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:

Global mental health intervention research and mass trauma

Meffert S, Ekblad S

Open Access Journal of Clinical Trials 2013, 5:61-69

Published Date: 14 March 2013

Peptide ligand and PEG-mediated long-circulating liposome targeted to FGFR overexpressing tumor in vivo

Cai L, Wang X, Wang W, Qiu N, Wen J, Duan X, Li X, Chen X, Yang L, Qian Z, Wei Y, Chen L

International Journal of Nanomedicine 2012, 7:4499-4510

Published Date: 14 August 2012

Insight into 144 patients with ocular vascular events during VEGF antagonist injections

Mansour AM, Shahin M, Kofoed PK, Parodi MB, Shami M, Schwartz SG

Clinical Ophthalmology 2012, 6:343-363

Published Date: 6 March 2012

Aminopropyltriethoxysilane-mediated surface functionalization of hydroxyapatite nanoparticles: synthesis, characterization, and in vitro toxicity assay

Wang S, Wen S, Shen M, Guo R, Cao X, Wang J, Shi X

International Journal of Nanomedicine 2011, 6:3449-3459

Published Date: 20 December 2011

Fungus-mediated biological synthesis of gold nanoparticles: potential in detection of liver cancer

Chauhan A, Zubair S, Tufail S, Sherwani A, Sajid M, Raman SC, Azam A, Owais M

International Journal of Nanomedicine 2011, 6:2305-2319

Published Date: 12 October 2011

Examining the clinical trial feasibility process and its implications for a trial site

Burgess LJ, Sulzer NU

Open Access Journal of Clinical Trials 2011, 3:51-54

Published Date: 9 September 2011

Role of aliskiren in cardio-renal protection and use in hypertensives with multiple risk factors

Eduardo Pimenta, Suzanne Oparil

Vascular Health and Risk Management 2009, 5:453-463

Published Date: 19 May 2009