Real-world Independent Testing of e-ASPECTS Software (RITeS): statistical analysis plan.
Real-world Independent Testing of e-ASPECTS Software (RITeS): statistical analysis plan.
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DOI：
10.12688/amrcopenres.12904.1
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发表时间：
2020-04-28
期刊：
影响因子：
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通讯作者：
Wardlaw JM
中科院分区：
文献类型：
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作者：
Mair G;Chappell F;Martin C;Dye D;Bath PM;Muir KW;von Kummer R;Al-Shahi Salman R;Sandercock PAG;Macleod M;Sprigg N;White P;Wardlaw JM
背景：基于人工智能的软件可以自动检测缺血性卒中病变并在CT上提供阿尔伯塔卒中计划早期CT评分（ASPECTS），识别动脉闭塞并在CTA上提供侧支评分。大规模的独立测试将为临床使用提供信息，但目前还缺乏。我们的目标是使用从一系列临床研究中获得的CT扫描来测试e-ASPECTS和e-CTA （Brainomix, Oxford UK）。方法：使用前瞻性收集的基线CT和CTA扫描，来自10个国家/国际临床卒中试验或注册中心（总计bbb6600例患者），我们将选择一个具有临床代表性的大样本来测试e-ASPECTS和e-CTA，并与之前获得的独立专家人类解释（参考标准）进行比较。我们的主要目的是测试软件衍生的和隐藏的人类专家方面之间的一致性，以及e-ASPECTS的诊断准确性，以识别中风症状的所有原因，使用随访成像和最终临床意见作为诊断的基础事实。我们的第二个目标是测试e-ASPECTS何时以及为什么更准确或更不准确，或成功/失败产生结果，e-CTA和人类专家CTA解释之间的一致性，以及e-ASPECTS/e-CTA结果的可重复性。所有测试将在意向分析的基础上进行。我们将评估软件和专家-人类评级之间的协议，并测试软件的诊断准确性。结论：RITeS将提供全面、稳健和具有代表性的e-ASPECTS和e-CTA测试，以对抗当前的金标准、专家-人类解释。
Background: Artificial intelligence-based software may automatically detect ischaemic stroke lesions and provide an Alberta Stroke Program Early CT score (ASPECTS) on CT, and identify arterial occlusion and provide a collateral score on CTA. Large-scale independent testing will inform clinical use, but is lacking. We aim to test e-ASPECTS and e-CTA (Brainomix, Oxford UK) using CT scans obtained from a range of clinical studies. Methods: Using prospectively collected baseline CT and CTA scans from 10 national/international clinical stroke trials or registries (total >6600 patients), we will select a large clinically representative sample for testing e-ASPECTS and e-CTA compared to previously acquired independent expert human interpretation (reference standard). Our primary aims are to test agreement between software-derived and masked human expert ASPECTS, and the diagnostic accuracy of e-ASPECTS for identifying all causes of stroke symptoms using follow-up imaging and final clinical opinion as diagnostic ground truth. Our secondary aims are to test when and why e-ASPECTS is more or less accurate, or succeeds/fails to produce results, agreement between e-CTA and human expert CTA interpretation, and repeatability of e-ASPECTS/e-CTA results. All testing will be conducted on an intention-to-analyse basis. We will assess agreement between software and expert-human ratings and test the diagnostic accuracy of software. Conclusions: RITeS will provide comprehensive, robust and representative testing of e-ASPECTS and e-CTA against the current gold-standard, expert-human interpretation.