Assessing the Readability of Clinical Trial Consent Forms for Surgical Specialties

• Published in: The Journal of surgical research Vol. 296; pp. 711 - 719
• Main Authors: Karimi, Amir H., Guyler, Maura R., Hecht, Christian J., Burkhart, Robert J., Acuña, Alexander J., Kamath, Atul F.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.04.2024
• Subjects: Clinical trials; Consent forms; Informed consent; Readability; Clinical trials; Informed consent; Readability; Consent forms
• ISSN: 0022-4804; 1095-8673
• DOI: 10.1016/j.jss.2024.01.045

To evaluate the readability of surgical clinical trial consent forms and compare readability across surgical specialties. We conducted a cross-sectional analysis of surgical clinical trial consent forms available on ClinicalTrials.gov to quantitatively evaluate readability, word count, and length variations among different specialties. The analysis was performed between November 2022 and January 2023. A total of 386 surgical clinical trial consent forms across 14 surgical specialties were included. The main outcomes were language complexity (measured using Flesch–Kincaid Grade Level), number of words (measured as word count), time to read (measured at reading speeds of 240 per min), and readability (measured by Flesch Reading Ease Score, Gunning Frog Index, Simple Measures of Gobbledygook Index, FORCAST, and Automated Readability Index). The surgical consent forms were a mean (standard deviation) of 2626 (1668) words long, with a mean of 12:53 min to read at 240 words per min. None of the surgical specialties had an average readability level of sixth grade or lower across all six indices, and only 16 out of 386 (4%) clinical trials met the recommended reading level. Furthermore, there was no significant difference in reading grade level between surgical specialties based on the Flesch–Kincaid Grade Level and Flesch Reading Ease indices. Our findings suggest that current surgical clinical trial consent documents are too long and complex, exceeding the recommended sixth-grade reading level. Ensuring readable clinical trial consent forms is not only ethically responsible but also crucial for protecting patients' rights and well-being by facilitating informed decision-making. •Largest meta-analysis study of more than 79,000 surgical patients.•Mortality is increased almost 10-fold in surgical patients with COVID-19.•COVID-induced mortality risk is double in low-income and middle-income countries.•Type of surgery is not associated with mortality risk.