Kirschner Stephan, Lützner Jörg, Günther Klaus-Peter, Eberlein-Gonska Maria, Krummenauer Frank
Department of Orthopedic Surgery University Hospital Carl Gustav Carus Medical Faculty of the Technical University of Dresden/Germany.
Patient Saf Surg. 2010 Aug 11;4(1):12. doi: 10.1186/1754-9493-4-12.
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.
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.
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.
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.
识别所有常见且可能避免的不良事件对于进一步提高医疗质量至关重要。本研究旨在评估一种关于全膝关节置换术中不良事件的标准化医生独立调查形式。对于手术干预期间发生的不良事件，采用了遵循国际人用药品注册技术协调会（ICH）药品注册技术要求国际会议的药品不良事件报告方案。
分析了一项引入全膝关节置换临床路径的前瞻性序贯队列试验的数据。由一名医生独立研究护士采用改良的ICH - 良好临床实践（GCP）格式（临床研究报告的结构和内容 - E3）对260例患者的不良事件进行报告。不良事件根据其严重程度及其与手术治疗的潜在关系进行分级。
共有55例患者（21%）发生不良事件，16例（6%）发生严重不良事件。38例患者发生1次不良事件，12例患者出现2次不良事件，5例患者同时发生不良事件和严重不良事件。仅11例患者发生严重不良事件。两组之间不良事件（Fisher p = 0.448）和严重不良事件（p = 0.126）的发生率无显著差异。最常见的不良事件是深静脉血栓形成（8%和5%），其次是伤口愈合问题（1%和0%）和血肿（1%和3%）。记录了多种发生率较低的非手术不良事件。
使用改良的ICH - GCP格式有助于不良事件报告的标准化。研究护士对不良事件的常规评估显示全膝关节置换术中不良事件的发生率较高。我们建议在常规临床护理中配备经过培训的辅助医务人员来记录不良事件。
