Evidence map›Paper›PMID 40798916›Full record

Trial reportJournal of pediatric gastroenterology and nutrition2025

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

Sara Mancell, Fiona Lavelle, Salma Ayis, Anil Dhawan, Kevin Whelan

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of pediatric gastroenterology and nutrition, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Sara MancellDepartment of Nutritional Sciences, King's College London, London, UK.ORCID https://orcid.org/0000-0002-6811-3461
Fiona LavelleDepartment of Nutritional Sciences, King's College London, London, UK.
Salma AyisDepartment of Population Health, King's College London, London, UK.
Anil DhawanPaediatric Liver, GI and Nutrition, King's College Hospital NHS Foundation Trust, London, UK.
Kevin WhelanDepartment of Nutritional Sciences, King's College London, London, UK.

Funding

Health Education England (HEE)/National Institute for Health and Care Research (NIHR) NIHR302152
6 · The paper itself

Abstract

objectivesParticipants 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.

methodsThe 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.

resultsPerceptions 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.

conclusionsThe 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 registrationTrial identifier: ISRCTN81936667.

Indexed as

Biliary AtresiaClinical Trials as TopicInformed ConsentPatient SelectionFeasibility StudiesFemaleHumansInfantMaleSurveys and Questionnairesinformation toolsrecruitmentresearch ethicsvideo

Identifiers

PMID40798916
PMCPMC12580458

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.