Examining the readability of patient-informed consent forms

Abstract

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