Background:Children from the age of 12, or in some countries from the age of 7, are legally allowed to give their consent/assent for participation in medical scientific research. The information provided in the consent document plays a pivotal role in their informed decision-making. However, very little research has been performed on the readability of these documents. As research on consent materials for adults indicates a readability gap between reading level of the document and the target group, such a gap could also be present in pediatric material. Therefore, pediatric materials were analyzed for readability and compared to other texts for children. Methods: Twenty-two pediatric consent documents from two major academic hospitals in the Netherlands were collected. Three 100word samples were selected from paragraphs on research aim, procedure, and risks & benefits. Readability was assessed with four tools: Flesch Reading Ease, Flesch-Douma Reading Ease, Flesch-Kincaid Grade Level and Gunning Fog Index. In addition, length of the documents (words/pages) and use of illustrations was recorded. Reading books for children were used as a comparison of reading levels. Results: Consent forms had an average Flesch Reading Ease of 49.71 and Flesch-Douma Reading Ease of 63.73, both well below the standard for adult material. Average Flesch-Kincaid Grade Level was 9.86 and Gunning Fog 13.28, equal to the reading level of at least a 15-year old. Length of the forms varied from two to eleven pages, with an average of 5 pages, average length in words was 1746. In only 3 forms illustrations were used to support the information. Flesch Reading Ease for comparison material was 71.75, Flesch-Douma Reading Ease 83.80, Flesch Kincaid Grade Level 6.54 and Gunning Fog 9.06 The difference in readability between consent material and comparison texts was significant for all tools. Discussion: The readability gap observed in adult consent materials is also present in pediatric documents. Although readability instruments can only offer an indication of reading ease, the current results are supported by the lack of understanding observed in young research participants. We plea for more awareness among writers of pediatric consent material, as informing children is of ethical as well as legal importance in enabling voluntary consent and assent. In order to overcome the limitations of readability instruments, further research should be performed with the intended target group.

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Public Communication of Science and Technology

 

Readability gap between pediatric consent material and children’s reading level

Ronella Grootens Wiegers   Leiden University - Science Communication & Society, Netherlands

Martine Vries   Leids Universitair Medisch Centrum, Netherlands

Jos van den Broek   Leiden University - Science Communication & Society, Netherlands

Background:Children from the age of 12, or in some countries from the age of 7, are legally allowed to give their consent/assent for participation in medical scientific research. The information provided in the consent document plays a pivotal role in their informed decision-making. However, very little research has been performed on the readability of these documents. As research on consent materials for adults indicates a readability gap between reading level of the document and the target group, such a gap could also be present in pediatric material. Therefore, pediatric materials were analyzed for readability and compared to other texts for children. Methods: Twenty-two pediatric consent documents from two major academic hospitals in the Netherlands were collected. Three 100word samples were selected from paragraphs on research aim, procedure, and risks & benefits. Readability was assessed with four tools: Flesch Reading Ease, Flesch-Douma Reading Ease, Flesch-Kincaid Grade Level and Gunning Fog Index. In addition, length of the documents (words/pages) and use of illustrations was recorded. Reading books for children were used as a comparison of reading levels. Results: Consent forms had an average Flesch Reading Ease of 49.71 and Flesch-Douma Reading Ease of 63.73, both well below the standard for adult material. Average Flesch-Kincaid Grade Level was 9.86 and Gunning Fog 13.28, equal to the reading level of at least a 15-year old. Length of the forms varied from two to eleven pages, with an average of 5 pages, average length in words was 1746. In only 3 forms illustrations were used to support the information. Flesch Reading Ease for comparison material was 71.75, Flesch-Douma Reading Ease 83.80, Flesch Kincaid Grade Level 6.54 and Gunning Fog 9.06 The difference in readability between consent material and comparison texts was significant for all tools. Discussion: The readability gap observed in adult consent materials is also present in pediatric documents. Although readability instruments can only offer an indication of reading ease, the current results are supported by the lack of understanding observed in young research participants. We plea for more awareness among writers of pediatric consent material, as informing children is of ethical as well as legal importance in enabling voluntary consent and assent. In order to overcome the limitations of readability instruments, further research should be performed with the intended target group.

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