Identifying adverse drug events: Development of a computer-based monitor and comparison with chart review and stimulated voluntary report
Identifying adverse drug events: Development of a computer-based monitor and comparison with chart review and stimulated voluntary report
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DOI：
10.1136/jamia.1998.0050305
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发表时间：
1998-05-01
影响因子：
6.4
通讯作者：
Bates, DW
中科院分区：
文献类型：
--
作者：
Jha, AK;Kuperman, GJ;Bates, DW
背景：药物不良事件 (ADE) 既常见又昂贵。大多数医院通过自发报告来识别不良事件，但这种方法缺乏敏感性；图表审查可以识别更多事件，但费用昂贵。基于计算机的 ADE 识别方法似乎很有前景，但尚未与图表审查进行直接比较，也没有广泛使用。目标：开发基于计算机的 ADE 监测仪，并将监测仪发现的 ADE 发生率和类型与图表审查和刺激自愿报告发现的进行比较。设计：在一家三级医院进行前瞻性队列研究。参与者：八个月内入住三级医院九个内科和外科病房的所有患者主要结果指标：通过基于计算机的监测器、图表审查和刺激自愿报告来识别药物不良事件。方法：基于计算机的监测程序识别警报，这些警报表明可能存在 ADE（例如，订购纳洛酮等解毒剂）。然后，训练有素的审查人员检查患者的医院记录，以确定是否发生了 ADE。基于计算机的监测策略的结果与其他两种 ADE 检测策略进行了比较：强化图表审查以及护士和药剂师的刺激自愿报告。监测和图表审查策略是独立的，审查者是盲的。结果：计算机监测策略识别出 2,620 个警报，其中 275 个被确定为 ADE。图表审查发现了 398 种 ADE，而自愿报告发现了 23 种。在通过至少一种方法检测到的 617 种 ADE 中，计算机监控和图表审查同时检测到了 76 种 ADE。电脑显示器识别出 45%；图表审查，65%；自愿报告，4%。与通过图表审查确定的 ADE 相比，通过计算机监控确定的 ADE 更有可能被归类为“严重”（51% vs 42%，p = 0.04）。在研究的前八周内，计算机生成的警报的阳性预测值为 16%；规则修改在最后八周内将这一比例增加至 23%。计算机策略需要每周 11 个人时来执行，而图表审查需要每周 55 个人时，自愿报告策略则需要 5 个人时。
Background: Adverse drug events (ADEs)aye both common and costly. Most hospitals identify ADEs using spontaneous reporting, but this approach lacks sensitivity; chart review identifies more events but is expensive. Computer-based approaches to ADE identification appear promising, but they have not been directly compared with chart review and they are not widely used.Objectives: To develop a computer-based ADE monitor, and to compare the rate and type of ADEs found with the monitor with those discovered by chart review and by stimulated voluntary report.Design: Prospective cohort study in one tertiary-care hospital.Participants: All patients admitted to nine medical and surgical units in a tertiary-care hospital over an eight-month period.Main Outcome Measure: Adverse drug events identified by the computer-based monitor, by chart review, and by stimulated voluntary report.Methods: A computer-based monitoring program identified alerts, which were situations suggesting that an ADE might be present (e.g., an order for an antidote such as naloxone). A trained reviewer then examined patients' hospital records to determine whether an ADE had occurred. The results of the computer-based monitoring strategy were compared with two other ADE detection strategies: intensive chart review and stimulated voluntary report by nurses and pharmacists. The monitor and the chart review strategies were independent, and the reviewers were blinded.Results: The computer monitoring strategy identified 2,620 alerts, of which 275 were determined to be ADEs. The chart review found 398 ADEs, whereas voluntary report detected 23. Of the 617 ADEs detected by at least one method, 76 ADEs were detected by both computer monitor and chart review. The computer monitor identified 45 percent; chart review, 65 percent; and voluntary report, 4 percent. The ADEs identified by computer monitor were more likely to be classified as "severe" than were those identified by chart review (51 versus 42 percent, p =.04). The positive predictive value of computer-generated alerts was 16 percent during the first eight weeks of the study; rule modifications increased this to 23 percent in the final eight weeks. The computer strategy required 11 person-hours per week to execute, whereas chart review required 55 person-hours per week and voluntary report strategy required 5.