Stengel Dirk, Rademacher Grit, Ekkernkamp Axel, Güthoff Claas, Mutze Sven
Centre for Clinical Research, Department of Trauma and Orthopaedic Surgery, Unfallkrankenhaus Berlin, Warener Str 7, Berlin, Germany, 12683.
Cochrane Database Syst Rev. 2015 Sep 14;2015(9):CD004446. doi: 10.1002/14651858.CD004446.pub4.
Ultrasonography (performed by means of a four-quadrant, focused assessment of sonography for trauma (FAST)) is regarded as a key instrument for the initial assessment of patients with suspected blunt abdominal and thoraco-abdominal trauma in the emergency department setting. FAST has a high specificity but low sensitivity in detecting and excluding visceral injuries. Proponents of FAST argue that ultrasound-based clinical pathways enhance the speed of primary trauma assessment, reduce the number of unnecessary multi-detector computed tomography (MDCT) scans, and enable quicker triage to surgical and non-surgical care. Given the proven accuracy, increasing availability of, and indication for, MDCT among patients with blunt abdominal and multiple injuries, we aimed to compile the best available evidence of the use of FAST-based assessment compared with other primary trauma assessment protocols.
To assess the effects of diagnostic algorithms using ultrasonography including in FAST examinations in the emergency department in relation to the early, late, and overall mortality of patients with suspected blunt abdominal trauma.
The most recent search was run on 30th June 2015. We searched the Cochrane Injuries Group Specialised Register, The Cochrane Library, MEDLINE (OvidSP), EMBASE (OvidSP), ISI Web of Science (SCI-EXPANDED, SSCI, CPCI-S, and CPSI-SSH), clinical trials registers, and screened reference lists. Trial authors were contacted for further information and individual patient data.
We included randomised controlled trials (RCTs). Participants were patients with blunt torso, abdominal, or multiple trauma undergoing diagnostic investigations for abdominal organ injury. The intervention was diagnostic algorithms comprising emergency ultrasonography (US). The control was diagnostic algorithms without US examinations (for example, primary computed tomography (CT) or diagnostic peritoneal lavage (DPL)). Outcomes were mortality, use of CT or invasive procedures (DPL, laparoscopy, laparotomy), and cost-effectiveness.
Two authors (DS and CG) independently selected trials for inclusion, assessed methodological quality, and extracted data. Methodological quality was assessed using the Cochrane Collaboration risk of bias tool. Where possible, data were pooled and relative risks (RRs), risk differences (RDs), and weighted mean differences, each with 95% confidence intervals (CIs), were calculated by fixed-effect or random-effects models as appropriate.
We identified four studies meeting our inclusion criteria. Overall, trials were of poor to moderate methodological quality. Few trial authors responded to our written inquiries seeking to resolve controversial issues and to obtain individual patient data. Strong heterogeneity amongst the trials prompted discussion between the review authors as to whether the data should or should not be pooled; we decided in favour of a quantitative synthesis to provide a rough impression about the effect sizes achievable with US-based triage algorithms. We pooled mortality data from three trials involving 1254 patients; the RR in favour of the FAST arm was 1.00 (95% CI 0.50 to 2.00). FAST-based pathways reduced the number of CT scans (random-effects model RD -0.52, 95% CI -0.83 to -0.21), but the meaning of this result was unclear.
AUTHORS' CONCLUSIONS: The experimental evidence justifying FAST-based clinical pathways in diagnosing patients with suspected abdominal or multiple blunt trauma remains poor. Because of strong heterogeneity between the trial results, the quantitative information provided by this review may only be used in an exploratory fashion. It is unlikely that FAST will ever be investigated by means of a confirmatory, large-scale RCT in the future. Thus, this Cochrane Review may be regarded as a review which provides the best available evidence for clinical practice guidelines and management recommendations. It can only be concluded from the few head-to-head studies that negative US scans are likely to reduce the incidence of MDCT scans which, given the low sensitivity of FAST (or reliability of negative results), may adversely affect the diagnostic yield of the trauma survey. At best, US has no negative impact on mortality or morbidity. Assuming that major blunt abdominal or multiple trauma is associated with 15% mortality and a CT-based diagnostic work-up is considered the current standard of care, 874, 3495, or 21,838 patients are needed per intervention group to demonstrate non-inferiority of FAST to CT-based algorithms with non-inferiority margins of 5%, 2.5%, and 1%, power of 90%, and a type-I error alpha of 5%.
