An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine
Elizabeth H. Golembiewski, Arch G. Mainous, III, Kiarash P. Rahmanian, Babette Brumback, Benjamin J. Rooks, Janice L. Krieger, Kenneth W. Goodman, Ray E. Moseley, Christopher A. Harle
Annals of Family Medicine, January-February 2021; 19(1) pp 16–23
Abstract
Purpose
Patients are frequently asked to share their personal health information. The objective of this study was to compare the effects on patient experiences of 3 electronic consent (e-consent) versions asking patients to share their health records for research.
Methods
A multi-arm randomized controlled trial was conducted from November 2017 through November 2018. Adult patients (n = 734) were recruited from 4 family medicine clinics in Florida. Using a tablet computer, participants were randomized to (1) a standard e-consent (standard), (2) an e-consent containing standard information plus hyperlinks to additional interactive details (interactive), or (3) an e-consent containing standard information, interactive hyperlinks, and factual messages about data protections and researcher training (trust-enhanced). Satisfaction (1 to 5), subjective understanding (0 to 100), and other outcomes were measured immediately, at 1 week, and at 6 months.
Results
A majority of participants (94%) consented to future uses of their health record information for research. No differences in study outcomes between versions were observed at immediate or 1-week follow-up. At 6-month follow-up, compared with the standard e-consent, participants who used the interactive e-consent reported greater satisfaction (B = 0.43; SE = 0.09; P <.001) and subjective understanding (B = 18.04; SE = 2.58; P <.001). At 6-month follow-up, compared with the interactive e-consent, participants who used the trust-enhanced e-consent reported greater satisfaction (B = 0.9; SE = 1.0; P <.001) and subjective understanding (B = 32.2; SE = 2.6, P <.001).
Conclusions
Patients who used e-consents with interactive research details and trust-enhancing messages reported higher satisfaction and understanding at 6-month follow-up. Research institutions should consider developing and further validating e-consents that interactively deliver information beyond that required by federal regulations, including facts that may enhance patient trust in research.

Digital approach to informed consent in bariatric surgery: a randomized controlled trial
Boris Zevin, Mohammad Almakky, Ugo Mancini, David I. Robertson
Surgical Endoscopy, 27 January 2021
Abstract
Background
Informed consent is of paramount importance in surgery. Digital media can be used to enhance patient’s comprehension of the proposed operation. The objective of this study was to examine the effects of adding a digital educational platform (DEP) to a standard verbal consent (SVC) for a laparoscopic Roux-en-Y gastric bypass (LRYGB) on patient’s knowledge of the procedure, satisfaction with the clinical encounter and duration of the consent appointment.
Methods
This prospective non-blinded randomized controlled trial allocated 51 patients, who were candidates for a LRYGB, into DEP+SVC (intervention, n = 26) or SVC (control, n = 25) groups. Data were collected at one Bariatric Centre of Excellence (Ontario, Canada) between December 2018 and December 2019. DEP consisted of a 29-slide video-supplemented module detailing the risks, benefits, expectations and outcomes for the LRYGB. Primary outcome was knowledge about the LRYGB operation following the consent discussion. Secondary outcomes were knowledge retention, patient satisfaction, and duration of time required to obtain an informed consent.
Results
Baseline demographic data were equivalent between groups except for a greater proportion of male patients in the DEP+SVC group (7/19 vs 0/25; p < 0.01). Baseline procedure-specific knowledge was equivalent between the groups (72.3 ± 11.3% vs 74.7 ± 9.6%; p = 0.41). Post-consent knowledge was significantly higher in the DEP + SVC vs SVC group (85.0 ± 8.8% vs 78.7 ± 8.7%; p = 0.01; ES = 0.72). The duration of time to obtain informed consent was significantly shorter for the DEP + SVC vs SVC group (358 ± 198 sec vs 751 ± 212 sec; p < 0.01; ES = 1.92). There was no difference in knowledge retention at 4–6 weeks (84.4 ± 10.2% vs 82.9 ± 6.8%; p = 0.55) and in patient satisfaction (31.5 ± 1.1 vs 31 ± 2.7; p = 0.10).
Conclusion
The addition of a DEP online module to a standard verbal consent for LRYGB resulted in improved patient’s understanding of the procedure-specific risks and benefits, high patient satisfaction, and over 50% time savings for the bariatric surgeon conducting the consent discussion.

