title: Readability of the written study information in pediatric research in France.
abstract: BACKGROUND
  The aim was to evaluate the readability of research information leaflets (RIL) for minors asked to participate in biomedical research studies and to assess the factors influencing this readability.
  
  
  RESULTS
  All the pediatric protocols from three French pediatric clinical research units were included (N = 104). Three criteria were used to evaluate readability: length of the text, Flesch's readability score and presence of illustrations. We compared the readability of RIL to texts specifically written for children (school textbooks, school exams or extracts from literary works). We assessed the effect of protocol characteristics on readability. The RIL had a median length of 608 words [350 words, 25(th) percentile; 1005 words, 75(th) percentile], corresponding to two pages. The readability of the RIL, with a median Flesch score of 40 [30; 47], was much poorer than that of pediatric reference texts, with a Flesch score of 67 [60; 73]. A small proportion of RIL (13/91; 14%) were illustrated. The RIL were longer (p<0.001), more readable (p<0.001) and more likely to be illustrated (p<0.009) for industrial than for institutional sponsors.
  
  
  CONCLUSIONS
  Researchers should routinely compute the reading ease of study information sheets and make greater efforts to improve the readability of written documents for potential participants.
authors.affiliation: Unité de Recherche Clinique Paris Centre, Hôpital Necker Enfants Malades, Assistance Publique Hôpitaux de Paris, Paris, France.
authors.forename: Véronique
authors.initials: V
authors.lastname: Ménoni
authors.forename: Noël
authors.initials: N
authors.lastname: Lucas
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Leforestier
authors.forename: François
authors.initials: F
authors.lastname: Doz
authors.forename: Gilles
authors.initials: G
authors.lastname: Chatellier
authors.forename: Evelyne
authors.initials: E
authors.lastname: Jacqz-Aigain
authors.forename: Carole
authors.initials: C
authors.lastname: Giraud
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Tréluyer
authors.forename: Hélène
authors.initials: H
authors.lastname: Chappuy
mesh_terms: D000293:Adolescent; D035843:Biomedical Research; D002648:Child; D032882:Comprehension; D005602:France; D006801:Humans; D007258:Informed Consent; D010372:Pediatrics; D014956:Writing