title: An analysis of the readability of patient information and consent forms used in research studies in anaesthesia in Australia and New Zealand.
abstract: The provision of written information is a component of the informed consent process for research participants. We conducted a readability analysis to test the hypothesis that the language used in patient information and consent forms in anaesthesia research in Australia and New Zealand does not meet the readability standards or expectations of the Good Clinical Practice Guidelines, the National Health and Medical Research Council in Australia and the Health Research Council of New Zealand. We calculated readability scores for 40 patient information and consent forms using the Simple Measure of Gobbledygook and Flesch-Kincaid formulas. The mean grade level of patient information and consent forms when using the Simple Measure of Gobbledygook and Flesch-Kincaid readability formulas was 12.9 (standard deviation of 0.8, 95% confidence interval 12.6 to 13.1) and 11.9 (standard deviation 1.1, 95% confidence interval 11.6 to 12.3), respectively. This exceeds the average literacy and comprehension of the general population in Australia and New Zealand. Complex language decreases readability and negatively impacts on the informed consent process. Care should be exercised when providing written information to research participants to ensure language and readability is appropriate for the audience.
authors.affiliation: Department of Anaesthesia and Pain Medicine, Western Hospital, Melbourne, Victoria, Australia. hughedwardtaylor@gmail.com
authors.forename: H E
authors.initials: HE
authors.lastname: Taylor
authors.forename: D E P
authors.initials: DE
authors.lastname: Bramley
mesh_terms: D000758:Anesthesia; D001315:Australia; D002986:Clinical Trials as Topic / Q000379:methods; D032882:Comprehension; D032962:Consent Forms / Q000592:standards*; D006801:Humans; D009520:New Zealand; D010353:Patient Education as Topic / Q000592:standards*; D035842:Research Subjects