Characteristics of Electronic Informed Consent Platforms for Consenting Patients to Research Studies: A Scoping Review

Characteristics of Electronic Informed Consent Platforms for Consenting Patients to Research Studies: A Scoping Review
Jennifer Guarino, Irena Parvanova, Joseph Finkelstein
Studies in Health Technology and Informatics, 6 June 2022; 290 pp 777-781
Abstract
Informed consent process assures that research study participants are properly informed about the study prior to their consent. Due to the increasing significance of electronic informed consent (eIC) platforms, particularly during the COVID-19 pandemic, we conducted a scoping review of eIC systems to address the following characteristics: 1) technological features of current eIC platforms, 2) eIC platforms usability and efficacy, and 3) areas for future eIC research. We performed a literature search using publicly available PubMed repository, where we included studies discussing an eIC platform or multimedia educational module given to patients prior to signing a consent form. In addition, we tracked first author, year of publication, sample size, study location, eIC procedure, methodology, and eIC’s comparison to paper consent. Our results showed that with a few noted exceptions, electronic consent improves patient usability, satisfaction, knowledge, and trust scores when compared to traditional paper consent.

Implementation of Surgical Education Video to Burn Patients Before the Informed Consent Process

Implementation of Surgical Education Video to Burn Patients Before the Informed Consent Process
Theses and Dissertations
Brian Piatkowski
Doctor of Nursing Practice, 28 May 2022
Open Access
Abstract
Purpose
Before the initiation of this evidence-based Doctor of Nursing Practice (DNP) project, a systematic review of literature set forth by other researchers regarding the informed consent process was done. The literature showed patient satisfaction scores increased, while anxiety decreased regarding surgical procedures after using a multimedia educational tool. The first goal of the project was to determine any gaps in knowledge of the burn surgical patient population. The second goal of the project was to determine gaps in knowledge and comfort levels with providers obtaining informed consent. The third goal was to determine the efficacy of implementing a surgical education video for patients and providers.
Background
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.
Evaluation
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. This tool can easily be modified with practice changes for sustainability. 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.

Participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent: A parallel-group pilot study among Danish citizens

Participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent: A parallel-group pilot study among Danish citizens
Anne Nyholm Gaarskjær, Meg Duroux, Rasmus Hogreffe
Contemporary Clinical Trials Communications, 27 May 2022
Abstract
Background
Teleconsent via video conferencing enables decentralized trials with remote consent and has the additional benefit of allowing a real-time reaction to potential misunderstandings. However, participant acceptance of and satisfaction with teleconsent versus in-person consent processes are unknown.
Methods
We conducted a parallel-group pilot study to evaluate participant comprehension and perspectives regarding the convenience, security, and satisfaction with teleconsent compared to in-person consent among Danish citizens for a hypothetical research study.
Results
There were no statistically significant differences in perceptions of security or satisfaction between teleconsent and in-person consent arms. However, participants viewed teleconsent as more convenient than in-person consent, as no transportation was needed and the process was less time-consuming. Recruitment was also faster in the teleconsent arm, and more people dropped out of the in-person arm, citing difficulties with transportation and time.
Conclusion
Decentralized clinical trials have been demonstrated to increase recruitment and enrollment rates, improve trial efficiency, and decrease dropout rates and trial delays. We add to this literature by suggesting that patients perceive teleconsent as similar to in-person consent, suggesting this is a feasible and acceptable substitution for in-person consent in multisite, decentralized trials. Future work should include patient perspectives from a larger, more diverse group of participants.

