One of the few studies of service user involvement in a clinical trials was published this month in the journal Trials: ‘Involving older people in a multi-centre randomised trial of a complex intervention in pre-hospital emergency care: implementation of a collaborative model‘. The study was part of the SAFER2 (Support and Assessment for Fall Emergency Referrals) trial led by the University of Swansea with Ambulance Services in the East Midlands, London and Wales and involving CaHRU at the University of Lincoln. The study was led by Bridie Evans and the trial lead was Prof Helen Snooks, both from Swansea University.
The study describes how it was planned for service users to be involved in the trial and how involvement actually occurred. The study team planned for service users to be involved at strategic level, at each study site and locally and this did take place. For example at strategic level, service users were involved in the trial management, trial steering, and data monitoring and ethics committees In addition, service users were also involved in study writing days and task and finish groups. Service users were also involved at study sites. Finally, service user reference groups were consulted at various points during the study.
Overall, the study showed how service users could be integrated into the activities of a clinical trial, the processes involved and facilitators and barriers to involvement at various levels.