P216: Co-Creating a Pediatric Assent Form: Integrating Advisory Board Insights to Improve Clarity and Engagement
Poster Presenter
Karen Hinkle
Associate Director, Medical Writing
Boehringer Ingelheim United States
Objectives
To describe how a pediatric patient advisory board informed the redesign of Boehringer Ingelheim’s assent forms to improve clarity, accessibility, and child-centered engagement.
Method
We received qualitative and quantitative feedback on the company’s existing pediatric assent forms from an international pediatric patient advisory board. We applied recommended revisions to generate an updated pediatric assent form template.
Results
Few publicly accessible exemplars or evidence-based guidelines exist for pediatric assent forms, leaving wide variability in readability, tone, and age-appropriate content. To address this gap, we conducted a pediatric patient advisory board to evaluate our existing assent materials.
Advisors reviewed the original assent forms for ages 6–10 and 10–17 years. Quantitative ratings reflected moderate satisfaction for the form for older children (average 3.33/5) and high satisfaction for the form for younger children (average 4.0/5). Qualitative feedback identified consistent recommendations: simplify language; increase clarity around the study purpose and procedures; ensure cultural adaptability; avoid triggering or developmentally inappropriate terminology; include phonetic aids and clear definitions (e.g., placebo, randomization); refine visuals so they are meaningful, diverse, and accessible rather than decorative; and emphasize autonomy, choice, and the child’s right to withdraw.
Advisors highlighted the importance of consistent terminology, transparent explanation of risks without overpromising benefit, and grouping visit procedures with simple icons plus brief text. Teens requested more mature formatting while still valuing clear visuals. Both groups stressed the need to explain the role of the study team and clarify that regular care continues alongside study participation.
Based on these insights, the revised assent forms now use direct, active language; simplified medical explanations; culturally flexible wording; improved layout and readability; clarified roles and responsibilities; child-appropriate descriptions of tests; and visual aids aligned communicative purpose rather than decoration. The updated forms reflect co-creation with pediatric patients, resulting in clearer, more engaging, and developmentally aligned assent materials.
Conclusion
Engaging pediatric patients and caregivers directly in the review of assent materials significantly enhanced clarity, relevance, and acceptability. Advisory board input revealed important gaps in language simplicity, cultural adaptability, visual communication, and consistency across age groups, areas not well covered in the publicly available literature. The co-created revisions resulted in assent forms that better support understanding, reduce anxiety, and promote informed decision making in pediatric clinical research.
This project demonstrates the value of structured patient engagement in developing ethically sound, child-centered trial materials. The resulting framework can serve as a model for other sponsors aiming to modernize pediatric assent processes and improve research accessibility and inclusiveness.