Does the use of video improve patient satisfaction in the consent process for local-anaesthetic urological procedures?
Original Paper
Allison L. Moore, Justin B. Howlett, Manraj K. Phull, Lukhona L. Mpungose & Sebastian R. Samson
International Urology and Nephrology, 3 January 2021
Abstract
Purpose
To assess patient satisfaction with the use of portable video media (PVM) for the purpose of taking informed consent for common urological outpatient procedures performed under local anaesthesia.
Methods
Patients undergoing the following procedures were approached for recruitment: flexible cystoscopy with or without biopsy, transrectal ultrasound-guided prostate biopsy or flexible cystoscopy with insertion or removal of a ureteric stent. Audio-visual media were developed for each procedure, with each script translated from English into isiXhosa and Afrikaans. The study involved a cross-over for each patient between standard verbal consent (SVC) and PVM consent, with each patient randomised to start with SVC or PVM consent. Each of these consent arms was assessed via a questionnaire.
Results
Sixty patients completed participation, with PVM as the first exposure for 28 patients and 32 patients receiving SVC as their first arm of the study. When comparing the overall satisfaction between SVC and PVM consent (the total scores out of 18 for the questionnaire), patients scored significantly higher for PVM consent (M = 16.3 ± 2.4) compared to SVC (M = 15.4 ± 2.9) (p = 0.002). 92% of the total patient sample preferred PVM consent.
Conclusion
Portable video media proved superior to SVC in improving satisfaction in the consent process for common outpatient urological procedures performed under local anaesthesia.

A graphic elicitation technique to represent patient rights
Methodology
Catherine R. McGowan, Nora Hellman, Louisa Baxter, Sonali Chakma, Samchun Nahar, Ahasan Ud Daula, Kelly Rowe, Josie Gilday, Patricia Kingori, Rachel Pounds, Rachael Cummings
Conflict and Health, 14 December 2020; 14(86)
Open Access
Abstract
Background
A patient charter is an explicit declaration of the rights of patients within a particular health care setting. In early 2020 the Save the Children Emergency Health Unit deployed to Cox’s Bazar Bangladesh to support the establishment of a severe acute respiratory infection isolation and treatment centre as part of the COVID-19 response. We developed a charter of patient rights and had it translated into Bangla and Burmese; however, the charter remained inaccessible to Rohingya and members of the host community with low literacy.
Methods
To both visualise and contextualise the patient charter we undertook a graphic elicitation method involving both the Rohingya and host communities. We carried out two focus group discussions during which we discussed the charter and agreed how best to illustrate the individual rights contained therein.
Results
Logistical constraints and infection prevention and control procedures limited our ability to follow up with the original focus group participants and to engage in back-translation as we had planned; however, we were able to elicit rich descriptions of each right. Reflecting on our method we were able to identify several key learnings relating to: 1) our technique for eliciting feedback on the charter verbatim versus a broader discussion of concepts referenced within each right, 2) our decision to include both men and women in the same focus group, 3) our decision to ask focus group participants to describe specific features of each illustration and how this benefited the inclusivity of our illustrations, and 4) the potential of the focus groups to act as a means to introduce the charter to communities.
Conclusions
Though executing our method was operationally challenging we were able to create culturally appropriate illustrations to accompany our patient charter. In contexts of limited literacy it is possible to enable access to critical clinical governance and accountability tools.

Audiovisual Modules to Enhance Informed Consent in the ICU: A Pilot Study
Original Clinical Report
Tyler J. Loftus, Maria E. Alfaro, Tiffany N. Anderson, Travis W. Murphy, Olga Zayko, John P. Davis, Zachary A. Hothem, Dijoia B. Darden, Rohit P. Patel, Wanda Whittet, Edward K. McGough, Azra Bihorac, Chasen A. Croft, Martin D. Rosenthal, R. Stephen Smith, Erin L. Vanzant, Fredrick A. Moore, Scott C. Brakenridge, Gabriela L. Ghita, Babette A. Brumback, Alicia M. Mohr, Philip A. Efron
Critical Care Explorations, 23 November 2020; 2(12)
Objectives
Obtaining informed consent for commonly performed ICU procedures is often compromised by variability in communication styles and inadequate verbal descriptions of anatomic concepts. The objective of this study was to evaluate the efficacy of an audiovisual module in improving the baseline knowledge of ICU procedures among patients and their caregivers.
Design
Prospective, observational study.
Setting
Forty-eight–bed adult surgical ICU at a tertiary care center.
Subjects
Critically ill surgical patients and their legally authorized representatives. .
Interventions
An audiovisual module describing eight commonly performed ICU procedures.
Measurements and Main Results
Fifty-nine subjects were enrolled and completed an 11-question pre- and postvideo test of knowledge regarding commonly performed ICU procedures and a brief satisfaction survey. Twenty-nine percent had a healthcare background. High school was the highest level of education for 37% percent of all subjects. Out of 11 questions on the ICU procedure knowledge test, subjects scored an average 8.0 ± 1.9 correct on the pretest and 8.4 ± 2.0 correct on the posttest (p = 0.055). On univariate logistic regression, having a healthcare background was a negative predictor of improved knowledge (odds ratio, 0.185; 95% CI, 0.045–0.765), indicating that those with a health background had a lower probability of improving their score on the posttest. Among subjects who did not have a healthcare background, scores increased from 7.7 ± 1.9 to 8.3 ± 2.1 (p = 0.019). Seventy-five percent of all subjects indicated that the video was easy to understand, and 70% believed that the video improved their understanding of ICU procedures.
Conclusions
Audiovisual modules may improve knowledge and comprehension of commonly performed ICU procedures among critically ill patients and caregivers who have no healthcare background.

