Abstract
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. The adverse events were graded to their severity and their potential relation to surgical treatment. RESULTS: A total of 55 patients (21%) suffered from an adverse event and 16 (6%) from a serious adverse event. In 38 patients' one adverse event occurred, 12 patients showed 2 adverse events and 5 patients suffered from a combination of an adverse and a serious adverse event. A serious adverse event alone occurred in 11 patients. The incidence of adverse events (Fisher p = 0.448) and serious adverse (p = 0.126) events showed no significant difference between the two cohorts. The most common adverse events were deep vein thrombosis (8% and 5%) followed by wound healing problems (1% and 0%) and haematoma (1% and 3%). A wide range of non surgical adverse events were recorded with low incidence levels. CONCLUSION: The use of the modified ICH-GCP format supports standardization of adverse event reporting. Routine assessment of adverse events by a study nurse revealed higher incidence rates of adverse events in total knee arthroplasty. We recommend the implementation of trained paramedical staff for the documentation of adverse events in routine clinical care.