中国科技论文统计源期刊 中文核心期刊  
美国《化学文摘》《国际药学文摘》
《乌利希期刊指南》
WHO《西太平洋地区医学索引》来源期刊  
日本科学技术振兴机构数据库(JST)
第七届湖北十大名刊提名奖  
医药导报, 2017, 36(10): 1091-1098
doi: 10.3870/j.issn.1004-0781.2017.10.002
全面触发工具应用现状*
Application Status of Global Trigger Tool
刘翌1,2,, 闫峻峰1,3,, 边原3,

摘要:

目的 了解目前全面触发工具(GTT)国内外应用情况,为GTT在我国医疗机构的应用与完善提供参考。方法 检索Pubmed、中国知网(CNKI)等数据库,查阅收集国内外GTT相关文献,并就GTT用于医疗不良事件(AE)检测相关应用进行分析与评价。结果 共纳入有效研究58项,文献分布15个国家。研究涉及GTT应用的多个方面:AE发生率的测定(62.07%),明确AE发生对象类别的相关研究(36.21%),评估GTT作为AE测量工具的效能(27.59%),GTT应用效能的改进与探索(23.41%),GTT与其他AE检测方法的对比(15.52%);18.97%研究审评者数量及标准均按照GTT白皮书建议,32.76%研究对审评者没有明确描述;报告AE发生率的方法最常用表达方式是住院患者发生AE的比例;研究对象包括一般住院患者、儿童、重症监护患者(ICU)等共11类;一般住院患者发生AE的比例3.4%~43.3%,可预防比例32.2%~72.4%;最常见的AE事件类型是药物相关不良事件、感染/院内获得性感染、手术相关并发症、血钾异常、压力性溃疡等。目前美国、韩国、西班牙、中国等多个国家地区评估显示GTT具有高效性,GTT与其他AE检测方法(包括自愿报告系统、HMPS、QPSIQ、DLCR等)相比具有优势;对GTT性能改良的探索涉及不同资质审评者、审评者经验、抽样方法、样本大小、触发器等对检测效能的影响等多方面。结论 GTT已在多个国家地区应用于医疗机构患者的AE检测,并显示出一定优势,GTT不失为一种有效的AE检测工具,可在我国医疗机构AE监测中推广应用。

关键词: 全面触发工具 ; 不良事件 ; 不良事件 ; 药物

Abstract:

Objective To understand the current application status of global trigger tool (GTT) in China and abroad, and to provide reference for application and improvement of GTT in medical institutes in China. Methods The databases of Pubmed and CNKI were searched, and the relevant literatures were reviewed and collected, and the application of GTT for measuring adverse events (AE) were analyzed and evaluated. Results Fifty-eight valid articles from 15 countries were included.The studies involve several aspects of GTT applications.Articles about GTT used for measuring the incidence of AE accounted for 62.07%, the researches on the object category of AE accounted for 36.21%, those evaluating the effectiveness of GTT as an AE measurement tool accounted for 27.59%, those about improvement and exploration of GTT application performance accounted for 23.41%, and those about comparison between GTT and other AE detection methods accounted for 15.52%.In 18.97% of the studies, the number of reviewers and criteria were accordant with the GTT White Paper, but 32.76% of the studies did not clearly describe the reviewers and criteria.The most common method for reporting the AE rate was the proportion of patients with AE.The research object includes 11 categories: common hospital patients, children, patients in intensive care unit (ICU), etc.; AE ratio of common hospital patients was 3.4% to 43.3%, the preventable proportion was between 32.2% and 72.4%.The most common types of AE were drug related adverse events, infection/hospital acquired infections, surgery-related complications, abnormal blood potassium, pressure ulcer and so on.Evaluation performed in the United States, Republic of Korea, Spain, China and other countries and regions’ showed GTT had higher efficiency and other advantages as compared with the other AE detection methods including voluntary reporting system, HMPS, QPSIQ DLCR.The exploration of GTT performance improvement involves many factors influencing the detection effectiveness such as different reviewers, review experience, sampling method, sample size, trigger etc. Conclusion GTT has been applied to AE detection of hospital patients in various countries, and it has shown some advantages.GTT is an effective tool for AE measuring, which could be widely used in AE monitoring of hospitalized patients in medical institutions of China.

Key words: Global trigger tool ; Adverse events ; Drug adverse events

目前,医疗不良事件(adverse events,AE)检测方法主要有自愿报告(voluntary reporting notification,VRN)和病历回顾。这两种方法可对AE的数据进行分析,具有一定的指导意义,但均属于“事后”被动措施,对AE发生趋势的判断具有滞后性[1]。有研究表明只有10%~20%AE被报道[2]。医疗机构需要一种更有效方法来识别可能对患者造成医疗伤害的AE,以便量化可能伤害的严重程度,并通过该方法尽可能降低医疗相关AE的发生。

全面触发工具(global trigger tool,GTT)是美国健康促进研究所(institute for healthcare improvement,IHI)2003年推出的医疗相关AE主动监测工具,2009年修订。GTT涉及AE不仅包括药物不良事件(ADE),也包括任何与医疗护理相关的有害或意外事件,其定义为由医疗导致的身体损伤,并且需要额外的监测、住院治疗或导致死亡等不良事件[2-3]。GTT在审查病历的基础上引入 “触发器”和“触发信号”的概念。世界卫生组织(WHO)给予触发信号定义为:“未知的或是至今尚未完全证实的药品与不良事件之间或许存在的因果关系”[4]。触发器,即检测不良事件线索,能有目的地定位AE相关内容,提高病例审查效率和准确性[5]。触发工具所应用触发器共分为6个模块,包括护理、用药、手术、重症监护(ICU)、围产期、急诊,临床可针对各类AE,选用不同模块的触发器。

GTT推出10年以来,国外已广泛应用于AE检测,而国内应用则相对滞后。笔者通过查阅文献,分析总结目前国内外GTT应用情况,包括AE发生率、AE表达方式、研究对象、事件类型、效能评价及改进探索等,以期对GTT在我国医疗机构的应用和研究提供参考。

1 资料来源

系统检索Pubmed、中国知网(CNKI)数据库(1996年—2016年11月),Pubmed检索关键词“global trigger tool”得到相关文献109篇,CNKI检索关键词“全面触发工具”“触发工具”,得到文献8篇,通过其他资源渠道获得6篇。排除重复文献1篇,系统评价及综述10篇,会议文献1篇,研究内容与“全面触发工具”无关的文献53篇,实际获得有效研究文献共58篇(英文53篇,中文5篇)。

2 数据分析与结果
2.1 文献来源及研究内容

2.1.1 文献来源 58项研究来自全球15个国家,以西方发达国家为主,其中美国21项(36.2%),西班牙、中国各6项(各10.3%),瑞典、挪威各4项(各6.9%),澳大利亚、丹麦各3项(各5.2%),英国、比利时、韩国各2项(各3.4%),新西兰、芬兰、土耳其、马来西亚、巴勒斯坦各1项(各1.7%)。

2.1.2 研究内容 系统检索所得相关文献58篇涵盖GTT应用于医疗AE的多个范畴,包括AE发生率及其表达方式、AE涉及对象及科室、AE可预防率等,评估GTT作为AE测量工具的效能,GTT效能改进探索(涉及触发器、样本大小、审评者的改变等),将GTT检测结果与其他AE检测方法检测值进行对比,包括AE自愿报告系统(voluntary reporting notification system,VRNS)、哈佛医学实践研究(Harvard medical practice study,HMPS)”等方法,见表1。

表1 文献主要研究内容
Tab.1 Reserch content of the included literature
序号 研究内容 文献 参考文献
数量 %
1 使用GTT测量AE发生率 36 62.1 [1,6-40]
2 评估GTT作为AE测量工具的效能 16 27.6 [1,8,10,16-17,21,28,30,34,41-47]
3 AE涉及对象及科室,可预防率等 21 36.2 [6,8,11-13,15-19,21,23-25,27,29-30,34,45-46,48]
4 效能改进的探索 13 22.4 [49-61]
5 将GTT测量结果与其他AE检测方法进行对比 9 15.5 [1,10,12,18-19,31,42-43,62]

表1 文献主要研究内容

Tab.1 Reserch content of the included literature

2.2 AE发生率表达方式及涉及对象

2.2.1 AE发生率表达方式 IHI推荐的GTT白皮书中对AE发生率有3种表达方式:住院患者发生AE的百分比、AEs/100住院患者、AEs/1 000患者天,其中推荐方式为AEs/1 000患者天[3]。系统检索到58篇文献中,AE发生率最常用的表达方法是住院患者发生AE的比例(34/58,58.6%),其次是“AEs/100住院患者”(18/58,31.0%),第3位是“AEs/1000患者天”(17/58,29.3%),同时使用3种方法占13.8%(8/58)。在36份使用GTT测量AE发生率的文献中,75.0%(27/36)使用住院患者发生AE的比例;36.1%(13/36)使用每100例住院患者发生的AE;27.8%(10/36)使用每1 000患者天发生的AE发生率,同时使用3种方法占16.7%(6/36)。

2.2.2 AE对象及发生率 58项研究涉及对象包括一般住院患者、儿童、ICU患者、外科手术者、ICU新生儿、ICU儿童、矫形患者、普通住院死亡患者、癌症患者、老年患者、牙科患者等11类。AE发生率范围及可预防/避免情况见表2。

2.3 事件类型与GTT检测效能

2.3.1 AE类型 在25项研究一般住院患者AE的文献中,12项对常见AE类型进行报道。最常见的是“药物相关不良事件”(4/12)[14,17,24-25],其次是“感染/院内获得性感染”(3/12)[17,54-55],以及“手术相关并发症”[8,13]、血钾异常[23,28]、压力性溃疡[17,55]等医疗相关不良事件。

2.3.2 GTT检测效能 目前多个国家地区的研究评估认为GTT检测方法具有高效性。如TAKATA等[34]使用GTT对12所儿童医院960例患者进行检测,结果显示该工具能有效检测住院儿童中的药物不良事件。HWANG等[46]对630份病历进行回顾性AE审查,结果显示GTT的6类触发器模块有大于50.0%的阳性预测值,表明该工具在韩国具有适用性;XU等[7]对240例患者记录进行回顾性审查分析,结果显示GTT是检测中国医院AE总体状态的可行且有效的工具。PEREZ ZAPATA等[16]、GUZMAN-RUIZ等[17]分别对一般住院患者、外科手术患者的不良事件进行检测,结果显示该GTT能高效检测AE。两项研究检测灵敏度分别为91.3%,86.0%,特异性分别为32.5%,93.6%,阳性预测值为42.5%,89.0%,阴性预测值为87.1%,92.0%,识别所有严重的AE预测值较高。

2.4 GTT与其他AE检测方法的比较

9份文献(9/51,17.6%)将GTT检测结果与其他AE检测方法结果进行对比,包括VRNS、HMPS、美国患者安全指标数据库(quality's patient safety indicators-fared)的方法、丹麦肺癌登记处(danish lung cancer registry,DLCR)收集结果。大部分研究显示GTT具有检测优势。

2.4.1 与VRNS比较 KURUTKAN等[10]对土耳其一家大学医院住院患者不良事件进行评估,结果显示GTT比VRNS灵敏19倍;RUTBERG等[12]使用GTT对瑞典一家大学医院住院患者检测出的不良事件为20.5%,但其在VRNS报告只有6.3%;HOOPER等[31]使用GTT对澳大利亚儿童重症监护病例记录中检测出98例不良事件,而VRNS仅报告4例;张海霞等[1]使用GTT对国内住院患者不良事件检出率为10.34%,而VRNS上报率为0.67%。

2.4.2 与HMPS比较 与HMPS比较,GTT检测AE的适用性更高。UNBECK等[42]对比GTT及HMPS方法,其总体触发器阳性预测值分别为40.3%和30.4%。关于两种方法的病历评审者可靠性评估,HANSKAMP-SEBREGTS等[64]汇总24项研究,系统评价GTT及HMPS方法中评审者之间的可靠性,结果显示GTT审评者间可靠性更高(κ值分别为0.65和0.55)。

