The language and communication attributes of graphic symbol communication aids – a systematic review and narrative synthesis
Review Article
Simon Judge, Nicola Randall, Juliet Goldbart, Yvonne Lynch, Liz Moulam, Stuart Meredith, Janice Murray
Disability and Rehabilitation: Assistive Technology, 23 April 2019; pp 652-662
Abstract
Background
Symbol communication aids are used by children with little or no intelligible speech as an Augmentative and Alternative Communication strategy. Graphic symbols are used to help support understanding of language and used in symbol communication aids to support expressive communication. The decision making related to the selection of a symbol communication aid for a child is poorly understood and little is known about what language and communication attributes are considered in this selection.
Aim
To identify from the literature the language or communication attributes of graphic symbol communication aids that currently influence AAC practice.
Method and Procedure
A search strategy was developed and searches were performed on a range of electronic databases for papers published since 1970. Quality appraisal was carried out using the CCAT tool and papers rated as weak were not included in the review.
Results
Eleven studies were included in the review reporting data from 66 participants. Weaknesses were identified in most studies that would limit the validity of the results for application to practice. Included studies investigated aspects of vocabulary organization and design, the process of vocabulary selection, and the choice of the symbol system and encoding method. Two studies also evaluated innovative communication aid attributes.
Conclusions
Information from studies reported in the research literature provides a sparse source of information about symbol communication aids from which clinicians, children or family members may make informed decisions.

Towards a Highly Usable, Mobile Electronic Platform for Patient Recruitment and Consent Management
Daniel Robins, Rachel Brody, In Cheol Jeong, Irena Parvanova, Jiazhen Liu, Joseph Finkelstein Abstract
Studies in health technology and informatics, 16 June 2020; 270 pp 1066-1070
Abstract
This study seeks to assess usability and acceptance of E-Consent on mobile devices such as tablet computers for collecting universal biobank consents. Usability inspection occurred via cognitive walkthroughs and heuristics evaluations, supplemented by surveys to capture health literacy, patient engagement, and other metrics. 17 patients of varied ages, backgrounds, and occupations participated in the study. The System Usability Scale (SUS) provided a standardized reference for usability and satisfaction, and the mean result of 84.4 placed this mobile iteration in the top 10th percentile. A semi-structured qualitative interview provided copious actionable feedback, which will inform the next iteration of this project. Overall, this implementation of the E-Consent framework on mobile devices was considered easy-to-use, satisfying, and engaging, allowing users to progress through the consent materials at their own pace. The platform has once again demonstrated high usability and high levels of user acceptance, this time in a novel setting.

Video Consent Improves Satisfaction in a Safety-Net Multi-Lingual Population
Gabriel Castillo, Zoe Lawrence, Janice Jang, Timothy A. Zaki, Adam J. Goodman, Demetrios Tzimas, Andrew Dikman, Renee Williams
Gastrointestinal Endoscopy, 2020; 91(6S) Tu1095
Open Access
Introduction
Informed consent for endoscopy is traditionally done verbally, which places an emphasis on auditory comprehension. Language discordance between providers and patients can negatively impact this process. Studies have shown that patients with low health literacy may prefer other methods of information delivery, such as visual media which may be more meaningful. The use of videos during informed consent for procedures may improve patient satisfaction and more sufficiently address pre-procedural concerns in comparison to verbal consent. Data on the use of video consent for endoscopy is limited, with recent studies focusing on the pediatric population. Our quality improvement project aimed to assess if the addition of an educational video to the consent process for endoscopy and colonoscopy improves patient comprehension and satisfaction in a safety-net setting with a diverse, underserved population.
Methods
We identified English and Spanish-speaking outpatients presenting for upper endoscopy and colonoscopy in our inner-city, public hospital. Videos detailing the procedures, risks, benefits, and alternatives were produced in both languages. All participants underwent a traditional verbal consent process, and a subset were randomly chosen to watch the video in their preferred language. All patients completed a questionnaire in their preferred language to assess comprehension and satisfaction. Unpaired t-test analysis was applied to the data.
Results
156 questionnaires were collected: 83 colonoscopy specific (58 English, 25 Spanish) and 73 endoscopy specific questionnaires (37 English, 36 Spanish). 80 patients provided education data, 64% reported an education level of high school or less. Among participants who viewed the colonoscopy video, 79% rated the information provided as excellent compared to 38% of participants who underwent only the traditional verbal consent (p Z <0.05). Among participants who viewed the endoscopy video, 88% rated the information provided as excellent compared to 35% of participants who did not watch the video (p < 0.05). In both cohorts, video consent patients reported improved satisfaction. Our prior results demonstrate a significant improvement in comprehension scores in video consent patients compared to traditional verbal consent (77% vs. 51%, p <0.0001).
Discussion
Our results demonstrate a significant improvement in patient satisfaction with the use of video consent for endoscopic procedures in a multi-lingual population with low educational levels and health literacy. Including a video in the consent process may satisfy multiple learning needs this population. Based on this data, we have obtained a patient care grant which will be used to incorporate this process within our endoscopy suite and compose videos in other languages in order to improve care for our patients.

