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.

Digital technology in informed consent for surgery: systematic review
Aoife Kiernan, Brian Fahey, Shaista S Guraya, Fiona Boland, Daragh Moneley, Frank Doyle, Denis W Harkin
British Journal of Surgery, 24 January 2023
Open Access
Abstract
Background
Informed consent is an ethical and legal requirement in healthcare and supports patient autonomy to make informed choices about their own care. This review explores the impact of digital technology for informed consent in surgery.
Methods
A systematic search of EBSCOhost (MEDLINE/CINAHL), Embase, Cochrane Central Register of Controlled Trials and Web of Science was performed in November 2021. All RCTs comparing outcomes of both digital and non-digital (standard) consent in surgery were included. Each included study underwent an evaluation of methodological quality using the Cochrane risk of bias (2.0) tool. Outcomes assessed included comprehension, level of satisfaction and anxiety, and feasibility of digital interventions in practice.
Results
A total of 40 studies, across 13 countries and 15 surgical specialties were included in this analysis. Digital consent interventions used active patient participation and passive patient participation in 15 and 25 studies respectively. Digital consent had a positive effect on early comprehension in 21 of 30 (70 per cent) studies and delayed comprehension in 9 of 20 (45 per cent) studies. Only 16 of 38 (42 per cent) studies assessed all four elements of informed consent: general information, risks, benefits, and alternatives. Most studies showed no difference in satisfaction or anxiety. A minority of studies reported on feasibility of digital technology in practice.
Conclusion
Digital technologies in informed consent for surgery were found to have a positive effect on early comprehension, without any negative effect on satisfaction or anxiety. It is recommended that future studies explore the feasibility of these applications for vulnerable patient groups and busy surgical practice.

Electronic Consent at US Cancer Centers: A Survey of Practices, Challenges, and Opportunities
Applied Research
Susan Chimonas, Allison Lipitz-Snyderman, Kemi Gaffney, Gilad J. Kuperman
JCO Clinical Cancer Informatics, 3 January 2023
Abstract
Purpose
Digital technologies create opportunities for improving consenting processes in cancer care and research. Yet, little is known about the prevalence of electronic consenting, or e-consent, at US cancer care institutions.
Methods
We surveyed institutions in the National Comprehensive Cancer Network about their capabilities for clinical, research, and administrative e-consents; technologies used; telemedicine consents; multilingual support; evaluations; and opportunities and challenges in moving from paper-based to electronic processes. Responses were summarized across responding institutions.
Results
Twenty-five institutions completed the survey (81% response rate). Respondents were from all census regions and included freestanding and matrix cancer centers. Twenty (80%) had e-consent capabilities, with variability in the extent of adoption: One (5%) had implemented e-consent for all clinical, research, and administrative needs while 19 (95%) had a mix of paper and electronic consenting. Among those with e-consent capabilities, the majority (14 of 20, 70%) were using features embedded in their electronic health record. Most had a combination of paper and e-consenting for clinical purposes (18, 72%). About two-thirds relied entirely on paper for research consents (16, 64%) but had at least some electronic processes for administrative consents (15, 60%). Obstacles to e-consenting included challenges with procuring or maintaining hardware, content management, workflow integration, and digital literacy of patients. Successes included positive user experiences, workflow improvements, and better record-keeping. Only two of 20 (10%) respondents with e-consent capabilities had evaluated the impact of automating consent processes.
Conclusion
E-consent was prevalent in our sample, with 80% of institutions reporting at least some capabilities. Further progress is needed for the benefits of e-consenting to be realized broadly.

Digitalizing the Clinical Research Informed Consent Process: Assessing the Participant Experience in Comparison With Traditional Paper-Based Methods
Michael T. Buckley, Molly R. O’Shea, Sangeeta Kundu, Allison Lipitz-Snyderman, Gilad Kuperman, Suken Shah, Alexia Iasonos, Collette Houston, Stephanie L. Terzulli, Joseph M. Lengfellner, Paul Sabbatini
JCO Oncology Practice, 19 December 2022
Abstract
Purpose
Consent processes are critical for clinical care and research and may benefit from incorporating digital strategies. We compared an electronic informed consent (eIC) option to paper consent across four outcomes: (1) technology burden, (2) protocol comprehension, (3) participant agency (ability to self-advocate), and (4) completion of required document fields.
Methods
We assessed participant experience with eIC processes compared with traditional paper-based consenting using surveys and compared completeness of required fields, over 3 years (2019-2021). Participants who consented to a clinical trial at a large academic cancer center via paper or eIC were invited to either pre-COVID-19 pandemic survey 1 (technology burden) or intrapandemic survey 2 (comprehension and agency). Consent document completeness was assessed via electronic health records.
Results
On survey 1, 83% of participants (n = 777) indicated eIC was easy or very easy to use; discomfort with technology overall was not correlated with discomfort using eIC. For survey 2, eIC (n = 262) and paper consenters (n = 193) had similar comprehension scores. All participants responded favorably to at least five of six agency statements; however, eIC generated a higher proportion of positive free-text comments (P < .05), with themes such as thoroughness of the discussion and consenter professionalism. eIC use yielded no completeness errors across 235 consents versus 6.4% for paper (P < .001).
Conclusion
Our findings suggest that eIC when compared with paper (1) did not increase technology burden, (2) supported comparable comprehension, (3) upheld key elements of participant agency, and (4) increased completion of mandatory consent fields. The results support a broader call for organizations to offer eIC for clinical research discussions to enhance the overall participant experience and increase the completeness of the consent process.

Animation supported consent before elective laparoscopic cholecystectomy
Emre Doganay, David Wald, Sam Parker, Frances Hughes
British Journal of Surgery, 7 December 2022
Abstract
Background
Patient understanding of surgical procedures is often incomplete at the time they are performed, invalidating consent, and exposing healthcare providers to complaints and claims of failure to inform. Remote consultations, language barriers and patient factors can hinder an effective consent pathway. New approaches are needed to support communication and shared decision-making.
Methods
Multi-language digital animations explaining laparoscopic cholecystectomy were introduced at The Royal London Hospital for patients who attended for elective surgery (www.explainmyprocedure.com). Patients completed questionnaires on the day of their procedure both before and after introduction of the animations. We assessed patient-reported understanding of the procedure, its intended benefits, the possible risks, and alternatives to treatment in 72 consecutive patients, 37 before (no animation group) and after 35 after introducing the animations into the consent pathway (animation group). Patient understanding in the two groups was compared.
Results
The two groups were well matched in respect of age, sex and whether English was their first spoken language. The proportions of patients who reported they completely understood the procedure, its benefits, risks, and alternatives in the no animation group were 54%, 57%, 38% and 24% and in the animation group, 91%, 91%, 74% and 77% respectively; p<0.01 for each comparison.
Conclusions
The integration of multi-language laparoscopic cholecystectomy video animations into the patient consent pathway was associated with substantial improvement in reported understanding of the procedure, benefits, risks, and alternatives to treatment. This approach can be applied across all surgical disciplines in a standardised manner in an era of accelerated elective work and remote consultations.