Facilitators, barriers, and recommendations related to the informed consent of Marshallese in a randomized control trial

2020 ◽  
Vol 15 (2) ◽  
pp. 75-83
Author(s):  
Rachel S Purvis ◽  
Leah R Eisenberg ◽  
Christopher R Trudeau ◽  
Christopher R Long ◽  
Pearl A McElfish
Keyword(s):  
Informed Consent ◽  
Randomized Control Trial ◽  
Diabetes Management ◽  
Community Based Participatory Research ◽  
Informed Consent Process ◽  
Consent Process ◽  
Research Approach ◽  
Community Based ◽  
Randomized Control ◽  
Participatory Research Approach

Background The Pacific Islander population is the second fasting growing population in the United States and Arkansas is home to the largest Marshallese population in the continental US. The Marshallese community have significant health disparities with high prevalence of diabetes, heart disease, and obesity compared to the general US population. Using a community-based participatory research approach, researchers and Marshallese community stakeholders identified diabetes as the top health issue for research. Methods From 2014 to 2018, a randomized control trial was conducted comparing standard diabetes management education with a culturally adapted family model of standard diabetes management education delivered in participants’ homes by Marshallese community health workers and certified diabetes educators. Interviews were held with Marshallese participants to document their experiences with and perceptions of the informed consent process for this randomized control trial. Results Participants provided feedback on the process of enrolling in the study, describing barriers and facilitators to giving informed consent from their perspective, and offering recommendations for improving the informed consent process. Conclusion Findings suggest that informed consent with underserved communities, including immigrant and migrant populations who do not speak English or have limited English proficiency, is possible, and that using a community-based participatory research approach can help facilitate the informed consent process.

Multimedia in the informed consent process for endoscopic sinus surgery: A randomized control trial

2015 ◽  
Vol 126 (6) ◽  
pp. 1273-1278 ◽  
Author(s):  
Jennifer M. Siu ◽  
Brian W. Rotenberg ◽  
Jason H. Franklin ◽  
Leigh J Sowerby
Keyword(s):  
Informed Consent ◽  
Endoscopic Sinus Surgery ◽  
Randomized Control Trial ◽  
Informed Consent Process ◽  
Sinus Surgery ◽  
Consent Process ◽  
Randomized Control

Comparing a Multimedia Digital Informed Consent Tool to Traditional Paper-based Methods Among GenEx Trial Participants: Randomized Control Trial (Preprint)

2020 ◽  
Author(s):  
Fuad Abujarad ◽  
Peter Peduzzi ◽  
Sophia Mun ◽  
Kristina Carlson ◽  
Siyuan Ma ◽  
...  
Keyword(s):  
Informed Consent ◽  
Randomized Control Trial ◽  
Cognitive Theory ◽  
Digital Health ◽  
Informed Consent Process ◽  
Ease Of Use ◽  
Consent Process ◽  
New Haven ◽  
Randomized Control ◽  
The Impact

BACKGROUND The traditional informed consent process rarely emphasizes research participants’ comprehension of medical information, leaving them vulnerable to unknown risks and consequences associated with procedures or studies. OBJECTIVE This paper explores how we evaluated the feasibility of a digital health tool called ‘VIC’ for advancing the informed consent process and compared the results to traditional paper-based methods of informed consent. METHODS By utilizing Digital Health and virtual coaching, we developed the ‘Virtual multimedia interactive Informed Consent’ (VIC) tool that uses multimedia and other interactive digital features to improve the current informed consent process. Development of the tool was based on the user-centered design (UCD) process and on Mayer’s cognitive theory of multimedia learning. In a randomized control trial, we compared VIC’s feasibility against standard paper consent to understand the impact of interactive digital consent. Participants were recruited from the Winchester Chest Clinic (WCC) at Yale New Haven Hospital in New haven, CT, as well as from the community using fliers. The trial was coordinator-assisted, and participants were randomized to complete the informed consent process using VIC on the iPad or with traditional paper consent. The study was conducted at WCC and the outcomes were self-assessed through coordinator-administrated questionnaires. RESULTS Overall 50 participants were recruited in the study (VIC: n=25; Paper: n=25). Participant comprehension was high in both groups. VIC participants reported higher satisfaction, higher perceived ease of use, higher ability to complete the consent independently, and a shorter perceived time for completing the consent process. CONCLUSIONS The use of dynamic, interactive audiovisual elements in VIC may improve participants satisfaction and facilitate the informed consent process. We believe that using VIC in an ongoing, real-world study rather than a hypothetical study improved the reliability of our findings which demonstrate VIC’s potential to improve research participant’s comprehension as well as the overall process of the informed consent. CLINICALTRIAL ClinicalTrials.gov NCT02537886; https://clinicaltrials.gov/ct2/show/NCT02537886.

A Community-Engaged Project Discovering the Sexuality Questions of Adults With Intellectual and Developmental Disabilities

Inclusion ◽  
2021 ◽  
Vol 9 (1) ◽  
pp. 2-16
Author(s):  
Rebecca R. Kammes ◽  
Rhonda S. Black ◽  
Trisha Easley
Keyword(s):  
Developmental Disabilities ◽  
Sexuality Education ◽  
Developmentally Appropriate ◽  
Community Based Participatory Research ◽  
Research Approach ◽  
Intellectual And Developmental Disabilities ◽  
Community Based ◽  
Sexual Health Information ◽  
Education Group ◽  
Participatory Research Approach

Abstract This study used a community-based participatory research approach to examine what adults with intellectual and developmental disabilities (IDD) view as important topics in sexuality education. A thematic analysis was conducted on questions written by adults with IDD regarding sexuality after attending a sexuality education group. Results were checked for accuracy using a community focus group. Findings provide direct implications for community-based sexuality education programs for adults with IDD, demonstrating the need for mentoring regarding authentic relationship experiences as well as developmentally appropriate sexual health information. Programs need to focus on helping adults with IDD navigate these interpersonal experiences. This study also demonstrates the importance of including the voices of adults with IDD in research in order to ensure its applicability and acceptability.

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