Developing a vitamin D paediatric clinical study: Pilot consultation involving young people
2014 Conference
Abstract:
Introduction: A paediatric clinical study comparing vitamin D (oily solution) dosed daily for 8 weeks (0.3-0.5mL = 6,000-10,000 Units) compared to a single large dose was proposed (7.5- 12.5mL = 150,000-250,000 Units). Specific issues identified as potential hurdles within this study were the need for two additional blood samples and the compliance with the therapy, particularly for daily dosing.
Methods: Focus groups were held with young people; these included research-naïve young people (n=30) as well as an experienced National Institute for Health Research (NIHR) young persons’ group (n=10). Specific topics for discussion within these focus groups included:
- Acceptability of two additional blood samples
- Strategies to ensure compliance to the therapeutic regime
Results: The requirement for two additional blood tests was not seen as a major barrier to participation in the study, however the children and young people suggested that these tests should be offered at convenient times and locations to maximise recruitment, for example at local GPs, walk-in centres or at their home. Children and young people reported that they are likely to forget to take a medicine daily, particularly when they are feeling well. They also raised concerns over the use of a large volume of oil for the single high dose.
Conclusions: The study team are reviewing their protocol to incorporate the views of young people, specifically regarding collection of additional blood samples and by inclusion of age-appropriate tools (eg sticker charts or test reminders) to aid in compliance for the daily dosing arm.
Authors
Batchelor ~ Hannah
Hannah Batchelor is a Paediatric Formulations Research Fellow at the University of Birmingham, funded by the Medicines for Children Research Network to support high quality clinical research into medicines for children and young people, ensuring that medicines are both safe and effective. Her previous experience within pharmaceutical industry and the NHS brings extensive knowledge of drug delivery and the design of clinical trials. Hannah is passionate about involving children and young people in research and undertakes a lot of public engagement activity.
View all articles by this authorCallens ~ Claire
Claire Callens is Research Portfolio Manager and User Involvement Co-ordinator - Paediatric Non Medicines Specialty Group, University of Birmingham. Claire joined the Central team in May 2007 as User Involvement Coordinator. This role involves involving families, young people and children in improving the design of Paediatric randomised controlled trials (RCTs). Claire is also the Research Portfolio Manager for the Paediatric Specialty Group within the West Midlands which involves facilitating the local study feasibility process, assisting with set up of research projects and management of patient recruitment data.
View all articles by this authorShaw ~ Nick
Consultant Paediatric Endocrinologist and Clinical Lead for Complex Childhood Osteogenesis Imperfecta, Birmingham Children's Hospital; Honorary Senior Clinical Lecturer, University of Birmingham.
View all articles by this authorTibbins ~ Carly
Carly Tibbins is User Involvement Co-ordinator at West Midland Medicines for Children Research Network, Birmingham Children’s Hospital. Carly joined the Stoke team in March 2009 from a background in Social Services working with children with emotional needs. Her primary function is to work with children, young people and parents/carers, to ensure their views are taken into consideration within the research process.
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