International Core Outcome Set for Acute Simple Appendicitis in Children: Results of a Systematic Review, Delphi
Max Knaapen1, Nigel J Hall2, Darcy Moulin3
1Department of Pediatric Surgery, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam & Vrije Universiteit, Amsterdam, The Netherlands.
Insights
A core outcome set (COS) was developed for pediatric appendicitis clinical trials. This standardized set of 12 outcomes ensures consistent reporting and facilitates evidence-based decision-making in pediatric appendicitis research.
Area of Science:
- Pediatric Surgery
- Clinical Trial Methodology
- Health Outcomes Research
Background:
- Acute simple appendicitis is common in children, but variability in outcome reporting across clinical trials hinders data synthesis.
- A prior systematic review identified 115 outcomes, highlighting the need for a standardized core outcome set (COS).
Approach:
- An updated systematic review identified outcomes, followed by a two-stage international Delphi survey involving parents and surgeons.
- Focus groups with young people identified additional outcomes, and international expert meetings ratified the final COS.
- The development involved a multi-phase, international consensus-building process.
Key Points:
- The systematic review identified 129 outcomes, refined to 43 unique terms for the Delphi survey.
- Consensus was reached on 10 outcomes through the Delphi study, with 2 additional outcomes added from youth focus groups.
- The final core outcome set includes 12 critical outcomes: mortality, bowel obstruction, intraabdominal abscess, recurrent appendicitis, complicated appendicitis, return to baseline health, readmission, reoperation, unplanned appendectomy, adverse events, and major/minor complications.
Conclusions:
- An evidence-informed core outcome set for pediatric appendicitis has been established through international consensus.
- This COS, developed with patient and parent input, is recommended for all future clinical trials.
- Implementing this COS will reduce study heterogeneity and improve data synthesis for evidence-based decision-making in pediatric appendicitis treatment.
Objective:
To develop an international core outcome set (COS), a minimal collection of outcomes that should be measured and reported in all future clinical trials evaluating treatments of acute simple appendicitis in children.
Summary Of Background Data:
A previous systematic review identified 115 outcomes in 60 trials and systematic reviews evaluating treatments for children with appendicitis, suggesting the need for a COS.
Methods:
The development process consisted of 4 phases: (1) an updated systematic review identifying all previously reported outcomes, (2) a 2-stage international Delphi study in which parents with their children and surgeons rated these outcomes for inclusion in the COS, (3) focus groups with young people to identify missing outcomes, and (4) international expert meetings to ratify the final COS.
Results:
The systematic review identified 129 outcomes which were mapped to 43 unique outcome terms for the Delphi survey. The first-round included 137 parents (8 countries) and 245 surgeons (10 countries), the second-round response rates were 61% and 85% respectively, with 10 outcomes emerging with consensus. After 2 young peoples' focus groups, 2 additional outcomes were added to the final COS (12): mortality, bowel obstruction, intraabdominal abscess, recurrent appendicitis, complicated appendicitis, return to baseline health, readmission, reoperation, unplanned appendectomy, adverse events related to treatment, major and minor complications.
Conclusion:
An evidence-informed COS based on international consensus, including patients and parents has been developed. This COS is recommended for all future studies evaluating treatment ofsimple appendicitis in children, to reduce heterogeneity between studies and facilitate data synthesis and evidence-based decision-making.
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