Participant representation
To ensure our findings are generalisable and applicable to various demographic groups, the study research methodology was designed in a pragmatic way to minimise bias and promote inclusivity in participant recruitment.
The four recruiting sites for PRECISE were purposively spread across England, including sites in the South, Southeast, Southwest and Northwest. This allowed for broad geographical representation across socioeconomic backgrounds, ages, ethnicities to ensure diversity within our recruited population.
The baseline demographics of PRECISE participants are broadly reflective of the paediatric secondary care population in the UK. The PRECISE analysis data set included 305 children aged 72 hours up to 18 years, the median age of participants was 3.7 (IQR 1.3–9.2) years, with 176/305 (57.7%) of the sample being male. Only 18/305 (5.9%) of PRECISE participants had non-White ethnicity, which is lower than overall UK population statistics.
BATCH trial entry criteria were designed to be as inclusive as possible. Through the promotion the use of NHS language line translation services, and use of site screening logs to monitor eligible participants who were not recruited due to language barriers (n = 265, 9.1%). Consideration was given to translating patient facing documentation into different languages to aid recruitment, however, as there was a wide variation in the languages spoken, with no language(s) being most commonly used, translation was not undertaken.
The non-conditional payment of the voucher to participants should have reduced non-response bias and encouraged responding, and thus increased the representation of children treated in hospital for SBI, than could otherwise be achieved.
Reflections on your research team and wider involvement
The BATCH and PRECISE research team had substantial PPI in study planning, the funding application, study delivery and dissemination. The BATCH PPI lead and co-applicant is the Senior Patient and Public Involvement Policy Manager at NIHR Alder Hey Clinical Research Facility and University of Liverpool, who was able to ensure involvement and representation from parent and young people stakeholder groups. Trial meetings were held as hybrid or online, improving access for those with mobility problems, physical disabilities or those with busy schedules and limited time availability.