A multicenter, hospital-based and non-inferiority study for diagnostic efficacy of automated whole breast ultrasound for breast cancer in China

Abstract This study is the first multi-center non-inferiority study that aims to critically evaluate the effectiveness of HHUS/ABUS in China breast cancer detection. This was a multicenter hospital-based study. Five hospitals participated in this study. Women (30–69 years old) with defined criteria...

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Autores principales:	Yujing Xin, Xinyuan Zhang, Yi Yang, Yi Chen, Yanan Wang, Xiang Zhou, Youlin Qiao
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/1342a74c313842c68f85a5a9562e1a45
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spelling	oai:doaj.org-article:1342a74c313842c68f85a5a9562e1a452021-12-02T15:39:50ZA multicenter, hospital-based and non-inferiority study for diagnostic efficacy of automated whole breast ultrasound for breast cancer in China10.1038/s41598-021-93350-12045-2322https://doaj.org/article/1342a74c313842c68f85a5a9562e1a452021-07-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-93350-1https://doaj.org/toc/2045-2322Abstract This study is the first multi-center non-inferiority study that aims to critically evaluate the effectiveness of HHUS/ABUS in China breast cancer detection. This was a multicenter hospital-based study. Five hospitals participated in this study. Women (30–69 years old) with defined criteria were invited for breast examination by HHUS, ABUS or/and mammography. For BI-RADS category 3, an additional magnetic resonance imaging (MRI) test was provided to distinguish the true negative results from false negative results. For women classified as BI-RADS category 4 or 5, either core aspiration biopsy or surgical biopsy was done to confirm the diagnosis. Between February 2016 and March 2017, 2844 women signed the informed consent form, and 1947 of them involved in final analysis (680 were 30 to 39 years old, 1267 were 40 to 69 years old).For all participants, ABUS sensitivity (91.81%) compared with HHUS sensitivity (94.70%) with non-inferior Z tests, P = 0.015. In the 40–69 age group, non-inferior Z tests showed that ABUS sensitivity (93.01%) was non-inferior to MG sensitivity (86.02%) with P < 0.001 and HHUS sensitivity (95.44%) was non-inferior to MG sensitivity (86.02%) with P < 0.001. Sensitivity of ABUS and HHUS are all superior to that of MG with P < 0.001 by superior test.For all participants, ABUS specificity (92.89%) was non-inferior to HHUS specificity (89.36%) with P < 0.001. Superiority test show that specificity of ABUS was superior to that of HHUS with P < 0.001. In the 40–69 age group, ABUS specificity (92.86%) was non-inferior to MG specificity (91.68%) with P < 0.001 and HHUS specificity (89.55%) was non-inferior to MG specificity (91.68%) with P < 0.001. ABUS is not superior to MG with P = 0.114 by superior test. The sensitivity of ABUS/HHUS is superior to that of MG. The specificity of ABUS/HHUS is non-inferior to that of MG. In China, for an experienced US radiologist, both HHUS and ABUS have better diagnostic efficacy than MG in symptomatic individuals.Yujing XinXinyuan ZhangYi YangYi ChenYanan WangXiang ZhouYoulin QiaoNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Yujing Xin Xinyuan Zhang Yi Yang Yi Chen Yanan Wang Xiang Zhou Youlin Qiao A multicenter, hospital-based and non-inferiority study for diagnostic efficacy of automated whole breast ultrasound for breast cancer in China
description	Abstract This study is the first multi-center non-inferiority study that aims to critically evaluate the effectiveness of HHUS/ABUS in China breast cancer detection. This was a multicenter hospital-based study. Five hospitals participated in this study. Women (30–69 years old) with defined criteria were invited for breast examination by HHUS, ABUS or/and mammography. For BI-RADS category 3, an additional magnetic resonance imaging (MRI) test was provided to distinguish the true negative results from false negative results. For women classified as BI-RADS category 4 or 5, either core aspiration biopsy or surgical biopsy was done to confirm the diagnosis. Between February 2016 and March 2017, 2844 women signed the informed consent form, and 1947 of them involved in final analysis (680 were 30 to 39 years old, 1267 were 40 to 69 years old).For all participants, ABUS sensitivity (91.81%) compared with HHUS sensitivity (94.70%) with non-inferior Z tests, P = 0.015. In the 40–69 age group, non-inferior Z tests showed that ABUS sensitivity (93.01%) was non-inferior to MG sensitivity (86.02%) with P < 0.001 and HHUS sensitivity (95.44%) was non-inferior to MG sensitivity (86.02%) with P < 0.001. Sensitivity of ABUS and HHUS are all superior to that of MG with P < 0.001 by superior test.For all participants, ABUS specificity (92.89%) was non-inferior to HHUS specificity (89.36%) with P < 0.001. Superiority test show that specificity of ABUS was superior to that of HHUS with P < 0.001. In the 40–69 age group, ABUS specificity (92.86%) was non-inferior to MG specificity (91.68%) with P < 0.001 and HHUS specificity (89.55%) was non-inferior to MG specificity (91.68%) with P < 0.001. ABUS is not superior to MG with P = 0.114 by superior test. The sensitivity of ABUS/HHUS is superior to that of MG. The specificity of ABUS/HHUS is non-inferior to that of MG. In China, for an experienced US radiologist, both HHUS and ABUS have better diagnostic efficacy than MG in symptomatic individuals.
format	article
author	Yujing Xin Xinyuan Zhang Yi Yang Yi Chen Yanan Wang Xiang Zhou Youlin Qiao
author_facet	Yujing Xin Xinyuan Zhang Yi Yang Yi Chen Yanan Wang Xiang Zhou Youlin Qiao
author_sort	Yujing Xin
title	A multicenter, hospital-based and non-inferiority study for diagnostic efficacy of automated whole breast ultrasound for breast cancer in China
title_short	A multicenter, hospital-based and non-inferiority study for diagnostic efficacy of automated whole breast ultrasound for breast cancer in China
title_full	A multicenter, hospital-based and non-inferiority study for diagnostic efficacy of automated whole breast ultrasound for breast cancer in China
title_fullStr	A multicenter, hospital-based and non-inferiority study for diagnostic efficacy of automated whole breast ultrasound for breast cancer in China
title_full_unstemmed	A multicenter, hospital-based and non-inferiority study for diagnostic efficacy of automated whole breast ultrasound for breast cancer in China
title_sort	multicenter, hospital-based and non-inferiority study for diagnostic efficacy of automated whole breast ultrasound for breast cancer in china
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/1342a74c313842c68f85a5a9562e1a45
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A multicenter, hospital-based and non-inferiority study for diagnostic efficacy of automated whole breast ultrasound for breast cancer in China

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