Replacing Paper Informed Consent with Electronic Informed Consent for Research in Academic Medical Centers: A Scoping Review
Cindy Chen, Pou-I Lee, Kevin J. Pain, Diana Delgado, Curtis L. Cole, Thomas R. Campion Jr.
AMIA Joint Summits on Translational Science Proceedings, 30 May 2020; pp 80-88
Open Access
Abstract
Although experts have identified benefits to replacing paper with electronic consent (eConsent) for research, a comprehensive understanding of strategies to overcome barriers to adoption is unknown. To address this gap, we performed a scoping review of the literature describing eConsent in academic medical centers. Of 69 studies that met inclusion criteria, 81% (n=56) addressed ethical, legal, and social issues; 67% (n=46) described user interface/user experience considerations; 39% (n=27) compared electronic versus paper approaches; 33% (n=23) discussed approaches to enterprise scalability; and 25% (n=17) described changes to consent elections. Findings indicate a lack of a leading commercial eConsent vendor, as articles described a myriad of homegrown systems and extensions of vendor EHR patient portals. Opportunities appear to exist for researchers and commercial software vendors to develop eConsent approaches that address the five critical areas identified in this review.

MSK eConsent: Digitalizing the informed consent process to improve participant engagement and understanding
Care Delivery and Regulatory Policy
Michael T. Buckley, Joseph M. Lengfellner, Matthew J. Koch, Benjamin Search, Carol Hoidra, Mary Lin, Sangeeta Kundu, Roy Cambria, Molly O’Shea, Jesse Galle, Jennifer Wang, Ann Rodavitch, Karima Yataghene, Jaclyn Pember, Stephanie Lucia Terzulli, Collette Houston, Eric Cottington, Paul Sabbatini
Journal of Clinical Oncology, 25 May 2020; 38(15)suppl.2066
Abstract
Background: eConsent was developed to digitize the research participant consenting experience with an educational engagement model. The eConsent platform tiers consent document content in an easy-to-navigate format, using videos, images, and access to supplementary information. We hypothesize that enhancing the consenting experience improves participant engagement and comprehension. Methods: Here we present two projects: 1) qualitative assessment of patient engagement in the eConsent process using a standardized 5-question survey sent to all patients who used it during 9 months in 2019, and 2) a report of our preliminary findings from exempt protocol, Assessing Participant Engagement and Protocol Education in the Consent Process (X19-055) that quantitatively compares paper and electronic consenting and a) assesses patient agency and b) tests comprehension of key consent elements in 2 protocols: Storage and Research Use of Human Biospecimens (06-107) and Genomic Profiling in Cancer Patients (12-245). Results: 1) 940 patients completed the qualitative experience survey (27% response). Most respondents (777; 83%) indicated that electronic consenting was very easy (371) or easy (406) to use. Only 25 (3%) said electronic consenting was somewhat difficult to use, 3 indicated it was difficult (0.3%), and 64 were neutral. Most (896; 95%) recommended electronic consenting to other MSK patients. Those who reported a 1 unit increase in technology discomfort, only reported a .48 unit increase in eConsent discomfort (P< .001). 2)Quantitative 10-question electronic tests were sent to each patient’s portal account within 72h after consenting via paper or eConsent to protocols 06-107 and 12-245. To date, for 06-107: 18 paper consenters completed the test with a score of 76% vs 23 eConsent users who scored 80%. For 12-245: 43 paper consenters scored 69% vs 13 eConsent users scoring 80%. Scores are a surrogate marker for patient comprehension and show that 12-245 protocol participants’ average testing scores are higher when participants are consented with eConsent vs paper (P < .01). 06-107 protocol participants’ average test scores are trending toward eConsent improving patient understanding (P= .11). We will follow this trend as our sample size increases to a total of 500 participants. Patient agency questions received favorable responses from most patients (100%-84%). Conclusions: eConsent enhances participant engagement and understanding and does not impose a digital burden on participants.

