Readability of the Written Study Information in Pediatric Research in France

Ménoni, Véronique; Lucas, Noël; Leforestier, Jean-François; Doz, François; Châtellier, Gilles; Jacqz-Aigain, Evelyne; Giraud, C; Tréluyer, Jean‐Marc; Chappuy, Hélène

doi:10.1371/journal.pone.0018484

Cited by 26 publications

(14 citation statements)

References 17 publications

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“…Results from our sample demonstrate that the language used in PICFs for research conducted in the field of anaesthesia in Australia and New Zealand exceeds the NHMRC recommended grade eight readability level. This is consistent with international studies of PICFs in other medical fields [16][17][18][19][20][21][22][23] . The two readability formulas achieve different scores for the same document because they count syllables differently depending on which part of the world they were developed (SMOG from England, Flesch-Kincaid from the USA).…”

Section: Discussionsupporting

confidence: 90%

An Analysis of the Readability of Patient Information and Consent forms used in Research Studies in Anaesthesia in Australia and New Zealand

Taylor

Bramley

2012

Anaesth Intensive Care

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The provision of written information is a component of the informed consent process for research participants. We conducted a readability analysis to test the hypothesis that the language used in patient information and consent forms in anaesthesia research in Australia and New Zealand does not meet the readability standards or expectations of the Good Clinical Practice Guidelines, the National Health and Medical Research Council in Australia and the Health Research Council of New Zealand. We calculated readability scores for 40 patient information and consent forms using the Simple Measure of Gobbledygook and Flesch-Kincaid formulas. The mean grade level of patient information and consent forms when using the Simple Measure of Gobbledygook and Flesch-Kincaid readability formulas was 12.9 (standard deviation of 0.8, 95% confidence interval 12.6 to 13.1) and 11.9 (standard deviation 1.1, 95% confidence interval 11.6 to 12.3), respectively. This exceeds the average literacy and comprehension of the general population in Australia and New Zealand. Complex language decreases readability and negatively impacts on the informed consent process. Care should be exercised when providing written information to research participants to ensure language and readability is appropriate for the audience.

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Section: Discussionsupporting

confidence: 90%

An Analysis of the Readability of Patient Information and Consent forms used in Research Studies in Anaesthesia in Australia and New Zealand

Taylor

Bramley

2012

Anaesth Intensive Care

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“…In one study, analysed forms had a Flesch Reading Ease comparable with academic journals . A comparison between research information and non‐medical texts illustrates this gap: a large difference was found for the Flesch Reading Ease . The third study described the development of research information material together with children, resulting in a Flesch Reading Ease of 86.3 and Flesch–Kincaid grade of 3.9 for children aged 6–12 years old …”

Section: Resultsmentioning

confidence: 99%

Research information for minors: Suitable formats and readability. A systematic review

Grootens-Wiegers

Vries

Broek

2014

J Paediatrics Child Health

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As children age, their capacity to consent or dissent to research participation increases. Numerous regulations and guidelines require that children should receive information 'according to their capacity of understanding'. In order to gain more insight in the quality of patient information forms for minors, a systematic literature search was performed. Two aspects of quality will be analysed in this paper: the effect of format on understanding and the readability of text in the documents. A systematic search was executed in PubMed, Embase and PsycINFO. Seventeen papers on format were included. Interventions testing information formats indicate that improvement is possible, but outcome measurement varied per study and no apparently successful intervention was repeated. Only three readability papers were found, all indicating a readability gap between patient information forms and children's actual reading level. The results indicate an urgent need for further research on how to adequately inform minors about clinical trials.

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“…One study assessed readability of pediatric consent forms in the United States and showed an average reading level comparable to a university reading level (Tarnowski, Allen, Mayhall, & Kelly, 1990). A study in France compared research information for children to nonmedical texts for children, such as novels (Menoni et al, 2011). The readability of research information was considerably poorer than the readability of nonmedical texts.…”

Section: Readability Gapmentioning

confidence: 99%

Readability and Visuals in Medical Research Information Forms for Children and Adolescents

Grootens-Wiegers

Vries

Vossen

et al. 2014

Science Communication

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Children are often-overlooked receivers of medical information, and little research addresses their information needs. However, young children are capable of understanding medical concepts, and they express the desire to be informed. This study addresses the quality of medical research information forms for children in the Netherlands, by assessing text readability and the role of visuals. Children's reading books, nonfiction books, and textbooks were used as comparison. Seven focus groups were conducted to identify children's preferences and needs for text and supporting visuals. We argue that the use of visuals is a powerful, but neglected, tool to improve medical information for minors.

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Readability of the Written Study Information in Pediatric Research in France

Cited by 26 publications

References 17 publications

An Analysis of the Readability of Patient Information and Consent forms used in Research Studies in Anaesthesia in Australia and New Zealand

An Analysis of the Readability of Patient Information and Consent forms used in Research Studies in Anaesthesia in Australia and New Zealand

Research information for minors: Suitable formats and readability. A systematic review

Readability and Visuals in Medical Research Information Forms for Children and Adolescents

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