Coming together to improve paediatric trials

Engaging Participants in Paediatric Randomised Controlled Trial Design and Delivery To Reduce Missing Data - A Guide

INTRODUCTION

Involving children, young people and their carers and schools in the design and delivery of paediatric randomised controlled trials is crucial for better data.

Sometimes, trialists might prioritise getting data efficiently and making trials work for the needs of the project, without considering the involvement of participants in detail. Or, how can I make this trial work for me/the team.

Instead, shifting this mindset to how do I make clinical trials enjoyable experiences for my participants improves their desire to be involved, increases participation and leads to better data collection as a result.

BUT HOW?

This guide is based on the analysis of qualitative interviews conducted with clinical trialists involved in paediatric randomised controlled trials by Dr Daisy Gaunt at the University of Bristol. It goes through general best practice for engaging participants, and then specific advice for working with the three key groups involved in paediatric randomised controlled trial participation: Children and teenagers

Wider family and caregivers

Teachers and schools

GENERAL BEST PRACTICE

Build in accessibility right from the beginning

Don’t assume when, how or what participants want when it comes to trial data collection and communications.

Consider co-designing the trial and methods of engagement with participants from the beginning to ensure information and data collection is accessible.

Communicate regularly, with lots of options to keep in touch

Share information regularly with participants, including reminders about data collection; AND keep people in the loop with what is happening in the trial and acknowledge their commitment. Consider including pictures of the trial team.

Make it easy for people to contact you through a variety of options, including online and over the phone. Reduce the friction to provide data by removing unnecessary steps or logins.

Ensure information about the trial and data collection is clear, and repeat it

Be clear about why data is needed and, how it will be collected. Don’t assume that everyone will take that in on the first go - repeat this information throughout the trial.

This is key if participants have limited trial contact (e.g. in-active treatment group), or if they feel better.

Use existing tools to monitor data

Use database checks and site engagement to make sure time-sensitive data is not missed.

FOR CHILDREN

data collection is safe (and fun!). If possible,

Provide appropriate incentives

Consider rewarding them for their participation in a way that is valuable to them - like toys or

FOR TEENAGERS

Assume interest

Don’t assume that teenagers don’t care! The research demonstrated that most clinical trialists felt teenage participants were genuinely interested in the process. Share as much information as possible about the trial, the wider research and the value of their data.

Be aware of privacy concerns

Create a sense of ownership

Teens may value independence from their carers. Ask them how they want to be involved, communicated with and kept in the loop

How peers perceive their involvement in research may be important to them. Be clear about how their data and privacy is protected and how their participation is managed. Personal logins and up-to-date or less visible data collection devices may help.

Provide appropriate incentives

Consider asking teens what they would value as a reward for their participation; this might not be gift vouchers.

Use technology to engage WhatsApp™ or text messages, rather than calls or email, was seen as the most accessible way for teens to engage - use communication, and technology, such as mobile apps, and

FOR WIDER FAMILY AND CAREGIVERS

Allow flexibility

Parents and carers be looking after many children, or juggling work and other caring commitments. Allow for flexibility in time, location and mode of data collection.

Don’t assume knowledge

Don’t assume technology literacy or access - work with them to find their preferred methods of data collection and communication, and be on hand for support via email or telephone

FOR SCHOOLS

Have a key contact

To make data collection and trial management easier, have an engaged key contact with influence at each school. Or consider hiring a school liaison manager with experience of the school sector to join the trial team to manage school relationships.

Reminders are helpful, not a hindrance

Regular reminders - if phrased correctly - were seen as helpful - as they value the nudge. Reminders may also encourage the routine of data collection. Consider including links to online surveys, log-ins or passwords. Reminders also help caregivers to get into the habit of responding to requests for data in future, which might reduce the need for researchers to help them with data completion.

Make it easy to participate

Reimburse travel costs for in-person visits, as soon

Engage parent champions

If parents are not directly contactable, consider sharing key information and encouraging data collection participation via a parent champion and informal networks (e.g. parent WhatsApp™ groups).

Not all schools need or want the same thing - work with individual schools to find an appropriate way to incentivise their engagement.

To find out more about the research that this guide was based on, visit: https://research-information.bris.ac.uk/en/persons/daisy-m-gaunt

Daisy Gaunt, Doctoral Research Fellow, NIHR300219 was funded by the NIHR for this research project. The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR, NHS or the UK Department of Health and Social Care.