Using a cartoon questionnaire to improve consent process in children: a randomized controlled survey

Area of Science:

• Pediatric Research
• Bioethics
• Informed Consent

Background:

• Obtaining informed consent from pediatric populations for biospecimen donation presents unique challenges.
• Traditional text-based questionnaires may not effectively engage children or ensure comprehension of complex medical information.
• Developing standardized, child-friendly methods is crucial for ethical research participation.

Purpose of the Study:

• To evaluate the effectiveness of an audio and animated cartoon questionnaire (AACQ) in improving the pediatric consent process for biospecimen donation.
• To compare the AACQ with a traditional text questionnaire (TQ) in terms of children's understanding, engagement, and willingness to donate.

Main Methods:

• A multi-center randomized controlled trial was conducted in two Chinese pediatric hospitals (2019-2020).
• Participants included 264 children (aged 7-18) in pediatric surgery wards, randomized into AACQ and TQ groups.
• Children's willingness, attitudes, and knowledge regarding biospecimen donation were assessed using a knowledge test.

Main Results:

• The AACQ group demonstrated a significantly higher response rate (89.85%) compared to the TQ group (68.44%; p < 0.001).
• AACQ improved children's understanding, engagement, and risk awareness related to biospecimen donation.
• Concerns about pain and privacy disclosure were primary reasons for refusal among children.

Conclusions:

• The audio and animated cartoon questionnaire (AACQ) is an effective and standardized tool for delivering information to pediatric surgical patients.
• AACQ enhances comprehension and engagement, suggesting its utility for improving informed consent in pediatric research.
• Children with a full understanding of biospecimen donation are better prepared to provide consent.