Kahn Susan R, Morrison David R, Cohen Jacqueline M, Emed Jessica, Tagalakis Vicky, Roussin Andre, Geerts William
Division of Internal Medicine and Department of Medicine, McGill University,Montreal, Canada.
Cochrane Database Syst Rev. 2013 Jul 16(7):CD008201. doi: 10.1002/14651858.CD008201.pub2.
Venous thromboembolism (VTE) is a leading cause of morbidity and mortality in hospitalized patients. Numerous randomized controlled trials (RCTs) show that using thromboprophylaxis in hospitalized patients at risk for VTE is safe, effective and cost-effective. Despite this, prophylactic therapies for VTE are underutilized. System-wide interventions may be more effective to improve the use of VTE prophylaxis than relying on individual providers' prescribing behaviors.
To assess the effects of interventions designed to increase the implementation of thromboprophylaxis in hospitalized adult medical and surgical patients at risk for venous thromboembolism (VTE), assessed in terms of: 1. Increase in the proportion of patients who receive prophylaxis and appropriate prophylaxis 2. Reduction in risk of symptomatic VTE3. Reduction in risk of asymptomatic VTE4. Safety of the intervention.
The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator (TSC) searched the Group's Specialised Register (last searched July 2010) and the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library) 2010, Issue 3. We searched the PubMed, EMBASE, and SCOPUS databases (19 April 2010) as well as the reference lists of relevant review articles.
We included all studies whose interventions aimed to increase the use of prophylaxis and/or appropriate prophylaxis, decrease the proportion of symptomatic VTE, or decrease the proportion of asymptomatic VTE in hospitalized adult patients. We excluded studies that simply distributed published guidelines and studies whose interventions were not clearly described.
We collected the following outcomes: the proportion of patients who received prophylaxis (RP), the proportion of patients who received appropriate prophylaxis (RAP) (primary outcomes), and the occurrence of symptomatic VTE, asymptomatic VTE, and safety outcomes such as bleeding. We categorized interventions into education, alerts, and multifaceted interventions. We meta-analyzed RCTs and non-randomized studies (NRS) separately by random effects meta-analysis, and assessed heterogeneity using the I(2)statistic and subgroup analyses. Before analysis, we decided that results would be pooled if three or more studies were available for a particular intervention. We assessed publication bias using funnel plots and cumulative meta-analysis.
We included a total of 55 studies. One of these reported data in patient-days and could not be quantitatively analyzed with the others. The 54 remaining studies (8 RCTs and 46 NRS) eligible for inclusion in our quantitative synthesis enrolled a total of 78,343 participants. Among RCTs, there were sufficient data to pool results for one primary outcome (received prophylaxis) for the 'alert' intervention. Alerts, such as computerized reminders or stickers on patients' charts, were associated with a risk difference (RD) of 13%, signifying an increase in the proportion of patients who received prophylaxis (95% confidence interval (CI) 1% to 25%). Among NRS, there were sufficient data to pool both primary outcomes for each intervention type. Pooled risk differences for received prophylaxis ranged from 8% to 17%, and for received appropriate prophylaxis ranged from 11% to 19%. Education and alerts were associated with statistically significant increases in prescription of appropriate prophylaxis, and multifaceted interventions were associated with statistically significant increases in prescription of any prophylaxis and appropriate prophylaxis. Multifaceted interventions had the largest pooled effects. I(2) results showed substantial statistical heterogeneity which was in part explained by patient types and type of hospital. A subgroup analysis showed that multifaceted interventions which included an alert may be more effective at improving rates of prophylaxis and appropriate prophylaxis than those without an alert. Results for VTE and safety outcomes did not show substantial benefits or harms, although most studies were underpowered to assess these outcomes.
AUTHORS' CONCLUSIONS: We reviewed a large number of studies which implemented a variety of system-wide strategies aimed to improve thromboprophylaxis rates in many settings and patient populations. We found statistically significant improvements in prescription of prophylaxis associated with alerts (RCTs) and multifaceted interventions (RCTs and NRS), and improvements in prescription of appropriate prophylaxis in NRS with the use of education, alerts and multifaceted interventions. Multifaceted interventions with an alert component may be the most effective. Demonstrated sources of heterogeneity included patient types and type of hospital. The results of our review will help physicians, nurses, pharmacists, hospital administrators and policy makers make practical decisions about local adoption of specific system-wide measures to improve prevention of VTE, an important public health issue. We did not find a significant benefit for VTE outcomes; however, earlier RCTs assessing the efficacy of thromboprophylaxis which were powered to address these outcomes have demonstrated the benefit of prophylactic therapies and a favourable balance of benefits versus the increased risk of bleeding events.
