Consumer perspectives on simplified, layered consent for a low risk, but complex pragmatic trial

Abstract Background For decades, the research community has called for participant information sheets/consent forms (PICFs) to be improved. Recommendations include simplifying content, reducing length, presenting information in layers and using multimedia. However, there are relatively few studies that have evaluated health consumers’ (patients/carers) perspectives on the type and organisation of information, and the level of detail to be included in a PICF to optimise an informed decision to enter a trial. We aimed to elicit consumers’ views on a layered approach to consent that provides the key information for decision-making in a short PICF (layer 1) with additional optional information that is accessed separately (layer 2). We also elicited consumers’ views on the optimal content and layout of the layered consent materials for a large and complex Bayesian adaptive platform trial (the SNAP trial). Methods We conducted a qualitative multicentre study (4 focus groups and 2 semi-structured interviews) involving adolescent and adult survivors of Staphylococcus aureus bloodstream infection (22) and their carers (2). Interview transcripts were examined using inductive thematic analysis. Results Consumers supported a layered approach to consent. The primary theme that emerged was the value of agency; the ability to exert some control over the amount of information read before the consent form is signed. Three other themes emerged; the need to prioritise participants’ information needs; the importance of health literacy; the importance of information about a trial’s benefits (over its risks) for decision-making and the interplay between the two. Conclusions Our findings suggest that consumers may challenge the one-size-fits-all approach currently applied to the development of PICFs in countries like Australia. Consumers supported a layered approach to consent that offers choice in the amount of information to be read before deciding whether to enter a trial. A 3-page PICF was considered sufficient for decision-making for the SNAP trial, provided that further information was available and accessible.摘要 背景 数十年来，国际学界一直呼吁优化受试者信息表/知情同意书（Participant Information Sheets/Consent Forms, PICFs）。相关改进建议包括简化内容、压缩篇幅、分层呈现信息以及运用多媒体形式。但目前针对健康消费者（患者/照护者）关于知情同意书的信息类型、组织结构与细节详略的研究相对较少，而这些要素正是优化受试者做出参与试验的知情决策的关键所在。本研究旨在征集健康消费者对分层知情同意模式的看法：该模式通过简短知情同意书（第一层）提供决策所需核心信息，同时设置可单独查阅的附加可选信息（第二层）。此外，本研究还收集了健康消费者针对一项大型复杂贝叶斯自适应平台试验（SNAP试验）的分层知情同意材料的最优内容与版式的意见。 方法 本研究为多中心定性研究，共开展4场焦点小组访谈与2次半结构化访谈，研究对象包括22名金黄色葡萄球菌血流感染青少年及成人幸存者，以及2名照护者。研究采用归纳式主题分析方法对访谈转录文本进行分析。 结果 健康消费者对分层知情同意模式表示支持。提炼出的核心主题为自主掌控权的价值：即受试者在签署知情同意书前，可自主控制阅读的信息量。此外还提炼出三个辅助主题：一是需优先满足受试者的信息需求；二是健康素养水平的重要性；三是试验获益相较于风险的信息对决策的关键作用，以及二者之间的相互影响。 结论 本研究结果显示，在澳大利亚等国家，当前受试者信息表/知情同意书开发采用的‘一刀切’模式可能会遭到健康消费者的质疑。健康消费者普遍支持分层知情同意模式，该模式允许受试者在决定是否参与试验前自主选择所需阅读的信息量。若可获取并便捷查阅进一步的补充信息，那么篇幅为3页的知情同意书足以支撑SNAP试验的决策需求。