15 May 2023
Abstract
Introduction
The informed consent process is a daily task for providers with a surgical patient population. In the burn population, informed consent is often presented by an intern or resident physician. Consent is comprised of surgical debridement with a multitude of options for coverage of their wounds. The current state of practice is a verbal overview of all the possible procedures that may be done to the patient’s wound(s). Patients often verbalize feeling overwhelmed with the amount of information on the consent and often have questions related to their procedure just before the brief of the operative case.
Methods
An educational video was developed that detailed the surgical procedure and the potential burn wound coverings. A 3-question survey was given to patients who have already been through the informed consent process. Survey metrics examined knowledge of consent when signed, the satisfaction of verbal explanation, and if a video would increase understanding. The video was given to the same patients to watch. After the video was viewed, those patients were then again surveyed. Providers were also given a 3-question survey before viewing the video. Survey metrics examined comfort of consent, knowledge of procedures, and if the video would increase patient understanding of consent topics. The providers were then surveyed after watching the video.
Results
Initial post-implementation data shows that patients and providers have increased comfort and knowledge in the informed consent process. Patients show an 80% increase in understanding of consent, a 72% increase in satisfaction with video vs verbal overview, and a 97% increase in satisfaction with material viewed. Provider data shows a 65% increase in the comfort of consent, a 64% increase in knowledge of procedures, and a 97% increase that the video will help patients understand their consent. This shows that this evidence-based project is an improvement from the current standard of practice.
Conclusions
The informed consent process is an opportunity for providers and patients to have a moment of discussion. It is a pivotal point in which a patient and a provider determine the next step of their care. The patient must have clear communication and education regarding the procedures to which they are consenting. It is also a discussion where a provider can provide education and support at what is an overwhelming time for patients in their hospital stay.
Applicability of Research to Practice
Implementation of a standardized audio/video teaching method for burn surgical patients is an effective way to increase patient and provider satisfaction regarding the informed consent process. Implementing this educational tool is a cost-effective and simple way to educate burn patients before their surgical procedures. There is an overall improvement in patient satisfaction and increased satisfaction in the providers who obtain the consent.

Effective Informed Consent Communication Skills for Senior Medical Students (Sub-Interns)
Katharine A. Robb, Hanna D. Zembrzuska, Marcy Rosenbaum
Patient Education and Counseling, April 2023
Abstract
Background
Obtaining informed consent from patients for procedural tests/treatments is an important communication task for health care providers, involving more than just getting a consent form signed. To ensure that patients have understanding to make informed decisions, effective communication skills are needed in conducting informed consent conversations. Several studies have demonstrated that new postgraduate learners (interns) lack skills to conduct these conversations effectively. Sub-internship rotations aimed at preparing senior medical students for their upcoming role as postgraduate trainees may be an appropriate place to introduce learners to informed consent skills.
Methods
We developed an educational intervention on effective informed consent communication skills for sub-interns in Internal Medicine. Educational components included: 1) A pre-workshop self-study module on blood transfusion and joint aspiration; 2) A two-hour experiential workshop on Zoom (or in person) where students learn about and practice effective informed consent conversation communication skills on the two procedures. Each student engages in a consent conversation (7-10 minutes) with a simulated patient while the other students watch, followed by debriefing and learner feedback. Two versions of each case are enacted (“easy” versus “apprehensive” patient) demonstrating how to apply the skills to patients with different reactions and concerns.
Assessment/evaluation
Pre-intervention assessments indicating the need for this session included data from entering intern OSCEs (N=33 over 3 years) in which interns scored lowest on the informed consent station and a needs assessment survey revealing sub-interns (N=24) desired formal training in informed consent skills. A post-intervention evaluation survey revealed all participating sub-interns found being able to practice, receive feedback and observe others practice was helpful in enhancing their informed consent skills. A pre-post retrospective survey will collect evaluation data from subsequent sessions.
Discussion
Time efficient experiential informed consent sessions are feasible to help better prepare senior learners for these important conversations and shared decision making.

