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

OBJECTIVES

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

CLINICAL TRIAL REGISTRATION: Trial identifier: ISRCTN81936667.