Video-assisted informed consent in a clinical trial of resuscitation of extremely preterm infants: Lessons learned

Video-assisted informed consent in a clinical trial of resuscitation of extremely preterm infants: Lessons learned
Namrita Jain Odackal, Catherine Grace Caruso, Melissa Klitzman, Mónica Rincón, Bobbi Byrne, Jameel Justin Winter, Gina Petroni, Karen D Fairchild, Jamie B Warren
American Journal of Perinatology, 26 May 2022
Abstract
Objective
Obtaining informed consent for clinical trials is challenging in acute clinical settings. For the VentFirst randomized clinical trial (assisting ventilation during delayed cord clamping for infants <29 weeks’ gestation), we created an informational video that sites could choose to use to supplement the standard in-person verbal and written consent. Using a post-consent survey, we sought to describe the impact of the video on subject recruitment, satisfaction with the consent process, and knowledge about the study.
Study design
Descriptive survey-based sub-study.
Results
Of the sites participating in the VentFirst trial that obtained IRB approval to allow use of the video to supplement the standard informed consent process, three elected to participate in the survey substudy. From February 2018 to January 2021, 82 women at these three sites were offered the video and completed the post-consent survey. Overall, 73 of these 82 women (89%) consented to participate in the primary study, 78 (95%) indicated the study was explained to them very well or extremely well, and the range of correct answers on 5 knowledge questions about the study was 63%-98%. Forty-six (56%) of the 82 women offered the video chose to watch it. There were no major differences in study participation, satisfaction with the consent process, or knowledge about the study between the women who chose to watch or not watch the video.
Conclusion
Watching an optional video to supplement the standard informed consent process did not have a major impact on outcomes in this small sub-study. The ways in which audiovisual tools might modify the traditional informed consent process deserve further study.

Improving comprehension, recall and attention using multimedia-informed assent among pediatric oncology patients: A comparative randomized controlled trial

Improving comprehension, recall and attention using multimedia-informed assent among pediatric oncology patients: A comparative randomized controlled trial
Psychosocial and Supportive Care: Research Article
Passara Wongthai, Apichat Photia, Chanchai Traivaree, Chalinee Monsereenusorn, Nawachai Lertvivatpong, Khemika Khemakanok Sudnawa, Piya Rujkijyanont
Pediatric Blood & Cancer, 25 May 2022
Abstract
Background
Assent should be obtained in all children involved in research in keeping with their level of maturity. Traditional assent forms contain too much information and are difficult to read. The study aimed to identify an effective tool to enhance children’s comprehension during the assent process and focused on those with cancer who are likely more engaged in research involving greater than minimal risk.
Methods
In all, 116 children with cancer were randomized to receive either a paper-based assent document or a multimedia-based assent document. Open-ended and multiple-choice questions were used to assess comprehension and recall. Time spent on the documents and children’s behavior during the assent process was recorded to determine their attention and satisfaction.
Results
Children randomized to a multimedia-based assent document achieved significant higher comprehension and recall assessment scores (p-values <.001). The high score achievement significantly correlated with the child’s age with adjusted odds ratio (OR) of 1.90 (p-value <.001; 95% confidence interval [CI]: 1.35–2.66) for comprehension assessment and 1.59 (p-value .001; 95% CI: 1.20–2.12) for recall assessment. Children randomized to a multimedia-based assent document had significant longer time spent on the document (p-value .001) with less numbers of inattention (p-value <.001) and expressed more signs of enjoyment during the assent process (p-values <.001).
Conclusion
Multimedia-based assent document successfully enhanced comprehension, recall, and attention with more satisfaction compared with a traditional paper-based document among children with cancer. This approach may be considered as an alternative format for children engaging in research involving greater than minimal risk.

Context, Prioritization, and Unexpectedness: Factors Influencing User Attitudes About Infographic and Comic Consent

Context, Prioritization, and Unexpectedness: Factors Influencing User Attitudes About Infographic and Comic Consent
Xengie Doan, Annika Selzer, Arianna Rossi, Wilhelmina Maria Botes, Gabriele Lenzini
WWW ’22 Companion, 25-29 April 2022; Lyon, France [Virtual Event]
Open Access
Abstract
Being asked to agree to data disclosure is a ubiquitous experience in digital services – yet it is rare to encounter a well-designed consent experience. Considering the momentum for a European data space where personal information easily flows across organizations, sectors, and nations, solving the thorny issue of “how to get consent right” cannot be postponed any further. In this paper, we describe the first findings from a study based on 24 semi-structured interviews investigating participants’ expectations and opinions toward a consent form redesigned as a comic and an infographic in a data-sharing scenario. We found that time, information prioritization, tone, and audience fit are crucial when individuals are invited to disclose their information and the infographic is a better fit in biomedical scenarios.

