Consent Forms, Readability, and Comprehension: The Need for New Assessment Tools

Recent efforts to evaluate the effectiveness of the informed consent process between physician and patient have focused on the ability of patients to understand written “informed consent” documents. Several researchers, employing traditional readability formulas to measure the reading level of such documents, have noted that many of these forms are written at a level too difficult for most people to understand. Readability formulas, such as those of Flesch and Fry, and the SMOG formula, have become convenient measures of the effectiveness of informed consent documents in conveying information to patients to enable them to make decisions about recommended therapies. Our experience, in a pilot study, with readability formulas to test an informed consent document used in childhood poliomyelitis immunizations led us to conclude that readability formulas are an inadequate measure of patients’ comprehension of written information about medical procedures.