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甲状腺结节剪切波弹性成像的可重复性是否足以用于临床?一项方法学研究。

Is the reproducibility of shear wave elastography of thyroid nodules high enough for clinical use? A methodological study.

作者信息

Swan Kristine Zøylner, Nielsen Viveque Egsgaard, Bibby Bo Martin, Bonnema Steen Joop

机构信息

Department of Otorhinolaryngology and Head- and Neck Surgery, Aarhus University Hospital, Aarhus, Denmark.

Department of Biostatistics, Aarhus University, Aarhus, Denmark.

出版信息

Clin Endocrinol (Oxf). 2017 Apr;86(4):606-613. doi: 10.1111/cen.13295. Epub 2017 Jan 16.

Abstract

OBJECTIVE

To systematically assess the reproducibility of thyroid ultrasonographic shear wave elastography (SWE).

CONTEXT

SWE has been suggested as a potential tool for thyroid nodule evaluation, but assessment of its reproducibility has been insufficiently addressed.

DESIGN

SWE examinations were performed prospectively by two investigators.

PATIENTS

Seventy-two patients (male/female: 19/53; mean age: 53 ± 14 years; malignant/benign 17/55) undergoing thyroid surgery were enrolled in the study.

MEASUREMENTS

Repeated and blinded measurements of elasticity index (EI) in predefined regions of interest (ROI) were collected. The inter- and intrarater agreement, along with the day-to-day agreement, was evaluated in terms of the 95% limits of agreement (LOA). Results are presented as a ratio, by which 1·0 indicates perfect agreement.

RESULTS

The interrater, intrarater and day-to-day LOA showed ratios between repeated measurements of 1·7-3·6, 1·8-3·7 and 2·2-2·9, respectively. These values reflect a low to moderate degree of agreement for all EI outcomes. The interrater LOA was higher for malignant nodules compared with benign nodules for six of seven EI outcomes (P < 0·001-0·03). The proportion of agreement calculated from the optimum cutoff point for differentiating malignant from benign nodules was 63-88% for the investigated EI outcomes.

CONCLUSIONS

In this methodological study, EI measured by thyroid SWE seems suboptimal for clinical use, due to a low inter- and intrarater agreement. That EI varies from day to day furthermore jeopardizes the validity of the method. Although the proportion of agreement was acceptable for some EI parameters, it is questionable whether EI assessments can reliably differentiate malignant from benign nodules in the individual patient.

摘要

目的

系统评估甲状腺超声剪切波弹性成像(SWE)的可重复性。

背景

SWE已被认为是评估甲状腺结节的一种潜在工具,但对其可重复性的评估尚不充分。

设计

由两名研究人员前瞻性地进行SWE检查。

患者

72例接受甲状腺手术的患者(男/女:19/53;平均年龄:53±14岁;恶性/良性17/55)纳入本研究。

测量

收集在预定义感兴趣区域(ROI)中对弹性指数(EI)进行的重复和盲法测量数据。根据95%一致性界限(LOA)评估评分者间、评分者内一致性以及每日一致性。结果以比率形式呈现,1.0表示完全一致。

结果

评分者间、评分者内以及每日的LOA显示重复测量之间的比率分别为1.7 - 3.6、1.8 - 3.7和2.2 - 2.9。这些值反映了所有EI结果的一致性程度为低到中度。在七个EI结果中的六个结果中,恶性结节的评分者间LOA高于良性结节(P < 0.001 - 0.03)。对于所研究的EI结果,根据区分恶性与良性结节的最佳截断点计算出的一致性比例为63% - 88%。

结论

在本方法学研究中,由于评分者间和评分者内一致性较低,甲状腺SWE测量的EI似乎不适合临床应用。EI每日变化进一步损害了该方法的有效性。尽管某些EI参数的一致性比例可以接受,但EI评估能否在个体患者中可靠地区分恶性与良性结节仍值得怀疑。

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