Developing a global core outcome set for acute appendicitis
Research type
Research Study
Full title
Development of a global core outcome set for treatment of uncomplicated appendicitis in children
IRAS ID
264208
Contact name
Nigel Hall
Contact email
Sponsor organisation
University Hospitals Southampton NHS Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Appendicitis is a common gastro-intestinal disease affecting roughly 1 in every 12 people in the world, with the highest incidence of occurrence between ages 10 and 19 years. In the last decade, there have been several developments in the treatment of appendicitis in children, with the most recent being non-operative treatment (NOT) for acute uncomplicated appendicitis. Studies investigating the effectiveness of NOT in children show promising results. However, the selected primary (and secondary) outcomes vary widely, which is also reflected in recent systematic reviews assessing the efficacy and safety of NOT. This may have contributed to their contradictory conclusions. Inconsistent selection and reporting of outcomes limits the ability to adequately compare and interpret clinical trial results. Furthermore, it hampers data pooling and subsequent meta-analysis. It also increases the risk of selective outcome reporting, a form of publication bias which in turn jeopardises the validity of results from individual trials and subsequent systematic reviews. A solution for this problem might be prospective meta-analyses (PMA), a type of meta-analysis that identifies, evaluates and determines study eligibility prior to publication of results. In order to perform a PMA, it is essential to make sure the new randomised controlled trials (RCTs) are designed uniformly, including the use of identical outcomes and outcome measurement instruments. The aim of this study is to systematically develop an international COS for the treatment of acute uncomplicated appendicitis in children.
REC name
North West - Haydock Research Ethics Committee
REC reference
19/NW/0359
Date of REC Opinion
14 Jun 2019
REC opinion
Favourable Opinion