[Can anybody understand the informed consent documents? A proposal to make it easier]

Abstract

Objective: To assess the readability of informed consent documents as written by doctors, by analysing the results and the differences between the sections of the document and services, with the aim of helping to improve them.

Material and methods: Descriptive study of the texts from 359 documents sent for accreditation in the Arrixaca Hospital (Murcia, Spain). Both length and readability are assessed. Length is measured in words (adequate up to 470, excessive over 940), and readability in INFLESZ points (suitable if over 55).

Results: Length ranged from 73 to 1018 words (mean 360, standard error 8.8, adequate length OR 3.66±0.81). The larger sections were "risks" and "nature of the procedure", and the shorter ones, "alternatives" and "contraindications", P<.0001. The INFLESZ value ranged from 18.1 to 86.4 points (mean 45.8, standard error 0.45), and was better in non-surgical services. Only 12.5% of the documents achieved an INFLESZ value over 55 (OR 0.12±0.03), with 70% in non-surgical procedures, P<.0001. The better readability sections were the "nature" and the "risks", and the worst ones, were "contraindications" and "alternatives", P<.0001.

Conclusions: The length of proposed documents is adequate, but they are not sufficiently readable, especially if they come from surgical services. The section length is unbalanced, with "contraindications" and "alternatives" being shorter and more difficult to understand. It is essential to check the readability before using an informed consent document. For this purpose, tools like that proposed could be useful.

Keywords: Consent forms; Estudios de evaluación; Evaluation studies; Formularios de consentimiento; Legibilidad; Readability.