Open Access Journal of Clinical Trials
Open access peer-reviewed scientific and medical journals.
Dove Medical Press is now a member of the Open Access Initiative
An Author's Guide
A guide to help authors get their paper published.
Support Open Access and Dove Press
Promotional Article Monitoring - further details
Favored Author Program
Real benefits for authors, including fast-track processing of papers.
Examining the readability of patient-informed consent forms
(6276) Total Article Views
Authors: Marli Terblanche, Lesley Burgess
Published Date October 2010
Volume 2010:2 Pages 157 - 162
Marli Terblanche, Lesley Burgess
TREAD Research/Cardiology Unit, Department of Internal Medicine, Tygerberg Hospital and University of Stellenbosch, Parow, South Africa
Primary objective: To investigate the readability of informed consent forms (ICF) used at TREAD Research, a private clinical trial research unit located in Tygerberg Hospital.
Secondary objective: To assess if there is a difference in readability between therapeutic areas, as well as a difference in readability over two time periods.
Methods: The readability of 84 ICFs given to patients at TREAD Research between the years 2000 and 2009 was quantitatively assessed by means of the Flesch–Kincaid Reading Ease, Flesch–Kincaid Grade Level, and Gunning-Fog index.
Results: The mean ± standard deviation (SD) Flesch–Kincaid Reading Ease score for the 84 ICFs was 46.60 ± 5.62 (range 33.2–65.6). The mean ± SD grade level was 12.13 ± 1.8 (range 8.3–14.9) using the Flesch–Kincaid formula and 13.96 ± 1.22 (range 10.3–16.6) using the Gunning-Fog index. Readability at grade level 8 was only found in 1.2% of all the ICFs assessed. No differences were found in readability between therapeutic areas or over the two time periods.
Conclusions: The main finding is that these forms are too complex to be understood by average study participants and their families.
Keywords: Informed consent forms, readability, literacy
Cannotea Citeulike Del.icio.us Facebook LinkedIn Twitter
Other articles by Mrs Marli Terblanche
Readers of this article also read:
"I was impressed at the rapidity of publication from submission to final acceptance." Dr Edwin Thrower, PhD, Yale University.
- The benefits and risks of testosterone replacement therapy: a review
- Enzalutamide: an evidence-based review of its use in the treatment of prostate cancer
- Tumor necrosis factor-alpha inhibitor treatment for sarcoidosis
- Tenofovir-associated bone density loss