“It’s what we call a randomised control trial” exploring how randomisation is presented by recruiters in RCTs

Background: The way recruiters’ present information to patients can
influence whether or not the patient agrees to participate in an RCT.

We know that many clinicians find it difficult to communicate about trials,
including the concept and justification of randomisation. Current clinical
guidance states that patients must be informed about randomisation but
there is little advice about how to do this in practice. The aim of this paper
is to show how randomisation was presented by recruiters, and provide
suggestions about key aspects that can inhibit/facilitate informed decision
making.

Methods: 94 audio recordings of recruitment appointments across 5 RCTs
were analysed. All references to randomisation were noted (including
when it was not explained). Explanations of randomisation were then
sorted into themes according to whether they related to the method or
process of allocation, reason for randomisation or other elements

Findings: A small proportion of recruitment appointments did not include
any reference to randomisation; in those that did, the method and process
of allocation were mentioned regularly, but reasons for randomisation
were rarely presented. Descriptions used by recruiters often drew on
metaphors, sometimes with inaccuracy. Some explanations led to patients
believing they would receive the treatment that was ‘best for them’.

Conclusions: The method and process of randomisation are usually
described by recruiters, but often awkwardly and with inaccuracy, but the
rationale for randomisation is rarely mentioned. Recruiters require support
and training to ensure patients are making fully informed decisions about
RCT participation.