Effective Communication of Personalized Risks and Patient Preferences During Surgical Informed Consent Using Data Visualization: Qualitative Semistructured Interview Study With Patients After Surgery

Effective Communication of Personalized Risks and Patient Preferences During Surgical Informed Consent Using Data Visualization: Qualitative Semistructured Interview Study With Patients After Surgery
Undina Gisladottir, Drashko Nakikj,  Rashi Jhunjhunwala, Jasmine Panton, Gabriel Brat, Nils Gehlenborg
JMIR Hum Factors, 1 April 2022; 9(2)
Abstract
Background
There is no consensus on which risks to communicate to a prospective surgical patient during informed consent or how. Complicating the process, patient preferences may diverge from clinical assumptions and are often not considered for discussion. Such discrepancies can lead to confusion and resentment, raising the potential for legal action. To overcome these issues, we propose a visual consent tool that incorporates patient preferences and communicates personalized risks to patients using data visualization. We used this platform to identify key effective visual elements to communicate personalized surgical risks.
Objective
Our main focus is to understand how to best communicate personalized risks using data visualization. To contextualize patient responses to the main question, we examine how patients perceive risks before surgery (research question 1), how suitably the visual consent tool is able to present personalized surgical risks (research question 2), how well our visualizations convey those personalized surgical risks (research question 3), and how the visual consent tool could improve the informed consent process and how it can be used (research question 4).
Methods
We designed a visual consent tool to meet the objectives of our study. To calculate and list personalized surgical risks, we used the American College of Surgeons risk calculator. We created multiple visualization mock-ups using visual elements previously determined to be well-received for risk communication. Semistructured interviews were conducted with patients after surgery, and each of the mock-ups was presented and evaluated independently and in the context of our visual consent tool design. The interviews were transcribed, and thematic analysis was performed to identify major themes. We also applied a quantitative approach to the analysis to assess the prevalence of different perceptions of the visualizations presented in our tool.
Results
In total, 20 patients were interviewed, with a median age of 59 (range 29-87) years. Thematic analysis revealed factors that influenced the perception of risk (the surgical procedure, the cognitive capacity of the patient, and the timing of consent; research question 1); factors that influenced the perceived value of risk visualizations (preference for rare event communication, preference for risk visualization, and usefulness of comparison with the average; research question 3); and perceived usefulness and use cases of the visual consent tool (research questions 2 and 4). Most importantly, we found that patients preferred the visual consent tool to current text-based documents and had no unified preferences for risk visualization. Furthermore, our findings suggest that patient concerns were not often represented in existing risk calculators.
Conclusions
We identified key elements that influence effective visual risk communication in the perioperative setting and pointed out the limitations of the existing calculators in addressing patient concerns. Patient preference is highly variable and should influence choices regarding risk presentation and visualization.

An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT)

