# Digital animation as a tool to enhance informed consent when recruiting infants with biliary atresia to a clinical trial

## TL;DR

This study explores using digital animation to improve understanding and informed consent for parents of infants with biliary atresia joining a clinical trial.

## Contribution

The study introduces digital animation as a novel recruitment tool to enhance informed consent in a clinical trial for infants with biliary atresia.

## Key findings

- Digital animation was highly positively perceived by participants and improved understanding of study information.
- The animation enabled participants to share information with others and may help those with comprehension difficulties or non-English speakers.
- Despite improved understanding, the animation did not increase the consent rate.

## Abstract

Participants may have a poor understanding of the research they are involved in due to the challenges of receiving information during acute illness and the complexity and length of participant information sheets. This study aimed to assess the impact and acceptability of using digital animation to recruit infants with biliary atresia to a clinical trial.

The mixed method design used questionnaires and interviews to assess the feasibility of using animation during recruitment to a feasibility trial (ISRCTN81936667). All participants received verbal and written information, and after the animation was introduced, participants additionally received the animation. Quantitative data are presented descriptively (median, frequencies), and recruitment before and after introducing the animation was compared using Fisher's exact test. Qualitative data were analysed thematically, and the combined quantitative and qualitative results were considered together.

Perceptions of the animation were highly positive, with between 81.3% to 100% agreeing with positively framed statements and 87.5% to 100% disagreeing with negatively framed statements. However, there was no difference in numbers consenting to participate before (14/16, 87.5%) and after (16/18, 88.9%) introducing the animation (p = 1.00). Three qualitative themes emerged relating to the animation: technical accessibility, cognitive accessibility and enabling understanding.

The animation was viewed positively by participants who felt it increased understanding and enabled them to share information with others. Although this improved the informed consent process, it did not impact the consent rate. Digital animation could represent an effective way to present study information, better enabling participants to provide valid informed consent.

Trial identifier: ISRCTN81936667

Participants may have a poor understanding of the research they participate in due to the challenges of receiving information during illness and the complexity and length of participant information sheets.Digital animation may help to improve informed consent to clinical trials.

Participants may have a poor understanding of the research they participate in due to the challenges of receiving information during illness and the complexity and length of participant information sheets.

Digital animation may help to improve informed consent to clinical trials.

Animation helped increase understanding of study information and enabled the sharing of this information with others.Animation may help those with comprehension difficulties and non‐English speakers understand study information.The stress experienced by parents of infants with biliary atresia after diagnosis may impact their capacity to access and cognitively process study information.

Animation helped increase understanding of study information and enabled the sharing of this information with others.

Animation may help those with comprehension difficulties and non‐English speakers understand study information.

The stress experienced by parents of infants with biliary atresia after diagnosis may impact their capacity to access and cognitively process study information.