Lay summaries for young trial participants
Children and adolescents who took part in a trial should be able to learn its results from a summary written for them: matched to the reader's age, sometimes told as a comic, and shaped by what testing different formats with children shows they understand and like.
Matching the summary to the reader's age
A summary written for a child differs from one written for an adult. Plain language summaries in general need to be written at a proficiency level of 2 to 3, roughly a 6th-to-8th-grade reading level, and writing one for children brings greater challenges. Although the specific requirements vary by age group, a summary for a child often has shorter sentences and simpler words, more white space and more graphics. These are not cosmetic: they are fundamental requirements for helping children understand the content and for holding their attention. The recommendations of the expert group on clinical trials for implementing the EU Clinical Trials Regulation say that sponsors of paediatric studies should consider a child-focused version of the summary that may differ in presentation and style, such as more illustrations or graphics, to help children understand the results, over and above what the regulation requires. Whatever the format, the sponsor must ensure that the information is non-promotional, not misleading and factually correct, while still easy to understand.
As in adult trials, children who took part in a trial should be able to learn its results, through a lay summary tailored to their age. The European Commission's Good Lay Summary Practice also states that the summary should be appropriate to the reader's maturity level. In one trial, the summary written for school-age children gives each page to one part of the trial, uses many images and much colour, and, for transparency, points the reader to the clinical-trial website for more information. The adolescent version of the same trial's summary keeps the illustrations and the colourful layout, uses graphics to show how the study was planned, presents the results as pie charts, and carries a QR code for a reader who wants more detail.
Results told as a comic
One sponsor produces comics for its paediatric trials, in alignment with Good Lay Summary Practice, which recommends visuals and storytelling for children. It uses comics only for the lay summary, not for its other lay documents. A comic is simple, playful and more appealing than text alone, and it embeds the trial results in a story whose context and situations a child can relate to, which makes the results easier to understand. The comic still has to be non-promotional and to meet every legal and ethical requirement for a lay document.
One comic, for a paediatric trial in which two medicines were tested for their effect on long-term blood sugar in children with type two diabetes, covers the same sections as the written lay summary over three scenes: outside the school, a hallway inside it, and an art class. Outside the school, one student takes a glucose meter out of his backpack, which introduces the condition. In the hallway he says that he took part in a clinical trial. In the art class the students discuss what the trial was about, who participated, where it took place, what the results were and whether there were any unwanted effects. The comic ends with the students leaving for their next class, and that scene carries the information on where to find out more.
The comic never stands apart from the written lay summary. Its pages open a single PDF that continues into the regular lay summary, and the whole document goes to the study participants.
Testing formats with children
A user test compared three versions of one summary, of a trial of a treatment for severe Japanese cedar pollinosis, a seasonal pollen allergy that the summary says affects around 30% of people living in Japan. The standard version met the minimum requirements: text suitable for readers with low to average literacy, simple words and sentence structure, basic graphics such as a study-design diagram and simple bar graphs for the primary endpoint, and simple tables for the safety results. The infographic version kept all of that, including the bar graphs for the primary endpoint, which earlier testing had suggested are easy to understand. It added icons and infographics where possible to support the text, shorten its paragraphs and add white space, turned the safety tables into infographics and opened with a glossary of the scientific terms used. The illustrated version started from the standard one, replaced its graphics and tables with comic-style drawings, and cut the text to be more concise, so as not to overwhelm the children and adolescents.
The children liked the infographic and illustrated versions more than the standard one and found them easier to understand. Thirty volunteers aged 9 to 16 read all three anonymised versions, face to face or online: 15 boys and 15 girls, 16 in the UK, 12 in India and 2 in the US, with 12 aged 9 to 11, 12 aged 12 to 13 and 6 aged 14 to 16. Rated from 1 to 10, mean likeability was 6.2 for the standard version, 8.4 for the infographic one and 7.1 for the illustrated one, and mean ease of understanding was 6.1, 8.1 and 7.8. Nineteen (63%) named the infographic version their favourite, 7 (23%) the illustrated one and 4 (14%) the standard one, and the preference did not differ with age. Most volunteers, including those aged 14 to 16, judged the illustrated version engaging and appropriate for their age group. They preferred the two graphic versions for their relatable and meaningful graphics, their balance of text and graphics and their white space. Appropriate graphics, more white space between sections and, in the infographic version, the opening glossary seemed to help them understand. Four asked for more colours than the infographic version's blue and black.
For these readers, the test suggests that design and layout matter more than length. Length is believed to affect how readable a summary is, the more so for children, given their shorter attention span. The standard and illustrated versions ran to 8 pages and the infographic one to 12. Twelve volunteers (40%), all aged 10 to 14, said a summary should not be too long or they would lose interest, and 14 (47%) said length did not matter as long as the summary was easy to understand. Yet 13 (43%) found the standard version too long and boring, although it was no longer than the illustrated version and shorter than the infographic one, which indicated that white space, graphics and format shaped how long the summary felt. A sponsor should avoid very long summaries, but should not drop graphics and white space to stay within a page limit.
Format may not directly influence trust in the sponsor. All 30 volunteers said the summaries left them trusting the trial's sponsor. Nineteen (63%) said the format made no difference to that trust, while 8 (27%) trusted the sponsor most in the format they liked best. This suggests that trust depends on several things, including how easy the document is to understand and how reliable its findings seem.
When writing a summary for a paediatric audience, a sponsor should:
- Not restrict the summary to a single template.
- Apply fundamental communication strategies for the different age groups within the paediatric audience.
- Balance text against engaging graphics.
- Provide tools such as a glossary at the start of the summary.
- Consider building user testing into the writing process.