2.4.3 与DLCR比较 DLCR是一个法律强制登记肺癌的国家组织,其数据完整性很高,超过90%[65]。LIPCZAK等[43]将收集某大学医院心胸外科及肺癌手术相关的并发症数量与GTT方法评估结果比较,结果显示两种方法检测值相似,不难推测,GTT具有较高的检测效能。

2.4.4 与其他方法比较 CLASSEN等[66]以美国盐湖城3家医院作为样本,比较VRNS、患者安全指标数据库、GTT3种检测方法,结果显示GTT检测出AE较其他方法高10倍以上。MULL等[19]研究显示GTT所检测到的109例AE中,有96例(88.1%)未被其他方法检测到;NAJJAR等[18]研究显示巴勒斯坦医院GTT检测AE发生率可能比以前报告的高20倍。

2.5 GTT检测效能的探索

2.5.1 关于触发器 CARNEVALI等[41]根据GTT的药物模块触发器检测医院ADE,结果显示有3项触发器从未检测出ADE,并且在已发现的ADE中有19例(31%)并未触发GTT的触发器。该篇研究建议在GTT的药物模块触发器基础上改进触发器列表,并应鼓励记录未触发的不良事件以提高检出效能。MATTSSON等[53]评价在GTT方法中增加肿瘤学模块是否会增加其检出效能。MENENDEZ FRAGA等[67]将WHO手术安全实施检查表(surgical safety checklist,SSC)中不合规项目作为“触发器”纳入全面触发工具手术模块,用于患者电子病例分析,结果显示外科AE从2011年的16.3%降至2014年的9.4%。

2.5.2 关于抽样方法 CIHANGIR等[60]改变抽样方法,使AE检出率明显增高。由于有前期研究表明AE常导致更长的住院时间,研究者通过加入“住院时间意外延长”触发器,在病例抽样时引入该方法来预先选择患者,使AE检出率增高。

2.5.3 关于样本量 MEVIK等[54]评估不同审查样本大小对GTT检出结果的影响。原版GTT要求每2周抽查10份病例,而该项研究加大抽样量,每2周选取70份病例,结果发现样本量大小虽然对AE检出种类和严重程度无明显影响,但AE发生率却随样本量增加而增高。大样本(1 680例)确定的AE发生率(39.3AEs/1 000患者天)是小样本(240例)AE发生率(27.2AEs/1 000患者天)的1.44倍,95%CI(1.07,1.97)倍。作者建议在无更多的研究前,将审查样本量按医院住院患者数调整,增加至出院总数的8%~10%。

2.5.4 关于AE 审评小组 IHI建议AE审评小组最少由3人组成,2位具有临床知识背景的审阅者作为主要记录者(通常为护士或药师),1位医师对前2位记录结果进行确认[3]。笔者在本研究收集58项研究中,只有19.0%使用这种方法;48.3%研究使用其他方法,如2名护士、1名护士/药师和1名医生、1名护士等;32.8%研究对审评小组没有明确描述。

多项研究探索评审小组对AE检测效能的影响。NAESSENS等[57]评估不同资质审评者对GTT检出结果的影响,结果显示在独立护士审查员之间在识别任何触发AE时,具有良好的可靠性。SHAREK等[58]同样评估不同审评者对GTT检出结果的影响,结果显示与经验丰富评审团队比较,医院内部团队的敏感性(49%)和特异性(94%)超过外部(合同研究组织)团队(34%及93%)。MEVIK等[56]评估当审查者被替换时对GTT检出结果的影响,结果显示如果1名非医生评审者保持一致,更换评审员则不影响结果。SCHILDMEIJER等[50]评估缺乏审查经验的团队对AE审查的一致性,结果显示不同团队间审查结果有巨大差异,69%AE只被一支团队识别而未被其他四支团队识别。该研究建议不鼓励医院之间使用GTT检测的AE发生率进行比较,且审查团队需经大量的训练以达到更高可信度的审查结果。

3 讨论
3.1 偏倚风险因素

表2可知,58项针对不同人群AE发生率的研究其测量结果差异较大,这可能与AE定义、触发器的选择及审评方法等有关。58项研究中有16项(27.6%)采用GTT白皮书中AE的定义,42项研究采用其他定义或无具体报道。不同研究采用相同AE定义时,AE测量值波动相对较小。例如58项有效研究中有24项针对一般住院患者,发生AE的比例3.4%~43.3%(中位数:15.54%),其中6项采用GTT中AE定义,其AE的发生率13.0%~32.10%(中位数:21.0%),波动明显小于总体范围。2009年版GTT白皮书中推荐的触发器是通过检索医疗机构不同部门的不良事件文献,并且在数百家医院进行测试后进行添加、删除和调整后得出[3]。针对触发器的选择,白皮书中推荐各医疗机构根据自身特点进行适当修订[62]。多项研究还评估不同资质评审者、评审者经验、样本大小、抽样方法对GTT检测效能的影响,这些因素的改变均可能导致AE的差异。

表2 不同研究对象及表达方式的AE发生率与可预防情况
Tab.2 AE rate and its prerentable rate in different subjects and expressive patterns
序号 研究对象 患者发生ADE
比例/%
每100例患者发生
AE/例
每1000例患者天
发生AE/例
可预防/避免
AE比例/%
参考文献
1 一般住院患者 3.4~43.3 13.1 ~50.8 2.03~80.72 32.2~72.41 [1,7-8,10,13-14,17-19,22-25,27-28,30,41,
44,46,54-55,58,62-63]
2 儿童 24.3 11.1 ~36.7 15.7~76.3 22.0~45.0 [11,21,29,34,45]
3 ICU患者 19.5~24.8 2.91~11.3 54.0 [6,26,37,48]
4 外科手术者 14.6~36.8 16 56.2 [16,32,52-53]
5 ICU新生儿 56.0 [33]
6 ICU儿童 59.9 [31]
7 矫形患者 30.0 [42]
8 普通住院死亡患者 12.1~16.3 [9]
9 癌症患者 31 [51]
10 老年患者 42.9 29.4 65.8 [15,36]
11 牙科患者 34 [49]

“…” means no report

“…”表示没有报道

表2 不同研究对象及表达方式的AE发生率与可预防情况

Tab.2 AE rate and its prerentable rate in different subjects and expressive patterns

3.2 关于AE检测方法

目前常用3种AE检测方法(病历回顾法、自愿报告法、触发工具检测法)各有特点。病历回顾法,即由评估人员进行病历回顾并初步判断,再由专家组对判断上有疑问的病历进行讨论,最终确定回顾的病历中哪些发生AE,这种方法的最大缺陷是对AE发生趋势的判断具有滞后性。不仅需要具有相关专业知识的人员对病历进行回顾,工作量巨大,耗时多,还不能持续监控AE的发生趋势,迅速判断所采取的改善患者安全的举措是否有效或者新近的某种治疗方法是否会给患者带来其他方面的损害。

自愿报告法,即AE发生后,由当事人或临床工作者直接对AE进行上报,是目前使用最广泛的方法。在欧美已经形成多个由政府部门或行业协会组建的强制或自愿的AE报告系统。该方法能够克服病历回顾方法的严重滞后,及时提供关于新的AE发生趋势的预告,同时也有助于对罕见AE进行监控。其所具局限性在于检测数据具有严重的不确定性,未报告的病例数量无法知晓,不能计算AE发生率。

IHI推荐的GTT作为一种AE触发工具检测法,以病历回顾方法为基础,主要是设定一些触发事件,通过对病历进行筛查。未发现任何触发事件的病历被认为无AE发生;如果检测到触发事件则仅需对存在触发事件的病历进行回顾。通过触发器有目的定位AE相关内容,GTT与自愿报告方法相比具有更强特异性,较单纯的病历审查方法相比具更高检测效率。

GTT白皮书中对AE发生率表达方式推荐使用“AEs/1000患者天”。但本研究检索的58篇文献中,以该方式表达17项,占24.1%,排位第3。白皮书显示“AEs/1000患者天”“AEs/100住院患者”的数据都应该在运行图中表示,在Y轴和X轴上以2周为时间增量,这两种表达方式均可随着时间的推移跟踪AE发生率[3]。随着时间的推移跟踪ADE是一种有效判断现行干预措施是否可减少AE发生率的方式[25]。但目前国内外应用GTT的研究大多为回顾性研究,病历选取范围一般在某个固定时间段内,不存在时间增量。以“AEs/1000患者天”“AEs/100住院患者”两种表达方式的GTT检测更有利于临床患者ADE的日常监测与管理。

由于检测方法不同,也可导致研究结果测定值的差异。虽然目前检索文献多认为GTT检测AE值具有优势,但也不能排除一些低水平GTT检测结果的研究未予公布。

3.3 我国ADE监测模式

WHO对ADE定义为:药物治疗过程中出现的不良临床事件,它不一定与该药有因果关系。ADE包括药品不良反应(ADR)、用药错误(medication errors)。用药错误被称为可预防的ADE。中国食品药品监督管理总局(CFDA)和国家卫生和计划生育委员会联合颁布的《药品不良反应报告和监测管理办法》(卫生部令第81号)对ADR定义为:合格药品在正常用法用量下出现的与用药目的无关的有害反应,并不包括用药错误。

我国目前ADR监测仍以自愿报告法为主要手段。2011年原卫生部发布修订后的《药品不良反应报告和监测管理办法》,进一步推动了ADR监测体系的开展。国家药品不良反应监测中心收到的“药品不良反应/事件报告”每年呈现上升趋势,2015年较2014年增长5.3%。我国药品不良反应/事件监测工作取得一定成效,但目前也存在一些问题,例如医疗机构上报的积极性不高、报告质量不高、药品生产企业ADR监测工作开展不力、公众对ADR的认知度较低、对ADR知识缺乏等。

基于GTT检测在我国已有应用,国内有研究显示GTT与自愿上报两种方法的AE类型有一定互补性[62],医疗机构同时应用两种方法,以便更好预防和减少ADE的发生。

3.4 GTT未来研究方向及建议

目前一些发达国家,如美国,小至老年疗养院、大到大型医疗机构,都已将GTT作为日常监测患者医疗、用药等方面安全的实用工具。但总体而言,使用GTT的相关研究仍多局限于测量AE发生率,且以一般住院患者为研究对象的“药物相关不良事件”居多;而对于其他研究对象、GTT用于其他研究方面、非“药物模块”的研究则相对薄弱。GTT在国内的应用更是滞后,目前国内仅见5项公开发表的对GTT检测ADE的应用研究文献。因此,特提出以下建议:①医疗机构可使用IHI推荐的GTT触发器对患者进行病例回顾性检验(根据ADE检测值,评估其有效性;根据触发器的阳性触发值,检验其适用性),加强后期数据分析,并根据检测结果对触发器进行调整、修改、增加、删除,最终建立具有医疗机构自身特性且适用于本地相关患者群体的ADE触发工具;②将建立的触发器嵌入医院HIS系统,一旦住院患者在治疗过程中触发,HIS系统即可提示临床医生及时给予临床干预,从而有效预防ADE发生。③在继续加大“药物”触发模块研究的同时,扩展至非“药物模块”研究及不同的监测对象(如肿瘤患者、妊娠期女性等特殊生理群体)研究,以使更多患者受益。医疗机构可将触发工具的“事先预防”及VRNS的“事后处置”进行有机结合,全面提升临床ADE监测水平,为持续改进医疗质量、保障患者治疗安全提供技术支撑。

The authors have declared that no competing interests exist.

