Cancer clinical trial consent forms: A readability analysis

Cancer clinical trial consent forms: A readability analysis
Health Services Research and Quality Improvement
Mohana Roy, Lidia Schapira
Journal of Clinical Oncology, 25 May 2020; 38(15) supplement e19075
Abstract
Background: The National Cancer Institute (NCI) provides a template for cancer clinical trial consent forms and recommends a reading grade level of eighth grade or lower for such forms. This recommendation aligns with the goal of making clinical trials accessible to more patients. Methods: We surveyed clinical trial leaders at a large tertiary academic cancer center, to provide consent forms for active or recently closed, interventional cancer clinical trials (as of 2019). We requested forms that were preferably from multi-center trials and those perceived to have the highest accruals. We received 26 consent forms representing nine disease groups. Results: The average Flesh-Kincaid reading grade level was 11.2 (reflecting a 11th grade reading level), and no single form met the 8th grade reading level mark. The grade levels were assessed with three additional readability analyses (SMOG, FORCAST, and Raygor, see Table). The average Flesch reading ease was 50.7, rated as “fairly difficult”, with a scale of 0-100 (100 =“very easy” to read). The general HIPAA consent followed similar patterns, with a reading level of 10.9 and a reading ease of 49.2. There was an average of 18-20 words used per sentence. The reading levels and ease did not significantly vary with disease group or phase of trial. Conclusions: The overall readability level of cancer clinical trial forms, at our center, still require at least at least a 10th grade reading level. These forms may be difficult to understand for those with lower English proficiency and/or health literacy. We recommend a basic readability screen of such forms, and use of shorter sentences and simplified writing structure, to aid in comprehension.

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