Gerkens Sophie, Beguin Claire, Crott Ralph, Closon Marie-Christine, Horsmans Yves
Université catholique de Louvain, School of Public Health, Brussels, Belgium.
J Eval Clin Pract. 2008 Aug;14(4):585-94. doi: 10.1111/j.1365-2753.2007.00926.x. Epub 2008 May 2.
RATIONALE, AIMS AND OBJECTIVES: 'Real world data' are needed to assess the quality of pharmacological treatments in clinical practice. The aim of this study was to determine whether administrative databases can be used to assess the quality of prophylaxis with low-molecular-weight heparin after major orthopaedic surgery.
The study was performed in a Belgian university hospital. Patients undergoing total hip replacement (THR), total knee replacement (TKR) or hip fracture surgery (HFS) were selected retrospectively from the hospital's 2002 and 2003 administrative databases. Readmissions during the same year as the procedure were also analysed. Three quality indicators were assessed: incidence of venous thromboembolism (VTE), major bleeding and death; adherence to guidelines; and the costs of care.
Although 70% of data were collected from administrative databases, patients' records also had to be examined. During the period studied, VTE and major bleeding events were rare. Patients undergoing HFS were at greater risk of having a pulmonary embolism [Exact odds ratio (OR)=3.78; 95% confidence interval (CI)=1.13-16.22; P=0.03] or of death from any cause (Exact OR=2.15; 95% CI=1.52-infinity; P<0.01) than patients undergoing THR or TKR. The hospital's prophylaxis protocol was not always followed. Half the patients received higher prophylaxis doses than recommended and 11% received lower doses but no impact on adverse events was demonstrated.
Results show that administrative databases contain enough information to measure the frequency of adverse events but complementary data on patient weight and on non-reimbursed drugs must be extracted from the patients' records to evaluate adherence to guidelines. Our findings stress the need for better integration of information systems.
原理、目的和目标:需要“真实世界数据”来评估临床实践中药物治疗的质量。本研究的目的是确定行政数据库是否可用于评估大型骨科手术后低分子量肝素预防治疗的质量。
该研究在比利时一家大学医院进行。从医院2002年和2003年的行政数据库中回顾性选取接受全髋关节置换术(THR)、全膝关节置换术(TKR)或髋部骨折手术(HFS)的患者。还分析了手术同年的再次入院情况。评估了三个质量指标:静脉血栓栓塞(VTE)、大出血和死亡的发生率;对指南的依从性;以及护理费用。
尽管70%的数据是从行政数据库收集的,但仍需检查患者记录。在研究期间,VTE和大出血事件很少见。与接受THR或TKR的患者相比,接受HFS的患者发生肺栓塞的风险更高[精确比值比(OR)=3.78;95%置信区间(CI)=1.13 - 16.22;P = 0.03]或因任何原因死亡的风险更高(精确OR = 2.15;95% CI = 1.52 - 无穷大;P < 0.01)。医院的预防方案并非总是得到遵循。一半的患者接受的预防剂量高于推荐剂量,11%的患者接受的剂量较低,但未显示对不良事件有影响。
结果表明行政数据库包含足够的信息来衡量不良事件的发生频率,但必须从患者记录中提取关于患者体重和非报销药物的补充数据,以评估对指南的依从性。我们的研究结果强调了更好地整合信息系统的必要性。