Purpose: Identification of all common and potentially avoidable adverse events is crucial to further improve the quality of medical care. The intention of the current study was to evaluate a standardized physician independent survey format on adverse events in total knee arthroplasty. The protocol for reporting adverse drug events following the International Conference of Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH) was adopted for adverse events occurring during surgical interventions.
Material and methods
Data of a prospective sequential cohort trial introducing a clinical pathway for total knee arthroplasty was analysed. Reporting of adverse events was done by a physician independent study nurse using the modified ICH-Good Clinical Practice (GCP) format (Structure and Content of Clinical study reports – E3) in 260 patients.