Hassan Ameer E, Ravi Saisree, Desai Sohum, Saei Hamzah M, Mckennon Ermias, Tekle Wondwossen G
Department of Neurology, University of Texas Rio Grande Valley School of Medicine, Harlingen, TX, USA.
Department of Neuroscience, Valley Baptist Medical Center, Harlingen, TX, USA.
Interv Neuroradiol. 2023 Jun 22:15910199231184604. doi: 10.1177/15910199231184604.
EMBOLISE (NCT04402632) is an ongoing randomized controlled trial investigating the safety and efficacy of middle meningeal artery embolization for the treatment of subacute or chronic subdural hematoma (SDH). Viz RECRUIT SDH is an artificial intelligence (AI)-based software platform that can automatically detect SDH in noncontrast computed tomography (NCHCT) images and report the volume, maximum thickness, and midline shift. We hypothesized that the mobile recruitment platform would aid enrollment and coordinate communication and image sharing among the entire research team.
Patient enrollment in EMBOLISE prior to and after implementation of Viz RECRUIT SDH at a large comprehensive stroke center was compared along with the performance of the software platform. The EMBOLISE trial was activated on May 5, 2021, and Viz RECRUIT SDH was activated on October 6, 2021. The pre-AI cohort consisted of all patients from EMBOLISE to AI activation (153 days), and the post-AI cohort consisted of all patients from AI activation until August 18, 2022 (316 days). All alerts for suspected SDH candidates were manually reviewed to determine the positive predictive value (PPV) of the algorithm.
Prior to AI-software implementation, there were 5 patients enrolled (0.99 patients/month) and one screen failure. After the implementation of the software, enrollment increased by 36% to 1.35 patients/month (14 total enrolled), and there were no screen failures. Over the entire post-AI period, a total of 6244 NCHCTs were processed by the system with 207 total SDH detections (3% prevalence). 35% of all alerts for suspected SDH were viewed within 10 min, and 50% were viewed within an hour. The PPV of the algorithm was 81.4 (CI [75.3, 86.7]).
The implementation of an AI-based software for the automatic screening of SDH patients increased the enrollment rate in the EMBOLISE trial, and the software performed well in a real-world, clinical trial setting.
EMBOLISE（NCT04402632）是一项正在进行的随机对照试验，旨在研究脑膜中动脉栓塞术治疗亚急性或慢性硬膜下血肿（SDH）的安全性和有效性。Viz RECRUIT SDH是一个基于人工智能（AI）的软件平台，它可以在非增强计算机断层扫描（NCHCT）图像中自动检测SDH，并报告其体积、最大厚度和中线移位情况。我们假设这个移动招募平台将有助于招募患者，并协调整个研究团队之间的沟通和图像共享。
比较了在一家大型综合卒中中心实施Viz RECRUIT SDH前后EMBOLISE试验的患者招募情况以及该软件平台的性能。EMBOLISE试验于2021年5月5日启动，Viz RECRUIT SDH于2021年10月6日启动。人工智能前队列包括从EMBOLISE试验开始到人工智能激活（153天）的所有患者，人工智能后队列包括从人工智能激活到2022年8月18日（316天）的所有患者。对所有疑似SDH候选患者的警报进行人工审核，以确定该算法的阳性预测值（PPV）。
在实施人工智能软件之前，招募了5名患者（0.99名患者/月），有1次筛选失败。软件实施后，招募人数增加了36%，达到1.35名患者/月（共招募14名），且没有筛选失败的情况。在整个人工智能后阶段，系统共处理了6244份NCHCT，共检测到207例SDH（患病率为3%）。所有疑似SDH警报中有35%在10分钟内被查看，50%在1小时内被查看。该算法的PPV为81.4（CI [75.3, 86.7]）。
实施用于自动筛选SDH患者的基于人工智能的软件提高了EMBOLISE试验的招募率，并且该软件在真实世界的临床试验环境中表现良好。
