Although the UK Department of Health has advocated the involvement of service users and carers in health research for several years, there is little evidence about their contribution to the design of randomized controlled trials (RCTs).Objective
To demonstrate how consulting parents about the design of a study, including which outcomes to use, led to the design and successful delivery of a RCT of osteopathy for children with cerebral palsy (CP).Design
Semi-structured interviews were carried out with 20 parents of children with CP and other neurological conditions, asking them to choose between four different trial designs, to talk about noticeable changes in their child’s condition and their views about payment for trial treatment.Setting and participants
The parents interviewed were all members of Cerebra, a charity for ‘brain-injured’ children and young people. All interviews were carried out at the parents’ homes.Results
Parents had mixed views about possible trial designs; however, a waitlist design which allowed all children eventually to receive the treatment emerged as a clear favourite. Parents did not focus on isolated outcomes, but suggested a range of factors relevant to their child’s quality of life. They expressed a clear preference for the costs of treatment to be funded by the trial.Conclusions
Involvement of parents helped design a trial which was acceptable to families and addressed outcomes that mattered to them. By consulting parents about the design of the research, the subsequent trial achieved excellent recruitment and retention rates.