Background The ethical principle, respect for persons, requires that subjects provide voluntary, informed consent prior to participation in research. In practice, there are often communication barriers that lead to misunderstandings and misconceptions during the informed consent process. While there is increasing evidence suggesting that interventions such a multimedia and interactive forms improve adult understanding of research, the unique needs of children and their families have often been left out of these efforts. The aim of this investigation was to engage children in creating an animated video that informs families about participation in clinical research to aid in the decision making process. Methods We conducted four stakeholder interviews with children and adolescents to 1) identify themes related to knowledge, concerns, and misconceptions of the research process, 2) determine which research concepts and terminology may be better explained with video, and 3) elucidate children’s preferred approaches to the consent process. Stakeholder groups consisted of children with serious chronic medical conditions and students from a local public high school; and are members of the International Children’s Advisory Network. Participants were led through guided exercises with open-ended questions used to focus discussions. Qualitative research methods were used to examine attitudes towards clinical research. Stakeholder groups were then re-convened to view the whiteboard animated video and assess the video on content objectives, clarity of concept, and appropriateness for a pediatric audience. Results Our stakeholders identified a number of misconceptions about research, including a poor understanding of commonly used terms (e.g., research, randomization, biobanking, etc.) and a number of fears (e.g., “things going wrong”, “dangerous”, “more harm than good”). The stakeholders identified several complex research topics that an animated video could aid in comprehension, such as informed consent, randomization, and placebos. Stakeholders proposed a series of short videos to be utilized as a tool during the consent process. The first video created presents information “important for kids and parents to know” before deciding to participate in a research study. We were successful in creating a patient-driven educational video entitled “What is Research.” Conclusions Our team developed a pediatric-focused introductory video on clinical research that was driven by pediatric feedback in order to combat misconceptions of what is “research.” The active engagement of this population in the development of tools to address these misconceptions has the potential to improve participant understanding during the consent process. The next steps for this initiative are to assess comprehension of the consent process enhanced by this video and to determine if the video has a direct impact on clinical research recruitment and retention.
Patient Driven Education: A novel approach to participant engagement in the research process
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Jamie Burgess, Christy Anton, Ferdynand Hebal, Elizabeth Kaurs, Jessica Macha, Adelaide D. McClure, Stefanie McCormack, Christine Stake; Patient Driven Education: A novel approach to participant engagement in the research process. Pediatrics May 2018; 142 (1_MeetingAbstract): 361. 10.1542/peds.142.1MA4.361
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