Warttig Sheryl, Alderson Phil, Evans David Jw, Lewis Sharon R, Kourbeti Irene S, Smith Andrew F
National Institute for Health and Care Excellence, Level 1A, City Tower, Piccadilly Plaza, Manchester, UK, M1 4BD.
Cochrane Database Syst Rev. 2018 Jun 25;6(6):CD012404. doi: 10.1002/14651858.CD012404.pub2.
BACKGROUND: Sepsis is a life-threatening condition that is usually diagnosed when a patient has a suspected or documented infection, and meets two or more criteria for systemic inflammatory response syndrome (SIRS). The incidence of sepsis is higher among people admitted to critical care settings such as the intensive care unit (ICU) than among people in other settings. If left untreated sepsis can quickly worsen; severe sepsis has a mortality rate of 40% or higher, depending on definition. Recognition of sepsis can be challenging as it usually requires patient data to be combined from multiple unconnected sources, and interpreted correctly, which can be complex and time consuming to do. Electronic systems that are designed to connect information sources together, and automatically collate, analyse, and continuously monitor the information, as well as alerting healthcare staff when pre-determined diagnostic thresholds are met, may offer benefits by facilitating earlier recognition of sepsis and faster initiation of treatment, such as antimicrobial therapy, fluid resuscitation, inotropes, and vasopressors if appropriate. However, there is the possibility that electronic, automated systems do not offer benefits, or even cause harm. This might happen if the systems are unable to correctly detect sepsis (meaning that treatment is not started when it should be, or it is started when it shouldn't be), or healthcare staff may not respond to alerts quickly enough, or get 'alarm fatigue' especially if the alarms go off frequently or give too many false alarms. OBJECTIVES: To evaluate whether automated systems for the early detection of sepsis can reduce the time to appropriate treatment (such as initiation of antibiotics, fluids, inotropes, and vasopressors) and improve clinical outcomes in critically ill patients in the ICU. SEARCH METHODS: We searched CENTRAL; MEDLINE; Embase; CINAHL; ISI Web of science; and LILACS, clinicaltrials.gov, and the World Health Organization trials portal. We searched all databases from their date of inception to 18 September 2017, with no restriction on country or language of publication. SELECTION CRITERIA: We included randomized controlled trials (RCTs) that compared automated sepsis-monitoring systems to standard care (such as paper-based systems) in participants of any age admitted to intensive or critical care units for critical illness. We defined an automated system as any process capable of screening patient records or data (one or more systems) automatically at intervals for markers or characteristics that are indicative of sepsis. We defined critical illness as including, but not limited to postsurgery, trauma, stroke, myocardial infarction, arrhythmia, burns, and hypovolaemic or haemorrhagic shock. We excluded non-randomized studies, quasi-randomized studies, and cross-over studies . We also excluded studies including people already diagnosed with sepsis. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. Our primary outcomes were: time to initiation of antimicrobial therapy; time to initiation of fluid resuscitation; and 30-day mortality. Secondary outcomes included: length of stay in ICU; failed detection of sepsis; and quality of life. We used GRADE to assess the quality of evidence for each outcome. MAIN RESULTS: We included three RCTs in this review. It was unclear if the RCTs were three separate studies involving 1199 participants in total, or if they were reports from the same study involving fewer participants. We decided to treat the studies separately, as we were unable to make contact with the study authors to clarify.All three RCTs are of very low study quality because of issues with unclear randomization methods, allocation concealment and uncertainty of effect size. Some of the studies were reported as abstracts only and contained limited data, which prevented meaningful analysis and assessment of potential biases.The studies included participants who all received automated electronic monitoring during their hospital stay. Participants were randomized to an intervention group (automated alerts sent from the system) or to usual care (no automated alerts sent from the system).Evidence from all three studies reported 'Time to initiation of antimicrobial therapy'. We were unable to pool the data, but the largest study involving 680 participants reported median time to initiation of antimicrobial therapy in the intervention group of 5.6 hours (interquartile range (IQR) 2.3 to 19.7) in the intervention group (n = not stated) and 7.8 hours (IQR 2.5 to 33.1) in the control group (n = not stated).No studies reported 'Time to initiation of fluid resuscitation' or the adverse event 'Mortality at 30 days'. However very low-quality evidence was available where mortality was reported at other time points. One study involving 77 participants reported 14-day mortality of 20% in the intervention group and 21% in the control group (numerator and denominator not stated). One study involving 442 participants reported mortality at 28 days, or discharge was 14% in the intervention group and 10% in the control group (numerator and denominator not reported). Sample sizes were not reported adequately for these outcomes and so we could not estimate confidence intervals.Very low-quality evidence from one study involving 442 participants reported 'Length of stay in ICU'. Median length of stay was 3.0 days in the intervention group (IQR = 2.0 to 5.0), and 3.0 days (IQR 2.0 to 4.0 in the control).Very low-quality evidence from one study involving at least 442 participants reported the adverse effect 'Failed detection of sepsis'. Data were only reported for failed detection of sepsis in two participants and it wasn't clear which group(s) this outcome occurred in.No studies reported 'Quality of life'. AUTHORS' CONCLUSIONS: It is unclear what effect automated systems for monitoring sepsis have on any of the outcomes included in this review. Very low-quality evidence is only available on automated alerts, which is only one component of automated monitoring systems. It is uncertain whether such systems can replace regular, careful review of the patient's condition by experienced healthcare staff.