超声检查(通过四象限、针对创伤的超声重点评估(FAST)进行)被视为急诊科对疑似钝性腹部和胸腹联合创伤患者进行初始评估的关键手段。FAST在检测和排除内脏损伤方面具有高特异性但低敏感性。FAST的支持者认为,基于超声的临床路径可提高初级创伤评估的速度,减少不必要的多排计算机断层扫描(MDCT)检查的数量,并能更快地分诊至手术和非手术治疗。鉴于MDCT在钝性腹部和多发伤患者中的准确性已得到证实,且其可用性和适应证不断增加,我们旨在汇总与其他初级创伤评估方案相比,基于FAST评估的最佳现有证据。
评估在急诊科使用包括FAST检查在内的超声诊断算法对疑似钝性腹部创伤患者的早期、晚期和总体死亡率的影响。
最近一次检索于2015年6月30日进行。我们检索了Cochrane损伤组专业注册库、Cochrane图书馆、MEDLINE(OvidSP)、EMBASE(OvidSP)、ISI科学网(SCI-EXPANDED、SSCI、CPCI-S和CPSI-SSH)、临床试验注册库,并筛选了参考文献列表。我们联系了试验作者以获取更多信息和个体患者数据。
我们纳入了随机对照试验(RCT)。参与者为钝性躯干、腹部或多发创伤且正在接受腹部器官损伤诊断检查的患者。干预措施为包括急诊超声(US)的诊断算法。对照为不进行超声检查的诊断算法(例如,初级计算机断层扫描(CT)或诊断性腹腔灌洗(DPL))。结局指标为死亡率、CT或侵入性操作(DPL、腹腔镜检查、剖腹手术)的使用情况以及成本效益。
两位作者(DS和CG)独立选择纳入试验、评估方法学质量并提取数据。使用Cochrane协作网偏倚风险工具评估方法学质量。在可能的情况下,汇总数据,并根据固定效应或随机效应模型酌情计算相对风险(RRs)、风险差异(RDs)和加权平均差异及其95%置信区间(CIs)。
我们确定了四项符合我们纳入标准的研究。总体而言,试验的方法学质量为差到中等。很少有试验作者回复我们旨在解决有争议问题并获取个体患者数据的书面询问。试验之间存在强烈的异质性,促使综述作者讨论是否应汇总数据;我们决定进行定量综合分析,以大致了解基于超声的分诊算法可实现的效应大小。我们汇总了三项涉及1254例患者的试验的死亡率数据;支持FAST组的RR为1.00(95%CI 0.50至2.00)。基于FAST的路径减少了CT扫描的数量(随机效应模型RD -0.52,95%CI -0.83至-0.21),但该结果的意义尚不清楚。
支持基于FAST的临床路径用于诊断疑似腹部或多发钝性创伤患者的实验证据仍然不足。由于试验结果之间存在强烈的异质性,本综述提供的定量信息可能仅以探索性方式使用。未来不太可能通过确定性的大规模RCT对FAST进行研究。因此,本Cochrane综述可被视为为临床实践指南和管理建议提供最佳现有证据的综述。仅从少数直接比较研究中可以得出,超声检查结果为阴性可能会降低MDCT扫描的发生率,鉴于FAST的低敏感性(或阴性结果的可靠性),这可能会对创伤检查的诊断率产生不利影响。充其量,超声对死亡率或发病率没有负面影响。假设主要钝性腹部或多发创伤的死亡率为15%,基于CT的诊断检查被视为当前的标准治疗方法,每个干预组需要874、3495或21838例患者,以证明FAST与基于CT的算法相比在非劣效性边缘为5%、2.5%和1%时的非劣效性,检验效能为90%,I类错误α为5%。