Patient and public involvement and engagement
antiseizure, epilepsy
CASTLE, RECRUITMENT, EPILEPSY
Children with RE and parents had been involved from the inception of the idea for the CASTLE trial. In the pre-funding stage, parents were involved in two stakeholder meetings and they helped to shape the design of the study and the development of the research questions. Our engagement with parents in the pre-trial stakeholder meetings meant that we were aware that some parents of children with RE had ambivalent feelings towards medicating their children and they talked of the difficulties they experienced when trying to weigh up the potential benefits and harms of treating their child’s epilepsy with antiseizure medications. In addition, our parent co-applicants made us aware of their uncertainty about which issues to discuss with clinicians at the time of an epilepsy diagnosis and when making treatment decisions. We were clear that these ambiguities and uncertainties would need to be carefully considered in the design of the study and child/parent-facing documents.We built on our pre-funding stakeholder work with parents when, in the early stages of the funded programme of work, we created our dedicated Patient and Public Involvement and Engagement (PPIE) Advisory Panel (AP). Our AP consists of 12 adults (including parents) with experience of childhood epilepsy, and five children with epilepsy. We recruited our AP through social media and liaison with health professionals and epilepsy charities. We worked with the AP members during face-to-face meetings and remotely (during lockdown) using open discussion facilitated by using creative methods such as road maps and idea trees and/or by email or through a dedicated WhatsApp group. The relationship and depth of consultation with the AP evolved over time and through sustained engagement.Our AP has been influential in the programme of research related to the trial. For example, we co-created a proposed Core Outcome Set (COS) for childhood epilepsy research using a Delphi process to decide which outcomes were of key importance to stakeholders and thus the trial [We specifically worked with the AP to develop the child/parent facing documentation (the trial information sheets, a short trial explainer animation) which we knew would be key to successful recruitment. Furthermore, the AP reported that the trial was quite complex for families to understand; therefore, appreciating the challenges associated with clinicians recruiting to trials we co-developed clinician-facing documentation such as a clinician guide ‘Top Tips for Recruiting Families’ sheet (Supplementary File 