Back to Browse Journals » Open Access Journal of Clinical Trials » Volume 2

Examining the readability of patient-informed consent forms

Authors Marli Terblanche, Lesley Burgess

Published Date October 2010 Volume 2010:2 Pages 157—162

DOI http://dx.doi.org/10.2147/OAJCT.S13608

Published 19 October 2010

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

Download Article [PDF] 

Creative Commons License 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:

The future of the pharmaceutical, biological and medical device industry

Burgess LJ, Terblanche M

Open Access Journal of Clinical Trials 2011, 3:45-50

Published Date: 7 September 2011

Readers of this article also read:

Design and in vivo evaluation of oxycodone once-a-day controlled-release tablets

Kim JY, Lee SH, Park CW, Rhee YS, Kim DW, Park J, Lee M, Seo JW, Park ES

Drug Design, Development and Therapy 2015, 9:695-706

Published Date: 30 January 2015

Progressive osseous heteroplasia: diagnosis, treatment, and prognosis

Pignolo RJ, Ramaswamy G, Fong JT, Shore EM, Kaplan FS

The Application of Clinical Genetics 2015, 8:37-48

Published Date: 30 January 2015

Diabetes reversal via gene transfer: building on successes in animal models

Gerace D, Martiniello-Wilks R, Simpson AM

Research and Reports in Endocrine Disorders 2015, 5:15-29

Published Date: 29 January 2015

Corneal laceration caused by river crab

Vinuthinee N, Azreen-Redzal A, Juanarita J, Zunaina E

Clinical Ophthalmology 2015, 9:203-206

Published Date: 29 January 2015

Multifunction hexagonal liquid-crystal containing modified surface TiO2 nanoparticles and terpinen-4-ol for controlled release

Manaia EB, Kaminski RCK, Oliveira AG, CorrĂȘa MA, Chiavacci LA

International Journal of Nanomedicine 2015, 10:811-819

Published Date: 22 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

International Journal of Nanomedicine 2015, 10:257-270

Published Date: 30 December 2014

Using registries to identify type 2 diabetes patients

Thomsen RW, Sørensen HT

Clinical Epidemiology 2015, 7:1-3

Published Date: 18 December 2014

Pharmacokinetics and pharmacodynamics of acetylsalicylic acid after intravenous and oral administration to healthy volunteers

Nagelschmitz J, Blunck M, Kraetzschmar J, Ludwig M, Wensing G, Hohlfeld T

Clinical Pharmacology: Advances and Applications 2014, 6:51-59

Published Date: 19 March 2014

Evaluation of in vitro glistening formation in hydrophobic acrylic intraocular lenses

Thomes BE, Callaghan TA

Clinical Ophthalmology 2013, 7:1529-1534

Published Date: 25 July 2013

Detemir as a once-daily basal insulin in type 2 diabetes

Nelson SE

Clinical Pharmacology: Advances and Applications 2011, 3:27-37

Published Date: 18 August 2011