How do people prefer randomisation to be explained in clinical trial information?

Details

Evidence indicates that clinical trial participants often struggle to understand participant information leaflets (PILs), including the concept of randomisation. The researchers analysed how PILs describe randomisation and sought to identify the most understandable and acceptable descriptions through feedback from participants and the public.

They collected 280 PILs or informed consent forms and one video animation from clinical research facilities and clinical trial units in Ireland and the UK. They extracted text describing randomisation, along with trial characteristics. They used content analysis to group randomisation phrases inductively. Phrases that appeared more than once or were very similar to others were then excluded. The final list was presented to an online panel of participants and members of the public. Panel members rated each phrase on a 5-point Likert scale for their understanding, confidence in that understanding and the phrase’s acceptability.

The 280 PILs and the transcribed text of the video animation represented 229 ongoing or concluded trials. Pragmatic content analysis produced five inductive categories: explanations of why randomisation is needed in trials; synonyms for randomisation; comparative phrases; elaborative phrases; and phrases describing the randomisation process. The researchers shared 48 unique phrases with 73 participants and members of the public.

Phrases that were well understood were not necessarily acceptable. Participants understood but disliked comparisons referring to gambling, such as tossing a coin, a lottery or rolling 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 descriptions that did not use comparisons.

The researchers concluded that potential trial participants are clear about their likes and dislikes concerning how randomisation is described in PILs. They made five recommendations for practice, although the abstract does not specify them.