静脉血栓栓塞症(VTE)是住院患者发病和死亡的主要原因。大量随机对照试验(RCT)表明,对有VTE风险的住院患者进行血栓预防是安全、有效且具有成本效益的。尽管如此,VTE的预防性治疗仍未得到充分利用。全系统干预可能比依赖个体医疗服务提供者的处方行为更有效地提高VTE预防措施的使用。
评估旨在增加对有静脉血栓栓塞症(VTE)风险的住院成年内科和外科患者实施血栓预防措施的干预效果,评估指标包括:1. 接受预防措施和适当预防措施的患者比例增加;2. 有症状VTE风险降低;3. 无症状VTE风险降低;4. 干预措施的安全性。
Cochrane外周血管疾病小组试验搜索协调员(TSC)检索了该小组的专业注册库(最后检索时间为2010年7月)以及Cochrane对照试验中央注册库(CENTRAL,Cochrane图书馆)2010年第3期。我们检索了PubMed、EMBASE和SCOPUS数据库(2010年4月19日)以及相关综述文章的参考文献列表。
我们纳入了所有干预措施旨在增加预防措施和/或适当预防措施的使用、降低有症状VTE比例或降低无症状VTE比例的住院成年患者研究。我们排除了仅分发已发表指南的研究以及干预措施未明确描述的研究。
我们收集了以下结果:接受预防措施的患者比例(RP)、接受适当预防措施的患者比例(RAP)(主要结果),以及有症状VTE、无症状VTE的发生情况和出血等安全性结果。我们将干预措施分为教育、警报和多方面干预。我们通过随机效应荟萃分析分别对RCT和非随机研究(NRS)进行荟萃分析,并使用I²统计量和亚组分析评估异质性。在分析之前,我们决定如果针对特定干预措施有三项或更多研究,则汇总结果。我们使用漏斗图和累积荟萃分析评估发表偏倚。
我们共纳入55项研究。其中一项报告的是患者日数据,无法与其他研究进行定量分析。其余54项符合纳入我们定量综合分析标准的研究(8项RCT和46项NRS)共纳入78,343名参与者。在RCT中,有足够的数据汇总“警报”干预措施一项主要结果(接受预防措施)的结果。警报,如计算机提醒或患者病历上的贴纸,与风险差异(RD)为13%相关,这意味着接受预防措施的患者比例增加(95%置信区间(CI)为1%至25%)。在NRS中,有足够的数据汇总每种干预类型的两项主要结果。接受预防措施汇总后的风险差异范围为8%至17%,接受适当预防措施的风险差异范围为11%至19%。教育和警报与适当预防措施处方的统计学显著增加相关,多方面干预与任何预防措施和适当预防措施处方的统计学显著增加相关。多方面干预的汇总效应最大。I²结果显示存在实质性统计异质性,部分原因可由患者类型和医院类型解释。亚组分析表明,包含警报的多方面干预在提高预防措施和适当预防措施使用率方面可能比不包含警报的干预更有效。VTE和安全性结果未显示出实质性益处或危害,尽管大多数研究在评估这些结果时样本量不足。
我们回顾了大量实施各种全系统策略的研究,这些策略旨在提高许多环境和患者群体中的血栓预防率。我们发现与警报(RCT)和多方面干预(RCT和NRS)相关的预防措施处方有统计学显著改善,并且在NRS中,通过使用教育、警报和多方面干预,适当预防措施的处方有改善。包含警报成分的多方面干预可能是最有效的。已证明的异质性来源包括患者类型和医院类型。我们的综述结果将有助于医生、护士、药剂师、医院管理人员和政策制定者就是否在当地采用特定的全系统措施以改善VTE预防(一个重要的公共卫生问题)做出实际决策。我们未发现VTE结果有显著益处;然而,早期评估血栓预防疗效且有足够样本量评估这些结果的RCT已证明预防性治疗的益处以及益处与出血事件风险增加之间的有利平衡。