A randomized controlled trial comparing video-assisted informed consent with standard consent for Mohs micrographic surgery
Original Article
Yueyue Miao, Victoria L. Venning, Kylie-Ann Mallitt, Julia E. J. Rhodes, Noah J. Isserman, Gilberto Moreno, Simon Lee, William Ryman, Gayle Fischer, Rebecca B. Saunderson
Journal of the American Academy of Dermatology International, July 2020; 1(1) pp 13-20
Open Access
Abstract
Background
There is a need for improvement in informed medical consent to address the lack of standardization and to increase patient engagement.
Objective
To investigate the use of a video to aid informed consent for Mohs micrographic surgery and evaluate patient understanding, satisfaction, anxiety, and time savings relative to verbal consent.
Methods
A 2-armed randomized controlled trial involving 102 patients compared video-assisted consent with a control group who underwent consent in the standard verbal manner. All participants underwent questionnaire-based testing of knowledge, satisfaction, and anxiety, and the time of each consultation was measured.
Results
Patients who watched the video performed significantly better in the knowledge questionnaire compared with the control group (P = .02), were more satisfied with their understanding of the risks of Mohs micrographic surgery (P = .013), and spent less time with their physician (P = .008). Additionally, 78.4% of video group patients reported that they preferred seeing the video before speaking with their physician.
Limitations
The study design may not replicate day-to-day clinical practice.
Conclusion
Video-assisted consent for Mohs micrographic surgery improves patient knowledge, leads to a better understanding of the risks, and saves physicians time without compromising patient satisfaction and anxiety levels in this study setting.

Informed Consent Through 3D Virtual Reality: A Randomized Clinical Trial
Alessandro Perin, Tommaso Francesco Galbiati, Roberta Ayadi, Enrico Gambatesa, Eleonora Francesca Orena, Nicole Irene Riker, Hagit Silberberg, Donatella Sgubin, Torstein Ragnar Meling, Francesco DiMeco
Acta Neurochirurgica, 3 April 2020
Abstract
Background
The informed consent is a defining moment that should allow patients to understand their condition, what procedure they are undergoing, and what consequences may follow. This process should foster trust and promote confidence, without increasing patients’ anxiety. New immersive 3D imaging technologies may serve as a tool to facilitate this endeavor.
Methods
In a prospective, single-center, randomized controlled clinical trial (SPLICE Study: Surgical Planning and Informed Consent Study; ClinicalTrials.gov NCT03503487), 40 patients undergoing surgery for intracranial tumors were enrolled. After undergoing a traditional surgical informed consent acquisition, 33 patients were randomized 1:1:1 to 3 groups: in 2 experimental groups, patients underwent a 3D, immersive informed consent with two different surgical planners (group 1 and group 2); in the control group, patients underwent an informed consent supported by traditional 2D radiological images.
Results
Patients in the experimental groups appreciated this communication experience, while their objective comprehension was higher ((score mean (SD)): group 1 82.65 (6.83); group 2 77.76 (10.19)), as compared with the control group (57.70 (12.49); P < 0.001). Subjective comprehension and anxiety levels did not differ between experimental groups and control group.
Conclusions
3D virtual reality can help surgeons and patients in building a better relationship before surgery; immersive 3D-supported informed consent improves patients’ comprehension of their condition without increasing anxiety. This new paradigm may foster trust between surgeons and patients, possibly restraining medical-legal acts.

Editor’s note: Acta Neurochirurgica is an Austrian journal.

