Readability of paediatric participant information leaflets in research studies

Information leaflets in research studies should be age-appropriate to be understood, however the formal readability of children's participant information leaflets (PILs) for research studies has not been assessed.

A single-centre cross-sectional study assessing paediatric PILs. Six readability tests were applied (Gunning Fog Index (GFI), Simple Measure of Gobbledygook (SMOG), Flesch Kincaid Grade Level (FKGL), Coleman-Liau Index (CLI), Automated Readability Index (ARI) and Flesch Reading Ease score (FRE). Results were compared between age groups, and whether the PIL was from either a commercially sponsored or investigator led study.

191 paediatric PILs were included. Age categories; <10 years (n = 65), ≤12 (n = 73), ≤15 (n = 73) and ≥16 (n = 61); were used for analysis. There were 39 commercial PILs and 226 non-commercial PILs. For the ≤10 and ≤12 age bands, all 6 median readability scores exceeded the target age group (thus hard to read, p < 0.005), and there was no difference in readability scores between these two age bands. Four scores from the readability tests were considered age-appropriate in the ≤15 year category, and all median scores were age-appropriate in the ≥16 years age groups. Readability scores for children's PILs were significantly higher in commercially sponsored versus non-commercial studies (P < 0.005).

Improvements are required to make children's PILs readable for the target audience, particularly in commercially sponsored research studies.

Paediatric participant information leaflets may not be readable in research studies, especially in younger age groups. PILs for children participating in commercially sponsored studies were less readable than non-commercial studies. Research teams writing PILs for a paediatric study need to consider the use of readability tools to ensure that the information they are providing is readable by the target audience.