TRAMS (Trials Research and Methodologies Unit), HRB Clinical Research Facility, University College Cork, Cork, Ireland.
Health Research Board Trial Methodology Research Network (HRB TMRN), University College Cork, Cork, Ireland.
Trials. 2024 Jun 18;25(1):391. doi: 10.1186/s13063-024-08217-3.
Evidence indicates that trial participants often struggle to understand participant information leaflets (PILs) for clinical trials, including the concept of randomisation. We analysed the language used to describe randomisation in PILs and determine the most understandable and acceptable description through public and participant feedback.
We collected 280 PILs/informed consent forms and one video animation from clinical research facilities/clinical trial units in Ireland and the UK. We extracted text on how randomisation was described, plus trial characteristics. We conducted content analysis to group the randomisation phrases inductively. We then excluded phrases that appeared more than once or were very similar to others. The final list of randomisation phrases was then presented to an online panel of participants and the public. Panel members were asked to rate each phrase on a 5-point Likert scale in terms of their understanding of the phrase, confidence in their understanding and acceptability of the phrase.
Two hundred and eighty PILs and the transcribed text from one video animation represented 229 ongoing or concluded trials. The pragmatic content analysis generated five inductive categories: (1) explanation of why randomisation is required in trials; (2) synonyms for randomisation; (3) comparative randomisation phrases; (4) elaborative phrases for randomisation (5) and phrases that describe the process of randomisation. We had 48 unique phrases, which were shared with 73 participants and members of the public. Phrases that were well understood were not necessarily acceptable. Participants understood, but disliked, comparative phrases that referenced gambling, e.g. toss of a coin, like a lottery, roll of a die. They also disliked phrases that attributed decision-making to computers or automated systems. Participants liked plain language descriptions of what randomisation is and those that did not use comparative phrases.
Potential trial participants are clear on their likes and dislikes when it comes to describing randomisation in PILs. We make five recommendations for practice.
有证据表明，临床试验的参与者通常难以理解临床试验的知情同意书（PIL），包括随机化的概念。我们分析了 PIL 中用于描述随机化的语言，并通过公众和参与者的反馈来确定最易懂和可接受的描述。
我们从爱尔兰和英国的临床研究机构/临床试验单位收集了 280 份 PIL/知情同意书和一份视频动画。我们提取了关于如何描述随机化的文本，以及试验特征。我们进行了内容分析，将随机化短语进行归纳分组。然后，我们排除了那些出现多次或与其他短语非常相似的短语。最后，将随机化短语列表提交给一个在线参与者和公众小组。小组成员被要求根据他们对短语的理解程度、对理解的信心以及对短语的可接受性，对每个短语进行 5 分制的李克特量表评分。
280 份 PIL 和一份视频动画的转录文本代表了 229 项正在进行或已完成的试验。实用主义内容分析产生了五个归纳类别：（1）解释为什么试验中需要随机化；（2）随机化的同义词；（3）比较随机化短语；（4）随机化的详细短语；（5）描述随机化过程的短语。我们有 48 个独特的短语，与 73 名参与者和公众分享。理解得好的短语不一定是可以接受的。参与者理解但不喜欢比较短语，例如掷硬币、像彩票、掷骰子，这些短语参考了赌博。他们也不喜欢将决策归因于计算机或自动化系统的短语。参与者喜欢对随机化进行简单明了的描述，不使用比较短语。
潜在的试验参与者在描述 PIL 中的随机化时，清楚地表达了他们的喜好和不喜欢。我们提出了五项实践建议。