Educational Video Addition to the Bariatric Surgery Informed Consent Process: a Randomized Controlled Trial
Original Contributions
Saglam K, Kayaalp C, Aktas A, Sumer F
Obesity Surgery, 11 Apr 2020
Abstract
Objective
Bariatric surgery is not a risk-free procedure and requires lifelong patient compliance in the postoperative period. Although the risks involved in bariatric surgery and the importance of lifelong follow-ups in the postoperative period are explained to patients in detail through verbal and written informed consent, the strong desire for weight loss can sometimes cause patients and their families to be ignorant of the mentioned issues preoperatively. The objective of this study is to evaluate the effectiveness of preoperative informational videos at improving the comprehension of informed consent content in bariatric surgery candidates.
Materials and Methods
A total of 74 bariatric surgery candidates were randomized into two groups. The first group was given a usual verbal-written informed consent. The second group got an additional informing video presentation informed consent, in addition to the usual verbal-written informed consent. Then, both groups got a questionnaire evaluating their knowledge of bariatric surgery informed consent. The correct response scores and their relationship with patient demographics were analyzed.
Results
Both groups had similar demographic features. Video-presented group had higher scores in questionnaire (11.3 ± 2.3 versus 9.4 ± 1.7, p = 0.001). Subgroup analysis showed that health care workers (12.5 ± 1.9 versus 10.3 ± 2.2, p = 0.005) and university graduates (11.6 ± 2.4 versus 10.1 ± 2.1, p = 0.03) got better results in the questionnaire. In multivariate analysis, video-assisted informing was found to be the only independent variable for high questionnaire scores (p = 0.0001).
Conclusions
This study showed that video-assisted informed consent improves patients’ comprehension prior to bariatric surgery. We recommend routine preoperative video-assisted informing for bariatric surgery candidates in addition to usual verbal-written informed consent.

Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research: A Randomized Controlled Trial
Research Article
Erin Rothwell, Erin Johnson, Bob Wong, Aaron Goldenberg, Beth A. Tarini, Naomi Riches, Louisa A. Stark, Christina Pries, Carrie Langbo, Elizabeth Langen, Jeffrey Botkin
Journal of Empirical Research on Human Research Ethics, 3 April 2020
Abstract
Obtaining informed consent for bloodspot research from newborn screening is particularly challenging due to the hectic environment of the postnatal period and the relatively abstract nature of future, unspecified research on the biospecimens. A randomized controlled trial was conducted in three Michigan hospitals to compare two different consent processes (video and interactive tablet “app”) with standard brochure-based consent in the Michigan BioTrust for Health. Results indicated higher knowledge scores for the video and app groups as well as significantly higher scores on satisfaction, amount of information, and clarity with the information provided. More research is needed to find the right amount of information for informed decision-making, and additional feasibility studies are needed to assess implementation strategies.

Animation-supported consent for urgent angiography and angioplasty: a service improvement initiative
Original Research
David S Wald, Oliver Casey-Gillman, Katrina Comer, Josephine Sarah Mansell, Howie Teo, Kyriacos Mouyis, Matthew Kelham, Fiona Chan, Selda Ahmet, Max Sayers, Vincent McCaughan, Nito Polenio
Heart, 10 March 2020
Open Access
Abstract
Objective
Patient understanding of angiography and angioplasty is often incomplete at the time of consent. Language barriers and time constraints are significant obstacles, particularly in the urgent setting. We introduced digital animations to support consent and assessed the effect on patient understanding.
Methods
Multi-language animations explaining angiography and angioplasty (www.explainmyprocedure.com/heart) were introduced at nine district hospitals for patients with acute coronary syndrome before urgent transfer to a cardiac centre for their procedure. Reported understanding of the reason for transfer, the procedure, its benefits and risks in 100 consecutive patients were recorded before introduction of the animations into practice (no animation group) and in 100 consecutive patients after their introduction (animation group). Patient understanding in the two groups was compared.
Results
Following introduction, 83/100 patients reported they had watched the animation before inter-hospital transfer (3 declined and 14 were overlooked). The proportions of patients who understood the reason for transfer, the procedure, its benefits and risks in the no animation group were 58%, 38%, 25% and 7% and in the animation group, 85%, 81%, 73% and 61%, respectively. The relative improvement (ratio of proportions) was 1.5 (95% CI 1.2 to 1.8), 2.1 (1.6 to 2.8), 2.9 (2.0 to 4.2) and 8.7 (4.2 to 18.1), respectively (p<0.001 for all comparisons).
Conclusion
Use of animations explaining angiography and angioplasty is feasible before urgent inter-hospital transfer and was associated with substantial improvement in reported understanding of the procedure, its risks and its benefits. The approach is not limited to cardiology and has the potential to be applied to all specialties in medicine.