Personalized surgical informed consent with stereoscopic visualization in neurosurgery—real benefit for the patient or unnecessary gimmick?
Original Article – Neurosurgery general
Nicolas Hertzsprung, Kiril Krantchev, Thomas Picht, Anna L. Roethe, Kerstin Rubarth, Josch Fuellhase, Peter Vajkoczy, Güliz Acker
Acta Neurochirurgica, 28 February 2023
Open Access
Abstract
Background
Informed consent of the patient prior to surgical procedures is obligatory. A good and informative communication improves patients’ understanding and confidence, thus may strengthen the patient-doctor relationship. The aim of our study was to investigate the usefulness of additional stereoscopic visualization of patient-specific imaging during informed consent conversation.
Methods
Patients scheduled for a brain tumor surgery were screened for this study prospectively. The primary exclusion criteria were cognitive or visual impairments. The participants were randomized into two groups. The first group underwent a conventional surgical informed consent performed by a neurosurgeon including a demonstration of the individual MRI on a 2D computer screen. The second group received an additional stereoscopic visualization of the same imaging to explain the pathology more in-depth. The patients were then asked to fill in a questionnaire after each part. This questionnaire was designed to assess the potential information gained from the patients with details on the anatomical location of the tumor as well as the surgical procedure and possible complications. Patients’ subjective impression about the informed consent was assessed using a 5-point Likert scale.
Results
A total of 27 patients were included in this study. After additional stereoscopic visualization, no significant increase in patient understanding was found for either objective criteria or subjective assessment. Participants’ anxiety was not increased by stereoscopic visualization. Overall, patients perceived stereoscopic imaging as helpful from a subjective perspective. Confidence in the department was high in both groups.
Conclusion
Stereoscopic visualization of MRI images within informed consent conversation did not improve the objective understanding of the patients in our series. Although no objective anatomical knowledge gain was noted in this series, patients felt that the addition of stereoscopic visualization improved their overall understanding. It therefore potentially increases patient confidence in treatment decisions.

Application of 3D printing technology for pre-operative evaluation, education and informed consent in pediatric retroperitoneal tumors
Joong Kee Youn, Sang Joon Park, Young-Hun Choi, Ji-Won Han, Dayoung Ko, Jeik Byun, Hee-Beom Yang, Hyun-Young Kim
Scientific Reports, 30 January 2023
Open Access
Abstract
To investigate usefulness of 3D printing for preoperative evaluations, student and resident education, and communication with parents or guardians of patients with pediatric retroperitoneal tumors. Ten patients planning retroperitoneal tumor resection between March and November 2019 were included. Preoperative computed tomography (CT) images were used for 3D reconstruction and printing. Surveyed items were understanding of preoperative lesions with 3 different modules (CT, 3D reconstruction, and 3D printing) by students, residents, and specialists; satisfaction of specialists; and comprehension by guardians after preoperative explanations with each module. The median age at operation was 4.2 years (range, 1.8–18.1), and 8 patients were diagnosed with neuroblastoma. The 3D printing was the most understandable module for all groups (for students, residents, and specialists, P = 0.002, 0.027, 0.013, respectively). No significant intraoperative adverse events or immediate postoperative complications occurred. All specialists stated that 3D printing enhanced their understanding of cases. Guardians answered that 3D printing were the easiest to comprehend among the 3 modules (P = 0.007). Use of 3D printing in treatment of pediatric patients with retroperitoneal tumors was useful for preoperative planning, education, and parental explaining with obtaining informed consent.

Effects of a video-based positive side-effect information framing: An online experiment
Friederike L. Bender, Winfried Rief, Joscha Brück, Marcel Wilhelm
Health Psychology, 2023
Abstract
Objective
Despite the public health value of vaccines, vaccination uptake rates are stagnating. Expected adverse events following immunization are a major source of concern and play a role in the emergence of vaccine hesitancy. Since nocebo mechanisms are involved in the perception of adverse reactions, positive side-effect communication is warranted. The aim of the present study was to compile a comprehensive communication strategy that minimizes expectations of nocebo effects while respecting the informed consent procedure.
Method
In a randomized 2 × 2 between-subject design, 652 participants received information about COVID-19 or influenza vaccination using either standard side-effect messaging or messaging enriched with proven elements of expectation-optimizing framing. A physician presented information online via video. Moderation analyses were conducted to examine effects among particular subpopulations. Expected adverse event ratings following an imagined immunization, cost-benefit ratios of the vaccination, and future vaccination intentions were assessed.
Results
Information content ratings were equally high in each group. Positive framing significantly decreased adverse event expectations in the COVID-19 information group and raised the cost-benefit ratio in the influenza condition, indicating higher benefits than cost expectations. Moderation analysis revealed that the framed side-effect communication lowered the expected COVID-19 vaccination uptake willingness in individuals with strong anti-vaccination attitudes.
Conclusions
Facing the ongoing coronavirus mass vaccinations, positive information frames have a small but significant impact on vaccination concerns while upholding informed consent. Although intervention trials are still pending, this approach could help decrease vaccine hesitancy by reducing fearful expectations. However, it seems that it should not be used without considering vaccination attitudes.