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Research information for minors: Suitable formats and readability. A systematic review
Petronella Grootens-Wiegers1, Martine C de Vries2, Jos M van den Broek1
1Department of Science Communication & Society, Leiden University, Leiden, The Netherlands.
Journal of Paediatrics and Child Health
|November 4, 2014
Summary
Informing minors about clinical trials requires better patient information forms. Research shows current forms have readability issues, hindering children's understanding and consent capacity.
Area of Science:
- Pediatric research ethics
- Informed consent in minors
- Clinical trial communication
Background:
- Children's capacity to consent to research increases with age.
- Regulations mandate information be provided according to a minor's understanding.
- Assessing the quality of patient information forms for minors is crucial.
Purpose of the Study:
- To evaluate the quality of patient information forms for minors.
- To analyze the impact of information format on children's understanding.
- To assess the readability of text within these forms.
Main Methods:
- A systematic literature search was conducted across PubMed, Embase, and PsycINFO databases.
- Seventeen papers focusing on information format interventions were included.
- Three papers specifically addressing text readability were analyzed.
Main Results:
- Format interventions show potential for improvement, but results are inconsistent.
- No single successful format intervention has been widely replicated.
- A significant readability gap exists between forms and children's reading levels.
Conclusions:
- Current patient information forms inadequately inform minors about clinical trials.
- Further research is urgently needed to develop effective methods for informing children.
- Improving form readability and format is essential for ethical research participation.