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Traditional medicine has been used worldwide in recent decades. The aim of this study was to determine the incidence of adverse events (AEs) in traditional medicine hospitals and investigate patient and health-care utilization factors associated with AE occurrence. A 2-stage review of 1152 randomly sampled charts in 2 teaching Korean traditional medicine hospitals was conducted. Three physicians and a quality improvement specialist identified AE occurrence, severity, and preventability using the Global Trigger Tool (Appendix 1, Supplemental Digital Content, http://links.lww.com/JPS/A19). Two traditional Korean medicine professors validated the findings. Logistic regression analysis was performed to determine factors associated with AE occurrence. One hundred twenty-two admissions (10.6%) had at least one AE (7.39 events per 1000 patient days and 14.5 events per 100 admissions). Among 167 AEs, 73.7% were mild and 70.7% were judged preventable. Procedure-related AEs were most common. After considering other patient and health-care utilization characteristics, factors associated with AE occurrence were altered mental status on admission (OR, 3.86; 95% confidence interval [CI], 1.20-12.44), use of various traditional medicine therapies (OR, 1.69; 95% CI, 1.32-2.15), length of stay (OR, 1.02; 95% CI, 1.01-1.03), and number of unique triggers (OR, 6.35; 95% CI, 4.54-8.89). Approximately 11% of inpatients in traditional medicine hospitals experienced AEs. Because patients have a higher risk of AEs, special attention should be paid to those with altered mental status on admission, receiving various traditional medicine therapies, staying for a longer period, and having various positive triggers.
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Abstract In 2005, our organization set a goal of zero preventable deaths by 2010--notionally a sound goal but extremely challenging to measure, monitor and evaluate. The development of an interdisciplinary Death and Adverse Event Review process has provided a measure and framework for action to decrease adverse events (AEs) that cause harm. Death and Adverse Event Review is a formal process in which trained reviewers consider patient deaths using a modified Global Trigger Tool to establish the presence of AEs or quality of care issues that may have potentially led to death or harm. When identified, these charts go to second-level review by a physician/interdisciplinary team to determine recommendations for actions to prevent future reoccurrences. Data have provided trending of system influences to patient safety. In 2008-2009, 1,817 deaths were reviewed and AE rates of 12.1% and 16.3% were identified. There were 422 AEs and 114 quality of care issues identified for follow-up. Of the 4.7% and 6.3% referred to the physician/interdisciplinary team for secondary review, 2.3% and 2.6% resulted in recommendations for improvement. In addition to local improvements, many system improvements have occurred as a result of the review, such as proposed minimum standards for physician documentation; a formal review of post-operative guidelines for patients with sleep apnea; and a working group to review nursing documentation, communication/follow-up of vital signs, fluid balance and pain management. The Death and Adverse Event Review process provides a new critical level of detail that supports continuous improvements to our care processes and ongoing progress toward our goal of zero preventable deaths.
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Patients decide to take antibiotics themselves in 21% of cases of acute respiratory viral infections, influenza and acute respiratory infections [1]. The main factor of drug purchase at a pharmacy is pharmacist's recommendation. In 14% of cases of purchase of antibiotics, patients describe the symptoms and do not name a specific drug. This provides opportunity for drug selection at a pharmacy [2]. In these circumstances the role of pharmacists in ensuring the rational use of antimicrobial agents increases significantly.To evaluate the knowledge of pharmacists about antibiotics for systemic use.Pharmacoepidemiological study was based on surveying pharmaceutical workers using a questionnaire. The questionnaire included 2 groups of questions: general questions aimed at identifying the socio-demographic characteristics of respondents (gender, age) and professional status (level of qualification, work experience), as well as specific questions aimed at identifying perceptions and knowledge of respondents about the studied group of drugs (range of used drugs, the factors determining and limiting the choice of drug, properties of individual drugs, etc.). The study involved 182 pharmaceutical workers at the age of 20 to 52 years. When processing the received data, we used Microsoft Excel and BioStat, and methods of nonparametric statistics (χ2-test). The survey was conducted anonymously, informed consent of the participants was not required. According to the recommendations of Ethical Committee of Saratov State Medical University n.a. V.I. Razumovsky (protocol No. 8 from 01.04.2014) the study is consistent with the basics of medical ethics.Interviewed pharmaceutical workers were mostly women (97%) with secondary pharmaceutical education (84%). The average age of the respondents was 27.0 ± 0.5 years. The work experience of the respondents ranged from 0.5 to 34 years (average experience 5.64 ± 0.41 years).Almost all pharmacists (97%) reported that they dispense antimicrobial drugs every day and consult patients about the choice and characteristics of antibiotic (99.5%). However, only 20% of the respondents indicated that they refuse to recommend antibiotics to the pharmacy visitors and send them to the doctor. Most often pharmaceutical employees recommended azithromycin (45%), amoxicillin in combination with clavulanic acid (41%), amoxicillin (26%). According to respondents, the choice of recommended antibiotic mostly depends (score on a scale of 1-5) on pharmacological characteristics of the drug: the effectiveness (of 4.66 ± 0.04) and safety (4.16 ± 0.07). Thus, pharmaceutical specialist should be knowledgeable about characteristics of antimicrobial agents to conduct proper consultation.According to the results of self-assessment of respondents' knowledge about antibiotics it is at an average level. 36.3% of respondents state that they are familiar with the range and features of most of the drugs. 41.8% of professionals are familiar with the range of the most popular drugs and their main features. Only 16.5% of respondents assess their knowledge about antibiotics at the highest level, indicating that they are fully familiar with the range and features of the drugs.Aiming at identifying knowledge about the side effects of antibiotics pharmacists were asked to compare the most commonly prescribed drugs and their respective side effects, to position the drugs and groups of drugs in the range according to the degree of toxicity and to indicate which antibiotics can be used during pregnancy. Knowledge of pharmaceutical workers is mainly limited to the perceptions of non-specific side reactions that can occur when taking any antibiotic (dyspepsia, allergic reactions, headache, candidiasis). 54.9% of respondents rightly pointed out nonspecific reactions for all 7 mentioned drug, for individual drugs the proportion of correct answers varied from 65,4% (linezolid) to 81,3% (amoxicillin+clavulanic acid). The analysis revealed no relationship between respondents' answers and their qualifications (χ2 = 0,053; p = 0,818), work experience (χ2 = 6,956; p = 0,096) and self-assessed knowledge about antimicrobial drugs (χ2 = 1,272; p = 1,000). There were no respondents who correctly reported specific adverse reactions (hearing disorder for azithromycin, hemopoiesis oppression for linezolid, etc.) for each antibiotic. The proportion of correct answers ranged from 6,0% for the combination amoxicillin+clavulanic acid to 43,4% for cefixime and doxycycline. The relationship between knowledge of respondents and frequency of recommendations of the same group of drugs could not be determined.Pharmacists assume that the safest antibiotics are macrolides (average rank place of 2,99 ± 0,15 of 8), cephalosporins (3,12 ± 0,15) and penicillins (3,38 ± 0,22), the most toxic are tetracyclines (5,61 ± 0,17). It should be noted that average rank places are quite similar, which means serious differences of opinion between the specialists. When assessing the toxicity of individual drugs a combination of amoxicillin+clavulanic acid (average rank place of 2,92 ± 0,29 of 15) and ampicillin (of 4,88 ± 0,36) were considered as the safest, the most toxic were tetracycline (10,13 ± 0,30) and gentamicin (10,14 ± 0,33). These perceptions are generally consistent with the views on the safety of antibiotics in outpatient practice [3].Half of the respondents (51,1%) correctly identified the antibiotics that can be used during pregnancy (FDA category B). 45,1% of respondents said that no antibiotics can be used during pregnancy. Only 2,7% of respondents named drugs contraindicated during pregnancy (category C and D) - gentamicin, doxycycline, ciprofloxacin.The study identified gaps in the knowledge of pharmacists about the safety of antimicrobial agents. Views of professionals about antibiotics are mostly consistent with current data about the properties of drugs. However, detailed analysis shows that such views are not supported by clear knowledge of the properties of each drug and are mostly intuitive. In terms of the prevalence of self-medication with antibiotics and OTC dispensing of antimicrobial drugs it is necessary to improve the professional knowledge of pharmaceutical workers on antibiotics for systemic use.
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A high-quality health system should deliver care that is free from harm. Few large-scale studies of adverse events have been undertaken in children's healthcare internationally, and none in Australia. The aim of this study is to measure the frequency and types of adverse events encountered in Australian paediatric care in a range of healthcare settings.A form of retrospective medical record review, the Institute of Healthcare Improvement's Global Trigger Tool, will be modified to collect data. Records of children aged <16鈥厃ears managed during 2012 and 2013 will be reviewed. We aim to review 6000-8000 records from a sample of healthcare practices (hospitals, general practices and specialists).Human Research Ethics Committee approvals have been received from the Sydney Children's Hospital Network, Children's Health Queensland Hospital and Health Service, and the Women's and Children's Hospital Network in South Australia. An application is under review with the Royal Australian College of General Practitioners. The authors will submit the results of the study to relevant journals and undertake national and international oral presentations to researchers, clinicians and policymakers.
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To describe the level, preventability and categories of adverse events (AEs) identified by medical record review using the Global Trigger Tool (GTT). To estimate when the AE occurred in the course of the hospital stay and to compare voluntary AE reporting with medical record reviewing.Two-stage retrospective record review.650-bed university hospital.20 randomly selected medical records were reviewed every month from 2009 to 2012.AE/1000 patient-days. Proportion of AEs found by GTT found also in the voluntary reporting system. AE categorisation. Description of when during hospital stay AEs occur.A total of 271 AEs were detected in the 960 medical records reviewed, corresponding to 33.2 AEs/1000 patient-days or 20.5% of the patients. Of the AEs, 6.3% were reported in the voluntary AE reporting system. Hospital-acquired infections were the most common AE category. The AEs occurred and were detected during the hospital stay in 65.5% of cases; the rest occurred or were detected within 30鈥卍ays before or after the hospital stay. The AE usually occurred early during the hospital stay, and the hospital stay was 5鈥卍ays longer on average for patients with an AE.Record reviewing identified AEs to a much larger extent than voluntary AE reporting. Healthcare organisations should consider using a portfolio of tools to gain a comprehensive picture of AEs. Substantial costs could be saved if AEs were prevented.
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OBJECTIVE: To report 5 years of adverse events (AEs) identified using an enhanced Global Trigger Tool (GTT) in a large health care system. STUDY SETTING: Records from monthly random samples of adults admitted to eight acute care hospitals from 2007 to 2011 with lengths of stay 鈮3 days were reviewed. STUDY DESIGN: We examined AE incidence overall and by presence on admission, severity, stemming from care provided versus omitted, preventability, and category; and the overlap with commonly used AE-detection systems. DATA COLLECTION: Professional nurse reviewers abstracted 9,017 records using the enhanced GTT, recording triggers and AEs. Medical record/account numbers were matched to identify overlapping voluntary reports or AHRQ Patient Safety Indicators (PSIs). PRINCIPAL FINDINGS: Estimated AE rates were as follows: 61.4 AEs/1,000 patient-days, 38.1 AEs/100 discharges, and 32.1 percent of patients with 鈮1 AE. Of 1,300 present-on-admission AEs (37.9 percent of total), 78.5 percent showed NCC-MERP level F harm and 87.6 percent were "preventable/possibly preventable." Of 2,129 hospital-acquired AEs, 63.3 percent had level E harm, 70.8 percent were "preventable/possibly preventable"; the most common category was "surgical/procedural" (40.5 percent). Voluntary reports and PSIs captured <5 percent of encounters with hospital-acquired AEs. CONCLUSIONS: AEs are common and potentially amenable to prevention. GTT-identified AEs are seldom caught by commonly used AE-detection systems.
