An assessment of provider satisfaction with the use of a standardized visual aid for informed consent for appendectomy in children
Brittany L. Johnson, Eric H. Rosenfeld, Brittany D. Carter, Monica E. Lopez, Annalyn S. DeMello, David E. Wesson, Mary L. Brandt
Journal of Pediatric Surgery, 1 February 2020
Abstract
Purpose
We previously validated a visual aid for the use in the consent process for an appendectomy showing improved parental satisfaction and understanding. In this study, we evaluated provider satisfaction and perceived value of using the visual aid.
Methods
An IRB approved survey was developed assessing provider experience with use of the visual aid. This was distributed and analyzed via Research Electronic Data Capture (RedCap) Database.
Results
We administered 58 surveys (45% response rate). Participants included faculty (n = 2), fellows (n = 1), residents (n = 6), and physician assistants (n = 17). The visual aid was used > 10 times by 50% of providers. The most common reason for not using the visual aid was not remembering it was available. Nearly half (40%) did not feel the visual aid added any time. 9/20 (45%) felt it added a small amount of time. Slightly over half of providers (52%) felt using the visual aid significantly increased family ability to give informed consent and made the consenting process easier for both providers and families.
Conclusion
Using a visual aid in consenting families for appendectomy does not add significant time and subjectively improves the process for providers and increases provider perception of parental understanding.

The effects of a humorous video on memory for orthodontic treatment consent information
Original Article
Timothy P. Levine
American Journal of Orthodontics and Dentofacial Orthopedics, February 2020; 157(2) pp 240-244
Abstract
Introduction
Communication of treatment information is critical in orthodontics. The challenge lies in doing so effectively such that patients will understand and remember, which is the definition of true informed consent. Previous studies have established that information is more readily remembered when presented using multimedia presentations. Likewise, humor has been shown to increase information retention.
Methods
Two videos, 1 humorous (H) and 1 unhumorous (U), were produced with identical information about orthodontic treatment consent. Thirty-eight new orthodontic patients were randomly selected and divided into H (n = 20) and U (n = 18) video groups. Identical questionnaires with multiple-choice responses to judge memory of the content were completed by both groups immediately after watching the video (T1) and 6 weeks later (T2). A one-tailed Welch’s t test was used to analyze the scores.
Results
At T1, there was no significant difference in the scores of the questionnaire between H and U groups, whereas at T2, there was a significant difference between groups. The intragroup score difference was also analyzed, with a significant decrease from T1 to T2 in the U, but not H, group. Subjective questions were also asked regarding content. No significant differences were found between the groups regarding the informativeness of each video; however, willingness to watch again and memorability of the content were significantly higher in the H group.
Conclusions
Patients who received orthodontic treatment information presented with humor retained significantly more of that information after 6 weeks compared with patients who received the same information without humor. Patients who received the humorous content subjectively stated they were more likely to rewatch the video and also found the information presented in this manner to be more memorable.

Multimedia in improving informed consent for caesarean section: A randomised controlled trial
Original Article
Alice Truong, Lenore Ellett, Lauren Hicks, Gabrielle Pell, Susan P. Walker
Obstetrics & Gynaecology, 28 January 2020
Abstract
Background
Multimedia modules have been used as an adjunct to improve patient knowledge and recall for various elective surgical procedures, but have been incompletely evaluated in patients undergoing caesarean section.
Aims
To compare the use of a supplementary multimedia module with written information in improving the informed consent process prior to elective caesarean section.
Materials and methods
This was a prospective randomised controlled trial (ACTRN12616000430437). Primary outcomes were knowledge and anxiety scores immediately following the intervention and on the day of surgery. Secondary outcomes were patient satisfaction, length of stay, time to cessation of analgesia, and patient assessment of the consent types.
Results
Seventy‐five patients completed the study. Both multimedia module and written information groups demonstrated a significant increase in knowledge scores with no difference between the groups. In the multimedia‐assisted consent group, scores improved from baseline by +2.31 (P < 0.001) immediately after watching the multimedia module and by +2.41 (P < 0.001) on the day of surgery. In the written information group, scores improved by +1.76 (P < <0.001), and +2.31 (P < 0.001) respectively. There was no adverse impact on anxiety in either group. Patient‐reported understanding (92.4% vs 78.5%, P = 0.001), and helpfulness (90.1% vs 73.3%, P = 0.001) was significantly higher in the multimedia module group than in the written information group. The multimedia module was assessed as ‘slightly too long’ and provided ‘slightly too much information’.
Conclusions
Multimedia modules are a valuable adjunct to traditional processes of obtaining informed consent for elective caesarean section and should be offered and made available to patients prior to surgery.

