Evaluation and improvement of the comprehension of informed consent documents

The information contained in a good informed consent form (ICF) must be understood by the patients. The aim of this study is to assess and improve the readability of the ICF submitted for accreditation in a tertiary hospital. Study of assessment and improvement of the quality of 132 ICF from 2 departments of a public tertiary hospital, divided into 3 phases: Initial assessment, intervention and reassessment. Both length and readability are assessed. Length is measured in words (adequate to 470, excessive over 940), and readability in INFLESZ points (suitable if over 55). The ICF contents initially proposed by departments were adapted by non-health-related trained persons, whose doubts about medical terms were resolved by the authors. To compare results between evaluations, relative improvement (in both length and INFLESZ) and statistical significances were calculated. 78.8% of the ICFs showed a desired length (CI95% 86,5-71,1) and a mean of 44.1 INFLESZ points (3.8% >55 points, CI95% 6,0-1,6). After the intervention, INFLESZ raised to 61.9 points (improvement 40.3%, P55 points. The resulting ICFs had a longer description of the nature of the procedure (P