Cited by 44Healthcare Technology and Patient MonitoringSimulation-Based Education in HealthcareModeling and Simulation Systems

Credibility Evidence for Computational Patient Models Used in the Development of Physiological Closed-Loop Controlled Devices for Critical Care Medicine

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Parvinian, Bahram, Pathmanathan, Pras, Daluwatte, Chathuri, Yaghouby, Farid, Gray, Richard A., Weininger, Sandy, Morrison, Tina M., Scully, Christopher G.·2019·Frontiers in Physiology

Abstract

Physiological closed-loop controlled medical devices automatically adjust therapy delivered to a patient to adjust a measured physiological variable. In critical care scenarios, these types of devices could automate, for example, fluid resuscitation, drug delivery, mechanical ventilation, and/or anesthesia and sedation. Evidence from simulations using computational models of physiological systems can play a crucial role in the development of physiological closed-loop controlled devices; but the utility of this evidence will depend on the credibility of the computational model used. Computational models of physiological systems can be complex with numerous non-linearities, time-varying properties, and unknown parameters, which leads to challenges in model assessment. Given the wide range of potential uses of computational patient models in the design and evaluation of physiological closed-loop controlled systems, and the varying risks associated with the diverse uses, the specific model as well as the necessary evidence to make a model credible for a use case may vary. In this review, we examine the various uses of computational patient models in the design and evaluation of critical care physiological closed-loop controlled systems (e.g., hemodynamic stability, mechanical ventilation, anesthetic delivery) as well as the types of evidence (e.g., verification, validation, and uncertainty quantification activities) presented to support the model for that use. We then examine and discuss how a credibility assessment framework (American Society of Mechanical Engineers Verification and Validation Subcommittee, V&V 40 Verification and Validation in Computational Modeling of Medical Devices) for medical devices can be applied to computational patient models used to test physiological closed-loop controlled systems.

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  1. Kharisov E. Beck C. L. Bloom M. (2012). “ Control of patient response to anesthesia using L1 adaptive methods,” in Proceedings of the 8th Annual IFAC Symposium on Biological and Medical Systems, Budapest.

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Authors
Parvinian, B., Pathmanathan, P., Daluwatte, C., Yaghouby, F., Gray, R. A., Weininger, S., Morrison, T. M., & Scully, C. G.
Affiliations
United States Food and Drug Administration (US)
Corresponding author
Parvinian, Bahram
Venue
Frontiers in Physiology
Published
2019-03-26
Volume
10
Pages
220-220
ISSN
1664-042X (ISSN-L)
OpenAlex
W2922820107
Cited by
44
References
106
Citations by year
2025: 3 · 2024: 7 · 2023: 4 · 2022: 8 · 2021: 9 · 2020: 8 · 2019: 5
FWCI
1.55
Type
journal article
Language
en
Open access
Locations
  • Frontiers in Physiology (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
  • U.S. Department of Energy
  • U.S. Food and Drug Administration
  • Oak Ridge Institute for Science and Education
Topics
  • Health Sciences › Medicine › Surgery › Healthcare Technology and Patient Monitoring
  • Health Sciences › Medicine › Physiology › Simulation-Based Education in Healthcare
  • Physical Sciences › Computer Science › Computational Theory and Mathematics › Modeling and Simulation Systems
Keywords
intensive care, model credibility, verification and validation, uncertainty quantification, hemodynamic stability, mechanical ventilation, anesthetic delivery, fluid resuscitation, medical device development

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