Department of Hospital Pharmacy, Academic Medical Centre, Amsterdam, The Netherlands.
J Eval Clin Pract. 2013 Dec;19(6):1073-82. doi: 10.1111/jep.12033. Epub 2013 Apr 18.
OBJECTIVES: This study demonstrates the development, reliability and outcome of a targeted method for standardized assessment of adverse drug events (ADEs) in surgical patients. METHODS: Initial practice evaluation of this ADE assessment method was carried out in a prospective single centre cohort study. In total, 262 electively admitted surgical patients were included. The surgical trigger tool was applied to patients' medical records by two independent reviewers, and subsequent assessment of causality, severity and preventability of ADEs was carried out by two independent expert panels consisting of a consultant surgeon and a clinical pharmacologist. The surgical trigger tool and causality assessment method were each tested on reliability in a separate group of 50 randomly selected patients using Fleiss and Cohen's kappa statistics and percentages of agreement. Comparison of this method with an existing trigger tool method for ADEs was performed. RESULTS: Our surgical trigger tool contains 51 triggers. The inter- and intra-rater calculations showed substantial to almost perfect levels of agreement (kappa range 0.71-0.83), with a 97.8-98.5% percentage of agreement. Fair to substantial levels of agreement were calculated for causality, severity and preventability (kappa range 0.38-0.79). The percentages of inter- and intra-rater agreement were 68.9 and 70.5% for causality, 67.0 and 82.0% for severity, and both 98.4% for preventability, respectively. Compared with the existing trigger tool method for ADEs, we found an additional 363 triggers, 18 ADEs (an extra 20%) and 3 preventable ADEs in our surgical cohort. CONCLUSIONS: This targeted trigger tool for standardized assessment of ADEs in surgical patients shows excellent agreement between reviewers. The assessment of medication-related harm had acceptable agreement. Compared with an existing ADE trigger tool method, the present method found almost 20% extra ADEs. This method can be a useful alternative to existing trigger tool methods, in particular to assess medication safety in surgical patients.
目的：本研究旨在展示一种针对手术患者不良药物事件（ADE）标准化评估的靶向方法的开发、可靠性和结果。
方法：本ADE 评估方法的初步实践评估是在一项前瞻性单中心队列研究中进行的。共纳入 262 例择期住院手术患者。两名独立审查员将手术触发工具应用于患者的病历中，随后由两名由顾问外科医生和临床药理学家组成的独立专家小组对 ADE 的因果关系、严重程度和可预防进行评估。在另一组 50 名随机选择的患者中，使用 Fleiss 和 Cohen 的kappa 统计和一致性百分比分别对手术触发工具和因果关系评估方法进行了可靠性测试。
结果：我们的手术触发工具包含 51 个触发器。组内和组间评分者的计算显示，一致性处于中等至高几乎完美的水平（kappa 范围 0.71-0.83），一致性百分比为 97.8-98.5%。因果关系、严重程度和可预防程度的计算结果显示，一致性处于公平至中等程度（kappa 范围 0.38-0.79）。因果关系的组内和组间评分者的一致性百分比分别为 68.9%和 70.5%，严重程度为 67.0%和 82.0%，可预防程度均为 98.4%。与现有的 ADE 触发工具方法相比，我们在手术队列中发现了另外 363 个触发器、18 个 ADE（额外 20%）和 3 个可预防的 ADE。
结论：本研究中用于评估手术患者 ADE 的靶向触发工具在审查者之间具有极好的一致性。药物相关伤害的评估具有可接受的一致性。与现有的 ADE 触发工具方法相比，本方法发现了近 20%的额外 ADE。该方法可以作为现有触发工具方法的有用替代方法，特别是在评估手术患者的药物安全性方面。
J Eval Clin Pract. 2013-4-18
Qual Saf Health Care. 2006-6
Eur J Cancer. 2014-12-27
Farm Hosp. 2009
PLoS One. 2014-7-9
Int J Clin Pharm. 2013-5-31
Zotero 插件