“A little (PPI) MAGIC can take you a long way” : involving children and young people in research from inception of a novel medical device to multi-centre clinical trial Roald Dahl, James and the Giant Peach (1961)

Abstract

Background There is often a great urgency to be inclusive when conducting research and to focus efforts with groups and communities that can be referred to as marginalised. This is especially the case in research concerning medical devices aimed at children and young people (CYP). Although involvement methodology has developed over the last two decades, it can be challenging to involve and engage CYP with confidence and clarity of purpose. Main body Our aim was to provide a reflective narrative account of the involvement of CYP, over a period of 5 years, in a research project from conception of a new paediatric medical device through to practical application. We explored a model of patient and public involvement (PPI) through the Nottingham Young Persons Advisory Group (YPAG), part of the National Institute for Health Research (NIHR) GenerationR Alliance, in a NIHR funded research project. The YPAG designed and created a model of the human gut, co-designed the Transicap™ mini-capsules and their packaging, co-produced patient information sheets, came up with the idea to disseminate through a project website and co-wrote and created animation videos. The YPAG involvement continued through the writing and award of the follow-on research grant (MAGIC2). During this process the YPAG modified the clinical study protocol insisting that all participants in the control arm were given the imaging test results as well, save for a delayed reading compared to the intervention arm. Conclusion Involvement of the YPAG over the last 5 years, led to the development of a mutually beneficial partnership, enabling genuine knowledge exchange between researchers and CYP. This influenced the design, plans and actions of the MAGIC study and well into the subsequent MAGIC2 follow-on project. Moreover, these involvement models applied within a feasibility study setting, have enhanced the realism and pragmatism of the study, contributing to the project’s overall success.

Online randomised trials with children: A scoping review

“…A 2020 scoping review of 69 papers describing electronic informed consent in medical centres (three paediatric trials, one trial with both children and adults, 65 with adults) found no universal approach to gaining consent online, and the legal requirements for consent by country or region varied [61]. Nine of the 69 trials found that participants understood online consent more easily than traditional, paper consent forms and that online or e-consent forms may present a more streamlined approach in paediatric trials because in-person parental consent appointments often challenge parents and researchers [61].…”

‘It's Powerful’ The impact of involving children and young people in developing paediatric research agendas: A qualitative interview study

“…7,8 Fortunately, there have been researchers who evaluated the impact of involving CYP and their families in paediatric research in general. [9][10][11][12] Vanderhout et al found three different forms of impact involving CYP: impact on the research process, on the research team and on the CYP and their families. 11 Other studies have shown that involving CYP in research impacted data analysis 10,12 and data dissemination.…”

“…Most studies focus on describing PPI processes rather than exploring the impact of PPI 7,8 . Fortunately, there have been researchers who evaluated the impact of involving CYP and their families in paediatric research in general 9–12 . Vanderhout et al found three different forms of impact involving CYP: impact on the research process, on the research team and on the CYP and their families 11 .…”

‘ZOOMing’ in on Consulting with Children and Parents Remotely to Co-Create Health Information Resources

“…Consultation is part of the wider endeavour of fostering public and patient involvement and engagement (PPIE) [ 16 , 17 ] and integral to many studies focusing on issues of concern to children and young people’s health services [ 18 , 19 ], including the design of information materials [ 20 ]. Children are keen to be involved in consultation and research [ 21 ].…”

“…Consultation is not research and is not subject to ethical approval or research governance, although it does need to be undertaken ethically. Providing it is not tokenistic, consultation can be extremely valuable as it can ensure that research and resources are underpinned and informed by the experiences of those who will benefit most [ 18 , 23 , 24 , 25 ]. One such area relates to children’s experiences of the outpatient parenteral antimicrobial therapy (OPAT) service.…”