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

Personalized Video Consent: A New Tool in the Preoperative Consent-Giving Process
Viewpoints
Debraj Shome, Komal Doshi, Sapna Vadera, Vaibhav Kumar, Rinky Kapoor
Plastic and Reconstructive Surgery, October 2021; 148(4) pp 677e-679e
Open Access
Excerpt
    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
Abstract
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
Abstract
Introduction
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.
Results
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).
Discussion
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
Summary
Background
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.
Aim
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.
Methods
Multi-language animations explaining 10 cardiac procedures, in coronary intervention, electrophysiology and cardiac surgery, (www.explainmyprocedure.com) 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.
Results
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).
Conclusion
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
Abstract
Objective
This study investigated the effects of supplementing standard informed consent (IC) with a graphic narrative on patient satisfaction, periprocedural anxiety and experience.
Methods
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).
Results
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.
Conclusion
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.

Informed Consent for Online Research—Is Anybody Reading?: Assessing Comprehension and Individual Differences in Readings of Digital Consent Forms

Informed Consent for Online Research—Is Anybody Reading?: Assessing Comprehension and Individual Differences in Readings of Digital Consent Forms
Research Article
Caitlin Geier, Robyn B. Adams, Katharine M. Mitchell, Bree E. Holtz
Journal of Empirical Research on Human Research Ethics, 24 May 2021
Abstract
Informed consent is an important part of the research process; however, some participants either do not read or skim the consent form. When participants do not read or comprehend informed consent, then they may not understand the potential benefits, risks, or details of the study before participating. This study used previous research to develop experimentally manipulated online consent forms utilizing various presentations of the consent form and interactive elements. Participants (n = 576) were randomly exposed to one of six form variations. Results found that the highly interactive condition was significantly better for comprehension than any of the other conditions. The highly interactive condition also performed better for readability, though not significantly. Further research should explore the effects of interactive elements to combat habituation and to engage participants with the parts of the consent form unique to the study.

Evaluation of two communication tools, slideshow and theater, to improve participants’ understanding of a clinical trial in the informed consent procedure on Pemba Island, Tanzania

Evaluation of two communication tools, slideshow and theater, to improve participants’ understanding of a clinical trial in the informed consent procedure on Pemba Island, Tanzania
Research Article
Marta S. Palmeirim, Ulfat A. Mohammed, Amanda Ross, Shaali M. Ame, Said M Ali, Jennifer Keiser
PLoS Neglected Tropical Disease, 14 May 2021
Abstract
Background
Clinical trial participants are required to sign an informed consent form (ICF). However, information is lacking on the most effective methods to convey trial relevant information prior to inviting participants to sign the ICF, being particularly pertinent in low income countries. A previous study on Pemba Island, Tanzania, found that an oral information session (IS) was significantly better than providing an ICF alone. However, knowledge gaps remained. Building on these findings, we investigated the effect of adding a slideshow or a theater to the IS in the informed consent procedure of an anthelminthic clinical trial.
Methodology/principal findings
A total of 604 caregivers were randomized into the control group that only received an ICF (n = 150) or an ICF plus one of three intervention strategies: (i) verbal IS (n = 135), (ii) verbal IS with a slideshow (n = 174) or (iii) verbal IS followed by a theater (n = 145). All modes of information covered the same key messages. Participants’ understanding was assessed using a semi-structured questionnaire. The mean score of caregivers in the control group (ICF only) was 4.41 (standard deviation = 1.47). Caregivers attending the IS alone were more knowledgeable than those in the control group (estimated difference in mean scores: 2.40, 95% confidence interval (CI) 1.95 to 2.86, p < 0.01). However, there was no evidence of an improvement compared to the IS only when participants attended a slideshow (0.09, 95% CI -0.53 to 0.35, p = 0.68) or a theater (0.28, 95% CI -0.27 to 0.82, p = 0.32). Three out of 10 key messages remained largely misunderstood, regardless of the mode of information group.
Conclusions/significance
Our study confirmed that, in this setting, an ICF alone was not sufficient to convey clinical trial-related information. An IS was beneficial, however, additional theater and slideshows did not further improve understanding. Future research should explore methods to improve communication between study teams and participants for different key messages, study types and settings.

Effect of Conventional vs. Multimedia Aid Regarding Informed Consent for Central Venous Catheter Insertion on Anxiety and Satisfaction among Patients Admitted in Selected Areas of A Tertiary Care Hospital, Ludhiana, Punjab

