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Table 2 Feedback from the Young Persons Advisory Group (YPAG)

From: “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)

Date Activity Feedback Impact
Sep 2014 The YPAG makes its debut on the MAGIC grant proposal. The first contact with the YPAG is mediated by the Clinical Research Network: East Midlands PPI specialist and YPAG group convenor The YPAG agrees to participate in the MAGIC programme, 5 meetings are planned throughout the proposed programme, including meeting the technology consultants, designers, and participating at a scientific conference. MAGIC has 6% of total cost in PPI funding (£34,053 over a grant total of £603,109) in the budget
Nov 2015 Split into 3 different groups based on age, 8–11, 12–15, 16–18.
 • Looked at mini capsule design
 • Completed tablet design questionnaire
 • Built gut transit model using plumbers plastic piping to educate group on study concept
The smaller, smooth and rounded shape design was preferred by all age groups, stating they would not want special tablet shape and that these could be difficult to swallow. Smooth texture would be preferred.
No flavour to tablets as will not be able to please everyone with a flavour.
When taking the tablets the children should have a choice about what they take this with. Recommended milkshake or squash.
Comments on capsules size, shape and characteristics were fed back to the designers.
The recommendation to swallow the mini-capsules with something nice such as juice or squash was added to the draft protocol and Ethics materials.
May 2016  • Discussed the Ethics application for project
 • Worked together on the Patient Information Leaflets
 • Updated the YPAG project progress and described the next steps
Group discussed information leaflets needed to be different for age ranges, and suggested that information be divided into 3 different age brackets.
Advised on wording and format of the patient information leaflets.
May be more interesting if there was a video to describe the study.
Feedback from the YPAG led us to produce different Ethics information sheets divided into three age appropriate bands.
They also suggested that we produce a video animation as information sheet, an idea we are working towards now.
Aug 2016  • Mini capsule packaging design - Packaging arts and crafts using food boxes and containers of different sizes and shapes
 • Discussed concept of creating cartoon/videos
 • Looked again at study information sheets
Group created packaging designs, which included splitting the tablets into three separate parts that children break off - this is so they would know what tablets had to be taken each day.
Looked at stacking the containers on top of each other.
Design of packaging to include three separate portions of tablets.
Sep 2016 Device designers and technology consultant working with YPAG to finalise mini capsule design
 • Looked at existing packaging options based on feedback from last session.
 • Reviewed designs produced by manufacturers based on feedback from the last session
Group preferred the 3 different containers that were joined together but could be broken off.
This would help children know how many they have to take and on which day.
Can also carry them around with you with packaging that is smaller.
After session with the YPAG group agreed on the chosen design with the manufacturers.
Mar 2017 Split into age groups to provide feedback on:
 • The value of the vouchers which will be offered to participants
 • Review and provide feedback on the study advertisement posters
 • Answer researchers queries regarding if participants should be given the option of receiving a picture of their MRI scan
 • Feedback on the number of questionnaires participants would have to complete
 • Provide a review on the Assent Form designed for the study
 • £20 maximum – If you participate you don’t go for the money.
 • Give a voucher that can be used at various places, e.g. shopping centres or give the participants a list of vouchers they can choose from.
 • More colours and pictures (the current pictures are not related)
 • Less writing.
 • Should have more important information at the top.
 • Add phone number as well as email address.
The YPAG suggestions on how to answer certain queries from the REC Ethics, and also the fact that we were able to say to the REC that the YPAG had participated in developing the answers to their queries, have allowed us to pass the scrutiny and obtain full Ethics approval hence the consultation has had a great impact on the research.
Have now incorporated YPAG’s suggestion in the revised version of study documentation and in the letter answering the REC Ethics queries - who praised the involvement of the YPAG.
May 2017 Students from the Nottingham Trent University attended a session to discuss the MAGIC animation video, looking to co-design the animation and script
Discussion of upcoming oral presentation at Nottingham Paediatric Research Showcase
Discussion on the need to hold the breath for short intervals when doing the MRI exam
The young people suggested this would be a good exercise to spend 5 min doing with the young people who would be having the MRI scans before they go in. Breath-hold practice recommended to study participants
YPAG members Anmol and Heera co-present with the investigator at the Nottingham Paediatric Research Showcase and with 2nd best oral presentation prize
Jul 2017 This session included recording animation information sheets, where the YPAG members read from a script they had co-produced for the animation.
Input into the design of the MAGIC study website
Some detailed suggestions on how to display the website.
YPAG member Lexie wrote a blog of the session with the animation specialist to adapt and read the scripts
The YPAG provided all the voice to be added to the animated videos, The website became a reality Many suggestions for the website were taken on board and take to the meeting of the investigator with the website designer company, including the dedicated YPAG tab where Lexie’s blog and some YPAG photos now appear
Sep 2017 The review of the animation video and feedback ready for finalisation.
Started to look at script for a second video.
Only small edits proposed, a couple of script phrases were re-recorded The animation videos were finalised and posted online
Jan 2018 Update on MAGIC Study:
 • Overview of where the project is now and how the YPAG have helped to date
 • Work on the new follow-on grant proposal MAGIC2 starts. Discussed how the YPAG could be further involved
 • Discuss the need to provide a YPAG paragraph of test for article on NIHR website
 • Discuss poster presentation at British Paediatric Gastroenterology conference
Initial comments of clinical trial including control arm need to include the MRI test too so that no young person would miss out
YPAG member Anmol collects feedback from the group and writes a paragraph for the NIHR case study on MAGIC
YPAG support to new grant proposal MAGIC2.
Study protocol changes with second arm including MRI test with delayed result reading
The YPAG features prominently in the ‘My research inspiration’ official case study that MAGIC has been portrayed in on the funder’s website.
A poster presentation at the British Paediatric Gastroenterology conference BSPGHAN is made with YPAG’s authorship
Apr 2019 Progress report from investigator
New device sachet packaging shown
Plans for MAGIC stand at upcoming community event Wonder
Comments on the new device packaging collated, mostly positive, suggestion to make the writing day 1 / day 2 / day 3 on the pots more prominent
Looked at possible study memento / mascot we could buy
Authorship of posters and co-presentation opportunity discussed and approved
Feedback on new sachet packaging typed up and shared with manufacturer, labelling of pots have changed as a result.
YPAG member Olivia co-presents with the investigator at the NIHR UK Clinical Research Facilities conference.
Jul 2019 Report back from success of MAGIC stand at Wonder community festival
Focus on the start of MAGIC2 project and YPAG involvement
YPAG representation on project management group
YPAG member Pavan writes a blog YPAG’s blog uploaded to the study website.
MAGIC becomes a NIHR Collaboration for Innovation case study on the NIHR website.
A YPAG member attends the project’s kick-off meeting as a full member of the management team
Sep 2019 Progress update
Answer specific questions on ethics sheets from the Clinical Trials Unit
Look at study memento / mascot for study participants
A number of suggestions for improvement of the Ethics info sheets for the new MAGIC2 clinical trial are collected, including the use of QR codes, the addition of a certificate of participation and a separate, personal bowel diary to avoid embarrassment when discussing toilet habits The YPAG’s suggestions are shared with the clinical trial unit to modify the information sheets for Ethics approval.
MAGIC2 has 4% of total cost in PPI funding (£46,755 over a grant total of £1,186,572) in the budget. Funding for MAGIC2 PPI is increased 37% compared to MAGIC.