Evaluation of Digital Breast Tomosynthesis as Replacement of Full-Field Digital Mammography Using an In Silico Imaging Trial
Evaluation of Digital Breast Tomosynthesis as Replacement of Full-Field Digital Mammography Using an In Silico Imaging Trial
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DOI：
10.1001/jamanetworkopen.2018.5474
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发表时间：
2018-11-01
影响因子：
13.8
通讯作者：
Myers, Kyle J.
中科院分区：
文献类型：
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作者：
Badano, Aldo;Graff, Christian G.;Myers, Kyle J.
我们使用大约25，000名ISIS同情者在Twitter上发布的超过190万条消息的数据集，探索ISIS如何利用社交媒体传播其宣传并从阿拉伯世界和地球仪招募武装分子。通过区分暴力驱动的，神学和宗派内容，我们跟踪网络言论和地面上的关键事件之间的联系。据我们所知，我们的研究是最早关注阿拉伯文内容的研究之一，而大多数文献都关注英文内容。我们的研究结果对激进激进组织如何利用社交媒体针对阿拉伯世界提供了新的重要见解，并揭示了他们宣传工作的重要模式。重要性昂贵而漫长的临床试验可能会延迟对创新技术的监管评估，影响患者获得高质量的医疗产品。模拟越来越多地用于产品开发，但很少用于监管应用。目的：进行计算机模拟成像试验，评估数字乳腺断层合成摄影（DBT）作为数字乳腺X射线摄影（DM）的替代品，并将结果与对照临床试验进行比较。用于监管评估的模拟虚拟成像临床试验（VICTRE）这项试验旨在复制一项使用人类患者和放射科医生的临床试验。通过快速Monte Carlo X射线传输使用计算机模拟版本的DM和DBT系统获得的图像由检测病变存在的计算读取器解释。使用分析方法生成了总计2986名基于合成图像的虚拟患者，其乳房尺寸和放射学密度代表筛选人群，压缩厚度为3.5至6 cm，其中解剖结构在预定义的乳房体积内随机创建，并在头尾方向压缩。一个阳性队列包含一个数字插入微钙化簇或毛刺mass.Main结果和措施试验终点是不同的受试者工作特征曲线下的病变检测模式。该试验的曲线下面积（AUC）变化的SE为0.01，是比较临床试验中不确定性的一半。结果在该试验中，计算读取器分析了来自2986名虚拟患者的31055例DM和27960例DBT病例，其乳腺成像报告和数据系统密度如下：286例（9.6%）为极致密，1200例（40.2%）为不均匀致密，1200例（40.2%）为散在纤维腺体密度，300例（10.0%）几乎全部为脂肪。AUC的平均（SE）变化为0.0587（0.0062）（P < .001），有利于DBT。肿块的AUC变化（平均值[SE]，0.0903 [0.0081]）大于钙化（平均值[SE]，0.0268 [0.004]），这与比较试验的结果（平均值[SE]）一致。0.065 [0.017]和-0.047 [0.032]钙化）。结论和相关性模拟VICTRE试验的结果与比较试验中观察到的性能一致。虽然需要进一步的研究来评估这些发现的普遍性，但计算机成像试验代表了成像设备监管证据的可行来源。
Using a dataset of over 1.9 million messages posted on Twitter by about 25,000 ISIS sympathizers, we explore how ISIS makes use of social media to spread its propaganda and recruit militants from the Arab world and across the globe. By distinguishing between violence-driven, theological, and sectarian content, we trace the connection between online rhetoric and key events on the ground. To the best of our knowledge, ours is one of the first studies to focus on Arabic content, while most literature focuses on English content. Our findings yield new important insights about how social media is used by radical militant groups to target the Arab-speaking world, and reveal important patterns in their propaganda efforts.IMPORTANCE Expensive and lengthy clinical trials can delay regulatory evaluation of innovative technologies, affecting patient access to high-quality medical products. Simulation is increasingly being used in product development but rarely in regulatory applications.OBJECTIVES To conduct a computer-simulated imaging trial evaluating digital breast tomosynthesis (DBT) as a replacement for digital mammography (DM) and to compare the results with a comparative clinical trial.DESIGN, SETTING, AND PARTICIPANTS The simulated Virtual Imaging Clinical Trial for Regulatory Evaluation (VICTRE) trial was designed to replicate a clinical trial that used human patients and radiologists. Images obtained with in silico versions of DM and DBT systems via fast Monte Carlo x-ray transport were interpreted by a computational reader detecting the presence of lesions. A total of 2986 synthetic image-based virtual patients with breast sizes and radiographic densities representative of a screening population and compressed thicknesses from 3.5 to 6 cm were generated using an analytic approach in which anatomical structures are randomly created within a predefined breast volume and compressed in the craniocaudal orientation. A positive cohort contained a digitally inserted microcalcification cluster or spiculated mass.MAIN OUTCOMES AND MEASURES The trial end point was the difference in area under the receiver operating characteristic curve between modalities for lesion detection. The trial was sized for an SE of 0.01 in the change in area under the curve (AUC), half the uncertainty in the comparative clinical trial.RESULTS In this trial, computational readers analyzed 31 055 DM and 27 960 DBT cases from 2986 virtual patients with the following Breast Imaging Reporting and Data System densities: 286 (9.6%) extremely dense, 1200 (40.2%) heterogeneously dense, 1200 (40.2%) scattered fibroglandular densities, and 300 (10.0%) almost entirely fat. The mean (SE) change in AUC was 0.0587 (0.0062) (P < .001) in favor of DBT. The change in AUC was larger for masses (mean [SE], 0.0903 [0.0081) than for calcifications (mean [SE], 0.0268 [0.004]), which was consistent with the findings of the comparative trial (mean [SE]. 0.065 [0.017] for masses and -0.047 [0.032] for calcifications).CONCLUSIONS AND RELEVANCE The results of the simulated VICTRE trial are consistent with the performance seen in the comparative trial. While further research is needed to assess the generalizability of these findings, in silico imaging trials represent a viable source of regulatory evidence for imaging devices.