Application of a Readability Score in Informed Consent forms for Clinical Studies

Miriam Valentini, Daniela D

Abstract

Study background: The Information Leaflet is the most important document for participants in clinical research to guarantee an ethical treatment. Methods: We compared readability of several Italian ILs with articles from Italian newspapers and explored if the ILs modified by Ethics Committees were more understandable than the original versions. We studied basic and modified ILs, newspaper general articles and medicine articles, using GULPEASE index, percentage of unusual words, words/ sentence ratio. Results and conclusion: Basic ILs and general articles were not understandable for people with low education. Percentage of unusual words is the highest in the general articles (31.7%) and the lowest in the modified ILs (21.16%). The difference between basic ILs and general articles is statistically significant (p=0.0021). The readability score and the other tests could be useful tools for improving ILs. However, they have intrinsic limits. The consideration about the use of the GULPEASE score could be valid for similar tests for other languages