Dr Kerry Woolfall Kerry_woolfall Talk 2: MRC Hubs for Trials Methodology Research Focus - Trials in paediatric critical care encounter practical and ethical difficulties because of limited time to seek informed consent in an emergency situation. We will present two NIHR HTA funded trial feasibility studies (EcLiPSe and FiSh) which involved parents in qualitative research at the design stage to inform approaches to recruitment and consent in this challenging setting. Content - This presentation will describe methods used to involve parents with relevant experience in qualitative trial feasibility studies. This will include an overview of how parents’ perspectives helped to optimise trial recruitment and assist clinician ‘buy in’ through site initiation training. Timeliness- Examples of the successful involvement of the public through their participation in trial feasibility studies are needed to inform future research. Appeal - This presentation will be of interest to researchers who wish to design clinical trials in a way that is patient centred.  

This little man needs emergency treatment for meningitis This little man needs emergency treatment for meningitis. However the most effective treatments for this, and many life threatening conditions in children are not know due to a lack of research. Conducting clinical trials in children’s critical care faces a number of challenges. The main challenge is seeking informed consent. In such circumstances, taking just a few moments to seek prospective informed consent before giving investigational treatments could mean the difference between life and death. Change in legislation to enable research to be conducted without prior consent Explain what this entails

Legislation is one thing, but what we didn’t know was whether conducting research in this setting was research was acceptable to families and if so, how to go about it. I’m going to described some qualitative pre- trial research which was conducted to inform two challenging NIHR funded studies.

Qualitative feasibility study aims Is this trial acceptable? Barriers? Decision making Need to conduct pre- trial research involving parents, children and practitioners to inform trial design

Recruitment 14/63 support groups responded 63 parent support groups contacted by telephone, 14 (22%) agreed to participate and sent the study invitation to parents by email or placed the request on their website or Facebook page. 25 registered interest, 17 interviewed Fish- 53 parents responded to social media- the majority in one day. Compared to 4 in the first week of a another sepsis study looking at fever Postal- about a 5% response rate. 21 interviewed. 14/63 support groups responded 25 parents registered interest 17 interviews 53 parents registered interest 4/68 (5%) response rate for postal contact 21 interviews

I worry about research without prior consent. How parents will react? I support this research, but….. How this is explained is important Timing Language used in PIS “use Keppra”

Using pre trial research with parents

Using pre trial research to assist clinician ‘buy in’ Created videos Presented the qualitative findings demonstrate how the protocol, PIS etc had been deve Valued aspects: videos, parent perspectives Following training there was a significant positive change in practitioners’ confidence in explaining: the study (p=<0.001); randomisation (p=<0.001), research without prior consent (p=<0.001), and responding to parents who object to the study (p=<0.001)

Conclusions Pre-trial feasibility research with parents/public can help ensure trials are patient centred Can help improve practitioners confidence in conducting challenging trials. Poster stands: EcLiPSE 434 FiSh 269 Children’s VOICES 178

Thank you @Kerry_woolfall P E R U K I P E R U K I Voices 178 Fish 269 Eclipse 434 P E R U K I The views and opinions expressed are those of the author and do not necessarily reflect those of the HTA Programme, NIHR, NHS or the Department of Health P E R U K I