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Abstract OBJECTIVE: Determine the degree of congruence between several measures of adverse events. DESIGN: Cross-sectional study to assess frequency and type of adverse events identified using a variety of methods. SETTING: Mayo Clinic Rochester hospitals. PARTICIPANTS: All inpatients discharged in 2005 (n = 60 599). INTERVENTIONS: Adverse events were identified through multiple methods: (i) Agency for Healthcare Research and Quality-defined patient safety indicators (PSIs) using ICD-9 diagnosis codes from administrative discharge abstracts, (ii) provider-reported events, and (iii) Institute for Healthcare Improvement Global Trigger Tool with physician confirmation. PSIs were adjusted to exclude patient conditions present at admission. MAIN OUTCOME MEASURE: Agreement of identification between methods. RESULTS: About 4% (2401) of hospital discharges had an adverse event identified by at least one method. Around 38% (922) of identified events were provider-reported events. Nearly 43% of provider-reported adverse events were skin integrity events, 23% medication events, 21% falls, 1.8% equipment events and 37% miscellaneous events. Patients with adverse events identified by one method were not usually identified using another method. Only 97 (6.2%) of hospitalizations with a PSI also had a provider-reported event and only 10.5% of provider-reported events had a PSI. CONCLUSIONS: Different detection methods identified different adverse events. Findings are consistent with studies that recommend combining approaches to measure patient safety for internal quality improvement. Potential reported adverse event inconsistencies, low association with documented harm and reporting differences across organizations, however, raise concerns about using these patient safety measures for public reporting and organizational performance comparison.
DOI:10.1093/intqhc/mzp027      PMID:19617381      URL    
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[15] SUAREZ C,MENENDEZ M D,ALONSO J,et al.Detection of adverse events in an acute geriatric hospital over a 6-year period using the global trigger tool[J].J Am Geriatr Soc,2014,62(5):896-900.
To assess the frequency, severity, and preventability of adverse events (AEs) detected using the Global Trigger Tool (GTT) in an acute geriatric hospital.DesignA 6-year retrospective study.SettingAn urban Spanish acute geriatric teaching hospital of 200 beds.ParticipantsTen randomly selected clinical records were chosen every fortnight from January 2007 to December 2012 (1,440 records, 240 per year).MeasurementsTriggers, AEs, Index of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) categories of severity, and Likert scale to evaluate the preventability of AEs.ResultsFour hundred twenty-four AEs (categories E to I of the NCC MERP Index) were identified in 335 of the 1,440 individuals scrutinized, which corresponded to 29.4 physical injuries per 100 admissions (95% confidence interval (CI) = 25.7–34.7). Of these, 351 (91.7%) occurred 3 or more days after admission; 279 harms (65.8%) were preventable. Significant decreases in the rate of harms per 1,000 patient-days (21.8 vs 27.1, relative risk (RR) = 0.77, 95% CI 0.66–0.91, P = .02) and in high-severity events (categories F to I) (11/720 clinical records in 2011–2012 vs 23/720 clinical records in 2007–2009) (RR = 0.48, 95% CI = 0.24–0.96, P = .04) were observed during the second half of the study from the first. The number needed to alert was 7.8.ConclusionThe frequency and severity of AEs decreased during the period of study. Factors possibly contributing to the decrease in AEs include new beds with variable height, pressure ulcer prevention, introduction of clinical electronic records, staff training on hand washing, surgical check list, correct patient identification, and Agency for Healthcare Research and Quality surveys on patient safety culture.
DOI:10.1111/jgs.12774      PMID:24697662      URL    
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[16] PEREZ ZAPATA A I,GUTIERREZ SAMANIEGO M,RO-DRIGUEZ CUELLAR E,et al.Detection of adverse events in general surgery using the "trigger tool" methodology[J].Cir Esp,2015,93(2):84-90.
DOI:10.1016/j.ciresp.2014.08.007      URL    
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[17] GUZMAN-RUIZ O,RUIZ-LOPEZ P,GOMEZ-CAMARA A,et al.Detection of adverse events in hospitalized adult patients by using the global trigger tool method[J].Rev Calid Asist,2015,30(4):166-174.
The tool used in this study is valid, useful and reproducible for the detection of AE. It also serves to determine rates of injury and to observe their progression over time. A high frequency of both AE and preventable events were observed in this study.
DOI:10.1016/j.cali.2015.03.003      URL    
[本文引用:4]
[18] NAJJAR S,HAMDAN M,EUWEMA M C,et al.The global trigger tool shows that one out of seven patients suffers harm in Palestinian hospitals:challenges for launching a strategic safety plan[J].Int J Qual Health Care,2013,25(6):640-647.
/st> The aim of this study was to evaluate patient safety levels in Palestinian hospitals and to provide guidance for policymakers involved in safety improvement efforts./st> Retrospective review of hospitalized patient records using the Global Trigger Tool./st> Two large hospitals in Palestine: a referral teaching hospital and a nonprofit, non-governmental hospital./st> A total of 640 random records of discharged patients were reviewed by experienced nurses and physicians from the selected hospitals./st> Assessment of adverse events./st> Prevalence of adverse events, their preventability and harm category. Descriptive statistics and Cohen kappa coefficients were calculated./st> One out of seven patients (91 [14.2%]) suffered harm. Fifty-four (59.3%) of these events were preventable; 64 (70.4%) resulted in temporary harm, requiring prolonged hospitalization. Good reliability was achieved among the independent reviewers in identifying adverse events. The Global Trigger Tool showed that adverse events in Palestinian hospitals likely occur at a rate of 20 times higher than previously reported. Although reviewers reported that detecting adverse events was feasible, we identified conditions suggesting that the tool may be challenging to use in daily practice./st> One out of seven patients suffers harm in Palestinian hospitals. Compromised safety represents serious problems for patients, hospitals and governments and should be a high priority public health issue. We argue that direct interventions should be launched immediately to improve safety. Additional costs associated with combating adverse events should be taken into consideration, especially in regions with limited resources, as in Palestine.
DOI:10.1093/intqhc/mzt066      PMID:24141012      URL    
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[19] MULL H J,BRENNAN C W,FOLKES T,et al.Identifying previously undetected harm:piloting the institute for healthcare improvement's global trigger tool in the veterans health administration[J].Qual Manag Health Care,2015,24(3):140-146.
DOI:10.1097/QMH.0000000000000060      URL    
[本文引用:1]
[20] GOOD V S,SALDANA M,GILDER R,et al.Large-scale deployment of the global trigger tool across a large hospital system:refinements for the characterisation of adverse events to support patient safety learning opportunities[J].BMJ Qual Saf,2011,20(1):25-30.
Background The Institute for Healthcare Improvement encourages use of the Global Trigger Tool to objectively determine and monitor adverse events (AEs). Setting Baylor Health Care System (BHCS) is an integrated healthcare delivery system in North Texas. The Global Trigger Tool was applied to BHCS's eight general acute care hospitals, two inpatient cardiovascular hospitals and two rehabilitation/long-term acute care hospitals. Strategy Data were collected from a monthly random sample of charts for each facility for patients discharged between 1 July 2006 and 30 June 2007 by external professional nurse auditors using an MS Access Tool developed for this initiative. In addition to the data elements recommended by Institute for Healthcare Improvement, BHCS developed fields to permit further characterisation of AEs to identify learning opportunities. A structured narrative description of each identified AE facilitated text mining to further characterise AEs. Initial findings Based on this sample, AE rates were found to be 68.1 per 1000 patient days, or 50.8 per 100 encounters, and 39.8% of admissions were found to have ≥1 AE. Of all AEs identified, 61.2% were hospital-acquired, 10.1% of which were associated with a National Coordinating Council – Medical Error Reporting and Prevention harm score of “H or I” (near death or death). Future Direction To enhance learning opportunities and guide quality improvement, BHCS collected data—such as preventability and AE source—to characterise the nature of AEs. Data are provided regularly to hospital teams to direct quality initiatives, moving from a general focus on reducing AEs to more specific programmes based on patterns of harm and preventability.
DOI:10.1136/bmjqs.2008.029181      PMID:21228072      URL    
[本文引用:0]
[21] KIRKENDALL E S,KLOPPENBORG E,PAPP J,et al.Measuring adverse events and levels of harm in pediatric inpatients with the global trigger tool[J].Pediatrics,2012,130(5):e1206-1214.
DOI:10.1542/peds.2012-0179      URL    
[本文引用:0]
[22] DEILKAS ET,BUKHOLM G,LINDSTROM J C,et al.Monitoring adverse events in Norwegian hospitals from 2010 to 2013[J].BMJ Open,2015,5(12):e008576.
Abstract OBJECTIVES: To describe how adverse event (AE) rates were monitored and estimated nationally across all Norwegian hospitals from 2010 to 2013, and how they developed during the monitoring period. Monitoring was based on medical record review with Global Trigger Tool (GTT). SETTING: All publicly and privately owned hospitals were mandated to review randomly selected medical records to monitor AE rates. The initiative was part of the Norwegian patient safety campaign, launched by the Norwegian Ministry of Health and Care Services. It started in January 2011 and lasted until December 2013. 2010 was the baseline for the review. One of the main aims of the campaign was to reduce patient harm. METHOD: To standardise the medical record reviews in all hospitals, GTT was chosen as a standard method. GTT teams from all hospitals reviewed 4061851 medical records randomly selected from 26124961957 discharges from 2010 to 2013. Data were plotted in time series for local measurement and national AE rates were estimated, plotted and monitored. RESULTS: AE rates were estimated and published nationally from 2010 to 2013. Estimated AE rates in severity categories E-I decreased significantly from 16.1% in 2011 to 13.0% in 2013 (-3.1% (95% CI -5.2% to -1.1%)). CONCLUSIONS: Monitoring estimated AE rates emerges as a potential element in national systems for patient safety. Estimated AE rates in the category of least severity decreased significantly during the first 261years of the monitoring. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
DOI:10.1136/bmjopen-2015-008576      PMID:26719311      URL    
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[23] HARKANEN M,KERVINEN M,AHONEN J,et al.Patient-specific risk factors of adverse drug events in adult inpatients -evidence detected using the global trigger tool method[J].J Clin Nurs,2015,24(3/4):582-591.
To identify the prevalence, preventability, and severity of adverse drug events in randomly selected adult hospital inpatients, and to study the association between adverse drug events and patient‐specific factors.
DOI:10.1111/jocn.12714      PMID:25393838      URL    
[本文引用:1]
[24] DE WET C,BOWIE P.The preliminary development and testing of a global trigger tool to detect error and patient harm in primary-care records[J].Postgrad Med J,2009,85(1002):176-180.
Abstract BACKGROUND: A multi-method strategy has been proposed to understand and improve the safety of primary care. The trigger tool is a relatively new method that has shown promise in American and secondary healthcare settings. It involves the focused review of a random sample of patient records using a series of "triggers" that alert reviewers to potential errors and previously undetected adverse events. AIM: To develop and test a global trigger tool to detect errors and adverse events in primary-care records. METHOD: Trigger tool development was informed by previous research and content validated by expert opinion. The tool was applied by trained reviewers who worked in pairs to conduct focused audits of 100 randomly selected electronic patient records in each of five urban general practices in central Scotland. RESULTS: Review of 500 records revealed 2251 consultations and 730 triggers. An adverse event was found in 47 records (9.4%), indicating that harm occurred at a rate of one event per 48 consultations. Of these, 27 were judged to be preventable (42%). A further 17 records (3.4%) contained evidence of a potential adverse event. Harm severity was low to moderate for most patients (82.9%). Error and harm rates were higher in those aged > or =60 years, and most were medication-related (59%). CONCLUSIONS: The trigger tool was successful in identifying undetected patient harm in primary-care records and may be the most reliable method for achieving this. However, the feasibility of its routine application is open to question. The tool may have greater utility as a research rather than an audit technique. Further testing in larger, representative study samples is required.
