Introduction In recent years, there has been growing interest in alternatives to appendicectomy. In particular, non-operative treatment of appendicitis, with antibiotics alone, has been proposed as a potential treatment. A small number of randomised controlled trials (RCTs) in adults and, more recently, children suggest that antibiotic treatment may be a valid alternative to appendicectomy. However, there is currently insufficient data to justify its widespread use. Prior to performing further efficacy studies of the treatment of appendicitis in children, it is imperative to identify the most relevant outcome measures for inclusion in the design of comparative studies. This is of particular importance when evaluating a novel treatment approach since the outcomes of importance may differ from those commonly reported with traditional therapies.
A review of the relevant literature and electronic resources failed to identify a core outcome set (COS) for children with appendicitis. We aim to define a COS for the measurement of treatment interventions in children (<18 years) with acute appendicitis.
Methods and analysis This project will entail: (1) a systematic review to identify previously reported acute uncomplicated appendicitis treatment outcomes; (2) assembly of stakeholder panels (paediatric and adult surgeons, patients and parents); (3) a three-stage Delphi process; and (4) a final consensus meeting to complete the COS.
Ethics and registration COS development is part of CONservative TReatment of Appendicitis in Children - a randomised controlled Trial (Feasibility) (CONTRACT) study, for which full ethical approval for CONTRACT has been granted. The COS development study is registered with the COMET Initiative in May 2017 (http://www.comet-initiative.org/studies/details/987).
- core outcomes
- core outcome set
- consensus meeting
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Contributors FCS, SE and NJH developed a first draft of the protocol. All authors advised on the development of the protocol and contributed towards the revision of the protocol for final submission.
Funding The CONTRACT study is supported by the United Kingdom National Institute for Health Research Health Technology Assessment Programme (Grant number: 14/192/90 http://www.nets.nihr.ac.uk/projects/hta/1419290).
Competing interests None declared.
Ethics approval South Central—Hampshire A Research Ethics Committee (REC ref: 16/SC/0596).
Provenance and peer review Not commissioned; externally peer reviewed.
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