Readability levels of informed consent documents was investigated by looking at website accessible dental electronic Informed Consent Documents (eICDs). The study focused on private practices, and on treatment eICDs, not those designed for clinical trials or other patient studies or investigations. The first objective was to demonstrate the practical use of the Internet and readability software as a survey instrument to assess the readability of eICDs used in clinical dentistry. The second objective was to examine eICDs using the Flesch Reading Ease (FRE) index and the Flesch-Kincaid Grade Level (FKG) and to use the data to statistically develop and test a null hypothesis regarding readability levels.
This is a cross sectional study which uses one sample, one sided t-tests to hypothesize that eICDs commonly fail to meet recommended eighth grade or less reading levels. The Flesch Reading Ease (FRE) and a Flesch-Kincaid Grade Level (FKG) were used to examine 109 eICDs. An FRE score of ≥60 or an FKG score of ≤8.0 was needed for an eICD to be categorized as “acceptably readable”.
The utility of the survey instrument to collect data was demonstrated. The limited sample analysis seems to indicate that readability for Specialist as well as General Dentistry eICDs may commonly exceed the recommended 8th Grade reading levels.
Current eICDs fared poorly using FRE and FKG testing. Readability is not the only element affecting understandability. In an increasingly heavy EHR environment, DPH administrators may find this approach relevant and such indices helpful.
Keywords: Evaluation and Informed Consent
See more of: Behavioral, Epidemiologic, and Health Services Research