DOI:10.1136/pgmj.2008.075788      PMID:19417164      URL    
[本文引用:1]
[25] SAM A T,LIAN JESSICA L L,PARASURAMAN S.A retrospective study on the incidences of adverse drug events and analysis of the contributing trigger factors[J].J Basic Clin Pharm,2015,6(2):64-68.
Abstract OBJECTIVES: To retrospectively determine the extent and types of adverse drug events (ADEs) from the patient cases sheets and identify the contributing factors of medication errors. To assess causality and severity using the World Health Organization (WHO) probability scale and Hartwig's scale, respectively. METHODS: Hundred patient case sheets were randomly selected, modified version of the Institute for Healthcare Improvement (IHI) Global Trigger Tool was utilized to identify the ADEs; causality and severity were calculated utilizing the WHO probability scale and Hartwig's severity assessment scale, respectively. RESULTS: In total, 153 adverse events (AEs) were identified using the IHI Global Trigger Tool. Majority of the AEs are due to medication errors (46.41%) followed by 60 adverse drug reactions (ADRs), 15 therapeutic failure incidents, and 7 over-dose cases. Out of the 153 AEs, 60 are due to ADRs such as rashes, nausea, and vomiting. Therapeutic failure contributes 9.80% of the AEs, while overdose contributes to 4.58% of the total 153 AEs. Using the trigger tools, we were able to detect 45 positive triggers in 36 patient records. Among it, 19 AEs were identified in 15 patient records. The percentage of AE/100 patients is 17%. The average ADEs/1000 doses is 2.03% (calculated). CONCLUSION: The IHI Global Trigger Tool is an effective method to aid provisionally-registered pharmacists to identify ADEs quicker.
DOI:10.4103/0976-0105.152095      PMID:25767366      URL    
[本文引用:2]
[26] RESAR R K,ROZICH J D,SIMMONDS T,et al.A trigger tool to identify adverse events in the intensive care unit[J].Jt Comm J Qual Patient Saf,2006,32(10):585-590.
DOI:10.1016/S1553-7250(06)32076-4      URL    
[本文引用:0]
[27] HIBBERT P,WILLIAMS H.The use of a global trigger tool to inform quality and safety in Australian general practice:a pilot study[J].Aust Fam Physician,2014,43(10):723-726.
Background: Systems to identify risks and adverse events (AEs) in Australia are limited. This study aims to explore whether general practice records contain information on AEs, and to conduct a pilot study on the type and frequency of AEs in general practice in Australia, using a global trigger tool (GTT). Methods: Five practices were recruited and consented to collect data. Practice nurses were trained to collect data at their practices. Records from randomly sampled patients aged 75 years or older were reviewed. Results: A total of 428 patient records were reviewed. A total of 44 AEs were detected in 41 records. The percentage of patients with an AE was 9.6%. Most low preventability AEs (21/29) were medication incidents. Discussion: The study found that significant levels of information about AEs exist in general practice medical records and rates of harm are broadly in line with a similar study in Scotland.
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[28] 边原,闫峻峰,杜姗,.全面触发工具在药品不良事件分析中的应用[J].中国新药与临床杂志,2015,34(9):726-731.
目的验证全面触发工具用于检测药品不良事件的可行性。方法利用临床药学管理系统(2.1)随机抽取本院2014年10-12月500份住院患者病历进行回顾性分析,评价病历记录中可能存在的药品不良事件。结果在调查的500份住院病历中,39项触发器有25项触发器显阳性,触发器阳性频次为459次。其中抗过敏应用药物项(编号:33)触发频次最多,71次,占15.5%。确定药品不良事件77次,涉及53例患者,ADE检出率为16.8%(77/459)。阳性预测值以血钾异常项(编号:7、8)较其他高,分别占34.8%和30.0%。不良事件伤害分级集中在“轻微伤害”与“中度伤害”级别。结论全面触发工具在防范药品不良事件方面具有积极作用,但尚待完善。
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[本文引用:1]
[29] 季欢欢,宋林,肖剑文,.全面触发工具用于住院儿童药品不良事件主动监测[J].中国新药与临床杂志,2016,35(9):674-679.
目的采用全面触发工具(GT-F)建立儿童住院患者药品不良事件(ADE)的主动监测方法,评价住院患儿的ADE发生情况。方法用专家咨询法建立儿童ADE触发器,采用等距随机抽样方法抽取本院2014年10月至2015年9月住院患儿9-3档病历600份,按GTT法进行回顾性病历审查。对触发器阳性所涉及情况进一步审查以确定或排除ADE,审查中发现的无触发器阳性但确定发生的ADE一并记录。所有ADE进行严重程度分级、类型分布及相关药物分析,计算ADE检出率及触发器阳性预测值(PPV)等。结果最终纳入587例病历,共检出119例患儿共计159例次ADE。GTT检出105例患儿共计120例次ADE,检出率17.9%(105/587),无触发器阳性但确定为ADE的39例次。建立的36项触发器,实际应用中有26项呈阳性(72%);触发器总阳性频次905次,检出ADE的有143次,触发器PPV15.8%(143/905)。159例次ADE中暂时性伤害占98.7%(E级77.4%、F级20.8%),最常累及胃肠系统,相关药物以抗菌药物为主(36.9%)。结论GTF对儿童ADE的监测及评价具有积极作用,但尚需进一步改进。
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[本文引用:0]
[30] 刘佳明,闫素英,刘琛,.全面触发工具在药品不良事件检测中的应用初探[M].药物不良反应杂志,2014,16(4):198-204.
[本文引用:0]
[31] HOOPER A J,TIBBALLST J.Comparison of a trigger tool and voluntary reporting to identify adverse events in a paediatric intensive care unit[J].Anaesth Intensive Care,2014,42:199-206.
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[32] GRIFFIN F A,CLASSEN D C.Detection of adverse events in surgical patients using the trigger tool approach[J].Qual Saf Health Care,2008,17:253-258.
ABSTRACT Most studies of healthcare complications identify surgery as a major contributor to the overall burden of complicated care that leads to injury or death. Indeed, surgical adverse events account for one-half to three-quarters of all adverse events in these studies. Despite the intensive current focus on improving medical quality and safety, only a minority of quality improvement efforts are focused on surgery. This study reports on the development and testing of a Trigger Tool to detect adverse events among patients undergoing inpatient surgery. Rather than relying on traditional voluntary reporting for safety outcome measures such as incident reports, surgical peer review, or morbidity and mortality conferences, the Institute for Healthcare Improvement (IHI) has employed a new method for the detection of surgical adverse events (SAEs). This approach, commonly referred to as the "Trigger Tool", identifies adverse events using a form of retrospective record review that has been developed and implemented in many areas of care. During a 12-month IHI Perioperative Safety Collaborative, 11 hospitals voluntarily submitted data from surgical inpatient record reviews. In 854 patients, 138 SAEs were detected in 125 records for a rate of 16 SAEs per 100 patients or 14.6% of patients; 61 (44%) of these events contributed to increased length of stay or readmission and 12 (8.7%) events required life-saving intervention or resulted in permanent harm or death. Hospital review teams reported verbally that most of the events identified during the Trigger Tool review process had not been detected or reported via any other existing mechanism. The IHI Surgical Trigger Tool may offer a practical, easy-to-use approach to detecting safety problems in patients undergoing surgery; it can be the basis not only for estimating the frequency of adverse events in an organisation, but also determining the impact of interventions that focus on reducing adverse events in surgical patients.
DOI:10.1136/qshc.2007.025080      PMID:18678721      URL    
[本文引用:0]
[33] SHAREK P J,HORBAR J D,MASON W,et al.Adverse events in the Neonatal intensive care unit:development,testing,and findings of an NICU-focused trigger tool to identify harm in north American NICUs[J].Pediatrics,2006,118(4):1332-1340.
Abstract OBJECTIVES: Currently there are few practical methods to identify and measure harm to hospitalized children. Patients in NICUs are at high risk and warrant a detailed assessment of harm to guide patient safety efforts. The purpose of this work was to develop a NICU-focused tool for adverse event detection and to describe the incidence of adverse events in NICUs identified by this tool. METHODS: A NICU-focused trigger tool for adverse event detection was developed and tested. Fifty patients from each site with a minimum 2-day NICU stay were randomly selected. All adverse events identified using the trigger tool were evaluated for severity, preventability, ability to mitigate, ability to identify the event earlier, and presence of associated occurrence report. Each trigger, and the entire tool, was evaluated for positive predictive value. Study chart reviewers, in aggregate, identified 88.0% of all potential triggers and 92.4% of all potential adverse events. RESULTS: Review of 749 randomly selected charts from 15 NICUs revealed 2218 triggers or 2.96 per patient, and 554 unique adverse events or 0.74 per patient. The positive predictive value of the trigger tool was 0.38. Adverse event rates were higher for patients <28 weeks' gestation and <1500 g birth weight. Fifty-six percent of all adverse events were deemed preventable; 16% could have been identified earlier, and 6% could have been mitigated more effectively. Only 8% of adverse events were identified in existing hospital-based occurrence reports. The most common adverse events identified were nosocomial infections, catheter infiltrates, and abnormal cranial imaging. CONCLUSIONS: Adverse event rates in the NICU setting are substantially higher than previously described. Many adverse events resulted in permanent harm and the majority were classified as preventable. Only 8% were identified using traditional voluntary reporting methods. Our NICU-focused trigger tool appears efficient and effective at identifying adverse events.
DOI:10.1542/peds.2006-0565      PMID:17015521      URL    
[本文引用:0]
[34] TAKATA G S,MASON W,TAKETOMO C,et al.Develop-ment,testing,and findings of a pediatric-focused trigger tool to identify medication-related harm in US children's hospitals[J].Pediatrics,2008,121(4):e927-e935.
DOI:10.1542/peds.2007-1779      URL    
[本文引用:1]
[35] FARUP P G.Are measurements of patient safety culture and adverse events valid and reliable?results from a cross sectional study[J].MC Health Serv Res,2015,15:186.
Background The association between measurements of the patient safety culture and the ???true??? patient safety has been insufficiently documented, and the validity of the tools used for the measurements has been questioned. This study explored associations between the patient safety culture and adverse events, and evaluated the validity of the tools. Methods In 2008/2009, a survey on patient safety culture was performed with Hospital Survey on Patient Safety Culture (HSOPSC) in two medical departments in two geographically separated hospitals of Innlandet Hospital Trust. Later, a retrospective analysis of adverse events during the same period was performed with the Global Trigger Tool (GTT). The safety culture and adverse events were compared between the departments. Results 185 employees participated in the study, and 272 patient records were analysed. The HSOPSC scores were lower and adverse events less prevalent in department 1 than in department 2. In departments 1 and 2 the mean HSOPSC scores (SD) were at the unit level 3.62 (0.42) and 3.90 (0.37) (p???&lt;???0.001), and at the hospital level 3.35 (1.53) and 3.67 (0.53) (ns, p???=???0.19) respectively. The proportion of records with adverse events were 10/135 (7%) and 28/137 (20%) (p???=???0.003) respectively. Conclusions There was an inverse association between the patient safety culture and adverse events. Until the criterion validity of the tools for measuring patient safety culture and tracking of adverse events have been further evaluated, measurement of patient safety culture could not be used as a proxy for the ???true??? safety.
DOI:10.1186/s12913-015-0852-x      PMID:4424527      URL    
[本文引用:0]
[36] MENENDEZ M D,ALONSO J,MINANA J C,et al.Charac-teristics and associated factors in patient falls,and effectiveness of the lower height of beds for the prevention of bed falls in an acute geriatric hospital[J].Rev Calid Asist,2013,28(5):277-284.
La prevención de caídas de pacientes es una tarea importante en las Unidades geriátricas con una potencial reducción de costes y da09os, algunas medidas como la bajada de la altura de la cama mostraron una reducción significativa de las caídas.
DOI:10.1016/j.cali.2013.01.007      PMID:23684046      URL    
[本文引用:0]
[37] CROFT L D,HARRIS A D,PINELES L,et al.The effect of universal glove and gown use on adverse events in intensive care unit patients[J].Clin Infect Dis,2015,61(4):545-553.
No randomized trials have examined the effect of contact precautions or universal glove and gown use on adverse events. We assessed if wearing gloves and gowns during all patient contact in the intensive care unit (ICU) changes adverse event rates.From January 2012 to October 2012, intervention ICUs of the 20-site Benefits of Universal Gloving and Gowning cluster randomized trial required that healthcare workers use gloves and gowns for all patient contact. We randomly sampled 1800 medical records of adult patients not colonized with antibiotic-resistant bacteria and reviewed them for adverse events using the Institute for Healthcare Improvement Global Trigger Tool.Four hundred forty-seven patients (24.8%) had 1 or more ICU adverse events. Adverse events were not associated with universal glove and gown use (incidence rate ratio [IRR], 0.81; 95% confidence interval [CI], .48-1.36). This did not change with adjustment for ICU type, severity of illness, academic hospital status, and ICU size, (IRR, 0.91; 95% CI, .59-1.42; P = .68). Rates of infectious adverse events also did not differ after adjusting for the same factors (IRR, 0.75; 95% CI, .47-1.21; P = .24).In ICUs where healthcare workers donned gloves and gowns for all patient contact, patients were no more likely to experience adverse events than in control ICUs. Concerns of adverse events resulting from universal glove and gown use were not supported. Similar considerations may be appropriate regarding use of contact precautions.NCT0131821.