背景:脓毒症是一种危及生命的病症,通常在患者存在疑似或确诊感染且符合两条或更多条全身炎症反应综合征(SIRS)标准时被诊断出来。在重症监护病房(ICU)等重症监护环境中收治的患者中,脓毒症的发病率高于其他环境中的患者。如果不进行治疗,脓毒症会迅速恶化;严重脓毒症的死亡率根据定义在40%或更高。识别脓毒症可能具有挑战性,因为这通常需要将来自多个不相关来源的患者数据进行整合并正确解读,而这可能既复杂又耗时。旨在将信息源连接在一起、自动整理、分析和持续监测信息,并在达到预定诊断阈值时提醒医护人员的电子系统,可能通过促进更早识别脓毒症和更快开始治疗(如抗菌治疗、液体复苏、血管活性药物和血管加压药等)而带来益处。然而,电子自动化系统有可能无法带来益处,甚至可能造成伤害。如果系统无法正确检测脓毒症(即治疗应开始时未开始,或不应开始时却开始了),或者医护人员可能对警报反应不够迅速,或者出现“警报疲劳”,特别是如果警报频繁响起或给出过多误报,就可能发生这种情况。 目的:评估用于早期检测脓毒症的自动化系统是否能减少重症监护病房(ICU)重症患者接受适当治疗(如开始使用抗生素、液体、血管活性药物和血管加压药)的时间,并改善临床结局。 检索方法:我们检索了Cochrane系统评价数据库、MEDLINE、Embase、CINAHL、科学引文索引(ISI Web of science)、拉丁美洲和加勒比卫生科学数据库(LILACS)、美国国立医学图书馆临床试验注册库(clinicaltrials.gov)以及世界卫生组织临床试验平台。我们检索了所有数据库从其创建日期至2017年9月18日的数据,对出版物的国家或语言没有限制。 入选标准:我们纳入了将自动化脓毒症监测系统与标准护理(如纸质系统)进行比较的随机对照试验(RCT),参与者为入住重症监护病房或危重症监护病房的任何年龄的危重症患者。我们将自动化系统定义为能够定期自动筛查患者记录或数据(一个或多个系统)以寻找指示脓毒症的标志物或特征的任何过程。我们将危重症定义为包括但不限于手术后、创伤、中风、心肌梗死、心律失常、烧伤以及低血容量或出血性休克。我们排除了非随机研究、半随机研究和交叉研究。我们还排除了纳入已确诊脓毒症患者的研究。 数据收集与分析:我们采用了Cochrane预期的标准方法程序。我们的主要结局为:开始抗菌治疗的时间;开始液体复苏的时间;以及30天死亡率。次要结局包括:在ICU的住院时间;脓毒症检测失败;以及生活质量。我们使用GRADE评估每个结局的证据质量。 主要结果:我们在本综述中纳入了三项RCT。尚不清楚这三项RCT是三项独立研究,总共涉及1199名参与者,还是同一研究的报告,涉及的参与者较少。由于随机化方法不明确、分配隐藏以及效应大小不确定等问题,所有三项RCT的研究质量都非常低。部分研究仅以摘要形式报告,数据有限,这妨碍了对潜在偏倚进行有意义的分析和评估。这些研究纳入的参与者在住院期间均接受了自动化电子监测。参与者被随机分配到干预组(系统发送自动化警报)或常规护理组(系统不发送自动化警报)。所有三项研究均报告了“开始抗菌治疗的时间”。我们无法汇总数据,但涉及680名参与者的最大规模研究报告干预组开始抗菌治疗的中位时间为5.6小时(四分位间距(IQR)2.3至19.7),对照组为7.8小时(IQR 2.5至33.1)(干预组和对照组的样本量未说明)。没有研究报告“开始液体复苏的时间”或不良事件“30天死亡率”。然而,在其他时间点报告死亡率时有非常低质量的证据。一项涉及77名参与者的研究报告干预组14天死亡率为20%,对照组为21%(分子和分母未说明)。一项涉及442名参与者的研究报告干预组28天或出院时的死亡率为14%,对照组为10%(分子和分母未报告)。这些结局的样本量报告不充分,因此我们无法估计置信区间。一项涉及442名参与者的研究提供了关于“在ICU的住院时间”的非常低质量的证据。干预组的中位住院时间为3.0天(IQR = 2.0至5.0),对照组为3.0天(IQR 2.0至4.0)。一项涉及至少442名参与者的研究提供了关于不良事件“脓毒症检测失败”的非常低质量的证据。仅报告了两名参与者脓毒症检测失败的数据,不清楚该结局发生在哪个组。没有研究报告“生活质量”。 作者结论:尚不清楚用于监测脓毒症的自动化系统对本综述中纳入的任何结局有何影响。仅关于自动化警报有非常低质量的证据,而自动化警报只是自动化监测系统的一个组成部分。不确定此类系统是否能取代经验丰富的医护人员对患者病情进行的定期、仔细评估。
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