Centre for Health Informatics, Australian Institute for Health Innovation, University of New South Wales, Sydney, Australia.
J Am Med Inform Assoc. 2012 Jan-Feb;19(1):45-53. doi: 10.1136/amiajnl-2011-000369. Epub 2011 Sep 8.
To expand an emerging classification for problems with health information technology (HIT) using reports submitted to the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database.
HIT events submitted to MAUDE were retrieved using a standardized search strategy. Using an emerging classification with 32 categories of HIT problems, a subset of relevant events were iteratively analyzed to identify new categories. Two coders then independently classified the remaining events into one or more categories. Free-text descriptions were analyzed to identify the consequences of events.
Descriptive statistics by number of reported problems per category and by consequence; inter-rater reliability analysis using the κ statistic for the major categories and consequences.
A search of 899 768 reports from January 2008 to July 2010 yielded 1100 reports about HIT. After removing duplicate and unrelated reports, 678 reports describing 436 events remained. The authors identified four new categories to describe problems with software functionality, system configuration, interface with devices, and network configuration; the authors' classification with 32 categories of HIT problems was expanded by the addition of these four categories. Examination of the 436 events revealed 712 problems, 96% were machine-related, and 4% were problems at the human-computer interface. Almost half (46%) of the events related to hazardous circumstances. Of the 46 events (11%) associated with patient harm, four deaths were linked to HIT problems (0.9% of 436 events).
Only 0.1% of the MAUDE reports searched were related to HIT. Nevertheless, Food and Drug Administration reports did prove to be a useful new source of information about the nature of software problems and their safety implications with potential to inform strategies for safe design and implementation.
利用向美国食品和药物管理局制造商和用户设施设备体验（MAUDE）数据库提交的报告，扩展健康信息技术（HIT）问题的新兴分类。
使用标准化搜索策略检索 MAUDE 中提交的 HIT 事件。使用具有 32 个 HIT 问题类别的新兴分类，对一组相关事件进行迭代分析以识别新类别。然后，两名编码员将其余事件独立分类到一个或多个类别中。对自由文本描述进行分析以确定事件的后果。
按每个类别报告的问题数量和后果进行描述性统计；使用κ统计量对主要类别和后果进行评分者间可靠性分析。
对 2008 年 1 月至 2010 年 7 月的 899768 份报告进行搜索，共获得 1100 份关于 HIT 的报告。删除重复和不相关的报告后，剩余 678 份报告描述了 436 起事件。作者确定了四个新类别来描述软件功能、系统配置、与设备的接口以及网络配置方面的问题；通过添加这四个类别，作者的 HIT 问题 32 个类别的分类得到了扩展。对 436 起事件进行检查后发现有 712 个问题，其中 96%与机器有关，4%与人机界面有关。近一半（46%）的事件与危险情况有关。在与患者伤害相关的 46 起事件（11%）中，有四起与 HIT 问题相关的死亡事件（436 起事件的 0.9%）。
在搜索的 MAUDE 报告中，仅有 0.1%与 HIT 相关。然而，FDA 报告确实成为有关软件问题性质及其安全影响的有用新信息来源，有可能为安全设计和实施策略提供信息。
