Abstract
Federal regulations mandate obtaining informed consent from patients before they undergo medical procedures or clinical research trials. These documents are intended to assure respect for patient autonomy and the right to make informed decisions on whether to accept the proposed medical treatments based on knowledge of their practicality, risks, and benefits. Past research has indicated that these lengthy and complex consent forms are often not read carefully by patients, resulting in a limited understanding of the important information presented in them. This study proposes two new ways of presenting information in an electronic consent form using concept and mind maps and investigates their effects on user comprehension by comparing them to a text-based consent form. Study participants were randomly assigned to read one of the three consent forms after viewing a brief scenario explaining the condition of a patient who is about to sign an informed consent document. They then indicated their level of willingness to sign or not sign the consent form and completed a comprehension questionnaire, a NASA-TLX survey, and a usability questionnaire. Statistically significant differences among the consent forms were found for the comprehension score and consent completion time, suggesting improvement in comprehension with the consent forms using concept and mind maps.
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