DOI:10.1093/cid/civ315      PMID:25900169      URL    
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[38] CROFT LD,LIQUORI M E,LADD J,et al.Frequency of adverse events before,during,and after hospital admission[J].South Med J,2016,109(10):631-635.
Abstract OBJECTIVES: Adverse events (AEs) are unintended physical injuries resulting from or contributed to by medical or surgical care. We determined the frequency and type of AEs before, during, and after hospital admission. METHODS: We conducted a cohort study of 296 adult hospital patients. We used the standardized Institute for Healthcare Improvement Global Trigger Tool for Measuring Adverse Events to review the medical records of the hospital patients for occurrence, timing relative to hospital admission, severity, and preventability of AEs. We also identified the primary physiologic system affected by the AE. RESULTS: Among 296 patients, we identified 338 AEs. AEs occurred with similar frequency before (n = 148; 43.8%) and during hospital admission (n = 162; 47.9%). Fewer AEs occurred after discharge (n = 28; 8.3%). Half of all AEs (n = 169; 50.0%) were severe, whereas 47.9% (n = 162) were preventable. CONCLUSIONS: AEs occur with similar frequency before and during hospitalization and may contribute more to hospital admissions than previously recognized. These findings suggest that efforts to improve patient safety should include outpatient settings in addition to the more commonly targeted acute care settings.
DOI:10.14423/SMJ.0000000000000536      PMID:27706501      URL    
[本文引用:0]
[39] ADLER L,YI D,LI M,et al.Impact of inpatient harms on hospital finances and patient clinical outcomes[J].J Patient Saf,2015, [Epub ahead of print].
Abstract OBJECTIVE: The aim of this study was to determine the impact of all-cause inpatient harms on hospital finances and patient clinical outcomes. RESEARCH DESIGN: A retrospective analysis of inpatient harm from 24 hospitals in a large multistate health system was conducted during 2009 to 2012 using the Institute of Healthcare Improvement Global Trigger Tool for Measuring Adverse Events. Inpatient harms were detected and categorized into harm (F-I), temporary harm (E), and no harm. RESULTS: Of the 21,007 inpatients in this study, 15,610 (74.3%) experienced no harm, 2818 (13.4%) experienced temporary harm, and 2579 (12.3%) experienced harm. A patient with harm was estimated to have higher total cost ($4617 [95% confidence interval (CI), $4364 to 4871]), higher variable cost ($1774 [95% CI, $1648 to $1900]), lower contribution margin (-$1112 [95% CI, -$1378 to -$847]), longer length of stay (2.6 d [95% CI, 2.5 to 2.8]), higher mortality probability (59%; odds ratio, 1.4 [95% CI, 1.0 to 2.0]), and higher 30-day readmission probability (74.4%; odds ratio, 2.9 [95% CI, 2.6 to 3.2]). A patient with temporary harm was estimated to have higher total cost ($2187 [95% CI, $2008 to $2366]), higher variable cost ($800 [95% CI, $709 to $892]), lower contribution margin (-$669 [95% CI, -$891 to -$446]), longer length of stay (1.3 d [95% CI, 1.2 to 1.4]), mortality probability not statistically different, and higher 30-day readmission probability (54.6%; odds ratio, 1.2 [95% CI, 1.1 to 1.4]). Total health system reduction of harm was associated with a decrease of $108 million in total cost, $48 million in variable cost, an increase of contribution margin by $18 million, and savings of 60,000 inpatient care days. CONCLUSIONS: This all-cause harm safety study indicates that inpatient harm has negative financial outcomes for hospitals and negative clinical outcomes for patients.This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially.
DOI:10.1097/PTS.0000000000000171      PMID:25803176      URL    
[本文引用:0]
[40] DOLORES MENENDEZ M,RANCANO I,GARCIA V,et al.Use of different patient safety reporting systems:much ado about nothing?[J].Rev Calid Asist,2010,25(4):232-236.
We have increased the adverse events reporting due the inclusion of the reporting systems and a clinical risk manager working a full time, with a clearer picture of the types of adverse events with an integration of different data and reporting systems, and a better approach to improvement, monitoring and review of the processes. The nature of the sources in the reporting systems does not permit to know the ranking and real figures of the adverse events, and it is necessary to established priorities and to stagger the different reporting systems in the time and in function of the cost effectiveness measures. The reporting systems are the first step to analysis and is necessary to improve and mitigate the adverse events.
DOI:10.1016/j.cali.2010.02.001      URL    
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[41] CARNEVALI L,KRUG B,AMANT F,et al.Performance of the adverse drug event trigger tool and the global trigger tool for identifying adverse drug events:experience in a Belgian hospital[J].Ann Pharmacother,2013,47(11):1414-1419.
Medication-related harm can be detected using the adverse drug event (ADE) trigger tool and the medication module of the Global Trigger Tool (GTT) developed by the Institute for Healthcare Improvement (IHI). In recent years, there has been some controversy on the performance of this method. In addition, there are limited data on the performance of the medication module of the GTT as compared with the ADE trigger tool.To evaluate the performance of the ADE trigger tool and of the medication module of the GTT for identifying ADEs.The methodology of the IHI was used. A random sample of 20 adult admissions per month was selected over a 12-month period in a teaching hospital in Belgium. The ADE trigger tool was adapted to the Belgian setting and included 20 triggers. The positive predictive value (PPV) of each trigger was calculated, as well as the proportion of ADEs that would have been identified with the medication module of the GTT as compared with the ADE trigger tool.A total of 200 triggers and 62 ADEs were found, representing 26 ADEs/100 admissions. Nineteen ADEs (31%) were found spontaneously without the presence of a trigger. Three triggers never occurred. The PPVs of other triggers varied from 0 to 0.67, with half of them having PPVs less than 0.20. If we had used the medication triggers included in the GTT (n = 11), we would have identified 77% of total ADEs and 67% of preventable ADEs.Applying the trigger tool method proposed by the IHI to a Belgian hospital led to the identification of one ADE out of 4 admissions. To increase performance, refining the list of triggers in the ADE trigger tool and in the medication module of the GTT would be needed. Recording nontriggered events should be encouraged.
DOI:10.1177/1060028013500939      PMID:24285758      URL    
[本文引用:1]
[42] UNBECK M,SCHILDMEIJER K,HENRIKSSON P,et al.Is detection of adverse events affected by record review methodology? an evaluation of the “Harvard Medical Practice Study” method and the “Global Trigger Tool”[J].Patient Saf Surg,2013,7(1):10.
Abstract BACKGROUND: There has been a theoretical debate as to which retrospective record review method is the most valid, reliable, cost efficient and feasible for detecting adverse events. The aim of the present study was to evaluate the feasibility and capability of two common retrospective record review methods, the "Harvard Medical Practice Study" method and the "Global Trigger Tool" in detecting adverse events in adult orthopaedic inpatients. METHODS: We performed a three-stage structured retrospective record review process in a random sample of 350 orthopaedic admissions during 2009 at a Swedish university hospital. Two teams comprised each of a registered nurse and two physicians were assigned, one to each method. All records were primarily reviewed by registered nurses. Records containing a potential adverse event were forwarded to physicians for review in stage 2. Physicians made an independent review regarding, for example, healthcare causation, preventability and severity. In the third review stage all adverse events that were found with the two methods together were compared and all discrepancies after review stage 2 were analysed. Events that had not been identified by one of the methods in the first two review stages were reviewed by the respective physicians. RESULTS: Altogether, 160 different adverse events were identified in 105 (30.0%) of the 350 records with both methods combined. The "Harvard Medical Practice Study" method identified 155 of the 160 (96.9%, 95% CI: 92.9-99.0) adverse events in 104 (29.7%) records compared with 137 (85.6%, 95% CI: 79.2-90.7) adverse events in 98 (28.0%) records using the "Global Trigger Tool". Adverse events "causing harm without permanent disability" accounted for most of the observed difference. The overall positive predictive value for criteria and triggers using the "Harvard Medical Practice Study" method and the "Global Trigger Tool" was 40.3% and 30.4%, respectively. CONCLUSIONS: More adverse events were identified using the "Harvard Medical Practice Study" method than using the "Global Trigger Tool". Differences in review methodology, perception of less severe adverse events and context knowledge may explain the observed difference between two expert review teams in the detection of adverse events.
DOI:10.1186/1754-9493-7-10      PMID:3637606      URL    
[本文引用:1]
[43] LIPCZAK H,NECKELMANN K,STEDING-JESSEN M,et al.Uncertain added value of global trigger tool for monitoring of patient safety in cancer care[J].Dan Med Bull,2011,58(11):A4337.
Monitoring patient safety is a challenging task. The lack of a golden standard has contributed to the recommendation and introduction of several methods. In 2000 the Danish Lung Cancer Registry (DLCR) was established to monitor the clinical management of lung cancer. In 2008 the Global Trigger Tool (GTT) was recommended in Denmark as a tool for the monitoring of patient safety. Ideally, the recommendation of a new tool should be preceded by a critical assessment of its added value.Data on complications related to lung cancer surgery from the Department of Cardiothoragic Surgery at Odense University Hospital were collected using the DLCR and the GTT in 2008. The capacity of these two methods to identify complications is compared and discussed.A total of 59 complications were registered in the DLCR, while 58 complications were registered using the GTT. The two methods were equally good at identifying complications, but the DLCR seemed to be borderline significantly better at detecting arrhythmia, while the GTT was significantly better at detecting "other events".Nearly half of the adverse events identified with the GTT were complications which were also registered by type in the DLCR. The two methods were almost equally good at identifying specific types of complications, but the GTT identified more "other events". The majority of these events were well-known to clinicians. The comparison illustrates why the implementation of new methods should be preceded by critical assessment. In this case, it is crucial to assess whether the current method should be modified by the addition of more patient safety indicators rather than by introducing a new method that partly duplicates existing data.
DOI:10.1016/S0140-6736(10)60660-5      PMID:22047933      URL    
[本文引用:1]
[44] LANDRIGAN C P,PARRY G J,BONES C B,et al.Tempor-al trends in rates of patient harm resulting from medical care[J].N Engl J Med,2010,363(22):2124-2134.
DOI:10.1056/NEJMsa1004404      URL    
[本文引用:0]
[45] STOCKWELL D C,BISARYA H,CLASSEN D C,et al.A trigger tool to detect harm in pediatric inpatient settings[J].Pediatrics,2015,135(6):1036-1042.
Abstract OBJECTIVES: An efficient and reliable process for measuring harm due to medical care is needed to advance pediatric patient safety. Several pediatric studies have assessed the use of trigger tools in varying inpatient environments. Using the Institute for Healthcare Improvement's adult-focused Global Trigger Tool as a model, we developed and pilot tested a trigger tool that would identify the most common causes of harm in pediatric inpatient environments. METHODS: After formal training, 6 academic children's hospitals used this novel pediatric trigger tool to review 100 randomly selected inpatient records per site from patients discharged during the month of February 2012. RESULTS: From the 600 patient charts evaluated, 240 harmful events ("harms") were identified, resulting in a rate of 40 harms per 100 patients admitted and 54.9 harms per 1000 patient days across the 6 hospitals. At least 1 harm was identified in 146 patients (24.3% of patients). Of the 240 total events, 108 (45.0%) were assessed to have been potentially or definitely preventable. The most common patient harms were intravenous catheter infiltrations/burns, respiratory distress, constipation, pain, and surgical complications. CONCLUSIONS: Consistent with earlier rates of all-cause harm in adult hospitals, harm occurs at high rates in hospitalized children. Availability and use of an all-cause harm identification tool will establish the epidemiology of harm and will provide a consistent approach to assessing the effect of interventions on harms in hospitalized children. Copyright 漏 2015 by the American Academy of Pediatrics.
