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减少手术部位错误和侵入性临床操作的干预措施。

Interventions for reducing wrong-site surgery and invasive clinical procedures.

作者信息

Algie Catherine M, Mahar Robert K, Wasiak Jason, Batty Lachlan, Gruen Russell L, Mahar Patrick D

机构信息

Department of Anaesthesia & Pain Medicine, Western Health, Gordon Street, Footscray, Locked Bag 2, Footscray, Victoria, Australia, 3011.

出版信息

Cochrane Database Syst Rev. 2015 Mar 30;2015(3):CD009404. doi: 10.1002/14651858.CD009404.pub3.

Abstract

BACKGROUND

Specific clinical interventions are needed to reduce wrong-site surgery, which is a rare but potentially disastrous clinical error. Risk factors contributing to wrong-site surgery are variable and complex. The introduction of organisational and professional clinical strategies have a role in minimising wrong-site surgery.

OBJECTIVES

To evaluate the effectiveness of organisational and professional interventions for reducing wrong-site surgery (including wrong-side, wrong-procedure and wrong-patient surgery), including non-surgical invasive clinical procedures such as regional blocks, dermatological, obstetric and dental procedures and emergency surgical procedures not undertaken within the operating theatre.

SEARCH METHODS

For this update, we searched the following electronic databases: the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register (January 2014), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2014), MEDLINE (June 2011 to January 2014), EMBASE (June 2011 to January 2014), CINAHL (June 2011 to January 2014), Dissertations and Theses (June 2011 to January 2014), African Index Medicus, Latin American and Caribbean Health Sciences database, Virtual Health Library, Pan American Health Organization Database and the World Health Organization Library Information System. Database searches were conducted in January 2014.

SELECTION CRITERIA

We searched for randomised controlled trials (RCTs), non-randomised controlled trials, controlled before-after studies (CBAs) with at least two intervention and control sites, and interrupted-time-series (ITS) studies where the intervention time was clearly defined and there were at least three data points before and three after the intervention. We included two ITS studies that evaluated the effectiveness of organisational and professional interventions for reducing wrong-site surgery, including wrong-side and wrong-procedure surgery. Participants included all healthcare professionals providing care to surgical patients; studies where patients were involved to avoid the incorrect procedures or studies with interventions addressed to healthcare managers, administrators, stakeholders or health insurers.

DATA COLLECTION AND ANALYSIS

Two review authors independently assesses the quality and abstracted data of all eligible studies using a standardised data extraction form, modified from the Cochrane EPOC checklists. We contacted study authors for additional information.

MAIN RESULTS

In the initial review, we included one ITS study that evaluated a targeted educational intervention aimed at reducing the incidence of wrong-site tooth extractions. The intervention included examination of previous cases of wrong-site tooth extractions, educational intervention including a presentation of cases of erroneous extractions, explanation of relevant clinical guidelines and feedback by an instructor. Data were reported from all patients on the surveillance system of a University Medical centre in Taiwan with a total of 24,406 tooth extractions before the intervention and 28,084 tooth extractions after the intervention. We re-analysed the data using the Prais-Winsten time series and the change in level for annual number of mishaps was statistically significant at -4.52 (95% confidence interval (CI) -6.83 to -2.217) (standard error (SE) 0.5380). The change in slope was statistically significant at -1.16 (95% CI -2.22 to -0.10) (SE 0.2472; P < 0.05).This update includes an additional study reporting on the incidence of neurological WSS at a university hospital both before and after the Universal Protocol's implementation. A total of 22,743 patients undergoing neurosurgical procedures at the University of Illionois College of Medicine at Peoria, Illinois, United States of America were reported. Of these, 7286 patients were reported before the intervention and 15,456 patients were reported after the intervention. The authors found a significant difference (P < 0.001) in the incidence of WSS between the before period, 1999 to 2004, and the after period, 2005 to 2011.  Similarly, data were re-analysed using Prais-Winsten regression to correct for autocorrelation. As the incidences were reported by year only and the intervention occurred in July 2004, the intervention year 2004 was excluded from the analysis. The change in level at the point the intervention was introduced was not statistically significant at -0.078 percentage points (pp) (95% CI -0.176 pp to 0.02 pp; SE 0.042; P = 0.103). The change in slope was statistically significant at 0.031 (95% CI 0.004 to 0.058; SE 0.012; P < 0.05).

