Abstract
BackgroundRandomised controlled trials are widely established as the best method for testing health interventions whilst minimising bias. However, recruitment and subsequent retention of children and adolescents in healthcare trials is challenging. Participant information sheets are often lengthy and difficult to read and understand. Presenting key information using multimedia may help to overcome these limitations and better support young people and their parents in deciding whether to participate in a clinical trial.MethodsThe TRECA (TRials Engagement in Children and Adolescents) study has two phases. The first phase involves a qualitative study with children and adolescents and their parents to inform the development of multimedia information resources and iterative user testing to refine the resources. The second phase will embed the use of the multimedia information resources into six host trials in the United Kingdom. Patients and parents approached to participate in the host trials will be randomly allocated to either use the multimedia information resource in conjunction with standard participant information sheets, the multimedia information resource alone, or the standard participant information sheets alone. The primary outcome will be the effect of the multimedia information resources on recruitment into trials. Other outcomes measured include the effect of multimedia information resources on retention of participants into the host trials and the impact on family members’ decision-making processes, when compared to standard participant information sheets alone.DiscussionThis study will inform whether multimedia information resources, when developed using participatory design principles, are able to increase recruitment and retention of children and adolescents into trials. There is also the potential for patients to make better informed decisions through the use of multimedia information resources. The multimedia information resources also have the potential to assist with providing information on other healthcare decisions outside of clinical trials.Trial registrationISRCTN registry: ISRCTN73136092 (doi:10.1186/ISRCTN73136092). Registered on 24 August 2016.
Highlights
Randomised controlled trials are widely established as the best method for testing health interventions whilst minimising bias
Phase two: evaluation of multimedia information (MMI) resources Embedded trials of MMI resources within host clinical trials – design The effectiveness of the two MMI resources will be evaluated in a series of trials embedded within six host trials in the UK that are recruiting children and adolescents with long-term health conditions, using methods we have developed previously [47]
The TRials Engagement in Children and Adolescents (TRECA) study will identify the information that children and adolescents consider to be most important when deciding whether or not to participate in clinical trials
Summary
Randomised controlled trials are widely established as the best method for testing health interventions whilst minimising bias. There is international recognition of the importance of paediatric clinical trials to inform healthcare decisions for children and adolescents [9,10,11,12]. The lack of successful clinical trials leads to many healthcare decisions for children and adolescents being made with inadequate evidence, including evidence extrapolated from trials involving adults [12]. The publication rate of trials in adults has almost doubled over a 20-year period, a rate increase that is around six times higher than for paediatric trials over the same period [13] In the past, this low rate of paediatric trials was thought to be mainly due to a concern for the vulnerability of children leading to a reluctance by clinicians to undertake clinical trials with young children [7, 14]. High rates of patient or parent refusal have been identified as a key barrier for successful completion of these trials [15], a recent study has shown lower refusal rates for paediatric trials involving therapeutic drugs [16]
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