DOI:10.1542/peds.2014-2152      PMID:25986015      URL    
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[46] HWANG J I,CHIN H J,CHANG Y S.Characteristics asso-ciated with the occurrence of adverse events:a retrospective medical record review using the global trigger tool in a fully digitalized tertiary teaching hospital in Korea[J].J Eval Clin Pract,2014,20(1):27-35.
This study aimed to examine the performance of the Global Trigger Tool and to investigate characteristics associated with the occurrence of adverse events (AEs).Retrospective medical record review.A tertiary teaching hospital, Korea.We employed two-stage review of a random sample of 630 charts for patients discharged between January and June 2011. Two quality improvement specialists reviewed the presence of AEs using 53 triggers developed by the Institute for Healthcare Improvement. Two physicians reviewed and validated the findings of adverse events. Positive predictive values for individual triggers were calculated. Logistic regression analysis was performed to determine factors associated with AEs.Of 629 patients, 45 (7%) experienced at least one AE during their hospitalization. Among the observed AEs, 61% were preventable. The frequent types of AEs were 'procedure-related' and 'medication-related'. Six triggers had positive predictive values of greater than 50.0%: 'health care-associated infection', 'any procedure complication', 'medication: other', 'return to surgery', 'occurrence of any operative complication' and 'intubation/reintubation'. Significant factors associated with the occurrence of AEs were length of stay (OR 1.13; 95% CI 1.07 to 1.20) and the number of triggers (OR 1.49; 95% CI 1.11 to 1.98).The Global Trigger Tool was useful for the detection of adverse events in a Korean hospital setting. Triggers with high positive predictive values should have priority for incorporation into routine screening systems. Furthermore, patients who stay longer in the hospital need to be closely monitored using triggers to improve patient safety.
DOI:10.1111/jep.12075      PMID:23890097      URL    
[本文引用:1]
[47] KENNERLY D A,SALDANA M,KUDYAKOV R,et al.Description and evaluation of adaptations to the global trigger tool to enhance value to adverse event reduction efforts[J].J Patient Saf,2013,9(2):87-95.
Abstract Objective: To adapt the Global Trigger Tool (GTT) as a sustainable monitoring tool able to characterize adverse events (AEs) for organizational learning, within the context of limited resources. Methods: Baylor Health Care System (BHCS) expanded the AE data collected to include judgments of preventability, presence on admission, relation to care provided or not provided, and narrative descriptions. To reduce costs, we focused on patients with length of stay (LOS) of 3 days or more, suspecting greater likelihood they had experienced an AE; adapted the sample size and frequency of review; and used a single nurse reviewer followed by quality assurance review within the Office of Patient Safety. We compared AE rates in patients with LOS of less than 3 days versus 3 days or greater, assessed trigger yields and interrater reliability, and submitted identified AEs to each hospital for validation as event types targeted for reduction. Results: In 2008, 91% of identified AEs were in patients with LOS of 3 days or greater; there were 6.4 AEs per 100 discharges with LOS of less than 3 days versus 27.1 AEs per 100 discharges with LOS of 3 days or greater. Over 4 years, we reviewed 16,172 medical records; 14,184 had positive triggers, 17.1% of which were associated with an AE. Most AEs were identified via the "surgical" (36.3%) and "patient care" (36.0%) trigger modules. Reviewers showed fair to good agreement (魏 = 0.62), and hospital clinical leaders strongly agreed that the identified events were AEs. Conclusions: The GTT can be adapted to health-care organizations' goals and resource limitations. This flexibility was essential in crossing our organization's "value threshold."
DOI:10.1097/PTS.0b013e31827cdc3b      PMID:23334632      URL    
[本文引用:0]
[48] SEYNAEVE S,VERBRUGGHE W,CLAES B.Adverse drug events in intensive care units:a cross-sectional study of prevalence and risk factors[J].Am J Crit Care,2011,20(6):131-140.
Abstract BACKGROUND: Adverse drug events are considered determinants of patient safety and quality of care. OBJECTIVE: To assess the characteristics of adverse drug events in patients admitted to an intensive care unit and determine the impact of severity of illness and nursing workload on the prevalence of the events. METHODS: A cross-sectional survey based on retrospective analysis of a high-quality patient data management system for a university-based intensive care unit was used. The prevalence of adverse drug events was measured by using a validated global trigger tool adapted for the critical care environment. Severity was determined by using a validated algorithm. Disease severity and nursing workload were assessed by using validated scoring systems. An investigator blinded to the study and a panel of experts assessed putative serious adverse drug events for each drug taken. Characteristics of patients with and without adverse drug events were compared by using univariate and stepwise multivariate logistic regression. RESULTS: During 175 of 1009 intensive care unit days screened, 230 adverse drug events occurred in 79 patients. The most common events were hypoglycemia, prolonged activated partial thromboplastin time, and hypokalemia. Of the adverse events, 96% were classified as causing temporary harm and 4% as causing complications. Both mean severity of disease and nursing workload were significantly higher on days when 1 or more adverse drug events occurred. CONCLUSION: Adverse drug events were common in intensive care unit patients and were associated with illness severity and nursing workload.
DOI:10.4037/ajcc2011818      PMID:22045149      URL    
[本文引用:0]
[49] KALENDERIAN E,WALJI M F,TAVARES A,et al.An adverse event trigger tool in dentistry:a new methodology for measuring harm in the dental office[J].J Am Dent Assoc,2013,144(7):808-814.
DOI:10.14219/jada.archive.2013.0191      URL    
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[50] SCHILDMEIJER K,NILSSON L,ARESTEDT K,et al.Assessment of adverse events in medical care:lack of consistency between experienced teams using the global trigger tool[J].BMJ Qual Saf,2012,21(4):307-314.
Abstract Many patients are harmed as the result of healthcare. A retrospective structured record review is one way to identify adverse events (AEs). One such review approach is the global trigger tool (GTT), a consistent and well-developed method used to detect AEs. The GTT was originally intended to be used for measuring data over time within a single organisation. However, as the method spreads, it is likely that comparisons of GTT safety outcomes between hospitals will occur. To evaluate agreement in judgement of AEs between well-trained GTT teams from different hospitals. Five teams from five hospitals of different sizes in the southeast of Sweden conducted a retrospective review of patient records from a random sample of 50 admissions between October 2009 and May 2010. Inter-rater reliability between teams was assessed using descriptive and 魏 statistics. The five teams identified 42 different AEs altogether. The number of identified AEs differed between the teams, corresponding to a level of AEs ranging from 27.2 to 99.7 per 1000 hospital days. Pair-wise agreement for detection of AEs ranged from 88% to 96%, with weighted 魏 values between 0.26 and 0.77. Of the AEs, 29 (69%) were identified by only one team and not by the other four groups. Most AEs resulted in minor and transient harm, the most common being healthcare-associated infections. The level of agreement regarding the potential for prevention showed a large variation between the teams. The results do not encourage the use of the GTT for making comparisons between hospitals. The use of the GTT to this end would require substantial training to achieve better agreement across reviewer teams.
DOI:10.1136/bmjqs-2011-000279      PMID:22362917      URL    
[本文引用:1]
[51] MATTSSON T O,KNUDSEN J L,LAURITSEN J,et al.Assessment of the global trigger tool to measure,monitor and evaluate patient safety in cancer patients:reliability concerns are raised[J].BMJ Qual Saf,2013,22(7):571-579.
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[52] KAAFARANI H M,ROSEN A K,NEBEKER J R,et al.Development of trigger tools for surveillance of adverse events in ambulatory surgery[J].Qual Saf Health Care,2010,19(5):425-429.
The trigger tool methodology uses clinical algorithms applied electronically to ‘flag’ medical records where adverse events (AEs) have most likely occurred. The authors sought to create surgical triggers to detect AEs in the ambulatory care setting.Four consecutive steps were used to develop ambulatory surgery triggers. First, the authors conducted a comprehensive literature review for surgical triggers. Second, a series of multidisciplinary focus groups (physicians, nurses, pharmacists and information technology specialists) provided user input on trigger selection. Third, a clinical advisory panel designed an initial set of 10 triggers. Finally, a three-phase Delphi process (surgical and trigger tool experts) evaluated and rated the suggested triggers.The authors designed an initial set of 10 surgical triggers including five global triggers (flagging medical records for the suspicion of any AE) and five AE-specific triggers (flagging medical records for the suspicion of specific AEs). Based on the Delphi rating of the trigger's utility for system-level interventions, the final triggers were: (1) emergency room visit(s) within 2161days from surgery; (2) unscheduled readmission within 3061days from surgery; (3) unscheduled procedure (interventional radiological, urological, dental, cardiac or gastroenterological) or reoperation within 3061days from surgery; (4) unplanned initial hospital length of stay more than 2461h; and (5) lower-extremity Doppler ultrasound order entry and ICD code for deep vein thrombosis or pulmonary embolus within 3061days from surgery.The authors therefore propose a systematic methodology to develop trigger tools that takes into consideration previously published work, end-user preferences and expert opinion.
DOI:10.1136/qshc.2008.031591      PMID:20513790      URL    
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[53] MATTSSON T O,KNUDSEN J L,BRIXEN K,et al.Does adding an appended oncology module to the global trigger tool increase its value?[J].Int J Qual Health Care,2014,26(5):553-560.
To determine any additional value in the evaluation of safety levels by adding an appended oncology module to the Institute for Healthcare Improvement's Global Trigger Tool (GTT).Comparison of two independent retrospective chart reviews: one review team using the general GTT method and one using the general GTT method plus the appended oncology module on the same inpatient charts.The Department of Clinical Oncology at a Danish University Hospital (1000 beds).All inpatients admitted to the hospital in 2010, n = 3692, biweekly sample of 10 admission charts resulting in a double review of 240 charts.Total number of identified adverse events (AEs), distribution of identified AEs in the harm categories of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP), AEs per 100 admissions and AEs per 1000 admission days.No significant (95% confidence interval) difference was found between review teams using the general GTT versus the general GTT plus the appended oncology module on the total number of identified AEs, AEs per 100 admissions, AEs per 1000 admission days or in the overall distribution of identified AEs in the five NCC MERP harm categories.The study showed that adding the appended oncology module to the GTT did not increase its value regarding the evaluation of safety levels. This finding could be due to the measurement error of the GTT. Further studies evaluating the measurement properties and the specific additional modules to the general GTT are needed.
DOI:10.1093/intqhc/mzu072      PMID:25080549      URL    
[本文引用:1]
[54] MEVIK K,GRIFFIN F A,HANSEN T E,et al.Does increa-sing the size of bi-weekly samples of records influence results when using the global trigger tool? An observational study of retrospective record reviews of two different sample sizes[J].BMJ Open,2016,6(4):e010700.
DOI:10.1136/bmjopen-2015-010700      URL    
[本文引用:2]
[55] VON PLESSEN C,KODAL A M,ANHEJ J.Experiences with global trigger tool reviews in five Danish hospitals:an implementation study[J].BMJ Open,2012,2(5):e001324.
DOI:10.1136/bmjopen-2012-001324      URL    
[本文引用:2]
[56] MEVIK K,GRIFFIN F A,HANSEN T E,et al.Is inter-rater reliability of global trigger tool results altered when members of the review team are replaced?[J].Int J Qual Health Care,2016,28(4):492-496.