A ResearchKit app to deliver paediatric electronic consent: Protocol of an observational study in adolescents with arthritis
Research Paper
Chitra Lalloo, Quynh Pham, Joseph Cafazzo, Elizabeth Stephenson, Jennifer Stinson
Contemporary Clinical Trials Communications, 14 January 2020
Open Access
Abstract
ResearchKit is an open-source software framework designed to streamline the process of screening and consenting participants into research studies. By digitizing traditionally analog processes, ResearchKit has potential to increase the reach, efficiency, and scalability of mobile health (mHealth) research. The model has been successfully applied in adult settings. However, to our knowledge, no group has sought to adapt ResearchKit for a pediatric research environment in Canada. The potential benefits for building paediatric mHealth apps compatible with remote eConsent are numerous: (1) access to studies can be broadened from small groups of children and families who live in close proximity to research sites to whole populations across geographical boundaries, (2) increased convenience for study participants because they can complete consent on their smartphone from their home, rather than in person or on paper, and (3) large-scale study enrollment can be conducted with fewer resources than traditional face-to-face methods. We describe the rationale and design of a proof-of-concept observational study focused on implementing remote eConsent in a Canadian pediatric population. A community-based sample of adolescents with arthritis will be remotely onboarded to use the iCanCope pain self-management app for 8-weeks. Outcomes will focus on: (1) fidelity and acceptability of the eConsent process, (2) fidelity of the iCanCope app in terms of engagement and acceptability, (3) participant study experience including level of perceived support and acceptability of study tasks, and (4) clinical outcomes related to use of the iCanCope app over an 8-week period.

Making clinical trials more patient-centered using digital interactive e-consent tools
Barbara Bowles Biesecker, Melissa R. Raspa, Douglas J. Rupert, Rebecca Munch Moultrie, Robert D. Furberg, Lauren A. McCormack
Occasional Paper, RTI International (published by RTI Press), October 2019
Open Access
Abstract
Research participants are required to give their consent to participate in clinical trials and nonexempt government-funded studies. The goal is to facilitate participant understanding of the intent of the research, its voluntary nature, and the potential benefits and harms. Ideally, participants make an informed choice whether to participate; one that is based on having sufficient relevant knowledge and that is consistent with their values and preferences. Achieving this objective can be challenging, and as such, many scholars have declared the consent process flawed or “broken.” Moreover, clinical trials are complex studies, and compelling evidence suggests that current consent processes are inadequate in achieving informed choice. E-consent offers a dynamic, engaging consent delivery mode that can effectively support making informed decisions about whether to participate in a trial.

Improved parental understanding by an enhanced informed consent form: a randomized controlled study nested in a paediatric drug trial
Nut Koonrungsesomboon, Chanchai Traivaree, Charnunnut Tiyapsane, Juntra Karbwang
BMJ Open, 26 November 2019; 9(11)
Open Access
Abstract
Objective 
This study was designed to evaluate the applicability and effectiveness of the enhanced informed consent form (ICF) methodology, proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), in paediatric research requiring parental consent. The objective of this study was to compare the parental understanding of information between the parents who read the SIDCER ICF and those who read the conventional ICF.
Design 
A prospective, randomized, controlled design.
Setting 
Paediatric Outpatients Department, Phramongkutklao Hospital, Thailand.
Participants 
210 parents of children with thalassemia (age=35.6 ± 13.1 years).
Interventions
The parents were randomly assigned to read either the SIDCER ICF (n=105) or the conventional ICF (n=105) of a paediatric drug trial.
Primary and secondary outcome measures 
Parental understanding of trial information was determined using 24 scenario-based questions. The primary endpoint was the proportion of parents who obtained the understanding score of more than 80%, and the secondary endpoint was the total score.
Results 
Forty-five parents (42.9%) in the SIDCER ICF group and 29 parents (27.6%) in the conventional ICF group achieved the primary endpoint (relative risk=1.552, 95% CI 1.061 to 2.270, p=0.021). The total score of the parents in the SIDCER ICF group was significantly higher than the conventional ICF group (18.07±3.71 vs 15.98±4.56, p=0.001).
Conclusions 
The SIDCER ICF was found to be superior to the conventional ICF in improving parental understanding of trial information.

