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Consulting parents about the design of a randomized controlled trial of osteopathy for children with cerebral palsy

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Randomized Controlled Trial, Clinical trial

-

Osteopathic Manipulative Treatment

Health Expect. 2011 Dec;14(4):429-38.

Authors:

Vanessa Edwards, Katrina Wyatt, Stuart Logan, Nicky Britten

Abstract.



Background: 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.

Publication Date: 

2011 Dec

OEID: 

2166

Edwards, V., Wyatt, K., Logan, S., Britten, N. (2011) 'Consulting parents about the design of a randomized controlled trial of osteopathy for children with cerebral palsy ', Health Expect. 2011 Dec;14(4):429-38.

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