Background: An important challenge in recruiting people to clinical trials is explaining randomised-controlled trials (RCTs). In the pilot phase of a RCT involving babies born at less than 32 weeks gestation that aimed to compare delayed and early cord clamping (CORD pilot trial), clinicians found it particularly difficult to explain why mothers in the study could not choose either option and why randomisation was important. We asked healthcare consumers, familiar with RCTs, to help us find ways to explain these issues in time-limited recruitment situations.

Objectives: To gain understanding from consumers on how to communicate randomisation to the public and to better inform potential participants of clinical trials.

Methods: An interactive 2-stage workshop was devised for consumers at a Cochrane Colloquium. In stage 1, workshop members were given magazine adverts promoting purported clinical benefits and asked to design a study that would address the claims made. Subsequent discussion progressed to the concept of randomisation, potential biases that can arise and how these can be minimised with careful study design.
With this background, in the second stage of the workshop, the consumers were asked to develop statements describing randomisation to potential study participants of the CORD pilot trial. The consumers, working in groups, were specifically asked for ways to explain to women why trial participants would not be able to choose which study group they could go into, and so would not have a say in when their baby’s cord would be clamped.
The final statements produced by the different groups were discussed by all workshop members and modifications suggested. This work was later presented at a CORD pilot trial collaborators’ meeting.

Results: The process identified expressions that consumers disliked and expressions that they preferred when discussing clinical trials. The issues raised will be presented along with the statements the consumers produced explaining the CORD pilot RCT.

Conclusions: Healthcare consumers can contribute to recruitment to RCTs by developing wording to help explain randomisation to potential trial participants.