Tivay Ali, Bighamian Ramin, Hahn Jin-Oh, Scully Christopher G
Mechanical Engineering, University of Maryland, College Park, MD 20742, USA.
Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20903 USA.
ASME Lett Dyn Syst Control. 2024 Aug 2;4(3). doi: 10.1115/1.4065934.
Physiological closed-loop control algorithms play an important role in the development of autonomous medical care systems, a promising area of research that has the potential to deliver healthcare therapies meeting each patient's specific needs. Computational approaches can support the evaluation of physiological closed-loop control algorithms considering various sources of patient variability that they may be presented with.
In this paper, we present a generative approach to testing the performance of physiological closed-loop control algorithms. This approach exploits a generative physiological model (which consists of stochastic and dynamic components that represent diverse physiological behaviors across a patient population) to generate a select group of virtual subjects. By testing a physiological closed-loop control algorithm against this select group, the approach estimates the distribution of relevant performance metrics in the represented population. We illustrate the promise of this approach by applying it to a practical case study on testing a closed-loop fluid resuscitation control algorithm designed for hemodynamic management.
In this context, we show that the proposed approach can test the algorithm against virtual subjects equipped with a wide range of plausible physiological characteristics and behavior, and that the test results can be used to estimate the distribution of relevant performance metrics in the represented population.
In sum, the generative testing approach may offer a practical, efficient solution for conducting pre-clinical tests on physiological closed-loop control algorithms.
生理闭环控制算法在自主医疗系统的发展中起着重要作用,自主医疗系统是一个很有前景的研究领域,有潜力提供满足每个患者特定需求的医疗疗法。计算方法可以支持对生理闭环控制算法的评估,同时考虑到算法可能面临的各种患者变异性来源。
在本文中,我们提出了一种生成式方法来测试生理闭环控制算法的性能。这种方法利用一个生成式生理模型(由随机和动态成分组成,代表患者群体中的各种生理行为)来生成一组选定的虚拟受试者。通过针对这组选定的受试者测试生理闭环控制算法,该方法估计所代表群体中相关性能指标的分布。我们通过将其应用于一个实际案例研究来测试一种为血流动力学管理设计的闭环液体复苏控制算法,来说明这种方法的前景。
在这种情况下,我们表明所提出的方法可以针对具有广泛合理生理特征和行为的虚拟受试者测试算法,并且测试结果可用于估计所代表群体中相关性能指标的分布。
总之,生成式测试方法可能为对生理闭环控制算法进行临床前测试提供一种实用、高效的解决方案。