Assessing the Readability of Clinical Trial Consent Forms for Surgical Specialties.

Autor: Karimi AH; Department of Orthopedic Surgery, Cleveland Clinic Foundation, Cleveland, Ohio., Guyler MR; Department of Orthopedic Surgery, Cleveland Clinic Foundation, Cleveland, Ohio., Hecht CJ 2nd; Department of Orthopedic Surgery, Cleveland Clinic Foundation, Cleveland, Ohio., Burkhart RJ; Department of Orthopedic Surgery, Cleveland Clinic Foundation, Cleveland, Ohio., Acuña AJ; Department of Orthopaedic Surgery, Midwest Orthopaedics at Rush, Chicago, Illinois., Kamath AF; Department of Orthopedic Surgery, Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address: kamatha@ccf.org.
Jazyk: angličtina
Zdroj: The Journal of surgical research [J Surg Res] 2024 Apr; Vol. 296, pp. 711-719. Date of Electronic Publication: 2024 Feb 16.
DOI: 10.1016/j.jss.2024.01.045
Abstrakt: Introduction: To evaluate the readability of surgical clinical trial consent forms and compare readability across surgical specialties.
Methods: 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.
Results: 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.
Conclusions: 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.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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