PDF(Pubmed)
Abstract：
OBJECTIVE: To evaluate the accuracy of two portable ultrasound machines (PUM) in assessing fetal biometry and estimated gestational age (EGA).
METHODS: This was a secondary analysis of data from the Fetal Age Machine Learning Initiative, an observational study of pregnant women in the USA and Zambia. Each participant underwent ultrasound assessment by an experienced sonographer using both a high-specification ultrasound machine (HSUM) and a PUM (Butterfly iQ or Clarius C3) to measure fetal biometry and calculate EGA at each visit. By comparing paired PUM and HSUM scans, we estimated agreement between individual biometry measurements and aggregate gestational age estimates by reporting mean difference, intraclass correlation coefficient (ICC) and Bland-Altman plots, adjusting for trend.
RESULTS: Between April and December 2021, 818 participants contributed 1386 paired PUM-HSUM ultrasound investigations, of which 991 PUM scans were obtained using the Butterfly iQ device and 395 using the Clarius C3 device. Gestational age at scan ranged from 7 to 38 weeks. Compared with HSUM, the Butterfly iQ PUM had a mean difference of -0.20 (95% CI, -0.60 to 0.20) days in the first trimester and -0.68 (95% CI, -0.93 to -0.44) days in the second/third trimesters. Compared with HSUM, the Clarius C3 PUM had a mean difference of -0.47 (95% CI, -1.11 to 0.18) days in the first trimester and -1.67 (95% CI, -2.10 to -1.25) days in the second/third trimesters. ICCs were 0.989 or greater throughout. Increasing gestational age was associated with increasing error and absolute error in EGA and fetal biometry. Both PUM devices demonstrated a modest trend toward underestimation of EGA with advancing gestational age in second/third-trimester scans, compared with HSUM.
CONCLUSIONS: The Butterfly iQ and Clarius C3 PUM devices were highly accurate in performing fetal biometry in a diverse population from the USA and Zambia. © 2023 International Society of Ultrasound in Obstetrics and Gynecology.
METHODS: This was a secondary analysis of data from the Fetal Age Machine Learning Initiative, an observational study of pregnant women in the USA and Zambia. Each participant underwent ultrasound assessment by an experienced sonographer using both a high-specification ultrasound machine (HSUM) and a PUM (Butterfly iQ or Clarius C3) to measure fetal biometry and calculate EGA at each visit. By comparing paired PUM and HSUM scans, we estimated agreement between individual biometry measurements and aggregate gestational age estimates by reporting mean difference, intraclass correlation coefficient (ICC) and Bland-Altman plots, adjusting for trend.
RESULTS: Between April and December 2021, 818 participants contributed 1386 paired PUM-HSUM ultrasound investigations, of which 991 PUM scans were obtained using the Butterfly iQ device and 395 using the Clarius C3 device. Gestational age at scan ranged from 7 to 38 weeks. Compared with HSUM, the Butterfly iQ PUM had a mean difference of -0.20 (95% CI, -0.60 to 0.20) days in the first trimester and -0.68 (95% CI, -0.93 to -0.44) days in the second/third trimesters. Compared with HSUM, the Clarius C3 PUM had a mean difference of -0.47 (95% CI, -1.11 to 0.18) days in the first trimester and -1.67 (95% CI, -2.10 to -1.25) days in the second/third trimesters. ICCs were 0.989 or greater throughout. Increasing gestational age was associated with increasing error and absolute error in EGA and fetal biometry. Both PUM devices demonstrated a modest trend toward underestimation of EGA with advancing gestational age in second/third-trimester scans, compared with HSUM.
CONCLUSIONS: The Butterfly iQ and Clarius C3 PUM devices were highly accurate in performing fetal biometry in a diverse population from the USA and Zambia. © 2023 International Society of Ultrasound in Obstetrics and Gynecology.
摘要：
目的：我们评估了两种便携式超声仪（PUM）在获取胎儿生物特征和估计胎龄方面的准确性。
方法：我们分析了来自胎儿年龄机器学习计划的数据，一项针对美国和赞比亚孕妇的观察性研究。每位参与者均由经验丰富的超声医师使用高规格超声机（HSUM）和PUM（ButterflyiQ或ClariusC3）进行评估，以测量胎儿生物特征并计算每次访问时的估计胎龄（EGA）。通过配对PUM-HSUM扫描的比较，我们通过报告平均差异来估计个体生物测量值和总体胎龄估计之间的一致性，以及类内相关系数(ICC)和Bland-Altman地块，适应趋势。
结果：在2021年4月至12月间，881名参与者贡献了1386项配对PUM-HSUM超声研究。PUM研究包括991个蝴蝶和395个Clarius。扫描时的妊娠年龄为7至38周。与HSUM相比，ButterflyPUM在妊娠早期的平均差为-0.20天(95CI±0.40),在妊娠晚期的平均差为-0.68天(95CI±0.68)。与HSUM相比，ClariusPUM在妊娠早期的平均差异为0.47天(95CI±0.64),在妊娠晚期的平均差异为-1.67天(95CI±0.43)。整个ICC为0.989或更高。胎龄的增加与误差和绝对误差的增加有关。两种PUM设备在妊娠2/3个月扫描中都表现出适度的低估EGA的趋势，与HSUM相比。
结论：在来自美国和赞比亚的不同人群中，ButterflyiQ和ClariusC3PUM装置在进行胎儿生物测量方面都非常准确。本文受版权保护。保留所有权利。
方法：我们分析了来自胎儿年龄机器学习计划的数据，一项针对美国和赞比亚孕妇的观察性研究。每位参与者均由经验丰富的超声医师使用高规格超声机（HSUM）和PUM（ButterflyiQ或ClariusC3）进行评估，以测量胎儿生物特征并计算每次访问时的估计胎龄（EGA）。通过配对PUM-HSUM扫描的比较，我们通过报告平均差异来估计个体生物测量值和总体胎龄估计之间的一致性，以及类内相关系数(ICC)和Bland-Altman地块，适应趋势。
结果：在2021年4月至12月间，881名参与者贡献了1386项配对PUM-HSUM超声研究。PUM研究包括991个蝴蝶和395个Clarius。扫描时的妊娠年龄为7至38周。与HSUM相比，ButterflyPUM在妊娠早期的平均差为-0.20天(95CI±0.40),在妊娠晚期的平均差为-0.68天(95CI±0.68)。与HSUM相比，ClariusPUM在妊娠早期的平均差异为0.47天(95CI±0.64),在妊娠晚期的平均差异为-1.67天(95CI±0.43)。整个ICC为0.989或更高。胎龄的增加与误差和绝对误差的增加有关。两种PUM设备在妊娠2/3个月扫描中都表现出适度的低估EGA的趋势，与HSUM相比。
结论：在来自美国和赞比亚的不同人群中，ButterflyiQ和ClariusC3PUM装置在进行胎儿生物测量方面都非常准确。本文受版权保护。保留所有权利。
