Readability and comprehension of paediatric informed consent and assent forms from a single institution in South Africa

Readability and comprehension of paediatric informed consent and assent forms from a single institution in South Africa
Mwanaidi Kafuye, Mariana Kruger
Tanzania Journal of Health Research, 2022; 23 pp 39-39
Abstract
Background
Informed consent and assent forms are fundamental prerequisites in the conduct of ethical paediatric health research. For paediatric research, parents or the legal caretaker of a child should provide informed consent along with the child or adolescent. Readability and comprehension of consent and assent forms in both therapeutic and non-therapeutic studies play a critical role during the informed decision-making process of study participants.
Objectives
To assess the readability scores and to determine the school grade level of informed consent forms (ICFs), and informed assent forms (IAFs) also to assess accuracy and completeness of elements of ICFs and IAFs.
Methods
We used web-based readability score calculator to determine scores of Flesch Kincaid Reading Ease (FRE), Flesch-Kincaid Grade Level (FKGL) and length (word count) of the assent and consent forms, respectively. We also assessed inclusion of essential elements in the ICFs and IAFs using consent form guidance available in the South African Department of Health: Ethics in Health Research Guidelines (2015) as standard.
Results
The mean Flesch Kincaid readability ease score for 28 ICFs was 57 while that of the23 IAFs was 68. Furthermore, the higher the Flesch Kincaid Reading Ease scores the lower was the Flesch-Kincaid Grade Level score (p < 0.001). The therapeutic ICF and IAF forms were substantially longer than the non-therapeutic ICF and assent forms (p < 0.001). Most ICFs and IAFs provided accurate and complete elements of ICF with regards to research information with adherence to the Ethics guideline of the South African Department of Health.
Conclusion and recommendations
There were higher word counts in both ICFs and IAFs for therapeutic studies versus non-therapeutic studies. The study concludes that both ICFs and IAFs were difficult to comprehend with significantly higher Flesch Kincaid reading grade levels than the NIH/AMA/USDHHS recommended reading grade level 6.