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经阴道超声测量中孕期宫颈长度:一项前瞻性观察性一致性和可靠性研究。

Second trimester cervical length measurements with transvaginal ultrasound: A prospective observational agreement and reliability study.

机构信息

Center of Perinatal Medicine and Health, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg, Sweden.

Department of Obstetrics and Gynecology, Södra Älvsborg Hospital, Borås, Sweden.

出版信息

Acta Obstet Gynecol Scand. 2020 Nov;99(11):1476-1485. doi: 10.1111/aogs.13895. Epub 2020 May 21.

Abstract

INTRODUCTION

Universal screening for preterm delivery by adding transvaginal ultrasound measurement of cervical length to routine second trimester ultrasound has been proposed. The aim is to estimate inter- and intraobserver agreement and reliability of second trimester transvaginal ultrasound measurements of cervical length performed by specially trained midwife sonographers.

MATERIAL AND METHODS

This is a prospective reliability and agreement study performed in seven Swedish ultrasound centers. In total, 18 midwife sonographers specially trained to perform ultrasound measurements of cervical length and 286 women in the second trimester were included. In each center, two midwife sonographers measured cervical length a few minutes apart in the same woman, the number of women examined per examiner pair varying between 24 and 30 (LIVE study). Sixteen midwife sonographers measured cervical length twice ≥2 months apart on 93 video clips (CLIPS study). The main outcome measures were mean difference, limits of agreement, intraclass correlation coefficient, intra-individual standard deviation, repeatability, Cohen's kappa and Fleiss kappa.

RESULTS

The limits of agreement and intraclass correlation coefficient of the best examiner pair in the LIVE study were -4.06 to 4.72 mm and 0.91, and those of the poorest were -11.11 to 11.39 mm and 0.31. In the CLIPS study, median (range) intra-individual standard deviation was 2.14 mm (1.40-3.46), repeatability 5.93 mm (3.88-9.58), intraclass correlation coefficient 0.84 (0.66-0.94). Median (range) interobserver agreement for cervical length ≤25 mm in the CLIPS study was 94.6% (84.9%-98.9%) and Cohen's kappa 0.56 (0.12-0.92), median (range) intraobserver agreement was 95.2% (87.1%-98.9%) and Cohen's kappa 0.68 (0.27-0.93).

CONCLUSIONS

Agreement and reliability of cervical length measurements differed substantially between examiner pairs and examiners. If cervical length measurements are used to guide management there is potential for both over- and under-treatment. Uniform training and rigorous supervision and quality control are advised.

摘要

简介

通过在常规的第二次妊娠超声检查中加入经阴道超声测量宫颈长度,对早产进行普遍筛查已被提出。目的是评估经过专门培训的助产士超声医师在第二次妊娠期间进行的经阴道超声宫颈长度测量的观察者间和观察者内的一致性和可靠性。

材料和方法

这是一项在瑞典 7 个超声中心进行的前瞻性可靠性和一致性研究。共有 18 名经过专门培训以进行宫颈长度超声测量的助产士超声医师和 286 名处于第二次妊娠的女性参与。在每个中心,两名助产士超声医师在同一名女性中隔几分钟进行宫颈长度测量,每个检查者对的受检女性数量在 24 至 30 人之间不等(LIVE 研究)。16 名助产士超声医师在 93 个视频剪辑上两次≥2 个月间隔测量宫颈长度(CLIPS 研究)。主要观察指标为平均差异、一致性界限、组内相关系数、个体内标准差、重复性、Cohen's kappa 和 Fleiss kappa。

结果

LIVE 研究中最佳检查者对的一致性界限和组内相关系数为-4.06 至 4.72mm 和 0.91,最差的为-11.11 至 11.39mm 和 0.31。在 CLIPS 研究中,个体内标准差的中位数(范围)为 2.14mm(1.40-3.46),重复性为 5.93mm(3.88-9.58),组内相关系数为 0.84(0.66-0.94)。CLIPS 研究中宫颈长度≤25mm 的观察者间一致性的中位数(范围)为 94.6%(84.9%-98.9%)和 Cohen's kappa 为 0.56(0.12-0.92),观察者内一致性的中位数(范围)为 95.2%(87.1%-98.9%)和 Cohen's kappa 为 0.68(0.27-0.93)。

结论

宫颈长度测量的一致性和可靠性在检查者对之间和检查者之间存在显著差异。如果使用宫颈长度测量来指导管理,可能会出现过度治疗和治疗不足的情况。建议进行统一的培训,并进行严格的监督和质量控制。

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