A cognitive approach for design of a multimedia informed consent video and website in pediatric research

Abstract

Objective Poor participant comprehension of research procedures following the conventional face-to-face consent process for biomedical research is common. We describe the development of a multimedia informed consent video and website that incorporates cognitive strategies to enhance comprehension of study related material directed to parents and adolescents. Materials and methods A multidisciplinary team was assembled for development of the video and website that included human subjects professionals; psychologist researchers; institutional video and web developers; bioinformaticians and programmers; and parent and adolescent stakeholders. Five learning strategies that included Sensory-Modality view, Coherence, Signaling, Redundancy, and Personalization were integrated into a 15-minute video and website material that describes a clinical research trial. Results A diverse team collaborated extensively over 15 months to design and build a multimedia platform for obtaining parental permission and adolescent assent for participant in as asthma clinical trial. Examples of the learning principles included, having a narrator describe what was being viewed on the video (sensory-modality); eliminating unnecessary text and graphics (coherence); having the initial portion of the video explain the sections of the video to be viewed (signaling); avoiding simultaneous presentation of text and graphics (redundancy); and having a consistent narrator throughout the video (personalization). Discussion Existing conventional and multimedia processes for obtaining research informed consent have not actively incorporated basic principles of human cognition and learning in the design and implementation of these processes. The present paper illustrates how this can be achieved, setting the stage for rigorous evaluation of potential benefits such as improved comprehension, satisfaction with the consent process, and completion of research objectives. Conclusion New consent strategies that have an integrated cognitive approach need to be developed and tested in controlled trials.

Learners and Teacher Toward The Problem-Solving Based Learning Media

“…The text and the life-creature animations were made attractively and lively to facilitate learners developing their ideas. The media could make a joyful, motivating, interesting, and resolutive learning atmosphere so that learners could solve the problems in the learning materials (Antal et al, 2017;Leatherman & Cleveland, 2020;Puspitarini & Hanif, 2019). The learning had a purpose to create learners with excellent, accurate, and quick problem-solving skills (Andriyani & Suniasih, 2021;Hwang et al, 2012).…”

Improved parental understanding by an enhanced informed consent form: a randomized controlled study nested in a paediatric drug trial

“…This emphasises the need of increased attention in particular during informed consent discussion to ensure adequate understanding of this concept among individuals who consent to a trial 26. A combination of the SIDCER ICF methodology with other means (eg, an integrated cognitive approach) may enhance parental understanding of this information in paediatric research 27…”

“…It may be worthwhile to consider using more graphics or pictographs to enhance visualisation of complex information in the SIDCER ICF,30 and further research may be required to determine the effectiveness of such additional means, especially in this group of populations. In addition to the enhanced ICF, a dialogue between the investigator (or a person designated by the investigator) and the parents are still indispensable, while complimentary methods of delivering trial-related information (eg, a multimedia video and website)27 may be warranted in some studies. Furthermore, formal evaluation of parental understanding during the process of informed consent may be necessary, especially in paediatric research that poses relatively high risks, with little or no potential direct benefit, to child subjects 31 32.…”

Pioneering Informed Consent for Return of Research Results to Breast Cancer Patients Facing Barriers to Implementation of Genomic Medicine: The Kenyan BRCA1/2 Testing Experience Using Whole Exome Sequencing

“…Lack of genetic counselors in Kenya necessitates the development of an innovative approach toward breast cancer genetic testing and return of research results. Incorporating cognitive strategies through a multimedia approach may in future enhance comprehension of research procedures, instead of using a single face-to-face method when consenting and counseling patients in biomedical research (Antal et al, 2017).…”