Design: Feasibility randomised controlled trial with embedded qualitative study to inform recruiter training to optimise recruitment and the design of a future definitive trial
Setting: Three specialist paediatric surgery centres in the United Kingdom
Patients: Children (aged 4-15 years) with a clinical diagnosis of uncomplicated acute appendicitis
Interventions: Appendicectomy or a non-operative treatment pathway (comprising broad-spectrum antibiotics and active observation)
Main outcome measures: Primary outcome measure was the proportion of eligible patients recruited. Secondary outcomes evaluated adherence to interventions, data collection during followup, safety of treatment pathways and clinical course.
Results: Fifty percent of eligible participants (95%CI 40-59) approached about the trial agreed to participate and were randomised. Repeated bespoke recruiter training was associated with an increase in recruitment rate over the course of the trial from 38% to 72%. There was high acceptance of randomisation, good patient and surgeon adherence to trial procedures and satisfactory completion of follow-up. Although more participants had perforated appendicitis than had been anticipated, treatment pathways were found to be safe and adverse event profiles acceptable.
Conclusion: Recruitment to a randomised controlled trial examining the effectiveness and costeffectiveness of a non-operative treatment pathway compared to appendicectomy for the treatment of uncomplicated acute appendicitis in children is feasible.
Bibliographical noteFunding Information:
Funding This study is part of a larger project, CONTRACT, funded by the UK National Institute for Health Research (NIHR) Health Technology Assessment programme (grant number: 14/192/90; http://www.nets.nihr.ac.uk/projects/hta/ 1419290). JMB is supported by the NIHR Bristol Biomedical Research Centre and is an NIHR Senior Investigator.
8Centre for Academic Child Health, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK 9National Institute of Health Research (NIHR), Research Design Service South Central, University of Southampton, Southampton, UK 10Department of Paediatric Surgery, Alder Hey Children’s NHS foundation Trust, Liverpool, UK 11Department of Paediatric Surgery, St George’s University Hospitals NHS Foundation Trust, London, UK 12Southampton Clinical Trials Unit, University of Southampton, Southampton, UK 13Patient and Public Involvement Representative, Southampton, UK 14Centre for Surgical Research and NIHR Bristol Biomedical Research Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK Acknowledgements SE and EW acknowledge support from NIHR Great Ormond Street Hospital Biomedical Research Centre. LB acknowledges support from the Medical Research Council ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures; MR/K025643/1).