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Establishing a core outcome set for treatment of uncomplicated appendicitis in children: study protocol for an
Max Knaapen1, Nigel J Hall2, Johanna H van der Lee3
1Paediatric Surgical Centre, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Vrije Universiteit, Amsterdam, The Netherlands.
Insights
This study aims to develop a global core outcome set (COS) for acute uncomplicated appendicitis in children. Standardizing outcomes will improve research comparability and data pooling for appendicitis treatments.
Area of Science:
- Pediatric surgery
- Clinical trial methodology
- Global health outcomes research
Background:
- Appendicitis is a common global disease, particularly in adolescents.
- Current research on appendicitis treatments lacks standardized outcome reporting.
- Varied outcomes in trials hinder comparison and data pooling.
Purpose of the Study:
- To develop a global core outcome set (COS) for acute uncomplicated appendicitis in children.
- To establish unified reporting standards for appendicitis treatment interventions.
- To enhance the comparability and interpretability of clinical trial results.
Main Methods:
- Utilizing international standard methodology for COS development.
- Conducting a systematic review of existing appendicitis outcome data.
- Implementing a three-step global Delphi study with surgeons and parents.
- Engaging children and young people through their parents and direct interaction.
Main Results:
- The study protocol outlines a phased approach to COS development.
- Involves systematic review, global Delphi survey, and expert consensus meeting.
- Aims to achieve consensus on core outcomes for pediatric appendicitis research.
Conclusions:
- A standardized core outcome set is crucial for appendicitis research.
- This initiative will facilitate better comparison of treatment interventions.
- The developed COS will improve the quality and utility of research data.
Introduction:
Appendicitis is a global disease affecting roughly 1 in every 12 people in the world, with the highest incidence between ages 10 and 19 years. To date, a wide variety of health outcomes have been reported in randomised controlled trials and meta-analyses evaluating treatments for appendicitis. This is especially the case in studies comparing non-operative treatment with operative treatment. A set of standard outcomes, to be reported in all future trials, is needed to allow for adequate comparison and interpretation of clinical trial results and to make data pooling possible. This protocol describes the development of such a global core outcome set (COS) to allow unified reporting of treatment interventions in children with acute uncomplicated appendicitis.
Methods And Analysis:
We use current international standard methodology for the development and reporting of this COS. Its development consists of three phases: (1) an update of the most recent systematic review on outcomes reported in uncomplicated paediatric appendicitis research to identify additional outcomes, (2) a three-step global Delphi study to identify a set of core outcomes for which there is consensus between parents and (paediatric) surgeons and (3) an expert meeting to finalise the COS and its definitions. Children and young people will be involved through their parents during phase 2 and will be engaged directly using a customised face-to-face approach.
Ethics And Dissemination:
The medical research ethics committee of the Academic Medical Center Amsterdam has approved the study. Each participating country/research group will ascertain ethics board approval. Electronic informed consent will be obtained from all participants. Results will be presented in peer-reviewed academic journals and at (international) conferences.
Trial Registration Number:
COMET registration: 1119.
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