Introduction: Paediatric clinical trials in critical care settings are challenging to conduct. Establishing trial acceptability can help inform trial design and avoid research waste. This paper reports on how research with parents and staff established and augmented perspectives and the design of a trial investigating temperature thresholds in critically ill children with fever and infection (Fever trial). //
Methods: We used a mixed methods approach to explore perspectives at three time points: 1) before, 2) during and 3) after a pilot trial. This included: 1) pre-trial focus groups with staff and interviews with parents; 2) questionnaires with parents of randomised children following trial recruitment; 3) post-trial interviews with parents and focus groups and a survey with staff. Data analysis drew on Sekhon et al (2017) theoretical framework of acceptability. //
Results: 1) 25 parents were interviewed and 56 staff took part focus groups, 2) 60 parents of 57 randomised children took part in questionnaires, 3) 19 parents were interviewed and 50 staff took part in focus group and 48 in a survey. There was initial support for the trial, although both groups raised concerns regarding proposed thresholds and not using paracetamol for pain or discomfort. Pre-trial findings informed pilot trial protocol changes and training, which assisted practitioner ‘buy in’. However, concerns about children being in pain or discomfort when weaned from ventilation led to cases of withdrawal and protocol non-adherence. Nevertheless, 95% of parents provided consent and all supported the trial. Those trained by the Fever team found the trial more acceptable than those trained by colleagues. Trusting parent and staff relationships were linked to trial acceptability. //
Conclusions: Pre-trial findings and pilot trial experience augmented perspectives, providing insight into how challenges may be overcome. The proposed trial was deemed feasible. We present an adapted theoretical framework of acceptability to inform the design of future trial feasibility studies
