4 FEASIBILITY OF RECRUITMENT TO A UK RANDOMISED CONTROLLED TRIAL COMPARING NON-OPERATIVE TREATMENT WITH APPENDICECTOMY IN CHILDREN WITH ACUTE UNCOMPLICATED APPENDICITIS
Nigel Hall1,2, Lucy Beasant3, Fran Sherrat4, Esther Crawley3, Isabel Reading5, Harriet Corbett6, Michael Stanton2, Dean Rex7, Natalie Hutchings8, Liz Dixon8, Jane Blazeby3, Bridget Young4
1University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, United Kingdom. 2Southampton Chidren's Hospital, Southampton, United Kingdom. 3University of Bristol, Bristol, United Kingdom. 4University of Liverpool, Liverpool, United Kingdom. 5Faculty of Medicine, University of Southampton, Southampton, United Kingdom. 6Alder Hey Children's Hospital, Liverpool, United Kingdom. 7St George's Hospital, London, United Kingdom. 8University of Southampton, Southampton, United Kingdom

Abstract

Aim of the study: A randomised controlled trial (RCT) comparing efficacy of non-operative treatment and appendicectomy for acute uncomplicated appendicitis in children in the UK is warranted. Recruitment is likely to be challenging due to the emergency nature and variable timing of hospital admission, complexity of interventions and inexperienced recruiting teams. We undertook a feasibility RCT to establish whether a main trial was possible in terms of recruitment, adherence to treatment and follow up. Here we report feasibility of recruitment.

 

Methods: Three-centre feasibility RCT comparing non-operative treatment pathway with appendicectomy in children (4-15yrs) with acute uncomplicated appendicitis diagnosed by a paediatric surgeon. Embedded qualitative research that included audio-recording of recruitment conversations and interviews with families and recruiters identified barriers and facilitators to recruitment. Qualitative data informed training for surgeon recruiters to optimise recruitment. Primary outcome was recruitment rate. Ethical approval:16/SC/0596.

 

Results: Of 236 children with acute appendicitis, 114 (48%) met eligibility criteria, of whom 100 were invited into the RCT. Of these, 46 agreed and were enrolled. Half (23/46) were recruited out-of-hours (18:00-08:00) and 19% (9/46) at weekends. Over 21 surgeons were involved in recruitment. Two participants (<5%) withdrew consent after randomisation and 2 (<5%) were non-compliant with assigned treatment. Qualitative research identified barriers to recruitment including imbalance in how surgeons initially presented treatment arms and stakeholder treatment preferences. In training sessions we encouraged surgeons to adjust their communication to give a more balanced presentation of trial arms and to explore families’ beliefs about antibiotics and surgery to address treatment preferences.


Conclusions: An appropriately powered UK RCT to understand the clinical effectiveness of these two approaches is feasible. All centres and surgeons were able to recruit with training. Qualitative research enhances communication with families and trial processes, and should be incorporated within a future trial.


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