Development of a core outcome set to determine the overall treatment success of acute uncomplicated appendicitis in children: a study protocol

Abstract

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: (i) a systematic review to identify previously reported acute uncomplicated appendicitis treatment outcomes; (ii) assembly of stakeholder panels (paediatric and adult surgeons, patients and parents); (iii) a three stage Delphi process, and; (iv) 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). KEY MESSAGES What is known about the subject? - Traditionally, appendicectomy has been the gold standard treatment for acute appendicitis in children but there has been increased interest in non-operative treatment (with antibiotics). - Core outcome sets are developed and adopted to avoid inconsistencies in outcome selection, measurement and reporting that may otherwise exist. - There is currently no core outcome set for the measurement of effectiveness of treatment interventions in children with acute uncomplicated appendicitis. What this study adds: - This project will involve defining a core outcome set for the measurement of effectiveness of treatment interventions in children with acute uncomplicated appendicitis. - Considering outcomes of importance to patients, parents of patients and health professionals is crucial for paediatric appendicitis research to be meaningful and relevant.

More information

Identifiers

ORCID for Nigel Hall: orcid.org/0000-0001-8570-9374

Catalogue record

Export record