Abstract Objective To evaluate the inter-rater reliability of results from Global Trigger Tool (GTT) reviews when one of the three reviewers remains consistent, while one or two reviewers rotate. Design Comparison of results from retrospective record review performed as a cross-sectional study with three review teams each consisting of two non-physicians and one physician; Team I (three consistent reviewers), Team II (one of the two non-physician reviewers or/and the physician from Team I are replaced for different review periods) and Team III (three consistent reviewers different from reviewers in Team I and Team II). Setting Medium-sized hospital trust in Northern Norway. Participants A total of 120 records were selected as biweekly samples of 10 from discharge lists between 1 July and 31 December 2010 for a 3-fold review. Intervention Replacement of review team members was tested to assess impact on inter-rater reliability and adverse events measurment. Main Outcome Measure(s) Inter-rater reliability assessed with the Cohen kappa coefficient between different teams regarding the presence and severity level of adverse events. Results Substantial inter-rater reliability regarding the presence and severity level of adverse events was obtained between Teams I and II, while moderate inter-rater reliability was obtained between Teams I and III. Conclusions Replacement of reviewers did not influence the results provided that one of the non-physician reviewers remains consistent. The experience of the consistent reviewer can result in continued consistency in interpretation with the new reviewer through discussion of events. These findings could encourage more hospital to rotate reviewers in order to optimize resources when using the GTT.
DOI:10.1093/intqhc/mzw054      PMID:27283442      URL    
[本文引用:1]
[57] NAESSENS J M,O'BYRNE T J,JOHNSON M G,et al.Measuring hospital adverse events:assessing inter-rater reliability and trigger performance of the global trigger tool[J].Int J Qual Health Care,2010,22(4):266-274.
To determine the inter-rater reliability of the Institute for Healthcare Improvement's Global Trigger Tool (GTT) in a practice setting, and explore the value of individual triggers.Prospective assessment of application of the GTT to monthly random samples of hospitalized patients at four hospitals across three regions in the USA.Mayo Clinic campuses are in Minnesota, Arizona and Florida.A total of 1138 non-pediatric inpatients from all units across the hospital.GTT was applied to randomly selected medical records with independent assessments of two registered nurses with a physician review for confirmation.The Cohen Kappa coefficient was used as a measure of inter-rater agreement. The positive predictive value was assessed for individual triggers.Good levels of reliability were obtained between independent nurse reviewers at the case-level for both the occurrence of any trigger and the identification of an adverse event. Nurse reviewer agreement for individual triggers was much more varied. Higher agreement appears to occur among triggers that are objective and consistently recorded in selected portions of the medical record. Individual triggers also varied on their yield to detect adverse events. Cases with adverse events had significantly more triggers identified (mean 4.7) than cases with no adverse events (mean 1.8).The trigger methodology appears to be a promising approach to the measurement of patient safety. However, automated processes could make the process more efficient in identifying adverse events and has a greater potential of improving care delivery and patient 'outcomes'.
DOI:10.1093/intqhc/mzq026      PMID:20534607      URL    
[本文引用:1]
[58] SHAREK P J,PARRY G,GOLDMANN D,et al.Performance characteristics of a methodology to quantify adverse events over time in hospitalized patients[J].Health Serv Res,2011,46(2):654-678.
DOI:10.1111/hesr.2011.46.issue-2      URL    
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[59] FALCONER N,NAND S,LIOW D,et al.Development of an electronic patient prioritization tool for clinical pharmacist interventions[J].Am J Health Syst Pharm,2014,71(4):311-320.
DOI:10.2146/ajhp130247      URL    
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[60] CIHANGIR S,BORGHANS I,HEKKERT K,et al.A pilot study on record reviewing with a priori patient selection[J].BMJ Open,2013,3(7):e003034.
To investigate whether a priori selection of patient records using unexpectedly long length of stay (UL-LOS) leads to detection of more records with adverse events (AEs) compared to non-UL-LOS.To investigate the opportunities of the UL-LOS, we looked for AEs in all records of patients with colorectal cancer. Within this group, we compared the number of AEs found in records of patients with a UL-LOS with the number found in records of patients who did not have a UL-LOS.Our study was done at a general hospital in The Netherlands. The hospital is medium sized with approximately 30 000 admissions on an annual basis. The hospital has two major locations in different cities where both primary and secondary care is provided.The patient records of 191 patients with colorectal cancer were reviewed.Number of triggers and adverse events were the primary outcome measures.In the records of patients with colorectal cancer who had a UL-LOS, 51% of the records contained one or more AEs compared with 9% in the reference group of non-UL-LOS patients. By reviewing only the UL-LOS group with at least one trigger, we found in 84% (43 out of 51) of these records at least one adverse event.A priori selection of patient records using the UL-LOS indicator appears to be a powerful selection method which could be an effective way for healthcare professionals to identify opportunities to improve patient safety in their day-to-day work.
DOI:10.1136/bmjopen-2013-003034      PMID:3717450      URL    
[本文引用:1]
[61] MENENDEZ FRAGA M D,CUEVA ALVAREZ M A,FRANCO CASTELLANOS M R,et al.Compliance with the surgical safety checklist and surgical events detected by the global trigger tool[J].Rev Calid Asist,2016,31(Suppl 1):20-23.
The implementing of the WHO Surgical Safety Checklist (SSC) has helped to improve patient safety. The aim of this study was to assess the level of compliance of the SSC, and incorporating the non-compliances as 芦triggers禄 in the Global Trigger Tool (GTT). Acute Geriatric Hospital (200 beds). Retrospective study, study period: 2011-2014. The SSC formulary and the methodology of the GTT were used for the analysis of electronic medical records and the compliance with the SSC. The NCCP MERP categories were used to assess the severity of the harm. Out of all the electronic medical records (EMR), a total of 227 (23.6%) discharged patients (1.7% of interventions in the four year study period) were analysed. All (100%) of the EMR included the SSC, with 94.4% of the items being completed, and 28.2% of SSC had all items completed in the 3 phases of the process. Surgical adverse events decreased from 16.3% in 2011 to 9.4% in 2014 (P=.2838, not significant), and compliance with all items of SSC was increased from 18.6% to 39.1% (P=.0246, significant). The GTT systematises and evaluates, at low cost, the triggers and incidents/ AEs found in the EMR in order to assess the compliance with the SSC and consider non-compliance of SSC as 芦triggers禄 for further analysis. This strategy has never been referred to in the GTT or in the SCC formulary.
PMID:27265381      URL    
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[62] 徐晓娣,吴华,袁颐捷,.全面触发工具回顾性监测与自愿上报的药品不良事件比较[J].药物流行病学杂志,2016,25(8):499-502.
目的:比较应用美国健康促进研究所推出的全面触发工具(GTT)主动监测药品不良事件(ADE)与采用自愿报告系统上报的ADE,为更好地应用两种监测方法预防和减少药品不良事件提供参考。方法:回顾性分析某院2014年应用GTT监测的成年住院患者的ADE与同期医院自愿报告的ADE的特点。结果:自愿上报ADE的可预防率为4.08%,GTT监测为18.75%。ADE相关患者中内科明显多于外科。自愿上报ADE中E级为主,且有F级、H级事件,GTT监测的ADE中E级与F级事件较多。ADE涉及的给药途径以静滴、口服和皮下给药为主,涉及的药品中频率最高的是中药、抗肿瘤药和胰岛素。结论:GTT监测与自愿上报两种方法监测到的ADE类型有一定互补性,建议医疗机构同时应用两种方法,以更好地预防和减少ADE的发生。
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[本文引用:2]
[63] GOOD V S,SALDANA M,GILDER R,et al.Large-scale deployment of the global trigger tool across a large hospital system:refinements for the characterisation of adverse events to support patient safety learning opportunities[J].BMJ Qual Saf,2011,20(1):25-30.
Background The Institute for Healthcare Improvement encourages use of the Global Trigger Tool to objectively determine and monitor adverse events (AEs). Setting Baylor Health Care System (BHCS) is an integrated healthcare delivery system in North Texas. The Global Trigger Tool was applied to BHCS's eight general acute care hospitals, two inpatient cardiovascular hospitals and two rehabilitation/long-term acute care hospitals. Strategy Data were collected from a monthly random sample of charts for each facility for patients discharged between 1 July 2006 and 30 June 2007 by external professional nurse auditors using an MS Access Tool developed for this initiative. In addition to the data elements recommended by Institute for Healthcare Improvement, BHCS developed fields to permit further characterisation of AEs to identify learning opportunities. A structured narrative description of each identified AE facilitated text mining to further characterise AEs. Initial findings Based on this sample, AE rates were found to be 68.1 per 1000 patient days, or 50.8 per 100 encounters, and 39.8% of admissions were found to have ≥1 AE. Of all AEs identified, 61.2% were hospital-acquired, 10.1% of which were associated with a National Coordinating Council – Medical Error Reporting and Prevention harm score of “H or I” (near death or death). Future Direction To enhance learning opportunities and guide quality improvement, BHCS collected data—such as preventability and AE source—to characterise the nature of AEs. Data are provided regularly to hospital teams to direct quality initiatives, moving from a general focus on reducing AEs to more specific programmes based on patterns of harm and preventability.
DOI:10.1136/bmjqs.2008.029181      PMID:21228072      URL    
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[64] HANSKAMP-SEBREGTS M,ZEGERS M,VINCENT C,et al.Measurement of patient safety:a systematic review of the reliability and validity of adverse event detection with record review[J].BMJ Open,2016,6(8):e011078.
Record review is the most used method to quantify patient safety. We systematically reviewed the reliability and validity of adverse event detection with record review. A systematic review of the literature. We searched PubMed, EMBASE, CINAHL, PsycINFO and the Cochrane Library and from their inception through February 2015. We included all studies that aimed to describe the reliability and/or validity of record review. Two reviewers conducted data extraction. We pooled 魏 values (魏) and analysed the differences in subgroups according to number of reviewers, reviewer experience and training level, adjusted for the prevalence of adverse events. In 25 studies, the psychometric data of the Global Trigger Tool (GTT) and the Harvard Medical Practice Study (HMPS) were reported and 24 studies were included for statistical pooling. The inter-rater reliability of the GTT and HMPS showed a pooled 魏 of 0.65 and 0.55, respectively. The inter-rater agreement was statistically significantly higher when the group of reviewers within a study consisted of a maximum five reviewers. We found no studies reporting on the validity of the GTT and HMPS. The reliability of record review is moderate to substantial and improved when a small group of reviewers carried out record review. The validity of the record review method has never been evaluated, while clinical data registries, autopsy or direct observations of patient care are potential reference methods that can be used to test concurrent validity.
DOI:10.1136/bmjopen-2016-011078      PMID:27550650      URL    
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[65] JAKOBSEN E, RASMUSSEN T R.The danish lung cancer registry[J].Clin Epidemiol,2016,8:537-541.
DOI:10.2147/CLEP      URL    
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[66] CLASSEN D C,RESAR R,GRIFFIN F,et al."Global trigger tool" shows that adverse events in hospitals may be ten times greater than previously measured[J].Health Aff(Millwood),2011,30(4):581-589.
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[67] MENENDEZ FRAGA M D,CUEVA ALVAREZ M A,FRANCO CASTELLANOS M R,et al.Compliance with the surgical safety checklist and surgical events detected by the Global Trigger Tool[J].Rev Calid Asist,2016,31(Suppl 1):20-23.
The implementing of the WHO Surgical Safety Checklist (SSC) has helped to improve patient safety. The aim of this study was to assess the level of compliance of the SSC, and incorporating the non-compliances as 芦triggers禄 in the Global Trigger Tool (GTT). Acute Geriatric Hospital (200 beds). Retrospective study, study period: 2011-2014. The SSC formulary and the methodology of the GTT were used for the analysis of electronic medical records and the compliance with the SSC. The NCCP MERP categories were used to assess the severity of the harm. Out of all the electronic medical records (EMR), a total of 227 (23.6%) discharged patients (1.7% of interventions in the four year study period) were analysed. All (100%) of the EMR included the SSC, with 94.4% of the items being completed, and 28.2% of SSC had all items completed in the 3 phases of the process. Surgical adverse events decreased from 16.3% in 2011 to 9.4% in 2014 (P=.2838, not significant), and compliance with all items of SSC was increased from 18.6% to 39.1% (P=.0246, significant). The GTT systematises and evaluates, at low cost, the triggers and incidents/ AEs found in the EMR in order to assess the compliance with the SSC and consider non-compliance of SSC as 芦triggers禄 for further analysis. This strategy has never been referred to in the GTT or in the SCC formulary.
PMID:27265381      URL    
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关键词(key words)
全面触发工具
不良事件
不良事件
药物

Global trigger tool
Adverse events
Drug adverse events

作者
刘翌
闫峻峰
边原

LIU Yi
YAN Junfeng
BIAN Yuan