Background:Research studies to inform clinical practice and policy in children and young people withappendicitis are hampered by inconsistent selection and reporting of outcomes. The aim of this study wasto develop a core outcome set for reporting all studies of uncomplicated acute appendicitis in childrenand young people.
Methods:Systematic literature reviews, qualitative interviews with parents and patients treated foruncomplicated acute appendicitis, and a Study-Specific Advisory Group informed a long list of outcomes.Outcomes were then prioritized by stakeholders based in the UK (patients, parents, and paediatricand general surgeons) in an online three-round Delphi consensus process, followed by face-to-face consensus meetings.
Results:A long list of 40 items was scored by 147 key stakeholders in the first Delphi round, of whom90 completed the two subsequent Delphi rounds. The final core outcome set comprises 14 outcomes:intra-abdominal abscess, reoperation (including interventional radiology procedure), readmission to hospital, bowel obstruction, wound infection, antibiotic failure, wound complication, negative appendicectomy, recurrent appendicitis, death, patient stress/psychological distress, length of hospital stay, time away from full activity and child’s quality of life.
Conclusion:A core outcome set comprising 14 outcomes across five key domains has been developed for reporting studies in children and young people with uncomplicated acute appendicitis. Further work is required to determine how and when to measure these outcomes.
F. C. Sherratt1, B. S. R. Allin2,J.J.Kirkham3,E.Walker4, B. Young1, W. Wood6, L. Beasant8,Appendicitis Core Outcome Set Study Group*, S. Eaton5and N. J. Hall7
1Institute of Population Health Sciences, University of Liverpool, Liverpool,2National Perinatal Epidemiology Unit, University of Oxford, Oxford,3Centre for Biostatistics, Manchester Academic Health Science Centre, University of Manchester, Manchester,4Centre for Outcomes and ExperienceResearch in Children’s Health Illness and Disability (ORCHID), Great Ormond Street Hospital for Children NHS Foundation Trust,and5Developmental Biology and Cancer Programme, University College London Great Ormond Street Institute of Child Health, London,6NationalInstitute for Health Research (NIHR) Research Design Service South Central, and7University Surgery Unit, Faculty of Medicine, University ofSouthampton, Southampton, and8Bristol Medical School, University of Bristol, Bristol, UK
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Systematic review
Systematic literature reviews, qualitative interviews with parents and patients treated for
uncomplicated acute appendicitis, and a Study-Specific Advisory Group informed a long list of outcomes. Outcomes were then prioritized by stakeholders based in the UK (patients, parents, and paediatric and general surgeons) in an online three-round Delphi consensus process, followed by face-to-face consensus meetings.