International Core Outcome Set for Acute Simple Appendicitis in Children: Results of a Systematic Review, Delphi Study, and Focus Croups With Young People

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 of simple appendicitis in children, to reduce heterogeneity between studies and
facilitate data synthesis and evidence-based decision-making.

Aim

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.

Contributors

Max Knaapen, Nigel J Hall, Darcy Moulin, Johanna H van der Lee, Nancy J Butcher, Peter C Minneci, Jan F Svensson, Shawn D St Peter, Susan Adams, Shireen A Nah, Erik D Skarsgard, Augusto Zani, Sherif Emil, Janne S Suominen, Dayang A Aziz, Rambha Rai, Martin Offringa, Ernst W van Heurn, Roel Bakx, Ramon R Gorter; pediatric appendicitis COS development group

Publication

Journal: Annals of Surgery
Volume: 276
Issue: 6
Pages: 1047 - 1055
Year: 2022
DOI: 10.1097/SLA.0000000000004707

Further Study Information

Current Stage: Completed
Date:
Funding source(s): This research was supported by the foundation of research and management projects in pediatric surgery (KCHOMP), from the Department of Pediatric Surgery, Amsterdam UMC

Health Area

Disease Category: Gastroenterology

Disease Name: Acute Appendicitis

Target Population

Age Range: 18

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)

Study Type

- COS for clinical trials or clinical research

Method(s)

- Consensus meeting
- Delphi process
- Focus group(s)
- Systematic review

Development consisted of 4 phases: (1) compilation of a list of outcomes for the Delphi study, by an update of the 2015 systematic review, identifying all previously reported outcomes, (2) a 2-round international Delphi study to identify a set of core outcomes for which there is consensus among parents (including, where appropriate, their child) and surgeons, (3) focus groups with young people to identify missing outcomes (4) international
expert meetings with parents, surgeons, and researchers to ratify the final COS.

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