Examining the readability of patient-informed consent forms
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
This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.Download Article [PDF]
Other article by this author:
Burgess LJ, Terblanche M
Published Date: 7 September 2011
Readers of this article also read:
Carr ME, Tortella BJ
Published Date: 3 September 2015
Janbain M, Leissinger CA, Kruse-Jarres R
Published Date: 8 May 2015
Published Date: 22 July 2014
Prozorova GF, Pozdnyakov AS, Kuznetsova NP, Korzhova SA, Emel’yanov AI, Ermakova TG, Fadeeva TV, Sosedova LM
Published Date: 16 April 2014
Single- and multiple-dose pharmacokinetics, pharmacodynamics, and safety of apixaban in healthy Chinese subjects [Corrigendum]
Cui Y, Song Y, Wang J, Yu Z, Schuster A, Barrett YC, Frost C
Published Date: 27 March 2014
Ashwanikumar N, Kumar NA, Nair SA, Kumar GS
Published Date: 15 November 2012
Deepa G, Thulasidasan AK, Anto RJ, Pillai JJ, Kumar GS
Published Date: 27 July 2012
Published Date: 17 September 2010
Pitipol Choopong, Nattaporn Tesavibul, Nattawut Rodanant
Published Date: 14 July 2010
Characterization of complexation of poly (N-isopropylacrylamide-co-2-(dimethylamino) ethyl methacrylate) thermoresponsive cationic nanogels with salmon sperm DNA
Jim Moselhy, Tasnim Vira, Fei-Fei Liu, et al
Published Date: 24 August 2009