Using a cartoon questionnaire to improve consent process in children: a randomized controlled survey
Clinical Research Article
Shanshan Qiu, Yang Xia, Feng Tian, Yanfang Yang, Jijun Song, Liqin Chen, Hao Mei, Fan Jiang, Nan Bao, Shijian Liu
Pediatric Research, 17 November 2020
Abstract
Objective
The aim of the study was to evaluate the effectiveness of an audio and animated cartoon questionnaire (AACQ) at improving consent process in child for biospecimen donation.
Methods
A multi-center randomized and controlled survey was performed at two pediatric hospitals in China from 2019 to 2020. Children aged from 7 to 18 years in the pediatric surgery wards were invited to investigate the participants’ willingness and attitudes for donating biospecimens. A total of 264 children, including 119 in the AACQ group and 145 in the TQ group, and 67 parents of children were analyzed. A separate knowledge test was acquired in the questionnaires.
Results
Our findings showed that the response rate of the AACQ group (89.85%) was significantly higher than that of the TQ group (68.44%; p < 0.001). AACQ can improve the child’s understanding, increase children’s engagement in biospecimen donation, reduced the differences in selected characteristics affecting children understanding, and enhanced their risk awareness of donating biospecimens. We also found that increasing pain and privacy disclosure were the most popular concern among children for the refusal to donate biospecimens.
Conclusions
AACQ is an effective and standardized tool of content delivery to children from the surgical wards. Children who fully understood of biospecimen donation are suggested to participate in the consent signing.

Informed Consent Smart Phone App Improved Level of Comfort and Knowledge Amongst Pediatric Residents
Cassandra Koid Jia Shin, Tania Lopez, Edwin Forman, Gwen Raphan
Academic Pediatrics, September–October 2020; 20(7) pp e12-e13
Abstract
Background
Obtaining informed consent is an integral part of medicine yet is a skill set that is not typically taught to residents formally. Lack of skill and confidence obtaining informed consent can have dire medical-legal consequences. Therefore, we created an informed consent smartphone app to give providers this information at their fingertips so they can successfully obtain informed consent on several common pediatric procedures in a more standardized fashion. Our objective was to assess if pediatric residents knowledge and comfort with obtaining informed consent would increase with an informed consent app.
Methods
A prototype smartphone app was designed on Adobe XD with a standardized approach to obtaining informed consent for pediatric procedures (RBC and platelet transfusions, LP, conscious sedation, central lines and vitamin K refusal). In 2020, an anonymous pre-intervention questionnaire was circulated amongst pediatric residents in Elmhurst Hospital Center. Participants were given an opportunity to navigate the informed consent app and given a post-intervention survey.
Results
Of the 25 residents who participated, all had previously obtained consent. Most learned how to obtain consent by observing another resident (72%) and surprisingly, 12% report that they obtained consent without any preparation at all. Self-reported level of comfort for procedures increased proportionally with every year of training. Residents’ comfort obtaining informed consent improved for every procedure after use of the informed consent app. 100% were comfortable obtaining informed consent with the app for all procedures with the exception of central lines which was not functioning on the app. 96% of residents agree that they would benefit from additional training in obtaining informed consent. 100% of residents agree that they would use the informed consent app.
Conclusions
With the informed consent app, residents’ level of comfort increased for all procedures. This quick intervention showed promise as an easy way for residency programs to standardize an approach to obtaining informed consent.

