Low Quality and Lack of Clarity of Current Informed Consent Forms in Cardiology: How to Improve Them

Guidelines on informed consent for clinical practice exhort physicians to use standard plain language to enhance patient comprehension and facilitate shared decision making. The aim of this study was to assess and improve quality and readability of current informed consent forms used in cardiology. We evaluated the currently used informed consent forms, previously written in Italian and English, of 7 common imaging examinations, according to the recommendations of scientific societies. For each text, we also developed a revised informed consent form according to reference standards, including Federal Plain Language guidelines. Regarding readability scores, we analyzed each text (standard and revised) with Flesch-Kincaid (F-K) grade level (higher numbers indicating harder-to-read text) and the Italian language-tailored Gulpease level (from 0 [difficult] to 100 [easy]). Overall quality and readability was poor for both the original English and Italian versions, and readability was improved with the revised form, with higher readability evidenced by changes in both F-K grade level (standard 10.2 ± 2.37% vs. revised 6.5 ± 0.41%; p