20 Development of an application for digital capture of informed consent in research [POSTER]
Azariah Kusi-Yeboah, Dan Ward, Ross Murray, Daiana Bassi, Sue Conner, Yun Fu, Dean Mohamedally, Gemma Molyneux, Graham Roberts, Neil Sebire
Archives of Disease in Childhood, 22 November 2019; 104(supplement 4)
Abstract
Introduction 
Clinical trials and research studies are vital for treatment innovations. In order to give informed consent, participants are provided with information sheets that describe the study in detail. The current system is paper based and documents must be retained and archived. The aim of this project was to create a system to digitalise the process.
Method 
As part of a joint collaboration between GOSH and UCL computer science (CS) through the industry exchange network programme, we developed a mobile application for digital capture and management of consent. The application was based on a standard 3-tier (presentation, logic and data), software architecture pattern. The presentation tier consists of mobile and web applications. The mobile app was developed in Ionic4, while the web app makes use of Bootstrap to create fully responsive web pages. The logic tier, which contains the application’s functional business logic, was written in Node.js and consists of the RESTful APIs the mobile and web app use to access data. The data tier comprises of a MySQL database.
Results 
A web application was developed to create study documentation that can be viewed and completed on a mobile app. The system allows for the management of study documents to ensure version control. User profiles for staff can be created to control access to studies, therefore only staff with permission can access documentation and consent participants to a research study. The application allows information sheets to be sent to by email to participants, and for signatures to be taken digitally. All completed paperwork can be stored on a cloud database.
Conclusion 
A proof of principle system for capturing consent electronically has been developed. This system could be further enhanced to provide a screen reader function and could incorporate animations or films to enhance the description of research studies to children.

Editor’s note: GOSH refers to the Great Ormond Street Hospital and UCL to the University College London.

Privacy Nudges: An Alternative Regulatory Mechanism to Informed Consent for Online Data Protection Behaviour
Sheng Yin Soh
European Data Protection Law Review, 1 October 2019; 65
Abstract
The informed consent paradigm of data protection law in the EU has failed to foster privacy-protective behaviour online, due to findings from behavioural science such as bounded rationality and asymmetric information. Hence, this article proposes a soft partnership approach through the use of “privacy nudges” as an alternative regulatory tool to informed consent to nudge users towards more optimal privacy protection decisions. This article also discussed the potential benefits of privacy nudges, some of the main critiques of nudging and future direction for improvement.

Access to an Online Video Enhances the Consent Process, Increases Knowledge, and Decreases Anxiety of Caregivers with Children Scheduled for Inguinal Hernia Repair: a Randomized Controlled Study
Friederike Book, Jan Goedeke, Alicia Poplawski, Oliver J. Muensterer
Journal of Pediatric Surgery, 25 October 2019
Abstract
Background
There is limited time within the clinical workflow of most pediatric surgeons to obtain a comprehensive, well informed consent. This study evaluates whether ad-lib access to an online video on the consent dialogue enhances the consent process for inguinal hernia repair (IHR) in children.
Methods
The study was approved by the state ethics board. A 6-min video of a consent speech on IHR was produced and uploaded to a nonpublic online channel, explaining the condition, procedure, complications, and postoperative expectations. A total of 50 families were randomized to conventional, face-to-face consenting in clinic either with (intervention) or without (control) access to the online video. During their child’s IHR, the parents were asked to complete the State–Trait-Anxiety-Inventory (STAI), a modified Friedlander questionnaire on assessing knowledge sufficient to provide informed consent, and a validated satisfaction survey. Scores of the intervention and control group were statistically compared.
Results
The intervention group demonstrated significantly decreased anxiety measured with the STAI (p = 0,026) and increased knowledge (p = 0,016) compared to controls. There was no difference in satisfaction (p = 0,557).
Conclusion
Preoperatively providing access to an online consent video regarding IHR reduces anxiety and enhances knowledge without altering satisfaction level. Adjunct online videos are a useful tool to enhance the consent process.

Patients’ Preference for Receiving Informed Consent Information Regarding Third Molar Surgery
Daniel M.Laskin
Journal of Oral and Maxillofacial Surgery, 15 October 2019
Abstract
Purpose
It is important that patients have adequate information about a surgical procedure and its risks and benefits prior to giving consent to proceed. The purpose of this study was to determine patients’ satisfaction with various methods of presenting such information and their preferred method.
Patients and Methods
Patients presenting for removal of impacted third molars were shown an informational video discussing the diagnosis of impacted teeth, the potential risks of not having them removed, their treatment, surgical complications, and anesthetic options and risks. They then met with the treating doctor who again reviewed the material shown in the video and answered any questions prior to the patient signing the informed consent document. Patients then completed a brief questionnaire asking them to rate their satisfaction with the two presentation methods and to indicate their preferred method.
Results
Fifty patients (18 males, 32 females; average age – 26yrs) completed the questionnaire. Fifty-eight percent had high school education, whereas 42% had some college or a college degree. Sixty-six percent of patients found the video very helpful and 78% found the oral presentation very helpful. However, when asked which format provided the best information, 62% indicted the video whereas 38% indicted the oral presentation.
Conclusion
Because there was no clear consensus among patients regarding the best format, providing both the video and an oral presentation is the ideal situation.