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 by Dove Medical Press Limited, and licensed under Creative Commons Attribution - Non Commercial (unported, v3.0) License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php
Other article by this author:
Burgess LJ, Terblanche M
Published Date: 7 September 2011
Readers of this article also read:
Published Date: 16 February 2015
Di Bartolomeo M, Maggi C, Ricchini F, Pietrantonio F, Iacovelli R, de Braud F, Inno A
Published Date: 5 January 2015
Codelivery of doxorubicin and curcumin with lipid nanoparticles results in improved efficacy of chemotherapy in liver cancer
Zhao XJ, Chen Q, Liu W, Li YS, Tang HB, Liu XH, Yang XL
Published Date: 30 December 2014
Self-assembled micelles of amphiphilic poly(L-phenylalanine)-b-poly(L-serine) polypeptides for tumor-targeted delivery
Zhao ZM, Wang Y, Han J, Wang KL, Yang D, Yang YH, Du Q, Song YJ, Yin XX
Published Date: 12 December 2014
Experience of insomnia, symptom attribution and treatment preferences in individuals with moderate to severe COPD: a qualitative study
Kauffman KS, Doede M, Diaz-Abad M, Scharf SM, Bell-Farrell W, Rogers VE, Geiger-Brown J
Published Date: 10 December 2014
Xia S, Li P, Chen Q, Armah M, Ying X, Wu J, Lai J
Published Date: 23 May 2014
Inhibited bacterial biofilm formation and improved osteogenic activity on gentamicin-loaded titania nanotubes with various diameters
Lin WT, Tan HL, Duan ZL, Yue B, Ma R, He G, Tang TT
Published Date: 7 March 2014
A possible role of IL-1RN gene polymorphism in the outcome of gastrointestinal diseases associated with H. pylori infection
Mattar R, Marques SB, dos Santos AF, Monteiro MS, Iriya K, Carrilho FJ
Published Date: 18 April 2013
Abreu JA, Abreu R, Cordovés LM, Aguilar JJ
Published Date: 15 March 2013
Moshirfar M, Neuffer MC, Kinard K, Lependu MT, Sikder S
Published Date: 22 July 2011