Skendi Mariela, Liard Roxane, Besacier Charlotte, Correas Jean-Michel, Moussaoui Sohela, Chastang Julie, Ibanez Gladys
Department of General Practice, Faculty of Medicine, Sorbonne University Paris France.
Department of Adult Radiology, Necker Hospital Paris France.
POCUS J. 2022 Nov 21;7(2):225-231. doi: 10.24908/pocus.v7i2.15458. eCollection 2022.
The main objective of this study is the evaluation of the accuracy and reliability of a handheld point of care ultrasound device (POCUS-hd) for intrauterine pregnancy (IUP) detection compared to comprehensive reference transabdominal ultrasound (TU). The secondary objectives were to evaluate POCUS-hd for intrauterine pregnancy (IUP) detection compared to transabdominal and transvaginal ultrasound (TUTV), evaluate the inter-device agreement and inter-rater reliability of gestational age during early pregnancy. It is an observational transverse study with consecutive patient recruitment. Two blinded operators systematically used POCUS-hd and reference transabdominal ultrasound for IUP diagnosis. The accuracy of POCUS-hd for IUP diagnosis was expressed as sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV). The gestational age (GA) was assessed based on the crown-rump length. The reliability and agreement of gestational age evaluation were assessed by Bland-Altman plots, kappa statistic, and intraclass correlation coefficients (ICC). POCUS-hd compared to TU had a sensitivity of 95-100%, a specifcity of 90-100%, PPV of 95-100% and NPV of 90-100%. Inter-rater agreement for IUP detection using POCUS-hd was very good, kappa=1.0; CI95% [0.9-1.0]. The inter-device agreement limits (mean difference ± 2SD) for GA were: -3 to +2.3 days by Operator 1, -3.4 to +3.3 days by Operator 2 for POCUS-hd vs. TU and -3.1 to +2.3 days for POCUS-hd versus TUTV. This handheld POCUS device is an accurate and reliable diagnostic tool that can be used for IUP positive findings and GA assessment during early pregnancy by clinicians in family planning settings or general practice.
本研究的主要目的是评估一种手持式即时超声设备（POCUS-hd）用于检测宫内妊娠（IUP）的准确性和可靠性，并与全面的经腹超声（TU）进行比较。次要目的是将POCUS-hd用于检测宫内妊娠（IUP）并与经腹和经阴道超声（TUTV）进行比较，评估早孕期间不同设备之间对胎龄的一致性以及不同评估者之间的可靠性。这是一项采用连续患者招募的观察性横断面研究。两名盲法操作者系统地使用POCUS-hd和参考经腹超声进行IUP诊断。POCUS-hd用于IUP诊断的准确性用灵敏度、特异度、阴性预测值（NPV）和阳性预测值（PPV）表示。根据头臀长度评估胎龄（GA）。通过Bland-Altman图、kappa统计量和组内相关系数（ICC）评估胎龄评估的可靠性和一致性。与TU相比，POCUS-hd的灵敏度为95 - 100%，特异度为90 - 100%，PPV为95 - 100%，NPV为90 - 100%。使用POCUS-hd进行IUP检测的评估者间一致性非常好，kappa = 1.0；95%置信区间[0.9 - 1.0]。POCUS-hd与TU相比，GA的设备间一致性界限（平均差异±2SD）为：操作者1为 - 3至 + 2.3天，操作者2为 - 3.4至 + 3.3天；POCUS-hd与TUTV相比为 - 3.1至 + 2.3天。这种手持式POCUS设备是一种准确可靠的诊断工具，可供计划生育机构或普通诊所的临床医生在早孕期间用于IUP阳性结果的检测和GA评估。
