"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.

Keywords: Children and young people (CYP); Children and young people in research; GenerationR; Involvement; Patient and public involvement (PPI); Young persons advisory group (YPAG).

Fig. 1

Timeline of YPAG MAGIC activities

Fig. 2

Diagram of the YPAG involvement process in the MAGIC project

Fig. 3

Examples of translation of YPAG ideas of mini-capsules’ packaging through designers’ sketches and to real manufacturing prototypes. a YPAG’s play-for-learning suggestion to use three separate round pots, b the designers’ sketch of what this could look line with cardboard box and c the corresponding real packaging prototype developed by the manufacturer. This type of packaging was further developed and went into actual use in the feasibility study. d An alternative YPAG suggestion was to use sachets represented with the designers’ sketch in (d). This design evolved into the real packaging (e) which is to be used in the follow-on clinical trial MAGIC2

Fig. 4

Examples of different use of language in the two patient information sheets. a Example from the 7–9 year olds patient information sheet. b Example from the 16–18 year old patient information sheet