Lay public's understanding of equipoise and randomisation in randomised controlled trials

Area of Science:

• Clinical Trials Methodology
• Health Psychology
• Informed Consent Research

Background:

• Lay public understanding of equipoise and randomisation in clinical trials is often poor.
• Current trial information leaflets may not be effectively understood or remembered.
• Inadequate understanding can lead to inadequately informed consent or refusal.

Purpose of the Study:

• To investigate public comprehension of equipoise and randomisation in randomised controlled trials (RCTs).
• To explore reasons for poor information retention and effects of improved information delivery.
• To examine how to help participants recognise the scientific benefits of randomisation.

Main Methods:

• Systematic review update and experimental psychology theories informed nine investigations.
• Participants engaged with hypothetical scenarios, written responses, and individual interviews.
• Assessed understanding of trial information, allocation methods, and equipoise concepts.

Main Results:

• Most participants identified random allocation but found it unacceptable.
• Many doubted individual equipoise and did not recognise scientific benefits of randomisation.
• Simple explanations accompanying written information were insufficient; active engagement with the trial's aim was key.

Conclusions:

• Potential trial participants may struggle to understand standard information on randomisation and equipoise.
• Addressing the gap between trial design assumptions and public understanding is complex.
• Accessible explanations of randomisation's benefits, coupled with reflection on knowledge advancement, may improve comprehension.