Consent Methods for the Enrolment in Acute Clinical Trials: A Functional Linguistic Perspective on an Abridged Information Sheet

Abstract

This article presents a functional linguistic analysis of a brief patient information sheet and consent form used in an international stroke study. The readability of the text document was assessed based on the fog index which fails to adequately capture the complexity of the standardised institutional text and the patients’ comprehension processes. Using a multi-level linguistic framework ((i) word, (ii) phrase/sentence, and (iii) text level), the analysis reveals various linguistic phenomena — including complex syntax, linguistic action patterns, parentheses, and technical terminology — that may challenge patients’ understanding, particularly in stressful and emotional situations in which they might also suffer from (temporal) cognitive impairments due to the acute stroke. The article argues that qualitative, hermeneutic, and (functional) linguistic approaches need to be used to assess and improve the readability of text documents with ethical and legal functions in the context of clinical trials. Based on the linguistic analysis, a revised version of the information sheet is proposed to enhance comprehension. Only when patients understand the provided information, they can give their informed consent which is a (research) ethical standard.