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Research information for minors: Suitable formats and readability. A systematic review
Author(s) -
GrootensWiegers Petronella,
Vries Martine C,
Broek Jos M
Publication year - 2015
Publication title -
journal of paediatrics and child health
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.631
H-Index - 76
eISSN - 1440-1754
pISSN - 1034-4810
DOI - 10.1111/jpc.12762
Subject(s) - readability , medicine , psychological intervention , quality (philosophy) , reading (process) , comprehension , intervention (counseling) , reading level , medical education , family medicine , nursing , computer science , philosophy , epistemology , political science , law , programming language
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 P ub M ed, E mbase and P syc INFO . 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.