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confidence - b单中心非随机临床试验

原文发布日期：2024-06-27

英文摘要：

摘要翻译：

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文章：

confidence - b单中心非随机临床试验

the CONFIDENT-B single-center, non-randomized clinical trial

原文发布日期：2024-06-27

英文摘要：

Pathologists’ assessment of sentinel lymph nodes (SNs) for breast cancer (BC) metastases is a treatment-guiding yet labor-intensive and costly task because of the performance of immunohistochemistry (IHC) in morphologically negative cases. This non-randomized, single-center clinical trial (International Standard Randomized Controlled Trial Number:14323711) assessed the efficacy of an artificial intelligence (AI)-assisted workflow for detecting BC metastases in SNs while maintaining diagnostic safety standards. From September 2022 to May 2023, 190 SN specimens were consecutively enrolled and allocated biweekly to the intervention arm (n = 100) or control arm (n = 90). In both arms, digital whole-slide images of hematoxylin–eosin sections of SN specimens were assessed by an expert pathologist, who was assisted by the ‘Metastasis Detection’ app (Visiopharm) in the intervention arm. Our primary endpoint showed a significantly reduced adjusted relative risk of IHC use (0.680, 95% confidence interval: 0.347–0.878) for AI-assisted pathologists, with subsequent cost savings of ~3,000 €. Secondary endpoints showed significant time reductions and up to 30% improved sensitivity for AI-assisted pathologists. This trial demonstrates the safety and potential for cost and time savings of AI assistance.

摘要翻译：

病理学家对乳腺癌转移性病灶中哨兵淋巴结(Sentinel lymph nodes, SNs)的评估，是一项治疗指导但因免疫组织化学(Impact histological chemistry, IHC)在形态学阴性病例中的操作而耗时费力且昂贵的任务。这项非随机、单中心临床试验(国际标准随机对照试验编号:14323711)旨在评估辅助人工智能(AI)流程对于SNs中乳腺癌转移检测的有效性，同时维持诊断安全标准。2022年9月至2023年5月，共连续纳入并按两周一次分配至干预组(n=100)或对照组(n=90)，总计入组190例SN标本。两组研究对象均使用Pathologist expert评估SN病灶的H&E切片数字全图谱，并借助Visiopharm的“转移检测”APP辅助的AI检测干预组。主要终点指标显示，辅助AI进行病理学检查的试验组显著降低了IHC使用调整后的相对风险值(0.680, 95%置信区间:0.347-0.878)，同时节省了约3000欧元成本。次要终点指标显示干预组在检测时间上和敏感性方面均有所改善，最高可提升30%。这项试验表明，AI辅助的检测流程不仅提升了安全性能，在成本时间和效率方面也具有很好的应用前景。