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.
RCT Entities:
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.
Authors: E Davis; B Davies; R Wolfe; R Raadsveld; B Heine; P Thomason; Fiona Dobson; H K Graham Journal: Dev Med Child Neurol Date: 2009-02 Impact factor: 5.449
Authors: Laura P Forsythe; Victoria Szydlowski; Mohammad Hassan Murad; Stanley Ip; Zhen Wang; Tarig A Elraiyah; Rachael Fleurence; David H Hickam Journal: J Gen Intern Med Date: 2014-08 Impact factor: 5.128
Authors: Nathan D Shippee; Juan Pablo Domecq Garces; Gabriela J Prutsky Lopez; Zhen Wang; Tarig A Elraiyah; Mohammed Nabhan; Juan P Brito; Kasey Boehmer; Rim Hasan; Belal Firwana; Patricia J Erwin; Victor M Montori; M Hassan Murad Journal: Health Expect Date: 2013-06-03 Impact factor: 3.377
Authors: Colin Macarthur; Catharine M Walsh; Francine Buchanan; Aliza Karoly; Linda Pires; Graham McCreath; Nicola L Jones Journal: Res Involv Engagem Date: 2021-05-10
Authors: Juan Pablo Domecq; Gabriela Prutsky; Tarig Elraiyah; Zhen Wang; Mohammed Nabhan; Nathan Shippee; Juan Pablo Brito; Kasey Boehmer; Rim Hasan; Belal Firwana; Patricia Erwin; David Eton; Jeff Sloan; Victor Montori; Noor Asi; Abd Moain Abu Dabrh; Mohammad Hassan Murad Journal: BMC Health Serv Res Date: 2014-02-26 Impact factor: 2.655
Authors: Laura P Forsythe; Lauren E Ellis; Lauren Edmundson; Raj Sabharwal; Alison Rein; Kristen Konopka; Lori Frank Journal: J Gen Intern Med Date: 2015-07-10 Impact factor: 5.128
Authors: Anne Hunt; Erica Brown; Jane Coad; Sophie Staniszewska; Suzanne Hacking; Brigit Chesworth; Lizzie Chambers Journal: J Child Health Care Date: 2013-11-21 Impact factor: 1.979
Authors: Bridie Angela Evans; Emma Bedson; Philip Bell; Hayley Hutchings; Lesley Lowes; David Rea; Anne Seagrove; Stefan Siebert; Graham Smith; Helen Snooks; Marie Thomas; Kym Thorne; Ian Russell Journal: Trials Date: 2013-07-17 Impact factor: 2.279