Validation of the Clavien-Madadi Classification for Unexpected Events in Pediatric Surgery: A Collaborative ERNICA Project

Omid Madadi-Sanjani; Joachim F Kuebler; Julia Brendel; Sara Costanzo; Anna L Granström; Emrah Aydin; Stavros Loukogeorgakis; Martin Lacher; Soeren Wiesner; Anja Domenghino; Pierre-Alain Clavien; Annika Mutanen; Simon Eaton; Benno M Ure

doi:10.1016/j.jpedsurg.2024.03.022

Validation of the Clavien-Madadi Classification for Unexpected Events in Pediatric Surgery: A Collaborative ERNICA Project

J Pediatr Surg. 2024 Mar 16:S0022-3468(24)00174-X. doi: 10.1016/j.jpedsurg.2024.03.022. Online ahead of print.

Authors

Affiliations

¹ Department of Pediatric Surgery, Hannover Medical School, Hannover, Germany; Department of Pediatric Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; European Reference Network for Rare Inherited and Congenital Anomalies (ERNICA), European Union, Netherlands. Electronic address: o.madadi-sanjani@uke.de.
² Department of Pediatric Surgery, Hannover Medical School, Hannover, Germany; European Reference Network for Rare Inherited and Congenital Anomalies (ERNICA), European Union, Netherlands.
³ Pediatric Surgery Department, Vittore Buzzi Children's Hospital, Milano, Italy.
⁴ European Reference Network for Rare Inherited and Congenital Anomalies (ERNICA), European Union, Netherlands; Division of Pediatric Surgery, Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden; Department of Women's and Children's Health, Karolinska Institute, Stockholm, Sweden.
⁵ Department of Pediatric Surgery, Faculty of Medicine, Tekirdağ Namık Kemal University, Tekirdağ, Turkey.
⁶ Stem Cells and Regenerative Medicine Section, UCL Great Ormond Street Institute of Child Health, London, UK.
⁷ Department of Pediatric Surgery, University of Leipzig, Leipzig, Germany.
⁸ Institute of Biostatistics, Hannover Medical School, Hannover, Germany.
⁹ Department of Surgery and Transplantation, University Hospital Zurich, Zurich, Switzerland.
¹⁰ European Reference Network for Rare Inherited and Congenital Anomalies (ERNICA), European Union, Netherlands; Department of Pediatric Surgery, New Children's Hospital, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
¹¹ European Reference Network for Rare Inherited and Congenital Anomalies (ERNICA), European Union, Netherlands; Stem Cells and Regenerative Medicine Section, UCL Great Ormond Street Institute of Child Health, London, UK.

PMID: 38582705
DOI: 10.1016/j.jpedsurg.2024.03.022

Abstract

Background: The Clavien-Madadi classification is a novel instrument for the assessment and grading of unexpected events in pediatric surgery, based on the Clavien-Dindo classification. The system has been adjusted to better fit the pediatric population in a prospective single-center study. There is a need now to validate the Clavien-Madadi classification within an international expert network.

Methods: A pediatric surgical working group created 19 case scenarios with unexpected events in a multi-staged process. Those were circulated within the European Reference Network of Inherited and Congenital Anomalies (ERNICA) and surgeons were instructed to rate the scenarios according to the Clavien-Madadi vs. Clavien-Dindo classification.

Results: 59 surgeons from 12 European countries completed the questionnaire. Based on ratings of the case scenarios, the Clavien-Madadi classification showed significantly superior agreement rates of the respondents (85.9% vs 76.2%; p < 0.05) and was less frequently considered inaccurate for rating the pediatric population compared to Clavien-Dindo (2.1% vs 11.1%; p = 0.05). Fleiss' kappa analysis showed slightly higher strength of agreement using the Clavien-Madadi classification (0.74 vs 0.69). Additionally, intraclass correlation coefficient was slightly higher for the Clavien-Madadi compared to the Clavien-Dindo classification (ICC_just 0.93 vs 0.89; ICC_unjust 0.93 vs 0.89). More pediatric surgeons preferred the Clavien-Madadi classification for the case scenarios (43.0% vs 11.8%; p = 0.002) and advantages of the Clavien-Madadi were confirmed by 81.4% of the surgeons.

Conclusion: The Clavien-Madadi classification is an accurate and reliable instrument for the grading of unexpected events in pediatric surgery. We therefore recommend its application in clinical and academic pediatric surgical practice.

Level of evidence: III.

Keywords: Adverse events; Clavien-Dindo; Clavien-Madadi; Complications; Unexpected events.