Isaacs Talia, Murdoch Jamie, Demjén Zsófia, Stevenson Fiona
University College London, London, UK.
University of East Anglia, Norwich, UK.
Health (London). 2022 Jul;26(4):431-456. doi: 10.1177/1363459320963431. Epub 2020 Oct 13.
Obtaining informed consent (IC) is an ethical imperative, signifying participants' understanding of the conditions and implications of research participation. One setting where the stakes for understanding are high is randomized controlled trials (RCTs), which test the effectiveness and safety of medical interventions. However, the use of legalese and medicalese in ethical forms coupled with the need to explain RCT-related concepts (e.g. randomization) can increase patients' cognitive load when reading text. There is a need to systematically examine the language demands of IC documents, including whether the processes intended to safeguard patients by providing clear information might do the opposite through complex, inaccessible language. Therefore, the goal of this study is to build an open-access corpus of patient information sheets (PIS) and consent forms (CF) and analyze each genre using an interdisciplinary approach to capture multidimensional measures of language quality beyond traditional readability measures. A search of publicly-available online IC documents for UK-based cancer RCTs (2000-17) yielded corpora of 27 PIS and 23 CF. Textual analysis using the computational tool, Coh-Metrix, revealed different linguistic dimensions relating to the complexity of IC documents, particularly low word concreteness for PIS and low referential and deep cohesion for CF, although both had high narrativity. Key part-of-speech analyses using Wmatrix corpus software revealed a contrast between the overrepresentation of the pronoun 'you' plus modal verbs in PIS and 'I' in CF, exposing the contradiction inherent in conveying uncertainty to patients using tentative language in PIS while making them affirm certainty in their understanding in CF.
获得知情同意是一项道德要求,意味着参与者理解研究参与的条件和影响。理解的利害关系较高的一个场景是随机对照试验(RCT),它用于测试医学干预措施的有效性和安全性。然而,伦理表格中使用法律术语和医学术语,再加上需要解释与RCT相关的概念(如随机化),可能会增加患者阅读文本时的认知负担。有必要系统地研究知情同意文件的语言要求,包括旨在通过提供清晰信息来保护患者的流程是否可能因语言复杂难懂而适得其反。因此,本研究的目标是建立一个患者信息表(PIS)和同意书(CF)的开放获取语料库,并采用跨学科方法分析每种体裁,以获取超越传统可读性指标的语言质量多维度度量。对英国癌症RCT(2000 - 2017年)公开可用的在线知情同意文件进行搜索,得到了27份患者信息表和23份同意书的语料库。使用计算工具Coh-Metrix进行文本分析发现,与知情同意文件的复杂性相关的不同语言维度,特别是患者信息表的词汇具体性较低,同意书的指代性和深层衔接性较低,尽管两者都具有较高的叙述性。使用Wmatrix语料库软件进行的关键词性分析揭示了患者信息表中代词“你”加情态动词与同意书中“我”的过度使用之间的对比,暴露了在患者信息表中使用试探性语言向患者传达不确定性,而在同意书中让他们确认自己理解的确定性时所固有的矛盾。