A Consent Tool for Secondary Use of Biomedical Data
Simon Adams, Gausegan Uthayathas, Murat Sariyar
Studies in Health Technology and Informatics, 16 May 2022; 292 pp 107-110
To pursue scientific goals with patient data usually requires informed consent from the data subjects. Such a consent constitutes a contract between the research institute and the patient. Several issues must be included in the consent to be valid, for example, how the data is processed and stored as well as specifics of the research questions for which the data is going to be used. Here, we describe the development and the implementation of a user-friendly IT solution that supports the process-oriented obtainment of consents. Current solutions often focus only on the benefits for the researcher. Our solution intends to add value to all participants and to reduce paperwork to a minimum. The consent Tool was evaluated by a usability test using the UEQ Method (User Experience Questionnaire) and received positive feedback – both efficiency and originality were rated above the average UEQ-Benchmark. Nevertheless, the lack of compatibility with the technical infrastructure of the hospital was a significant shortcoming. Hence, although there is a general interest in digitized solutions in the healthcare sector, there are still many hurdles to implement them and roll them out.
Health-related confidentiality and consent among minors: Data on adult perspectives from Belgium and The Netherlands
David De Coninck, Koen Matthijs. Peter de Winter, Jaan Toelen
Data in Brief, June 2022; 42
The data presented in this article provide one of the first large-scale insights on adult preferences for confidentiality and consent with regards to medical decision-making for minors. We collected data on these preferences through 12 hypothetical scenario’s that were presented, for which each participant had to indicate if they would (not) follow the minor’s preferences. Data regarding family communication, relationship quality, and sociodemographic characteristics were also collected. The data were collected through an online survey in September and October 2020, which yielded responses from 1000 Belgian and 1000 Dutch participants between 35 and 55 years of age. We selected this age range because it increased the chances that they had a child near the age of the fictional minor in the hypothetical cases. These data can be of interest for family researchers and/or health workers who want to explore adults’ perceptions regarding confidentiality and consent among minors.
Getting parental consent when treating children
BDJ Team, 20 May 2022; 9 pp 20–21
When treating young children, it may be necessary to get the authority of someone with parental responsibility. With complex family relationships however, it might not be clear to dental professionals who has parental responsibility, and this can create a dilemma. Here we explain the principles and procedures around parental responsibility when treating younger children…
Editor’s note: BDJ Team is a product of the British Dental Association.
Implementation of Surgical Education Video to Burn Patients Before the Informed Consent Process
Theses and Dissertations
Doctor of Nursing Practice, 28 May 2022
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.
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.
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.
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.
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
Anne Nyholm Gaarskjær, Meg Duroux, Rasmus Hogreffe
Contemporary Clinical Trials Communications, 27 May 2022
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.
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.
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.
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
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
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.
Descriptive survey-based sub-study.
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.
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
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
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.
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.
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).
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
Xengie Doan, Annika Selzer, Arianna Rossi, Wilhelmina Maria Botes, Gabriele Lenzini
WWW ’22 Companion, 25-29 April 2022; Lyon, France [Virtual Event]
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
Undina Gisladottir, Drashko Nakikj, Rashi Jhunjhunwala, Jasmine Panton, Gabriel Brat, Nils Gehlenborg
JMIR Hum Factors, 1 April 2022; 9(2)
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.
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).
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.
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.
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.
Impact of Informed Consent and Education on Care Engagement After Opioid Initiation in the Veterans Health Administration
Tigran Avoundjian, Lara Troszak, Jennifer Cohen, Mary Beth Foglia, Jodie Trafton, Amanda Midboe
Journal of Pain Research, 25 May 2022; 15 pp 1553-1562
To ensure all patients receiving long-term opioid therapy (LTOT) understand the risks, benefits and treatment alternatives, the Veterans Health Administration (VHA) released a national policy in 2014 to standardize a signature informed consent (SIC) process. We evaluated the impact of this policy on medical follow-up after LTOT initiation, a guideline recommended practice.
Using VHA administrative data, we identified patients initiating LTOT between May 2013 and May 2016. We used an interrupted time series design to compare the monthly rates of medical follow-up within 30 days and primary care visits within 3 months after LTOT initiation across three periods: 12 months before the policy (Year 1); 12 months after policy release (Year 2); and 12– 24 months after policy release, when the SIC process was mandatory (Year 3).
Among the 409,895 patients who experienced 758,416 LTOT initiations, medical follow-up within 30 days and primary care engagement within 3 months increased by 4% between Year 1 and Year 3. Compared to Year 1, patients in Year 3 were 1.12 times more likely to have any medical follow-up (95% CI: 1.10, 1.13) and 1.13 times more likely to have a primary care visit (95% CI: 1.12, 1.15). Facilities with a greater proportion of patients receiving SIC had increased medical follow-up (RR: 1.04, 95% CI: 1.01, 1.07) and primary care engagement (RR: 1.06, 95% CI: 1.03, 1.10).
The VHA’s SIC policy is associated with increased medical follow-up among patients initiating LTOT, which may result in improved patient safety and has implications for other healthcare settings.