Effect of video-assisted education on informed consent and patient education for peripherally inserted central catheters: a randomized controlled trial
Perspective Clinical Research Report
Jia Li, Xue-fang Huang, Jie-lin Luo, Jiang-yun Zhang, Xiao-lin Liang, Chun-li Huang, Hui-ying Qin
Journal of International Medical Research, 10 September 2020; 48(9)
Open Access
Abstract
Objective
To evaluate the effects of a video-assisted education intervention on informed consent and patient education for peripherally inserted central catheters (PICCs).
Methods
We conducted a randomized controlled trial comparing the effects on informed consent of video-assisted patient education and traditional face-to-face discussion in a catheter outpatient ward of a cancer centre in Guangzhou, China, in 2018. Participants were 140 patients randomly allocated (1:1 ratio) to two groups: video-assisted or traditional intervention. General information, patient retention of PICC-related information, working time spent by nurses on the procedure, and patient and nurse satisfaction with the procedure were assessed.
Results
The time used for informed consent was significantly shorter in the experimental group (1.02 ± 0.24 minutes) than in the control group (6.87 ± 1.10 minutes). The time used for PICC-related education was significantly shorter in the experimental group (1.03 ± 0.28 minutes) than in the control group (5.11 ± 0.57 minutes). Nurses’ degree of satisfaction with the procedure was significantly higher in the experimental group (4.10 ± 0.57) than in the control group (2.60 ± 0.70).
Conclusion
The use of video-assisted informed consent and patient education in this cancer centre decreased nurses’ working time and improved nurses’ satisfaction.

Pictorial Consent in Cardiac Surgery: A far better option rather than Standard Informed Written Consent
Debmalya Saha, Pawan Singh, Soumyaranjan Das, Ravi Kumar Gupta, Satyajit Samal, Muhammad Abid Geelani
International Journal of Scientific and Research Publications, September 2020; 10(9)
Open Access
Abstract
Because of the complexity of the procedures, high level of clarification for the patients as well as their attendants while taking consent is a must as cardiac surgery is associated with significant morbidity and mortality. Pictorial consent with preoperative education is a far better option in this regard. We randomly took a total of 150 patients within the age group of 18 to 70 years, and they were explained with standard consent followed by pictorial consent and vice versa by the same informant. And they were given a preset questionnaire format after both consents. Later, based on their answers, comparison in relation to the level of clarity was done. Questionnaire was formatted after rigorous modification from the reviews of literature.

A Novel Framework Using Remote Telesimulation With Standardized Parents to Improve Research Staff Preparedness for Informed Consent in Pediatric Critical Care Research
Denise LaMarra, Jaclyn French, Christine Bailey, Martha T. Sisko, Kerry Coughlin-Wells, Michael S. Agus, Vijay Srinivasan, Vinay M. Nadkarni
Pediatric Critical Care Medicine, 28 July 2020
Open Access
Abstract
Objectives
The Heart And Lung Failure—Pediatric INsulin Titration study was experiencing poor subject enrollment due to low rates of informed consent. Heart And Lung Failure—Pediatric INsulin Titration investigators collaborated with the Perelman School of Medicine Standardized Patient Program to explore the novel use of telesimulation with standardized parents to train research staff to approach parents of critically ill children for informed consent. We describe the feasibility, learner acceptance, and financial costs of this novel intervention and performed a post hoc analysis to determine if this intervention improved study consent rates.
Design
Observational, comparative effectiveness study.
Setting
Heart And Lung Failure—Pediatric INsulin Titration study enrolling sites.
Subjects
Research staff (at the remote site).
Interventions
Individual 90-minute Skype telesimulation sessions with standardized parent and simulation facilitator (at the training site).
Measurements and Main Results
Forty telesimulation sessions with 79 Heart And Lung Failure—Pediatric INsulin Titration research staff (participants) at 24 remote sites were conducted. Despite some technical delays, 40 out of 40 simulations (100%) were completed. Based on feedback surveys, 100% of respondents agreed (81% strongly agreed) that telesimulation sessions achieved intended learning objectives to prepare research staff to approach parents of eligible critically ill children to obtain informed consent. Additionally, 100% of respondents agreed (74% strongly agreed) that they would use lessons from the telesimulation when approaching parents to obtain informed consent for research. Telesimulation with standardized parents achieved lower financial costs (approximately $85 per session) compared with traditional in-person site visits for training research staff. There was no significant improvement in study consent rates with the intervention (pre: 46% vs post: 48%; p = 0.78).
Conclusions
Remote telesimulation with standardized parents is feasible, acceptable, and associated with lower financial costs to prepare research staff to obtain informed consent from parents of critically ill children eligible for clinical research trials. Despite this novel approach, Heart And Lung Failure—Pediatric INsulin Titration study consent rates did not improve, suggesting that other factors influence parental consent and decision making in complex multicenter clinical research trials.