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-min video and website material that describes a clinical research trial.

Results: A diverse team collaborated extensively over 15months 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.

Trial registration: ClinicalTrials.gov NCT02061280.

Keywords: Electronic; Informed consent; Learning theory; Multimedia; Video; Website.

Conflict of interest statement

Conflicts of Interest

Manuscript entitled, “A Cognitive Approach for Design of a Multimedia Informed Consent Video and Website in Pediatric Research”

We have no conflicts of interest to disclose.

Copyright © 2017 Elsevier Inc. All rights reserved.

Figures

Figure 1

Welcome page of the consent video website. The welcome page orients the viewer to the layout and steps for viewing the video and website material.

Figure 2

Coherence principal. The Coherence principal as depicted in the consent video was used to avoid unnecessary text and graphics in order to maximize the likelihood for participant and parent retaining study information.

Figure 3

Signaling principle. The Signaling principle is represented by the visible author and sidebar for reinforcement of information. The visible author guides the viewer through the video information. The sidebar tab is highlighted when a relevant section of the video is reached and additional information can be accessed in the sidebar. The video tabs are highlighted for the section the participant/parent are currently viewing.