Effect of Conventional vs. Multimedia Aid Regarding Informed Consent for Central Venous Catheter Insertion on Anxiety and Satisfaction among Patients Admitted in Selected Areas of A Tertiary Care Hospital, Ludhiana, Punjab
Ramit Sharma, Kapil Sharma
International Journal of Nursing Critical Care, 2021; 7(1)
Open Access
Abstract
Central venous catheter insertion is a very invasive procedure for prolonged administration of medication, parental fluids and blood products. Patients are involved in decision making regarding this procedure. The term Informed consent is used to discuss with patients complete, clear and easy to understand information about a medical procedure or surgical process in clinical settings or hospitals. Multimedia patient decision aid have been heavily utilized as supplemental educational tools instead of conventional method. A quasi-experimental study by using convenience sampling technique was conducted on 40 patients (control n = 20 and experimental n = 20) admitted in ICUs of DMC & Hospital, Ludhiana, Punjab. In pre-test assess the anxiety of patients for regarding central venous catheter insertion (CVC insertion) procedure done by (State-Trait Anxiety Inventory (STAI) scale.)) and in intervention (Provide multimedia aid regarding informed consent for central venous catheter insertion procedure) for each patients for 5 mints (only in experimental group) and in posttest assess and compare the anxiety and satisfaction of patients by (State-Trait Anxiety Inventory (STAI) scale.) and satisfaction by using modified Agency for Healthcare Researcher and quality (AHRQ) scale. Patient satisfaction with the consent process, Most of the subjects had severe anxiety among control and experimental group in pre-test and post-test (16 vs. 15), whereas the 15 (75%) subjects among experimental group had severe anxiety in pre-test which was decreased to moderate in post-test. The finding of the present study also revealed that mean anxiety score was decreased from pre-test and post-test among experimental group (52.00 ± 04.34 Vs. 42.10 ± 05.70) and control group (54.35 ± 05.15 Vs. 50.15 ± 05.61). The difference in finding were found to be statistically significant (p<0.05). It was also revealed that all the subjects were satisfied with the multimedia (14.5 ± 1.28). Whereas only 3 (15%) subjects were satisfied (8.3 ± 1.84) with conventional method. The present study concluded that multimedia aid regarding informed consent for CVC insertion is better than the conventional aid in reference to the anxiety and satisfaction of the patients.

073: Improving Consent with a Visual Tool for Communicating Surgical Risks

073: Improving Consent with a Visual Tool for Communicating Surgical Risks
SJ Tingle, JK Ramsingh, RD Bliss, PP Truran
British Journal of Surgery, 27 April 2021; Volume 108(Supplement 1)
Abstract
Introduction
Patients must understand the risks of a procedure to provide valid consent. Guidance from the General Medical Council and Royal College of Surgeons of England highlights that surgeons need to communicate risks in a way that patients can understand, and both institutions specifically mention the use of written information. We aimed to improve communication of surgical risks to patients undergoing thyroid surgery.
Method
Over 3 months, all patients undergoing thyroid surgery in a tertiary referral centre were included (n=51). Participants were given a 10 point questionnaire after the consent process. Each question had 4 options (very common, common, uncommon and rare) and tested participant understanding of surgical risks. Our intervention was a single page annotated graphic, which used a traffic-light system to explain surgical risks.
Result
When consented prior to our intervention (n=28), patient understanding of the magnitude of surgical risks was poor; median questionnaire score was 4.5 out of 10, and for some questions <15% of participants selected the correct answer. Following introduction of our surgical risk tool (n=23) median overall participant score increased from 4.5 (range 2-7) to 8.0 (4-10) out of 10 (P<0.0001; Mann-Whitney U test).
Conclusion
Patients must understand the risks of an operation, and the magnitude of those risks, in order to provide valid consent. Addition of a visual surgical risk tool enabled us to increase patient understanding of surgical risks, improving the consent process. This has implications not just for thyroid surgery, but for any procedure requiring consent.
Take-home message
Clear communication of surgical risks is essential to obtain valid consent. The use of a visual surgical risk tool increases patient understanding of risks, and therefore improves the consent process.

Randomized comparison of two interventions to enhance understanding during the informed consent process for research

Randomized comparison of two interventions to enhance understanding during the informed consent process for research
Research Article
Holly A Taylor, Daphne Washington, Nae-Yuh Wang, Hiten Patel, Daniel Ford, Nancy E Kass, Joseph
Clinical Trials, 23 April 2021
Abstract
Background/Aims
Many investigators have tested interventions to improve research participant understanding of information shared during the informed consent process, using a variety of methods and with mixed results. A valid criticism of most consent research is that studies are often conducted in simulated research settings rather than ongoing clinical studies. The present study rigorously tested two simple and easily adoptable strategies for presenting key consent information to participants eligible to enroll in six actual clinical trials (i.e. six parent studies).
Methods
In collaboration with the study team from each parent study, we developed two consent interventions: a fact sheet and an interview-style video. The content of each of the intervention was based on the information shared in the consent form approved for each parent study. Participants were randomized to the standard consent process, or to one of the two interventions. Once exposed to the assigned consent mode, participants were asked to complete an assessment of understanding. The study was powered to determine whether those exposed to the fact sheet or video performed better on the consent assessment compared to those exposed to the standard consent. We also assessed participant satisfaction with the consent process.
Results
A total of 284 participants were randomized to one of the three consent arms. Assessments of understanding were completed with a total of 273 participants from July 2017 to April 2019. Participants exposed to the video had better understanding scores compared to those exposed to the standard consent form process (p value = 0.020). Participants were more satisfied with the video when compared to the standard consent. Participants who received the fact sheet did not achieve higher overall understanding or satisfaction scores when compared to the standard consent process.
Conclusion
This randomized study of two novel consent interventions across six different clinical trials demonstrated a statistically significant difference in participant understanding based on overall scores among those exposed to the video intervention compared to those exposed to the standard consent.