School of Nursing and Midwifery, Queen's University Belfast, Belfast, UK.
Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD005529. doi: 10.1002/14651858.CD005529.pub3.
Early warning systems (EWS) and rapid response systems (RRS) have been implemented internationally in acute hospitals to facilitate early recognition, referral and response to patient deterioration as a solution to address suboptimal ward-based care. EWS and RRS facilitate healthcare decision-making using checklists and provide structure to organisational practices through governance and clinical audit. However, it is unclear whether these systems improve patient outcomes. This is the first update of a previously published (2007) Cochrane Review.
To determine the effect of EWS and RRS implementation on adults who deteriorate on acute hospital wards compared to people receiving hospital care without EWS and RRS in place.
We searched CENTRAL, MEDLINE, Embase and two trial registers on 28 March 2019. We subsequently ran a MEDLINE update on 15 May 2020 that identified no further studies. We checked references of included studies, conducted citation searching, and contacted experts and critical care organisations.
We included randomised trials, non-randomised studies, controlled before-after (CBA) studies, and interrupted time series (ITS) designs measuring our outcomes of interest following implementation of EWS and RRS in acute hospital wards compared to ward settings without EWS and RRS.
Two review authors independently checked studies for inclusion, extracted data and assessed methodological quality using standard Cochrane and Effective Practice and Organisation of Care (EPOC) Group methods. Where possible, we standardised data to rates per 1000 admissions; and calculated risk differences and 95% confidence intervals (CI) using the Newcombe and Altman method. We reanalysed three CBA studies as ITS designs using segmented regression analysis with Newey-West autocorrelation adjusted standard errors with lag of order 1. We assessed the certainty of evidence using the GRADE approach.
We included four randomised trials (455,226 participants) and seven non-randomised studies (210,905 participants reported in three studies). All 11 studies implemented an intervention comprising an EWS and RRS conducted in high- or middle-income countries. Participants were admitted to 282 acute hospitals. We were unable to perform meta-analyses due to clinical and methodological heterogeneity across studies. Randomised trials were assessed as high risk of bias due to lack of blinding participants and personnel across all studies. Risk of bias for non-randomised studies was critical (three studies) due to high risk of confounding and unclear risk of bias due to no reporting of deviation from protocol or serious (four studies) but not critical due to use of statistical methods to control for some but not all baseline confounders. Where possible we presented original study data which reported the adjusted relative effect given these were appropriately adjusted for design and participant characteristics. We compared outcomes of randomised and non-randomised studies reported them separately to determine which studies contributed to the overall certainty of evidence. We reported findings from key comparisons. Hospital mortality Randomised trials provided low-certainty evidence that an EWS and RRS intervention may result in little or no difference in hospital mortality (4 studies, 455,226 participants; results not pooled). The evidence on hospital mortality from three non-randomised studies was of very low certainty (210,905 participants). Composite outcome (unexpected cardiac arrests, unplanned ICU admissions and death) One randomised study showed that an EWS and RRS intervention probably results in no difference in this composite outcome (adjusted odds ratio (aOR) 0.98, 95% CI 0.83 to 1.16; 364,094 participants; moderate-certainty evidence). One non-randomised study suggests that implementation of an EWS and RRS intervention may slightly reduce this composite outcome (aOR 0.85, 95% CI 0.72 to 0.99; 57,858 participants; low-certainty evidence). Unplanned ICU admissions Randomised trials provided low-certainty evidence that an EWS and RRS intervention may result in little or no difference in unplanned ICU admissions (3 studies, 452,434 participants; results not pooled). The evidence from one non-randomised study is of very low certainty (aOR 0.88, 95% CI 0.75 to 1.02; 57,858 participants). ICU readmissions No studies reported this outcome. Length of hospital stay Randomised trials provided low-certainty evidence that an EWS and RRS intervention may have little or no effect on hospital length of stay (2 studies, 21,417 participants; results not pooled). Adverse events (unexpected cardiac or respiratory arrest) Randomised trials provided low-certainty evidence that an EWS and RRS intervention may result in little or no difference in adverse events (3 studies, 452,434 participants; results not pooled). The evidence on adverse events from three non-randomised studies (210,905 participants) is very uncertain.
AUTHORS' CONCLUSIONS: Given the low-to-very low certainty evidence for all outcomes from non-randomised studies, we have drawn our conclusions from the randomised evidence. This evidence provides low-certainty evidence that EWS and RRS may lead to little or no difference in hospital mortality, unplanned ICU admissions, length of hospital stay or adverse events; and moderate-certainty evidence of little to no difference on composite outcome. The evidence from this review update highlights the diversity in outcome selection and poor methodological quality of most studies investigating EWS and RRS. As a result, no strong recommendations can be made regarding the effectiveness of EWS and RRS based on the evidence currently available. There is a need for development of a patient-informed core outcome set comprising clear and consistent definitions and recommendations for measurement as well as EWS and RRS interventions conforming to a standard to facilitate meaningful comparison and future meta-analyses.
