Core Outcome Measures in Effectiveness Trials

A Core Outcome Set For Use In Determining The Overall Success Of Acute Uncomplicated Appendicitis Treatment In Children

General Information

Summary:
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 COS for children with appendicitis. This project will entail a Delphi process and consensus meeting to define a core outcome set for the measurement of treatment interventions in children (< 18 years) with acute appendicitis.

Contributors:
Principal investigators: Dr Simon Eaton, UCL Great Ormond Street Institute of Child Health and Mr Nigel Hall, University of Southampton
Dr Frances Sherratt and Professor Bridget Young, University of Liverpool
Ms Lucy Beasant, Professor Esther Crawley and Professor Jane Blazeby, University of Bristol
Dr Erin Walker, Great Ormond Street Hospital, London

Further Study Information

Current Stage:
Planning
Date:
March 2017 - September 2018
Funding source(s):
NIHR

Health Area

Disease Category
Child health

Disease Name
Acute Appendicitis

Target Population

Age Range
5 - 18

Sex
Either


Nature / type of Intervention
Surgery
Antibiotics

Method(s)

Consensus conference
Consensus meeting
Delphi process
Survey
Systematic review

Questions will be identified by a systematic literature review. This will be followed by a Delphi process and finally a consensus meeting.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Families
Patient/ support group representatives

Study Type

COS for clinical trials or clinical research

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