Does a comic style informed assent form improve comprehension for minors participating in clinical trials?

Abstract

Background

Several authors have shown that children and adolescents have limited understanding of critical elements of the research studies in which they are participating. The inclusion of graphic elements is a promising approach to increase the understandability of assent forms of clinical trials.

Objectives

To design a new assent form in comic strip format for minors participating in clinical trials and to compare the comprehension of this new document with a traditional assent form.

Methods

This study included an assessment of the readability of standard informed assents, the evaluation of the comprehension of one of these documents, the development of a new (comic format) informed assent from the original document previously evaluated, and the analysis of readability and comprehension of the new informed assent. The readability of the documents was assessed using previously validated formulas, whereas comprehension analyses were performed through a questionnaire taken by two groups of 12-year-old students of secondary schools.

Ethical considerations: All procedures involving human participants were in accordance with the ethical standards of the 1964 Helsinki Declaration and its later amendments.

Findings

Compared with the original document, the comic assent form improved the grammatical readability of the “Aims, Risks and Benefits and How to Get More Information” sections, the comprehension scores in the Aims and Procedure sections, the understanding of ideas, and the formation of macro-ideas. The benefits of the comic strip format were more noticeable among participants in the lower percentiles of the comprehension score.

Conclusions

Our results show that the comic assent form has high readability and comprehensibility compared with its original form, particularly in the domains of knowledge-based inferences and macro-ideas formation. The use of forms that combine text and comic strips may help the comprehension of minors participating of a clinical trial, supporting their autonomy in decision-making.