早期预警系统(EWS)和快速反应系统(RRS)已在国际上的急性医院中实施,以促进对患者恶化的早期识别、转介和反应,从而解决基于病房的护理不理想的问题。EWS 和 RRS 使用清单促进医疗保健决策,并通过治理和临床审计为组织实践提供结构。然而,目前尚不清楚这些系统是否能改善患者的预后。这是之前发表的(2007 年)Cochrane 综述的首次更新。
确定 EWS 和 RRS 实施对在急性医院病房恶化的成年人与接受没有 EWS 和 RRS 的医院护理的人相比的效果。
我们于 2019 年 3 月 28 日检索了 CENTRAL、MEDLINE、Embase 和两个试验注册库。随后,我们于 2020 年 5 月 15 日对 MEDLINE 进行了更新,未发现进一步的研究。我们检查了纳入研究的参考文献,进行了引文搜索,并联系了专家和重症监护组织。
我们纳入了随机试验、非随机研究、对照前后(CBA)研究和中断时间序列(ITS)设计,这些研究在急性医院病房实施 EWS 和 RRS 后与没有 EWS 和 RRS 的病房环境进行了比较。
两名综述作者独立检查了研究的纳入情况,使用标准的 Cochrane 和有效实践与护理组织(EPOC)组方法提取数据并评估方法学质量。在可能的情况下,我们将数据标准化为每 1000 例入院的发生率;并使用 Newcombe 和 Altman 方法计算风险差异和 95%置信区间(CI)。我们使用具有 Newey-West 自相关调整标准误差的一阶滞后的分段回归分析重新分析了三项 CBA 研究作为 ITS 设计。我们使用 GRADE 方法评估证据的确定性。
我们纳入了四项随机试验(455226 名参与者)和七项非随机研究(在三项研究中报告了 210905 名参与者)。所有 11 项研究均实施了包含 EWS 和 RRS 的干预措施,这些干预措施在高收入和中等收入国家进行。参与者被收治在 282 家急性医院。由于所有研究均缺乏对参与者和人员的盲法,因此我们无法进行荟萃分析。由于存在高混杂风险和未报告偏离方案或严重偏倚(四项研究),因此非随机研究的偏倚风险为关键(三项研究),但由于使用统计方法控制了部分而非全部基线混杂因素,因此偏倚风险为严重但非关键。在可能的情况下,我们呈现了原始研究数据,这些数据报告了调整后的相对效果,因为这些数据是根据设计和参与者特征进行了适当调整的。我们比较了随机和非随机研究报告的结果,并分别报告它们,以确定哪些研究对总体证据的确定性有贡献。我们报告了关键比较的结果。
随机试验提供的低确定性证据表明,EWS 和 RRS 干预可能对医院死亡率几乎没有影响(4 项研究,455226 名参与者;结果未汇总)。三项非随机研究的医院死亡率证据非常低(210905 名参与者)。
复合结局(意外心搏骤停、非计划 ICU 入院和死亡):一项随机研究表明,EWS 和 RRS 干预可能对这一复合结局几乎没有影响(调整后的优势比(OR)0.98,95%CI 0.83 至 1.16;364094 名参与者;中等确定性证据)。一项非随机研究表明,实施 EWS 和 RRS 干预可能会稍微降低这一复合结局(OR 0.85,95%CI 0.72 至 0.99;57858 名参与者;低确定性证据)。
非计划 ICU 入院:随机试验提供的低确定性证据表明,EWS 和 RRS 干预可能对非计划 ICU 入院几乎没有影响(3 项研究,452434 名参与者;结果未汇总)。一项非随机研究的证据非常低(OR 0.88,95%CI 0.75 至 1.02;57858 名参与者)。
ICU 再入院:没有研究报告这一结局。
随机试验提供的低确定性证据表明,EWS 和 RRS 干预可能对住院时间几乎没有影响(2 项研究,21417 名参与者;结果未汇总)。
不良事件(意外心搏骤停或呼吸骤停):随机试验提供的低确定性证据表明,EWS 和 RRS 干预可能对不良事件几乎没有影响(3 项研究,452434 名参与者;结果未汇总)。三项非随机研究(210905 名参与者)的不良事件证据非常不确定。
鉴于所有非随机研究的结局都存在低至非常低的确定性证据,我们从随机证据中得出了结论。这些证据提供了低确定性证据,表明 EWS 和 RRS 可能导致医院死亡率、非计划 ICU 入院、住院时间或不良事件几乎没有差异;以及中等确定性证据,表明复合结局几乎没有差异。本综述更新的证据突出了 EWS 和 RRS 调查中结局选择的多样性和大多数研究方法学质量差的问题。因此,目前基于现有证据,不能对 EWS 和 RRS 的有效性做出强有力的推荐。需要制定一个以患者为中心的核心结局集,其中包含明确和一致的定义以及测量建议,以及符合标准的 EWS 和 RRS 干预措施,以促进有意义的比较和未来的荟萃分析。