AUTHORS' CONCLUSIONS: The findings of this update added one additional ITS study to the previous review which contained one ITS study. The original review suggested that the use of a specific educational intervention in the context of a dental outpatient setting, which targets junior dental staff using a training session that included cases of wrong-site surgery, presentation of clinical guidelines and feedback by an instructor, was associated with a reduction in the incidence of wrong-site tooth extractions. The additional study in this update evaluated the annual incidence rates of wrong-site surgery in a neurosurgical population before and after the implementation of the Universal Protocol. The data suggested a strong downward trend in the incidence of wrong-site surgery prior to the intervention with the incidence rate approaching zero. The effect of the intervention in these studies however remains unclear, as data reflect only two small low-quality studies in very specific population groups.

摘要

背景

需要采取特定的临床干预措施来减少手术部位错误,这是一种罕见但可能造成灾难性后果的临床失误。导致手术部位错误的风险因素多样且复杂。引入组织和专业临床策略有助于将手术部位错误降至最低。

目的

评估组织和专业干预措施对减少手术部位错误(包括手术侧别错误、手术程序错误和手术患者错误)的有效性,包括非手术侵入性临床操作,如区域阻滞、皮肤科、产科和牙科手术以及不在手术室进行的急诊手术。

检索方法

本次更新中,我们检索了以下电子数据库:Cochrane有效实践与护理组织(EPOC)小组专业注册库(2014年1月)、Cochrane对照试验中心注册库(Cochrane图书馆2014年)、MEDLINE(2011年6月至2014年1月)、EMBASE(2011年6月至2014年1月)、CINAHL(2011年6月至2014年1月)、学位论文(2011年6月至2014年1月)、非洲医学索引、拉丁美洲和加勒比健康科学数据库、虚拟健康图书馆、泛美卫生组织数据库以及世界卫生组织图书馆信息系统。数据库检索于2014年1月进行。

入选标准

我们检索了随机对照试验(RCT)、非随机对照试验、具有至少两个干预组和对照组的前后对照研究(CBA)以及干预时间明确且干预前后至少有三个数据点的中断时间序列(ITS)研究。我们纳入了两项评估组织和专业干预措施对减少手术部位错误有效性的ITS研究,包括手术侧别错误和手术程序错误。参与者包括所有为手术患者提供护理的医疗保健专业人员;涉及患者以避免错误程序的研究或针对医疗保健管理人员、行政人员、利益相关者或健康保险公司的干预研究。

数据收集与分析

两位综述作者使用从Cochrane EPOC清单修改而来的标准化数据提取表,独立评估所有符合条件研究的质量并提取数据。我们与研究作者联系以获取更多信息。

主要结果

在初始综述中,我们纳入了一项ITS研究,该研究评估了旨在降低手术部位错误拔牙发生率的针对性教育干预措施。干预措施包括检查既往手术部位错误拔牙病例、教育干预(包括展示错误拔牙病例、解释相关临床指南以及由指导教师提供反馈)。台湾一所大学医学中心监测系统报告了所有患者的数据,干预前共拔牙24,406颗,干预后共拔牙28,084颗。我们使用Prais-Winsten时间序列重新分析数据,每年失误次数的水平变化在统计学上具有显著意义,为-4.52(95%置信区间(CI)-6.83至-2.217)(标准误(SE)0.5380)。斜率变化在统计学上具有显著意义,为-1.16(95% CI -2.22至-0.10)(SE 0.2472;P < 0.05)。本次更新纳入了另一项研究,报告了一所大学医院在实施通用协议前后神经外科手术部位错误(WSS)的发生率。美国伊利诺伊州皮奥里亚市伊利诺伊大学医学院共报告了22,743例接受神经外科手术的患者。其中,干预前报告了7286例患者,干预后报告了15,456例患者。作者发现1999年至2004年干预前期间与2005年至2011年干预后期间WSS发生率存在显著差异(P < 0.001)。同样,使用Prais-Winsten回归重新分析数据以校正自相关。由于发病率仅按年份报告且干预于2004年7月发生,分析中排除了干预年份2004。引入干预时水平的变化在统计学上不具有显著意义,为-0.078个百分点(pp)(95% CI -0.176 pp至0.02 pp;SE 0.042;P = 0.103)。斜率变化在统计学上具有显著意义,为0.031(95% CI 0.004至0.058;SE 0.012;P < 0.05)。

作者结论

本次更新的结果在之前包含一项ITS研究的综述基础上又增加了一项ITS研究。原综述表明,在牙科门诊环境中使用特定教育干预措施,针对初级牙科工作人员开展培训课程,内容包括手术部位错误病例、临床指南展示以及指导教师反馈,与手术部位错误拔牙发生率降低相关。本次更新中的另一项研究评估了通用协议实施前后神经外科人群手术部位错误的年发生率。数据表明干预前手术部位错误发生率呈强烈下降趋势,发生率接近零。然而,这些研究中干预的效果仍不明确,因为数据仅反映了两个非常特定人群组中的小型低质量研究。

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