Computers and Education 2009; 53: 1285–1296. Julie Menzies1, Carly Tibbins2, Claire Callens2, Heather Duncan1, Kevin Morris1, John Marriott3 1Birmingham Children’s Hospital, Birmingham, UK, 2Medicines for Children Research Network, Birmingham, UK, 3University of Birmingham, Birmingham, UK Consulting with representatives from the public in a meaningful way

helps to ensure optimal research design1. The research instrument was a digitally recorded focus group designed to determine who, what and how researchers should engage with in future qualitative work exploring the design of Pharmacokinetic Lumacaftor in vivo (PK) studies in children. The outcome was a developed and strengthened protocol which satisfied NHS Research Ethics Integrated Research Application System (IRAS) requirements. Historically there has been a reluctance to conduct research in children; this is further complicated in paediatric pharmacokinetic (PK) research where multiple specimens are required, involving additional painful procedures2. PRESCRIBE (Pharmacokinetic REsearch Study in the CRitically Ill: facilitating the BEst design is a programme of research

which aims PF01367338 to determine the optimum design of PK research in children. A significant element of the project involves exploring the views and attitudes of stakeholders towards PK studies. Consumer consultation was undertaken in order to develop a reliable and acceptable research protocol which could achieve this aim. To conduct consumer involvement at the pre-protocol stage to determine: Who are the stakeholders in paediatric PK research? What do we need to ask them? What methods or forums should we use to communicate with stakeholders? A focus group was conducted with an established, expert panel of children and young people group (YPG) who meet regularly with a remit to improve the conduct of research in paediatrics, including pharmacy research. Six children aged 9–17years attended two sessions in April and July 2011. These sessions were digitally

recorded, transcribed and analysed using NVivo Enzalutamide software (NVivo 8). The YPG identified six key groups of stakeholders (children and young people, parents, nurses and research staff, doctors, hospital managers and research ethics committee members) who should be included in future qualitative work streams. Topics to discuss with stakeholders in future study designs included sampling considerations, potential pain, scarring, study duration, study requirements, hospital visits, staffing of the project and availability of the results. The YPG recommended keeping engagement with stakeholders simple using face-to-face methods such as focus groups, interviews and personally distributed questionnaires. Above all the group felt strongly that future work must directly include children and young people, allowing them to have a say in the way future research is designed.