Aim of the study
Non-operative treatment (NOT) of acute uncomplicated appendicitis in children has been proposed as an alternative to appendicectomy, but there is a lack of randomised controlled trial (RCT) evidence. Such an RCT is likely challenging to conduct. We conducted a qualitative study, embedded within a feasibility RCT comparing NOT with appendicectomy for acute appendicitis. Our aim was to enhance how surgeons communicated with families about the trial to optimise informed consent and recruitment.
Trial recruitment consultations (N=56) and semi-structured interviews with health professionals (N=33) and families (N=20), including those who participated in and declined the trial, were audio-recorded in three UK children’s hospitals. Thematic analysis of recruitment consultations and interview transcripts informed ongoing training for surgeon recruiters and communication with families. Ethical approval: 16/SC/0596.
Families who were less open to NOT were less willing to participate in the trial. Parents who declined to participate often described concerns about NOT treatment failure and appendicitis recurrence. Parents with previous experience of perforated or complicated appendicitis were more likely to favour surgery and were less likely to participate. Parents’ and patients’ treatment preferences often diverged. Informed by the qualitative findings, the study team devised and delivered training to highlight recruitment barriers, provide balanced information about treatment arms during consultations, and explore treatment preferences with families. Recruitment rose from 32% to 43% following training.
This embedded qualitative study has identified barriers to recruitment in this urgent care setting feasibility trial. The results have improved patient information sheets and informed recruitment training that has been associated with increased recruitment rates. The findings have provided lessons for improving informed consent and recruitment in a future definitive RCT.