Supporting children and young people when making decisions about joining clinical trials : qualitative study to inform multimedia website development

Abstract

Objectives To understand stakeholders’ views regarding the content and design of paediatric clinical trial multimedia websites. To describe how this knowledge informed the development of the multimedia websites. Design Qualitative study comprising two rounds of interviews or focus groups, with thematic analysis of interview transcripts. Participants Sixty-two people (21 children and young people with long-term health conditions, 24 parents and 17 professionals). Setting One UK children’s hospital and one UK Young Persons’ Advisory Group. Results When asked what was important in deciding whether to join a trial, children, young people and parents prioritised information about what participation would involve, what the trial was testing, potential benefits and risks of participation and knowing they could leave the trial if they later changed their minds. Young people and parents trusted trial teams to follow regulatory and quality requirements and therefore did not think such information was a priority for the websites, although logos of trusted organisations could lend credibility. Professionals largely concurred with these views. Children and young people advised on the importance of designing the multimedia website to ensure its appearance, tone and wording suited the intended audience and on using animated characters to facilitate children’s engagement. Conclusions Our study provides insights into the information that families value when deciding about healthcare trial participation. It provides guidance on the design of information resources to appeal to children and young people, while also being acceptable to parents and professionals who are often gatekeepers of children’s access to information. Our findings will be of use to others developing similar multimedia websites. We report specific information needs and new visual preferences that are not usually addressed in printed trial information. Our work illustrates what qualitative research and participatory design practices can contribute to the development of information resources more generally.

Metadata

Authors/Creators:

Martin-Kerry, Jacqueline Maree https://orcid.org/0000-0002-9299-1360
Knapp, Peter Raymond https://orcid.org/0000-0001-5904-8699
Atkin, Karl Michael https://orcid.org/0000-0003-1070-8670
Bower, Peter
Watt, Ian Scot https://orcid.org/0000-0002-3147-8299
Stones, Catherine
Higgins, Steven
Sheridan, Rebecca https://orcid.org/0000-0002-7715-1224
Preston, Jennifer
Horton-Taylor, Danielle
Baines, Paul
Young, Bridget

Funding Information: Acknowledgements We gratefully acknowledge all the children, young people, parents and health professionals who participated in the interviews and provided invaluable details about their needs and preferences of a healthcare trial website. We would like to thank members of our TRials Engagement in Children and Adolescents (TRECA) Study Advisory Group who are not authors on this paper (Professor Carrol Gamble, Professor Michael Beresford and Ms Robyn Challinor), the TRECA Study Steering Committee members (Professor Faith Gibson, Professor Louise Locock, Dr Bob Philips, Dr Louca-Mai Brady and Dr Matt Sydes) and the TRECA Study Patient and Parent Advisory Group for their input into the study. Thank you to those who helped us identify and recruit participants for the interviews. We would like to thank the SCIPI Trial Investigators for allowing us to use content from the SCIPI trial when developing these multimedia websites. The SCIPI trial was funded by the NIHR Health Technology Assessment programme (08/14/39). We would also like to thank the Hi-Light trial investigators for allowing access to their participant video for use in the interviews. We would also like to thank Morph (https://morph.co.uk/), who developed the multimedia websites based on data from each round of interviews. Funding Information: Funding The TRECA study was funded by the NIHR Health Services & Delivery Research Programme (project number 14/21/21). Publisher Copyright: © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

Keywords:

adolescents, children, clinical trials, informed consent, multimedia information, participatory design, qualitative research, websites, young people

Dates: