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VTE 筛查试验中静脉超声的中心评估:失败原因。

Central adjudication of venous ultrasound in VTE screening trials: reasons for failure.

机构信息

University Centre for Vascular Medicine and Department of Medicine III, Section Angiology, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany.

出版信息

J Thromb Haemost. 2011 Mar;9(3):457-63. doi: 10.1111/j.1538-7836.2010.04166.x.

DOI:10.1111/j.1538-7836.2010.04166.x
PMID:21143379
Abstract

BACKGROUND

The accuracy of screening ultrasound for venous thrombosis in asymptomatic patients is still a matter of debate. The VENUS study evaluated the accuracy of centrally adjudicated venous ultrasound against venography in patients after major orthopedic surgery and found the sensitivity of ultrasound to be poor for both proximal and distal deep vein thrombus (DVT).

OBJECTIVES

To evaluate whether thrombus characteristics such as location or size influence the diagnostic performance of centrally adjudicated venous ultrasound.

METHODS

All false negative sonograms of the VENUS study were re-evaluated against the corresponding venograms. Discrepancies were categorized into types of diagnostic failures. Within these categories, thrombus characteristics such as location, length or size of thrombus were evaluated.

RESULTS

One hundred and twelve pairs of discrepant ultrasound and venography documents were compared with 28 pairs with concordant results. Discrepancies were caused by local documentation failure (37.5%), failure of the ultrasound method (43.7%) and failure of the central adjudication process (18.7%). The overall size of thrombi was small, which caused about 40% of all sonographic failures with a detection threshold of five Marder points, a thrombus length of 9.5 cm and a number of 3.5 pathological compression manoeuvres. Proximal or distal location of DVT did not affect thrombus detection.

CONCLUSION

If centrally adjudicated ultrasound is to be used in future VTE screening trials, training of local sonographers and central adjudicators needs to be intensified, because asymptomatic DVTs seem to be small and ultrasound sensitivity depends on the number of pathological compression manoeuvres documented in the ultrasound document. In contrast, distal or proximal thrombus location itself does not influence sensitivity.

摘要

背景

在无症状患者中,筛查超声对静脉血栓形成的准确性仍存在争议。VENUS 研究评估了中心审查的静脉超声对大型骨科手术后患者静脉造影的准确性,发现超声对近端和远端深静脉血栓形成(DVT)的敏感性均较差。

目的

评估血栓特征(如位置或大小)是否会影响中心审查的静脉超声的诊断性能。

方法

对 VENUS 研究中所有假阴性的超声图像与相应的静脉造影进行重新评估。将差异分为不同类型的诊断失败。在这些类别中,评估了血栓的位置、长度或大小等血栓特征。

结果

比较了 112 对不一致的超声和静脉造影文档与 28 对一致的文档。差异是由局部文档记录失败(37.5%)、超声方法失败(43.7%)和中心审查过程失败(18.7%)引起的。血栓的总体大小较小,这导致了约 40%的所有超声失败,检测阈值为 5 个 Marder 点,血栓长度为 9.5 厘米,病理压迫手法为 3.5 次。DVT 的近端或远端位置并不影响血栓检测。

结论

如果要在未来的 VTE 筛查试验中使用中心审查的超声,需要加强对当地超声医师和中心审查者的培训,因为无症状的 DVT 似乎较小,超声敏感性取决于超声文件中记录的病理压迫手法的数量。相比之下,远端或近端血栓位置本身并不影响敏感性。

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