Patient and public involvement in a study of multimedia clinical trial information for children, young people and families

Abstract

There is increasing recognition of the need to involve the public in health research, but accounts of how best to achieve this are scarce. This article describes public involvement in the TRials Engagement in Children and Adolescents (TRECA) study, which is developing and evaluating multimedia information resources to inform children, young people and their familes about clinical trials. A dedicated group of young people with long-term health conditions and their parents met regularly throughout the study; further involvement was sought when specific input was required. Review of formal impact records and informal discussions highlighted how public involvement can positively influence research practice and the people involved. By detailing the methods of involvement used, this work also provides guidance for successfully implementing public involvement in research, and highlights challenges that should be considered in future research projects.

The effects of multimedia information on recruitment and retention in a children’s cardiac surgery trial: a randomised controlled SWAT (study within a trial)

“…26 Hence, 147 (96.1%) participants were included in the analyses. 33 Participants were between 0 and 16 years old. The median age of the participants was 0.67 years (IQR 0.33, 3.75) and a higher proportion were male (62%).…”

Does digital, multimedia information increase recruitment and retention in a children’s wrist fracture treatment trial, and what do people think of it? A randomised controlled Study Within A Trial (SWAT)

“…The TRECA MMI was developed through extensive qualitative research and user testing, where principles of participatory design were used to develop their style and format32–34 and informed by information design and principles of plain English,35 readability and age appropriateness. The TRECA PPI Group commented on the design and content of the MMI during their development 36…”

“…The TRECA PPI Group commented Open access on the design and content of the MMI during their development. 36 The MMI included five short video animations, each lasting 45-60 s (one specific to FORCE: 'Summary of the key aspects of the FORCE trial'; and four that were trial generic: 'Why do we do trials? '; 'What are trials?…”

Evaluating the use of multimedia information when recruiting adolescents to orthodontics research: A randomised controlled trial

“…The TRECA study websites drew on extensive underpinning qualitative research ( Martin-Kerry et al, 2019 ) and user testing ( Sheridan et al, 2019 ), and were informed by principles of Plain English and information design ( Knapp et al, 2011 ), as well as age-appropriateness and readability formulae ( Readabilityformulas.com ). The TRECA Patient and Public Involvement Group commented on the content and design of the websites throughout their development ( Sheridan et al, 2020b ).…”

“…A higher DMQ score indicates better quality of decision-making. The DMQ comprised items evaluating aspects of trial participation decision-making indicated as important in the underpinning empirical work ( Martin-Kerry et al, 2017 , 2019 ; Sheridan et al, 2019 , 2020b ), including items on: information content; the experience of participation; uncertainty in trials; participation advantages and disadvantages; the process of decision-making; and decisional confidence. The nine scale items were followed by three free-text questions that asked respondents: to suggest any additional information they would have wanted; to identify aspects that were explained well; and for any other comments.…”