Definition, Documentation, and Classification of Complications in Pediatric Surgical Literature—A Plea for Standardization

Abstract

Severity grading systems for complications in surgical patients have been used since 1992. An increasing assessment of these instruments in pediatric surgery is also noticed, without their validation in children. To analyze the current practice, we performed a literature review with focus on the assessment and grading of complications. The review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Studies reporting on postoperative complications as a primary or secondary endpoint using a severity grading system were included. Definition for simple adverse events, classification systems used, and the time horizon of postoperative documentation were analyzed. A total of 566 articles were screened, of which 36 met the inclusion criteria. About 86.1% of the papers were retrospective and 13.9% prospective analyses. None of the studies were prospective-randomized trials. Twenty (55.6%) studies did not include a definition of adverse events, whereas the remaining 16 (44.4%) showed variations in their definitions. All studies applied the Clavien-Dindo classification, whereas five (13.9%) additionally used the Comprehensive Complication Index. One study compared alternative grading instruments with the Clavien-Dindo classification, without demonstrating the superiority of any classification in pediatric surgery. Twenty-two studies (61.1%) did not report the time horizon of perioperative complication documentation, while 8 studies (22.2%) used 30 days and 6 studies (16.7%) used 3 months of postoperative documentation. Definition and classification of postoperative complications are inconsistent in the pediatric surgical literature. Establishment of a standardized protocol is mandatory to accurately compare outcome data.

Benchmarks for Pediatric Surgical Registries: Recommendations for the Assessment and Grading of Complications

“…-the implementation of prospective databases, -the evaluation of adverse events by designated teams, -the adoption of consistent definitions of complications and events, -the application of severity grading systems, -the definition of a specific timeframe for documenting postoperative complications and adverse events (Table 1). 37…”

“…Recently published recommendations for the definition, documentation, and classification of complications in pediatric surgical literature 37…”

“…[34][35][36] Reporting of Adverse and Unexpected Events in the Pediatric Surgical Literature A recent review of the limitations of event reporting in the pediatric surgical literature resulted in a plea for standardization of the definition, documentation, and classification of complications. 37 While the Clavien-Dindo classification has been increasingly used in pediatric studies on children, the instrument has never been validated in pediatric cohorts. A study by the Hannover group failed to demonstrate any advantages of the Clavien-Dindo classification when applied to children compared with other available severity grading systems.…”

“…13 The authors concluded that while the Clavien-Dindo classification has broad application, more effort should be devoted to validating its suitability for use in children. 37 Drawing from the adult surgical literature, the authors proposed benchmarks for documenting unexpected events in pediatric surgery.…”

Discussing Complications after Surgery Consists of Multiple Dimensions

“…Madadi-Sanjani et al 15 give an overview on current scientific practices of the assessment and classification of adverse events in the pediatric surgical literature, concluding practical guidelines for future application.…”