An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT)
Study Protocol
Lydia O’Sullivan, Stefano Savinelli, Stephen O’Hare, Sinéad Holden, Ciara McHugh, Patrick Mallon, Peter Doran
Trials, 17 January 2022; 23(50)
Open Access
Abstract
Background
It is the investigator’s responsibility to communicate the relevant information about a clinical trial to participants before they provide informed consent to take part. Systematic reviews indicate that participants often have a poor understanding of the concepts which are key to ensuring valid informed consent, such as randomisation and risks/discomforts. Paper-based participant information leaflets and informed consent forms (PIL/ICFs) are becoming longer and are often too complex for many participants. Multimedia interventions and enhanced PIL/ICFs have been trialled in an attempt to improve participants’ understanding of various aspects of research studies. However, there is insufficient empirical evidence to determine how effective such interventions are. This protocol describes a study to evaluate whether an enhanced PIL/ICF and website help research participants to understand important information about a human immunodeficiency virus (HIV) randomised clinical trial.
Methods
This Study Within A Trial (SWAT) is a prospective, multi-centre, randomised, controlled, parallel-group study embedded in a host clinical trial. The host trial (the SWIFT trial; EudraCT: 2019-002314-39) is a prospective, multi-centre, randomised, open-label, controlled trial investigating if semaglutide along with dietary advice assists individuals with HIV and obesity to lose weight, compared to dietary advice alone. For the SWAT, participants will be randomised in a 1:1 ratio to either the control (standard PIL/ICF) or the intervention (an enhanced PIL/ICF and a website which includes animations). The enhanced PIL/ICF and website were developed in line with the guidance from organisations which promote plain English and accessible public-facing materials in conjunction with HIV Ireland, a HIV advocacy organisation, and our previous work on consent documents. The primary outcome of the SWAT is the quality of informed consent, assessed by a validated comprehension test—the modified Deaconess Informed Consent Comprehension Test (DICCT). The DICCT will be administered within 48 h of consent to the host trial. The secondary is recall, measured by the modified DICCT questionnaire scores 2 weeks post-consent to the host trial.
Discussion
The results of this SWAT will add to the methodological evidence base on the use of multimedia to improve the quality of informed consent to randomised clinical trials.

Cognitive Testing of an Electronic Consent Platform: Researcher Perspectives

Cognitive Testing of an Electronic Consent Platform: Researcher Perspectives
Daniel Robins, Rachel Brody, Irena Parvanova, Joseph Finkelsein
Nurses and Midwives in the Digital Age, December 2021
Open Access
Abstract
This study focuses on feedback from domain experts to assess usability and acceptance of the E-Consent electronic consent platform. Quantitative and qualitative data were captured throughout the usability inspection, which was structured around a cognitive walkthrough with heuristics evaluation. Additional surveys measured biobanking knowledge and attitudes and familiarity with informed consent. A semi-structured qualitative interview captured open-ended feedback. 23 researchers of various ages and job titles were included for analysis. The System Usability Scale (SUS) provided a standardized reference for usability and satisfaction, and the mean result of 86.7 corresponds with an ‘above average’ usability rating in the >90th percentile. Overall, participants believe that electronic consenting using this platform will be faster than previous workflows while enhancing patient understanding, and human rapport is still a key component of the consent process. Expert review has provided valuable insight and actionable information that will be used to further enhance this maturing platform.

Developing an e-consent system

Developing an e-consent system
K. Burke, N. Grover, L. Zhang, N. Amdeeb, E. Liu, A. Sapozhnikova
Clinical Trials, 2021; 18(supplement 5) pp 87-88
Abstract
With the COVID-19 pandemic, the ability to coordinate and manage research studies remotely has become increasingly important. Most systems offer a variation of a mobile interface for study participants to complete self-administered questionnaires outside of the clinical setting. However, there was a need for functionality to allow a potential participant to virtually and electronically complete a screening questionnaire and provide consent. The web development team and research staff at the George Washington University Biostatistics Center collaborated to create a web-based public form and electronic informed consent system. This system allows potential participants to be screened and join studies without the need to be physically present to sign regulatory documents. The e-consent system is based on the Biostatistics Center’s existing electronic patient report outcome system. Users are able to access the system on a variety of devices, as the display is tailored to the size of the screen. To assure data quality and security, the system incorporates reCAPTCHA verification, email verification, tailored in-system messaging, personal links and codes, link expiration, electronic signature, and encryption. Existing features from the electronically patient report outcome system-such as skip patterns, range checks, lookup tables, and partial saving-were utilized to minimize data quality issues. In describing the design, implementation, successes, and challenges of this system, the Biostatistics Center team hopes to inform other coordinating centers and research studies interested in utilizing virtual enrollment systems for remote research.