TY - JOUR
T1 - International Core Outcome Set for Acute Simple Appendicitis in Children
T2 - Results of a Systematic Review, Delphi Study, and Focus Croups with Young People
AU - Knaapen, Max
AU - Hall, Nigel J.
AU - Moulin, Darcy
AU - van der Lee, Johanna H.
AU - Butcher, Nancy J.
AU - Minneci, Peter C.
AU - Svensson, Jan F.
AU - St. Peter, Shawn D.
AU - Adams, Susan
AU - Nah, Shireen A.
AU - Skarsgard, Erik D.
AU - Zani, Augusto
AU - Emil, Sherif
AU - Suominen, Janne S.
AU - Aziz, Dayang A.
AU - Rai, Rambha
AU - Offringa, Martin
AU - van Heurn, Ernst W.
AU - Bakx, Roel
AU - Gorter, Ramon R.
N1 - Funding Information:
Olivier Abbo, MD - Hôpital des Enfants de Toulouse - CHU de Toulouse, France Alexix P Arnaud, MD - Hôpital Sud, University Hospital, Rennes, France Agostino Pierro, PhD - The Hospital for Sick Children & University of Toronto, Toronto, ON, Canada Mark Stasiewicz, MsC - The Hospital for Sick Children & University of Toronto, Toronto, ON, Canada Nadia Safa, MD - Montreal Children’s Hospital, Montreal, QC, Canada Crystal Ng - British Columbia Children’s Hospital, Vancouver, BC, Canada Zarina A Latiff MD - Department of Pediatric Surgery, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia Marjmin Osman MD - Department of Pediatric Surgery, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia. Azrina S K Zaman MD - Department of Pediatric Surgery, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia. This research was supported by the foundation of research and management projects in pediatric surgery (KCHOMP), from the Department of Pediatric Surgery, Amsterdam UMC.
Publisher Copyright:
© 2022 Lippincott Williams and Wilkins. All rights reserved.
PY - 2022/12/1
Y1 - 2022/12/1
N2 - 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.
AB - 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.
KW - appendicitis
KW - appendicitis research
KW - core outcome set
KW - nonoperative treatment
KW - simple appendicitis
UR - https://www.scopus.com/pages/publications/85141894762
U2 - 10.1097/SLA.0000000000004707
DO - 10.1097/SLA.0000000000004707
M3 - Article
C2 - 33630468
SN - 0003-4932
VL - 276
SP - 1047
EP - 1055
JO - Annals of Surgery
JF - Annals of Surgery
IS - 6
ER -