International core outcome set for acute simple appendicitis in children: Results of a systematic review, delphi study, and focus croups with young people
Document Type
Article
Publication Date
1-1-2022
Abstract
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. © 2022 Lippincott Williams and Wilkins. All rights reserved.
Keywords
Acute disease, Adolescent, Appendicitis, Child, Consensus, Delphi technique, Humans, Outcome assessment, Health care, Research design, Treatment outcome, Abdominal abscess, Acute appendicitis, Adolescent, Adult, All cause mortality, Appendectomy, Article, Child, Clinical evaluation, Clinical outcome, Clinical trial (topic), Consensus, Conservative treatment, Core outcome set, Data synthesis, Delphi study, Female, Hospital readmission, Human, Information processing, Intestine obstruction, Male, Medical expert, Meta analysis, Middle aged, Outcome assessment, Postoperative complication, Reoperation, Surgeon, Systematic review, Acute disease, Appendicitis, Methodology, Procedures, Treatment outcome
Divisions
surgerydept
Funders
Department of Pediatric Surgery,Amsterdam University Medical Centers
Publication Title
Annals of Surgery
Volume
276
Issue
6
Publisher
Lippincott, Williams & Wilkins